the Document - Alliance for Safe Online Pharmacies

 The Alliance for Safe Online Pharmacies' Response to the U.S. Intellectual Property Enforcement Coordinator's Request for Public Comment on the Development of the Joint Strategic Plan on Intellectual Property Enforcement August 2012 TABLE OF CONTENTS ASOP Response to June 2012 IPEC Request for Comments………….……………………………..Page 3 ‐ 10 ASOP Response to March 2010 IPEC Request for Comments …………………………………....Appendix A National Association of Boards of Pharmacy Letter to Secretary Sebelius, Secretary of the US Department of Health and Human Services…….…………..................Appendix B National Association of Boards of Pharmacy gTLD Flier.................................................Appendix C ASOP's Facts Database……………………………………...………………………………………..………..…..Appendix D Page 2 of 10
The Alliance for Safe Online Pharmacies' Response to the U.S. Intellectual Property Enforcement Coordinator's Request for Public Comment on the Development of the Joint Strategic Plan on Intellectual Property Enforcement INTRODUCTION The Alliance for Safe Online Pharmacies (“ASOP”) seeks to protect patient safety and ensure patient access to safe and legitimate online pharmacies that comply with applicable laws. ASOP’s membership includes the American Pharmacists Association, Eli Lilly and Company, Enforce the Act, the European Alliance for Access to Safe Medicines, the International Pharmaceutical Federation, LegitScript, Men's Health Network, the National Association of Chain Drug Stores, NeedyMeds, the Partnership at Drug‐Free.org, and Takeda Pharmaceuticals. We believe that patients deserve the right to enjoy the convenience of the Internet and access safe and legitimate websites to receive their medicines. Despite the existence of many safe online pharmacies which do adhere to safety standards, the nature of the Internet has opened the door to thousands of criminal (aka “rogue”) Internet sites posing as legitimate pharmacies and selling potentially unsafe medicines. The result: patients are just one click away from purchasing medicine that could have a dangerous or fatal consequence. ASOP appreciates the opportunity to provide comments to the Intellectual Property Enforcement Coordinator (IPEC) on the development of a new Joint Strategic Plan on intellectual property enforcement. The inaugural Joint Strategic Plan, issued in 2010, recognized the problem of online counterfeit medicine sales, and called for a coordinated response from the U.S. Government and voluntary action from the private sector. See IPEC Joint Strategic Plan 2010, pg. 13 "Establishment of a Counterfeit Pharmaceutical Interagency." ASOP continues to strongly support those objectives. As discussed in ASOP’s response to the 2010 request for comments on the inaugural Joint Strategic Plan (attached as Appendix A), the Internet is a positive source of information, freedom of expression, and commerce. However, the rise in Internet access combined with the demand for prescription drugs, low barriers to market entry for online storefronts, an increasingly global pharmaceutical supply chain, and the difficulties of enforcement has led to a proliferation of illegal online drug sellers peddling counterfeit and otherwise illegitimate medications. See Appendix A, pg. 2‐3. Since ASOP submitted comments in 2010, both the government and the private sector have taken meaningful action to address illegal online drug sellers, including (in chronological order):  Google, followed by Yahoo! and Bing, adopted advertising policies to allow only online pharmacy websites accredited by National Association of Boards of Pharmacy (NABP) to appear in sponsored links; Page 3 of 10
 The Obama Administration targeted the problem of illegal online drug sellers in the IPEC 2010 Joint Strategic Plan;  Eleven Internet commerce companies agreed to form a nonprofit organization to address the problem of illegal online drug sellers, now called the Center for Safe Internet Pharmacies (CSIP);  NABP applied to the Internet Corporation for Assigned Names and Numbers (ICANN) for a “.pharmacy” generic top‐level domain (gTLD) with support from ASOP and other stakeholders;  Bipartisan legislation (S. 2002/H.R. 4095) was introduced in the Senate and House, aimed at curbing illegal online drug sellers and providing new tools for consumers, law enforcement, and the Internet ecosystem;  President Obama and G‐8 leaders committed to do more to combat illegal online drug sellers;  A mandatory Government Accountability Office (GAO) report on the problem of illegal online drug sellers and solutions was included in the Food and Drug Administration Safety and Innovation Act signed by President Obama on July 9, 2012 (also known as PDUFA V);  CSIP collaborated with ASOP on public messages and unveiled plans for a national consumer campaign; and  ASOP EU has been formed with both public health and Internet ecosystem stakeholders concerned for EU patients. DISCUSSION ASOP’s submission provides (1) strategic recommendations in response to threats to public health and safety, and (2) public safety information regarding illegal online drug sellers and the online sale of counterfeit medicines. IPEC is encouraged to reference ASOP's March 2010 comments for elaborate background information on referenced issues (attached as Appendix A). I. Strategic Recommendations in Response to Threats to Public Health and Safety A. Encourage Voluntary Actions and Seek Tangible Outcomes from CSIP and Other Internet Stakeholders B. Support Updating of Laws and Regulations, including the Federal Food Drug and Cosmetics Act C. Foster Improved International Cooperation D. Develop Robust Consumer Education Efforts E. Encourage Cooperation Between Customs and Border Patrol and the Food and Drug Administration on Destruction Authority II. Information on Public Safety Threats Page 4 of 10
I. Strategic Recommendations in Response to Threats to Public Health and Safety A. Encourage Voluntary Actions and Seek Tangible Outcomes from CSIP and Other Internet Stakeholders Internet commerce companies can, and ASOP believes should, play a critical role in combating the growing epidemic of illegal online drug sellers. Recognizing this, eleven such companies ‐‐
including American Express, Discover, enom, Go Daddy, Google, MasterCard, Microsoft, Neustar, PayPal, Visa, and Yahoo! ‐‐ established CSIP with the mission to promote and encourage safe online pharmacies through education, enforcement, and information sharing. On July 23, 2012, CSIP publically embarked upon this work by announcing that the nonprofit has developed the functional infrastructure to facilitate the sharing of information about suspect online pharmacy websites amongst its members, unveiling plans to collaborate with the U.S. Food and Drug Administration (FDA), ASOP, and others on a national public safety education campaign, and committing to work with FDA on Operation Pangea, an international law enforcement initiative to identify and address illegal online drug sellers. We applaud these commitments from CSIP, and anxiously await the outcomes of their plans. But the private sector’s involvement in protecting the public health from Internet criminals should not end there. We urge IPEC to maintain consistent dialogue with CSIP and other Internet commerce companies to:  Reiterate the Administration's commitment to combating illegal online drug sellers and encouraging voluntary action from private sector stakeholders consistent with IPEC's 2010 Annual Report (2010 U.S. Intellectual Property Enforcement Coordinator Annual Report on Intellectual Property Enforcement pg. 28);  Emphasize the importance of tangible outcomes with a focus on metrics, so implemented private sector solutions may be effectively analyzed;  Support and facilitate the adoption and sharing of best practices, including the voluntary private sector policies and initiatives, that enhance consumer safety against illegal online drug sellers, with the goal of creating tools and a replicable model for other corporations and key stakeholders, both in the U.S. and in other countries; and  Encourage federal agencies – including but not limited to FDA, Department of Homeland Security (DHS), Department of Commerce (DOC), Department of State (DOS), Customs and Border Protection (CBP) and Immigration and Customs Enforcement (ICE) – to support and proactively capitalize upon voluntary private sector cooperation and initiatives in order to enhance protection to the consumer. B. Support Updating of Laws and Regulations, including the Federal Food Drug and Cosmetic Act Page 5 of 10
As IPEC recognized in the March 2011 IPEC Legislative Recommendations, updating appropriate laws and regulations, including the Federal Food Drug and Cosmetic Act (FFDCA), may be necessary to ensure an open and free Internet, while also protecting patient safety in the age of the Internet. One important legislative recommendation you made in 2011 is the need to establish a clear minimum standard for the prescribing of prescription drugs on the Internet, as this would give federal law enforcement a necessary tool to fight some of the most common and prevalent illegal online drug sellers. ASOP agrees. We strongly support the establishment of a definition of "valid prescription" in the FFDCA, similar to the requirement in the Controlled Substances Act added to federal law under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110–425). This is a simple but important update. Updating the FFDCA would harmonize federal law, and provide federal law enforcement with enhanced abilities to prosecute illegal online drug sellers who peddle either controlled or non‐controlled prescription medications. We thank IPEC for making this legislative recommendation a priority in 2011 and urge the Administration to continue to press for this needed reform. The FFDCA was enacted in 1938, prior to the commercialization and wide‐spread use of the Internet. It is time the FDA regulatory framework is updated to reflect the new reality of an Internet‐savvy society and a growing use of the Internet by consumers as well as sophisticated online criminals. C. Foster International Cooperation From the exponential global expansion of high‐speed access to the role played by social media in various international movements, there is no denying the power and influence of the Internet on globalization and the interconnectedness of society. There is also no denying the transnational, interconnected nature of the criminals behind the counterfeit drug trade and their use of the Internet to achieve anonymity and escape legal repercussions. In the near, mid and long‐term, the ability to protect U.S. consumers from counterfeit medicines and illegal online drug sellers will be as dependent on strong domestic policies as it is on improved global cooperation to align strategies and harmonize international efforts. The G‐8 clearly recognized the importance of this reality when they announced the intention to cooperate to combat counterfeit medicines and share information on rogue sites selling counterfeit drugs. We encourage IPEC to build upon the G‐8 communiqué and adopt a broad international focus that will help to ensure concrete outcomes and consistent progress in cooperation to combat illegal online drug sellers. To promote such harmonization, we recommend IPEC focus on international cooperation, specifically:  Government to Government Cooperation o Demonstrate measurable U.S. successes that can serve as model for foreign governments and foster cooperation; o Collaborate directly with the European Union to capitalize on shared goals and develop novel strategies; Page 6 of 10
o Coordinate bilateral and multilateral cooperation between law enforcement agencies in order to take down illegitimate websites and successfully prosecute criminal actors. This cooperation should include operations like Pangea, as well as bilateral cooperation with countries that have identified drug safety as a priority, including in the European Union and Japan, where falsified medicines sold on the Internet have been identified as a priority, as well as leveraging new areas for cooperation with countries like the People’s Republic of China, where targeting the counterfeit drug trade has now been elevated as a top priority by the State Council as part of their 2012 National Drug Safety Plan; o Establish Memorandums of Understanding on policies regarding counterfeit medicine being sold over the Internet; and o Maintain the commitment made at the "G‐8 Conference" to exchange information on rogue Internet pharmacy websites and share best practices on combating counterfeit medicine through tangible next steps. 
Private/Public Sector Cooperation o Facilitate and encourage the sharing of information and best practices; o Develop a mechanism to enable public/private partnerships to advance consumer safety and explore a partnership with CSIP, ASOP, and others to conduct studies or collect data that would help inform new policies and education for the public and health care professionals; and o Partner with national and state medical boards to provide information to licensed prescribers, in order to educate prescribers regarding the dangers of illegal online rouge sellers posing as legitimate pharmacies. Additionally, provide education showing the benefits of prescribers engaging patients about the source of their medicines as part of other routine questions/discussions. D. Develop Robust Consumer Education Efforts Illegal online drug sellers frequently use sophisticated web‐design and deceptive advertisements to promote a false sense of security amongst consumers in order to prey on their misplaced trust. A cornerstone of the Administration’s work should continue to be the coordination of law enforcement efforts targeting the criminals behind these sites, in addition to the role of choke‐points in preventing the abuse of the Internet with illegal activity. However, it is also critical that the Administration play a role in efforts to educate consumers about the quantity of sites that are illegitimate. Direct consumer education ought to be a significant element of the Administration’s strategy for protecting individuals who purchase medicines online. ASOP encourages IPEC to promote and actively engage educational Page 7 of 10
initiatives in the following manner:  Develop a public registry of legitimate online pharmacy websites for use as a tool in education and enforcement efforts. In order to be meaningful and useful, any consumer education campaign regarding safely purchasing medications online must inform consumers about how they can purchase their medicines on the Internet without undue risk to their safety, and therefore should direct them to a list of legitimate online pharmacy websites. Unlike other rogue sites that sell unsafe or counterfeit products, fake online drug sellers can be compared against a finite list of registered pharmacies that are licensed by law to sell and dispense drugs in the United States. The value of the laws, regulations, and standards put in place to protect patients and oversee drug dispensing in the United States is that it creates a tool for preventing unlicensed, unregistered, and illegitimate drug sellers. As articulated in a letter from NABP to the Department of Health and Human Services (attached as Appendix B), a registry of this type would be a publically available list of all online pharmacy websites that meet defined safety standards in compliance with U.S. Federal and State laws. The goal of its creation would be to provide a resource for private sector actors and consumers who deserve this kind of tool to help them distinguish between legitimate and illegitimate online pharmacy websites.  Promote NABP's ".pharmacy" initiative.1 As described in NABP's educational brochure (attached as Appendix C), where today it is common to see, amongst a few others, .com and .org URL suffixes, soon the Internet may have more than a thousand new generic top level domains. In January 2012, applications were submitted to ICANN for new, industry specific gTLDs, such as .legal, .hotel, and even .pharmacy. NABP applied for the rights to .pharmacy to keep this gTLD out of the hands of rogue actors and instead develop it as a new consumer tool. NABP’s application specifies that only legitimate Internet pharmacies meeting certain regulatory standards will be allowed to operate a .pharmacy website. The goal is that consumers will use .pharmacy as method to confirm whether they are dealing with a legitimate Internet pharmacy by simply looking to the right of the dot of a website address.  Create U.S. Government campaigns in order to educate consumers about how to purchase medications safely online, and about the serious personal health and financial identify theft risks associated with the proliferation of illegal online drug sellers. 1
Current stakeholders that support this initiative include the Alliance for Safe Online Pharmacies, Amgen Inc., British Brands Group, Boehringer Ingelheim, Drugdepot.com, DrugSource, Inc., Eli Lilly and Company, Enforce The Act, the European Alliance for Access to Safe Medicines, the International Pharmaceutical Federation, Gilead, Ipsen Pharma, Janssen Therapeutics, the North Dakota State Board of Pharmacy, Novo Nordisk, Inc., Rx Direct, Inc., Sanofi, the Indiana Board of Pharmacy, and the National Association of Pharmacy Regulator Authorities. Page 8 of 10
E. Encourage Cooperation Between Customs and Border Patrol and the Food and Drug Administration on Destruction Authority ASOP encourages IPEC to continue to facilitate collaboration between FDA and Customs and Border Protection in order to increase the seizures and appropriate destruction of illegal/counterfeit medical products, including those purchased via the Internet from illegitimate sources. Coordinated multi‐agency efforts have been successful and even better coordination can help to increase the number of seizures, enhance data about the threat, and maximize consumer safety. II. Information on Public Safety Threats Collecting real life stories of patients harmed by prescription drugs sold online is challenging because collecting data from patients and caretakers is difficult, either for privacy or legal reasons, or because individuals are reluctant or afraid to disclose details about the incident. Indeed, patients may be worried about legal repercussions, embarrassed about their decision to go online, the medicines they purchased, or their medical condition. Additionally, they may not know or remember which online drug seller they patronized, or they may have already consumed or thrown away the medicine/packaging, making it difficult to test and evaluate the product after an adverse reaction. As is true for many medical issues, showing direct causation of harm from medication purchased from an online drug seller is time‐intensive, costly, and is not likely to be part of the patient’s treatment plan. In addition, a counterfeit prescription drug that is a placebo or sub‐potent dosage may not elicit the patient’s or provider’s attention; instead the medicine may merely be deemed to not work for a specific patient, resulting in a lack of treatment, with no signal other than symptoms related to the actual medical condition. As a result, there is a limited ability to access and quantify patient stories or adverse event reports, despite what may be a rampant public health impact. ASOP has compiled a list of published stories regarding patient harms from medications purchased from illegal online drug sellers. Please see Appendix D for this list. Conclusion The pervasive threat of illegal online drug sellers cannot be reduced without the collective and cooperative efforts of both the public and private sectors. IPEC has played a pivotal role in developing a strategy to enhance such efforts already, and ASOP believes this has a significant impact on global public health, far surpassing intellectual property enforcement. Though criminal networks often reap significant profit from the anonymous, online sale of counterfeit versions of medicines protected by IP rights, these profits fuel much larger criminal networks and operations that create counterfeit versions of generic medicines as well, including antibiotics, antimalarials, and vaccines. The counterfeit drug trade is not limited to branded medicines. The sales and profit of the fake online drug sellers result in the proliferation of these sites, criminals, and distribution chains, creating a greater global supply of fake medical products. These are crimes against global public health that require innovative thinking and Page 9 of 10
policies on the part of all nations. ASOP looks forward to working with the Administration on these recommendations in vigorous pursuit of protecting patients globally and their access to safe and legal medications. Page 10 of 10
APPENDIX A
March 24, 2010
Response of the Alliance for Safe Online Pharmacies (“ASOP”) to the Request for
Comments from United States Intellectual Property Enforcement Coordinator and
the Office of Management and Budget, For the Coordination and Strategic Planning
of the Federal Effort against Intellectual Property Infringement (Federal Register
Notice of February 23, 2010)
INTRODUCTION
The Alliance for Safe Online Pharmacies (“ASOP”) seeks to protect patient safety and
ensure patient access to safe and legitimate online pharmacies in accordance with U.S.
laws. ASOP’s stakeholders include leading organizations representing pharmacists,
pharmacies, pharmaceutical manufacturers, patients, and medication safety stakeholders
who believe that patients deserve the right to enjoy the convenience of the Internet and
access safe and legitimate websites to receive their medicines.
Despite the existence of many safe online pharmacies which do adhere to safety
standards, the nature of the Internet has opened the door to thousands of illegal Internet
sites posing as legitimate pharmacies but selling potentially unsafe, and often counterfeit,
medicines. The result: patients are just one click away from purchasing alleged
pharmaceutical products that could result in dangerous or even fatal outcomes.
In response to the request for written submissions for comment on the Intellectual
Property Enforcement Coordinator’s development of a Joint Strategic Plan for new
intellectual property enforcement strategies for the Federal Government (the “Request”),
ASOP submits the following research results and recommendations regarding the threat
posed to the American public from the sale of counterfeit and other IP-infringing drugs
conducted through the Internet.
This Response is divided into three parts, corresponding to those set forth in the Request:
•
PART I describes the economic and safety threats posed by the sale of counterfeit
pharmaceuticals through the Internet, and by related online IP violations.
•
PART II provides specific recommendations to address the problem, focusing in
particular on two areas in which we believe effective solutions can be implemented
without overtaxing the resources of the federal government: search engine and domain
name registrar practices.
•
PART III provides responses to relevant “Supplemental Comment Topics” set
forth in the Request, including a description of successful existing cooperative efforts by
search engine operators and registrars to prevent online IP abuses, and recommendations
for expanding such cooperation to materially improve these efforts.
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I.
THREAT POSED BY ONLINE PHARMACEUTICAL IP VIOLATIONS
The proliferation of counterfeit sales over the Internet is especially problematic in the
area of prescription drugs. While U.S. consumers who use brick-and-mortar pharmacies
can trust that their medicines are safe, as the pharmacy, pharmacist and pharmaceutical
product are all subject to safety laws and standards, consumers who purchase prescription
products online often do not enjoy the same protections.
Entering the brand name of a prescription drug or drug maker into a search engine does
not guarantee that:
¾ websites listed in the search results (whether in the “natural” or “sponsored”
results) offer only genuine products;
¾ the entity to which those websites are connected is authorized to sell
pharmaceutical products in the U.S.; or
¾ the entity offers pharmaceuticals that are genuine and approved by the Food and
Drug Administration (“FDA”).
As FDA Commissioner Margaret Hamburg stated in connection with a government effort
in 2009 to curb illegal online sales of medical products:
Many U.S. consumers are being misled in the hopes of saving money by
purchasing prescription drugs over the Internet from illegal pharmacies.
Unfortunately, these drugs are often counterfeit, contaminated, or
unapproved products, or contain an inconsistent amount of the active
ingredient. Taking these drugs can pose a danger to consumers.1
Sales of counterfeit drugs and other online pharmaceutical IP violations, often involving
infringements of both trademarks and patents as well as violating laws governing the
approval of medicines, create both economic threats and serious threats to the health and
safety of American consumers.
A.
The Economic Threat.
Increasingly in today’s global marketplace, many sellers of counterfeit pharmaceuticals
conduct their illicit activity almost entirely online – advertising and taking orders online,
and arranging for direct shipment of the counterfeit goods from third party manufacturers
to the customers. As a result, statutory remedies enacted prior to the explosion in Internet
popularity are falling short.2 When combined with the Internet’s low barriers to entry,
1
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm (Nov. 19, 2009 FDA
News Release).
2
For example, those offering counterfeit goods via the Internet may have no storefront or other “brick-andmortar” premises from which to seize goods pursuant to Section 34(d) of the Lanham Act, which was
adopted in the 1980s to combat counterfeiting. See 15 U.S.C. § 1116(d). And, because the online sellers
can use aliases and provide false identifying information to those hosting their websites, and may be
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this has led to a proliferation of online sellers of counterfeit and otherwise illegal
pharmaceuticals who are able to undercut the prices offered at traditional brick-andmortar pharmacies and avoid the oversight of U.S. regulatory agencies by: (1) basing
their operations on non-U.S. web servers, shipping and warehouse facilities; and (2)
importing products from countries that do not respect the patent laws of the United
States.3 There are currently believed to be over 36,000 rogue online pharmacies
operating via the Internet.4
Online sellers of counterfeits, like online sellers of genuine pharmaceutical products, can
take steps to “optimize” or achieve higher search engine listings for their websites in the
“natural” search results and (subject to evolving search engine rules) purchase an IP
owner’s trademark as a keyword to secure a listing in the “sponsored” results (discussed
in more detail in Part II-B below). Online purchasers seeking to buy genuine
pharmaceuticals – and intending to pay for genuine pharmaceuticals – may instead
receive counterfeits. And it is easy for online sellers of counterfeit pharmaceuticals to
deceive consumers. For example, Internet sellers can easily post pictures showing
genuine products, but then ship counterfeits to those consumers once the sale is placed
This is in contrast to sales at brick-and-mortar pharmacies, where
online.5
pharmaceutical products and pharmacists are subject to federal and state regulation and
licensing requirements.
The result is a significant impact on the U.S. economy and tax revenues. It is estimated
that ten percent (10%) of global pharmaceutical sales are of counterfeit drugs.6 The
World Health Organization estimates that “8% of the bulk drugs imported into the U.S.
are counterfeit, unapproved, or substandard” and that “10% of global pharmaceutical
The online sale of
commerce, or $21 billion, involves counterfeit drugs.”7
located in countries where judgments from foreign courts are difficult to enforce, they may be difficult to
trace and difficult to sue. See also Perfect 10, Inc. v. Visa Int’l Serv. Ass’n, 494 F.3d 788 (9th Cir. 2007)
(payment service providers were not liable for unlawful online transactions consummated using their
services even after being placed on notice of such transactions).
3
See, e.g., Sarah D. Scalet, “Auction Blocks,” CSO Magazine, Aug. 2005, available at
http://www.csoonline.com/read/080105/auction.html, (last visited March 16, 2010); CTV.ca News Staff,
“Group smashes toys to ‘crush’ counterfeiting,” CTV.ca, Oct. 25, 2007, available at
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20071025/crush_counterfeiting_071025?s_name
=&no_ads, (last visited March 16, 2010).
4
See http://www.legitscript.com/, which identifies 36,809 online pharmacies as of March 16, 2010 that do
not meet the standards for certification from LegitScript.
5
“Buying Authentic Products Online,” Squidoo.com, available at http://www.squidoo.com/buyauthentic,
(last visited March 16, 2010).
6
Eoin Gleeson, “The Booming Trade in Fake Drugs,” MoneyWeek, Feb. 13, 2009, available at
http://www.moneyweek.com/news-and-charts/economics/the-booming-trade-in-fake-drugs-42209.aspx
(last visited March 16, 2010); see also “Knock-offs catch on,” The Economist, March 4, 2010, available
at
http://www.economist.com/business-finance/displaystory.cfm?story_id=15610089&source=hptext
feature (last visited March 23, 2010) (online sales of all counterfeit goods are estimated to comprise 57% of the more than $200 billion in annual online sales).
7
Albert I. Wertheimer, et al, “Counterfeit Pharmaceuticals: Current Status and Future Projections,” 43 J.
Am. Pharm. Assoc. 710-8 (2003).
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3
pharmaceuticals is largely unregulated and untaxed due to its multi-national reach and
inherent illegality. With total pharmaceutical sales in 2008 expected to have reached
nearly $1 trillion, it is clear how large of a potential problem counterfeit medications pose
to the U.S. economy and tax revenues.8
B.
The Health and Safety Threat.
IP violations in the prescription drug context create perhaps an even greater threat to the
health and safety of Americans.9
The U.S. Food and Drug Administration (“FDA”) has established an extensive
submission and approval process to ensure that drugs purchased by U.S. consumers are
safe and effective.10 The shipment into the United States of drugs lacking FDA approval
is a violation of U.S. law and FDA rules.11 However, the FDA cannot and does not
monitor every one of the countless foreign websites offering illegal versions of brand
name drugs, including products that are counterfeit, unapproved and/or trademark- or
patent-infringing – and lacks the resources to review every shipment into the U.S. As
FDA Commissioner Hamburg recently explained, “It is simply not possible for FDA to
inspect our way to safety.”12
Online sales of unlawful pharmaceutical products pose a significant health and safety risk
to U.S. consumers. Unless a website has been verified as adhering to standards required
by the National Association of Boards of Pharmacy (NABP), consumers purchasing
pharmaceuticals via the Internet currently have no way of knowing if the drugs they
receive will contain the correct active ingredients, the correct amount of active ingredient
in each dose, a completely different active ingredient, no active ingredient at all – or if
the doses will contain toxic or hazardous materials. Problems associated with counterfeit
drugs have been documented in countries around the globe. In Haiti, 100 fatal cases of
kidney failure were attributed to patients who ingested cough syrup that had been made
with antifreeze. In Niger, 60,000 to 80,000 children were treated with an inactive vaccine
which may have led to 2,500 fatal infections that would have otherwise been prevented
8
Albert I Wertheimer, “Identifying and combating counterfeit drugs,” 2008, Expert Rev. Clin. Pharmacol.
1(3), 333-336.
9
See, e.g., City of New York Office of Comptroller, William C. Thompson, Jr., Comptroller, “Bootleg
Billions: The Impact of the Counterfeit Goods Trade on new York City,” November 2004, available at
http://www.comptroller.nyc.gov/bureaus/bud/04reports/Bootleg-Billions.pdf (last visited March 16,
2010).
10
See http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm
2008).
11
12
(last visited February 6,
See 21 U.S.C. § 331.
Dr. Margaret Hamburg as Commissioner of Food and Drugs, Remarks at the Center for Strategic and
International Studies (February 4, 2010) (transcript available at http://www.fda.gov/NewsEvents/
Speeches/ucm199926.htm (last visited March 23, 2010)).
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4
by the vaccine.13 In China, it is suspected that as many as 300,000 people per year die
after taking substandard or fake medications.14
Selena Walrond of the United Kingdom died after ingesting unlicensed diet pills from a
Chinese website. The diet pills, containing the pesticide dinitrophenol, had been banned
in the United Kingdom since the late 1930s.15 Marcia Ann Bergeron of British
Columbia, Canada died with 15 times the normal level of aluminum in her liver after
purchasing Zolpidem, a hypnotic drug not legally available in Canada, from an online
pharmacy suspected of selling counterfeit drugs.16
Similar problems afflict U.S. patients. Reports include a U.S. patient in Illinois who fell
into a coma after purchasing Xanax pills online that contained quadruple the usual dosage
that would be prescribed by a doctor,17 and another who died after purchasing counterfeit
anti-depression drugs from an online pharmacy.18 Tracy Taylor of Wichita, Kansas died
after purchasing Soma, a pain medication, without a prescription and without consulting
with a doctor, from an illegal online pharmacy based in Kansas.19 Studies have found
that counterfeit anti-HIV medications, cholesterol-lowering drugs and anti-arthritis
medications have been sold in the U.S. containing cement, gypsum, sawdust, industrial
solvents and yellow paint.20
In addition, there is a well-documented link between sales of counterfeits – including
counterfeit drugs – and funding of terrorist activities. For example, some federal
investigations, indictments or convictions have linked the counterfeiting of prescription
drugs to Middle Eastern terrorist organizations.21 Other reports have noted that some
13
Martijn ten Ham, “Health Risks of Counterfeit Pharmaceuticals,” 26 (14) Drug Safety 991-997 (2003)
and Roger Bate, “The Deadly World of Fake Drugs,” Sept./Oct. 2008, Foreign Policy, pp. 56-65.
14
See Steve Boggan, “Headache pills made of rat poison and Viagra made of chalk: We reveal the chilling
truth about Internet drugs,” April 27, 2009, MailOnline, http://www.dailymail.co.uk/health/article1173735/After-deacons-daughter-killed-medicine-bought-online--chilling-truth-Internet-black-marketprescription-drugs.html (last visited March 16, 2010).
15
See “Woman dies after buying banned slimming pills on the Internet,” June 27, 2008, MailOnline,
http://www.dailymail.co.uk/news/article-1029920/Woman-dies-buying-banned-slimming-pills-Internet.
html (last visited March 16, 2010).
16
See “Counterfeit pills bought online led to death, coroner confirms,” July 6, 2007, Victoria Times
Colonist, http://www.canada.com/victoriatimescolonist/news/story.html?id=05142ca2-9796-4868-bf4276e939915fa5&k=29039 (last visited March 16, 2010).
17
See Keith Epstein, “Online Extra: The Deadly Side Effects of Net Pharmacies,” Dec. 18, 2006,
BusinessWeek, available at http://www.businessweek.com/magazine/content/06_51/b4014070.htm (last
visited March 16, 2010).
18
See Angie Cannon, “Dicey Drugs from Abroad,” June 18, 2001, U.S. News & World Report.
19
See http://safemedicines.blogspot.com/, Weekly News Update, March 28, 2008 (last visited March 16,
2010).
20
See Henry I. Miller, “Imported Drugs: Hidden Disasters,” April 8, 2008, New York Post.
21
See, e.g., Ed White, “Detroit-area man guilty in cigarette scheme,” Chicago Tribune, Jan. 12, 2009,
http://archives.chicagotribune.com/2009/jan/12/news/chi-ap-mi-cigarettesmugglin (last visited March 23,
2010); Reuters, “Counterfeit goods are linked to terror groups,” International Herald Tribune, Feb. 12,
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counterfeit drug activity is facilitated by “Russian mafia” groups – more accurately
described as organized crime networks mostly based in Russia and Eastern Europe – and
Chinese triads, both of which often provide the Internet architecture and financial
assistance or money laundering for illicit pharmaceutical operations.22 Thus at least one
potential future threat created by the prevalence of Internet pharmacies is that terrorists
could set up rogue websites designed to sell poisonous fake drugs to unsuspecting
Americans, or finance other terror-related activity through the illicit sale of counterfeit
drugs. As FDA Commissioner Hamburg has recently stated, “we know that we are also
vulnerable to potential attacks involving our food or drug supply by terrorists determined
to do harm.”23
II.
SPECIFIC RECOMMENDATIONS
As set forth above, the problem of online sales of counterfeit drugs and related online IP
violations with respect to prescription pharmaceuticals creates both economic threats and
serious threats to the health and safety of American consumers. As described below, we
believe that the problem can be combatted more effectively with the assistance of certain
online “gate-keepers.”
A.
The Opportunity For Online Gate-Keepers to Help Combat The Problem.
The Internet presents special challenges to pharmaceutical IP owners trying to track down
and stop sellers of counterfeit products, who often do not have physical storefronts or
storage facilities from which illicit goods can be seized, and who operate in a virtual
world in which it costs little to open new sales outlets or change identities.24
2007, available at http://www.iht.com/articles/2007/02/12/business/fake.php (last visited March 16,
2010).
22
Wyatt Yankus, American Council on Science and Health, “Counterfeit Drugs: Coming to a Pharmacy Near You”,
August 2006. See also Graham Satchwell, Sick Business: counterfeit medicines and organized crime (London:
Stockholm Network, 2004); See also INTERPOL media release, “INTERPOL warns of link between
counterfeiting and terrorism. Cites evidence that terrorists fund operations from proceeds,” July 16,
2003, available at http://www.interpol.int/Public/ICPO/PressReleases/PR2003/PR200319.asp (last
visited March 16, 2010); Carratu International, Plc, “Rise in Counterfeit Market Linked to Terrorist
Funding,” June 26, 2002, available at http://www.pressbox.co.uk/Detailed/6073.html (last visited March
16, 2010) (counterfeiting proceeds linked to Al-Qaeda, the Irish Republican Army, ETA, the Mafia,
Chinese Triad gangs, the Japanese Yakuza crime syndicates, Russian organized criminals and
international illegal drug cartels); Revenues from counterfeiting are also reported to finance international
crime syndicates that deal in money laundering, human trafficking, and child labor. Dana Thomas, “The
Fake Trade,” Harper’s Bazaar, Jan. 2008, p.71; OECD, “The Economic Impact of Counterfeiting and
Piracy – Executive Summary,” available at http://www.oecd.org/dataoecd/13/12/38707619.pdf (last
visited March 16, 2010) (OECD analysis indicates that criminal networks and organized crime thrive via
counterfeiting and piracy activities).
23
Dr. Margaret Hamburg as Commissioner of Food and Drugs, Remarks at the Center for Strategic and
International
Studies
(February
4,
2010)
(transcript
available
at
http://www.fda.gov/NewsEvents/Speeches/ucm199926.htm (last visited March 23, 2010)).
24
Trademark owners also face obstacles trying to tackle this problem using traditional legal theories of
trademark infringement and secondary liability that were largely developed in a pre-Internet world. See,
e.g., Perfect 10, Inc. v. Visa Int’l Serv. Ass’n, No. C 04-00371 JW, 2005 WL 2007932, at *4-*5 (N.D.
{F0600247.5 }
6
On the other hand, illicit activity on the Internet is often easier to see than more
traditional back alley and underground black markets, and there are a handful of
convenient chokepoints at which illicit online drug commerce can be blocked
electronically – without the cost of sending armed enforcement personnel to thousands of
far-flung physical locations. Thus, with cooperation from those in position to block such
transactions, there is hope that all stakeholders, including trademark and patent owners
and health authorities, could make significant progress in combating online sales of
counterfeits.
There are a number of “gate-keepers” involved in the process through which counterfeit
and other illicit drugs are advertised, sold and distributed to consumers through the
Internet. Each of these gate-keepers may profit from the activity, albeit often
unwittingly. Registrars sell domain names to online illegal drug sellers who use them to
deceptively attract consumers to the sellers’ sites; search engine companies offer sellers
the ability to advertise and consumers to link to the sellers’ sites; Internet service
providers (“ISPs”) host the sellers’ websites on computer servers; credit card companies
and other payment service providers enable the sellers to consummate sales online; and
shippers provide the infringing goods to the (often unsuspecting) consumers.
Each of these gate-keepers is potentially in a position to help deter the illegal activity, and
we are supportive of a multi-pronged approach involving all of them. This Response
focuses on two gate-keeping areas in which we believe effective solutions can be most
efficiently and effectively implemented25 without the need for additional legislation and
without overtaxing the resources of the federal government: search engine operators
and domain name registrars.26
We believe that, with the encouragement and assistance of the Intellectual Property
Enforcement Coordinator, existing voluntary protocols can be uniformly adopted and
extended by the relevant parties to significantly reduce the danger created by rogue
pharmaceutical websites that abuse our nation’s IP laws. ASOP has concluded that
securing additional cooperation from search engine operators and domain name registrars
– supplementing regimes that have already been voluntarily established with the
cooperation of some of them, and regularizing the ad hoc assistance often provided to
particular IP owners by these gate-keepers – would have a significant impact on the
problem.
Cal. Aug. 12, 2005) (noting that “technological advances” and the “ever evolving Internet environment”
can make application of current standards difficult).
25
For example, the simple removal of a search engine link to a rogue Internet pharmacy could alleviate the
need for the pharmaceutical trademark owner to take many additional and costly actions including
tracking down the identities of those selling the goods (which is time-consuming and expensive, when it
is even possible), instituting lawsuits against the sellers in a court with jurisdiction (also time-consuming
and expensive, when feasible), prosecuting the cases to conclusion and enforcing any resulting judgments
(also time-consuming, expensive, and not always possible).
26
ASOP believes it is reasonable to expect such gate-keepers, who benefit from online commerce, to take
some actions to assist in curbing the illegal sale of pharmaceuticals on the Internet, especially since they
are in the best position to efficiently and effectively help stop the problem. Moreover, removal of rogue
website listings from search results will presumably lead to a better experience for search engine users.
{F0600247.5 }
7
ASOP is sensitive to the challenges posed by placing any additional burdens on those like
search engine operators and registrars that provide the structural underpinnings for the
highly desirable online economy. ASOP also accepts that the primary burden for
monitoring online sales by rogue Internet pharmacies may need to remain with others,
such as affected pharmaceutical companies, and those involved with regulation of
pharmacies and prescription pharmaceutical products in the U.S.27 However, ASOP
believes that the status quo is unacceptable and that new steps must be taken by those in
the best position to protect the public from rogue Internet sellers of fake and illegal
prescription drugs.
B.
Search Engine Operators as Effective Gate-Keepers.
Most of the more than 200 million Internet users in the U.S.28 rely on search engines to
find websites offering what they are seeking.29 Approximately 213 million searches are
conducted on search engines in the U.S. each day.30 Thus, if links to illegal online drug
sellers did not appear in search engine results, counterfeit pharmaceutical sales would be
significantly reduced.
Nearly all U.S. search engine traffic is handled by a small handful of search engines, with
Google leading the way.31 Although search engine methodologies differ, each search
engine company provides two kinds of search results: “natural” search results
(sometimes referred to as “organic” search results) that include links to websites
27
As described in Part III-B below, in November 2009, law enforcement agencies around the world
completed a coordinated, weeklong, “International Internet Week of Action” to address the problem of
online rogue pharmacies. In total, INTERPOL and the World Health Organization’s (WHO)
International Medical Products Anti-Counterfeiting Taskforce (IMPACT) coordinated efforts in 24
countries to target 751 websites “engaged in illegal activity including offering controlled or prescription
only drugs.” http://www.medicalnewstoday.com/articles/171689.php (last visited March 16, 2010). In
the United States, the F.D.A. issued 22 warning letters to Web site operators and notified Internet service
providers and domain name registrars that those sites were selling pharmaceutical products in violation
of U.S. law. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm (last
visited March 16, 2010).
28
Internet World Stats – Usage and Population Statistics, http://www.Internetworldstats.com/stats2.htm
(last visited March 16, 2010); Danny Sullivan, “Searches Per Day,” Search Engine Watch, available at
http://searchenginewatch.com/showPage.html?page=2156461 (last visited March 16, 2010).
29
See Rank for Sales, Search Engine News Section, “Most Users Search to Find Web Sites and
Information,” http://news-01.rankforsales.com/news-br/001206-0804050746910314-sem-news.html (last
visited March 16, 2010).
30
See Danny Sullivan, “Searches Per Day,” Search Engine Watch, available at http://search
enginewatch.com/showPage.html?page=2156461 (last visited March 16, 2010).
31
“Nielsen Reports February 2010 U.S. Search Rankings,” http://blog.nielsen.com/nielsenwire/online_
mobile/nielsen-reports-february-2010-u-s-search-rankings/ (last visited March 16, 2010) (February 2010
Nielsen/NetRatings figures showed 94.1% of the U.S. search engine traffic is handled by only four
search engines, Google (65.2%), Yahoo! (14.1%), (Microsoft’s MSN/Windows Live/Bing (12.5 %) and
AOL (2.3%). See also Juan Carlos Perez, “Google crushes competitors in U.S. search market,”
http://www.itworld.com/AppDev/1634/060724googlesearch/ (last visited March 16, 2010).
{F0600247.5 }
8
“relevant” to the search identified by an algorithm,32 and “sponsored” results (often
placed above or to the right of the “natural” results), for which advertisers pay to have
links to their websites appear. If a user enters a search that includes the advertiser’s
keyword – even in conjunction with other terms (e.g., “cheap [pharmaceutical
trademark]”), a link to the advertiser’s website may be included in the “sponsored links”
section of the search results.
As described in Part III-A below, search engine operators have, to varying extents,
implemented policies to curb advertising by rogue drug sellers through “sponsored links.”
These policies generally fall into two categories: (1) blocking links to online pharmacies
not certified by an accreditation body, and (2) allowing notice and takedown of links to
illegal online drug sellers. An example of the first category is Google’s Pharmacy
Policy,33 which requires online pharmacies targeting customers in the United States to be
accredited by the National Association of Boards of Pharmacy’s VIPPS program.34
Those not accredited are blocked from appearing in sponsored links. An example of the
second category is Yahoo!’s False & Misleading Policy, which requires pharmaceutical
IP owners to submit written complaints about rogue drug sellers advertising counterfeits
and infringing drugs through sponsored links. Such “notice and takedown” policies
generally permit the advertiser an opportunity to dispute the claim of IP infringement or
other wrongdoing, to ensure that pharmaceutical IP owners are not overreaching35 –
similar to the protections afforded to accused online copyright infringers under the notice
and take-down procedures in the Digital Millennium Copyright Act (“DMCA”).36
ASOP applauds these policies to block and takedown links to illegal drug sellers in
sponsored links, and sees them as an important step in the right direction. However,
search engine operators have not always complied with requests to remove links to
counterfeit drug sellers and other rogue internet pharmacies from the “natural” results –
leaving the public vulnerable to potentially harmful non-FDA approved drugs.
It is believed that the primary rationale for the reluctance to block such listings is that it
would affect the purity of the “natural” results upon which users rely. However, the
32
See, e.g., “Technology Overview,” http://www.google.com/corporate/tech.html (last visited March 16,
2010) (“We use more than 200 signals, including our patented PageRank™ algorithm, to examine the
entire link structure of the web and determine which pages are most important. We then conduct
hypertext-matching analysis to determine which pages are relevant to the specific search being
conducted. By combining overall importance and query-specific relevance, we're able to put the most
relevant and reliable results first.”)
33
See, http://adwords.google.com/support/aw/bin/answer.py?hl=en&answer=7463 (last visited March 23,
2010).
34
For more information on VIPPS certifications, see http://vipps.nabp.net/verify.asp (last visited March 23,
2010).
35
See, e.g., http://searchmarketing.yahoo.com/legal/lsstrademarks.php (last visited March 16, 2010).
36
See 17 U.S.C. § 512(c).
{F0600247.5 }
9
“natural” results are not truly pure in the first place. For example, search engines have
routinely blocked and/or removed listings for a number of reasons, including:37
¾ To comply with U.S. restrictions on the advertising of gambling;38
¾ To comply with DMCA take-down notices regarding copyright infringements as
required by search engine-specific provisions of the U.S. Copyright Act;39
¾ To prevent website owners from engaging in certain conduct designed to boost
their search engine results ratings;40 and
¾ To comply with French and German laws prohibiting the display and sale of Nazi
memorabilia.41
ASOP respectfully submits that the danger created by the sale of fake and illegal
prescription drugs poses at least as great a threat to public safety – and should be taken at
least as seriously by search engine operators – as the above-listed grounds for removal
37
Until very recently, Google also filtered natural search results in China to comply with restrictions
imposed by the Chinese government, which required “blacklisting” of certain search terms and filtering
out many websites from search results – including those relating to independence movements in Taiwan
and Tibet, promotion of democracy, and the Falun Gong religious movement – in exchange for
permission to operate in that country. See Bruce Einhorn, “Search Engines Censured for Censorship,”
BusinessWeek online, August 10, 2006, http://www.businessweek.com/globalbiz/content/aug2006/
gb20060810_220695.htm? campaign_id=rss_null (last visited March 16, 2010); The SEO Blog, “Google
Takes the Rap for the Tech Gang of 4,” Apr. 10, 2006, http://www.stepforth.com/blog/2006/googletakes-the-rap-for-the-tech-gang-of-4/ (last visited March 16, 2010).
38
See 31 U.S.C. §§ 5361-5367, “Unlawful Internet Gambling Enforcement Act.” That Act requires
financial institutions to “code” and “block” transactions from Internet casinos.
39
15 U.S.C. § 512(d); Declan McCullagh, “Google excluding controversial sites,” cnet news.com, Oct. 24,
2002 (including complaints by the Church of Scientology concerning posting of its papers without
authorization), http://news.com.com/Google+excluding+controversial+sites/2100-1023_3-963132.html
(last visited March 16, 2010). See also Declan McCullagh, “Google pulls links to Kazaa imitator,” cnet
news.com, Sept. 3, 2003, http://news.com.com/2100-1032_3-5070227.html (last visited March 16, 2010)
(Google removed links to eight sites distributing hacked version of Kazaa file-sharing software, and
posted a notice stating: “In response to a complaint we received under the Digital Millennium Copyright
Act, we have removed eight result(s) from this page. If you wish, you may read the DMCA complaint
for these removed results”).
40
In 2004, Google and Yahoo disabled all links to adware maker WhenU when the search engine operators
discovered that WhenU was engaging in “cloaking,” a technique to boost its search engine results ratings,
in violation of both companies’ policies. Stephanie Olsen, “Search engines delete adware company,”
CNET News.com, May 13, 2004, http://news.com.com/2100-1024_3-5212479.html (last visited March
16, 2010).
41
CNN.com, “Yahoo! loses Nazi auction case,” Nov. 20, 2000, http://archives.cnn.com/2000/TECH/
computing/11/20/france.yahoo.02/ (last visited March 16, 2010); Declan McCullagh, “Google excluding
controversial sites,” cnet news.com, Oct. 24, 2002, http://news.com.com/Google+excluding
+controversial+sites/2100-1023_3-963132.html (last visited March 16, 2010). For example, Google.fr
and Google.de filter out of results listings websites that are anti-Semitic, pro-Nazi, or affiliated with
white supremacists. McCullagh, supra.
{F0600247.5 }
10
from “natural” search engine results.42 And we are aware of no evidence indicating that
removing listings for sites that sell counterfeit and illegal prescription drugs – the
knowing sale of which is a criminal act under the laws of the United States and elsewhere
– would be more difficult to implement than removing these other listings.
ASOP also notes that increased cooperation by these potential “gate-keepers” could be
beneficial to the gate-keepers themselves. Search engines promise their users a selection
system that provides links to “relevant” and “high-quality websites,”43 and it would be
difficult to argue that sites trafficking in counterfeit and illegal prescription drugs – which
are by definition engaging in fraudulent, criminal and dangerous conduct – are “relevant”
or “high-quality websites.” Removal of illegal listings from search results will
presumably lead to a better experience for search engine users. Thus, ASOP sees this as
an opportunity to create a “win-win-win” situation for search engine operators,
pharmaceutical IP owners, and the public, who will be protected from the unwitting
purchase of potentially dangerous counterfeit drugs online.
Accordingly, ASOP suggests that appropriate government personnel seek to coordinate
and assist efforts by pharmaceutical IP owners and those involved with the regulation of
pharmacies and pharmaceutical products in the U.S. to (1) secure uniform search engine
policies with respect to sponsored links, and (2) have search engine operators adopt takedown protocols with respect to links in “natural” search results.
C.
Registrars as Effective Gate-Keepers.
The websites of rogue online drug sellers often use domain names that incorporate (or in
the case of typo-squatting, misspell) pharmaceutical IP owners’ product trademarks to
attract consumers looking for genuine prescription drugs. In such circumstances, the
trademark owner may be able to impede the online seller by recovering the domain name
through an alternative dispute resolution procedure such as ICANN’s Uniform Domain
Name Dispute Resolution Policy (“UDRP”), or through a civil suit under the AntiCybersquatting Protection Act (“ACPA”).44
However, there are serious limitations to such procedures. UDRP actions cost a
minimum of $1,000 in filing fees (depending on the ADR provider, the number of
domain names in dispute, and the number of arbitrators deciding the case) plus thousands
more in attorney’s fees to prepare the necessary filings, and the only remedy is obtaining
42
We also note that search engines enjoy Congressionally-mandated immunity by virtue of the
Communications Decency Act for exercising “a publisher’s traditional editorial functions -- such as
deciding whether to publish, withdraw, postpone, or alter content,” and therefore have full discretion to
determine what results to include and not include. Langdon v. Google, Inc., Civ. Action No. 06-319-JJF,
2007 U.S. Dist. LEXIS 11902, (D. Del. February 20, 2007).
43
http://yhoo.client.shareholder.com/press/overview.cfm (“Yahoo!'s vision is to be the center of people's
online lives by delivering personally relevant, meaningful Internet experiences.”) (last visited March 16,
2010); http://www.google.com/intl/en/corporate/ (“We are constantly working to provide you with more
relevant results so that you find what you're looking for faster.”) (last visited March 16, 2010).
44
The ACPA is codified in Section 43(d) of the U.S. Trademark (Lanham) Act, 15 U.S.C. § 1125(d)).
{F0600247.5 }
11
ownership of the domain name within several months of filing – there are no civil or
criminal penalties for the illegal squatting and no recovery of attorney’s fees or costs.45
The ACPA provides for monetary remedies, but it requires institution of a civil court
action and can therefore be far more expensive and time-consuming. It can also be
difficult to secure and collect a judgment against cybersquatters based outside the U.S.
Thus, the financial and time barriers to pursuing relief through these avenues are
significant.
Registrars, the parties entrusted to assign domain names to those wishing to operate
websites on the Internet, are in a position to provide a more efficient means of recourse
by promptly preventing or suspending the posting of websites that use domain names
sold by the registrars. The not-for-profit Internet Corporation for Assigned Names and
Numbers (ICANN) grants a select number of registrars the privilege of leasing (for
varying periods of time) domain names to website operators.46 One of the policy and
contractual requirements placed upon registrars by ICANN is that they must contractually
prohibit domain name registrants from using the domain names for unlawful purposes.47
Registrars have the ability, and retain, under the terms of service with their customers, the
right to disable websites that use the domain names they supply. And unlike ISPs that
host websites, who are also in a position to disable access to rogue sites, there is a more
limited number of registrars, and they must be accredited by ICANN to retain the
privilege of maintaining their role. This places registrars in a good position to efficiently
stop rogue Internet sellers of counterfeit pharmaceuticals, and provides justification for
asking them to provide such cooperation – as opposed to letting them profit from
unlawful conduct of domain name registrants that abuse the process to sell illegal
prescription drugs.
As with search engine operators, we propose that pharmaceutical IP owners and those
involved with regulation of pharmacies and pharmaceutical products in the U.S. be
willing to continue monitoring domain name registrations (rather than impose prescreening requirements on registrars) and to notify the registrars of rogue registrants
(rather than requiring registrars to ferret out the rogues). And, as with search engine
operators, there has already been some cooperation. Some registrars will remove access
to a domain name and the website associated with it upon receipt of notification and
evidence that it is being used for unlawful activity, and there are registrars that will
actively assist brand owners by providing information about infringing registrants.48
45
An additional drawback to UDRP proceedings for the purposes of stopping counterfeiters is the strict
requirements for successful UDRP actions, including the requirement that in addition to demonstrating
trademark rights in the infringed name, the UDRP complainant must show that the registrant both
registered the domain name in bad faith and has used the domain name in bad faith. Thus, UDRP actions
have failed in cases addressing bad-faith use following a good-faith registration.
46
See ICANN website at http://www.icann.org/en/about/ (last visited March 16, 2010).
47
See Uniform Dispute Resolution Policy, Paragraph II, available at the ICANN website at
http://www.icann.org/en/udrp/udrp-policy-24oct99.htm.
48
Melbourne IT, for example, has offered a fee-based service called “Registrant Investigation Services”
which provides brand owners with a report summarizing all relevant information on a registrant of a
{F0600247.5 }
12
Overall, however, compliance with ICANN policies and procedures relating to unlawful
activity and intellectual property infringement is inconsistent, and varies by registrar.
Several registrars refuse to disable access to rogue online drug sellers absent a UDRP
decision or court order, or provide other cooperation to pharmaceutical IP owners – again
despite their own stated policies prohibiting infringing and unlawful conduct. Refusing to
suspend domains clearly used in illegal activity, such as offering counterfeit or
unapproved prescription drug products, or selling prescription drugs without requiring a
prescription, puts the registrar in the position of knowingly facilitating and even profiting
from criminal activity, and may result in potential vicarious or contributory liability. It
also prevents the registrar from playing the role that ICANN, through its policies,
envisions registrars should play in helping protect Internet users from websites engaged
in intellectual property violations or unlawful activity, such as the sale of counterfeit
drugs. Some registrars also exacerbate the problem by selling their customers
“shielding” or “proxy” services that prevent the public listing of the domain name
owner’s identity and address, even though domain name registrants are required to
provide the registrar with this information.
ASOP sees domain name registrars as potentially very helpful allies in the effort to shut
down websites selling pharmaceuticals to U.S. patients in violation of U.S. intellectual
property rights and health and safety laws. On the other hand, registrars that are given
notice of infringing or unlawful websites but refuse to take action are not only ignoring
their ICANN-imposed contractual requirements, they arguably become allies of illegal
Internet drug sellers who facilitate the criminal and infringing activity.
Accordingly, ASOP suggests that appropriate government personnel seek to coordinate
and assist efforts by pharmaceutical IP owners and those involved with the regulation of
pharmacies and pharmaceutical products in the U.S. to secure cooperation by registrars to
carry out their terms of service with their customers, and to take steps (including
warnings and, for repeat violators, the disabling of websites) to cut the problem off at its
source. To the extent registrars are concerned about customer complaints, this could be
addressed through agreements in which monitoring parties are required to affirm and
stand behind their representations as to the illegality of the rogue sites’ conduct under
U.S. law.
*
*
*
particular domain name. See http://www.melbourneitdbs.com/online-brand-infringement/registrantinvestigation-services.php (last visited March 16, 2010).
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13
III.
SUPPLEMENTAL COMMENT TOPICS
Below, as requested, are ASOP’s comments with respect to relevant “supplemental”
topics set forth in Part III of the Request.
A.
Successful Agreements Among Stakeholders; Suggested Methods to Minimize
Threat Posed by Infringing Goods, Limit Use of Internet to Disseminate
Infringing Goods, and Reduce Threats to Public Health and Safety (e.g.,
Counterfeit Drugs).
(Supplemental Comment Topics 4, 13, 14, 17)
(i)
Expand Development and Application of “Best Efforts” Protocols
by IP Owners and Search Engines Concerning “Natural” Results.
As noted in Part II-B above, successful voluntary efforts have been made to help IP
owners have sponsored links to rogue websites (e.g., sellers of counterfeit prescription
drugs) removed from search engine listings. For example, an International Trademark
Association (“INTA”) working group that included trademark owners and search engine
company representatives developed a set of “best practices” for securing search engine
owners’ cooperation based on trademark owners’ submission of information deemed
sufficient to justify the removal of the links.49
Indeed, some search engines now have online forms through which IP owners can submit
their complaints about sponsored advertisers, provide links to the offending pages, and
set forth the basis for the complaint all online. These complaint forms exist for general
trademark violations with respect to sponsored links, as well as for violations of the
search engine’s particular policy with respect to the sale of counterfeit merchandise.50
Although these procedures are not perfect (see Comment A(ii) below) and do not require
responses within set timeframes as the DMCA does, we applaud these efforts by the
search engines that are making them.
What is plainly needed now is the development of and voluntary compliance with similar
“best efforts” guidelines or protocols for removing natural search engine results that link
to websites offering counterfeit pharmaceuticals and engaging in other illegal conduct
involving violation of pharmaceutical IP rights. As discussed in Part II-B above, we
believe that the danger threatened by fake drug sellers is at least as significant as that
threatened by copyright infringers, gambling sites, and others whose sites are regularly
removed from the natural results of search engines. And our hope and belief is that, with
government assistance, this can be achieved voluntarily.51
49
See “Best Practices for Addressing the Sale of Counterfeits on the Internet,” INTA Bulletin, Vol. 64,
No. 16, Sept. 1, 2009.
50
For general trademark complaints: https://services.google.com/inquiry/aw_tmcomplaint; for counterfeit
complaints: http://services.google.com/inquiry/aw_counterfeit (sites last visited March 16, 2010).
51
For example, Google does not offer a procedure for government agencies or brand owners to seek
removal of a listing removed from the natural search results. Instead, such parties are instructed by
Google to contact the “site’s webmaster and request that the content is removed”; only once a brand
{F0600247.5 }
14
We believe that through cooperative efforts involving all concerned parties and, as
necessary, appropriate government agencies, there can be further open exchange of ideas
and solutions that would target counterfeiting and IP infringing drug abuses utilizing a
search engine’s natural and sponsored search results. Ultimately, whatever solution
results from these efforts must include a method for blocking websites and links to
websites suspected of selling or facilitating the sale of counterfeit or otherwise illegal
medicines.
(ii)
Expanded Cooperation of Search Engines and IP Owners on “Sponsored Links.”
On February 9, 2010, Google announced a revision to the Google AdWords Pharmacy
Policy in the United States and Canada. Under the new policy, only online pharmacy
websites accredited by the U.S.-based National Association Boards of Pharmacy’s VIPPS
program are allowed to advertise in the U.S. using Google’s AdWords keyword purchase
program.
Furthermore, pharmacies are now only allowed to target AdWords
advertisements to users in the country in which they are accredited.52 ASOP members
have observed that this policy change has greatly reduced the number of sponsored link
advertisements for brand name prescription drug products. We believe that all search
engine operators should be encouraged to adopt similar measures.
In addition, ASOP encourages simplification of the process for submitting complaints to
search engines such as Google, Yahoo! and Bing with respect to websites that sell
counterfeit drugs or otherwise infringe pharmaceutical IP rights. In addition, we believe
that it should be easier for aggrieved consumers to submit complaints, including by
allowing anonymous submissions (to avoid discouraging reporting for fear of admitting
to an illegal purchase of drugs online without a prescription), and by removing
requirements that such consumers identify the IP owner and rights being violated –
information to which a typical consumer may not have access.
(iii)
Expand ICANN Protocol and Registrars’ Assistance.
Consistent with the discussion in Part II-C above, we believe that domain name
registrars should be encouraged to provide more consistent cooperation with IP owners,
including by enforcing their own terms of service (e.g., content guidelines) to disable
access to sites that infringe the IP rights of others and/or conduct unlawful activity,
particularly when the illegal sale of prescription drugs are involved. Industry and
government should work together to encourage all domain name registrars to explicitly
prohibit the use of their services to facilitate the sale of prescription drugs in a way that
owner and site’s webmaster have resolved their dispute can either party contact Google to have any
cached versions of the website removed that were stored by Google’s computers prior to the change. See
http://www.google.com/support/webmasters/bin/answer.py?hl=en&answer=164734 (last visited March
16, 2010). But it is virtually impossible to contact or even locate many of the operators of rogue online
pharmacies, and they have no incentive to cooperate if contacted.
52
See Dan Friedman, “Update to Pharmacy Policy in U.S. and Canada,” Feb. 9, 2010, available at
http://adwords.blogspot.com/2010/02/update-to-pharmacy-policy-in-us-and.html (last visited March 16,
2010).
{F0600247.5 }
15
violates drug and pharmacy regulations designed to protect the public against counterfeit
medicines.53
B.
Existing Effective Government Procedures/Policies and Existing Processes
Involving Cooperation Between Stakeholders and Governments.
(Supplemental Comment Topics 2 & 3)
International Internet Week of Action, November 2009. The FDA’s Office of Criminal
Investigations, in conjunction with the Center for Drug Evaluation and Research and the
Office of Regulatory Affair, Office of Enforcement, targeted over 100 websites (none for
genuine U.S. or Canadian pharmacies) engaged in the illegal sale of unapproved or
misbranded drugs to U.S. consumers. According to an FDA news release, the agency
issued warnings to the website operators and gave notice to ISPs and domain name
registrars, whose policies would permit blocking of the websites.54
During the week, OCI and FDA import specialists reportedly joined with Immigration
and Customs Enforcement (“ICE”), Customs and Border Protection (“CBP”), the Drug
Enforcement Administration (“DEA”) and the U.S. Postal Inspection Service to target
and interdict shipments of illegal drugs through certain International Mail Facilities and
express courier hubs. Coordinated actions of this type produce significant efficiencies as
they avoid the need for the numerous different pharmaceutical IP owners to take separate
actions and they are able to exploit information and other resources not available to
private companies.
We applaud this coordinated enforcement effort, especially the takedown of over 100
websites selling illegal medicines. As discussed elsewhere in this Response, this
takedown effort should be expanded.
C.
Suggestions for Information-Sharing Between Stakeholders and U.S. Agencies.
(Supplemental Comment Topic 5)
The National Center for Missing and Exploited Children (“NCMEC”) Public-Private
Partnership Model. NCMEC is a public-private group that, among other things, works to
stop distribution of child pornography over the Internet using both public and private
resources. NCMEC works with the Financial Coalition Against Child Pornography,
whose members include the major payment service providers (American Express,
MasterCard, Visa and PayPal), and search engine companies (Google, Yahoo!, Microsoft
and AOL). The participation of government representatives provides the resources to
53
Even without this explicit change to existing terms of service, if domain name registries, domain name
registrars, Internet service providers and WhoIs privacy protection service providers were to exercise
their discretion to terminate service to all individuals and companies that are found to be selling
counterfeit or illegal pharmaceuticals, particularly upon receiving notice from interested rights owners,
this would go a long way to curbing the explosive growth in online sales of counterfeit and illegal
medicines.
54
See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm (Nov. 19, 2009
FDA News Release) (last visited March 16, 2010).
{F0600247.5 }
16
ferret out and address the abuses, and also provides NCMEC determinations with
legitimacy that enables PSPs and others to confidently rely on its recommendations. The
participation of private players also helps to fund that project.
We would encourage a similar initiative with respect to the online trade in fake and
illegal prescription drugs. In addition, such a partnership might be able to adjudicate any
disputes that arise in implementing best practices, such as determining when a site is
engaged in unlawful activity requiring removal from search engine results or suspending
a domain name to disable the site.
D.
Suggestions on Public Education and Awareness Programs for Consumers.
(Supplemental Comment Topic 20)
Government agencies are engaged in education efforts to alert consumers about public
health risks posed by illegal online drug sellers, but more action is needed.55 ASOP
encourages government agencies, including the FDA, CDC and DEA in coordination
with the IPEC, as appropriate, to educate consumers about these risks. The public,
including patients and health care providers, need to know that that not all medicine
purchased online is sold by legitimate online pharmacies in accordance with U.S. laws.
Medicine should not be a “buyer beware” transaction; too much is at stake.
Public-private partnerships could facilitate public education programs focusing on online
pharmaceutical products. For example, as done in the past by the DEA, government
agencies could partner with search engine providers so that “pop-up” public safety
messages appear in response to a consumer’s select keyword search, e.g. “cheap
[trademarked drug name].” Such public-private partnerships could also arrange for
patient safety-focused websites to always appear at the top of the select keyword search
results (in the sponsored links section). ASOP also supports government-supported,
sector-focused grassroots educational efforts, including targeted materials with data that
health care providers, patient organizations, manufacturers and payors could share with
their constituencies about how to access safe and legitimate medicine through online
pharmacies.
Another method of increasing public awareness about how to avoid fake medicine when
shopping online for pharmaceuticals is for the FDA to facilitate the use of an FDA icon
that would link a patient to FDA-approved labeling for the particular medical product.
These links could be required to be used by any FDA-regulated entity in its own
communication and promotional activities, but may also be used voluntarily, according to
certain FDA standards and guidelines, by entities not currently regulated by the FDA
(such as by safe, legal online pharmacies). Legitimacy for non-regulated entities that are
approved to use such an FDA icon would be enhanced, and patient safety would be
improved by providing a quick and easy pathway to FDA-approved labeling. Risk of
55
In late 2009, the FDA warned the public about fake H1N1 treatments where they found that "products
represented online as Tamiflu (oseltamivir)” either contained no active ingredient or contained various
levels of active ingredient, but were not approved for sale in the United States.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm (last visited March
17, 2010).
{F0600247.5 }
17
unauthorized use of such an icon could be reduced by technical measures and by
increased penalties for counterfeiting that icon.56
*
*
*
We thank the IPEC for allowing ASOP this opportunity to provide comments on the
strategic plan to increase enforcement of U.S. intellectual property rights. Online drug
sellers are not above the law, nor are they beyond the reach of the law. We look forward
to working together with the IPEC to put in place a strategy and enforcement steps to
ensure that is true.
56
ASOP recommended this approach in comments to the FDA on the Promotion of Food and Drug
Administration-Regulated Medical Products Using the Internet and Social Media Tools, Docket No.
FDA-2009-N-0441.
{F0600247.5 }
18
APPENDIX B
June 25, 2012
The Honorable Kathleen Sebelius
Secretary
US Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Sebelius:
I am writing on behalf of the National Association of Boards of Pharmacy® (NABP®) to seek
your support for the creation of a comprehensive list of legitimate online pharmacy Web sites; a
list that is sorely needed in order to assist with protecting patients from the dangers of rogue and
illegal web sites and drug outlets. As you may know, NABP is the international association that
represents all boards of pharmacy in the United States, eight provinces of Canada, Australia, and
New Zealand. Our purpose is to serve as the independent, international, and impartial
Association that assists states and provinces in developing, implementing, and enforcing uniform
standards for the purpose of protecting the public health. Over the past 108 years, NABP has
been repeatedly called upon to develop programs and services to assist the state boards in their
charge to protect the public health, safety, and welfare.
The creation of this comprehensive list will enhance patient safety as it relates to purchasing
medicines on the Internet. It will do so by expanding upon the currently available information
compiled by NABP for its Verified Internet Pharmacy Practice SitesCM (VIPPS®) program,
which is recognized by the Food and Drug Administration (FDA), and our e-Advertiser
program, in order to create a user-friendly and accessible list of safe online pharmacies.
As background, the VIPPS program has accredited 30 Internet pharmacy sites representing over
12,000 pharmacies. In addition, in an effort to identify rogue operators, NABP has reviewed
more than 9800 Web sites selling prescription drugs. The findings are startling - only 3%, or 291,
of these sites appear to be in compliance with state and federal laws and NABP patient safety
and pharmacy practice standards. The other 97% are considered rogue. NABP findings include:
• 87% of these sites do not require a valid prescription
• 50% offer foreign or non-FDA-approved drugs
• 59% use online questionnaire to evaluate the patient
• 24% are located outside the US
The Honorable Kathleen Sebelius
June 25, 2012
Page 2
While we are proud to have accredited 30 Internet pharmacy sites and discovered nearly 300
potentially legitimately operating sites, there are estimated to be several thousand legitimately
operating sites that NABP has not reviewed. For this, we seek your assistance. We urge you to
reallocate end-of-year program funding to expand upon currently available information from
NABP to create a comprehensive list of safe online pharmacy Web sites. Attached is a proposal
for this effort that provides details on how the funding would be allocated.
As you can see, the vast majority of the work needed to create this list is already being
performed by NABP. FDA support of this effort would not oblige the federal government to
certify the legitimacy or safety of online pharmacies, or to monitor the Internet for rogue actors.
By providing NABP additional support to expand its existing capabilities, the list could be
created with limited cost and burden on the federal government, while creating a tool that may
contribute immeasurable value to the public health.
By supporting NABP’s creation of a comprehensive list, you will enable patients to be better
informed and have more choices for how to buy medications safely, and corporate actors to
voluntarily stop doing business with illegitimate online drug sellers.
Thank you for prompt consideration of this matter given the deadlines for reallocating FDA
resources. If you need any further information, please contact me via e-mail at ceo@nabp.net or
via phone at 847/391-4410. For additional background information about this issue, please
contact Melissa Madigan at mmadigan@nabp.net or 847/391-4487.
Sincerely,
NATIONAL ASSOCIATION OF
BOARDS OF PHARMACY
Carmen A. Catizone, MS, RPh, DPh
Executive Director/Secretary
cc: Deputy Secretary Bill Corr, US Department of Health and Human Services
NABP Proposal to FDA: To Provide Funding to Support the Creation of a
Comprehensive List of All Safe Online Pharmacy Websites
•
Proposal: To expand upon currently available information from the National Association of Boards of Pharmacy
(NABP) -- including the NABP VIPPS list which is recognized by state and federal government agencies including the
FDA 1 -- to create a comprehensive list of safe online pharmacy websites.
•
Given the NABP’s unique role in representing the state government agencies that license and regulate pharmacies and
pharmacists, this could be done directly through a sole source contract with NABP. NABP may wish to sub-contract
portions of the review and monitoring process to a qualified third-party with expertise in monitoring Internet pharmacies
such as LegitScript, the only third-party service currently endorsed by the NABP to conduct Internet pharmacy
monitoring and verification.
•
This benefits of FDA’s support to NABP to create a comprehensive list:
 Improves the accuracy and quality of information available to the public and good corporate actors, thereby
improving the likelihood that consumers and corporate actors will use the list
 Increases the ability of corporate actors to utilize the list to inform responsible business practices
 Reduces administrative and cost burden on FDA if the agency were to do this work itself
 Does not require FDA to certify the legitimacy of online pharmacy websites or the associated companies
 Does not require FDA to monitor approved websites
 Is available for no cost to consumers
Why This Approach will be an Efficient and Effective Alternative Means of Providing a Listing of Legitimate Online
Pharmacy Websites
•
The National Association of Boards of Pharmacy (NABP) and LegitScript, a third-party Internet pharmacy monitoring
service recognized by NABP, already have existing different but complementary capabilities in place, with NABP
focusing on pharmacy practice and LegitScript on cyber-intelligence. Illegal online drug seller operators are cybercriminals who go to great lengths to feign legitimately; consequently, expertise in both pharmacy practice and cybercrime are needed to efficiently and effectively evaluate these websites.
•
NABP has relationships with the various pharmacy boards and can quickly confirm licensure requirements, prior
discipline, and the results of any pharmacy inspections. LegitScript maintains the world’s largest database of Internet
pharmacies, and has an advanced process that monitors Internet pharmacies’ online presence and activities, capturing
screenshots, the Registrar, ISP, name servers, mail servers, registrant, geo-location, registration history, and other
important information required to white list (or, alternatively, prevent the white listing of) an Internet pharmacy.
The Value of a Comprehensive List
•
Patient safety. Patients who choose to fill a prescription online need an authoritative list to check whether the Internet
pharmacy is legitimate and safe.
•
Public education: Consumers users will continue to look to the Internet for prescription drugs, and one of the most
common questions they have is: “Which websites should I consider using to fill a prescription?” A comprehensive list
would play an invaluable role in public education, and provides a simple message to Internet users: “If you choose to
fill a prescription online, make sure that it’s on the safe list. If it isn’t, be aware of the dangers associated with unverified
Internet pharmacy websites.”
o
o
1
Indeed, in 2011, the Ad Council, the United States Patent and Trademark Office, FDA, and IPEC were
contemplating a nationwide consumer education campaign about online pharmacies. This campaign has not
yet moved forward, in part due to concerns that the Public Service Announcements would not be able to direct
consumers to a comprehensive list of safe online pharmacy websites.
Likewise, the list would advance FDA’s objectives to increase national consumer education campaign relating
to purchasing medicines on the Internet. Rather than continuing to direct consumers to the VIPPS list of
See FDA Website: http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm
online pharmacies which is only a partial list of legitimate online pharmacy websites, FDA’s campaign
message and website could direct consumers to the more comprehensive list (housed on NABP's website or
elsewhere as determined by the Secretary), or make a tool/widget available to enable access to the list.
o
•
NABP and LegitScript estimate such a comprehensive list could contain 1,250 – 1,500 legitimate online
pharmacy websites.
Internet compliance. Upstanding Internet companies -- like those in the Center for Safe Internet Pharmacies (CSIP),
including search engines, Domain Name Registrars, Registries, and payment processors -- have stated that they do
not want to do business with illegal online drug sellers. However, it is difficult for non-search engine companies to
require inclusion on the VIPPS list, as the VIPPS list does not represent the entire universe of Internet pharmacies that
adhere to applicable federal and state laws. Therefore, if they were provided with a comprehensive list of safe, lawabiding online pharmacy websites, it would be an extremely valuable tool to assist their voluntary compliance
programs. However, because there is no comprehensive list, illegal online drug selling operators are able to use this
vacuum to continue to target US consumers and businesses by claiming legitimacy.
Implementation and Draft Budget Options
Implementation and full-time operation of the list will require additional resources and staff from NABP or LegitScript due to the
increased and ongoing monitoring of the online pharmacy community. The draft budgets below outline these anticipated
additional operating costs that could be incurred by NABP and LegitScript. Actual costs could be slightly higher or lower,
depending on the terms of the contract.
A. Full, Immediate Implementation: This is the optimal result – a full, continually updated and monitored list of all
legitimate online pharmacy websites.
Service
Staff Needed
Professional evaluators –
pharmacists and lawyers
7 FTEs
Technical operations and
ongoing contract support
1 FTE
ESTIMATED TOTAL
8 FTEs
Estimated Additional Operating Costs
$125,000 - $150,000/person
Subtotal: $875,000 - $1,050,000/year
$125,000 /person
Subtotal: $125,000 /year
$1,000,000 - $1,175,000/year
B. Phased-In Implementation: While not ideal, should budget constraints limit the government’s ability to contract for full,
immediate implementation, phased-in implementation would nonetheless provide a way to advance the policy objective
of providing consumers and private sector companies with more complete information about legitimate online
pharmacy websites.
Concept: Use of an initial funding commitment (e.g. $500,000) for the review and approval of a few hundred online
pharmacy websites. NABP and LegitScript would simply approve as many online pharmacy websites as possible for
the list. At the end of a six-month or one-year period, HHS, NABP and LegitScript could reassess financial
opportunities and requirements, and provide an assessment of future costs required to move toward the development
of a fully comprehensive list.
The budget for this approach could be more flexible so long as there is an understanding that the number of online
pharmacies websites approved, and the rate at which they are approved, will drive the number of websites included on
the list in a given period of time.
BDDB01 9323441v1
APPENDIX C
In 2012, the Internet will be restructured.
Don’t let counterfeiters take advantage of it.
.pharmacy: look to the right of the dot
Until now, there have only been a limited number of “suffixes”
for website names: .com, .edu and about 20 others (plus country
codes, like .fr for France).
That’s all about to change. In January 2012, the Internet
Corporation for Assigned Names and Numbers (ICANN), which
oversees the structure of the Internet, will accept applications for
new generic top-level domains (gTLDs), like .legal, .hotel ––
and .pharmacy.
It’s imperative that .pharmacy be kept out of criminals’ and
counterfeiters’ hands, and be administered by a legitimate
organization.
That’s why the National Association of Boards of Pharmacy
(NABP), the impartial non-profit organization that represents
pharmacy regulators, is seeking your support in its application to
administer “dot-pharmacy” in a way that protects the public health.
.pharmacy: Look to the right of the dot
Public education:
Look to the right of the dot.
Rogue Internet pharmacies
are big business.
The online sale of unregulated medicines is
worth an estimated $75 billion per year –– and growing. Consider the following:
➡ The National Association of Boards of
Pharmacy has consistently found that
over 95% of Internet pharmacies
operate out of compliance with the law.
➡ LegitScript.com estimates that at any
one time, there are over 50,000
Internet pharmacies in operation.
➡ In September 2011, 50,000+ packages
shipped from rogue Internet pharmacy
websites were seized containing more
than 2.4 million illicit and counterfeit
pills worth $6.3 million. Samples of
drug products obtained were
composed of only talc and
starch."
➡ Prescription drug abuse is now the
second-highest drug abuse problem in
the US, ahead of cocaine,
methamphetamine and heroin
combined.
For the average Internet user, it’s tough to
tell the difference between a legitimate Internet
pharmacy and an illicit one.
“Dot-pharmacy” in the wrong hands would be
disastrous. But in the right hands, it can be a
valuable public education tool.
NABP’s application will specify that only
legitimate Internet pharmacies meeting all
regulatory standards, including pharmacy
licensure, drug authenticity and valid prescription
requirements, will be allowed to operate
a .pharmacy website.
This becomes a simple, quick way for
Internet users to confirm whether they are
dealing with a legitimate Internet pharmacy:
simply look to the right of the dot. If it’s
a .pharmacy website, then it meets legal
requirements for drug and patient safety.
.pharmacy: Look to the right of the dot
Dear Colleague:
Since the 1990s, rogue Internet pharmacies –– websites that sell unregulated (even counterfeit)
medicines, or prescription drugs without requiring a prescription –– have risked the health and
safety of Internet users across the world.
The National Association of Boards of Pharmacy (NABP) is the impartial non-profit organization
representing the government agencies that license and regulate pharmacies and pharmacists in
all 50 US states, the Canadian provinces and jurisdictions in Australia and New Zealand.
In January 2012, the Internet Corporation for Assigned Names and Numbers (ICANN), the
organization that oversees the structure of the Internet, will accept applications for new top-level
domains (TLDs), including “dot-pharmacy.” NABP will be submitting an application to ICANN
to administer “dot-pharmacy,” and we are seeking your support.
It’s critical that we act now. Rogue Internet pharmacies are big business: it’s inevitable that
someone will apply for –– and be granted –– the right to administer “dot-pharmacy.” Unless a
legitimate organization submits an application with international support, there is a real risk
that .pharmacy will end up unregulated and in the wrong hands. In the right hands, it can be a
helpful public education tool, telling Internet users that to verify whether an Internet pharmacy is
legitimate, they simply need to look to the right of the dot.
The process is an expensive one, costing an estimated $750,000 to $1,000,000. NABP will
partner with regulatory agencies outside of the US to ensure that the administration
of .pharmacy is international and takes other nations’ safety concerns into account. To ensure
that NABP’s application is to be successful, we are seeking financial commitments from credible
organizations that are also concerned about the negative effects of illegal online pharmacies.
Thank you for your support of NABP’s application to ensure that .pharmacy is developed as a
safe, legitimate section of the Internet that protects Internet users’ health. For more information,
please contact the NABP at 847 391 4406, or Libby Baney at the Alliance for Safe Online
Pharmacies, at 202 312 7434.
Sincerely,
Carmen Catizone
Executive Director, NABP
questions and answers
FAQs
Q. What happens if the NABP’s
application is unsuccessful?
A. It’s highly likely that ICANN will
award .pharmacy to someone. If
it is awarded to a less-thanlegitimate entity, that entity could
freely sell .pharmacy domain
names (even to non-pharmacy
entities).
What’s the cost?
• $750,000 - $1M (startup)
Includes $185,000 application
fee plus development costs
and additional fees
• $100,000+ (annually)
Includes $25,000 annual fee
and maintenance costs
Q. How will people know to
use .pharmacy?
A. It will be important to launch a
public education campaign
telling people who choose to fill
a prescription online to “look to
the right of the dot.” This
message can be spread via
partnerships with regulators,
organizations like the Alliance
for Safe Online Pharmacies,
and websites like awarerx.com.
Q. I’m a pharmacy. Why would I
want to spend the money to
apply to have a .pharmacy
domain name for my
website?
A. As new gTLDs are approved, it
becomes a new way of
organizing information on the
Internet. Our guess is
that .pharmacy websites will
eventually rank higher in search
engines’ results when a query is
run for a pharmacy.
1. Obtain funding commitments
for NABP from private
sector: pharmaceutical
manufacturers and
wholesalers, pharmacies,
and other interested
stakeholders
2. Obtain Letters of Support
from Governmental Entities
(FDA, DEA, FBI, IPEC, etc.)
Q. What about non-US
pharmacies?
A. New gTLDs must eventually be
global. NABP is committed to
working with regulatory
agencies in the EU, Asia and
across the globe to ensure that
legitimately operating
pharmacies around the world
have equal access to obtain
a .pharmacy website.
What are the next
steps?
To help, contact NABP at 847 391 4406,
or Libby Baney of the Alliance for Safe
Online Pharmacies at 202 312 7434.
Who will Contribute?
NABP is seeking financial
support and letters of
endorsement from the private
sector: pharmaceutical
companies, pharmacies,
wholesalers, non-profits,
government agencies and other
entities with a commitment to
Internet prescription drug safety.
The goal is to gain a broad base
of international support and
lessen the individual cost for
each contributor.
3. Obtain Letters of Support
from NGOs (CSIP, ASOP,
PhRMA, etc.)
4. Seek support from
international government
agencies and NGOs
(MHRA, Interpol, WGEO,
AIFA, IMB, bFARM, MEB,
etc.)
5. Compile and submit
Application beginning
January 12, 2012
Couldn’t someone
else just apply
for .pharma,
.drugstore, etc.?
Competing applicants are
allowed, but the application
process has a built-in
mechanism that is designed
to prevent the award of more
than one gTLD with similar
meaning, called “string
contention.” However, that
string contention process has
not yet been tested.
.pharmacy: Look to the right of the dot
APPENDIX D
Fact
Source Cite
Cannon, A. "Dicey Drugs From Abroad," U.S. News & Chicago native Todd Rode died after taking anti‐
World Report. Web. 18 June 2001. depressant pills that he purchased online from a foreign <http://www2.lib.purdue.edu:2059/login.aspx?direct
country. =true&db=mih&AN=4568535&site=ehost‐live>.
Date of publication
Patient Harm
Abuse‐able
6/18/2001 X
The World Health Organization (WHO) estimates that 8% of the bulk drugs imported into the U.S. are counterfeit, unapproved, or substandard.
US
International
Controlled Substance (US classification)
X
Seeking Theraputic Outcomes
Scope of Problem
Enforcement
Internet Ecosystem Response
Counterfeits
Other
X
X
X
Capell, K. and Timmons, S. "What's In That Pill? In Latin America, Fake Drugs are as Lucrative as Cocaine." BusinessWeek. Web. 18 June 2001. <http://www.businessweek.com/magazine/content/0
1_25/b3737153.htm>.
6/18/2001
Gilbert, G and Flaherty, P. "Doctors Medicate Strangers on Web: Some Physicians Face Own Troubles." Washington Post. Web. 23 Oct. 2003. <http://www.washingtonpost.com/wp‐
dyn/articles/A55845‐2003Oct20.html>.
Gilbert, G and Flaherty, P. "Doctors Medicate Dr. Ernesto A. Cantu prescribed more than 1 million Strangers on Web: Some Physicians Face Own doses of hydrocodone and other dangerous drugs while Troubles." Washington Post. Web. 23 Oct. 2003. working for the online drug seller thepillbox.com. These <http://www.washingtonpost.com/wp‐
dyn/articles/A55845‐2003Oct20.html>.
prescriptions were made based only on telephone A New Jersey mother previously treated for substance abuse received more than 800 doses of hydrocodone from an online drug seller
11/23/2003 X
X
X
X
11/23/2003 X
X
X
X
11/23/2003 X
X
X
X
11/23/2003 X
X
X
X
12/18/2006 X
X
X
X
7/6/2007 X
X
conversations. According to state and federal records, at least five of Dr. Cantu's customers were addicts or became addicts.
An Alabama patient suffering from chronic alcohol abuse and depression overdosed on hydrocodone purchased online and was hospitalized for nine months.
Gilbert, G and Flaherty, P. "Doctors Medicate Strangers on Web: Some Physicians Face Own Troubles." Washington Post. Web. 23 Oct. 2003. <http://www.washingtonpost.com/wp‐
dyn/articles/A55845‐2003Oct20.html>.
A San Francisco patient addicted to narcotics developed Gilbert, G and Flaherty, P. "Doctors Medicate Strangers on Web: Some Physicians Face Own liver damage after receiving multiple orders of the Troubles." Washington Post. Web. 23 Oct. 2003. <http://www.washingtonpost.com/wp‐
painkiller Darvocet from the Internet.
dyn/articles/A55845‐2003Oct20.html>.
Epstein, K. "Online Extra: The Deadly Side Effects of Craig Schmidt, a 30‐year‐old plastics salesman, Net Pharmacies." Business Week. Web. 18 Dec. 2006. purchased Xanax (an anxiety drug) and Ultram (a <http://www.businessweek.com/magazine/content/0
painkiller) from an online drug seller without seeing or 6_51/b4014070.htm>.
speaking to the doctor that prescribed the medications. After taking the drugs, he nearly died and has been left permanently impaired with brain damage that inhibits him from driving or even walking without stumbling.
Marcia Ann Bergeron of British Columbia, Canada died with 15 times the normal level of aluminum in her liver after purchasing Ambien from an online pharmacy.
“Counterfeit Pills Bought Online Led to Death, Coroner Confirms.” Canada.com. Web. 6 July 2007. <http://www.canada.com/victoriatimescolonist/news
/story.html?id=05142ca2‐9796‐4868‐bf42‐
76e939915fa5&k=29039>.
X
“Medications” from illegal online drug sellers have been Solomon S. "BC woman killed by fake drugs bought online" National Review of Medicine. 30 July 2007. found to contain powdered concrete, chalk, antifreeze, Vol. 4 No. 13. <http://www.nationalreviewofmedicine.com/issue/20
aluminum, tin, arsenic, and even boric acid.
07/07_30/4_policy_politics_13.html>. Last accessed June 20; see also, "L.E.A.D.E.R.’s Guide for Nurses". The Partnership for Safemedicines.org. Web. <http://www.safemedicines.org/resources/PSM%20L
EADERS%20Guide%20for%20Nurses%2010.25.pdf>. Last accessed June 20, 2012.
7/30/2007
X
In 2007, controlled substances accounted for 11 percent Mckee, J."Rogue Internet Pharmacies: is S. 980 the Answer? of dosages at legitimate pharmacies; they accounted for "NAAGazette. 6 Nov. 2007. 95 percent of dosages from illegal online drug sellers. <http://www.naag.org/rogue_internet_pharmacies_is
_s._980_the_answer.php>. Last accessed June 25, 2012.
11/6/2007
X
X
X
Fact
Source Cite
Griffin, D. and Fitzpatrick, D. “Widow: My Husband A man from Wichita, Kansas died from an accidental Died from Online Drugs.” CNN. Web. 21 May 2008. overdose of drugs he received from an online drug <http://articles.cnn.com/2008‐05‐
seller. He obtained these drugs without ever visiting a 21/health/online.drugs_1_legitimate‐prescription‐war‐
doctor. The man's wife described her husband as "an on‐drug‐abuse‐carmen‐catizone?_s=PM:HEALTH>. Last accessed June 20, 2012.
addict ‐‐ and that the Internet websites that sold him the drugs were his pushers."
Date of publication
Patient Harm
5/21/2008 X
Abuse‐able
US
X
X
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
Scope of Problem
Enforcement
Internet Ecosystem Response
Counterfeits
Other
X
X
X
Selena Walrond of the United Kingdom died after taking Camber, R. “Woman Dies After Buying Banned Slimming Pills on the Internet.” Mail Online. Web. 27 an unlicensed weight loss drug purchased from a June 2008.
Chinese website. The drug she ingested, dinitrophenol, was never licensed in the United Kingdome and has been banned in the United States since the late 1930s.
6/27/2008 X
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"Brand Jacking Index: Online Risks in Pharmaceutical "Online pharmacies have increased their market Market." Mark Monitor. Web. 2009. footprint, growing to an estimated $11 billion in sales in <https://www.markmonitor.com/download/bji/Brand
jackingIndex‐Summer2009.pdf>.
2009, up from an estimated $4 billion in 2007."
"The U.S. continues to host the bulk of online pharmacies, with 36% of the total. Both Germany and the Netherlands increased their share of online pharmacies hosted in those countries with 13% and 10%, respectively. Pharmacies hosted in the U.K. dropped from 12% in 2008 to 7% in 2009 while Canada grew slightly to 6%." Christian Hageseth III, M.D., of Fort Collins, Colorado was not licensed in California when he prescribed fluoxetine to 19‐year‐old, California resident John McKay through an Internet site. McKay later committed suicide, something he was at increased risk for from the fluoxetine. Dr. Hageseth was sentence to nine months in jail for his actions.
6/1/2009
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6/1/2009
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"Brand Jacking Index: Online Risks in Pharmaceutical Market." Mark Monitor. Web. 2009. <https://www.markmonitor.com/download/bji/Brand
jackingIndex‐Summer2009.pdf>
Sorrel, A. "Doctor Gets Jail Time for Online, Out‐of‐
State Prescribing." American Medical News. Web. 8 June 2009. <http://www.ama‐
assn.org/amednews/2009/06/01/prsd0601.htm>.
6/8/2009 X
"FDA Warns of Unapproved and Illegal H1N1 Drug An order purchased online by the FDA for Tamiflu Products Purchased Over the Internet" FDA Web 15 arrived in an unmarked envelope with a postmark from Oct 2009.<http://www.fda.gov/NewsEvents/Newsroom/P
India, consisted of unlabeled, white tablets taped ressAnnouncements/2009/ucm186861.htm>. Last between two pieces of paper. When analyzed by the accessed June 27 2012. FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.
Thompson, L. "Fraud Alert Over Fake Diet and Viagra Rebecca Farrell fell victim to a diet pill scam after Pills." The Times. Web. 30 Jan. 2010. spotting an advertisement on Facebook. The 25‐year‐ <http://www.timesonline.co.uk/tol/money/article700
old Manchester, UK woman signed up for a free trial of 8367.ece>.
"acai berry" and "life cleanse" tablets from a company called viv3, paying only £1 for postage and packaging using her debit card. The tablets arrived, but they made Ms. Farrell feel sick and she stopped taking them after a week. She then noticed that two debits of £76.73 each had been taken from her bank account, which she had not authorized. 10/15/2009
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A British woman spent $106 (£66) on buying Proactoltm Thompson, L. "Fraud Alert Over Fake Diet and Viagra Pills." The Times. Web. 30 Jan. 2010. (a diet tablet) online. She used the product for two <http://www.timesonline.co.uk/tol/money/article700
weeks, exactly as directed. However, instead of losing 8367.ece>.
weight, her stomach became very swollen and she gained 6 lbs. Two days after she stopped taking the product, the woman suffered from constant diarrhea for
four days.
Fact
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Date of publication
Patient Harm
Abuse‐able
US
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
Scope of Problem
Enforcement
Internet Ecosystem Response
Counterfeits
Favole, J. "U.S. Charges Two With Illegally Importing A man started taking an authentic, government‐
Diet Medicines." The Wall Street Journal. Web. 26 approved version of a GlaxoSmithKline PLC drug, March 2010. tm
Alli , when he found a Web site offering purported <http://online.wsj.com/article/SB1000142405274870
4094104575144560727634680.html>.
cheaper versions of the medicine. The man ordered the pills and began suffering from headaches, chills and heart‐attack‐like symptoms.
3/26/2010 X
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4/12/2010 X
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"Intellectual Property: Observations on Efforts to "Counterfeit pharmaceuticals may include toxic or Quantify the Economic Effects of Counterfeit and nonactive ingredients, correct ingredients in incorrect Pirated Goods." United States Government quantities, or other mislabeling. These products can be Accountability Office. Web. 2010. ineffective in treating ailments or may lead to adverse <http://www.gao.gov/new.items/d10423.pdf>.
reactions, drug resistance, or even death." As an example, "the FDA in recent years has found cases of a counterfeit HIV/AIDS drug that contained nonsterile tap water instead of an active ingredient; a fake schizophrenia medication that contained aspirin; a counterfeit influenza vaccine; and a misbranded cough suppressant that caused the death of five consumers." An estimated 1 in 6 (36 million) American adults have purchased prescription medication via the Internet without a valid prescription.
X
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Besson, C. "Thirty‐Six Million Americans Have Bought Medications Online Without a Doctor’s Prescription." Partnership at Drugfree.org. Web. 14 Dec. 2010. <http://www.drugfree.org/newsroom/thirty‐six‐
million‐americans‐have‐bought‐medications‐online‐
without‐a‐doctor%E2%80%99s‐prescription‐2>.
12/14/2010
X
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FDA purchased and analyzed several products that were "The Possible Dangers of Buying Medicines over the Internet". FDA Web 26 Jan represented online as Tamiflu (oseltamivir). One of the 2011.<http://www.fda.gov/ForConsumers/Consumer
orders, which arrived in an unmarked envelope with a Updates/ucm048396.htm> Last accesed June 27 2012.
postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.
1/26/2011
The FDA has received reports from patients ordering Ambien, Xanax, Lexapro, and Ativan. Instead of receiving the drug they ordered, customers received foreign versions of Haldol, a powerful anti‐psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol
X
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"The Possible Dangers of Buying Medicines over the Internet". FDA Web 26 Jan 2011.<http://www.fda.gov/ForConsumers/Consumer
Updates/ucm048396.htm> Last accesed June 27 2012.
1/26/2011 X
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2/25/2011 X
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Ryan Haight died from adverse reactions to painkillers Liang, B., "Don’t Underestimate the Danger of Drugs from Abroad." The San Diego Union‐
that he purchased over the Internet. He was only Tribune. Web. 25 Feb. 2011. required to fill out a questionnaire that was “examined” < http://www.signonsandiego.com/news/2011
by a doctor who had never met him.
/feb/25/dont‐underestimate‐the‐danger‐of‐
drugs‐from‐abroad/>.
An emergency room doctor, from Texas, suffered a stroke from ingesting counterfeit Alli from www.2daydietshopping.com. The counterfeit Alli was produced using the controlled substance sibutramine, rather than the approved ingredient orlistat, and then shipped to the US for redistribution. This site was operated by two individuals. The first is a Chinese citizen who has been sentenced to 7 years in federal prison, $504,815.39 in restitution to victims, and deportation following his sentence. The second US citizen received 3 years probation.
U.S. Department of Justice Press Release. Web. 3 June 2011. <http://www.fda.gov/ICECI/CriminalInvestigations/uc
m257912.htm>.
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In Ireland, the death of two men was believed to be the Lucey, A. Hough, J. “Internet Drugs Linked to Deaths.” IrishExaminer.com. Web. 17 June 2011. result of ingested counterfeit tranquillizers purchased <http://www.examiner.ie/ireland/internet‐drugs‐
linked‐to‐deaths‐158146.html#ixzz1To1nYbpQ>.
over the Internet.
Steven Kovacs, a 22 year old, began to self‐
medicate through online Internet drug sellers and died on June 8th 2009, by mixing Adderall, Xanax, and Oxycodone.
Date of publication
Patient Harm
Abuse‐able
6/17/2011 X
X
7/10/2011 X
X
US
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
Scope of Problem
Enforcement
Internet Ecosystem Response
X
Counterfeits
Other
X
Larrocco, P. "Mom, Schumer urge Web pharmacy crackdown". Newsday 10 July 2011. Web. <http://www.newsday.com/long‐island/mom‐
schumer‐urge‐web‐pharmacy‐crackdown‐1.3016581>. Last accessed June 20, 2012. X
X
Large rogue Internet drug sellers can generate between Krebbs, B. "Americans Use Spam for Cheaper Prescription Drugs." Technology Review. 11 July 2011. $1 million and $2.5 million in sales each month.
Web. Internet security experts estimate that 25% of all email is spam advertising counterfeit and/or unlicensed, unapproved drugs.
<http://www.technologyreview.com/web/38023/pag
e1/>.
Jackson, G., Patel, S. and Khan, S. (2012), Assessing the problem of counterfeit medications in the United Kingdom. International Journal of Clinical Practice, 66: 241–250. doi: 10.1111/j.1742‐1241.2011.02826.
7/11/2011
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"Peter Pitts, president of The Center for Medicine in the Toscano, P. “The Dangerous World of Counterfeit Prescription Drugs,” USA Today. Web. 7 Oct. 2011. Public Interest and former FDA associate commissioner, <http://www.usatoday.com/money/industries/health
estimates that in 2010, activities related to counterfeit /drugs/story/2011‐10‐09/cnbc‐drugs/50690880/1>.
drugs generated $75 billion, based on information obtained from government organizations. He expects it to grow by 20 percent annually in the coming years." X
In August 2011, the U.S. Department of Justice required Toscano, P. “The Dangerous World of Counterfeit Prescription Drugs,” USA Today. Web. 7 Oct. 2011. Google to forfeit $500 million in revenue generated by <http://www.usatoday.com/money/industries/health
online ads for prescription drug sales by rogue online /drugs/story/2011‐10‐09/cnbc‐drugs/50690880/1>.
drug sellers "…[W]hen $500 million is spent by a network of independent retailers for search marketing, it is likely not a stretch to assume there is a lucrative business behind the scenes."
10/7/2011
Toscano, P. “The Dangerous World of Counterfeit "Groups that have been associated with counterfeit Prescription Drugs,” USA Today. Web. 7 Oct. 2011. drugs or online pharmacies include the Russian Mafia, <http://www.usatoday.com/money/industries/health
/drugs/story/2011‐10‐09/cnbc‐drugs/50690880/1>.
the Chinese triads, the Japanese Yakuza, and the Neapolitan Camorra, among others, who also engage in a range of counterfeiting activities, according to the U.N."
"Intellectual Property Rights Violations: A Report on "Many Americans trust Canadian pharmacies will Threats to United States Interests at Home and provide them with genuine drugs identical to what they Abroad." National Intellectual Property Rights Coordination Center. Web. November 2011. would obtain from their local pharmacy, only for a cheaper price. In contrast, a poll found 54 percent of <http://www.iprcenter.gov/reports/IPR%20Center%2
0Threat%20Report%20and%20Survey.pdf/view >
Americans distrust drugs made in India and 70 percent distrust drugs made in China. Internet pharmacies fool many customers by implying they are based in Canada. There are fewer than 300 government authorized online pharmacies in Canada but more than 11,000 fake Canadian pharmacies operating online from overseas jurisdictions. Some of these Canadian pharmacies are based in Russia or India and distribute counterfeit pharmaceuticals produced in China." X
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11/1/2011
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Fact
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An FDA investigation found 88 percent of the 2,069 drug "FDA Says Consumers Continue to Buy Risky Drugs Online". FDA Web 1 Nov 2011. packages intercepted appeared to be prescription <http://www.fda.gov/NewsEvents/Newsroom/PressA
nnouncements/2007/ucm109018.htm>. Last accessed medicines available in the United States. Of the remaining products, some were dietary supplements, June 27 2012.
some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA‐approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
Date of publication
11/1/2011
Patient Harm
Abuse‐able
US
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
X
Scope of Problem
Enforcement
X
X
Internet Ecosystem Response
Counterfeits
"The Pharmaceutical [Security] Institute (PSI) recently Toscano, P. “The Dangerous World of Counterfeit Prescription Drugs,” USA Today. Web. 7 Oct. 2011. analyzed total seizures and found that in 2010, the most <http://www.usatoday.com/money/industries/health
/drugs/story/2011‐10‐09/cnbc‐drugs/50690880/1>.
dramatic trend in counterfeiting took place in the 'metabolism' category—up by 182 percent, a category that includes diabetic medical products such as Glyburide…. Tom Kubic, president and CEO of PSI, told CNBC.com that 'with the global rise of diabetes, we see a concomitant interest of counterfeiters in making counterfeit versions of drugs needed to treat this condition."
11/7/2011
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11/7/2011
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11/30/2011
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Toscano, P. “The Dangerous World of Counterfeit "The WHO and other government groups have also Prescription Drugs,” USA Today. Web. 7 Oct. 2011. tracked examples of counterfeit drugs and list examples <http://www.usatoday.com/money/industries/health
/drugs/story/2011‐10‐09/cnbc‐drugs/50690880/1>.
from brand names such as Lipitor (cholesterol) and Zyprexa (anti‐psychotic) to anti‐diabetics, anti‐obesity, and anti‐malarial drugs. The FDA confirmed that counterfeit versions of legitimate drugs, including Ambien, Xanax, Lexapro, and Ativan, are available for Americans to purchase online. Although counterfeit drug production was originally concerned with lifestyle medications treating non‐life threatening conditions, the industry has expanded to produce nearly every type of medicine."
A Consumer Reports National Research Center survey "Is It Safe to Buy Medication from Online Pharmacy Sites Outside U.S.?" Fox 59 WXIN. 30 Nov. 2011. Web. found that in 2011 nearly three million people ordered a < http://www.fox59.com/news/wxin‐online‐
prescription drug from an online drug seller outside the pharmacy‐sites‐is‐it‐safe‐to‐buy‐medicines‐from‐
online‐pharmacy‐sites‐outside‐us‐
U.S.
20111130,0,7189230.column>.
Abuse of controlled prescription medications in the Jena, Goldman, et al. “Prescription Medication Abuse and Illegitimate Internet‐Based Pharmacies.” Annals United States, available through traditional of Internal Medicine. 2011. Web and Print. 848‐850. channels and able to be purchased online without a <http://www.annals.org/content/155/12/848.full.pdf
+html>
prescription, exceeds that of all illicit drugs combined except marijuana and has grown considerably in the past decade. 12/20/2011
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Fact
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Jena, Goldman, et al. “Prescription Medication Abuse Abuse of controlled prescription medications in the and Illegitimate Internet‐Based Pharmacies.” Annals United States, available through traditional channels of Internal Medicine. 2011. Web and Print. 848‐850. and able to be purchased online without a prescription, <http://www.annals.org/content/155/12/848.full.pdf
+html>
exceeds that of all illicit drugs combined except marijuana and has grown considerably in the past decade. Experts believe that approximately 10% of prescription Goldwert, L. "Online pharmacies feed prescription drug abuse", NY Daily News. Web. 20 Dec. 2011. drug users get their meds online — and they emphasize <http://articles.nydailynews.com/2011‐12‐
20/news/30540082_1_prescription‐drugs‐online‐
that the estimation is probably on the low end. Date of publication
12/20/2011
Patient Harm
Abuse‐able
US
X
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
X
Scope of Problem
Enforcement
Internet Ecosystem Response
Counterfeits
Other
X
pharmacies‐internet>
A site designed to look like illegal online pharmacies generated 593,232 views (182,602 unique visitors) in 9 weeks. It is anticipated that if this site were actually selling drugs it would have generated between 15 to 43 million dollars and 1 million visitors.
European Alliance for Access to Safe Medicines, "Counterfeiting the Counterfeiter". Web. 2012. <http://v35.pixelcms.com/ams/assets/312296678531
/100145_EAASM%20CTC%20small_report%202012_V
15.pdf>
A German firm demonstrated that emailed "spam" solicitation for drug sales works better, 8% response rate, than the industrial average, 5% response rate.
European Alliance for Access to Safe Medicines, "Counterfeiting the Counterfeiter". Web. 2012. <http://v35.pixelcms.com/ams/assets/312296678531
/100145_EAASM%20CTC%20small_report%202012_V
15.pdf>
12/20/2011
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1/1/2012
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1/1/2012
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Illegal online drug sellers disregard State and Federal "Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October laws and pharmacy practice standards and dupe 2011." The National Association of Boards of Pharmacy. Web. 2 Jan. 2012 patients by promising "deals" on medicine ‐‐ even <http://www.nabp.net/programs/assets/IDOI_Report
abusable controlled substances ‐‐ in exchange for _10‐11.pdf>; see also LegitScript. Web. 2 January sensitive personal health and financial information. This 2012 <www.legitscript.com>.
is not a rare occurrence; more than 96% of websites that offer to sell prescription medications are doing so in violation of U.S. law.
1/2/2012
A 2011 White House Report called prescription drug abuse "the nation's fastest growing drug problem."
184 Internet sites offering statins were surveyed, 92% of these sites did not include information on contraindications for statins, 96% of the sites didn't include information on adverse symptoms to watch out for.
An analysis of 2,383 seized ‘Viagra’ samples carried out by Pfizer found that only 14% were authentic. “Epidemic: Responding to America’s Prescription Drug Abuse Crises. The White House, 2011 Report. Web. 2 Jan. 2012. <http://www.whitehouse.gov/sites/default/files/ondc
p/issues‐content/prescription‐
drugs/rx_abuse_plan.pdf>.
Reinberg, S. " It's 'Buyer Beware' When Getting Statins Off the Internet", US News. Web 2 Feb. 2012. < http://health.usnews.com/health‐
news/news/articles/2012/02/02/its‐buyer‐beware‐
when‐getting‐statins‐off‐the‐internet>
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2/2/2012
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2/26/2012
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Their, D."Review: Market Flooding With Dangerous Counterfeit Drugs", Forbes. Web. 26 Feb. 2012. <http://www.forbes.com/sites/davidthier/2012/02/2
6/review‐market‐flooding‐with‐dangerous‐counterfeit‐
drugs/>.
Multiple surveys estimate at least 3% of controlled prescription drug abusers purchase their drug of choice online.
Prescription Medication Abuse and Illegitimate Internet‐Based Pharmacies ANN INTERN MED December 2011 155:12848‐850
A US study found that 85% of the 159 websites surveyed that offer controlled substances did not require a prescription.
Jackson et al. International Journal of Clinical Practice. 66.3, pp241–250. (March 2012).
2/27/2012
3/1/2012
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Fact
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In Febuary of 2012 the FDA reported about a chain of Keteyian, A. "Fake Avastin shipper tied to Canadadrugs.com", CBS News, Web 3/22/12.< fake Avastin which caused patients to receive http://www.cbsnews.com/8301‐505263_162‐
subtheraputic cancer treatment. While the origins of 57402214/fake‐avastin‐shipper‐tied‐to‐
canadadrugs.com/>. Last accessed June 28 2012.
the fake Avastin remain unknown the FDA are investigating two Canadians in the distribution. Kris Thorkelson, CEO of Canadadrugs.com and his brother‐in‐
law, Tom Haughton, owner of several pharmaceutical distributors and thousands of domain names. Tom admits his distribution companies are both one of Canadadrugs.com's key suppliers and responsible for at least 36 vials of counterfeit Avastin that entered physician practices. Canadadrugs.com sells to both physician practices as well as individual patients in the US.
Date of publication
Patient Harm
3/22/2012
Abuse‐able
US
X
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
Scope of Problem
Enforcement
X
X
Internet Ecosystem Response
Counterfeits
Other
X
X
X
X
X
IPEC March/April 2012 Newsletter. "Intellectual On April 24, two men pleaded guilty and were Property Spotlight", sentenced for smuggling counterfeit and <http://www.ice.gov/news/releases/1204/120424stlo
misbranded pharmaceuticals into the U.S. Both men uis.htm>
operated an Internet business in Israel that used multiple websites to illegally sell large amounts of prescription drugs to U.S. purchasers. In total, they sent about 9,000 separate drug shipments to U.S. purchasers, generating over $1.4 million in gross proceeds. Ultimately, one man received 10 months in federal prison, was fined $30,000 and forfeited $50,000. The other man received one year of probation, was fined $15,000 and forfeited $15,000.
4/1/2012
The World Health Organization (WHO) estimates that counterfeiting, substandard formulation, contamination, fakery, and active ingredient substitution constitute a $431 billion market; 83.4 percent of that, or $359 billion, had direct public health impact, representing a 300 percent increase over such clinically dangerous sales in 2000. Garrett, L. "Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply", Council on Foreign Relations Press, May 2012. < http://www.cfr.org/global‐health/ensuring‐safety‐
integrity‐worlds‐drug‐vaccine‐medicines‐
supply/p28256>
"Buyer beware" is not an appropriate warning, as patients and physicians cannot typically discern the authenticity and safety of the treatments they use.
Garrett, L. "Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply", Council on Foreign Relations Press, May 2012. < http://www.cfr.org/global‐health/ensuring‐safety‐
integrity‐worlds‐drug‐vaccine‐medicines‐
supply/p28256>
Garrett, L. "Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply", Council on Foreign Relations Press, May 2012. < http://www.cfr.org/global‐health/ensuring‐safety‐
integrity‐worlds‐drug‐vaccine‐medicines‐
supply/p28256>
"Action 9 Investigates online pharmacy scam" Web 11 June 2012. <http://www.wftv.com/news/news/local/action9‐
investigates‐dea‐scam/nPQ6m/>. Last accessed June 27 2012.
GoDaddy.com, has removed eighty thousand illegal rogue sites in just two years, this is estimated to represent 2 percent of illegal online drug sellers websites worldwide
4 years after purchasing prescriptions drugs online, several Florida families were called and threatened. Criminals pretending to be the DEA requested large somes of money to be wired or to go to jail for their prior purchases.
About 90 percent of counterfeit drugs... are at some point marketed and sold on the Internet.
Catherine Dauphin, a World Health Organization expert on pharmaceutical policy, stated that more than half the drugs sold on Internet sites without approval from governments were fake.
5/19/2012
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5/19/2012
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6/11/2012 X
"Internet led to global 'explosion' of fake drugs". Medicalspress. Web 14 June 2012. <http://medicalxpress.com/news/2012‐06‐internet‐
global‐explosion‐fake‐drugs.html>. Last accessed June 27 2012.
"Internet led to global 'explosion' of fake drugs". Medicalspress. Web 14 June 2012. <http://medicalxpress.com/news/2012‐06‐internet‐
global‐explosion‐fake‐drugs.html>. Last accessed June 27 2012.
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6/14/2012
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6/14/2012
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Date of publication
Fact
Source Cite
At any one time there are roughly 40,000 active rogue "Legitscript ‐ Enforcement Page". Legitscript. Web. <http://www.legitscript.com/services/enforcement>. websites pushing counterfeit or otherwise illegitimate Last accessed June 20, 2012.
medicines to U.S. consumers, often without requiring a doctor’s evaluation in accordance with U.S. state and Date Unknown
federal laws.
Patient Harm
Abuse‐able
US
International
Controlled Substance (US classification)
Seeking Theraputic Outcomes
Scope of Problem
X
Enforcement
Internet Ecosystem Response
Counterfeits
X
Other