Searching for safety: Addressing search engine, website, and provider accountability for illicit online drug sales

American Journal of Law and Medicine

Volumn 35, Issue 1, 2009, Pages 125-184

  Liang, Bryan A ^a,b   Mackey, Tim ^a  

^a CALIFORNIA WESTERN SCHOOL OF LAW   (United States)

^b University of California   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; COMMERCIAL PHENOMENA; CONSUMER; DRUG CONTROL; DRUG INDUSTRY; ECONOMICS; HUMAN; INTERNET; LEGAL ASPECT; LICENSING; PHARMACY;

COMMERCE; CONSUMER PARTICIPATION; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; HUMANS; INTERNET; LICENSURE, PHARMACY; PHARMACEUTICAL PREPARATIONS; PHARMACEUTICAL SERVICES;

EID: 68049084526     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880903500104     Document Type: Article

References (352)

1. See U. S. CENSUS BUREAU, STATISTICAL ABSTRACT OF THE UNITED STATES: 2008 718 (2008), available at http://www.census.gov/prod/2007pubs/08abstract/ infocomm.pdf.
2. Bryan A. Liang, Fade to Black: Importation and Counterfeit Drugs, 32 AM. J. L. & MED. 279, 285-287 (2006).
3. Bryan A. Liang, A Dose of Reality: Promoting Access to Pharmaceuticals, 8 WAKE FOREST INTELL. PROP. L. J. 301 (2008).
4. If done correctly, there are also some legitimate potential benefits that Internet pharmacies offer as a delivery model over traditional "brick and mortar" pharmacies that consumers have cited as reasons for purchasing online. These include 24/7 access, convenience of delivery to one's home, and more efficient centralized order-processing systems to reduce overall cost passed on to the consumer. See Constance. H. Fung et al., Controversies and Legal Issues of Prescribing and Dispensing Medications Using the Internet, 79 (2) MAYO CLIN. PROC. 188, 189 (2004).
5. See Stephanie Y. Crawford, Internet Pharmacy: Issues of Access, Quality, Cost, and Regulation, 27 (1) J. Med. Syst. 57, 58 (2003) ($20 billion estimate) ;
6. Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 (1) J. L. MED. & ETHICS 98, 98 (2000) ($15 billion estimate).
7. See NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, "YOU'VE GOT DRUGS!" V: PRESCRIPTION DRUG PUSHERS ON THE INTERNET 1 (2008), http://www.casacolumbia.org/articlefiles/531- 2008%20You%27ve%20Got%20Drugs%20V.pdf.
8. See id. at 2. Indeed, in a 2007 hearing before the Senate Judiciary Committee, it was reported that Internet dealers of controlled substances increased by over 70% in the last year.
9. See Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking: Hearing Before the S. Judiciary Comm., 109th Cong. (2007) (statement of Joseph Califano, Jr., Chairman and President, National Center on Addiction and Substance Abuse at Columbia University), available at http://judiciary.senate.gov/hearings/testimony.cfm?id=2755&wit-id=6464. However, details regarding online sales of these controlled substances indicates escalating dangers. The Drug Enforcement Administration ("DEA") in its investigations found that in 2006, fully 95% of all Internet prescription sales involved controlled substances, compared with a maximum of 11% of those types of prescription drugs filled in traditional, regulated pharmacies.
10. See NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, supra note 6, at 4. DEA concluded that on the basis of these figures, unregulated online sales are primarily drug purchases for abuse.
11. See id.
12. We avoid the use of "Internet pharmacies" in this paper because the websites of interest that are selling drugs are not true pharmacies, but instead are illicit operations.
13. See NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, supra note 6, at 5-6 (describing portal, anchor, and Internet drug seller pyramid) ;
14. National Association of Board of Pharmacies - Frequently Asked Questions, http://www.nabp. net (last visited Feb. 1, 2009).
15. Internet search of the words "internet" & "pharmacy, " Google.com, May 9, 2008.
16. See Erick Eckholm, Most Drug Web Sites Breaking Federal Law, SFGATE. COM, July 9, 2008, available at http://www.sfgate.com/cgibin/article.cgi?f=/c/a/ 2008/07/08/MNJ711M1KB. DTL.
17. * as well as other logos to promote the image of legitimacy).
18. See Frank B. Palumbo et al., Policy Implications of Drug Importation, 29 CLINICAL THERAPEUTICS 2758 (2007) (noting increased risks of counterfeits and tainted medications through consumer drug importation using the Internet) ; National Association of Board of Pharmacies - Buying Medicine Online, http://www.nabp. net (last visited Feb. 1, 2009).
19. See Eckholm, supra note 11.
20. See, e.g., Peter Gernburd & Alejandro R. Jadad, Will Spam Overwhelm Our Defenses? Evaluating Offerings for Drugs and Natural Health Products, 4 PLoS MED., Sept. 18, 2007, available at http://medicine.plosjournals.org/perlserv/? request=getdocument&doi=10.1371/journal.pmed.0040274&ct=1 (discussing study that found easily accessed online purchasing without a prescription from spam e-mail and reporting 2/3 orders resulted in no products) ;
21. Patrick White, No Prescription, No Problem, globeandmail.com, Sept. 18, 2007, http://www.theglobeandmail.com/servlet/story/RTGAM.20070918.wldrugs18/ BNStory/Perso nalTech (reporting on the PLoS study).
22. See Oliver, supra note 5, at 98;
23. World Health Organization, Medical Products and the Internet: A Guide to Finding Reliable Information (1999), http://www.who.int/medicinedocs/index.fcgi? a=d&d=Js2277e.6&1=fr#Js2277e.6 (last visited Feb. 1, 2009) ;
24. see also Jonathan Ma, Lowering Prescription Drug Prices in the United States: Are Reimportation and Internet Pharmacies the Answer?, 15 S. CAL. INTERDISC. L. J. 345, 362-363, 370 (2006). Ma notes that: It is also not always an easy task to distinguish between a legitimate Internet pharmacy website and one that seeks to deceive consumers by selling adulterated or inappropriately prescribed drugs.... With current technology, it can also be quite easy for a company to shirk responsibility and avoid risk exposure for operating an Internet pharmacy simply by covering up the source of supplied medication and the responsible party.... Since an Internet pharmacy prescription is arranged without personal interaction, there is no practical way for a patient to verify a prescribing doctor's credentials or training or even the appropriateness of medical attention provided.... There is no way for a patient to ensure that a prescribing physician actually is who he claims to be and that the physician is practicing lawfully.... Other dangers posed to consumers using Internet pharmacies involve fraudulent or questionable business practices and consumer access to unapproved or counterfeit drugs.... [W]hen weighed against the serious health and safety risks associated with Internet pharmacies, the limited and uncertain potential cost savings do not make Internet pharmacies a viable solution to the problem of high prescription drug prices. Id. (citations omitted).
25. See infra notes 21-28 and accompanying text (discussing why consumers purchase online) ;
26. see also Thomas Ginsberg, Online Drug Bust is Casting a Wide Net: Some Customers with Valid Medical Needs Were Using the Internet Pharmacy. Experts Say Battling Sites Will Be Hard, PHILA. INQUIRER, Apr. 22, 2005, at B1 (describing the case of patient Nina, who used an illegal online drug seller to obtain life-saving drugs after losing health insurance). It is interesting to note that at least some of the price differential driving high risk pharmaceutical purchasing may come from the legal system itself, or a "tort tax".
27. See, e.g., Brian Crowley, Americans Pay Big Tort Tax on Drugs, PROVIDENCE J., Jan. 6, 2009, available at http://www.projo.com/opinion/contributors/ content/CT-crowley6-01-06-09-HVCQDKJ-v13.3e33db5.html (summarizing studies showing tort tax effect on pharmaceutical pricing that drives U. S. prices higher than Canada).
28. See Buyer Beware: The Danger of Purchasing Pharmaceuticals on the Internet: Hearing Before the Subcomm. on Investigations Comm. on Governmental Affairs, 108th Cong. (2004) (statement of Karen Tandy, Administrator, Drug Enforcement Administration), available at http://www.usdoj.gov/dea/pubs/ cngrtest/ct072204.html.
29. See, e.g., Joseph Menn, Spammers Are Making Real Money on Fake Drugs, L. A. TIMES, June 11, 2008, available at 2008 WLNR 10976454 (describing how major spammers created the virus Storm to infect millions of computers and has coordinated with Russian drug counterfeiter for large profits).
30. See, e.g., Joe Cantlupe, Victim's Mother Pleads for Online-Drug Clampdown, SIGNONSANDIEGO. COM, June 18, 2004, http://www.signonsandiego.com/ uniontrib/200406l8/news-lnl8drugs.html (reporting on Ryan Haight, a 17 year old honors student who died because of prescription drugs obtained over the Internet). The Ryan Haight case illustrates the need for strictly regulated online drug sales to place a barrier between illicit sellers and vulnerable buyers.
31. See Jarrod Booker, Action Urged on Internet Drugs, NEW ZEALAND HERALD, Sept. 30, 2008, available at http://www.nzherald.co.nz/nz/news/article.cfm?c-id= 1&objectid=10534908 (describing the case of mental health patient Graham David Goodwin who died after taking drugs ordered from an Indian mail order drug seller through the Internet) ;
32. Drew Griffin & David Fitzpatrick, Widow: My Husband Died from Online Drugs, CNNHEALTH. COM, May 22, 2008, http://www.cnn. com/2008/HEALTH/05/21/ online.drugs/index.html (describing case of patient who bought muscle relaxant prescription drugs online, became addicted, and overdosed) ;
33. Sam Solomon, BC Woman Killed by Fake Drugs Bought Online, 4 NAT'L REV. MED. (2007), available at http://www.nationalreviewofmedicine.com/issue/2007/07- 30/4-policy-politics-13.html (describing the case of Marcia Bergeron, a fifty-seven year old women who was killed by counterfeit drugs purchased online) ;
34. Mallika Marshall, Online Pharmacies: Dangerous Prescription?, CBS NEWS, May 31, 2008, http://www.cbsnews.com/stories/2008/05/31/earlyshow/health/ main4142407.shtml. Marshall notes that: One man who was suffering from severe back pain received an e-mail offering Xanax and Ultam, two pain-killers. He took one of each tablet, suffered a heart attack and went into a coma. The tablets contained four times the usual starting dosage. A woman who decided she suffered from chronic fatigue syndrome bought steroids online, and ended up with severe cataracts, so severe they couldn't be removed.... In some cases, the problem is the pills are either placebos, made of sugar with only a minimal amount of the drug in them. But some have been found to contain other substances that are dangerous, even potentially deadly. One offshore drugmaker was manufacturing Viagra tablets that were 85-percent cement. There are reports of Viagra that is actually made of vodka. Allergy medications were found to contain steroids, to suppress the symptoms. You just don't know what these counterfeit pills may be made of. Id.
35. See infra notes 143-52 and accompanying text (describing the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a federal effort to respond to the dangers of Internet drug sellers).
36. See supra note 17 and accompanying text. Note that unfortunately, many of the drugs ordered online by patients are not cheaper at the online site. See, e.g., Press Release, U. S. Food and Drug Administration, FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet: Practice Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing (July 2, 2007) available at http://www.fda.gov/bbs/topics/NEWS/20O7/NEW0l663.html (noting large fraction of drugs purchased over the Internet available more cheaply in the United States).
37. See infra Section IV.
38. See sources cited supra note 20;
39. see also NATIONAL CONSUMERS LEAGUE, COUNTERFEIT DRUG SURVEY (2004), http://www.nclnet.org/pressroom/fakedrugsreport.htm.
40. See NATIONAL CONSUMERS LEAGUE, supra note 23.
41. See id.
42. See id.
43. See id.
44. See id. Even in parts of the world where counterfeits are relatively well known, such as the EU, there is very limited knowledge as to the risks of counterfeits. See, e.g., Katrina Megget, Survey Asks: What to Do about Counterfeit Drugs?, IN-PHARMA TECHNOLOGIST, Oct. 30, 2007, http://www.in- pharmatechnologist.com/news/ng.asp?n=80987-together-healthwho-counterfeit-drugs- legal-intervention-impact (reporting on an EU study that found only 18% of patients were concerned about counterfeit drugs, reflecting "a worrying lack of knowledge among patients and patient organizations into the scale of the counterfeit medicines problems across Europe").
45. See Stephanie Y. Crawford, supra note 5, at 57-58.
46. See Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking: Hearing Before the S. Judiciary Comm., 109th Cong. (2007) (testimony of Thomas McLellan, Chief Executive Officer, Treatment Research Institute), available at http://judiciary.senate.gov/hearings/hearing.cfm?id= 2755 (describing study by which TRI estimated that close to 80% of online pharmaceutical sites originate from outside the United States and import drugs illegally).
47. See Marshall, supra note 20.
48. See Oliver, supra note 5, at 98-99. Other methods include transferring existing prescriptions to Internet pharmacies by directing their current pharmacy to do so; inputting prescription information directly to the website; and Internet sellers' allowing consumers to use prescriptions that have previously been filled online.
49. See id.
50. See David Hasemyer, An Internet Prescription for Disaster?, SIGNONSANDIEGO. COM, Dec. 20, 2003, http://www.signonsandiego.com/news/health/ 20031220-9999-ln20interdoc.html.
51. See NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, supra note 6, at 3-4.
52. See id. (describing deaths and addictions due to Internet cyberdoctor prescribing) ;
53. Ma, supra note 16 and accompanying text.
54. See infra notes 58-62 and accompanying text (discussing web sites that allow for purchase without a valid prescription) ;
55. see also NATIONAL CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, supra note 6, at 3-4 (indicating that most online sellers of controlled prescription drugs do not to require a prescription) ;
56. Ma, supra note 16 and accompanying text.
57. See Fung et al., supra note 4, at 190;
58. Ma, supra note 16.
59. See Sana Siwolop, Personal Business; Buying Your Pills Online May Save You Money, But Who's Selling Them?, N. Y. TIMES, Sept. 29, 2002, available at 2002 WLNR 4032486.
60. See Liang, supra note 2, at 311.
61. The debate on drug importation as a strategy to address access to drugs is beyond the scope of this article; instead, the focus here is the risks of unregulated drug sales, particularly to vulnerable patient populations. However, interested readers may wish to review (on the pro-importation side) articles such as: Tim Gilbert & Sana Halwani, Confusion and Contradiction: Untangling Drug Importation and Counterfeit Drugs, 36 CAL. W. INT'L L. J. 41 (2005) (arguing that banning Canadian importation will not eliminate issues of counterfeit drugs in the U. S.) ;
62. Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 YALE J. HEALTH POL'Y L. & ETHICS 193 (2005) (arguing some forms of pharmaceutical arbitrage through importation and cross-border purchasing are beneficial and do not adversely impact innovation, and that the threat of pharmaceutical arbitrage is overstated) ;
63. Kevin Outterson & Ryan Smith, Counterfeit Drugs: The Good, the Bad, and the Ugly, 16 ALB. L. J. SCI. & TECH. 525, 537 (2006) (arguing that "conflating criminal placebos with importation... only serves the interest of drug company profits rather than a serious discussion of public health") ;
64. Andy Troszok, Reimportation from Canada and Beyond, 36 CAL. W. INT'L L. J. 55, 55 (2005) (arguing Canadian importation is safe and those criticizing importation are "fear mongering") ;
65. Michael Moreno, Prescription Drug Importation Beyond Canada, 36 CAL. W. INT'L L. J. 125 (2005) (supporting drug importation from Canada).
66. The articles above may be contrasted with (on the con side of importation) : William P. Bro, Importation of Prescription Drugs and Risks to Patient Safety, 36 CAL. W. INT'L L. J. 105 (2005) (indicating from a patient's perspective that importation would result in increased risks to consumers) ;
67. Robert P. Giacolone, Drug Wholesaling and Importation: Challenges and Opportunities, 36 CAL. W. INT'L L. J. 65 (2005) (noting that from a wholesaler's perspective, infusion of imported drugs into the U. S. supply chain may undermine integrity of the supply chain) ;
68. Daniel Gilman, Oy Canada! Trade's Non-Solution to "The Problem"of U. S. Drug Prices, 32 AM. J. L. & MED. 247 (2006) (arguing drug reimportation will not address U. S. drug pricing issues due to regulatory challenges across borders) ;
69. Aidan Hollis & Peter Ibbott, How Parallel Trade Affects Drug Policies and Prices in Canada and the United States, 32 AM. J. L. & MED. 193 (2006) (drug importation from Canada unlikely to substantively benefit U. S. and may harm Canada) ;
70. Mary Ellen Fleck Kleiman, State Regulation of Canadian Pharmacies: A Prescription to Violate the Supremacy Clause, 32 AM. J. L. & MED. 219 (2006) (arguing statebased drug importation programs violate Supremacy Clause of the U. S. Constitution) ;
71. Edward L. Langston, The Quality Quandary, 36 CAL. W. INT'L LJ. 19 (2005) (discussing misunderstanding of regulatory safety for Canadian imported drugs) ;
72. Liang, supra note 2 (arguing drug importation not an appropriate policy alternative due to challenges in drug supply vulnerability and international regulatory regimes) ;
73. Liang, supra note 3 (arguing strategies such as drug importation and technology-based supply chain safety efforts are both failed policy efforts to promote appropriate access to pharmaceuticals for vulnerable patient populations) ;
74. Bryan A. Liang, Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply, 16 ALB. L. J. SCI. & TECH. 483 (2006) (reviewing technology to track and detect suspect drugs and concluding they are inadequate for ensuring safety of the vast U. S. drug supply) ;
75. Bryan A. Liang, Parallel Trade in Pharmaceuticals: Injecting the Counterfeit Element into the Public's Health, 31 N. C. J. INT'L L. & COM. REG. 847 (2006) (discussing risks of importation due to challenges with safety of parallel trade in countries from which the U. S. would import drugs) ;
76. Bryan A. Liang, Over the Virtual and Geographic Borders: Understanding Importation and Counterfeit Drugs, 36 CAL. W. INT'L L. J. 7 (2005) (warning that unfettered importation may put patients at risk for substandard and counterfeit drugs) ;
77. Ma, supra note 16, at 371 ("Reimportation has surfaced in the last few years as a possible remedy for the prescription drug price situation in the United States, but has been criticized for putting consumer heath and safety at risk and negatively impacting research and development efforts.') ;
78. Jared Martin, United States Prescription Drug Crisis: Reimportation of Canadian Prescription Drugs Is Not the Answer, 27 J. LEGAL MED. 477, 489-90 (2006) ("Canada's proposed ban on the reimportation of prescription drugs should send a strong message to the United States that its citizens can no longer depend on obtaining their prescription drugs from the less expensive Canadian market.") ;
79. Rene F. Rodriguez, Drug Importation and the Hispanic Physician, 36 CAL. W. INT'L L. J. 117, 124 (2005) (arguing that alternative drug programs, such as drug importation, create a two-tier system that puts the brunt of policy risk upon the poor) ;
80. Marv Shepherd, Drug Quality, Safety Issues and Threats of Drug Importation, 36 CAL. W. INT'L L. J. 77 (2005) (noting that current state of understanding of risks of imported drugs indicates importation not appropriate policy answer to drug access) ;
81. Devlin Taylor, Importing a Headache for which There's No Medicine: Why Drug Reimportation Should and Will Fail, 15 J. L. & POL'Y 1421, 1446 (2007) ("[A]n increase in insurance costs could potentially mitigate any savings a comprehensive drug reimportation plan would bear.") ;
82. Adam T. Teufel, Legalized Importation of of Canadian Prescription Drugs: Short-Term Solution to a Long-Term Problem, 22 J. CONTEMP. HEALTH L. & POL'T 383 (2006) (arguing Congress should not jeopardize drug safety and efficacy by legalizing importation) ;
83. John A. Vernon et al., The Economics of Pharmaceutical Price Regulation and Importation: Refocusing the Debate, 32 AM. J. L. & MED. 175 (2006) (under an economic analysis, reimportation will not achieve costs savings for U. S. consumers).
84. See Rick Carr, Search Engine Wars: Making Money Off Search (National Public Radio broadcast Apr. 14, 2004), http://www.npr.org/templates/story/story. php?storyld=1836736. Note that Google, Yahoo, and MSN represent virtually the entire search engine market, with almost 90% of ad server market share.
85. See, e.g., Get Your Fair Share of the Ad Network Pie, http://www.attributor.com/blog/get-your-fair-share-of-the-ad-network-pie/(Mar. 30, 2008).
86. See Carr, supra note 40.
87. See Google's Online Pharmacy Qualification Process, http://www.google. com/adwords/pharmacy-qualification. html (last visited Feb. 1, 2009) ;
88. Microsoft Advertising Editorial Guidelines, http://advertising.microsoft. com/Home/Article.aspx?pageid=&Adv-ArticleID=3211 (last visited Feb. 1, 2009) ;
89. PharmacyChecker.com Verification Program, http://www.pharmacychecker.com/ sealprogram/choose.asp (last visited Feb. 1, 2009) ;
90. Yahoo Search Marketing Pharmacy Certification Program, http://searchmarketing.yahoo.com/legal/rx.php (last visited Feb. 1, 2009).
91. VIPPS is a much more rigorous system focused on safety. The VIPPS program requires a pharmacy to comply with: (i) licensing and inspection requirements of their home state; (ii) licensing and inspection requirements of each state to which they dispense pharmaceuticals; (iii) verification of valid prescriptions from licensed physicians; and (iv) NABP VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists.
92. See National Association of Boards of Pharmacy - Verified Internet Pharmacy Practice Sites (VIPPS), http://www.nabp. net/index.html?target=/vipps/ intro.asp& (last visited Feb. 1, 2009).
93. See PharmacyChecker.com - Price Comparisons, http://www.pharmacychecker. com/ListingAlpha.asp (last visited Feb. 1, 2009).
94. See websites cited supra note 42.
95. See Liang, supra note 2, at 297.
96. Press Release, Partnership for Safe Medicines, Sharp Increase in Foreign Prescription Drugs Entering Canada, (Apr. 6, 2004), http://www.accessmylibrary. com/coms2/summary-0286-20927552-ITM?email=bliang@cwsl.edu&library. Note that even these countries' legitimate supply chain is suspect.
97. See, e.g., John R. Wilke, Ranbaxy Probe Extends to Africa Drugs, WALL ST. J., July 15, 2008, available at http://www.aegis.com/news/wsj/2008/WJ080703. html (reporting Ranbaxy, India's largest drug company, under FDA and Department of Justice investigation for manufacturing substandard generic drugs, pattern of systemic fraudulent conduct, and fabrication of documents to cover up substandard products; and reporting that 2006 investigation of Ranbaxy found quality problems with Ranbaxy plant in India).
98. See Liang, supra note 2, at 297.
99. There has been a tremendous increase in imported drugs into Canada from questionable sources, including "significant increases in Canadian imports of pharmaceuticals from Singapore (30%), Ecuador (198%), China (43%), Iran (2, 753%), Argentina (221%), South Africa (84%) and Thailand (52%) between September 2002 and September 2003."
100. See Partnership for Safe Medicines, supra note 47. This global sourcing also extends increasingly to generic forms of drugs.
101. See, e.g., Gardiner Harris, Drug Making's Move Abroad Stirs Concerns, N. Y. TIMES, Jan. 23, 2009, available at http://www.nytimes.com/2009/01/20/health/ policy/20drug.html (noting the increase in generic drug manufacturing overseas creates safety risks) ;
102. see also Bryan A. Liang, Pigs, Drugs, and Terrorists, PATIENT SAFETY & QUALITY HEALTHCARE, Nov.-Dec. 2008, at 10-12 (describing risks of globalization of drug supply). It should be noted that generic drugs are, worldwide, the most frequently counterfeited set of drugs.
103. see Julian Harris & Philip Stevens, Fake Drugs and Failed Governance, CHINA POST, Jan. 16, 2009, available at http://www.chinapost.com.tw/commentary/ the-china-post/special-to-the-chinapost/2009/01/16/192286/pl/Fake-drugs.htm (noting generics are the most consumed drug type and calling for greater governance to promote access to medicines).
104. See id.
105. See Kathy Tomlinson, Ex-worker Blows Whistle on Popular Web Pharmacy, CTV. CA, May 26, 2006, http://www.ctv. ca/servlet/ArticleNews/story/CTVNews/ 20060510/whistleblower-internetdr ugs-060525/20060525/(reporting on Edward Hector, a whistleblower who outlined practice of using Bahamas facility to dispense Rx North drugs not from Canada and other problematic business practices including drugs shipped that were near expiration or with expiration dates concealed).
106. See Assessing the Safety of Our Nation's Drug Supply: Hearing Before Subcotnm. on Health of the H. Comm. on Energy and Commerce, 110th Cong. 4-5 (2007) (testimony of John Theriault, Chief Security Officer and Vice President, Global Security, Pfizer Inc.), available at http://energycommerce.house.gov/ cmte-mtgs/110-he-hrg. O50907. Theriault-testimony.pd0 [hereinafter Testimony of John Theriault].
107. See Tomlinson, supra note 51.
108. See Testimony of John Theriault, supra note 52, at 4-5.
109. See id. at 5.
110. See id.
111. See id.
112. See id.
113. See Walt Bogdanich, A Toxic Pipeline: Counterfeit Drugs' Path Eased by Free Trade Zones, N. Y. TIMES, Dec. 17, 2007, available at http://www.nytimes. com/2007/12/l7/world/middleeast/l7freezone.html?ex=1198558800&en =2f54219f6ae8d265&ei=5070&emc=et al.;
114. see also Patsy Moy, HK at Center of Global Drugs Scam, THE STANDARD (H. K.), Feb. 11, 2008, available at http://www.thestandard.com.hk/news-detail.asp? pp-cat=12&art-id=6l319&sid=17539318&c on-type=1 (discussing Hong Kong as transshipment port for China counterfeit drugs and its status as a "free port") ;
115. and P. B. Jayakumar, Asian Nations Unite against Spurious Drugs, BUSINESS STANDARD (India), Feb. 12, 2008, available at http://www.businessstandard.com/ common/news-article.php?leftnm=lmnu4&subLeft=5&autono= 313403&tab=r (discussing industry, government customs, and Interpol program on counterfeits and reporting that only 5% of medicines inspected at free trade ports).
116. See Bogdanich, supra note 59.
117. See id.
118. See Many Rx Web Sites Lack Proper Licensing: Analysis, http://gulftnd.com/Drug%20Info/ManyRxWebSitesLackProperLicensing.asp?id=9 (last visited Feb. 1, 2009).
119. See Bogdanich, supra note 59;
120. CanadaDrugs.com Is Proud to Serve Rx North Customers, http://www.canadadrugs.com/rxnorth/index.php?REF=Redirect/keyword=rxnorth.com (last visited Feb. 1, 2009).
121. * or "Oxycodone no prescription. "
122. See supra notes 6-7 and accompanying text (describing large percentage of drug sellers online that do not require a valid prescription) ;
123. see also Press Release, Drugs.com, MarkMonitor Brandjacking Index Exposes Online Scams That Threaten Top Pharmaceutical Brands and Hurt Consumers (Aug. 20, 2007), http://www.drugs.com/news/markmonitorbrandjacking-index-exposes- online-scams-threaten-top-pharmaceutical-brands-hurt-67l6.html (demonstrating that of greater than 3, 000 Internet drug seller sites most visited, 10% openly indicated that no prescription was necessary for drug purchases).
124. See id.
125. See Pharmacy Ratings and Profiles, http://www.pharmacychecker.com/ OnlinePharmacyRatings.asp (last visited Feb. 1, 2009).
126. See Ricardo Alonso-Zaldivar, FDA Casts Suspicion on Online Pharmacies, SEATTLE TIMES, June 15, 2005, at ¶ 3, available at http://seattletimes. nwsource.com/html/nationworld/2002336462-fdal5.html. Countries to which the web sites were registered included the United States, Vietnam, the Czech Republic, and Barbados.
127. Id. at ¶ 4;
128. see also David Work, Phony Medicines Available Online: Bogus Pharmacies on Internet Spread Drugs that Can Be Dangerous, Deadly, WINSTON-SALEM J., Feb. 16, 2009, available at http://www2.journalnow.com/content/2009/feb/07/ phonymedicines-available-online/opinion/(discussing extensive nature of fake drugs and how a website with listed Canadian location forwarded drug orders to Israel and then financial information to Russia where the credit card transaction was processed; the pharmaceutical was shipped from India to a consumer in the United States) ;
129. G. Jackson, Faking It: The Dangers of Counterfeit Medicine on the Internet, 63 INT'L J. CLIN. PRAC. 181 (2009) (describing another Canadian website operating a drug selling scheme that on inspection had its domain name hosted Korea, registered in St. Kitts, with orders dispatched from Oklahoma City).
130. See Liang, supra note 2, at 310;
131. see also Press Release, U. S. Food and Drug Administration, FDA Says Consumers Continue to Buy Risky Drugs Online ¶ 4 (Nov. 1, 2007), http://www.fda.gov/bbs/topics/NEWS/2007/NEW01735.html (describing Operation Bait and Switch, where FDA officials that only 15% of drugs claimed to be of Canadian origin actually originated there).
132. See Associated Press, State Sues Web Pharmacy on Slack Rules, NWANEWS. COM, Dec. 12, 2007, available at http://www.nwanews.com/adg/News/210398.
133. See, e.g., drugstorescripts.com, scriptsatdiscount.com, atcostpharma.com, bestmedvalues.com, emedsaver.com, disountprescriptionmedications.com, rxpop. com, buymedsquick.com, and others. This search and analysis was performed on June 20, 2008;
134. of course, the nature of the Internet allows these websites to come and go with little detection. Unfortunately, this lack of verification simply reflects the limited or non-existent accountability of search engines generally.
135. See, e.g., Oren Bracha & Frank Pasquale, Federal Search Commission? Access, Fairness, and Accountability in the Law of Search, 93 CORNELL L. REV. 1149 (2008) (calling for regulation of search engines due to oligopoly of search engines dominating market) ;
136. Frank Pasquale, Asterisk Revisited: Debating a Right of Reply on Search Results, 3 J. BUS. & TECH. L. 61 (2008) (outlining proposal to allow right of reply to ameliorate potential search engine results that are damaging or inaccurate) ;
137. Frank Pasquale, Rankings, Reductionism, and Responsibility, 54 CLEV. ST. L. REV. 115, 117 (2006) ("[S]ome accountability for search engine results is increasingly necessary as they become the primary portal for net users.").
138. Scott Carr & Michael Bluett, Spotting Mirrors, Affiliates, and Similar Sites, DMOZ MONTHLY, http://www.dmoz.org/newsletter/200lSep/spam.html.
139. See id.; for an example of how this system works, see imaté Affiliate Program, http://www.imate.com.au/affiliate-app. html (last visited Feb. 1, 2009).
140. See Internet Drug Sales: Hearing Before the H. R. Comm. on Government Reform, 108th Cong. (2004) (statement of William K. Hubbard, Associate Commissioner for Policy and Planning and Legislation, U. S. Food and Drug Administration), available at http://www.fda.gov/ola/2004/Internetdrugs0318. html;
141. Andy Greenberg, Brandjacking Big Pharma, FORBES. COM, Aug. 20, 2007, available at http://www.forbes.com/technology/2007/08/20/brandjacking- drugspharmaceuticals-tech-cx-ag-0820brand.html (describing challenges to public and private online sales) ;
142. Buying Medicines over the Internet: MHRA, http://www.mhra.gov. uk/Safetyinformation/Generalsafetyinformationandadvice/Adviceandin formationforconsumers/BuyingmedicinesovertheInternet/CON0196l0 (last visited Feb. 6, 2009) (describing jurisdiction and accountability issues for online sales of drugs).
143. See World Health Organization, WHO Drug Information, 15 WORLD DRUG INFO. 146, 149 (2001), available at http://www.who.int/medicinedocs/en/d/Jh2989e/ #Jh2989e.2.1.
144. See id. at 149.
145. See WORLD HEALTH ORGANIZATION, PHARMACEUTICALS AND THE INTERNET: DRUG REGULATORY AUTHORITIES' PERSPECTIVE (2001), http://whqlibdoc.who.int/hq/2001/ a74987.pdf.
146. See id. at 8.
147. See id. at 7-8. In addition, as part of the international concern regarding safety of drugs being sold in nontraditional sectors, the Organization of Economic and Community Development and WIPO have also convened meetings;
148. see, e.g., Bryan A. Liang, Presentation at the Joint Meeting of the Organization of Economic and Community Development and the World Intellectual Property Organization (Oct. 18, 2005) (discussing the social and economic costs on intellectual property in the broader context of counterfeit products) ;
149. OECD and WIPO, Counterfeiting and Piracy, Expert Meeting on Measurement and Statistical Issues, Organization of Economic and Community Development and World International Property Organization, Geneva, Switzerland, October 17-18, 2005 (discussing means to track and investigate suspect drug epidemiology) ;
150. OECD, THE ECONOMIC IMPACT OF COUNTERFEITING AND PIRACY, PART I: OVERALL ASSESSMENT DRAFT (2007), http://www.oecd.org/dataoecd/36/36/39543399.pdf.
151. See WHO and Partners Accelerate Fight against Counterfeit Medicines, http://www.who.int/mediacentre/news/releases/2006/pr69/en/index.html (last visited Feb. 1, 2009). When there is no physical address associated or listed with the website, WHO estimates that greater than 50% of drugs sold from these sources are fake. See Counterfeit Medicines, http://www.who.int/medicines/ services/counterfeit/impact/ImpactF-S/en/index.html (last visited Feb. 1, 2009) ;
152. see also Press Release, International Medical Products Anti-Counterfeiting Taskforce, Counterfeit Medicines: An Update on Estimates (Nov. 15, 2006), http://www.dangerouspill.com/assets/files/ TheNewEstimatesCounterfeit.pdf.
153. See Liang, supra note 2, at 296.
154. See Gang Guilty of Fake Viagra Scam, BBC NEWS, Sept. 17, 2007, http://news.bbc.co. Uk/2/hi/uk-news/6999160.stm.
155. EUROPEAN ALLIANCE FOR ACCESS TO SAFE MEDICINES, THE COUNTERFEITING SUPERHIGHWAY (2008), http://v35.pixelcms.com/ams/assets/312296678531/455-EAASM- counterfeiting%20report-020608.pdf.
156. See id. at 19.
157. See id. at 20.
158. See id. at 28.
159. See id. at 22. Note also that the U. K. authorities have indicated that other drugs seized from online sellers included counterfeit heart attack and cancer treatment.
160. See Men Warned over Counterfeit Drugs, BBC NEWS, Nov. 12, 2008, available at http://news.bbc.co.uk/2/hi/health/7721789.stm. It has been estimated that counterfeiting gangs in China are manufacturing fakes with an estimated 8 million counterfeit pills reaching the National Health Service patients.
161. See Mark Townsend, Health Fears Grow as Fake Drugs Flood into Britain, OBSERVER (UK), Jan. 4, 2009, available at http://www.guardian.co.uk/business/ 2009/jan/04/fake-pharmaceuticals-drugs-china-nhs (describing fake anti-psychotic drug made in China, labeled in French, shipped to Singapore, and ending up in Liverpool and sold in the UK National Health Service) ;
162. Paul Burnell, How Fake Drugs Got into the NHS, BBC NEWS, Feb. 3, 2009, available at http://news.bbc.co.uk/2/hi/health/7865569.stm (describing UK Medicines Health products Regulatory Agency emergency recall notices to recoup thousands of packages of fake drugs for stroke patients, prostate cancer victims, and schizophrenics) ;
163. Andrew Jack, Drugs Watchdog Demands Tough Powers, FIN. TIMES, Jan. 3, 2009, available at http://www.ft.com/cms/s/0/157863eO-d925-lldd-ab5f- 000077b07658.html (reporting UK regulator requesting more powers to clamp down on UK illegal medicine sales).
164. See Andy Greenberg, The Drug Business: Pharma's Black Market Boom, FORBES. COM, Aug. 26, 2008, available at http://www.forbes.com/2008/08/25/ onlinepharma-scams-tech-security-cx-ag-0826drugscam.html (noting that the online drug selling "business seems to be booming').
165. See id.
166. See id.
167. See National Association of Boards of Pharmacy, NAPB Findings Underscore Dangers of Purchasing Prescription Medicine Online and From Foreign Sources, INT'L BUS. TIMES, Oct. 23, 2008, available at http://www.ibtimes.com/prnews/ 20081023/napb-webmeds-safety.htm.
168. See id.
169. ™ INTERNATIONAL CONFERENCE OF DRUG REGULATORY AUTHORITIES 117-19 (2002), http://www.who.int/medicinedocs/collect/medicinedocs/pdf/s4923e/ s4923e.pdf.
170. International Medical Products Anti-Counterfeiting Taskforce, http://www.who.int/impact/en/(last visited Feb. 3, 2009). IMPACT includes members from groups such as Interpol, Organization for Economic Co-operation and Development, World Customs Organization, World Intellectual Property Organization, World Trade Organization, International Federation of Pharmaceutical and Manufacturers' Associations, International Generic Pharmaceuticals Alliance, World Self-medication Industry, Asociacion Latino Americana de Industrias Farmaceuticas, World Bank, European Commission, Council of Europe, Commonwealth Secretariat, ASEAN Secretariat, International Federation of Pharmaceutical Wholesalers, European Association of Pharmaceutical Full-line Wholesalers, International Pharmaceutical Federation, International Council of Nurses, World Medical Association, and Pharmaciens sans frontiers. See WHO IMPACT Frequently Asked Questions, http://www.who.int/impact/impact-q-a/en/ index.html (last visited Feb. 3, 2009). Note that IMPACT should not be confused with ACTA, or the Anti-Counterfeiting Trade Agreement efforts. ACTA is a proposed multi-country, voluntary trade agreement that would attempt to address the world-wide presence of counterfeit goods by strengthening intellectual property rights enforcement and, as well, implement Internet restrictions on counterfeit goods sales.
171. See, e.g., New Zealand Ministry of Economic Development, Anti-Counterfeiting Trade Agreement, available at http://vyww.med.povt.nz/ templates/ContentTopicSummarv 34357.aspx:
172. Electronic Frontier Foundation, http://www.eff.org/issues/acta (last visited Feb. 3, 2009). There has been tremendous controversy surrounding ACTA, primarily because of negotiations that have been non-public
173. see Mike Masnick, EU Continues to Give Bogus Reasons for Keeping ACTA Secret, TECHDIRT. COM, Nov. 11, 2008, http://techdirt.com/articles/20081111/ 0254142796.shtml, as well as privacy and search concerns
174. see Speak Out Against ACTA, http://www.fsf.org/campaigns/acta/(last visited Feb. 3, 2009). Negotiations on this proposed multi-lateral agreement will apparently continue into 2009.
175. See The Anti-Counterfeiting Trade Agreement Fact Sheet, http://trade.ec.europa.eu/doclib/docs/2008/october/tradoc-140836.11.08.pdf (last visited Feb. 3. 2009).
176. For example, IMPACT was only formed in 2006. IMPACT - About Us, http://www.who.int/impact/about/en/(last visited Feb. 3, 2009).
177. Allan D. Frank, Illegal Viagra Leads 24% Jump in Counterfeit Medicines Seizure, BLOOMBERG. COM, June 10, 2008, available at http://www.bloomberg.com/ apps/news?pid=newsarchive&sid=aoD.ehqNgFpY.
178. See Fung et al., supra note 4, at 190.
179. Id.
180. See Press Release, U. S. Department of Health and Human Services, FDA Announces New Efforts to Help Curb Illegal Prescription Drug, Marketing on the Internet (July 30, 1999) http://www.fda.gov/bbs/topics/NEWS/NEW00686.html.
181. See Oliver, supra note 5, at 99.
182. See Buying Medicines and Medical Products Online, http://www.fda.gov/ buyonline (last visited Feb. 1, 2009).
183. See id.
184. See Press Release, U. S. Food and Drug Administration, FDA Says Consumers Continue to Buy Risky Drugs Online (Nov. 1, 2007), http://www.fda.gov/bbs/ topics/NEWS/2007/NEW01735.html.
185. See supra notes 23-27 and accompanying text (describing consumers who believe purchasing online is safe and that if online sellers indicate drug is legitimate, that is sufficient assurance).
186. See Buying Prescription Medicine From Internet Pharmacies, http://www.cbp. gov/xp/cgov/newsroom/alerts/alerts/foreign-medication. xml (last visited Feb. 1, 2009).
187. See Michelle Meadows, Imported Drugs Raise Safety Concerns, FDA CONSUMER MAGAZINE, September-October 2002, available at http://www.fda.gov/fdac/features/ 2002/502-import.html.
188. See Oliver, supra note 5, at 100. Note that in most cases when the FDA identifies a site that is illegally selling pharmaceuticals within its jurisdiction, it works with the Department of Justice (DOJ) to build evidence for future prosecution and civil or criminal enforcement action.
189. See Jane E. Henney, Cyberpharmacies and the Role of the US. Food and Drug Administration, 3 J. MED. INTERNET RES. (2001), available at http://www.jmir.org/2001/l/e3.
190. Meadows, supra note 106.
191. See U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES., HHS TASK FORCE ON DRUG IMPORTATION: REPORT ON PRESCRIPTION DRUG IMPORTATION 56 fig. 5.3 (2004), http://archive.hhs.gov/importtaskforce/Reportl220.pdf. Note that this figure does not include other delivery mechanisms such as Federal Express, UPS, etc.
192. See MARV D. SHEPHERD, IMPROVING PATIENT CARE AND MEDICATION SAFETY 8 (2004), http://www.ashp.org/s-ashp/docs/files/2004LeadershipSummary.pdf. Shepherd also indicates that there was a 1000% increase in the number of drug packages destined for U. S. customers from 2003 to 2004.
193. See Marv Shepherd, Drug Quality, Safety Issues and Threats of Drug Importation, 36 CAL. W. INT'L L. J. 77, 79 (2005).
194. See Press Release, Steve Buyer, Cracking Down on Counterfeit Prescription Drug Distribution (Apr. 22, 2008), http://www.house.gov/apps/list/press/in04- buyer/counterfit-perscription-drugs.html.
195. See 21 U. S. C. § 381 (a) (2000) ;
196. C. F. R. § 1.94 (2008).
197. "According to FDA investigators, in most instances, the addressee does not present evidence to support the drugs' admissibility, and the drugs are ultimately provided to CBP or the U. S. Postal Service for return to sender." See Prescription Drugs: Enhanced Efforts and Better Agency Coordination Needed-to Address Illegal Importation: Hearing Before the H. Subcomm. on Oversight and Investigations, 109th Cong. 33 (2005) (statement of Richard M. Stana, Director, Homeland Security and Justice Issues), available at http://www.gao.gov/new.items/d06l75t.pdf[hereinafter Statement of Richard Stana].
198. "[W]ith the current process, packages that are returned to the sender could, in turn, be sent back by the original sender to go through the process again. "
199. See id. at 35.
200. See id. at 21.
201. See id. at 22.
202. See id. at 26 n. 4. Note that: [S]mall mail shipments [at international mail facilities] are excluded [from FDA formal foreign inspection eligibility] because they are generally of a lower value and do not reach the threshold of a formal entry. The international mail system remains an un-automated, paper-based system and packages coming through it are not routed through FDA's electronic screening system. They are off-line and virtually unevaluated for risk, unless a wary, experienced Customs official targets a package for further FDA review. However, even in those situations, FDA can review only a very small fraction of the packages targeted by Customs. FDA Foreign Drug Inspection Program: A System at Risk: Hearing Before the H. Subcomm. on Oversight & Investigations, Comm. on Energy & Commerce, 110th Cong. (2007) (statement of Benjamin L. England, Attorney, Jones Walker), available at http://energycommerce.house.gov/cmte- mtgs/110-oi-hrg.110107-England-Testimony.pdf. In addition, generally any shipment with less than a $2000 value is "essentially given a free pass as an informal Customs entry."
203. See FDA Foreign Drug Inspection Program: A System at Risk: Hearing Before the Subcomm. on Oversight & Investigations of the H. Comm. on Energy & Commerce, 110th Cong. 11 (2007) (statement of Carl R. Nielsen, Retired Director of the Division of Import Operations and Policy, U. S. Food and Drug Administration), available at http://energycommerce.house.gov/images/stories/ Documents/Hearings/PDF/110-oihrg. H0107. Nielsen-Testimony.pdf.
204. See Statement of Richard Stana, supra note 112, at 26.
205. Pharmaceutical Sales Over the Internet: Hearing Before the H. Coram, on Government Reform, 108th Cong. (2003) (statement of William Hubbard, Associate Commissioner for Policy, Planning, and Legislation, U. S. Food and Drug Administration), available at http://www.fda.gov/ola/2003/pharmsales0327.html.
206. See Frank, supra note 96.
207. See Dispensing and Purchasing Controlled Substances over the Internet, 66 Fed. Reg. 21181 (Apr. 27, 2001), available at http://www.deadiversion. usdoj.gov/fed-regs/notices/2001/frO427.htm.
208. See id.
209. See id.
210. See id.
211. See id.
212. See id.
213. See Press Release, U. S. Drug Enforcement Administration, DEA Warning-Buying Drugs Online May Be Illegal and Dangerous!, http://www. deadiversion. usdoj.gov/consumer-alert.htm.
214. See id.
215. In addition, the Federal Bureau of Investigation ("FBI"), U. S. Postal Service, and Internal Revenue Service participated in the operation.
216. See John R. Castronova, Operation Cyber Chase and Other Agency Efforts to Control Internet Drug Trafficking: The 'Virtual" Enforcement Initiative Is Virtually Useless, 27 J. LEGAL MED. 207, 207-208 (2006).
217. See Karen Tandy, Administrator, U. S. Drug Enforcement Administration, Address at Operation Cyber Chase Press Conference (Apr. 20, 2005), http://www.usdoj.gov/dea/speeches/s042005.html.
218. See Castronova, supra note 129, at 221-22;
219. see also Testimony of John Theriault, supra note 52, at 8-9 (indicating the global nature of online drug sales, including a "doctor" issuing a prescription in one location, a pharmacy at another, the origin of the drug at another, the website at another, and the computers serving the portal and anchor sites at two more).
220. The DEA reports that since October 2005 it has initiated over 236 investigations into online pharmacies, seized over $14.5 million dollars in assets in FY2004 as a result of these actions, stemmed the flow of pharmaceutical supply to illegal online drug sites through the success of inter-agency cooperation in investigations such as "Operation CYBERx" which involved the Office of National Drug Policy (ONDCP), Immigration and Customs Enforcement (ICE), Customs and Border Patrol (CBP) and the FDA.
221. See The National Synthetic Drug Control Strategy: Hearing on the Synthetic Drug Control Strategy Before the Subcomm. on Criminal Justice, Drug Policy and Human Resources of the H. Comm. on Govt. Reform, 109th Cong. (2006) (statement of Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, DEA), available at http://www.usdoj.gov/dea/pubs/cngrtest/ ct06l606.html. More recently, the DEA reported that for 2007, it seized assets valued at $39.4 million.
222. See Federica Narancio, DEA Seeks New Restrictions on Internet Pharmacies, MCCLATCHY, June 25, 2008, available at http://www.mcclatchydc.com/251/story/ 42082.html.
223. Note also that other governmental groups work on this area, but have limited jurisdiction. For example, the Federal Trade Commission ("FTC") also works to address online drug sales. The FTC's role in addressing the practices of online pharmacies is derived from the agency's authority as promulgated in Section 5 of the Federal Trade Commission Act, which allows enforcement for the prevention of deceptive or unfair acts or practices in commerce.
224. See Drugstores on the Net: The Benefits and Risks of Online Pharmacies: Hearing before the Subcomm. on Oversight and Investigations of the H. Comm. on Commerce, 106th Cong. (2006) (statement of Jodie Bernstein, Director of the Bureau on Consumer Protection, FTC), available at http://www.ftc.gov/os/1999/07/ pharmacytestimony.htm. Primarily, the FTC investigates actions in which an Internet pharmacy makes false or misleading claims about the products or services it provides as well as the regulation of marketing practices that cause or are likely to cause substantial consumer injury which is not reasonably avoidable by consumers or outweighed by countervailing benefits to consumers or competition. Actions within the FTC's scope of authority include monitoring websites, conducting investigations, making referrals to other federal and state authorities and also acting through an interagency working group (comprised of the FTC, FDA, DOJ, DEA and other federal and state agencies).
225. See id. In addition, the FTC reserves the right to bring action against Internet marketers of health care products for health care fraud on the Internet, such as those actions taken through "Operation Cure All, " which may prove to be the most effective tool it can exercise against Internet pharmacies within its limited power.
226. See id. However, the FTC specifically notes that it has limited jurisdiction over the Internet pharmacy industry and regulation of these business practices is primarily a function of the state pharmacy boards and the FDA.
227. See id.
228. See Narancio, supra note 132;
229. see also Press Release, U. S. Immigration and Customs Enforcement, Chinese Internet distributor convicted of trafficking in fake prescription drugs (July 7, 2008), http://www.ice.gov/pi/nr/0807/080707houston. htm (describing conviction of Kevin Xu, an Internet drug seller who attempted to sell and distribute fake Plavix, Casodex, Zyprexa, Aricept, and Tamiflu sourced from China).
230. See Menn, supra note 19 (describing illegal spamming systems that primarily tout drugs from websites such as MyCanadianPharmacy.com with approximately $150 million in sales annually).
231. See id.;
232. see also Wailin Wong, Feds Bust Alleged Spam Network Behind Billions of Viagra E-mails, CHI. TRIB., Oct. 14, 2008, available at http://www. chicagotribune.com/business/chi-biz-fcc-spam-bust-octl4, 0, 3147108.story (describing FTC global spam network investigation involving billions of spam notices that involved U. S., New Zealand, Cyprus, and Georgia conspirators using servers in China and worldwide "botnets" - networks of hijacked personal computers to disseminate spam - that made millions of dollars in sales of fake erectile dysfunction drugs made in China and India). Unfortunately, India, and especially China, have been the source of increasing recognition of poor quality drug and other products.
233. See Gardiner Harris, The Safety Gap, N. Y. TIMES, Oct. 31, 2008, available at http://www.nytimes.com/2008/11/02/magazine/02fda-t.html?-r= l&ei=5070&oref=slogin&emc=et al.&pagewanted=all. It should be noted that the ineffectiveness of spam legislation for online drug sales, as well as access to pornography and fraudulent business deals, is additional indicia that current legal efforts are ineffective in addressing Internet sales.
234. See, e.g., Carolyn D. Marsan, CAN-SPAM: What Went Wrongf, NETWORK WORLD, Oct. 6, 2008, available at http://www.networkworld.com/news/2008/100608-can- spam.html (outlining a ten-fold increase in spam over the last five years despite CAN-SPAM Act of 2003).
235. These challenges are also faced by state governments, but are exacerbated by the state limitation of jurisdiction within its borders. For example, challenges of state efforts including the inability to assert personal jurisdiction over out-of-state defendants such as international sites, limitations on the regulation of interstate commerce imposed by the commerce clause of the U. S. Constitution as it applies to Internet commerce, difficulties in locating operators of illegal Internet sellers and the extradition of out-of-state defendants.
236. See Castronova, supra note 129, at 215-17.
237. See Liang, supra note 3
238. (citing Statement of Richard Stana, supra note 112, at 30).
239. See Bogdanich, supra note 59.
240. See supra notes 48-60 and accompanying text (describing the RxNorth.com case).
241. See Bogdanich, supra note 59.
242. See id.
243. See Liang, supra note 3, at 341.
244. Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. No. 110-425, available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname= 110-cong-bill&sdocid=f:h6353en r.txt.pdf [hereinafter Ryan Haight Act].
245. These include: (a) display of adherence to the Act on the online pharmacy's homepage
246. see id. § 311 (a) ;
247. (b) compliance with state licensure requirements
248. see id. § 311 (b) ;
249. (c) disclosure of information regarding contact information of the pharmacy, qualifications of its pharmacist-in-charge and certification of its registration under the Act
250. see id. § 311 (d) ; and
251. (d) notification to the Attorney General and applicable state boards of pharmacy at least 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet
252. see id. § 311
253. (e). The bill also provides for (i) enhanced enforcement mechanisms against Internet pharmacies by providing for increased criminal penalties involving controlled substances in Schedules II, IV and V of the Controlled Substances Act
254. see id. § 311
255. (f) ; and (ii) authorizes states to seek injunctions or obtain damages and other civil remedies against online pharmacies within their jurisdiction
256. see id. § 31l (i).
257. See id. § 309 (e).
258. See supra notes 128-139 and accompanying text (noting challenges of law enforcement efforts in attempting to regulate offshore Internet drug sales).
259. See supra note 144 (describing provisions).
260. See Ryan Haight Act, supra note 143, § 2.
261. See Bryan A. Liang, Online Pharmacy Bill, A Good Start but Needs More, THE HILL, Sept. 14, 2006, http://thehill.com/op-eds/online-pharmacy-bill-a-good- start-but-needs-more-2006-09-14.html.
262. This is the same mode of business practice in other illicit pharmaceutical drug sales sites, i.e., over the border in Mexico. Consumers purchase drugs from "farmacias" that have arrangements with "doctors" who will write prescriptions for medications without the need for a medical exam for as low as $20.
263. See Mary P. Flaherty & Gilbert M. Gaul, Millions of Americans Look Outside US. for Drugs, WASH. POST, Oct. 23, 2003, available at http://www.washingtonpost.com/wp-dyn/content/article/2007/06/28/ AR200706280l634-5.html.
264. See NAT'L CTR. ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA UNIVERSITY, supra note 6, at 4
265. ("Some rogue Internet pharmacies provide online consultations free of charge; others refer customers to 'script doctors' who are willing to write prescriptions for a fee... ranging from $10 to $180.").
266. See id. at 14.
267. Safeguarding America's Pharmaceuticals Act of 2008, H. R. 5839, 110th Cong. (2008), available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi? bname=110-cong-bill&sdocid=f:h5839ih.txt.pdf.
268. See id. §§ 5-6.
269. See id. §5. Note that there are significant weaknesses in the use of technology such as RFID to address problems in the legitimate supply chain.
270. See Liang, supra note 3 passim;
271. Liang, Structurally Sophisticated or Lamentably Limited?, supra note 39 passim (discussing limitations of technology in its current state for drug supply safety).
272. See Safeguarding America's Pharmaceuticals Act, supra note 153, §10.
273. See id. § 5.
274. See id. § 6.
275. See id. §5.
276. See id. §7.
277. See id. § 13.
278. See Buyer, supra note 110.
279. See U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, supra note 109, at 56 (noting only 16.9 FTE of the FDA assigned to all international mail facilities).
280. See supra note 112 and accompanying text (noting that suspect packages not inspected by FDA within 24 hours released to U. S. Postal Service for delivery).
281. Safe Internet Pharmacy Act of 2007, S. 596, 110th Cong. (2007), available at http://thomas.loc.gov/cgi-bin/query/z?c110:S.596.
282. See id. § 511 (c).
283. See id.
284. See id. § 511
285. (c) (2) (A) (iv). Note that this may apply to hold harmless agreements that states with Canadian importation programs require to be signed before patient access.
286. See supra text accompanying note 39 (discussing state importation programs and access only after signing waivers).
287. See id. § 511 (c) (2) (B).
288. See id. § 511 (c) (4).
289. See id. § 511 (c) (5).
290. See id. § 511 (c) (9).
291. See id. § 511 (d).
292. See id. § 511 (e).
293. See id. § 511 (e) (3) (A).
294. See supra notes 40-41 and accompanying text.
295. See, e.g., Richard A. Epstein, The Social Consequences of Common Law Rules, 95 HARV. L. REV. 1717 (1982) (noting that legislation is a more efficient and effective method to achieve social change than common law).
296. An unannotated version of the bill is included in the Appendix.
297. 21 U. S. C. §§ 501-511 (2006).
298. See NATIONAL CONSUMERS LEAGUE, supra note 23 (discussing price-sensitive vulnerable patient populations who purchase drugs online).
299. See Liang, supra note 3, at 369-84 (proposing an access program to address issues of price and authenticity).
300. See Partnership for Prescription Assistance, http://www.pparx.org (last visited Feb. 5, 2009).
301. See id.
302. The phone number for the Partnership for Prescription Assistance is 1-800-4PPA-NOW (1-800-477-2669).
303. See id.;
304. See also Bryan A. Liang, Addressing Limited English Proficiency: A Call far Action to Promote Patient Safety, 3 J. PATIENT SAFETY 57 (2007) (discussing limited literacy and English proficiency as important issues for consideration in promoting safe drug access).
305. See Home Page - The Office of Minority Health, http://www.omhrc.gov (last visited Feb. 5, 2009).
306. See Advisory Committee on Minority Health - The Office of Minority Health, www.omhrc.gov/templates/content.aspx?ID=3872 (last visited Feb. 5, 2009).
307. Unfortunately, many patients are eligible for public health insurance but do not access it.
308. See, e.g., Gregory D. Stevens et al., Enrolling Vulnerable, Uninsured But Eligible Children in Public Health Insurance: Association with Health Status and Primary Care Access, 117 PEDIATRICS e751 (2006) (noting greater than two-thirds of uninsured children in California are eligible for public health insurance coverage). A program that links drug access with health insurance would have great potential to increase the percentage of insureds.
309. See, e.g., SARA R. COLLINS ET Al., A ROADMAP TO HEALTH INSURANCE FOR ALL: PRINCIPLES FOR REFORM (2007), http://www.commonwealthfund.org/usr-doc/Collins- roadmaphltinsforall-1066.pdf?section= 4039 (finding that access to health insurance is directly related to access to high quality care).
310. See, e.g., Dorie Hightower, Minority Participation in Clinical Trials, BENCHMARKS, Sept. 6, 2006, http://www.cancer.gov/newscenter/benchmarks-vol6- issue4 (noting that minorities are particularly underrepresented in cancer clinical trials) ;
311. GOVERNMENT ACCOUNTABILITY OFFICE, PRESCRIPTION DRUGS : FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials (2007) (noting effects of drugs not known on seniors because many clinical trials exclude them from participation and calling for better FDA oversight).
312. Brand name drug companies do fund a fraction of the costs associated with new chemical or biologic drug application review.
313. See, e.g., Prescription Drug User Fee Rates for Fiscal Year 2007, 71 Fed. Reg. 43, 780 (July 26, 2006) ;
314. Prescription Drug User Fee Amendments of 2002, 21 U. S. C. § 379g (2006) ;
315. see also SUSAN THAUL, CONGRESSIONAL RESEARCH SERVICE, THE PRESCRIPTION DRUG USER FEE ACT (PDUFA) : BACKGROUND AND ISSUES FOR PDUDA IV REAUTHORIZATION 14 (2007), available at http://opencrs.cdt.org/rpts/RL33914-20070313.pdf (reporting that in Fiscal Year 2006, user fees covered 19.9% of FDA salary and expenses) ;
316. U. S. FOOD AND DRUG ADMINISTRATION, FY 2005 PDUFA FINANCIAL REPORT 4 (2006), available at http://www.fda.gov/oc/pdufa/finreport2005/PDUFA05finrpt.pdf (reporting user fees accounted for 56% of all FDA funds from all sources in support of human drug application review). At the present time, generic drug applications are not funded by generic company applicants. But citizens through their government fund the balance. In addition, clinical trials require participation by citizens, and research funded by public grant funded work and research performed by the National Institutes of Health, the National Science Foundation, and others, benefit pharmaceutical companies. Hence, an exchange between pharmaceutical companies and the public that allows for monopoly pricing via the patent regime, resources for additional innovation, and a focus on legitimate drugs being used by patients in exchange for FDA review, participation in the DAP building on extant industry programs, and increased access by vulnerable patient populations is a reasonable exchange. Indeed, this exchange can be considered a bargain for pharmaceutical companies because the marginal costs associated with making the next dose of a particular drug is extremely small.
317. See, e.g., Asymptomatically Free Goods, http://arnoldkling.com/-arnoldsk/ aimst5/aimst506.html (Feb. 24, 2002) (noting "The marginal cost of manufacturing prescription drugs is low.") ;
318. Patricia M. Danzon & Adrian Towse, Differential Pricing for Pharmaceuticals: Reconciling Access, R&D and Patents, 3 INT'L J. HEALTH CARE FIN. & ECON. 183, 185 (2003) ("Marginal cost [of drug production and sales] includes only the variable cost of producing and selling additional units, which is usually very low.").
319. See The Impact of Direct-to-Consumer Drug Advertising on Seniors Health Care and Health Costs: Hearing before the Special Comm. on Aging, 109th Cong. (2005) (statement of Rachel E. Behrman Deputy Director, Office of Medical Policy, U. S. Food and Drug Administration), available at http://www.fda.gov/ ola/2005/idcda0929.html;
320. M. B. Rosenthal et al., Promotion of Prescription Drugs to Consumers, 346 NEW ENG. J. MED. 498 (2002) ;
321. M. B. Rosenthal et al., Promotion of Prescription Drugs to Consumers, 346 NEW ENG. J. MED. 498 (2002) ;
322. T. V. Terzian, Direct-to-Consumer Prescription Drug Advertising, 25 AM. J. L. & MED. 149 (1999) ;
323. KAISER FAMILY FOUNDATION, IMPACT OF DIRECT-TO-CONSUMER ADVERTISING ON PRESCRIPTION DRUG SPENDING (2003), http://www.kff.org/rxdrugs/6084-index.cfm.
324. Drug approvals by the FDA are under the Food, Drug, and Cosmetic Act and the Public Health Service Act. New drug applications, or NDAs, are evaluated under section 505 (b) (1) and (b) (2) of the Food, Drug, and Cosmetic Act. 21 U. S. C. § 355 (b) (l) - (2) (2000). Every new chemical drug, such as the familiar prescription pills obtained from a pharmacy is reviewed under the NDA premarketing process by the FDA and must be approved by the FDA before sale, as described in §505 (b) (l).
325. See Bryan A. Liang, Regulating Follow-On Biologics, 44 HARV. J. ON LEGIS. 363, 367, 384-86 (2007).
326. Generic chemical drugs are reviewed using an abbreviated approach under the Abbreviated New Drug Application (ANDA), section 505 (j) of the Food, Drug, and Cosmetic Act, 21 U. S. C. § 355 (j) (2000).
327. See id. at 386-90. Biologic medicines, such as vaccines, cancer drugs, and other injectable drugs, which are much larger and complex compared with chemical medicines
328. see id. at 368-69, are regulated as both drugs under section 505 (b) (2) of the Food, Drug, and Cosmetic Act and as biologics under section 351 of the Public Health Service Act, 42 U. S. C. § 262 (2004). With respect to smaller biologies, such as insulin and growth hormone, they are usually reviewed under a parallel NDA application process delineated by section 505 (b) (2) of the Food, Drug, and Cosmetic Act, whereas new, larger, and more complex biologies are regulated under the Biological License Application process, or BLA, under section 351 of the Public Health Service Act, which is similar in scope to the NDA process.
329. See id. at 390-92.
330. As Danzon & Towse note: [E]ven though patents may in theory enable a firm to charge a price above marginal cost, this may not be in the firm's self-interest in markets where consumers cannot afford to pay. Thus, a patent-holder may rationally set prices near marginal cost in low-income markets where demand is highly price-elastic, provided that these low prices cannot spill-over to other, potentially higher-priced markets in the same country or other countries. Danzon & Towse, supra note 190, at 185-86;
331. see also supra note 190 and accompanying text (discussing bargain for pharmaceutical companies in social contract because of limited cost of producing marginal unit of drugs).
332. This may be important in preemption considerations. See, e.g., Bryan A. Liang, Patient Injury Incentives in Law, 17 YALE L. & POL'Y REV. 1, 23 (1998) (discussing federal preemption when Congress may so completely preempt a particular area that any complaint raising a select group of claims is necessarily federal in character and removable to federal court, even if a federal issue does not appear on the face of the plaintiffs complaint).
333. See supra notes 108-10 and accompanying text (discussing legal challenges to destroy contraband materials intercepted in the mails).
334. This paper adopts for the most part the provisions from section 3 of
335. See National Association of Boards of Pharmacy - Verified Internet Pharmacy Practice Sites (VIPPS), supra note 43. Note, however, that this describes the full VIPPS accreditation program, and does not refer to the more recently established "mid-level" group status that appear to comply with pharmacy practice law but remain unaccredited. See, e.g., National Association of Boards of Pharmacy, NABP Creates Middle Tier for Unaccredited Internet Pharmacies That Appear to Comply with Pharmacy Law, Practice Standards, June 27, 2008, REUTERS, available at http://www.reuters.com/article/ pressRelease/idUS194999+27-Jun-2008+PRN20080627.
336. See National Association of Boards of Pharmacy - Verified Internet Pharmacy Practice Sites (VIPPS), supra note 43.
337. See id.
338. This paper includes some definitions and modifies some of the provisions from Senator Gregg's Safe Internet Pharmacy Act of 2007 in its proposed FDCA section 511 (a) (4) and section 511 (c) (2). See Safe Internet Pharamacy Act of 1007, supra note 165.
339. The AMA takes a strong position on Internet prescribing by physicians and has issued policy document H-120.949 to emphasize that physicians who prescribe over the Internet shall establish or have established a valid patient-physician relationship based on AMA criteria for an acceptable clinical encounter and follow up. See AMERICAN MEDICAL ASSOCIATION, GUIDANCE FOR PHYSICIANS ON INTERNET PRESCRIBING 97, available at http://www.ama-assn.org/ad-com/polfind/Hlth- Ethics.pdf. This guidance on Internet prescribing also limits prescribing across state lines and specifically mentions that physicians who prescribe only using online questionnaires or online consultation may be subject to greater personal liability exposure and have not met the appropriate medical standard of care. See id.;
340. see also AMERICAN MEDICAL ASSOCIATION, DIRECTIVES OF THE AMA HOUSE OF DELEGATES 34, http://www.ama-assn.org/ad-com/polfind/Directives.pdf. The AMA expresses its desire to develop model federal legislation addressing Internet pharmacies which includes the following elements: (a) mandatory accreditation by the VIPPS program; (b) in order to be valid, prescriptions must be authorized by a U. S. licensed physician with a valid patient-physician relationship; (c) mandatory disclosure of identifying information; and (d) authorizing the federal government to take action against ISPs and credit card processors against non certified sites.
341. See supra note 34 and accompanying text (noting "cyber doctors" are violating standards of the Federation of State Medical Boards, DEA, as well as the American Medical Association).
342. See supra note 189 and accompanying text (describing limited participation of minorities and seniors in clinical trials).
343. See supra § (c) (1) (E) of the proposed bill.
344. See 45 C. F. R. §§ 160-64 (2006).
345. Perhaps a good contractee for this role would be the National Association of Boards of Pharmacy.
346. Such an approach is similar to the ban of accepting funds for illegal Internet gambling. See 31 U. S. C. § 5363 (2007) (banning the acceptance of funds from bettors by online gambling websites).
347. See Safe Internet Pharmacy Act of 2007, supra note 165, § 511 (d).
348. 31 U. S. C. § 5364 (2006).
349. Safe Internet Pharmacy Act of 2007, supra note 165, § 511 (e).
350. 15 U. S. C. §§ 41-58 (2006).
351. See 31 U. S. C. § 5365 (2006) (allowing for civil remedies to prevent unlawful Internet gambling transactions).
352. 18 U. S. C. § 2 (2006) provides: (a) Whoever commits an offense against the United States or aids, abets, counsels, commands, induces or procures its commission, is punishable as a principal. (b) Whoever willfully causes an act to be done which if directly performed by him or another would be an offense against the United States, is punishable as a principal.