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Searching for Safety: A Reply to Cooperman and Levitt

Published online by Cambridge University Press:  06 January 2021

Bryan A. Liang
Affiliation:
Institute of Health Law Studies, California Western School of Law
Tim Mackey
Affiliation:
Department of Anesthesiology, San Diego Center for Patient Safety, UCSD School of Medicine

Abstract

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Type
Letters to the Editor
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2009

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References

1 Tod Cooperman & Gabriel Levitt, Letter to the Editor, supra.

2 Liang, Bryan A. & Mackey, Tim, Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales, 35 Am. J. Law & Med. 125 (2009)CrossRefGoogle ScholarPubMed.

3 See Liang, supra note 1.

4 See id.

5 See, e.g., Liang, Bryan A., Pigs, Drugs and Terrorists, 5 Patient Saftey & Quality Healthcare 10 (2008)Google Scholar; Liang, Bryan A., A Dose of Reality: Promoting Access to Pharmaceuticals, 8 Wake Forest Intel. Prop. L.J. 301 (2008)Google Scholar [hereinafter Dose]; Liang, Bryan A., Fade to Black: Importation and Counterfeit Drugs, 32 Am. J. Law & Med. 279 (2006)CrossRefGoogle ScholarPubMed [hereinafter Fade to Black]; Liang, Bryan A., Over the Virtual and Geographic Borders: Understanding Importation and Counterfeit Drugs, 36 Cal. West. Int’l L.J. 7 (2005)Google Scholar; Liang, Bryan A., Parallel Trade in Pharmaceuticals: Injecting the Counterfeit Element into the Public's Health, 31 N.C. J. Int’l L. Comm. Reg. 847 (2006)Google Scholar [hereinafter Parallel Trade; and Liang, Bryan A., Regulating Follow-on Biologics, 44 Harv. J. Legis. 363 (2007)Google Scholar; Liang, Bryan A., Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply, 16 Alb. L.J. Sci. & Tech. 483 (2006)Google Scholar [hereinafter Structurally Sophisticated].

6 See, e.g., Bryan A. Liang, How to Crack Down on Counterfeit Drugs from China, N.H. Union Leader, Mar. 14, 2008, available at http://www.unionleader.com/article.aspx?headline=Brian+Liang%3A+How+to+crack+down+on+counterfeit+drugs+from+China&articleId=75f1146e-d577-489a-8edb-38a730f93887; Bryan A. Liang, Recognizing a prescription for disaster, Star-Tribune (VA), Sept. 29, 2008, available at http://www.wpcva.com/articles/2008/09/29/chatham/opinion/opinion09.txt, and Bryan A. Liang, A Very Real Drug Importation Threat, San Diego Union Trib., Dec. 21, 2007, available at http://www.signonsandiego.com/uniontrib/20071221/news_lz1e21liang.html.

7 See, e.g., New Year, New President, New Packaging?, ePACKAGE NEWSLETTER, Jan. 6, 2009, available at http://www.devicelink.com/pmpn/newsletters/01_06_09.html (referring to Liang as “vice president, Partnership for Safe Medicines”); Elaine Kurtenbach, Companies Fight Back Against China Piracy, July 2, 2006, available at http://www.foxnews.com/wires/2006Jul02/0,4670,ChinaFightingFakes,00.html (last visited Oct. 3, 2009) (referring to Liang as “vice president, Partnership for Safe Medicines); Elaine Kurtenbach, Heparin Highlights Problems Regulating Global Drugs, MANUFACTURING.NET, Apr. 11, 2008, available at, http://www.manufacturing.net/News-Heparin-Highlights-Problems-Regulating-Global-Drugs.aspx?menuid=282 (referring to Liang as “an advisor to the Partnership for Safe Medicines”).

8 See, e.g., Partnership for Safe Medicines, Partnership for Safe Medicines Board of Directors, http://www.safemedicines.org/psmboard.html (last visited Sept. 10, 2009); Partnership for Safe Medicines, Bryan A. Liang, MD, PhD, JD, http://www.safemedicines.org/2007/11/bryan-a-liang-md-phd-jd.html (last visited Oct. 1, 2009); as well as numerous blog entries, see Partnership for Safe Medicines, http://www.safemedicines.org/bryan-a-liang-md-phd-jd/ (last visited Oct. 1, 2009).

9 See Partnership for Safe Medicines, About Us,http://www.safemedicines.org/aboutpsm.html (last visited Oct. 3, 2009) [hereinafter Partnership for Safe Medicines].

10 See Partnership for Safe Medicines, Partnership for Safe Medicines Consumer Resources, http://www.safemedicines.org/consumer_resources.html (last visited Oct. 3, 2009).

11 See Partnership for Safe Medicines, Counterfeit Drug Incident Encyclopedia, http://www.safemedicines.org/counterfeit-drug-incident-encyclopedia.html (last visited Oct. 3, 2009); Principles for Drug Safety, http://www.safemedicines.org/doctrine_principles.html (last visited Oct. 3, 2009).

12 See Partnership for Safe Medicines, LEADER's Guide for Pharmacists, available at http://www.safemedicines.org/resources/PSM%20LEADERs%20Guide.pdf ; Partnership for Safe Medicines, Simple Steps for SAFE Sourcing, http://www.safemedicines.org/safesourcing.html (last visited Oct. 3, 2009).

13 See Partnership for Safe Medicines, Peer Reviewed Articles, http://www.safemedicines.org/peer-reviewed-articles/ (last visited Oct. 4, 2009).

14 See Laing, supra note 1.

15 See id.

16 See Partnership for Safe Medicines, supra note 9.

17 See Partnership for Safe Medicines, Partnership for Safe Medicines Members, available at http://www.safemedicines.org/psm_members.html (last visited Oct. 4, 2009).

18 See Fade to Black, supra note 4.

19 See Structurally Sophisticated, supra note 4.

20 See Parallel Trade, supra note 4.

21 See Dose, supra note 4.

22 See Liang, supra note 1.

23 See Fade to Black, supra note 4 at 308 n.188 (quoting Office of Regulatory Affairs, U.S. Food and Drug Admin., Subpart Coverage of Pers. Importations in Regulatory Procedures Manual).

24 See id. (quoting Letter from Randall W. Lutter, Ph.D., Assoc. Comm’r for Policy and Planning, U.S. Food and Drug Admin., to Governor Kenny Guinn, Governor of Nev. (May 20, 2005)).

25 See Liang & Mackey, supra note 2, at 139.

26 See, e.g., DoctorSolve.com, http://www.doctorsolve.com (last visited Sept. 5, 2009) (indicating “Your health profile is reviewed by our Canadian graduate nurses and pharmacy technicians. All prescriptions are dispensed by licensed pharmacists.”); OnlicePharmaciescanada, http://www.onlinepharmaciescanada.com (“Upon ordering your discount canadian [sic] prescriptions your health profile is consulted with [sic] our Canadian graduate nurse or pharmacy technician and promptly filled by a licensed pharmacist.”); SelfServeRX, http://www.selfserverx.com/viagra.asp (“Follow these simple steps to order: 1. Select a quantity from the list below. 2. Register if you are a new customer or log-in. 3. Complete the online consultation. 4. Checkout.”). Further, in another interesting twist and illustration of PharmacyChecker.com verification process weakness, some verified online drug sellers are selling prescription drugs without a prescription by claiming that “Once a product has been classified as an OTC [over-the-counter] product in one developed country, it will inevitably become an OTC product in many other countries … . The reason you can buy the no prescription Flonase (Fluticasone Propionate) from MedStore International is because it is an OTC product in the country from where it is sourced.” Medstoreinternational, Buy no prescription Flonase online,http://www.medstoreinternational.com/buy-Flonase.php (last visited Sept. 10, 2009) (emphasis supplied).

27 See ShopEastWest.com, New Patient Fax Order Form, available at, http://www.shopeastwest.com/med/Print%20and%20Order%20form.pdf (directing patient to “Attach Prescription Here or Fill Out the Risk Release Form”, id. at 1, and “Incase [sic] No Prescription Is provided Please Also Fill the Risk Release Form and Fax Along with the Above Details”, id. at 6).

28 See SuperDrugSaver.com, Pain Relief, http://www.Superdrugsaver.com/category/7/Pain-Relief.html (last visited Sept. 5, 2009). Ironically, in its FAQs, the website indicates it does not sell controlled substances. See Superdrugsaver.com, FAQ: Do You Dispense Controlled Substances?, https://www.superdrugsaver.com/faq.php (last visited Sept. 6, 2009) (answer to this question is “No. We do not dispense any controlled substance.”).

29 See SuperDrugSaver.com, FAQ: Do I require a prescription?, https://www.superdrugsaver.com/faq.php (last visited Sept. 6, 2009) (“We Prefer that you have a Valid Prescription by agreeing to the terms and conditions of the site you attest that you have a prescription or will obtain one by your physician in your country of residence, [sic] In order to fulfill your medical needs, our licensed physician upon request reviews each patient's medical history, and issues a prescription. Thus, for each order we can legally fill and ship your prescription in a discreet package that assures your confidentiality and privacy”).

30 See SuperDrugSaver.com, Affiliate Program, http://www.superdrugsaver.com/affiliate/affsignup.php (last visited Sept. 6, 2009), cf. ShopEastWest.com, Affiliate Program, https://www.shopeastwest.com/med/affiliate/affiliatesignup.php (last visited Sept. 6, 2009).

31 See Illegal online pharmacies, CNN, Feb. 2, 2009, available at http://www.cnn.com/video/#/video/health/2009/02/02/dcl.giffin.online.drugs.cnn?iref=videosearch; and LegitScript, CNN identifies PharmacyChecker-approved website linked to noprescription-required Xanax, (Feb. 4, 2009), http://www.legitscript.com/blog/72.

32 See CNN, supra note 31.

33 See LegitScript, supra note 31.

34 See Pharmnet.com, About Our Pharmacy, http://www.pharmnet.com/pharmacy/aboutour-pharmacy.htm (last visited Sept. 5, 2009) (“PharmNet-Rx has been a member of pharmacy verification programs since they were established in 2003 … The Pharmacy Checker Seal indicates that a website markets prescription drugs dispensed from a pharmacy in good standing.”). The CNN story aired Feb. 2, 2009, so at the time of this search, greater than six months had passed without action by PharmacyChecker.com to have, at a minimum, its logo removed from Pharmnet.com. Note that PharmacyChecker.com does not disclose all of its verified sites on its web page. See Liang & Mackey, supra note 2, at 139.

35 See LegitScript, supra note 31.

36 See LegitScript, supra note 31, and Pharmnet.com, supra note 34.

37 See Liang & Mackey, supra note 2, at 136.

38 See id. at 138.

39 See id. at 137 nn. 59-63 and accompanying text (discussing New York Times investigative series); id. at 137-138 nn. 52-58 and accompanying text (discussing Congressional hearings on counterfeits and online drug selling in RxNorth case).

40 See Liang & Mackey, supra note 37, at 138.

41 See Liang, supra note 1.

42 See Liang & Mackey, supra note 2, at 135-139 (outlining limited verification of online drug sellers).

43 See id. at 138 n.64 and accompanying text (noting LegalMedsDirect.com, a verified PharmacyChecker.com website, selling controlled substances such as Oxycodone, without a prescription).

44 See U.S. Department of Justice, Drug Enforcement Administration, Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, 74 Fed. Reg. 15596 (Apr. 6, 2009).

45 See Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Docket Folder, available at http://www.regulations.gov/search/Regs/home.html#docketDetail?R=DEA-2009-0004 (last visited Sept. 3, 2009).

46 Final regulations will take into account comments received up until June 5, 2009. See U.S. Department of Justice, supra note 44.

47 See Liang, supra note 1.

48 See, e.g., Liang & Mackey, supra note 2 at 134-140.

49 See Legitscript & Knujon, No Prescription Required: Bing.Com Prescription Drug Ads (2009), available at http://www.legitscript.com/BingRxReport.pdf [hereinafter No Prescription Required]; and Legitscript & Knujon, Yahoo Internet Pharmacy Advertisements: A Closer Look at Rogue Internet Pharmacies Sponsored by Yahoo's Online Advertising Program (2009), available at: http://www.legitscript.com/YahooRxAnalysis.pdf [hereinafter Yahoo Internet Pharmacy Advertisements]; see also Mainous, Arch G. et al., Availability of Antibiotics for Purchase Without a Prescription on the Internet, 7 Ann. Fam. Med. 431 (2009)CrossRefGoogle ScholarPubMed (finding antibiotics available on Internet without prescription creating significant public health concern); and Orizio, Grazia et al., Cyberdrugs: a cross-sectional study of online pharmacies characteristics, 19 Eur. J. Pub. Health 375 (2009)CrossRefGoogle ScholarPubMed (reporting 81.4% online pharmacies found using Google searches did not require prescription from a physician).

50 See No Prescription Required, supra note 49, at 3; Yahoo Internet Pharmacy Advertisements, supra note 49, at 3.

51 See No Prescription Required, supra note 49, at 3; and Yahoo Internet Pharmacy Advertisements, supra note 49, at 3, 30, 37.

52 See NO PRESCRIPTION REQUIRED, supra note 49, at 5; YAHOO INTERNET PHARMACY ADVERTISEMENTS, supra note49, at 41.

53 See Liang, supra note 1.

54 See Liang & Mackey, supra note 2, at 175.