“ME-TOO” DRUG REVOLUTION: A PRODUCT OF REGULATORY IMPROPRIETY
Amidst all the brouhaha, often the regulatory agencies, for instance the United States Food and Drug Administration’s (US-FDA) role in bringing about what is being so cleverly termed as the ‘me-too drug revolution’, has escaped scrutiny. Bearing in mind the pre-eminent status of USFDA in regulatory world, it would be useful to examine some of their strategies that have helped facilitate this revolution. The surge seen in the approval of me-too drugs can be attributed to a regressive policy of evaluating a new drug against a placebo or using non-inferiority trials, which in turn has often allowed an easy rite of passage for the me-too drugs. So has the Prescription Drug User Fees Act (PDUFA) by allowing rapid approval of drugs. However, this has not necessarily translated into safer drugs! Further, advisory committees that are rife with conflicts of interest, a legally weakened status bestowed upon the USFDA and a no-holds barred approach adopted by the industry towards direct to consumer advertisements (DTCA), has allowed me-too drugs with dubious safety profiles to flourish in the markets. It has been suggested on many fronts that by undertaking measures, for instance an increment in the US congress appropriations to the US-FDA, vesting punitive powers in the agency to rein in the errant pharmaceutical companies as well as dealing with the conflicts of interest within the advisory committees could go a long way in preventing the undue and potentially dangerous proliferation of me-too drugs.
2. Baycol Final Printed Labeling [Internet]. Rockville, MD, USA: US-FDA; 2000 [cited 2016 May 20]. Available from:
3. Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med. 2001; 2(5): 205-7.
4. Echt DS, Liebson PR, Brent Mitchell L, Peters RW, Obias-Manno D, Barker AH, et al. Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo - The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991; 324(12): 781-8.
5. Light DW, Lexchin J, Darrow JJ. Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs. J Law Med Ethics. 2013; 41(3): 590-600.
6. Notice of Initiation of disqualification proceedings and opportunity to explain (NIDPOE) [Internet]. Rockville, MD, USA: US-FDA; 2006 [cited 2016 May 20]. Available from:
7. Mathews AW. Infected Data: Fraud, Errors Taint Key Study of widely used Sanofi Drug [Internet]. New York: The Wall Street Journal; 2006 [cited 2016 May 20]. Available from:
8. Lisse JR, Perlman M, Johansson G, Shoemaker JR, Schechtman J, Skalky CS, et al. Gastrointestinal Tolerability and Effectiveness of Rofecoxib versus Naproxen in the Treatment of Osteoarthritis. A Randomized, Controlled Trial. Ann Intern Med. 2003; 139(7): 539-46.
9. Kondro W. Dispute over Vioxx study plays out in New England journal. CMAJ. 2006; 174(10): 1397.
10. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015; 351: h4633.
11. Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, et al. Era Of Faster FDA Drug Approval has also seen increased Black-Box warnings and market withdrawals. Health Aff (Millwood). 2014; 33(8): 1453-9.
12. FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market [Internet]. Rockville, MD, USA: US-FDA; 2010 [cited 2016 May 20]. Available from:
13. Latisse (Bimnatoprost) Summary Review [Internet]. Rockyville, MD, USA: US-FDA; 2008 [cited 2016 May 20]. Available from:
14. Zuckerman DM. FDA Advisory Committees: Does Approval Mean Safety? Washington, DC: National Research center for Women & Families. 2006.
15. Smith JF, Townsend SA, Singh N, Ma P. FDA advisory committee meeting outcomes. Nat Rev Drug Discov. 2012; 11(7): 513-4.
16. Summary minutes for the February 16, 17 and 18, 2005, Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee [Internet]. Rockville, MD, USA: US-FDA; 2005 [cited 2016 May 20]. Available from:
17. Harris G, Berenson A. 10 Voters on Panel Backing Pain Pills Had Industry Ties [Internet]. New York, NY, USA: The New York Times; 2005 [cited 2016 May 20]. Available from:
18. Feeley J, Kresge N. Bayer’s Yasmin Lawsuit Settlement Rise to $402.6 Million [Internet]. New York, NY, USA: Bloomberg News; 2012 [cited 2016 May 20]. Available from:
19. Lenzer J, Epstein K. The Yaz Men: Members of FDA Panel Reviewing the Risks of Popular Bayer Contraceptive Had Industry Ties [Internet]. Washington, DC, USA: Washington Monthly; 2012 [cited 2016 May 20]. Available from:
20. Strom BL. Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: A Counterpoint. JAMA. 2004; 292(21): 2643-6.
21. Tiedt TN. The Drug Safety Conundrum. Food Drug Law J. 2007; 62(3): 547-58.
22. Furberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL. The FDA and Drug Safety: a proposal for sweeping changes. Arch Intern Med. 2006; 166(18): 1938-42.
23. Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability [Internet]. Rockville, MD, USA: US-FDA, Health and Human Services (HHS); 2007 [cited 2016 May 20]. Available from:
24. Guidance for Industry; Postmarketing Studies and Clinical Trials - Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act [Internet]. Rockville, MD, USA: US-FDA, Health and Human Services (HHS); 2011 [cited 2016 May 20]. Available from:
25. Associated Press. Lipitor becomes world's top-selling drug [Internet]. New York, NY, USA: Crain’s New York Business; 2011 [cited 2016 May 20]. Available from: http://www.crainsnewyork.com/article/20111228/HEALTH_CARE/111229902
26. Purvis L, Schondelmeyer SW. Rx Price Watch Case Study: Efforts to Reduce the Impact of Generic Competition for Lipitor. Washington, DC: AARP. 2013.
27. Humphreys G. Direct-to-consumer advertising under fire. Bull World Health Organ. 2009; 87: 576-7.
28. Scussa F. Growth of spending on direct-to-consumer promotion has been curtailed as consumer, government, and regulatory pressures mount [Internet]. California, CA, USA: Med Ad News; 2002 [cited 2016 May 20]. Available from:
29. Gilchrist A. 10 Most-Advertised Brand-Name Drugs [Internet]. New Jersey, NJ, USA: Pharmacy Times; 2015 [cited 2016 May 20]. Available from:
30. Rosenberg M. 13 Drugs Whose Risks Emerged Only When They Went Off Patent, Part One [Internet]. New York, NY, USA: The Huffington Post; 2014 [cited 2016 May 20]. Available from:
31. Commonwealth Of Massachusetts, Superior Court, Trial Court Department. Commonwealth Care Alliance, Health Care For All, Glenn Crenshaw and Paula Crenshaw, individually and on behalf of persons similarly situated. v.Astra Zeneca Pharmaceuticals L.P. and Zeneca Holdings, Inc.[Internet]. 2005 [cited 2016 May 20]. Available from:
32. Diclegis - Warning Letter [Internet]. Rockville, MD, USA: US-FDA; 2015 [cited 2016 May 20]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf
33. Shenvi C. Diclegis: Drug Makes 30-Year Comeback [Internet]. North Carolina, NC, USA: Medpage Today; 2015 [cited 2016 May 20]. Available from:
34. Ventola CL. Direct-to-Consumer Pharmaceutical Advertising; Therapeutic or Toxic? P&T. 2011; 36(10): 669-74,681-4.
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