The FDA’s new clothes?
FDA’s new clothes?
Alain Braillon, David Menkes
Senior Consultant, University Hospital, Amiens. France.
Associate Professor of Psychiatry, University of Auckland, Hamilton. New Zealand.
Light and Lexchin’s perceptive editorial about FDA drug approval should have titled “FDA, the king, has been naked for too long!”(1,2,3)
Indeed, this is not a news as it was disclosed by insiders: from December 1992, to July 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications but clinical benefit was confirmed in post-approval trials for only 26 of these 47 indications and confirmatory trials were not performed as requested by the Agency for 14 new indications.(4)
We suggest a simple solution: accelerated drug withdrawal programs! In half of cases of withdrawal because of deaths, more than 2 years elapsed after the first report of this adverse outcome; withdrawals for commercial reasons are more frequent than those prompted by risk of harms.(5,6) Regarding inefficacy, the inertia is even worse, as illustrated by delays in withdrawing drotrecogin alfa (10 years) and bevacizumab (45 months); in a further example, the FDA banned sibutramine 9 months after the EMA , allowing a further 160,000 prescriptions to be filled in the US. However, the FDA can act quickly, for example when it banned Mimolette (May 2013), a French cheese. Coincidentally, this was when Europe began to discuss banning US export of GMO foods.
Sadly, the problem also concerns Europe. Prescrire’s third consecutive annual (2015) list of “drugs to avoid” (drugs with adverse effects that outweigh benefits, or drugs superseded by others with a better harm-benefit balance), identified 71 such drugs (7). Remarkably, marketing of these drugs is yet to face any action from the EMA or the French agency.
1 Light DW, Lexchin J. The FDA's new clothes. BMJ. 2015;351:h4897.
2. 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.
3 Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs inUnited States, 2005-14: systematic review. BMJ. 2015;351:h4679.
4 Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R. Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 2011;103:636-44.
5 Onakpoya IJ, Heneghan CJ, Aronson JK. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Med 2015;13:26.
6 Prasad V. The withdrawal of drugs for commercial reasons. The incomplete story of Tositumomab. JAMA Intern Med 2014;174:1887-1888.
7 Toussaint B. Prescrire: France’s Choosing Wisely initiative. BMJ 2015;350:h3325.
Competing interests: No competing interests