Healthy Skepticism Library item: 3727

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Berndt ER, Gottschalk AH, Philipson TJ, Strobeck MW.
Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.
Nat Rev Drug Discov 2005 Jul; 4:(7):545-54
http://www.nature.com/nrd/journal/v4/n7/abs/nrd1774_fs.html;jsessionid=6DC8F63114D6CEAB8D0F8190F4F3072B

Abstract:

The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA’s safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.

Keywords:
Drug Approval/economics* Drug Industry/economics* Drug Industry/trends* Pharmaceutical Preparations/adverse effects United States United States Food and Drug Administration/economics* United States Food and Drug Administration/trends*