Healthy Skepticism Library item: 7348

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

Carpenter D, Chernew M, Smith DG, Fendrick AM.
Approval times for new drugs: does the source of funding for FDA staff matter?
Health Aff (Millwood) 2003 Jul-Dec; Suppl:
http://content.healthaffairs.org/cgi/reprint/hlthaff.w3.618v1

Abstract:

The Food and Drug Administration (FDA) has been criticized for injudicious and excessively rapid approval of new drugs as a result of pharmaceutical industry influence. Many critics focus on the Prescription Drug User Fee Act (PDUFA) of 1992, which augmented the FDA’s budget through the charging of user fees. We assess the effect of FDA staffing patterns and attributes of submitting firms on approval times for 843 new drug applications (NDAs) submitted between 1977 and 2000. NDA review times shortened by 3.3 months for every 100 additional FDA staff. The amount of funding for FDA staff appears to be a much more important influence on NDA review time than the source of funding.

Keywords:
Drug Approval*/economics Drug Approval*/legislation & jurisprudence Drug Industry Personnel Staffing and Scheduling Time and Motion Studies* United States United States Food and Drug Administration