Monday, Nov 3
Carpenter, D., Michael Chernew, D.G. Smith, and A. Mark Fendrick. 2003. "Approval Times for New Drugs: Does the Funding Source for FDA Staff Matter?" Health Affairs. Web-Exclusive Supplement W3, 618-624.
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.