title: Approval times for new drugs: does the source of funding for FDA staff matter?
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.
authors.affiliation: Department of Government, Harvard University, Cambridge, Massachusetts, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Carpenter
authors.forename: Michael
authors.initials: M
authors.lastname: Chernew
authors.forename: Dean G
authors.initials: DG
authors.lastname: Smith
authors.forename: A Mark
authors.initials: AM
authors.lastname: Fendrick
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004345:Drug Industry; D010561:Personnel Staffing and Scheduling; D013996:Time and Motion Studies; D014481:United States; D014486:United States Food and Drug Administration