title: A proposal for FDA reform.
abstract: Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation.
authors.affiliation: Hoover Institution, Stanford University, Stanford, California 94305-6010, USA. miller@hoover.stanford.edu
authors.forename: Henry I
authors.initials: HI
authors.lastname: Miller
mesh_terms: D006801:Humans; D007880:Legislation, Drug / Q000191:economics / Q000592:standards / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards / Q000639:trends