Has the FDA Amendments Act of 2007 impaired drug development?
Perched at the midpoint of "v.4" of the Prescription Drug User Fee Act (PDUFA-4), better known as the US Food and Drug Administration Amendments Act (FDAAA), it seems presumptuous to draw critical conclusions based on an "interim analysis" of this work in progress. Because drug development is a complex process measured in decades, one must rely on "surrogate markers" to impute FDAAA outcomes. Even so, there are many indications that the FDAAA has doused the fires of innovation, in scope, spirit, and interim results.
B&D Consulting, Washington, DC, USA.
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Franson
D055808:Drug Discovery; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration