Assessing the safety and efficacy of the FDA: the case of the Prescription Drug User Fee Acts

The US Food and drug Administration (FDA) is estimated to regulate markets accounting for about 20% of consumer spending in the US. This paper proposes a general methodology to evaluate FDA policies, in general, and the central speed-safety tradeoff it faces, in particular. We apply this methodology...

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Bibliographic Details
Format: Book
Language:English
Published: Cambridge, Mass. National Bureau of Economic Research 2005
Series:National Bureau of Economic Research <Cambridge, Mass.>: NBER working paper series 11724
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Online Access:Volltext
Summary:The US Food and drug Administration (FDA) is estimated to regulate markets accounting for about 20% of consumer spending in the US. This paper proposes a general methodology to evaluate FDA policies, in general, and the central speed-safety tradeoff it faces, in particular. We apply this methodology to estimate the welfare effects of a major piece of legislation affecting this tradeoff, the Prescription Drug User Fee Acts (PDUFA). We find that PDUFA raised the private surplus of producers, and thus innovative returns, by about
Physical Description:41 S. graph. Darst.

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