Rx for FDA Inaction: Competition

01 Apr 1995

Executive Summary

The FDA won't reform itself because it is a monopoly, argues Peter Barton Hutt. His solution: competition: if either the European Medicines Evaluation Agency or the UK's Medicines Control Agency approves a drug, the FDA would have 90 days to veto a sponsor's application for approval--any veto having to be accompanied by a specific clinical rationale.

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BioPharmaceutical
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Regulation

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Rx for FDA Inaction: Competition

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