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Do Off-label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts
2003
Social Science Research Network
The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug's efficacy. The act requires efficacy certification for the drug's initial ("on-label") uses, but does not require certification before physicians may prescribe for subsequent ("off-label") uses. Are there good reasons for this inconsistency? Using a sequential online survey we carried on a "virtual conversation" with some 500 physicians. The survey asked whether efficacy
doi:10.2139/ssrn.425791
fatcat:teytxz2mbzhpfkuf5g2j4s72jq