The Food and Drug Administration has scheduled hearings for November (and a public comment period that will extend to January) regarding the agency's current approach to the marketing of off-label uses of FDA-approved medications. Drug and device manufacturers have been waiting years for this opportunity to change the agency's stance on off-label marketing.
This is not good news.
First, a definition: Drugs approved by the FDA are approved only for the specific conditions for which they were tested in clinical trials conducted by the manufacturer. These a...
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