Gavin: FDA and Off-Label Drug Use: Danger Ahead

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...