Jeffrey S. Bucholtz, Lisa M. Dwyer, and John C. Richter
The Department of Justice aggressively prosecutes manufacturers who promote FDA-approved drugs or medical devices for off-label uses. The government's stance raises serious First Amendment questions that the government has largely managed to avoid by extracting onerous settlements from manufacturers. Until now, that is. The Southern District of New York recently granted a pharmaceutical manufacturer's request for a declaration that the First Amendment precludes the government from imposing criminal liability for truthful speech about off-label uses. The same issue is presented in other pending cases. This presentation will explore the recent developments in this area and offer guidance about how to mount successful First Amendment challenges to the government's off-label promotion regime.
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Glenda R. Smith
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