FDA Off-Label Policy Under Fire: Court Rulings Pile Up, House E&C Floats New Bill
This article was originally published in RPM Report
The Republican leadership in the House Energy & Commerce Committee is reviving efforts to legislate changes to FDA’s off-label policy by pressuring the release of a long-awaited guidance document and by floating legislation that would allow broad free speech protections. That renewed pressure comes as the courts are increasingly challenging FDA’s ability to bar truthful speech about unapproved indications.
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