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BioPharmaceutical United States Advertising, Marketing & Sales

FDA Off-Label Policy Under Fire: Court Rulings Pile Up, House E&C Floats New Bill

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Executive Summary

Republican leadership on the House Energy and Commerce Committee is reviving efforts to legislate changes to FDA’s off-label policy. That renewed pressure comes as the courts are increasingly challenging FDA’s ability to bar truthful speech about unapproved indications.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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