FDA Says All Off-Label Communications Can Fall Within Regulatory Purview

January 24, 2017

The First Amendment does not preclude drugmakers from FDA’s oversight of off-label communication even if what they say is truthful, the agency said.

The agency has the authority to regulate all off-label communication to ensure unapproved drugs do not reach the market, according to an FDA memo.

The FDA cannot explicitly restrict communication on off-label uses, but it has the power to regulate the introduction of unapproved or misbranded drugs and a company’s promotions might be relevant to enforcement.

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