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Pharmaceuticals / Regulatory Affairs

FDA’s Unapproved-Use Communication Rules Prompt First Amendment Worries

May 2, 2017

An FDA memo outlining restrictions on communications over unapproved uses could restrict the flow of important information, and conflict with a company’s freedom of speech, say drugmakers and industry groups.

Going forward, FDA’s position on such communications needs to balance safety and the free flow of information, according to PhRMA. The agency should, at a minimum, allow communications about unapproved uses that are medically accepted and based on scientifically sound data, it said.

In January, FDA issued a memo stating the First Amendment does not give drugmakers an unrestricted right to off-label communications. The provisions of the memo do not meet the “last resort” burden imposed by the First Amendment, PhRMA wrote in comments on a public docket.

BIO acknowledged that drugmaker communications should not cause confusion on which uses are approved; however, they wrote, manufacturers can convey such information by providing appropriate disclosures and context with product communications, rather than the FDA potentially chilling speech.

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