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# FDA Not Conceding on Off-label Communications: Attorneys
- URL: https://www.fdaweb.com/fda-not-conceding-on-off-label-communications-attorneys/
- Published: 2017-02-01T12:00:00.000Z
- Updated: 2026-09-14T22:04:05.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137884

Skadden Arp attorneys have issued a paper analyzing several documents FDA issued in the waning hours of the **Obama** administration staking out a strong position on its ability to regulate manufacturer communication on off-label uses. “Because the identity of the next FDA commissioner is still unknown,” the [paper](https://www.skadden.com/insights/fda-doubles-down-on-angencys-ability-to-prohibit-off-label-communications?ref=fdaweb.com) says, “it remains to be seen whether the change in administration will impact the implementation of the positions outlined in FDA’s recent publications.”

Reviewed are the agency’s final rule on the regulatory definition of “intended use,” an agency memo on the First Amendment implications of off-label communications, and two draft guidances on communications consistent with FDA-required labeling and communications with payors, formulary committees, and similar entities.

The attorneys write that the final rule and the First Amendment memo make it clear that FDA continues to believe it has the statutory and constitutional authority to regulate off-label communications, including truthful, non-misleading communications. The guidances, they say, clarify and expand the scope of communications that FDA does not consider to be subject to enforcement action.

“Taken together,” the authors conclude, “these actions suggest an effort by FDA to stake out a strong position for its continued ability to regulate off-label promotional communication, while narrowing the types of communications to which that position will apply.”