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# Ease Off-label Speech Restrictions: WLF
- URL: https://www.fdaweb.com/ease-off-label-speech-restrictions-wlf/
- Published: 2017-01-04T12:00:00.000Z
- Updated: 2026-09-14T21:58:04.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137625

Washington Legal Foundation (WLF) says that FDA should ease its restrictions on manufacturer dissemination of truthful and non-misleading information about off-label uses of approved medical products. In 12/30/16 [comments](http://www.wlf.org/litigating/case%5Fdetail.asp?id=879&ref=fdaweb.com) provided in response to an agency 9/1/16 formal request for input, WLF said that the current restrictions prevent doctors from learning about the latest medical advances and violate First Amendment constraints on the government’s power to suppress truthful commercial speech.

The medical community’s knowledge about the safety and efficacy of FDA-approved drugs and medical devices inevitably outpaces the products’ approved labeling, WLF said. While FDA recognizes the importance of off-label uses and does not regulate physician use of FDA-approved products for unapproved uses, it still tries to prevent manufacturers from speaking truthfully about such uses, it said.

The document noted that FDA has been on an “extended losing streak” in the courts in its efforts to defend its restrictive position. According to WLF chief counsel **Richard Samp**: “For two decades, federal courts have reminded FDA that the First Amendment constrains its power to censor truthful speech by drug and device manufacturers. FDA is to be applauded for agreeing to reexamine its draconian restrictions on manufacturer speech. But public health will continue to suffer unless FDA begins to respect those First Amendment constraints. FDA ought to focus on restricting false or misleading speech, and scientific information can’t be deemed ‘false’ simply because FDA has not yet verified its accuracy.”