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# Attorney Disputes Increased Liability in Off-label Promotion
- URL: https://www.fdaweb.com/attorney-disputes-increased-liability-in-off-label-promotion/
- Published: 2017-03-22T12:00:00.000Z
- Updated: 2026-09-14T22:13:14.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5138266

Attorney **James Beck** (Reed Smith) says that if FDA ends its ban on truthful off-label promotion under incoming commissioner **Scott Gottlieb**, warnings that drug and medical device companies will face increased liability don’t ring true. Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=9d324924-0291-47d3-9bbd-c7d7090b4eec&ref=fdaweb.com), Beck disputes assertions made in a 3/15 *Bloomberg News* article that drug company liability would increase if FDA retreats from its ban on off-label promotion.

He says the result actually could be less liability for companies because off-label use would remain off-label, even if truthful promotion were to become broadly legal. “FDA … can order a drug’s label to contain statements (usually warnings) about an off-label use,” Beck writes. “That’s important because … only FDA can do this. Drug companies are not allowed to discuss off-label uses in their labels whenever they want. Without FDA telling them to, that is a form of misbranding. Should truthful off-label promotion become legal, it may be expected that FDA would react by ordering more warnings about those uses to appear on drug/device labeling.” He says such a situation would actually help company preemption defenses for several reasons.

After reviewing other arguments in the article and his response to them, Beck concludes that the article’s “prediction of ‘more’ liability in the event of the demise of FDA’s ban on truthful off-label promotion is simply the other side’s wishful thinking. There will be some liability, just as there is now for on-label statements and promotion, but legalization isn’t going to have much effect, if any, on preemption. To the extent legalization has any effect, both precedent and common sense suggest that such effect will be positive from a defense perspective. The biggest thing that legalization will do is eliminate the other side’s arguments that defendants are acting illegally despite telling the truth. The demise of ‘you broke the law’ arguments can only be beneficial to the defense.”