FDA proposes off-label communication norms for medical products

(Reuters) - The U.S. health regulator issued draft guidance for promotional materials and data not on the label of medical products, recommending manufacturers characterize relevant information, including disclosing unfavorable or inconsistent findings.

The U.S. Food and Drug Administration typically determines what information goes on the labels of medical drugs and devices, after evaluating whether the product is safe and effective for the proposed indication.

However, drugmakers have long wanted to communicate information that isn't on the label, but which concerns the approved use of the product. (

If a firm communicates information, including on promotional material, that has not been evaluated by the regulator, but appears to be FDA-ratified, then it could lead to misbranding, and could subject firms to enforcement action if the representations or suggestions are considered false or misleading.

To avert this, the FDA recommended on Wednesday that companies disclose why the additional data is contextually relevant, and divulge limitations related to the study design, methodology.

The guidance is available for comment for about three months, after which the FDA will release its final determinations.

As of March, Amarin Corp Plc could promote its fish-oil pill for unapproved uses after the FDA decided not to appeal a judge’s ruling that the company has the right under the First Amendment to make truthful and non-misleading statements about its products.