(Reuters) - The U.S. health regulator issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the label of medical products.
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.
Drugmakers have long wanted to communicate supplementary information that isn't on the label, but which concerns the cleared use of the product. (bit.ly/2jz9dRh)
However, the FDA said it does not consider the supplementary information that is consistent with the FDA-required labeling guidelines alone to be evidence of a new intended use.
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. [nL1N16G20L]
Reporting by Divya Grover in Bengaluru; Editing by Martina D'Couto