FDA proposes off-label communication norms for medical products

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By Divya Grover

<span class="articleLocation”>The U.S. health regulator issued draft guidance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. (bit.ly/2jz9dRh)

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.



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