Consumer-Focused Off-Label Promotion Seems Possible After Amarin Settlement
Legal agreement with FDA allowing communication about off-label Vascepa use is not limited by audience, speaker or setting, attorneys say.
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Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
For now, FDA is using a case-by-case approach for reviewing and approving expanded access applications asking for off-label uses.
REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.