Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label?

Who says FDA can’t bring off-label cases? They may just morph into REMS violation cases – if, that is, FDA starts using the REMS authority more often.

Aegerion Pharmaceuticals Inc.’s proposed settlement with the Department of Justice over its marketing of the homozygous familial hypercholesterolemia therapy Juxtapid includes one count related to violation of the FDA-mandated Risk Evaluation & Mitigation Strategy for the product.

The company’s May 12 announcement of a preliminary settlement with DoJ and the Securities & Exchange Commission does not get deeply into the specifics of the violations

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