Catalyst lawsuit challenges FDA's ability to bend the law to lower prices

FDA’s ability to bend the law to create competition for a drug is being challenged in federal court. The case, filed Tuesday by Catalyst against HHS and FDA, will test the agency’s ability to use regulatory flexibility to temper the effects of orphan and new drug exclusivities.

The lawsuit, filed in the U.S. District Court for the Southern District of Florida, claims that FDA violated numerous agency regulations and laws when it approved Ruzurgi amifampridine from Jacobus Pharmaceutical Co. Inc. (Princeton, N.J.) to treat pediatric patients diagnosed with Lambert-Eaton myasthenic syndrome (LEMS). Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) markets Firdapse amifampridine phosphate to treat adult patients with LEMS. ...