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Pharmaceuticals / Regulatory Affairs

Sanders Urges FDA to Allow Cheaper Versions of Firdapse

March 11, 2019
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Sen. Bernie Sanders (I-Vt.) urged the FDA to allow cheaper versions of Catalyst Pharmaceuticals’ Firdapse (amifampridine).

The treatment for the rare neuromuscular disease, Lambert-Eaton myasthenic syndrome, has an annual list price of $375,000. In a letter to the FDA, Sanders called on FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar to announce they will not take enforcement action against manufacturers selling a cheaper version of the drug, despite Catalyst’s exclusivity.

“Catalyst Pharmaceuticals’ decision to set a price of $375,000 is a prime example of price gouging,” Sanders wrote, noting Gottlieb’s repeated castigation of drugmakers engaging in such practices. The price was set “without regard to public health and takes advantage of patients who need this medicine to survive,” he said.

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