Internal FDA emails reveal how price, Sanders’s pressure played a role in competitor’s approval, Catalyst claims


13 February 2020 - A series of partially redacted internal emails from the US FDA, released as part of a lawsuit related to competing treatments for the rare disorder Lambert-Eaton Myasthenic syndrome, attempt to show how price and Sen. Bernie Sanders’s pressure played a role in FDA’s approval of a competitor.

The case concerns Catalyst Pharmaceuticals, which sued FDA last June in the US District Court for the Southern District of Florida because FDA approved rival Jacobus Pharmaceutical’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic syndrome (LEMS).

Catalyst claims that the orphan drug exclusivity on its competing but more expensive LEMS treatment Firdapse (amifampridine) should have barred Jacobus from winning approval for Ruzurgi.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation