Internal FDA emails reveal how price, Sanders’ pressure played a role in competitor’s approval, Catalyst claims
A series of partially redacted internal emails from the FDA, released as part of a lawsuit related to competing treatments for the rare disorder Lambert-Eaton Myasthenic Syndrome (LEMS), attempt to show how price and Sen. Bernie Sanders’s (D-VT) pressure played a role in FDA’s approval of a competitor.
The case concerns Catalyst Pharmaceuticals, which sued the 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 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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