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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