News Briefs

A magistrate judge recommended dismissing a lawsuit filed by Catalyst Pharmaceuticals, Inc. against the FDA, HHS and Jacobus Pharmaceutical Company, Inc. Catalyst filed the suit (Case No. 1:19-cv-22425-BB) last year over the FDA’s approval of Jacobus’ Ruzurgi (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome in patients aged 6 years old to 17 (RSP 5/19, p. 8) less than six months after the agency approved Catalyst’s Firdapse (amifampridine) for LEMS in adults, an indication for which the company had orphan drug designation (RSP 12/18, p. 6). Catalyst contends that the FDA approval of Ruzurgi was tied to Firdapse’s $375,000 annual cost, which came under fire from Sen. Bernie Sanders (I-Vt.) last year (RSP 2/19, p. 12). Prior to Firdapse’s approval, Jacobus offered amifampridine for free through a compassionate use program. View the recommendation at http://freepdfhosting.com/14470b13c3.pdf.

The U.S. Court of Appeals for the District of Columbia Circuit reversed a lower court’s decision that had prevented CMS from implementing a 28.5% cut in Medicare Part B payments for hospitals purchasing drugs under the 340B Drug Pricing Program (No. 19-508). Several hospitals and hospital associations filed the initial lawsuit (No. 1:18-cv-02084-RC). The court ruled that the payment cut was based on a “reasonable interpretation of the Medicare statute.” View the decision at https://bit.ly/3ibXIuh.

AIS Health Staff

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