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.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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