12:08 PM
May 18, 2018
 |  BC Week In Review  |  Company News  |  Other News

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs.

The list includes complaints about branded drugmakers improperly using REMS requirements to restrict access to samples of branded drugs that are necessary to conduct FDA-required tests to demonstrate bioequivalence. In other instances, Gottlieb said branded drug companies may have placed restrictions in commercial agreements that limit the ability of distributors, wholesalers or specialty pharmacies to sell samples.

FDA reported 164 complaints dating back to at least 2007. Celgene Corp. (NASDAQ:CELG), Actelion Ltd., Gilead Sciences Inc. (NASDAQ:GILD) and Novartis AG (NYSE:NVS; SIX:NOVN) each are...

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