Generics Industry Pushes Congress On Brand-Name Samples

Law360, New York (June 7, 2012, 8:50 PM EDT) -- The generic-drug industry advised lawmakers reconciling two versions of the U.S. Food and Drug Administration user fee bills to adopt Senate language that would side with generics makers in a fight over getting drug samples from brand-name makers, in a letter released Thursday.

The Generic Pharmaceutical Association asked the lawmakers to include a provision that would prevent brand-name drug makers from refusing to provide samples of their products to companies seeking to replicate the drugs.

At issue are the “risk evaluation and mitigation strategies,” or REMS,...
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