FDA Blasted Over Shared Risk Plans For Brand, Generic Cos.

Law360, New York (May 28, 2013, 9:53 PM EDT) -- The U.S. Food and Drug Administration has left pharmaceutical companies exposed to antitrust enforcement and product liability suits by failing to explain clearly how brand-name drugmakers and generics companies can negotiate shared risk-reduction plans for certain medicines, Prometheus Laboratories Inc. charged in a citizen petition released Tuesday.

The May 10 petition, which requests rulemaking to help flesh out the FDA’s policies, comes as Prometheus wages a patent infringement suit against Roxane Laboratories Inc., which is hoping to sell a generic version of irritable bowel syndrome treatment...
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