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Analysis

FDA Shames Anti-Generic Tactics, Putting Onus On Congress

Law360 (May 17, 2018, 10:20 PM EDT) -- The U.S. Food and Drug Administration on Thursday named and shamed drugmakers suspected of impeding lower-cost generics by withholding product samples, a splashy move that could jolt Congress into taking action.

The shaming marked the latest salvo in FDA Commissioner Scott Gottlieb's campaign against "shenanigans" by brand-name drugmakers. At issue are "risk evaluation and mitigation strategies," or REMS, that restrict distribution of riskier prescription drugs and can be cited to withhold samples that generics makers need to develop copycat products.

In a list posted online, the FDA...
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