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FDA Risk-Evaluation Guidance Unlikely To Help Generics

by Gregory Asciolla, Matthew Perez
Law 360 |
Gregory Asciolla and Matthew Perez discuss the U.S. FDA’s guidances concerning risk evaluation and mitigation strategies and the likely minimal impact they will have on the development of a Single Shared System for REMS.

Last week, the U.S. Food and Drug Administration issued two draft guidances concerning risk evaluation mitigation strategies, or REMS, which are programs designed to track the use, and deter the potential misuse, of drug products that pose significant health risks. One guidance addressed the development of a single shared system for REMS. The other addressed waivers from the SSS for REMS. The FDA proffered these guidances as a means of enhancing cooperation and competition in response to complaints that brand drug manufacturers were using REMS requirements “to block timely generic entry.” Yet, however well-intended, their substance actually reveals the limits of FDA policy and might in preventing gamesmanship in the development of SSS for REMS.

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