Premier Statement on FDA Draft Guidance for Improving Review of Risk Evaluation and Mitigation Strategies Last Updated: November 8, 2017
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By Blair Childs, senior vice president of public affairs, Premier

Premier and its members commend the FDA for taking important steps through draft guidance to stem drug manufacturers’ abuse of the Risk Evaluation and Mitigation Strategy (REMS) – a process that was implemented as a move to increase patient safety but has been exploited by some drugmakers that use it as a regulatory loophole to block generic entrants into the market and stifle competition.

Premier also encourages Congress to take further action and enact legislation which levels the playing field for new market entrants and fosters competition, helping drive down inflated drug prices. The Fair Access for Safe and Timely (FAST) Generics Act and Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act provides clear a bipartisan solution to abusive, anticompetitive business practices that increase costs to the American healthcare system by impeding patient access to generic and biosimilar medicines.

-By Blair Childs, senior vice president of public affairs, Premier

About Premier Inc.

Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of approximately 3,900 U.S. hospitals and health systems and approximately 150,000 other providers and organizations. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. Premier, a Malcolm Baldrige National Quality Award recipient, plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier’s news and investor sites on www.premierinc.com; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier’s blog for more information about the company.