Premier Statement on the FDA Efforts to Inject Competition in the Drug Market Last Updated: June 4, 2018
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By Blair Childs, Senior Vice President of Public Affairs, Premier

We applaud FDA’s proactive leadership to promote competitive markets by calling out manufacturers that abuse well-intentioned programs like the Risk Evaluation and Mitigation Strategy (REMS) to block new market entrants. While Commissioner Scott Gottlieb deserves great credit for shining a light on this problem and for taking important preliminary actions, we believe FDA’s authority only goes so far. We also need Congress to enact the CREATES Act (S.974/H.R.2212) that will create a legally enforceable, clear process for generic manufactures to obtain product samples.

We also support the FDA’s willingness to review and examine its policies and authorities to help prevent drug shortages. Premier is intensely focused on reducing and managing drug shortages overall, and we have made a number of recommendations to FDA on how to better managing them. From advocating for the DEA to address the shortage of injectable narcotic medications to assisting hospitals obtain critical IV saline solution products after key suppliers were ravaged by hurricanes in 2017, Premier has been a crucial player in preventing shortages from escalating and impacting patient care. We are encouraged by and supportive of  FDA’s willingness to explore an improved and more dynamic procedure for advanced notification of impending shortages, as well as the potential for new authorities that could be used to prevent or mitigate ongoing drug shortages that have serious implications for public health.

-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 to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting 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.