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1 1 (March 12, 2019)

handle is hein.crs/govzig0001 and id is 1 raw text is: Congressional ______ *Research Service The CREATES Act of 2019 and Lowering Drug Prices: Legal Background & Overview March 12, 2019 On February 5, 2019, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act) was reintroduced in both the Senate and the House. The bill, first introduced in the 114th Congress (S. 3056) and again in the 115th Congress (S. 974 and H.R. 2212), aims to facilitate the timely entry of lower-cost generic and biosimilar versions of brand-name drugs and biological products (i.e., products such as vaccines and blood components that are derived from living organisms) to promote competition in the market for such products. Specifically, the CREATES Act aims to address the concern that some brand manufacturers have improperly restricted the distribution of their products, including by invoking a distribution safety protocol known as Risk Evaluation and Mitigation Strategies (REMS), to deny generic product developers access to samples of brand products. (For ease of reference, this Sidebar uses generic product to refer to both generic drugs and biosimilars). Because generic product developers need samples to conduct certain comparative testing required by the U.S. Food and Drug Administration (FDA), some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products. To remedy this concern, the CREATES Act would create a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on commercially reasonable, market-based terms. This Sidebar provides an overview of the generic drug and biosimilar application process, noting the view that some brand manufacturers have used restricted distribution to deny generic product developers the brand samples needed for regulatory approval. It next explains how the existing legal framework addresses these practices and how the CREATES Act would modify that legal framework. Generic Drug and Biosimilar Application Process To encourage market entry by generic drugs, the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act, P.L. 98-417) created an expedited pathway for generic drug approval. Unlike a brand manufacturer, who must submit an extensive new drug application (NDA) that includes, among other things, clinical trial data, a generic manufacturer may submit an abbreviated NDA (ANDA) that demonstrates that the generic is bioequivalent to a previously approved brand drug. Similarly, the Biologics Price Competition and Innovation Act of 2009 (BPCIA, P.L. 111-148) created an expedited Congressional Research Service https://crsreports.congress.gov LSB10272 CRS Legal Sidebar Prepared for Members and Committees of Congress

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