[20190312]LSB10272_2019年《创建法案》和降低药品价格：法律背景和概述.pdf

CRS Legal Sidebar Prepared for Members and Committees of Congress Legal SidebarLegal Sidebari i 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