[20161031]IF10494_风险评估和缓解策略（REMS）和非专利药物.pdf

https:/crsreports.congress.gov October 31, 2016Risk Evaluation and Mitigation Strategies (REMS) and Generic DrugsBackground: REMS The Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA; P.L. 110-85) expanded the risk-management authority of FDA, authorizing the agency to require, under specified conditions, a risk evaluation and mitigation strategy (REMS) for certain drugs. As part of a REMS, a drug manufacturer may be required to provide certain information to patients (e.g., a medication guide) and health care providers, or to impose restriction on a drugs sale and distribution via one or more “Elements to Assure Safe Use” (ETASU). An ETASU is a restriction on distribution or use that is intended to (1) allow access to those who could benefit from a drug while minimizing the risk of adverse events, and (2) block access to those for whom the risks would outweigh the potential benefits. For example, an ETASU could require that pharmacies, practitioners, or health care settings that dispense the drug be specially certified, or that the patient using the drug be subject to monitoring. By requiring a REMS, FDA is able to approve a drug that it otherwise would have to ke