Risk management and comparative effectiveness research: Implications of the new collaborative FDA-CMS initiative

Abstract

The US Food and Drug Administration's (FDA's) expanded authority to require Risk Evaluation and Mitigation Strategies (REMS) and the increasing importance of comparative effectiveness research and reviews (CERs) under the Affordable Care Act raise a number of public policy issues for prescription drug safety. In addition, the formalization of an interface between the Centers for Medicare and Medicaid Services (CMS) and the FDA to expedite early coverage of drugs, devices and diagnostics raises a number of questions about the extension of CERs into post-marketing drug surveillance requirements. In this commentary, we address the potential applications of CERs and REMS in risk-benefit assessments. © 2011 The Authors. JPHSR © 2011 Royal Pharmaceutical Society.