Open AccessRisk management and comparative effectiveness research: implications of the new collaborative FDA‐CMS initiative
Author(s) -
Freeman Robert,
Sparks Jeremiah,
Davidson Nancy
Publication year - 2011
Publication title -
journal of pharmaceutical health services research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.244
H-Index - 15
eISSN - 1759-8893
pISSN - 1759-8885
DOI - 10.1111/j.1759-8893.2011.00055.x
Subject(s) - medicine , food and drug administration , medicaid , prescription drug , medical prescription , drug approval , comparative effectiveness research , drug , risk management , patient protection and affordable care act , risk analysis (engineering) , actuarial science , family medicine , alternative medicine , pharmacology , health care , business , finance , economic growth , pathology , economics
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.