title: Drug safety proposals and the intrusion of federal regulation into patient freedom and medical practice.
abstract: Life-cycle management of drug safety issues requires vigilant postmarket monitoring. Increasingly, however, this concept also includes direct management of how drugs are used, to minimize risks and maximize benefits. Legislative proposals from Senators Kennedy and Enzi, as well as plans offered by the Institute of Medicine, are promoting the more widespread adoption of risk-management plans to mitigate a broader range of safety-related issues. These proposals seek to modify physician prescribing patterns to tip risk-benefit balancing in individual prescription decisions. Yet these policies would do nothing to mitigate the drug safety-related issues that have been the source of recent public interest.
authors.affiliation: American Enterprise Institute, Washington, DC, USA. Scott.Gottlieb@mssm.edu
authors.forename: Scott
authors.initials: S
authors.lastname: Gottlieb
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D028701:Patient Rights; D010819:Physician's Role; D010818:Practice Patterns, Physicians'; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration