title: Risk management and intrusions on medical practice: striking a balance.
abstract: All drugs have risks. Scott Gottlieb suggests that the federal government should leave management of those risks to medical professionals. At issue is legislation to strengthen the Food and Drug Administration's (FDA's) authority and ability to manage those risks over a drug's life cycle. The Enhancing Drug Safety and Innovation Act (S. 484) would codify the FDA's authority to impose restrictions on distribution and use after approval of a drug and require those restrictions to be adapted to new information about the safety of the drug. The legislation strikes a realistic balance between risk management and intrusions on medical practice.
authors.affiliation: Senate Health, Education, Labor, and Pensions Committee, USA.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Enzi
authors.forename: Edward M
authors.initials: EM
authors.lastname: Kennedy
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence; D006801:Humans; D010818:Practice Patterns, Physicians'; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration