Drug Safety Proposals And The Intrusion Of Federal Regulation Into Patient Freedom And Medical Practice
Open Access
- 1 May 2007
- journal article
- Published by Health Affairs (Project Hope) in Health Affairs
- Vol. 26 (3) , 664-677
- https://doi.org/10.1377/hlthaff.26.3.664
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.Keywords
This publication has 4 references indexed in Scilit:
- Evidence-Based Risk Management: How Can We Succeed?: Deliberations from a Risk Management Advisory CouncilDrug Information Journal, 2003
- The United States Food and Drug Administration’s Risk Management FrameworkDrug Information Journal, 2002
- Liver Enzyme Monitoring in Patients Treated With TroglitazoneJAMA, 2001
- Clozapine-Induced Agranulocytosis -- Incidence and Risk Factors in the United StatesNew England Journal of Medicine, 1993