Healthy Skepticism Library item: 10825

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Gottlieb S.
Drug safety proposals and the intrusion of federal regulation into patient freedom and medical practice.
Health Aff (Millwood) 2007 May-Jun; 26:(3):664-77
http://content.healthaffairs.org/cgi/pmidlookup?view=long&pmid=17485742

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:
Drug Approval/legislation & jurisprudence* Drug Industry/legislation & jurisprudence Government Regulation* Humans Institute of Medicine (U.S.) Patient Rights* Physician's Practice Patterns* Physician's Role Risk Management/methods* United States United States Food and Drug Administration