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Health Affairs, 26, no. 3 (2007): 664-677
doi: 10.1377/hlthaff.26.3.664
© 2007 by Project HOPE
 
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Tools & Incentives

Drug Safety Proposals And The Intrusion Of Federal Regulation Into Patient Freedom And Medical Practice

Scott Gottlieb

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.


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This article has been cited by other articles:


Home page
Health Aff (Millwood)Home page
M. B. Enzi and E. M. Kennedy
Risk Management And Intrusions On Medical Practice: Striking A Balance
Health Aff., May 1, 2007; 26(3): 678 - 680.
[Abstract] [Full Text] [PDF]


Home page
Health Aff (Millwood)Home page
D. Meltzer
Risks And Benefits Of Risk-Management Plans
Health Aff., May 1, 2007; 26(3): 681 - 683.
[Abstract] [Full Text] [PDF]



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