Health Affairs, 26, no. 3 (2007): 663 doi: 10.1377/hlthaff.26.3.663 © 2007 by Project HOPE	New Online   Pay Cuts For Medicare Docs   Access To Care Woes   Public Coverage More Efficient   Empowering Consumers

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Tools & Incentives

PROLOGUE

Regulatory Tools And Incentives For Dealing With Health-Related Risk

Two events have achieved almost iconic status in this regard. Reports in the medical literature linking newer antidepressants to suicide led to suggestions that these agents, known collectively as selective serotonin reuptake inhibitors (SSRIs), be prescribed less frequently and monitored more closely. Right on the heels of the SSRI brouhaha, the decision to remove Vioxx from the market because of data linking the painkiller to cardiovascular disease created another impetus to reevaluate policies for drug prescribing and postmarketing surveillance.

The Institute of Medicine conducted a study that culminated in a recommendation that the Food and Drug Administration (FDA) require increased implementation of "risk-management" plans for new pharmaceuticals. Senators Edward M. Kennedy (D-MA) and Mike Enzi (R-WY) have proposed that the FDA establish risk-management procedures to regulate the way in which drugs are prescribed.

Reaction to these policy initiatives has been vigorous and varied. Scott Gottlieb argues here that the widespread imposition of "risk management" will put the government in the business of regulating the practice of medicine while making it more difficult for many patients to get new medicines. David Meltzer counters that "risk management," while not perfect, nonetheless brings us one step closer to ensuring that risks and benefits are carefully balanced in patients’ interest. Enzi and Kennedy also contribute a Perspective discussing their legislation.

Looking at risk through the lens of cost-effectiveness, Anupam Jena and Tomas Philipson write that pharmaceutical and biotechnology companies deserve a high return on their investment, to foster continued innovation. The current generation pays so that the next generation will benefit from new technology.

Lou Garrison and his coauthors tackle the issue by recommending more emphasis on outcomes research to produce a more structured and transparent process for balancing risks and benefits. Finally, Peter Jacobson focuses on the fact that consumer-directed care, if it catches on, will not only offer the patient more autonomy but will also place new demands on physicians and insurers to provide patients with up-to-date, comprehensible information on which to base decision making. This dynamic, he suggests, will lead to new issues in health law.

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