Health Affairs, 23, no. 1 (2004): 51 doi: 10.1377/hlthaff.23.1.51 © 2004 by Project HOPE	New Online   New Issue: China & India   Obesity In China   Pay Cuts For Medicare Docs   Access To Care Woes

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Environment

The Evolving Environment For Prescription Drugs

Regulation by the U.S. Food and Drug Administration (FDA) is the cornerstone for policy making affecting the pharmaceutical industry; reduction in FDA approval times for new products has been one of the most important developments in drug policy in the past decade. But opinion about the approval process is polarized, and technical issues frequently obscure our view of how it works. Newcomers to the subject might be surprised to learn in the analysis by Dan Carpenter of Harvard University that until recently the public was more concerned about the FDA approving drugs too quickly rather than too slowly. Carpenter brings a political scientist’s range of vision to his subject and finds that important environmental factors influence the agency’s behavior, as well as the strictly technical and scientific issues it addresses.

Academe is the traditional locus of discovery research in the life sciences, but as Eric Campbell and colleagues point out next, the pace of collaboration between university-based researchers and private industry has picked up considerably since passage of the Bayh-Dole Act in 1980. Important synergies have been realized by this deliberate stimulation of "technology transfer" between publicly funded research and the private sector, these authors conclude. But the acceleration of technology transfer brings the risk of research bias and other potential problems. Improved methods of monitoring and evaluating the effects of university–industry partnerships are needed to preserve the gains that have been achieved.

Finally, Robert Califf of Duke University offers a clinician’s perspective on the implications of expanding scientific opportunities for the clinical trials process and the general problem of providing patients and providers with adequate information on the risks and benefits of new treatments. Trials are now geared to meeting the FDA’s requirements for assurances of safety and efficacy. But before the promise of the new fields of genomics and proteomics is realized, researchers and regulators will need to augment their current capacity for predicting and monitoring the effects of new therapies on a myriad of patient subgroups who may over time respond differently to the same medications.

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