Most research on the safety and efficacy of prescription drugs and medical devices has traditionally been done before the drugs and products are approved by the Food and Drug Administration (FDA) for marketing. This situation, however, may now change, at least for some drugs and devices.

The FDA, under its Modernization Act of 1997, has authorized the Department of Health and Human Services’ Agency for Health Care Policy and Research (AHCPR) to launch a new research program. The program should provide physicians, pharmacists, and patients with the scientific information they need to use existing prescription drugs and medical products more safely and effectively than is currently the case.

As part of this research program, the AHCPR has established four Centers for Education and Research on Therapeutics. They are at Duke University, the University of North Carolina, Vanderbilt University, and Georgetown University.

The Duke center, for instance, is going to study currently approved therapies for cardiovascular medicine. Georgetown University will be exploring various drug interactions. And it is possible that at one or more of the four centers, drugs or medical products will be compared for safety and efficacy.

Although none of the current research efforts at these centers is related to psychiatry, this situation could change, AHCPR spokesperson Karen Migdail told Psychiatric News. For example, the University of North Carolina may examine treatments for attention deficit/hyperactivity disorder.

AHCPR will be administering the program in consultation with the FDA.

The web site for the AHCPR’s new research program is <www.ahcpr.gov/news/press/pr1999/medpropr.htm>.