Committee Makes Recommendations for Long-term Oversight of Drugs Following FDA Approval

VCU expert serves on Institute of Medicine’s Committee

The Institute of Medicine's Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs released a report this month, sponsored by the U.S. Food and Drug Administration, recommending a “life-cycle” approach to monitoring and approving drugs.

Larry Palmer, former director of the VCU-William and Mary Health Policy and Law Initiative and affiliate professor in VCU’s Department of Health Administration, served on the committee and can comment on the importance of its recommendations.

The report's recommendations build on the new authorities and tools provided to the FDA through the Food and Drug Administration Amendments Act of 2007, which increased the agency's capacity to monitor drugs after approval and act if signs of safety problems appear.

A “life-cycle” approach to monitoring and approving drugs is based on the idea that the full range of a medication’s effects may not become apparent until a product has been used by larger, more diverse populations than those tested during the approval process.

He says drugs are identified as safe to go to market after only a sample population is tested, “but once millions of people around the world start taking them, issues can arise. This report helps focus on after approval risks and benefits.”

One of the key words in that statement is “benefits.”

“The purpose of the report is not necessarily to take drugs off the market because of risks. That might not be best for the patients,” Palmer said. “There could be benefits that outweigh the risks.”

Palmer, who specializes in public health, health care needs of vulnerable populations and areas where health, law and policy intersect, spent 27 years at Cornell University as a law professor, vice president and vice provost.

He can discuss the committee’s several specific suggestions to the FDA about moving toward a “life-cycle” approach to drug monitoring. The suggestions include publicly accessible benefit/risk assessment and management plans for each new drug, post-market study requirements based on existing research and evidence and ethical considerations to help protect research participants and overall public health.

EDITOR’S NOTE: A full copy of the committee’s report and more information can be found at