Skip to main content

Ethics and science experts call for FDA to improve its system for assessing drugs on the market


The commentary follows the release of an Institute of Medicine report, “Ethical and Scientific Issues in Studying the Safety of Approved Drugs,” on Tuesday. That report evaluated options available to the FDA in the wake of a 2007 law that provides the FDA with more tools to monitor and regulate drugs after they have been approved for the market.

“We believe the FDA should be as serious about monitoring the safety of approved drugs on the market as it is about testing drugs before they get to the market. It’s largely a matter of using authority they already possess, but they need to take action,” said Eric M. Meslin, Ph.D., director of the Indiana University Center for Bioethics and associate dean for bioethics at the IU School of Medicine. Meslin co-authored the JAMA commentary and was a member of the Institute of Medicine committee that wrote Tuesday’s report.

The other JAMA authors are lead author Bruce M. Psaty, M.D., Ph.D., of the University of Washington and Alasdair Breckenridge, M.D., FRCP, chairman of the United Kingdom’s drug regulatory agency. Both were also members of the Institute of Medicine committee.

Despite years of testing involving thousands of people, some effects of drugs may not appear until they have been used by a larger, and more diverse, group of patients. In some instances, highly successful drugs have been withdrawn from the market or severely restricted in use because dangerous side effects emerged after the drugs had been on the market for years.

The Institute of Medicine report recommends that the FDA create a benefit and risk assessment and management plan for each drug while it is on the market. The document would be a publicly accessible report detailing any safety issues that exist when a drug is approved or that emerge later, along with evaluations of benefits and risks, any subsequent studies and other information about the drug.

“Because many current regulations were formulated for drugs that were not the products of modern innovative techniques, new methods are needed,” the JAMA authors wrote.

Careful development and implementation of such a system “as new drugs are reviewed and approved, will provide an ongoing opportunity to evaluate approval methods and regulatory actions for the next generation of medicines,” they said.

The Institute of Medicine is the private, nonprofit health arm of the National Academy of Sciences, created to provide advice on medical matters to the policymakers and the public.