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Institute of Medicine Urges Improved FDA Monitoring of Drugs After Market Approval


The Institute of Medicine report Ethical and Scientific Issues in Studying the Safety of Approved Drugs 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.

“The main message in my view is that 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. They already have a lot of this authority now – they just need to use it,” 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 is one of 12 members of an expert committee that was created to study the issue.

Although prescription drugs undergo years of testing and must show that the benefits of the drug outweigh the risks, the report noted that some of a drug’s effects may not appear until it has been used over long periods of time by a larger, more diverse population of patients. In some instances highly successful drugs have been withdrawn from the market or severely restricted in use due to dangerous side effects emerged after the drugs had been on the market for years.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 plant 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.

The report also makes recommendations about the procedures the FDA should follow when determining whether to require a manufacturer to conduct further studies of a drug already on the market.

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