An Institute of Medicine committee report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, recommends that the FDA monitor a drug’s safety after initial approval and throughout its time on the market.
In the report, it is recommended that, upon approval, each drug have a comprehensive Benefit and Risk Assessment and Management Plan to serve as a main, revisable source of side effects and other information. Much of this information is already collected by the FDA, but the data are held within multiple records rather than combined in 1 location.
“A drug’s full range of risks and benefits become apparent after it is used widely over time, and so it is crucial that the FDA continue to monitor drugs throughout their market life cycle with a systematic and transparent process,” says committee cochair Ruth Faden, PhD, MPH, director of the Johns Hopkins Berman Institute of Bioethics.
The committee also recommends that the FDA establish a new team to attend to and provide advice for the ethical issues brought about by postmarket monitoring.
In regard to postmarket research, the committee discovered that observational studies have ethical and practical benefits over clinical trials once drugs are on the market. The studies allow for quicker results, and therefore regulatory action can be taken sooner.
“Our report focuses on how the agency can be proactive, so that when a drug’s risk outweighs its benefit, the FDA will know earlier and respond quickly, while honoring its ethical obligations to protect both public health and research participants,” says Faden.