FDA Needs Systematic Process to Monitor Drugs Throughout Lifecycle, Report Says

The Food and Drug Administration needs a more systematic and transparent process to collect, assess, and act on data about a medication’s benefit-risk profile throughout the drug’s lifecycle, from approval until it is no longer marketed, according to a report released May 1 by the Institute of Medicine.

The report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, said that the full range of a medication’s effects might not become apparent until a product reaches the market and has been used by a larger, more diverse population over an extended time.

FDA sponsored the report.

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