The Safety of Newly Approved Medicines
Do Recent Market Removals Mean There Is a Problem?
- Michael A. Friedman, MD;
- Janet Woodcock, MD;
- Murray M. Lumpkin, MD;
- Jeffrey E. Shuren, MD, JD;
- Arthur E. Hass;
- Larry J. Thompson, MS
- Author Affiliations: Office of the Commissioner (Dr Friedman), Center for Drug Research and Evaluation (Drs Woodcock and Lumpkin), Office of Policy, (Dr Shuren), Office of Performance Evaluation, (Mr Hass), and Office of Public Affairs (Mr thompson), Office of the Commissioner, The US Food and Drug Administration, Rockville, Md.
Abstract
The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug review process at the US Food and Drug Administration (FDA). Specifically, concerns were raised about improvements in drug review efficiency that significantly reduced FDA review times. We have reviewed the circumstances of the 5 removals to determine whether there was any relationship to the increased efficiencies in the drug review process. When the removed drugs were analyzed by date of approval, no increase in the number of drugs taken off the market was seen, demonstrating that reduced review processing time was not the reason for the cluster of removals. We conclude that the agency's drug review procedures and postmarketing surveillance system after a drug has been marketed are currently adequate but must continually adjust to future challenges.
