Citing a range of problems including chronic underfunding, insufficient regulatory authority, staff conflicts, and poor management, an Institute of Medicine committee has called for sweeping changes in the way the US Food and Drug Administration (FDA) monitors drug safety.
The changes urge the FDA to adopt a “lifecycle” approach to monitoring drug safety, paying close attention to the safety of the drug from development until the end of a drug's useful life. Fifteen experts from a variety of disciplines served on the committee, which the FDA commissioned to address growing public concerns about the safety of FDA-approved drugs. Several other federal agencies, including the National Institutes of Health and the Veterans Administration, cosponsored the review.
Kuehn BM. IOM: Overhaul Drug Safety Monitoring. JAMA. 2006;296(17):2075-2076. doi:10.1001/jama.296.17.2075