This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Drug Therapy, Other  • Adverse Effects  • Alert me on articles by topic

Bridget M. Kuehn

JAMA. 2006;296:2075-2076.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The FDA must boost postmarketing tracking for safety problems in drugs, according to a report from the Institute of Medicine.

The committee's report outlines 25 recommendations aimed at correcting the problems it . . . [Full Text of this Article]

SEEKING BALANCE