/publications/issue/2005/2005-01/2005-01-9108

FDA Moves to Strengthen Postmarketing Rx Safety

Author: Ken Rankin

Shaken by the discovery of serious safety problems with Vioxx and a number of antidepressant drugs approved for marketing in the United States, the FDA announced a series of new steps designed to identify risks associated with prescription medicines currently on the nation's pharmacy shelves.

The measures include a new FDA-sponsored study by the Institute of Medicine to examine the effectiveness of the nation's new drug approval system, and a series of workshops and Advisory Committee meetings that will explore "emerging concerns" about medications already on the market.

The FDA also plans to implement a new program for adjudicating differences of professional opinion concerning possible safety risks posed by approved drugs. Because these scientific "disagreements can have a potentially significant public health impact," the new system will employ an independent "ad hoc panel" of experts to review and resolve disputes, a representative from the agency said.