FDA forms drug safety board

In response to recent criticism over its ability to ensure the safety of the nation's prescription drugs, the Food and Drug Administration is establishing an independent advisory board to monitor the safety of medications after they are on the market.

The Drug Safety Oversight Board is being put in place to help provide emerging information on the risks and benefits of available medications to physicians and their patients, said Health and Human Services Secretary Michael Leavitt, MD, when announcing the new board Feb. 15.

The board, which will be made up of FDA staff and medical experts from other HHS agencies and government departments, will oversee the management of drug safety issues within the FDA's Center for Drug Evaluation and Research. The board also will consult with other experts and patient and consumer groups, according to the FDA.

In addition, the agency will take steps to ensure that emerging drug safety data are quickly made available, said Acting FDA Commissioner Lester M. Crawford, DVM, PhD. The agency is proposing that a new consumer-friendly "Drug Watch" Web site be developed that allows easy access to new information.

One-page information sheets for physicians and other health care professionals also will be made available for all drugs on FDA's Drug Watch and for all drugs with Medication Guides. The information sheets will contain the most important new information for safe and effective use of a medication, according to the FDA.

The FDA's actions came on the eve of a three-day hearing by two agency advisory panels on the safety of Cox-2 inhibitors. The hearing was called in the wake of the withdrawal last fall of the pain medication Vioxx, and resulting concerns raised about related drugs including Celebrex and Bextra.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/03/07/hlbf0307.htm.