FDA to create drug oversight board

WASHINGTON — The Food and Drug Administration will create an independent board to monitor the safety of drugs after they are approved, according to published reports. The FDA has come under criticism recently for allegedly responding slowly to safety issues involving COX-2 inhibitors and other drugs.

The purpose of the board will be to monitor FDA-approved medicines once they are on the market and to update physicians and the public with emerging information on approved drugs’ risks and benefits, an Associated Press report said.

Health and Human Services Secretary Mike Leavitt said that the U.S. public wants more information from the FDA and wants the agency to have more oversight once a drug has been approved for marketing, according to the AP.

The new board will include FDA employees, medical experts from other HHS agencies and governmental departments, and it will consult with outside medical experts, and consumer and patient groups, the AP reported. The board also plans to create a drug safety Web site that will include emerging information such as side effects, safety risks and steps patients can take to minimize risks for both approved and newly improved medications, according to the AP.

“FDA will also increase the transparency of the Agency’s decision-making process by establishing new and expanding existing communication channels to provide targeted drug safety information to the public,” the FDA said on its Web site.

The independent agency will solicit public input on how the FDA should manage potential concerns associated with disseminating emerging information before taking regulatory action, according to the FDA Web site.

In December, the AP reported that about 66% of FDA scientists are less than fully confident in the agency’s monitoring of the safety of prescription drugs. An internal survey of 400 FDA scientists showed that 31% were only “somewhat confident” in the agency’s ability to render safety decisions in a timely manner, the AP reported.

Also in December, an AP poll found that consumers were still confident in the safety of prescription drugs sold in the United States, although some indicated that their confidence was limited.

In related news, Lester Crawford, MD, was officially nominated to be the FDA commissioner on Feb. 14; Dr. Crawford has been acting commissioner since early 2004.