FDA will create new drug safety board
February 17 2005 12:00 AM ET
The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines--including HIV antiretroviral drugs and treatments for the adverse side effects of anti-HIV drugs--once they're on the market and update physicians and patients with emerging information on risks and benefits. House and Human Services secretary Mike Leavitt announced the creation of the board during a meeting with FDA employees Tuesday. The agency has been criticized sharply in recent months as reacting too slowly to reports linking the arthritis drug Vioxx and pain drug Celebrex to increased risks of heart attack and stroke.
Leavitt said it's clear that people want more oversight and openness from the agency. "They want to know what we know, what we do with information, and why we do it," he said, promising to create "a new culture of openness and enhanced independence." The board will recommend what information and updates to put on the government's Drug Watch, resolve disputes over drug safety issues, and oversee the development of a drug safety policy. It will be composed of FDA employees and medical experts from other HHS agencies and governmental departments and consult with outside medical experts as well as consumer and patient groups, officials said.
To improve new drug safety information reaching patients and doctors, the board will create a drug safety Web page with emerging information--such as side effects, safety risks, and steps that can be taken to minimize them--for both previously and newly improved drugs. Also, separate information sheets for health care professionals and patients will be made widely available, officials said. (AP)