FDA to Establish New Drug Oversight Board

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The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they’re on the market and update physicians and patients with emerging information on risks and benefits.

Health 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, 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 for both previously and newly improved drugs, such as side effects, safety risks and steps that can be taken to minimize them.

One-page information sheets for health care professionals and another for patients also will be made widely available, officials said.

Lester M. Crawford, the acting FDA commissioner who was nominated Monday by President Bush to assume the post permanently, said the agency now “understands that the public expects better and more prompt information.”

Newly sworn in himself, Leavitt said last week that he expected the FDA to adopt “an emboldened vision for that agency” to meet 21th-century threats.

Chief among them is bioterrorism. Outgoing HHS Secretary Tommy Thompson said in December that the nation’s food supply is so vulnerable he was surprised terrorists had not yet tainted it, saying, “it is so easy to do.”

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