Magazine article Clinical Psychiatry News

FDA's New Drug Safety Board under Scrutiny: Critics Say Board May Lack Independence and Authority, and May Not Have Sufficient Resources

Magazine article Clinical Psychiatry News

FDA's New Drug Safety Board under Scrutiny: Critics Say Board May Lack Independence and Authority, and May Not Have Sufficient Resources

Article excerpt

Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.

Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and "openness" at the Food and Drug Administration.

"Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers," said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.

The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.

Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.

If the new board reports in a similar manner, "it may be a stretch to call it an independent board," Mr. Sasich commented.

Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.

The safety board would be composed of FDA officials and medical experts from other federal agencies. Outside medical experts and consumer representatives would serve as consultants.

"We hope to nominate and confirm board members within the next few months," an FDA spokeswoman said.

As another component of the new oversight initiative, FDA plans to create a new "Drug Watch" Web page, a site to include emerging information for approved drugs about possible serious side effects, or other safety risks.

The Web site would also house drug safety information sheets for health care professionals and patients. Such information also would be available through Med-Watch.

Through these direct communication channels, the agency plans to discuss emerging or potential safety problems with the public--even before considering a regulatory action.

Some lawmakers thought the department's new initiatives didn't go far enough to ensure drug safety.

"Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency," Sen. …

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