FDA's New Drug Safety Board Under Scrutiny


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 said.

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 comprised 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 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 MedWatch.

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. Christopher Dodd (D-Conn.) said in a statement.

Sen. Dodd also expressed concern that the FDA wouldn't have the resources to adequately oversee drug safety. “The president's budget provides only a $6.5 million increase for this critically important need, and that's far short of what is needed.”

Additional actions should be taken to increase FDA's resources to monitor drugs and to give it the authority to require drug companies to initiate and complete appropriate safety studies, suggested Sen. Edward M. Kennedy (D-Mass.)

The agency will eventually seek input on the quality and usefulness of this information, an FDA spokeswoman said.“We are not soliciting for public comment, or treating this as a proposed rule.”

The agency does plan on issuing draft guidance on procedures and criteria for identifying drugs and information for the Web page.

A spokesman for the Pharmaceutical Research and Manufacturers of America said that that organization supports any effort to address the quality of information used by the agency.

“For health care professionals and patients, it is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk,” said Jeff Trewhitt, adding that PhRMA would study the initiatives and respond to the FDA's request for input.

But Public Citizen's Mr. Sasich said the effort to step up monitoring of drugs seems like an attempt to deflect recent criticisms that FDA hasn't been meeting its charge as a public safety agency.

In particular, FDA has been criticized for not acting quickly enough to inform physicians and patients about the possible health repercussions of cyclooxygenase-2 (COX-2) inhibitor Vioxx (rofecoxib), which was withdrawn from the market last September 2004.

In PhRMA's view, the FDA has already responded “quickly and constructively” to concerns about Vioxx, Mr. Trewhitt said.

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