Washington Editor

WASHINGTON - The FDA's watchdog powers could expand substantially if some lawmakers on Capitol Hill get their way in a push for greater safety oversight at the agency.

New legislation recently introduced by Sens. Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.) aims to set up an independent division, although still within the FDA, to review drugs and biological products once they are on the market. Called the Center for Post-Market Drug Evaluation and Research (CPDER), it would have the authority to pull drugs off shelves, change labels, mandate post-approval studies and limit advertising.

Currently, the FDA can recommend only that drug companies comply with such orders.

"Our initiative to establish this independent drug safety office is part of our effort to restore balance at the Food and Drug Administration," Grassley said. "We need the FDA to be a vigilant watchdog."

Essentially, the proposed Food and Drug Administration Safety Act of 2005 is designed to move the agency away from conflicts of interest and take action when a drug risk is identified. To that end, the FDA's current safety division, the Office of Drug Safety, would no longer be a part of its approval division, the Center for Drug Evaluation and Research (CDER). The CPDER would consist of the Office of Drug Safety, independent of CDER, and the CPDER's director would report directly to the FDA's commissioner. It would be financed through $500 million in appropriations over five years, rather than by funds collected from drug development companies through the Prescription Drug and User Fee Act (PDUFA).

The reshuffling of those divisions within the FDA addresses what some have pointed to as an underlying problem within the agency. Sidney Wolfe, of Public Citizen, a Washington-based consumer protection group, has told BioWorld Today that "the fundamental problem with the Office of Drug Safety is that it is buried within, and subservient to, the rest of the CDER power structure." Recently, he echoed those sentiments and lauded the proposed legislation for its call to create a more independent safety division at the agency.

"The idea of removing this important part of the FDA from out of the clutches of CDER is a good idea," he said, adding that he does not advocate separating the drug safety group completely from the FDA. "And similarly, it's also a good idea to have it funded entirely by appropriated money, not at all by money from the industry. It's long overdue."

Wolfe also supported another provision of the Grassley-Dodd bill, which would give the agency the power to impose civil monetary fines on companies that do not comply.

The flap over the FDA's role as a public safeguard has been a concern for many months, and the matter refuses to subside. In addition to the recently introduced bill, last week saw yet another congressional committee on the subject and the CEO of Vioxx maker Merck and Co. Inc. resigned. That drug's market withdrawal in September brought the issue to light and generated exposure and far-reaching fallout.

Amit Sachdev, the newly named executive vice president for health at the Washington-based Biotechnology Industry Organization, said the trade association does not view the proposed legislation as necessary. The existing Office of Drug Safety, he said, already has appropriate authorities and independence within the FDA.

"We feel that the agency has probably got the best opportunity to address the question about how to get improved information for drugs that already have been marketed," Sachdev told BioWorld Today. "PDUFA III, when it was reauthorized, for the first time put a funding commitment in for post-market surveillance, which flows through the user-fee program to the Office of Drug Safety."

Wolfe countered that funding from the industry creates a conflict of interest and he remains opposed to PDUFA-generated finances being steered to the agency's drug safety division.

Sachdev pointed to two steps already taken to improve the FDA's surveillance of approved products: the creation of a website for its Drug Watch program to improve transparency at the agency, and the establishment of the Drug Safety Oversight Board to improve its dialogue with the external medical community.

"BIO supports additional appropriations to help the Office of Drug Safety develop and utilize better tools for post-market surveillance," said Sachdev, who previously served as the FDA's deputy commissioner for policy. "But it doesn't think that separating it from CDER, for instance, or the Office of New Drugs, promotes improved drug safety, necessarily."

BIO also has called for additional funding for "programs that are designed to build better data-collection mechanisms for already marketed drugs," he added, also noting support for the FDA's Critical Path Initiative that requests expanded use of biomarkers and other predictive technologies.

According to various news reports, other legislation to address drug safety is being jointly developed by Sens. Mike Enzi (R-Wyo.) and Ted Kennedy (D-Mass.). Enzi chairs the Senate Committee on Health, Education, Labor and Pensions, which oversees FDA matters; Kennedy is its ranking member.

Regardless, Wolfe called the Grassley-Dodd bill "an important start."

In addition to Public Citizen's endorsment, the bill has received support from the Center for Medical Consumers, the Consumer Federation of America, Consumers Union, the National Women's Health Network and the U.S. Public Interest Research Group.