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Groups Want a Tougher FDA

Panel Considers Calls for More Agency Power
By
WebMD Health News
Reviewed by Louise Chang, MD

Jan. 19, 2006 (Washington) -- Several health care groups on Thursday called on Congress to boost the FDA's authority to police medications in the wake of several safety problems that have sullied the agency's reputation.

Groups told an expert panel set up to review the FDA's safety practices that the agency lacks the clout it needs to force drugmakers to alter drug labels and order widespread studies of drug safety.

Advocates also backed proposals to restructure the FDA in an effort to improve how it polices the safety of drugs already on the market.

Drug company executives maintained that the agency has the legal authority it needs to ensure drug safety and that granting it more power would slow down drug development and deprive patients of needed medications.

The testimony came during the last of three days of hearings before an Institute of Medicine expert committee investigating how the FDA monitors drug safety. The panel was convened after several recent safety problems rocked the agency, including the widely publicized pulling of the drug Vioxx from the market after evidence that it doubled the risk of heart attack and stroke in millions of patients.

Several other safety problems, including new warnings of suicidal risks in adolescents taking SSRI antidepressants and the recall of thousands of electrical pacemakers, increased scrutiny on the agency.

Calls for Reform

Some safety experts have criticized the fact that the FDA lacks the legal authority to order companies to change drug labels, even when new data reveal safety concerns. Instead, regulators often end up in protracted negotiations with drugmakers over label content.

Fran Visco, president of the National Breast Cancer Coalition, told panelists that the FDA's structure should be changed to separate the office monitoring the safety of marketed dugs from the one that approves new medications. Visco echoed concerns that the offices now suffer from conflict of interest because regulators who approve a new drug are reluctant to later admit it has safety problems.

"The public needs a watchdog that is real; that is independent; that it can trust. We don't feel like that exists now," Visco said.

Other experts told the panel during hearings that drug companies often don't publish scientific results that question a product's safety or effectiveness, skewing the doctors' and the public's perception of the drugs.

Visco backed efforts to force drug companies to register all clinical trials and to report all findings to the public. "That is not happening now," she said.

James Kotsanos, MD, head of endocrine and cardiovascular drug development for drugmaker Eli Lilly and Co., told the panel that most companies now have voluntary web sites displaying trial information and that those sites are improving. "We even have an independent auditor checking the information," he said.

The agency also does not have the right to order companies to perform safety studies on drugs already on the U.S. market. Panelists pointed to data showing companies often don't complete promised safety studies for drugs already on the market.

Committee member Bruce M. Psaty, MD, cited research showing that 827 studies made by drug companies still remain unfulfilled. He called the figure "a large percentage" of the total commitments made by companies.

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