Safety issues remain at FDA

GAO report says agency can't monitor drugs for long-term problems


WASHINGTON -- More than a year after the Food and Drug Administration announced that it had strengthened its drug safety system, the agency lacks a reliable way to keep track of emerging problems, congressional investigators concluded in a report to be released today.

The Government Accountability Office found that a new Drug Safety Oversight Board and other FDA initiatives "are unlikely to address all the gaps" in the agency's system for monitoring the long-term safety of prescription drugs approved for market.

While the board might help straighten out high-profile cases, the GAO said, day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the FDA bureau that reviews drugs for approval and a smaller safety office depicted in the report as a bureaucratic stepchild.

The safety office "serves primarily as a consultant" to the Office of New Drugs "and does not have any independent decision-making responsibility," the report said. In some cases, it found, the new drug bureau has excluded safety officers from presenting their findings to scientific panels that the FDA relies on for advice.

With eight directors of its safety office in the past 10 years, the FDA "has not effectively overseen post-market drug safety issues, and as a result, it is unclear how [the agency] can know that important safety concerns have been addressed and resolved in a timely manner," the report said.

It is too early to tell whether the report will provide a boost for stalled legislation to strengthen the FDA's safety office and make it an independent center within the agency. While GAO investigators outlined a long list of unresolved problems, they credited the FDA for working to make improvements. In a statement, the FDA vigorously disputed the finding that its safety office plays a secondary role.

Two key lawmakers who requested the GAO inquiry were divided in their reactions to the report.

"The GAO report shows that the drug safety system is not in crisis, but the FDA's process may need some fine tuning," said Rep. Joe L. Barton, a Texas Republican and chairman of the Energy and Commerce Committee, which oversees the pharmaceutical industry.

A spokesman said Barton would wait for a National Academy of Sciences report this summer before deciding whether to pursue legislation.

Sen. Charles E. Grassley, an Iowa Republican and co-author of the FDA reform bill, said the findings by nonpartisan investigators bolstered his proposal. Grassley held widely publicized hearings into the FDA's failure to identify the heart risks of Vioxx despite warnings from its safety office. The hearings followed an unexpected decision by manufacturer Merck & Co. to withdraw the painkiller, which had racked up blockbuster sales and profits.

"At the Vioxx hearing, some said there was a crisis at the FDA and others said everything is all right," Grassley said. "This report provides solid evidence that everything is not all right [and that] the FDA's problems are systemic and cultural, not isolated or easily fixed."

In preparing their report, GAO investigators interviewed FDA scientists and managers and reviewed internal documents usually not provided to the public. Meetings of the drug safety board are closed.

The FDA's oversight problems begin with spotty data, investigators found.

In most cases, the agency lacks legal authority to order manufacturers to conduct follow-up safety studies once a drug is approved. Grassley's bill would grant the agency such authority.

Investigators found that the new drug bureau and the safety office repeatedly get bogged down in bickering over what the data means. These scientific disputes can continue for months, even years.

The GAO report depicted the safety office, with 106 employees and a $27 million budget, as a junior bureaucratic partner, sometimes ignored or dismissed by the new drug bureau, with 715 employees and a $111 million budget.

The chief of the new drug bureau reports directly to the head of the FDA's Center for Drug Evaluation and Research, while the director of the safety office must go through another supervisory level before reaching the head of the center.

The FDA disputed the finding that the safety office merely plays a "consultant" role, saying the two offices are equally respected, and that 51 percent of the work of the new drug bureau involves safety.

Congressional investigators said the FDA needs to set up a more effective system for settling such disputes between the two offices.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.