Drug makers often promise timely follow-up studies, but they often delay going ahead, the agency said. As a result, the FDA can lack useful data in determining whether an approved drug really is safe, according to a report being released Monday by the Government Accountability Office.
Investigators also are urging Congress to change how the FDA tracks potential concerns about drug safety, makes major decisions and settles internal disputes, especially between the two offices that now assess drug safety.
"FDA lacks clear and effective processes for making decisions about and providing management oversight of, post-market safety issues," the report says.
In a response included in the report, the FDA said the conclusions were reasonable and consistent with actions the agency had planned or already begun.
Sen. Charles Grassley, R-Iowa, and Rep. Joe Barton, R-Texas, requested the investigation after several recent drug safety cases, including the withdrawal from the market of the pain killer Vioxx in 2004.
"This report provides solid evidence that everything is not all right at the FDA and calls for long-overdue reform. The FDA's problems are systemic and cultural, not isolated or easily fixed," Grassley said.
Grassley and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA the power to require drug companies to carry out studies of drugs already on the market. The bill was referred to the Senate Committee on Health, Education, Labor and Pensions nearly a year ago.
The FDA recently reported that of 1,231 studies that companies pledged to conduct, often in exchange for expedited approval of a drug, nearly two-thirds had yet to get under way as of last Sept. 30.
The FDA would have "real teeth" if it had the recommended authority, Grassley said.
The agency has taken steps to address the issue raised in the report:
In 2005, the FDA asked the Institute of Medicine, part of the National Academy of Sciences, to study drug safety.
Also last year, the FDA set up a Drug Safety Oversight Board and separately commissioned an evaluation of how the agency handles companies' commitments to post-marketing studies.
Last week, Dr. Paul Seligman was named to a new position overseeing drug safety issues and policies. Seligman said one goal was better managing the roughly 600 reviews of drugs with potential safety concerns that the FDA carries out each year.
Dr. Alastair Wood, associate dean of Vanderbilt Medical School, urged more sweeping changes, including creation of a drug safety board that is independent of the FDA.
"Clearly, independence is not shuffling the deck chairs on the Titanic, which is what the FDA did," Wood said.