April 23, 2006

Congress Should Strengthen FDA, Report Finds

WASHINGTON -- Lawmakers should give the Food and Drug Administration the power to require additional studies from drug-makers after their products hit the market, according to a report released on Monday that found lingering safety problems at the agency.

The Government Accountability Office said there is no clear process for the FDA to monitor already approved products.

"FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues," the GAO report said. "We observed that there is a lack of criteria for determining what safety actions to take and when to take them."

The agency sometimes approves products under the condition that companies later provide more data, but it does not have the authority to require such studies in most cases. The GAO said longer trials after approval could "answer safety questions about risks associated with the longer-term use of drugs."

The findings were released by Senate Finance Committee Chairman Charles Grassley, who requested the report in late 2004 after Merck & Co. Inc. recalled arthritis pill Vioxx that was linked to heart problems.

FDA officials have also been criticized for their handling of a string of other safety issues, including antidepressant use among children and teenagers amid evidence it may cause suicidal behavior.

"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," said Grassley, who has introduced legislation to bolster the agency's power to review drugs after approval.

Grassley, an Iowa Republican, has investigated several agency decisions, including FDA's approval of Cyberonics Inc.'s VNS Therapy device for depression as well as a controversial trial of Northfield Laboratories Inc.'s experimental blood product.


House of Representatives Energy and Commerce Committee Chairman Joe Barton, a Texas Republican who also requested the report, said "the drug-safety system is not in crisis, but the FDA's process may need some fine-tuning."

FDA officials, in comments submitted to the GAO, said if the review process seems complicated it is because weighing the benefits and risks of new drugs is "inherently complex."

The agency has taken steps to address drug safety, including setting up a drug safety board.

Still, the GAO found those measures "will not address all the gaps we identified." The review board may help oversee major decisions, but will not fix more systemic problems between the two offices that review drugs, it added.

The Office of Drug Safety serves as a "consultant" to the larger Office of New Drugs, the report concluded. FDA disagreed.

For the report, GAO reviewed agency documents and interviewed current and former FDA officials as well as outside experts.

It also examined case studies of four drugs -- the Sanofi-Aventis arthritis drug Arava, Bayer AG's withdrawn cholesterol pill Baycol, Pfizer Inc.'s recalled arthritis drug Bextra, and Johnson & Johnson's discontinued heartburn medicine Propulsid.

FDA's drug safety review process has been a concern for decades, the report said, but it came under renewed debate in 1992 when Congress began requiring drug-makers to pay a fee for each new drug submitted for review.

That legislation has been renewed twice and is set to expire in 2007 if Congress does not extend it. Critics contend it creates a conflict of interest that forces the FDA to serve drug-makers, not consumers.

FDA officials did not comment on the report's recommendations.