April 25, 2006

A Government Accountability Office (GAO) report on shortfalls in the FDA's drug review protocols did not go far enough in recommending changes, but it still may provide the momentum for dormant legislative reforms to become law, sources say.

The GAO report, "Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process," was sought by numerous lawmakers in response to several high-profile drug safety cases, including complications resulting from use of the arthritis drug Vioxx (rofecoxib). The agency has been under fire for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems.

The GAO report found that the agency lacks sufficient processes for making decisions about, and providing oversight of, postmarket safety issues. "The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management and data constraints," the report concluded.

While the April 24 report found a number of gaps in the FDA's drug safety approach, critics say the report does not go far enough in its recommendations. The report is "too mild and mediocre," Rep. Maurice Hinchey (D-N.Y.) told FDAnews, pointing out that GAO did not address the potential conflicts of interest that come from the agency being funded by industry user fees. Hinchey said he is planning to follow up with GAO staff to find out why this issue and other problems, such as conflicts of interest in FDA advisory boards, were not addressed.

The GAO did not address these issues because they were "outside the scope" of the original congressional request, said Marcia Crosse, the agency's director of health care issues. The GAO can only review what lawmakers ask for, she added. But the report will help address drug safety problems by confirming that there are still issues that need to be addressed.

As for Hinchey's concerns, the GAO is already undertaking a review of potential conflicts of interest within the FDA, Crosse said. The review, which was requested last September by Sens. Mike Enzi (R-Wyo.), Edward Kennedy (D-Mass.) and Richard Durbin (D-Ill.), should be completed in a few months. Also, if Hinchey wants additional reviews he should get a committee chairman to ask for this because the GAO assesses lower priority to individual lawmaker's requests, she said.

However, the report will still provide the momentum to move stalled legislation through Congress and "helps get the issue out on the table," Hinchey said. H.R. 2090, a bill to improve FDA drug safety reviews introduced by Hinchey last May has made no progress since being referred to the House Health Subcommittee soon thereafter. "We'll take what we can" to get the bill moving, Hinchey's spokesman said.

Sen. Chuck Grassley, (R-Iowa) whose own drug safety bill, S.930, has languished in the Senate since last April also believes that the report will provide momentum for his legislation. The report "validates the problems" that Grassley and other lawmakers have identified with the agency's drug safety program, said his spokeswoman, Jill Kozeny. The report "contributes to his effort in a valid way."

However, at least one critic of FDA policy says the report may undercut legislative efforts. GAO's report is "incomplete" because it does not recommend many necessary changes Grassley sought in his bill, said Sidney Wolfe, Public Citizen Health Research Group director. By not calling for these changes, he said, the GAO report leaves the Grassley bill lacking what he believes would be a helpful endorsement. (http://www.fdanews.com/did/5_81/)