Senators Plan Bill to Revamp FDA Drug Safety

Senators Plan Bill to Revamp FDA Drug Safety

(June 22, 2006) -- Two top U.S. senators plan to propose bipartisan legislation next month to revamp the Food and Drug Administration's handling of drug safety issues, a senior Republican aide said on Wednesday.

The move comes as the FDA, which has been without a permanent leader for most of the Bush administration, grapples with renewed safety concerns following the withdrawal of a popular painkiller and warnings over possible suicide risk with antidepressants.

However, the aide to Senate Health, Education, Labor and Pension Committee Chairman Mike Enzi of Wyoming also said the Senate was "highly unlikely" to confirm acting FDA chief Andrew von Eschenbach this year, although the committee may hold a hearing later this year.

The bill being worked on by Enzi and Sen. Edward Kennedy of Massachusetts, the health panel's top Democrat, aims to integrate the FDA's drug safety review with the overall approval process, the aide told an investment conference.

"What the bill will require is better planning before approval of how drugmakers and the FDA are going to identify and manage risks after approval," the aide said.

A government expert who has seen an outline of the proposal said it would require drug companies to include a risk-management plan with their drug approval submission.

The proposal would also penalize companies that do not follow the risk plan and would require them to disclose results from major clinical trials, according to a New York Times report.

In April, the Government Accountability Office found lingering safety issues at the agency, citing an unclear process of monitoring products once they are on the market.

Another FDA drug safety report is expected next month from the independent Institutes of Medicine.

The lawmakers are still seeking input from industry leaders, patient groups and the FDA, but want to introduce the bill before Congress adjourns for its summer recess in August, the aide said at the event sponsored by Bank of America Corp..

Enzi and Kennedy appear to be taking a different approach than Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, who has proposed a bill to make the FDA's Office of Drug Safety independent of the drug-approval office.

FDA spokeswoman Susan Bro said the agency has been taking steps to improve safety and welcomed additional ideas. She declined to comment on von Eschenbach's nomination.

Von Eschenbach has been acting chief since September but his nomination has been halted by political friction over "morning after" emergency contraception.

Last updated: 6/06

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Senators Plan Bill to Revamp FDA Drug Safety