Pressure on to rekindle drug bill

WASHINGTON — A year ago, a bill giving the Food and Drug Administration (FDA) the authority to make pharmaceutical companies conduct safety studies of drugs after they're approved disappeared into the Senate committee that handles health matters.

But the results of a new report by congressional investigators on continuing safety problems at the FDA may put pressure on members of that committee to revive the bill.

Among those senators is Patty Murray, who has not been vocal on general drug-safety issues. The Washington Democrat has served on the Senate Health Education Labor and Pensions panel since 1996.

The bill's author, Sen. Charles Grassley, R-Iowa, applauded the study by the Government Accountability Office (GAO) on Monday, saying it vindicated testimony at a Senate hearing he held in late 2004 on the FDA's safety procedures.

Grassley called the FDA "an agency in denial" and said it's time to act on his bill.

The GAO report released Monday concludes that the FDA does not have a reliable process for tracking safety problems involving drugs already on the market.

Grassley requested the investigation after disclosures that federal regulators and the drug giant Merck allowed Vioxx, its billion-dollar painkiller, to remain on the market despite growing evidence linking it to heart attacks. Merck withdrew Vioxx in 2004.

Murray has been outspoken about women's health issues, such as the FDA's refusal to approve the Plan B "morning after" contraceptive for over-the-counter sales. She is one of two senators holding up the confirmation of a new FDA commissioner because of the Plan B situation.

Asked about the GAO report and Grassley's call for action, Murray's spokeswoman, Alex Glass, said Murray has been looking at the matter during the past year.

"She is working on a bipartisan bill on the drug-approval process" with the health committee chairman, Mike Enzi, R-Wyo., Glass said. About 150 recommendations have been sent to the health committee, including those from drugmakers.

Among Grassley's supporters is Dr. Bruce Psaty, co-director of the cardiovascular research unit at the University of Washington. Psaty worked with Grassley's staff to help develop the drug-safety legislation, which is now stalled.

Psaty was one of three researchers, including a top FDA epidemiologist, who testified before Grassley's Senate Finance Committee in late 2004 about the FDA's handling of Vioxx. Psaty has published several articles on dangerous drugs and the potential for drug-research manipulation.

In March last year, Psaty testified on those same concerns before Murray's health committee, which was noncommittal on the need for new legislation. But afterward, the Institute of Medicine, a government agency that is part of the National Academies of Science, asked him to help with its review of the U.S. drug-safety system.

Psaty declined to comment on the drug-safety issues until the Institute of Medicine completes its own report in July.

Grassley's bill would require that companies conduct studies of previously approved drugs when safety concerns arise and spread. It also would give the FDA authority to penalize companies for not conducting studies they agreed to during the approval process.

The bill has never been the subject of a hearing in the Senate health committee.

"Senator Murray has said we need to restore consumer confidence in the FDA but not to dismantle the FDA," spokeswoman Glass said.

The drug-safety system is not broken, she added.

Grassley disagrees. He's become a leading proponent of FDA reform and says his Finance Committee has an interest in the issue because it oversees hundreds of millions of dollars for Medicaid and Medicare drugs.

Alicia Mundy: 202-662-7457 or amundy@seattletimes.com