The Food and Drug Administration would have to establish a system to monitor the safety of new drugs after they hit the market and the pharmaceutical industry would be required to register clinical trials of new medicines in a publicly available database under legislation approved yesterday by the Senate.
The provisions are part of a sweeping bill, approved by a 93-to-1 vote, that would reauthorize the federal practice of charging drug makers hundreds of millions of dollars in fees each year to speed up FDA review approval of new drugs. The system of fees will expire Sept. 30 unless Congress reauthorizes it before then. The House has not yet taken up similar legislation.
The Senate bill also would enable the FDA to fine companies that fail to report contaminated food and require the government to establish labeling standards for pet food and to create a system to detect tainted pet food and notify the public of recalls.
It would provide for fines of up to $2 million for pharmaceutical companies that do not comply with the new system to measure the risks of new and high risk drugs in the first few years after they become available in the marketplace.
"This legislation is going to make the prescription drugs that families take safer and our food safer, and it's going to ensure that the agency has the resources to do follow-on reviews and continue to be the gold standard for safety," said Senator Edward Kennedy, Democrat of Massachusetts, chairman of the Senate Health, Education, Labor, and Pensions Committee and a lead sponsor of the bill.
Senator Mike Enzi, Republican of Wyoming , the chief Republican sponsor of the bill, said: "The changes made in the drug safety components of this legislation are critical to restoring peace of mind to Americans who want to be assured that the drugs they purchase to treat illnesses and chronic medical conditions can be relied upon and trusted."
Peter Lurie, deputy director of the health research group at the nonpartisan advocacy organization Public Citizen, agreed that the bill improves drug safety, but said lawmakers failed to address the core issue: that the FDA user fee system requires a regulated industry to fund its regulators.
"It is a fundamental conflict of interest to have an industry be able to dictate to an agency the speed at which reviews will take place," Lurie said. "And yet that's exactly what happens and nobody challenged that in a fundamental way."
The Senate legislation was shaped in part by an analysis by the Institute of Medicine last year that concluded the federal system for approving and regulating drugs is in serious disrepair. That report, requested by the FDA, followed two years of controversy over drug safety after the 2004 withdrawal of the arthritis drug Vioxx because of the risk of heart attacks.
Much of the institute report focused on a key gap in drug regulation: While the FDA requires stricter data on the safety and effectiveness from clinical trials before approving a new drug, less attention is paid after the drug reaches the market.
The Senate bill requires stepped up monitoring of new drugs for dangerous side effects and gives the FDA new authority to limit the sale of medicines if problems are found.
Drug makers could be required to undertake new studies of drugs after approval, and physicians who prescribe certain high-risk drugs would have to undergo special training.