By Christopher Lee
Washington Post Staff Writer
Thursday, May 10, 2007
The Food and Drug Administration would have to establish new systems to monitor the safety of medicines after they hit the market and for the first time could fine drugmakers for false or misleading advertising under a bill approved yesterday by the Senate.
The provisions are part of a major bill to reauthorize the current system that charges drugmakers hundreds of millions of dollars in fees each year to pay for speeded-up reviews of prospective new drugs. The government's authority to levy those fees will expire Sept. 30 unless Congress acts before then. The House has not yet taken up similar legislation.
Senators approved the measure 93 to 1, with Bernard Sanders (I-Vt.) casting the dissenting vote
"This legislation is going to make the prescription drugs that families take safer and our food safer," said Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Health, Education, Labor and Pensions Committee and a lead sponsor of the bill.
Sen. Mike Enzi (Wyo.), the chief Republican sponsor, called the bill "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."
Sanders said he opposed the bill because it does not legalize the importation of lower-priced drugs from Canada and other countries, it fails to curtail advertising that drives up drug spending, and it paves the way for the FDA to block state laws permitting the use of marijuana for medical purposes.
"Safe drugs are obviously important, and there are a lot of good provisions in this bill," Sanders said. "But a safe drug doesn't mean anything to somebody who can't afford it."
The bill would substantially expand the size of the staff that monitors drug safety. It would also provide for fines of up to $2 million for pharmaceutical companies that do not comply with the new system for monitoring the risks of new and high-risk drugs in the first few years after they become available. Drugmakers would also have to include clear warnings of possible negative side effects of drugs in radio and television ads. And they would be required to register clinical trials of new drugs in a publicly available database.
The bill also would enable the FDA to fine companies that fail to report contaminated food and would require the government to establish labeling standards for pet food and create a system to detect tainted pet food and notify the public of recalls.
Peter Lurie, deputy director of the health research group at the nonpartisan advocacy organization Public Citizen, agreed that the bill would improve drug safety but said having the FDA rely on user fees -- about $300 million in fiscal 2007 -- is a problem. "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.
W.J. "Billy" Tauzin, head of the Pharmaceutical Research and Manufacturers of America trade group, said the real impact of the bill would be to ensure that new medicines are safe and reach consumers promptly.
In a study last year, the Institute of Medicine concluded that 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 attack.
The report found that while the FDA requires strict data on safety and effectiveness from clinical trials before approving a new drug, less attention is paid after the drug reaches the market. The Senate bill would require more monitoring of new drugs for dangerous side effects and give the FDA new authority to limit their sale if problems arise.
The institute's report also called for a ban on consumer advertising of newly approved classes of drugs until they have been on the market long enough for any problems to emerge. Although a Senate committee approved a two-year moratorium on advertising for some new drugs, the final legislation included only the prospect of fines of up to $150,000 for a first offense for false or misleading ads.