House panel approves major drug safety bills

Thursday, June 21, 2007

House Panel Overwhelmingly Approves Major Drug Safety Legislation to Protect Patients, Consumers; Full House Vote Up Next

(Washington, D.C.) – The House Energy and Commerce Committee Thursday unanimously passed a major package of prescription drug safety reforms – including requiring the drug industry to contribute almost $400 million over five years to improve safety measures and to register most of their clinical trial studies so the public can know more about potential harmful drug side effects.
The committee, led by Chairman John Dingell and Health Chairman Frank Pallone, approved amendments to require the FDA reach certain safety goals with industry user fees and make public transcripts of negotiations between industry and the FDA. The panel also was in agreement to increase the fines on companies that run false or misleading drug advertisements.
The panel beat back attempts to weaken the legislation on conflicts of interest on drug advisory boards and clinical trial results requirements.
“There is no question the drug industry is putting huge pressure on Congress to weaken these important patient-safety reforms,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “So many members worked tirelessly for this strong legislation, and their efforts will be counted in the number of lives saved by more quickly and publicly dealing with drug safety risks.”
The House bill gives the FDA power to change drug labels and require companies conduct further safety studies once they are on the market. It also requires drug makers to register most of their clinical trials; details on how results will be made public are still being worked out.
“The committee appears to have stood firm and made sure drug companies can’t downplay or hide the safety risk information that often comes out of these clinical studies,” Vaughan said.
Like the Senate bill passed last month, the House measure includes almost $400 million in user fees on the industry over the next five years to fund drug safety measures, including mining large health databases to spot those drugs that might cause health problems.
But the House bill included some measures that expanded drug safety beyond the Senate, including:
• Limiting conflicts of interest waivers on drug advisory committees to one per panel. Currently, the panels that recommend drugs for market often include several members with financial ties to the company whose drug is up for approval, and the FDA routinely waives the conflict laws. The Senate bill did not limit the number of waivers.
• An amendment by Rep. Stupak directing that safety funds be spent to aggressively use the data collected by the adverse event reporting system, make public any office of drug safety consultations with the Office of New Drugs so that consumers and outside researchers can see where areas of controversy are, and cleaning up the backlog of hundreds of unstarted clinical trials.
• Requiring all direct-to-consumer advertisements carry an 800-number and Web site address where consumers could report adverse reactions to drugs to the FDA.
• Allowing consumer and patient members to be involved in the next round of negotiations between the drug industry and the FDA on how user fees should be collected and spent to approve new drugs. An amendment by Rep. Stupak was also approved today requiring a public transcript of the negotiations, which currently are held behind closed doors.
• Providing somewhat more meaningful penalties for violations of FDA safety laws. The House Civil Monetary Penalties and penalties for repeated false and misleading ads are higher than the Senate’s and are more likely to ensure compliance.
• Requires a review of the safety of a drug in the 7th year after it has been approved; since on average only half of all adverse events are known by the 7th year, this provision forces a review of the benefits and risks of a drug at a time when more is known about it.
• Ensure that any health databases used to look for drug safety problems de-identify patient’s personal information.
“We look forward to the full House passing this important drug safety legislation, and moving it on to conference and then the President’s desk,” Vaughan said.
Susan Herold, Bill Vaughan
(202) 462-6262