Wednesday, July 11, 2007
(Washington, D.C.) – Wedensday’s overwhelming House vote for a major prescription drug safety and FDA reform bill is good news for Americans who have been kept in the dark about dangerous drug side effects, and Consumers Union is urging conference committee members to not weaken consumer protections in the bill before sending it to the President.
“The House has taken a major step forward in protecting consumers and putting the pharmaceutical companies on notice by passing the first major drug safety reforms in 45 years,” said Jim Guest, president of Consumers Union, publisher of Consumer Reports. “Now it’s up to a small group of House and Senate members to reconcile the two drug safety reform bills, and it is vital they keep the strongest safety provisions in the bill sent to the President.
“As we approach the third anniversary of the news that Vioxx may have caused thousands of Americans to have heart attacks or strokes, it is well past time for Congress to deliver to the President a bill that will help prevent such future drug safety disasters,” Guest added.
The House voted 403-16 to pass HR 2900, the Food and Drug Administration Amendments Act of 2007. The Senate already has passed its version of the bill (S 1082). Both measures include nearly $400 million over the next five years in industry user fees to help pay for improved drug safety monitoring, and give the FDA increased authority for the safety of drugs once they are already on the market, such as requiring drug companies to add warning labels and conduct post-market safety studies.
But the House version includes a number of stronger consumer safety protections than the Senate bill going into conference, where the two bills will be hammered out behind closed doors before being sent to the President. Because the measure also includes reauthorization of the industry user fee program to speed approval of new drugs, set to expire Sept. 30, the bill is likely to be moved quickly to the President’s desk.
Consumers Union is urging the conference committee members to keep stronger
House language to ensure drug company clinical trial results are made public – these results often reveal dangerous side effects – improve safety monitoring of drugs on the market, reduce the conflicts of interest among the industry and regulators, and impose higher fines on companies that run misleading drug ads.
“The message we’re hearing from consumers couldn’t be clearer – they want strong laws to ensure our prescription drugs are as safe and effective as possible, and we have that opportunity within our reach,” Guest said.
A Consumer Reports national poll conducted in March found that 60 percent of Americans agreed that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs. And 8 out of 10 consumers agreed that the government should “have the authority to take any action necessary” to ensure drug safety.
“Right now drug companies can game the system by touting the positive results from their drug studies, while downplaying information about harmful side effects,” Guest added. “Americans are fed up with being kept in the dark about critical health and safety information, and they overwhelmingly want change.”
While the Senate bill includes some stronger consumer provisions relating to transparency and openness in the way the FDA operates which also should be kept in the final bill, the stronger House measures include:
Clinical trials database: Both bills call for the creation of a public clinical trial results database so doctors, researchers and patients would know about the effectiveness and safety risks of the drug. But the House bill would require within a year the creation of such a site, while the Senate bill calls for a study on how to create such a registry and gives the FDA 2 ½ years to implement it. Exactly what the registry will require under the Senate bill is uncertain.
Safety goals: Requires a review of the safety of a drug in the 7th year after it has been approved, and ensures safety funds collected from industry are tied to specific goals, such as reducing the backlog of uncompleted safety studies.
DTC advertising: The FDA could make companies submit their television drug ads for review prior to running them, and includes heavier fines for running misleading ads. All ads would also have to include a toll-free number and a Web site address for reporting side effects to the FDA.
Conflicts of interest: 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.
More transparency in industry negotiation: Consumer and patient groups would be allowed to participate in the next round of user fee negotiations between industry and FDA, and it would also requires a public transcript of the negotiations.