Near finish line: Drug safety vote set Wednesday


Tuesday, July 10, 2007

House Vote Set Wednesday on First Major Prescription Drug Safety Improvements in Nearly Half Century

Consumers Union urges passage and sending of strong bill to President

(Washington, D.C.) – Consumers Union is urging the House of Representatives Wednesday to pass the first major prescription drug safety improvements in nearly half a century and work on sending a strong bill to the President to help prevent future Vioxx-type disasters.
“This is the strongest improvement in the Food and Drug Administration in 45 years and it will help ensure safer prescription drugs for future generations of Americans,” said Jim Guest, president of Consumers Union, publisher of Consumer Reports, in a letter to House Speaker Nancy Pelosi.
“The public simply has not been given the full story about all the potential risks of medications,” Guest added. “That is why Congress must pass this bill, which will significantly strengthen our drug safety laws and adequately fund safety efforts at the FDA.”
The House is slated to vote Wednesday on 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 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 going to the floor includes some stronger consumer protections, including:
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.
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.
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 attend the next round of user fee negotiations between industry and FDA, and it would also require a public transcript of the negotiations.
Contact:
Bill Vaughan, Susan Herold, 202-462-6262