Lawmakers blast FDA drug safety oversight

WASHINGTON (Reuters) - U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.

At a hearing on the FDA's drug safety oversight, lawmakers said the agency stifled dissent about the risks of drugs when top managers disagreed. They cited problems with Sanofi's antibiotic, Ketek, Merck & Co. Inc.'s withdrawn arthritis drug Vioxx and antidepressants made by several companies.

"With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," said Rep. Bart Stupak, a Michigan Democrat who chairs a subcommittee of the House of Representatives Energy and Commerce.

"One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?" Stupak said.

Iowa Republican Sen. Charles Grassley, a vocal FDA critic, told the committee that "scientific dissent is discouraged, quashed and sometimes muzzled" inside the agency and "there's widespread fear of retaliation for speaking up about problems."

Congress is considering legislation to strengthen the FDA's oversight of drug side effects.

The committee was set to hear from current and former FDA reviewers, who worked on the Ketek application.

FDA whistleblower David Graham, who told Congress in 2004 that the agency was unable to protect patients from dangerous drugs such as Vioxx, said the agency had failed to fix its problems.

"I am here to tell you our nation is still at risk," Graham said in remarks prepared for delivery. Graham is an associate director in the FDA office that monitors the side effects of drugs after they reach the market.

Republicans on the committee complained that neither the FDA nor Sanofi had been invited to testify at the hearing. Stupak said they would be asked to speak at a later date.

FDA spokespeople had no immediate comment.

On Monday, the FDA announced it had withdrawn Ketek's approval for sinusitis and bronchitis because officials felt the drug was too risky for treating those relatively mild infections. Sanofi can sell Ketek for treating pneumonia.

Concerns about Ketek arose a year ago after reports of severe liver damage and death in some users. The drug was approved for sale in 2004.

Lawmakers have proposed various measures to improve the FDA's monitoring of drug safety. Some suggest creation of a more independent office to monitor side effects after approval, while others want to give the FDA more power to force drug makers to complete post-approval studies.

(Editing by Leslie Gevirtz; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202-310-5691))