Senator Says FDA Needs Independent Safety Office

March 20, 2005

http://story.news./news?tmpl=story2 & u=/nm/20050310/hl_nm/health_fda_dc

Thu Mar 10, 3:59 PM ET

Health - Reuters

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) needs an independent drug safety office with the power to order warning labels on dangerous medicines and suspend television ads while potential side effects are under investigation, a top Senate Republican said on Thursday.

Senate Finance Committee Chairman Charles Grassley said he was preparing legislation to establish such an office in response to controversies surrounding Merck & Co. Inc's withdrawn Vioxx arthritis pill and other drugs.

"We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA (news - web sites)," Grassley said during a speech to a Consumer Federation of America conference.

The new drug safety office would have an independent director and the regulatory authority to require label changes, the Iowa Republican said.

After the speech, Grassley told reporters the office also would have the power to tell a company to suspend television advertisements while a safety concern was being investigated.

The senator's office later said a decision had not yet been made on whether the bill would give the new office the authority to suspend the ads.

Grassley said he hoped the legislation, which is being crafted with Connecticut Democratic Sen. Christopher Dodd (news, bio, voting record), would be ready within two weeks.

Grassley and other lawmakers are probing the FDA's monitoring of medicine's side effects, which came into question after two agency scientists said their warnings about drug dangers were ignored or suppressed.

The senator said his committee has had trouble obtaining documents from the FDA, and the delay has raised questions about whether Acting FDA Commissioner Lester Crawford should be confirmed as permanent chief.

Grassley said Crawford had assured him the committee would get the requested information.

"It could be that, regardless of his heart being in the right place, that if he doesn't control these people down below that are not responding to us, and there's all this bureaucratic impediment, then is he the person for the job?" Grassley said.

The senator said he would not decide whether to support Crawford until after the Senate Health, Education, Labor and Pensions Committee holds confirmation hearings.

The FDA responded to criticism last month by announcing the creation of a drug safety board, but Grassley said it did not appear to have enough independence from the Office of New Drugs, which approves medicines and may be reluctant to acknowledge safety problems later.

"We welcome suggestions about how to make the system even stronger," FDA spokeswoman Kathleen Quinn said.

Grassley said the FDA had done "decades of good work" but became "too cozy" with drug makers that in some cases had engaged in fraud. He said the Justice Department (news - web sites) was aware of about 100 whistle-blowers who had made fraud allegations against 200 drug companies.

"In this fraudulent environment, the FDA's mission is more important than ever before," he said. "The FDA absolutely has to do a top-notch job on ensuring drug safety."