Monday, April 24, 2006

Congressional Investigators Are Critical of F.D.A.'s Efforts to Detect Drug Dangers

The New York Times
Congressional Investigators Are Critical of F.D.A.'s Efforts to Detect Drug Dangers

WASHINGTON, April 23 — Disorganization, bureaucratic infighting and an inability to force drug makers to conduct needed safety tests have undercut efforts at the Food and Drug Administration to uncover drug dangers, government auditors say.

When drug safety specialists raise alarms about certain medicines, they sometimes feel that their recommendations fall "into a 'black hole' or 'abyss' " at the agency, according to a report to be released Monday by the Government Accountability Office, the auditing arm of Congress.

Top agency officials sometimes excluded drug safety specialists from presenting findings at public hearings, and tensions between officials who approve drugs and those who ensure that they are safe are common, the report said.

"F.D.A. lacks clear and effective processes for making decisions about, and providing management oversight of" issues involving the safety of popular medicines, the report states.

The F.D.A. told the accountability office that its conclusions were "reasonable," the report said.

Last year, the agency created a drug safety oversight board and asked the Institute of Medicine to examine its drug safety practices. The institute's report is due in July. The accountability office said in its report that the agency's responses so far might help "but will not address all gaps."

Susan Bro, an F.D.A. spokeswoman, said, "The F.D.A. welcomes the G.A.O. report and is currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues."

The report comes after a series of drug withdrawals led agency critics and some on Capitol Hill to suggest that the agency was failing in its mission to protect the public from dangerous drugs. Since 2000, pharmaceutical companies have withdrawn 10 drugs after deaths and other injuries belatedly demonstrated that the medicines were unsafe.

Many critics have said that the agency should never have approved these drugs for sale in the first place.

Senator Charles E. Grassley, an Iowa Republican who is chairman of the Senate Finance Committee, said the accountability office's report showed that "the F.D.A.'s problems are systemic and cultural, not isolated or easily fixed."

But Representative Joe L. Barton, a Republican from Texas who is chairman of the House Energy and Commerce Committee, said the report "shows that the drug safety system is not in crisis, but the F.D.A.'s process may need some fine-tuning."

The auditors recommended that Congress vote to give the agency power to force drug makers to undertake or complete drug safety studies. Mr. Grassley has proposed legislation that would do that.

When it approves new drugs for sale, the drug agency often requires manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects once they get into a broader market.

But the agency announced in March that two-thirds of these promised studies had not even been started, and hundreds of trials have been pending for years.

In many cases, pharmaceutical makers had guaranteed they would undertake the studies as a way to speed their drugs' approval.

The Bush administration has opposed efforts to give the agency greater authority to force drug makers to complete these trials, and top agency officials have for years told Congressional committees that the agency did not need any additional authority.

"One senior F.D.A. official and several outside drug safety experts told us that F.D.A. needs greater authority to require such studies," the accountability office's report says.

Dr. Alastair Wood, associate dean of the Vanderbilt medical school, said the report demonstrated that the drug agency needed more authority and should create an independent department that evaluates the safety of medicines.

"It confirms that the current system needs fixing," Dr. Wood said.

The report said the agency lacked the money needed to construct an effective system to monitor the safety of marketed drugs.

Much of the drug agency's functions are financed by fees paid by drug makers, but the industry mostly opposed proposals that would have allowed the agency to use this money to determine whether already approved medicines cause unexpected injuries or deaths. And neither the administration nor Congress has provided enough money to make up the difference.

The accountability office's report said that the drug agency's budget to undertake its own studies of drug dangers amounted to less than $1 million annually from 2002 to 2005, and that this figure was expected to rise to only $1.1 million annually through 2010.

Just one clinical trial to study the long-term safety of one drug can cost as much as $7 million, the report said.

"I think the report is terrific," said Dr. Curt Furberg, a professor of public health sciences at Wake Forest University School of Medicine. "The F.D.A.'s office of drug safety has absolutely no clout and no money, and the report showed that."