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

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.

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.

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.

Courtesy of the NY Times

Steve - The last two paragraphs are astounding. Is $1 million per year for the FDA to study drug dangers on its own going to get it done? With so much of our population dependent on medication, it is unconscionable that our government does not have a budget to independently research drug safety. As we have seen just in the last few years, allowing this to happen has had some devastating results.