Barely Tested Government Approved

FDA Is Criticized Over Drugs' Safety Problems

By Marc Kaufman
Washington Post Staff Writer
Monday, April 24, 2006

The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.

The review by the Government Accountability Office found that the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings.

The report also calls on Congress to consider expanding the FDA's authority to require that drug companies conduct studies of already-approved products. The agency's ability to order post-market studies is now limited, and many drug companies have been slow to conduct studies that they had agreed to undertake as a condition of gaining FDA approval.

The GAO inquiry was requested by Congress in 2004 after the sudden withdrawal of the blockbuster painkiller Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users. Several bills that would toughen the FDA's safety oversight were introduced after the Vioxx withdrawal, and the report offers their sponsors new ammunition.

The FDA was widely criticized for moving too slowly in its review of the potential health problems with Vioxx, which was taken by millions, but the GAO report took the criticism a major step forward: It concluded that the agency's entire system for reviewing the safety of drugs already on the market is too limited and broadly flawed.

GAO's examiners studied the agency's handling of four controversial drugs -- the cholesterol-lowering drug Baycol, the painkiller Bextra, the rheumatoid arthritis drug Arava, and the nighttime heartburn medication Propulsid -- and concluded that "there is a lack of criteria for determining what safety actions to take and when to take them."

All but Arava were ultimately taken off the market because of safety concerns, but the GAO found that disputes between two arms of the FDA's Center for Drug Evaluation and Research slowed the process. Since 2000, 10 drugs have been withdrawn by their manufacturers for safety reasons.

The report found that the Office of Drug Safety, which monitors reports of emerging safety risks, at times made recommendations that were ignored by the larger and more influential Office of New Drugs. The GAO also criticized the way experts in the Office of Drug Safety were kept from speaking at important advisory committee meetings on drugs they were studying. The drug safety office has seen considerable turnover, with eight directors in the past 10 years.

The agency has been crippled by political appointees that were more interested in carrying the water for the multinationals than protecting the citizens. The GAO simply states what many of us have suspected for years, it's just a shame that many people had to be injured or killed to get the public's attention.

Teddy must wish he could rise from the grave and wield his "big stick" again to set them straight.