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Drug Safety Overhaul Is Urged

The FDA spends far more time on approvals than on follow-ups, a review finds. Calls for reform include warning labels and limits on ads.

September 23, 2006|Ricardo Alonso-Zaldivar and Denise Gellene | Times Staff Writers

WASHINGTON — The government's drug safety system is seriously out of balance, devoting too much attention to approving new medications and not enough follow-up to uncovering risky side effects, a blue-ribbon scientific panel concluded in a major report released Friday.

Convened at the request of the Food and Drug Administration after a popular painkiller was linked to heart attacks, the experts in medicine, pharmacology, law and other fields issued a sweeping call for reform. Its 25 recommendations include establishing a fixed term for the FDA commissioner, restricting ubiquitous drug commercials and placing a special cautionary symbol on the packaging of newly approved medications.

The panel found "an imbalance in the regulatory attention and the resources available before and after approval" of new drugs, said Chairwoman Sheila Burke, a former Republican Senate staffer who now is chief operating officer of the Smithsonian. "Staff and resources devoted to pre-approval are substantially greater than those available post-approval."

The panel urged greater legal authority for FDA regulators to compel drug companies to carry out safety monitoring and called for significant increases in agency funding -- although it failed to spell out exactly how much and where it would come from.

Consumer groups and advocates of overhauling the FDA hailed the report, while the drug industry issued a cautionary reaction. "Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed," Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement.

The recommendations will frame a legislative debate over the future of the FDA, expected to be joined in earnest next year when Congress must renew user-fee legislation that provides much of the agency's funding.

The 15-member panel operated under the auspices of the Institute of Medicine, part of the National Academy of Sciences, which provides scientific advice to the government.

The FDA requested the review after the sudden withdrawal of Vioxx in 2004 generated a firestorm of criticism over its drug safety program. The widely used drug was pulled from the market by manufacturer Merck & Co. after a company-sponsored study confirmed that patients taking Vioxx were more likely to suffer heart attacks than those who did not.

An FDA safety reviewer, Dr. David Graham, had reached the same conclusion months earlier, only to have his warnings dismissed by superiors.

FDA officials on Friday were guarded in their reaction to the report. While praising the panel's effort, Acting Commissioner Andrew C. von Eschenbach said it would take time to review the findings. "We are at a point where we are assessing and analyzing the report," he said. "We are very committed to an effort of continuous improvement."

The head of the agency's drug review center expressed disappointment that the report focused closely on infighting between the scientists who evaluate new medications and those who monitor their safety after approval.

"I don't think there is any question that there are some cultural issues in the center," said Dr. Steven K. Galson, director of the Center for Drug Evaluation and Research. "What the report doesn't do really well is explain that the vast majority of the interactions within the center are very successful."

A previous investigation by the congressional Government Accountability Office had also concluded that the center's powerful new drugs branch -- which gets the lion's share of funding and staff -- treated the safety office as a sort of bureaucratic stepchild. Some FDA officials complained the new report did not take sufficient note of what it called two years of internal efforts to improve communication, both within the agency and with doctors and patients.

Graham, the FDA's most well known whistle-blower, saw vindication in the findings, although he said the recommendations did not go far enough. "The language is amazingly harsh," Graham said of the report. "This ... was written by academicians by consensus, and to have strong language come through as it does means things are terribly, terribly bad at the FDA."

The report did not mince words:

"The committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture that is not optimally functional; and unclear and insufficient regulatory authorities, particularly with respect to enforcement."

Although some leading reformers -- including Graham -- advocate the creation of an independent safety center within the FDA, the panel took another approach. It urged that a beefed-up safety office should work closely with the new drugs office in reviewing medications and, more important, in tracking potential problems after approval.

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