- The Washington Times - Friday, September 22, 2006


A dysfunctional Food and Drug Administration still can’t adequately track the safety of new drugs and respond quickly to problems two years after the withdrawal of the painkiller Vioxx, a panel of analysts said yesterday.

The Institute of Medicine said the FDA needs more money, people and power to ensure it maintains focus on the safety of the drugs it regulates throughout the time they are on the market. The agency needs cultural changes, too, to avoid the tensions that can upset the weighing of drugs’ risks and benefits, the panel said.

Also needed are labeling and advertising restrictions on newly approved drugs that would stress the uncertainties that remain about their safety, the institute said in “The Future of Drug Safety,” an FDA-commissioned report issued yesterday.

The Institute of Medicine advises the government on health policy.

Problems in FDA oversight were highlighted when the popular painkiller Vioxx was pulled from the market in 2004, five years following its approval, after long-term use was linked to an increased risk of heart attack and stroke.

The institute said there was an appearance of a crisis in drug safety but did not determine whether one actually exists. It did paint the picture of a lopsided agency, with less-than-adequate amounts of time and money being spent on monitoring the safety of drugs once people begin using them in great numbers.

“We found an imbalance in the regulatory attention and resources available before and after approval,” Sheila Burke, chair of the panel that wrote the report. “Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market.”

Nor does the FDA have the resources to keep up, once the drugs reach the market, in assessing safety or informing the public about any risks that might develop.

“I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission,” said Andrew von Eschenbach, the FDA’s acting commissioner. Others within the FDA were quick to tout the steps the agency has already taken.

“We’re simply saying we have been on a trajectory to address the issues,” said Janet Woodcock, the FDA’s deputy commissioner for operations.

Ms. Burke called much of the effort little more than “moving boxes” around on organizational charts.

“They have not been an integrative solution. They have addressed pieces of it but not in a fulsome way,” she said.

The institute proposed a series of steps to improve safety review, including boosting FDA’s budget whether through an appropriation from Congress or taxes. It also recommended lifting restrictions on how FDA can spend the fees collected from drug companies. Those fees now underwrite the cost of reviewing new drugs prior to approval.

It also recommended the FDA review the safety of all new drugs five years after their introduction — making their initial approval almost tentative and subject to withdrawal.

New drugs also would carry a symbol — perhaps a black triangle — for two years alerting patients and doctors that uncertainties may remain about their risks and benefits. Advertising would be restricted during that two-year period, if legally permissible, according to the report.

A drug industry group reacted coolly to that proposal.

“Drugs are approved as safe and effective by FDA under the conditions that are prescribed on the label. The label can highlight that there are issues with the drugs, with respect to how they are used. I don’t think it’s fair to characterize all new drugs as requiring heightened regulatory uncertainty,” said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America.

The report does not recommend setting up a separate center to oversee the safety of drugs, as some anticipated. Ms. Burke and others said the committee felt strongly that safety should be integrated throughout the approval process.

It does suggest that Congress grant the FDA the regulatory authority to compel pharmaceutical companies to study the risk of their drugs once they’re on the market.



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