Video: Study: FDA poorly tracking drug safety

updated 9/22/2006 7:29:59 PM ET 2006-09-22T23:29:59

Two years after the withdrawal of the painkiller Vioxx, federal health regulators still lack the resources necessary to track the safety of new drugs and respond quickly to any problems that might crop up, a panel of experts said Friday.

The Institute of Medicine experts said the Food and Drug Administration needs more money, people and power to ensure the safety of the drugs it regulates. Also needed are labeling and advertising restrictions on newly approved drugs that would stress the uncertainties that remain about their safety, the Institute of Medicine said in "The Future of Drug Safety," a report issued Friday.

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

"FDA's performance in approving drugs or monitoring their safety after approval has been questioned and criticized," the report noted.

Not enough time spent on safety after drug approval
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 drugs' safety once people begin using them in great numbers.

"More drugs are being approved faster with less time to intensively investigate premarketing safety data," the report said. And FDA does not 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.

"We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila Burke, chairwoman of the committee 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."

The experts acknowledged that the agency and others in the drug industry had taken some steps to try to improve drug safety but that they were not "equal to the task. Major obstacles remain."

"While we have done a lot of work over the past two years to improve the drug safety enterprise at FDA, we recognize more remains to be done," said FDA spokeswoman Susan Bro, adding that new efforts were forthcoming. "All drugs have risks. Our challenge is to uncover them as soon as possible and effectively communicate them to providers and patients so they can make informed decisions about their health care."

Five year follow-up
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 the FDA review the safety of all new drugs five years after their introduction — making their initial approval almost tentative and subject to withdrawal.

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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.

The report does not recommend the setting up of a separate center to oversee drug safety, as some anticipated. 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. Such authority should include the ability to assess fines and impose injunctions, the report said. The FDA also should step up its own monitoring of the safety of drugs, it said.

"This report confirms what many of us in Congress have been arguing all along _ that the Food and Drug Administration's authority must be strengthened to empower the agency to take rapid and decisive actions on drug safety," said Rep. Rosa DeLauro, D-Conn. DeLauro is the ranking Democrat on the House subcommittee that oversees the FDA and its budget.

The Institute of Medicine advises the government on health policy. The FDA partially sponsored the report.

Copyright 2006 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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