Board to Track FDA-Approved Drugs’ Safety
Feb. 16–WASHINGTON — Under fire over lax safety checks for some of the nation’s most-prescribed medications, the Food and Drug Administration Tuesday said it is establishing a new oversight board to monitor U.S.-approved drugs once they go on the market.
U.S. Health and Human Services Secretary Mike Leavitt said the new Drug Safety Oversight Board would update physicians, patients and consumers with the latest information about drug risks and benefits.
“The public has spoken and they want more oversight and openness,” Leavitt said during a meeting with FDA employees at the agency’s headquarters in Rockville, Md. “They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence.”
The Bush administration’s announcement came on the eve of a much-anticipated three-day drug advisory meeting charged with examining the safety of widely prescribed painkillers Celebrex, Bextra and Vioxx. It will also examine how effectively the FDA evaluated the drugs after they were approved.
Much of the criticism heaped on the FDA in recent months follows reports linking all three drugs to risks of heart attacks or strokes.
The FDA’s reputation is on the line heading into the start of the hearings Wednesday because of accusations that the agency moved too slowly in reacting to safety concerns involving Vioxx.
On Sept. 30, Vioxx maker Merck & Co. pulled the drug from the market in the wake of a new study linking the drug to an increased risk of heart attacks and strokes. Earlier studies of Vioxx and allegations dating back four years or longer had demonstrated similar cardiovascular risks, but the FDA allowed Merck to promote the drugs heavily even as Merck investigated the issue.
Tuesday’s announcement is the second big change at the FDA in as many days.
On Monday President Bush said that he would nominate Lester Crawford, the agency’s acting director, to be permanent director. That post has been vacant for almost a year.
The new safety board’s primary role will be to make information about drugs’ potential risks more readily available.
Already, a bill wending its way through Congress seeks to address what some have called an inherent conflict at the FDA. The agency, critics say, is charged with approving new treatments and would be reluctant to withdraw medications it had approved earlier.
To improve drug safety information reaching consumers and medical professionals, the new board will also create a drug safety Web page with emerging information.
The board will recommend what information and updates to put on the Drug Watch Web page, resolve disputes over drug safety and oversee development of a drug safety policy.
“The FDA often didn’t say or do anything until they had proof” that there was a problem, said Health and Human Services spokesman Bill Pierce. The creation of this new board allows the opportunity to say “things that aren’t necessarily conclusive but that you as a patient or a physician need to know,” he said.
The new board will be composed of FDA employees and medical experts from other Health and Human Services agencies and government departments. It will consult with outside medical experts as well as consumer and patient groups, officials said.
The new board is unlikely to mute criticism in Congress, which is expected to forge ahead with several hearings on the FDA in coming weeks.
“Based on all the details we know at this time, the FDA’s plan for a new drug safety oversight board is a farce,” said Rep. Maurice Hinchey (D-N.Y.). “Despite claims that this new oversight board would be independent, the FDA announced that the panel would be comprised of FDA officials and medical experts from other HHS agencies. That is not independent at all.”
At least one influential Republican thought the administration’s move is a good first step but vowed to forge ahead with legislation that would create an independent office of drug safety with expanded authority within the FDA.
“I’m drafting legislation to clearly establish this independence and provide the office the authority needed to do its job,” said Sen. Chuck Grassley (R-Iowa), chairman of the powerful Senate Finance Committee, which has a significant say in funding of federal health agencies. “In addition, it remains necessary that Congress require a clinical trials registry to bring more transparency to the studies used to determine the safety of prescription drugs.”
This week’s gathering of advisers to the FDA is drawing much attention because it may lead to more stringent warnings on some of the nation’s most widely used painkillers.
The panel, made up of medical experts, is charged with finding out why certain painkillers increase the risk of heart attack or stroke, an effort that consumer groups and doctors hope will provide clarity for millions of Americans who suffer pain from osteoarthritis.
The three days of hearings are expected to be the most closely watched in years because drug safety has become an increasingly controversial issue and the drugs under discussion are so widely used.
The panel will focus largely on the so-called Cox-2 drugs, Celebrex, Bextra and Vioxx, a class that has been hailed by the makers and by doctors because they are perceived to be safer for the stomach than older painkillers.
“People are looking forward to this meeting because of the number of people that take these medications–millions who took Cox-2 inhibitors,” said Dr. Mark Fendrick, an internist and a professor of health management at the University of Michigan. “The economic and business implications alone are enormous; a $6 billion market is completely in turmoil.”
The panel’s ultimate recommendations could transform one of the nation’s most widely used categories of prescriptions. Its potentially most severe recommendation could be an outright ban of Celebrex and Bextra, the two remaining Cox-2 drugs on the market. Combined, they generated more than $5.2 billion in worldwide sales last year for the drugs’ maker, New York-based pharmaceuticals giant Pfizer Inc.
More likely, analysts say, would be additional restrictions on the drugs, possibly recommending lower dosages for certain patients or tougher labeling of the drugs to highlight possible cardiovascular risks.
The current FDA-recommended dosage of Celebrex is 100 milligrams to 200 milligrams of the drug, but many doctors are known to prescribe the 200-milligram tablet twice a day, according to some industry data.
By Bruce Japsen and Judith Graham, Tribune staff reporters. Bruce Japsen reported from Washington; Judith Graham reported from Denver.
FDA ENHANCEMENTS
In an effort to improve drug-safety monitoring, the FDA is:
–Creating a new Drug Safety Oversight Board that will monitor the management of important drug safety issues within the Center for Drug Evaluation and Research.
–Proposing a new “Drug Watch” Web page for easy dissemination of emerging data and risk information for professionals and patients.
–Soliciting input from the public on how to manage potential concerns related to the agency’s release of information prior to regulatory action.
Source: Food and Drug Administration
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