FDA to Institute Safety Board
The Food and Drug Administration, responding to concern about dangerous side effects in drugs it approved for use by millions of consumers, said Tuesday that it would create a safety board to better protect the public.
The Drug Safety Oversight Board, staffed primarily by FDA and other government scientists but receiving help from outside experts as well, will focus on spotting and responding quickly to signs of problems with drugs that have been approved for market. Board members will have direct access to the FDA commissioner.
A drug watch website, meanwhile, will be created to help transmit early warning information to researchers, doctors and consumers.
The announcement of the safety measures marked a turn in the Bush administration’s effort to deal with an increasingly high-profile problem.
It came one day before a major scientific conference was scheduled to begin examining several widely prescribed drugs that turned out to have dangerous side effects. The conference is expected to produce recommendations that could have far-reaching effects for tens of millions of patients, as well as for billions of dollars in drug industry revenue.
In particular, the focus of the three-day conference will be on a class of painkillers called Cox-2 inhibitors, which include Vioxx and Celebrex. Also, possible risks from naproxen, the active ingredient in Aleve, will be considered.
Some members of Congress and outside critics said the steps announced Tuesday did not go far enough.
The agency has come under pressure in recent months after one of its own scientists and several outside experts spotlighted its failure to act quickly on evidence of problems with approved drugs.
Senior federal officials appeared to recognize that more sweeping changes would have to follow.
Health and Human Services Secretary Mike Leavitt, announcing the plans in a speech to FDA employees, said his ultimate goal was nothing less than a transformation of their agency to instill “a culture of openness, an enhanced sense of independence [and] a commitment to monitor drugs after they have been approved.”
Acting FDA Commissioner Lester M. Crawford said the agency must change a culture that had placed a high priority on not alarming the public when warning signs popped up.
“When we get a signal, we find that in the majority of cases, it was a false signal,” Crawford said, explaining the FDA’s traditional reluctance to publicize early signs of trouble with approved drugs. But he added: “That era has passed. What the public is demanding is to know as soon as we know.
“Our system can best be described as a passive system,” relying heavily on drug makers to report potential dangers, Crawford said. On Monday, Crawford was nominated by President Bush to be FDA commissioner.
The government must play a more active role in spotting and responding to signs of trouble, he said.
Officials said they would move quickly to put the new safety measures in place. No information was provided on costs. Reacting to the announcement of the new safety board and the drug watch website, some members of Congress and other critics said more far-reaching reforms were needed.
“This is a step in the right direction, but it doesn’t go nearly far enough,” Sen. Christopher J. Dodd (D-Conn.) said. “Consumer confidence in the FDA has been shaken to the core, and it will take more than cosmetic reforms to fix structural problems within the agency.”
Sen. Charles E. Grassley (R-Iowa) said he would move ahead with legislation to create an independent drug safety office and establish a public registry for clinical trials conducted by drug manufacturers.
“Much more needs to be done to strengthen FDA’s ability to address drug safety,” said Rep. Henry A. Waxman (D-Los Angeles). “The agency needs to have additional resources, additional authority, and strong leadership at its helm.”
Concern about problems in drugs already approved for the market was triggered in part by evidence that some Cox-2 inhibitors carried increased risks of heart attacks and strokes. Among the drugs in this class are Vioxx, Celebrex and Bextra.
The FDA approved Vioxx in 1999 for arthritis-related pain. It was taken by millions of patients despite mounting scientific concerns that it could lead to heart attacks and strokes. Manufacturer Merck withdrew Vioxx from the market last fall after a company-sponsored study confirmed the risks.
Celebrex and Bextra remain on the market, but the FDA has recommended that doctors prescribe them in limited situations.
The scientific meeting that begins today under the FDA’s aegis is widely seen as a test of the agency’s commitment to play a more vigorous watchdog role.
Two advisory panels -- one on drug safety, the other on arthritis medications -- will jointly hear technical presentations on the risks and benefits of Cox-2 inhibitors.
They will also hear evidence of potential heart risks with naproxen, the active ingredient in Aleve, a nonprescription painkiller.
“This whole experience reveals the inadequacy of the tools that we’ve used to assure the public that newly approved drugs are safe for widespread use,” said Arthur A. Levin, director of New York’s Center for Medical Consumers and a member of one of the advisory panels.
Drugs are tested only on a few thousand people before being approved. Dangerous side effects -- if they are rare -- may not emerge until hundreds of thousands of patients have used a medication.
“This is a very imperfect system for predicting the future,” Levin said about standard clinical tests. “The Cox-2 lesson is that you can get into big trouble. We’ve been lucky in many respects.”
Panel members will be asked to vote on whether the heart attack risks seen with Vioxx are unique to that drug or are symptomatic of problems with the entire class of medications.
If the experts find a problem with the entire class, they will be asked to recommend what the FDA should do about Celebrex and Bextra, which provided nearly $5 billion in worldwide revenue for Pfizer last year.
Options include much stronger warnings to doctors and patients, restrictions on the use of the drugs or an outright ban. A spokeswoman for Pfizer was not available for comment Tuesday, although the company has defended the medications as safe when taken as directed.
“What we do around Celebrex is probably one of the thorniest issues,” Levin said.
Panel members will also be asked for their recommendations on two Cox-2 drugs that the FDA is reviewing but has not yet approved.
The agency can choose to disregard the panels’ recommendations, but that may be difficult in the current politically charged climate.
The FDA already has reversed one decision it took in planning for the advisory meetings.
It had initially dropped a Wake Forest University professor from one of the panels because he had publicly raised concerns about Bextra’s safety.
But the scientist, Dr. Curt Furberg, was reinstated after a wave of complaints to the FDA. “After a few days they called and said, ‘We’re sorry, we made a mistake,’ ” Furberg said.