FDA officials announced Friday that they will launch a review of the agency’s drug monitoring policies in the wake of recent high-profile safety concerns about widely used drugs, including antidepressants and Vioxx (search).
The agency said it is also installing new procedures enabling its scientists to formally challenge regulatory decisions when the reviewers think public health could be at risk.
The FDA was widely criticized for ignoring staff warnings about the safety of the arthritis drug Vioxx long before it was pulled from the market by its manufacturer, Merck & Co., on Sept. 30 because of new evidence that the drug increased the risk of cardiovascular complications.
Similar allegations plagued the agency before safety concerns prompted it in October to order strict labeling changes to antidepressant drugs warning of increased suicide risk in children who use them. These labeling changes included a "black box" warning, the strongest warning the FDA can place on drugs.
“We think it’s highly unusual that these sorts of problems occur,” says Steven Galson, the acting director of the agency’s Center for Drug Evaluation and Research.
The highly publicized controversies led to pressure from lawmakers and outside groups for the FDA to provide more transparency of its drug review process.
Galson says the new procedure will allow FDA scientists to formally address concerns over safety decisions to a three-member panel that includes outside experts. The panel would then have 30 days to issue a decision on how to proceed with the review in light of the objections.
Galson declined to say whether the review procedure would have made any difference in the Vioxx or antidepressant cases. The agency is also contracting with the Institute of Medicine to perform an outside review of how it handles post-market safety monitoring of drugs.
“We’re willing to make changes in our policies and programs if they’re needed, as science evolves,” he says.
In both the Vioxx and antidepressant cases, drugs were approved and on the market before studies began showing that they could have widespread, dangerous side effects. And in both cases, FDA scientists eventually complained that the agency resisted their efforts to warn the public about possible safety concerts.
In the case of Vioxx, FDA scientist David Graham reportedly complained to lawmakers that he was ostracized and intimidated when he attempted to have the agency disclose his research suggesting the drug was potentially unsafe.
Another safety reviewer, Andrew D. Musholder, MD, was barred from informing an advisory panel about safety concerns with antidepressants seven months before the agency eventually moved to alter the drugs’ labels because of suicide risk.
The agency also announced that it would move more quickly to hire a director for its Office of Drug Safety, a post left vacant since January 2003.
Not Enough, Critics Say
Galson denied accusations of "a culture of silence" that intimidated FDA scientists. “Silence is just about the opposite of what we’ve got at FDA,” he says.
But critics say that the agency’s action does not go far enough to improve the safety of prescription drugs that reach U.S. patients.
Sidney Wolfe, MD, director of the Health Research Group at Public Citizen, a government watchdog group, points out that the FDA’s contract for the Institute of Medicine study appears only to look at the FDA’s evaluation of drugs after, not before, they go to market.
“Without examining the process that occurs prior to approval, you’re not going to address drug safety,” he says in an interview.
Wolfe also criticized the internal appeals process for scientists, saying that it is still unlikely that consumers will know when significant drug safety concerns are raised inside the FDA.
“It is not clear that the public will ever be apprised of both sides of the issue,” he says.
By Todd Zwillich, reviewed by Brunilda Nazario, MD
SOURCES: Steven Galson, acting director, FDA Center for Drug Evaluation and Research. Sidney Wolfe, MD, director, Public Citizen Health Research Group. Statement of Sen. Charles E. Grassley (R-Iowa), Oct. 7, 2004.
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