FDA Creates Safety Plan
Embarrassed by recent safety debacles, the Food and Drug Administration pledged Friday to improve its monitoring of dangerous side effects from medications that it had approved for patients.
The agency’s action follows the withdrawal of Vioxx, an arthritis drug, and new warnings about prescribing antidepressants to children and teens.
“We don’t always understand the full magnitude of drug risks prior to approval,” acknowledged Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.
Galson announced five steps that he said would guarantee the FDA had “the best post-marketing drug safety program in the world.” They include filling the post of FDA drug safety director, which has been vacant for about a year. An acting director has been handling the responsibility.
Critics said the measures did not go far enough to correct what they said was the pharmaceutical industry’s excessive influence on the agency.
“This is a cosmetic move by the FDA,” said Dr. Sidney Wolfe of Public Citizen’s Health Research Group, a consumer advocacy organization. “The balance of power [at the agency] is in favor of approving a drug or keeping it on the market without a warning. There is no guarantee the balance of power will swing.”
Galson said the problems had been exceptions in a process that usually worked smoothly. “We don’t really think there is a need for overwhelming cultural change,” he said.
In two recent cases, the agency has been strongly criticized for moving slowly.
At the end of September, Merck & Co. voluntarily withdrew its arthritis drug Vioxx after a study showed an increased risk of heart attacks and strokes among patients taking it for 18 months or longer. A report published this week in the British medical journal Lancet concluded that the risks were evident four years ago from data that were not analyzed properly.
Last month, the FDA belatedly issued a warning on antidepressant use by children and teens, responding to accumulating evidence that such medications could lead to suicidal thoughts and actions.
The measures announced Friday were an effort to improve the workings of an FDA office that tracks problems with drugs that had been cleared for use by patients. This responsibility is handled separately from the testing and approval process for new drugs.
Galson said one of the reforms involved creating a process that would allow dissenting opinions about the safety of a drug to reach agency superiors. That would create formal channels for what had been an “ad hoc” process until now, he said. Under the change, a panel of agency experts not involved with a particular drug could be appointed to evaluate concerns about its safety.
The agency will also ask the Institute of Medicine, one of the National Academies, to study the U.S. drug safety system. A panel of experts would concentrate on what happened after a drug was cleared for use and would recommend changes that could help the agency spot dangerous trends more rapidly.
In addition, the FDA said it planned to conduct workshops with experts on drug safety risks and to issue guidelines to the industry for monitoring adverse reactions to medications.
Wolfe, the consumer advocate, said more fundamental changes were needed. Since the early 1990s, the agency has emphasized efficiency in the approval of new drugs, he said. In some cases, that has overridden safety concerns raised by the agency’s experts.
“There is a serious problem in the failure of the FDA to be more cautious in approving drugs their own physicians say are too dangerous,” Wolfe said.
