Congress weighs FDA restraints to improve drug safety
WASHINGTON -- Federal officials responsible for ensuring that medications are safe face a major limitation: A new drug often is tested on a few thousand patients, but a serious side effect might not be recognized fully until the drug's users number in the hundreds of thousands.
''To a real degree, the people who get the drug in the first few years after its approval are being experimented on," said Dr. Brian L. Strom, a professor of biostatistics and epidemiology at the University of Pennsylvania.
Now, pushed by an acknowledged safety disaster with one drug and heightened suspicions about several others, Congress is considering steps to limit the risks of what Strom and others see as the ''experiment" of newly marketed drugs.
But opinions diverge widely on what changes should be made, if any, at the nation's drug watchdog, the Food and Drug Administration.
The FDA says it can fix any problems on its own. Its critics are calling for legislators to impose changes on the agency and possibly on the drug industry -- with some urging a ban on advertising new drugs until their safety is established more fully.
The debate gained new force recently after an unusual hearing before the Senate Finance Committee on Nov. 18, in which government witnesses and other specialists said federal regulators and drugmaker
Merck took Vioxx off the market Sept. 30, after about 20 million Americans had taken the drug, when tests indicated that Vioxx nearly doubled the risks of heart attack and stroke among patients who took it for at least 18 months.
At the same hearing, Dr. David J. Graham, a longtime drug reviewer for the FDA, contended that five other widely used medications warranted reappraisal for possible safety problems. And in a sharp criticism of the current monitoring system, the editors of the Journal of the American Medical Association this week called for considering a new board, independent of the FDA, that would track the safety of drugs and medical devices once they were on the market and in wide use.
The system of FDA oversight ''requires a long-overdue major restructuring," the journal said in an editorial. Until then, it said, ''the United States will still be far short of having an effective, vigilant, and trustworthy system."
