FDA officials consider longer trials; promise early warnings
Friday, 04 March, 2005
US regulators are moving to get drug safety warnings to patients and physicians earlier, which should limit prescribing and cut the number of dangerous side effects, a top US Food and Drug Administration official has told the United States congress.
FDA acting deputy commissioner for operations, Dr Janet Woodcock, said those efforts, plus improvements in health and information technology, would address recent concerns over drug side effects.
FDA officials are also considering whether longer pre-market trials are needed to catch problems earlier, Woodcock said. "It's something we are going to have to wrestle with," she said.
"It is really a continuum between pre-market and post-market (reviews). It is by no means 'we simply forget this drug' after it's been approved," she said.
"We are now... planning to put information out directly to the public on emerging safety issues" even before the FDA and a manufacturer agree to change the drug label, Woodcock told the Senate Health, Education, Labor and Pensions Committee.
Lawmakers are considering whether to give the FDA new authority or funding, or to change the agency's structure to improve the monitoring of medicines already on the market. The FDA has proposed a new drug safety board, but some lawmakers want a panel completely independent of the agency.
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