Drug Industry Officials See Room to Improve Safety
Posted on: Friday, 20 January 2006, 00:25 CST
By Lisa Richwine
WASHINGTON -- The U.S. government's monitoring of drug side effects could be strengthened but does not need the major changes critics have advocated, industry officials told an expert panel on Thursday.
Additional funding for the Food and Drug Administration and better ways to collect and analyze safety information could help improve detection of unexpected problems after drugs reach the market, the officials said.
"Drug safety in the U.S. definitely needs improvement. It needs a careful, focused treatment, but I would argue not radical exploratory surgery," said Geoffrey Levitt, chief counsel for regulatory and research at Wyeth.
A string of serious side effects linked to widely used prescription drugs has led to calls for major changes, such as moving safety oversight to an independent board outside the
FDA.
Industry officials who spoke to an Institute of Medicine (IOM) panel said they felt that that proposal, as well as suggestions that companies re-apply for approval five to 10 years after a drug launch, were unnecessary and could have negative consequences.
"We think that moving oversight of safety to another federal agency seems extreme and could significantly stall incremental progress," said James Nickas, senior director of development at Genentech Inc.
The panel will consider the input as it prepares a report on drug safety oversight that is scheduled to be completed this summer. The FDA requested the investigation last year after the agency was criticized as being slow to respond to signs of problems with antidepressants and Merck & Co. Inc.'s withdrawn painkiller Vioxx.
The IOM is an independent, scientific organization that advises the government. Most of the group's funding comes from government agencies.
Consumer activist Sidney Wolfe said the FDA needed to conduct detailed "post-mortems" of what happened each time a drug is pulled from the market.
"A critical part of improving the system for drug safety is remembering, admitting and learning from past mistakes," Wolfe said.
Wyeth's Levitt made a similar suggestion for a "thorough dispassionate, forensic review of all cases of post-market withdrawals and major safety warnings."
Source: REUTERS
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