Concern Over FDA's Handling of Serious Side Effects Issues, Including Recent Drug Recalls Involving Vioxx and Bextra
Members of an FDA advisory panel have voted unanimously in favor of having the federal agency provide this panel of outside consultants with detailed information about actions leading up to the recalls of Merck & Co. Inc.'s Vioxx and Pfizer Inc.'s Bextra painkillers. This action came on May 19, 2005 during the second day of a two-day meeting convened by the FDA so that the outside consultants could help identify areas for improvement as regards how the agency has handled drug recalls and serious safety issues in the recent past.
In more detail, the purpose of last week's two-day meeting of outside consultants was to advise the FDA on how it could improve its work in the drug safety realm. Significantly, however, this panel of outside experts is only in a position to provide non-binding recommendations to the FDA.
In comments regarding the advisory panel May 19 vote, Anne Trontell, deputy director of the FDA's Office of Drug Safety, said that the agency will consider the panel's suggestion. Ms. Trontell stressed, however, that FDA officials were already looking at ways to improve its drug-safety oversight efforts; "It's already an area of active interest," she said. For example, Ms. Trontell pointed out, the FDA has asked the Institute of Medicine to review its post-approval reviews of drug safety.
At least one of the panelists, Dr. Curt Furberg, an epidemiologist at Wake Forest University, expressed some doubt after the May 19 vote about whether the FDA would acquiesce to the advisory panel's request for detailed information concerning the agency's action, and inaction, as it relates to the Vioxx and Bextra recalls as well as other drug-safety issues.
As has been widely reported, the FDA's drug-safety monitoring work has come under intense scrutiny from all quarters following the Bextra recall in April 2005 and the Vioxx recall in September 2004.
- Read more about the FDA advisory panel meeting
(Posted by: Tom Lamb)