Chairman Dr. Peter Gross Suggests Two Changes: Open Meetings And Public Representatives
In mid-February 2006 Dr. Peter Gross, the outgoing chairman of the FDA's drug-safety and risk-management advisory committee, said that the agency's relatively new Drug Safety Oversight Board should make some changes to improve its public perception. Dr. Gross, who is also chairman of the internal-medicine department at Hackensack University Medical Center in New Jersey, said specifically that the FDA should consider adding some outside experts to this advisory board.
At present, the FDA's Drug Safety Oversight Board members are all federal government employees: senior FDA officials together with representatives from the National Institutes of Health and the Department of Veterans Affairs.
The FDA established the Drug Safety Oversight Board in 2005, seemingly as a response to widespread criticism that the agency was slow in reacting to drug-safety issues such as the Vioxx debacle. This board is suppose to help the FDA to move more quickly when the agency learns of unexpected side effects after it has approved a prescription drug for use in the U.S.
A February 13, 2006 article published by Reuters succinctly states Dr. Gross' case:
"You are setting yourself up for failure with this oversight board," Gross told FDA officials at a meeting of the advisory panel. "In this age of transparency, you decide to have a committee that's responsible, according to its name, for overall safety, and yet it meets in private. You don't have public representatives."
Dr. Gross commented, also, that the name of the oversight board is "misleading to the public", and implies that it is the sole government entity that makes drug-safety decisions.
The FDA's retort to the points raised by Dr. Gross was presented by Dr. Sandra Kweder, deputy director of the FDA's office of new drugs. According to several news reports in February 2006, Dr. Kweder stressed that the Drug Safety Oversight Board is an internal board that was not meant to replace any use of drug-safety advisory panels, which usually involve "outside" medical experts. Dr. Kweder pointed out that new legislation would be needed in order to add those outside medical experts as "public" members of this board.
Furthermore, the FDA has maintained that Drug Safety Oversight Board was designed specifically to be an internal management group, in part because at times this board must discuss confidential company information.