FDA Advisory Panel Voices Persistent Safety Concerns

Extract

The U.S. Food and Drug Administration has not done enough to improve oversight of the drug approval and surveillance process, according to a panel of safety experts that advises the agency.

At the February meeting of the FDA's Drug Safety and Risk Management Advisory Committee, members sharply questioned officials over the seeming lack of independence of the new Drug Safety Oversight Board appointed last May that is made up almost entirely of agency employees, holds closed meetings, and considers much of the decision-making process proprietary. The board was created as one part of a larger initiative to improve openness and oversight at the FDA.

The board may be misnamed if it gives the public the impression that it operates like the National Transportation Safety Board, an independent agency that is in a position to fault the government and/or industry, said committee member Arthur Levin, director of the Center for Medical Consumers in New York. More public input is needed to bring transparency into this process, he said.