Acting FDA Commissioner Lester Crawford Announces Drug Safety Oversight Board Members
Acting FDA Commissioner Lester Crawford recently appointed members of the agency's new Drug Safety Oversight Board, which was announced in February as part of a series of drug-safety initiatives to address criticism about the agency's drug regulation, CQ HealthBeat reports. Crawford named Susan Cummins as the board's executive director and FDA Center for Drug Evaluation and Research Deputy Director Douglas Throckmorton as the board's nonvoting chair.
The board, which has 15 voting members, includes representatives from the Center for Biologic Evaluation and Research and the Center for Devices and Radiological Health. Members and alternates from the Department of Veterans Affairs and the National Cancer Institute also were selected (CQ HealthBeat, 5/19). Earlier this month, FDA announced that members also will be chosen from the agency's Office of New Drugs.
Board members will be permitted to confer with outside consultants. The board will discuss emerging drug-safety issues and be responsible for information posted on the recently launched Drug Watch Web site. The agency will not publicize most of the board's deliberations. The CDER director will have the final vote on drug-safety issues (California Healthline, 5/9).
The board will work with existing FDA drug safety offices, but it will not have any authority over them. It will meet regularly, with the first meeting expected to occur this summer (CQ HealthBeat, 5/19).