Drug Safety Oversight Board Consists of Mostly CDER Officials

Center for Drug Evaluation and Research (CDER) officials hold 14 of the 18 seats on the FDA's recently established Drug Safety Oversight Board (DSB) -- a majority position some observers say could prevent the board from making impartial decisions.

When the FDA announced the creation of the DSB in February, the agency said the board would "enhance the independence of [the FDA's] internal deliberations and decisions regarding risk-benefit analyses and consumer safety." Industry observers, however, said that goal could be difficult to achieve given the final make-up of the board.

"How can the oversight board make objective decisions on drug safety when the vast majority of the board members are from the same center that is approving the drugs?" said one industry source, who declined to be identified. "If the agency really wants to promote independence, it needs to either diversify the membership or move the board out of [CDER]."

The DSB consists of 18 members total, three of which are nonvoting members, including the board's chairman and executive director. CDER acting Deputy Director Douglas Throckmorton is chairing the board and Susan Cummins is its executive director.

Eleven of the DSB's 15 voting members are CDER officials, led by Office of New Drugs Director John Jenkins, Office of Drug Safety Deputy Director Anne Trontell and Office of Pharmacoepidemiology and Statistical Science Director Paul Seligman. The board's four remaining voting members hail from the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Department of Veterans Affairs and the NIH.