FDA Creates Panel on Drug Safety

FDA is creating an independent Drug Safety Oversight Board to oversee management of drug safety issues. Creation of the board comes at a time when FDA is under intense pressure from Congress and the public to improve monitoring of drugs after approval.

"The public expects better and more prompt information about the medicines they take every day," said Acting FDA Commissioner Lester M. Crawford Jr., who has just been nominated to head the agency. "Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs approved for sale to U.S. consumers."

Board members will come mostly from within FDA and include medical experts from other government departments. The board will consult with outside experts and representatives from patient and consumer groups.

Sen. Charles E. Grassley (R-Iowa), chairman of the Finance Committee, worries about the new board's independence. He has been a vocal critic of current FDA drug evaluation boards' reliance on industry.

"A new drug safety board may contribute to oversight at FDA, but it remains necessary that the [existing] drug safety office within FDA be made truly independent," Grassley says.

While the industry supports improvements in information quality, it is concerned that FDA is moving too fast. "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgment regarding benefit and risk," says Jeff Trewhitt, spokesman for the Pharmaceutical Research & Manufacturers of America. "PhRMA will carefully study the initiatives and will respond to FDA's request for input."

Creation of the safety board came as FDA held a three-day public meeting before an independent panel to discuss the safety of COX-2 inhibitor painkillers. That panel will make recommendations about the continued use of the drugs.