The FDA's ability to protect Americans' health is at risk, the agency's commissioner said, citing increasing responsibilities and funding that hasn't kept pace.

The FDA's regulatory role has expanded and its workforce has been overextended, Commissioner Andrew von Eschenbach said in a speech recently. The FDA "may fail in its mission to protect and promote the health of every American," von Eschenbach says. "Peril exists."

Last fall a panel of outside advisers to the agency wrote in a report that American lives are in danger because the FDA lacks the funding to keep up with scientific advances. The agency's budget is more than $2 billion annually. Democratic lawmakers have criticized von Eschenbach for failing to press publicly for more funding.

The FDA needs to be "stronger, bigger, and better" to continue to be "the world's gold standard as a regulatory agency," von Eschenbach said.  

President George W. Bush has proposed increasing the FDA's budget by 5.7% to $2.4 billion for fiscal 2009, and the agency has said von Eschenbach had sought more without saying how much he recommended.

The panel of outside advisers to the FDA said the agency's budget will need to increase to $3.7 billion by 2013, excluding rent for offices and revenue from the fees drugmakers pay for the FDA to review new product applications. The advisers, known as the Science Board, recommended increasing funding by $375 million to $460 million each year.