FDA still underfunded, say lawmakers

The Food and Drug Administration's latest budget proposal isn't enough to protect the country's food and drug supplies, according to some Democratic lawmakers.

FDA's fiscal 2009 request is nearly $2.4 billion, including $1.77 billion in budget authority and $626 million in industry user fees. If enacted, the request, would amount to a 5.7 percent increase from fiscal 2008, but critics worry that it's not enough to remedy the agency's current shortfalls in staffing and other resources.

"The administration's slight funding increase proposed for the FDA is woefully inadequate," Rep. Bart Stupak, D-Mich. "I am eager to hear how Commissioner [Andrew] von Eschenbach plans to implement the dramatic changes necessary at the FDA with a budget increase that barely covers the cost of inflation."

FDA said the proposal included strategic increases to strengthen food protection, modernize drug safety, expedite approval of generic drugs, and improve the safety and review of medical devices. The agency also announced it would boost its full-time staff by 526 in fiscal 2009, as the budget proposal supports additional staff for priority areas.

"This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety of development drugs, vaccines, devices and other medical products," Eschenbach said.

A November report from FDA's Science Board found that the agency was inadequately funded and "can no longer fulfill its mission without substantial and sustained additional appropriations." The agency's responsibilities have expanded in recent years and budget increases have not kept pace.

"Although our government always faces financial constraints, we cannot afford to put FDA, which performs tasks vital to the public health, in a situation in which it cannot succeed," wrote Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass., in last week's request to the Government Accountability Office to examine the staff, information technology and other resources necessary for FDA to fulfill its mission.

High-profile food recalls over the past year and the agency's now-defunct plan to shutter several labs and regional offices have thrust FDA under the microscope. Food safety advocates, federal employee unions and lawmakers rallied against the consolidation plan, which was suspended in August and eventually prohibited by a provision in the 2008 omnibus appropriations package. "It is extremely disappointing the administration appears not to have learned the clear lessons of the past year that the Food and Drug Administration is dangerously overextended and underfunded," said Colleen Kelley, president of the National Treasury Employees Union, which represents FDA employees.

NTEU is calling for fiscal 2009 appropriations of $2.1 billion, a $380 million increase over the fiscal 2008 funds and $330 million more than the figure proposed for fiscal 2009. That number does not include industry user fees. "An increase in that amount represents less than a 20 percent increase in funding from last year -- and it is a small, but necessary, price to pay to ensure the safety and efficacy of these critical products," Kelley said.