FDA to gain funding in FY 2009 budget proposal; industry still concerned
"The FDA is committed to protecting and promoting the health of the American people," said Andrew C. von Eschenbach, MD, commissioner of the FDA. "This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices and other medical products."
The FY 2009 request, which covers the period of Oct. 1 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees, including $17.4 million in budget authority and $79million in user fees for medical product safety.
According to von Eschenbach, the FY 2009 budget implements new drug and medical device safety programs in FDA Amendments Act that are funded by user fees. As a result, the FDA will strengthen its ability to regulate medical products and assure the safety and effectiveness of these products for the American public, he said.
The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes funds to cover cost of living increases for FDA employees that perform the agency's scientific and public health mission, von Eschenbach said.
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said AdvaMed praises the proposed increased funding for the FDA, but he raised concerns about the administrations proposals to expand competitive bidding for diagnostic tests.
“This vital funding will enable the agency to expand [FDA] resources to fulfill its mission to promote and protect the public health and to oversee the increasingly sophisticated medical technologies that play such a vital role in improving patient care and we are encouraged by the President’s commitment to provide additional resources to expand and promote the adoption of health IT,” Ubl said.
“We are deeply concerned, however, by the administration’s proposal to expand competitive bidding for diagnostic tests. Lab tests account for less than two percent of Medicare program expenditures, but they guide 70 percent or more of medical decision-making,” he added. “AdvaMed also is troubled by the significant reductions in payments to providers in both inpatient and ambulatory settings. These significant reductions may limit patient access to innovative new treatments and technologies that improve health and save lives,” he said.
Concern remains as well for FDA resource shortfalls and their effect on staffing and IT, which were recently called under investigation to the Government Accountability Office by Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee.
According to a November 2007 report from the Science and Technology Subcommittee of the FDA Science Board, the agency is so under funded that it does not have the science foundation, staff or information technology to meet mounting the demands of overseeing the nation’s food, drug and medical device safety.
Among FDA’s proposed spending for IT, the FY 2009 budget would provide $16.8 million for information and computer technologies, $9.7 million for its MedWatch Plus adverse event reporting system and $11.2 million for its Mission Accomplishment and Regulatory Compliance Services, which seeks to integrate existing systems into one program.
“It [the budget] barely covers the cost of inflation and continues the trend of the inadequate budgets of previous years that have led to the current crisis at the agency,” the lawmakers said in the letter to Gail Cassell, former chairwoman of the Science Board’s subcommittee. “We want to ensure that funding for FDA is sufficient to permit the agency to fulfill its many regulatory responsibilities.”