By AARON LORENZO
Diagnostics & Imaging Week Washington Writer

and DON LONG
Diagnostics & Imaging Week

WASHINGTON – The FDA is set to receive a modest budget increase next year, about 4%, according to President George Bush's proposed fiscal request unveiled Monday.

While that isn't much, it is substantially better than the proverbial piece of coal coming to the National Institutes of Health (NIH; Bethesda, Maryland) in the form of a zero increase.

In both cases, the budget indicates for FY07 a clear belt-tightening effort in federal spending for the medical sciences.

The FDA is scheduled to get $1.95 billion in the new budget, representing a $71 million increase over the current fiscal year. The total comprises about $1.5 billion in budget authority and $402 million in industry user fees.

The proposed FDA budget is a small slice of the total projected for its parent agency, the Department of Health and Human Services, for which the president proposed a $58 billion increase to $698 billion. Characterizing the proposed spending plan as "fiscally responsible," HHS Secretary Mike Leavitt said it "represents a hopeful agenda for the coming fiscal year."

Included in the FDA's enhanced appropriation is funding for medical product safety ($6.43 million), the Critical Path for Personalized Medicine Initiative ($5.94 million), and pandemic preparedness ($30.49 million).

Of the spending for medical product safety, $3.96 million of the increase is for improvements in monitoring drug safety and a little under $2.48 million for a program to involve surveillance of human tissues that can transmit disease.

In its summary, the FDA designated no increases for postmarket surveillance of medical devices, a program that the Center for Devices and Radiological Health said it would be beefing up.

It cited $7.42 million in funding supporting the continuing collection of user fees under the Medical Device User Fee and Modernization Act and Animal Drugs User Fee Act. Altogether, it cited an increase of $20.17 million for increases in all categories of user fees.

The FDA said it also is proposing two new mandatory user fees: $22 million for "reinspection and other FDA follow-up work" after a manufacturer fails to meet Good Manufacturing Practices requirements; and some $3.54 million for issuing food and animal feed expert certificates.

Andrew von Eschenbach, acting commissioner of the FDA, said the budget "strengthens the FDA's vital mission of advancing medical and other health-promoting products while protecting the public."

The FDA's Office of Drug Safety is slated for $4 million in funding growth to $39 million. Leavitt called safe and effective drugs "a treasure to the American public," and the increase in safety resources is earmarked for modernizing the Adverse Event Reporting System and coordinating drug usage databases currently maintained by the Centers for Medicare and Medicaid Services with the FDA's safety watches.

Compared to increases going to the FDA, other HHS components face budget cuts. Notably, funding for the National Institutes of Health will remain flat at $28.6 billion. "We had to make some hard choices," Leavitt conceded.

Funding for the NIH includes cuts across all but one of its member institutes, the National Institute of Allergy and Infectious Diseases, slated for a $12 million increase to nearly $4.4 billion. The most highly funded component of the NIH, the National Cancer Institute, is scheduled for a $40 million cut to less than $4.8 billion, and the National Heart, Lung and Blood Institute is facing a $21 million cut to $2.9 billion.

Other reductions drew immediate critical responses.

The American Diabetes Association (Alexandria, Virginia) noted an $11 million reduction for the National Institute of Diabetes & Digestive & Kidney Diseases and a $20 million reduction for chronic disease prevention at the Centers for Disease Control and Prevention (CDC; Atlanta), cuts that it said would hamper efforts to curb the increase in diabetes.

"By any measure, diabetes is a disease that requires grant federal attention, and yet the administration's response is to weaken the federal resources needed to fight this national epidemic," the association's statement said.

And the American Heart Association (Dallas) said that failures to increase funding to the NIH and CDC had put the fight against heart disease and stroke on the "back burner."

It specifically noted termination of an automated external defibrillator (AED) program of the Health Resources and Services Administration, "even though communities with aggressive AED placement plans have achieved survival rates from sudden cardiac arrest as high as 40%."

Among the notable increases in the budget, the NIH's Office of the Director has been tabbed for a $140 million budget increase to $668 million. Also slated for increased spending is the research agency's Genes, Environment and Health Initiative, for which the budget expands funds by $49 million to $68 million.

Leavitt concluded that the proposed spending for HHS is consistent with administration goals of moderating increases as part of a larger effort to lower the federal deficit and cut it in half by 2009. But critics charged that the president's overall budget proposal would do the opposite, deepening the deficit.

The proposals now go to Congress for review, with Leavitt scheduled to testify before the Senate Finance Committee today. The 2007 fiscal year begins Oct. 1.

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