Washington Editor

WASHINGTON - The FDA is set to receive a modest budget increase next year, about 4 percent, according to President Bush's proposed fiscal requests unveiled here Monday.

The federal regulatory agency is scheduled to get a $1.9 billion budget, which represents 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. Characterized as a "responsible budget" by HHS Secretary Michael Leavitt, he said it "represents a hopeful agenda for the coming fiscal year."

Included in the FDA's enhanced appropriation is funding for drug safety initiatives, pandemic flu preparedness and the Critical Path program. Acting Commissioner Andrew von Eschenbach said the budget "strengthens the FDA's vital mission of advancing medical and other health-promoting products while protecting the public."

Although the FDA is scheduled for a slight increase, many other HHS components are facing 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.

For the FDA, the new budget includes $745 million for its human drugs and biologics programs, which, taken collectively, represent the biggest chunk of the agency's proposed spending. The $535 million to be allocated to human drugs is a $17 million increase over this year, and the $210 million for biologics is a $15 million increase. Of the total funding for those programs, $289 million will come from industry user fees.

The budget also requests $55 million for pandemic flu preparedness efforts at the FDA, a $30 million increase. The new amount includes $15 million for a collaborative effort with the Centers for Disease Control and Prevention in Atlanta on vaccine candidate development, as well as another $15 million for safeguarding food supplies by detecting and containing domestic outbreaks.

Those proposals all fall under HHS' $2.6 billion in funding requests for pandemic planning and preparedness, a total that includes resources for product research and development, stockpiling and surveillance spread across several agencies. The broader HHS budget also includes a $4.4 billion request for bioterrorism-related spending.

The FDA's Office of Drug Safety is slated for a $4 million 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.

The budget also proposes $22 million for a new user fee program to require companies to pay reinspection costs, should they fail to meet FDA requirements during an inspection. The Critical Path Initiative, which Leavitt said holds promise for "the new frontier in medicine," is set for $6 million in funding.

Funding for the NIH includes cuts across all but one of its member institutes, the National Institute of Allergy and Infectious Diseases, which is 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.

Notably, 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 on Thursday. The 2007 fiscal year begins Oct. 1.