Washington Editor

WASHINGTON - The FDA's next budget is tabbed for about $2.1 billion under President Bush's proposal for fiscal 2008, reflecting a $283 million, 12.5 percent increase over the agency's current operating plan.

That's a $106 million, 5.3 percent uptick from last year's request. The latter figures are more illustrative of an amended continuing resolution passed last week by the House of Representatives, and soon expected to clear a Senate vote too, for funding the FDA.

"We're building a trajectory of strategic investments," Commissioner Andrew von Eschenbach said at a Monday press conference to release the new numbers. "We need to build the budget, just as we build programs. We do it not with the idea that this is a one-time fix to everything. [Instead] this is an ongoing part of a strategic plan, a business plan, to strengthen the FDA to address the challenges that we're facing in the 21st century."

The budget includes a little more than $1.6 billion in discretionary budget authority, boosted by almost $444 million in myriad user fees.

Included is $787 million for the agency's human drugs and biologics programs, which is $20 million more than last year's request, and $87 million higher than the continuing resolution is funding at present. In total, $571 million is to be set aside for human drugs and $216 million for biologics, and industry-specific user fees are to cover $307 million of those costs.

Of note, those total Prescription Drug User Fee Act (PDUFA) charges are not adjusted from current levels, since efforts are under way to renew the law ahead of the coming government fiscal year that begins Oct. 1.

Accounting for such "enhancements," and accompanying higher costs of $393 million for the coming fiscal year, would be "too much in advance" at this time, said Patrick McGarey, the director of budget formulation and presentation in the FDA's Office of Management. "We'd be ahead of ourselves."

A public meeting on the preliminary, industry-negotiated proposal to reauthorize PDUFA is scheduled for Feb. 16. (See BioWorld Today, Jan. 12, 2007.)

The FDA's budget request also calls for $139 million in drug safety-related funding. That's an $11.2 million increase over last year's proposal to further strengthen that system "at every stage of the drug life cycle," McGarey said, from pre-market testing and development through post-approval surveillance and risk management.

With added funds, the agency plans to increase the staff that reviews annual safety reports, conduct a pilot program to review the safety profiles of new molecular entities and develop an electronic drug safety tracking system.

Such plans were outlined just last week as part of the FDA's response to last fall's Institute of Medicine report on its drug safety surveillance capabilities. A significant part of the agency's planned efforts to improve its oversight through the science of drug safety "in a very real way" encompass the Critical Path Initiative, von Eschenbach told BioWorld Today. "The science that's contained in the Critical Path, biomarkers, can be applicable to determining a drug's efficacy as well as its safety."

The FDA budget also includes a $16 million generic drug user fee, marking the first official proposal for such a program, as well as $27 million in other user fees related to site reinspections and export certifications for food and animal feed. The latter two programs were requested but not funded last year.

Nearly 10,000 employees are accounted for in the new budget, and all the FDA user fees would pay for about a fifth of them.

Under last year's proposal, the regulatory agency was scheduled to receive nearly $2 billion in the aggregate, a total comprised of about $1.5 billion in budget authority and $402 million in industry user fees. (See BioWorld Today, Feb. 7, 2006.)

Its request is a small sliver of the total budget proposal for the Department of Health and Human Services (HHS), which amounts to $698 billion for fiscal 2008, a $28 billion increase over estimated outlays under the continuing resolution.

HHS Secretary Michael Leavitt labeled the new budget "aggressive yet responsible" in noting the president's total $2.9 trillion proposal for fiscal 2008, which includes a broad plan for balancing the federal budget in five years by curtailing entitlement spending in programs such as Medicare and Medicaid.

Included in HHS' proposed spending is $28.7 billion for the National Institutes of Health; $5.8 billion for the Centers for Disease Control and Prevention in Atlanta; nearly $2.5 billion to research, develop and procure bioterrorism countermeasures; and $870 million to support the continued development of a vaccine and diagnostics for pandemic flu, as well as for purchasing antiviral medications.