FDA URGES PATIENCE IN ASSESSING ITS DRUG REVIEW, SAFETY EFFORTS
The Bush administration is cautioning critics of the FDA budget to consider the agency's long-term plans when assessing the fiscal 2008 budget proposal. The agency is proposing slight increases in funding for its drug review and safety programs, with particular emphasis on accelerating generic drug approvals.
The proposed FDA budget for fiscal 2008 will be $2.1 billion, $105.8 million more than the president's fiscal 2007 request, including an estimated $444 million in industry user fees. The agency is also proposing new fees for generic drugs and inspections. That request is part of an overall $700 billion budget for HHS, a $28 billion increase from the administration's fiscal 2007 request.
But critics say these increases are not enough to handle rising costs and an increased workload, not to mention inflation. While "every little bit helps," the FDA proposal "doesn't amount to any more than just a little bit" of an increase, Peter Pitts, director of the Center for Medicine in the Public Interest, said. "The additional monies for drug safety do nothing to off-set the starvation budget this represents for the FDA."
The FDA Alliance, a coalition seeking increased agency funding, believes the FDA needs more money than proposed in the budget. The group, which is calling for an additional $250 million in new appropriations in the fiscal 2008 budget, includes PhRMA and other trade organizations and nonprofits such as the National Organization for Rare Disorders.
But HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach said this budget proposal is sufficient and needs to be viewed in a larger context. The budget shows a "clear commitment" by the administration to fund drug safety efforts and reviews, Leavitt said. The additional funding and fees will also ensure "more efficient and more rapid approval of generic drugs."
These funds are part of an "ongoing investment" in drug safety, von Eschenbach added. This budget is part of a "trajectory that really keeps us growing in response to the opportunities and challenges in drug safety," he added. "Don't see it as a one-time fix. It's not intended to be a one-time fix. It's intended to be a well-developed strategy, both programmatic and resource-wise, to modernize and strengthen the FDA."