It’s Budget Time at the FDA!

In a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come from new fees on food facilities ($220 million) and generic drug makers ($38 million in user application fees similar to PDUFA fees for new drugs). Of interest to all drug producers is a proposal for a ‘reinspection user fee’ – a fee to pay the full cost of reinspections and associated follow-up work due to the firms’ failure to meet FDA standards. FDA is expecting $27 million from this reinspection fee.

Four major initiatives have been defined as major highlights for the FY2011 budget requested by the U.S. Food and Drug Administration. These include: Transforming Food Safety budgeted for $318.3 million, Protecting Patients budgeted for $100.8 million, Advancing Regulatory Science budgeted for $25 million and Tobacco budgeted for $215 million.

These initiatives are intended to allow an Agency focus on medical product safety, improvement in the FDA core scientific capacity, and allow the Agency to identify improved pathways to product development and approval for promising new technologies.

The directionality of this proposed budget gives some insight into what the primary drivers will be for the FDA as the year unfolds. We will keep a watchful eye on the budget process as it is reviewed and revised for indications of the strength of these convictions.