The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7 million allocated for initiatives associated with what it calls “key areas,” including improving the safety and quality of medical products, implementing a new food safety system and modernizing the FDA, as well as $277.2 million allocated for user fees.
The budget reflects the agency’s expanded scope of activities – which has grown both as the number of imported food and medical products continues to increase, and through significant legislation like the Patient Protection and Affordable Care Act, the Food Safety Modernization Act, the FDA Safety and Innovation Act (FDASIA), and the Drug Quality and Security Act.
Commissioner Margaret A. Hamburg said that the FDA is looking to expand on a number of fronts amid an “increasingly complex and scientifically demanding” regulatory landscape, and thus needs the appropriate resources. She noted in a letter posted on the FDA blog that the products her agency oversees account for more than 20 cents of every dollar that American consumers spend. Despite the regulator’s vast mandate, however, Hamburg said that American taxpayers actually only contribute roughly $8 each, per year, to the budget.
In her letter, Hamburg wrote that the request includes a nearly $148 million increase in budget authority to concentrate on a number of areas, including several relating to medical product safety, such as:
- Addressing the growing threat of antibiotic resistance ($14.8 million increase);
- Encouraging the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to “personalize” the diagnosis, treatment and prevention of disease ($9.7 million increase);
- Implementing FDASIA requirements to improve medical product review and inspections ($5 million increase); and
- Addressing the safety of compounded drugs ($0.7 million increase).
The budget request also includes an anticipated 15% increase in user fee collections, with $277.2 million allocated to this revenue source.
According to the FDA’s budget request, the agency estimates that medical product safety will account for 54.8% of its major activities in FY 2016, while food safety will make up 31.0%, tobacco 12.2%, medical countermeasures 0.5% and “other” 1.5%.