Trump Budget Proposes Flat $6.2 Billion FDA Budget
President Trump has proposed a relatively flat (1.6% increase) $6.2 billion budget for FDA’s fiscal year 2021 budget, which includes $3.3 billion for budget authority and $2.9 billion in user fees. The only medical product program area seeing any increase (5%) is medical devices with its budget growing $21 million from $395 million in FY 2020 to a proposed $416 million for FY 2021.
Trump’s budget also calls for the Center for Tobacco Products to be moved out of FDA and into a new agency directly under HHS that would focus solely on tobacco regulation. It calls for a $100 million increase for user fees collected under the tobacco program and adds electronic nicotine delivery system manufacturers and importers as entities subject to the user fees.
The new tobacco agency would be “led by a Senate-confirmed director in order to increase direct accountability and more effectively respond to this critical area of public health concern,” the proposal says. “A new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity of new tobacco products. In addition, this reorganization would allow the FDA commissioner to focus on its traditional mission of ensuring the safety of the nation’s food and medical products supply.”
Additionally, the budget proposal seeks reforms to the over-the-counter (OTC) drug monograph program and includes a total of $28 million in new user fees for this effort. FDA currently regulates OTC products through a slow, three-phase public rulemaking process to establish standards or drug monographs for an OTC therapeutic drug class. The proposal would provide additional resources and authorities for FDA to efficiently bring new OTC products into the market. The budget also proposes a new user fee program to support innovative food activities totaling $28 million.
A cautious Alliance for a Stronger FDA said that in relative terms, it is pleased that the Trump Administration’s commitment to the agency “remains strong, even while many other worthwhile agencies are proposed for cuts. In absolute terms, further increases are going to be needed because the mission and responsibilities of FDA are still growing and the science is becoming more complex.” The Alliance also noted that when the budget is first released, the top numbers can be inaccurate and “support for FDA is likely to be overstated because of the complexity of the FDA budget.” The group will be working on an analysis in the coming days.