White House 2021 Budget Proposal Provides Modest Boost for FDA

The proposed 2021 budget put forth by the White House Monday includes some significant funding cuts for the U.S. Department of Health and Human Services, including long-term changes to Medicaid and the Affordable Care Act.

One agency in the health arena that does see a boost though, is the U.S. Food and Drug Administration (FDA). In an analysis of the proposal, Regulatory Focus, the publication of the Regulatory Affairs Professional Society (RAPS), noted that the FDA, under the proposal, could see $6.2 billion in overall funding. That includes $3.3 billion in discretionary budget authority and $2.9 billion in user fees, RAPS said. The proposal from the White House is a slight increase to the FDA’s current budget. The proposal shows a $25.4 million increase in budgetary authority funds and the user fees funding is about $240 million over the 2020 funding, the publication noted.

While the White House has provided some additional funding in its proposal to the FDA, that is all the numbers amount to – a proposal. The budget is authored by Congress and will see many changes in financial figures before both chambers ultimately agree on a funding plan. The full budget proposal for the FDA can be found here.

Some of the proposed budgetary numbers include an $18 million increase in funding to develop a knowledge management system and portal for medical devices. RAPS said the funding increase is important due to the increase of new or modified medical devices the FDA has approved – on average 12 per day. To add to the importance of such a knowledge-based system, RAPS said the FDA gave the breakthrough designation to more than 100 devices last year, double the number of designations awarded in 2018.

Opioid enforcement will continue to be of importance under the president’s proposed budget. The plan provides an additional $45 million to “increase the enforcement of opioids at international mail facilities.”

More than $8 million will be provided to support the continued development of an artificial intelligence infrastructure at the FDA.

One change that could come to the FDA under the proposed presidential budget is removing oversight of tobacco regulation from the agency. The White House suggested creating a new agency to oversee and regulate tobacco products. The proposal suggests making the Center for Tobacco Products independent from the FDA with a Senate-confirmed director, The Hill reported. The budget proposal suggests that having a single agency oversee tobacco regulation and “its impact on public health” would allow the new entity to respond to the “growing complexity of new tobacco products,” The Hill said, citing the budget proposal. Over the past several years, e-cigarettes and vaping products have been a significant concern for the FDA.

The new agency, should it ever be approved, would be under the auspices of Health and Human Services.