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# 13% Boost in FDA Budget Proposed by Trump
- URL: https://www.fdaweb.com/13-boost-in-fda-budget-proposed-by-trump/
- Published: 2018-02-12T12:00:00.000Z
- Updated: 2026-09-14T23:21:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140735

FDA stands to gain a $663 million (13%) budget boost in President Trump’s just-released fiscal year (FY) 2019 budget proposal, treatment not afforded most other non-military programs, which face massive cuts in the unlikely event that Congress agrees to all of those reductions.  

The budget includes $5.8 billion in total resources for FDA, which includes an increase of $190 million in user fees, while increasing budget authority by $473 million. In addition, the budget provides an initial $10 million for agency activities related to the opioid epidemic for “regulatory science activities to develop tools to stem the misuse and abuse of opioids,” the proposal says. It notes that $20 million would go to funding the new Oncology Center of Excellence, and $31 million above the FY 2018 continuing resolution for FDA infrastructure that will “allow facilities to support cutting-edge and innovative regulatory science, and continue planned activities at both FDA headquarters and in the field.”

The budget also addresses FDA efforts to reduce drug costs and praises it for approving the highest annual total number of generic drugs (1,027) in its history last year. “FDA is also increasing competition in the market for prescription drugs, and facilitating entry of lower-cost alternatives, by providing greater transparency and expediting the review of generic drug applications for products with limited competition,” it says. “The budget also proposes to give FDA greater ability to bring generics to the market faster by incentivizing more competition among generic manufacturers. The budget proposes to ensure that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period.”

Under the proposal, when a first-to-file generic application is not approved due to deficiencies, FDA would be able to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock. “Triggering the start of the 180 day-exclusivity period for first-to-file applicants who ‘park’ their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers,” it says.

Additionally, the budget includes a legislative proposal to modernize the over-the-counter drug monograph system. It envisions a “framework that converts burdensome rulemaking to a streamlined administrative order process; removes barriers to innovation; implements a new mechanism for quickly responding to urgent safety issues; reduces the backlog by finalizing unfinished monographs; and creates a user fee program for over-the-counter monograph drugs.” To support this effort, FDA proposes to collect $22 million in user fee resources in FY 2019 and a further $134 million over the following five years.  
  
Reacting to the budget proposal, the Alliance for a Stronger FDA applauded the Trump Administration’s “significant funding increase for the FDA.” The group noted that the agency’s budget authority appropriation would grow by $473 million to target “major expansion of FDA’s capabilities in advancing the availability of innovative drugs and medical devices. This is the largest increase ever proposed for the FDA.”