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User Fees

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

House Health Subcommittee Members Agree OMUFA Crucial, Split On FDA Staff Cuts’ Impact

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Doctors In The House: Sunscreen Innovation Diagnoses From Health Subcommittee

Energy and Commerce Health Subcommittee members, including several health care professionals, make clear their concerns about the US sunscreen market during hearing on reauthorizing FDA’s OMUFA program.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

Democrats Torch Trump’s HHS Layoffs During House Hearing On OMUFA Reauthorization

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.