HR-4273-119
Placed on the Union Calendar, Calendar No. 254.
Sponsored by Robert Latta (R-OH)
What it does
This bill would reauthorize the user fee program that funds the FDA's review of over-the-counter (OTC) monograph drugs — common non-prescription products like pain relievers, antacids, and cold medicines whose ingredients are evaluated under a standardized "monograph" system rather than individual drug applications. Under this system, drug manufacturers pay fees to the FDA, which uses those funds to staff and conduct safety and efficacy reviews of OTC drug ingredients and labeling. The bill would extend or amend the fee structure and program terms established by the original OTC Monograph Drug User Fee program, which was created by the CARES Act in 2020.
Who benefits
FDA, which receives continued funding to conduct OTC drug reviews without relying solely on annual congressional appropriations. Consumers who use OTC medications and benefit from timely FDA safety and efficacy reviews. Generic and brand-name OTC drug manufacturers who gain regulatory predictability and faster FDA review timelines. Pharmacies and retailers that stock OTC products. Patients who cannot afford prescription drugs and rely on OTC alternatives.
Who is hurt
OTC drug manufacturers who pay the user fees — particularly smaller companies for whom fees represent a larger share of operating costs. Manufacturers of products whose monograph reviews are delayed or whose fees increase under the amended structure. Consumers could indirectly bear costs if manufacturers pass fee increases through to product prices. Companies that had budgeted under the prior fee schedule may face adjustment costs.
Supporters argue
Supporters argue that the OTC monograph user fee program has been essential to clearing a decades-long backlog of unreviewed OTC drug ingredients, with the FDA having made more progress on monograph orders since 2020 than in the prior 30 years combined. They contend that reauthorizing the fee program ensures the FDA has stable, dedicated funding to continue this work, protecting consumers from products whose safety and efficacy have not been fully evaluated and giving manufacturers the regulatory certainty needed to bring new OTC products to market efficiently.
Opponents argue
Opponents argue that user fee programs structurally create a conflict of interest, as the FDA becomes financially dependent on the very industry it regulates, potentially skewing review priorities toward fee-paying manufacturers rather than public health needs. They contend that OTC drug oversight should be funded through general congressional appropriations to preserve regulatory independence, and that fee increases imposed on manufacturers — especially smaller ones — may consolidate the OTC drug market by pricing out smaller competitors, reducing consumer choice.
Constitutional context
Congress has broad authority to impose fees on regulated industries and fund agency operations under the Taxing and Spending Clause (Art. I, §8, cl. 1) and the Necessary and Proper Clause (Art. I, §8, cl. 18). No significant constitutional challenge is apparent; user fee programs for FDA functions are well-established and have not generated active litigation. Post-Loper Bright (2024), any FDA regulations implementing the fee structure would face independent judicial review rather than automatic deference, though this is unlikely to affect the core fee-setting authority.
Checks and balances
Congress sets the fee structure and program terms by statute; the FDA administers the fees and conducts reviews; Congress retains oversight authority through reauthorization cycles, which require the agency to justify its performance before fees are renewed.
Historical precedent
The original OTC Monograph Drug User Fee program was established by the CARES Act (2020), itself modeled on earlier FDA user fee programs like PDUFA (1992) and GDUFA (2012), all of which have been reauthorized multiple times without significant constitutional challenge.