S-2292-119
Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Sponsored by Jim Banks (R-IN)
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 safety and effectiveness are evaluated under a standardized process. Under the existing framework established by the CARES Act (2020), drug manufacturers pay fees to the FDA to support this review process. This bill would amend that fee structure, likely extending or adjusting the fee authority beyond its current authorization period.
Who benefits
Consumers who use OTC medications and benefit from a funded, functioning FDA review process that evaluates product safety and effectiveness. Generic and brand-name OTC drug manufacturers who gain regulatory certainty and a predictable review timeline. Retailers and pharmacies that stock OTC products. FDA staff whose positions are funded by the user fee program. Patients who rely on affordable non-prescription medicines as an alternative to costlier prescription drugs.
Who is hurt
OTC drug manufacturers who pay the user fees, which represent a direct operating cost — smaller manufacturers may bear a proportionally heavier burden. Consumers could indirectly bear some fee costs if manufacturers pass them through in product pricing. New market entrants seeking to introduce novel OTC monograph products may face higher barriers if fee levels increase. Taxpayers who previously subsidized this review through general appropriations may see a shift in who bears the cost, though this is a pre-existing dynamic from the 2020 framework.
Supporters argue
Supporters argue that the OTC monograph user fee program, established by the CARES Act in 2020, modernized a review process that had been stalled for decades — with some products languishing in regulatory limbo for over 30 years. They contend that continued fee authority gives the FDA stable, dedicated funding to clear its review backlog, ensuring that consumers have timely access to safe and effective non-prescription products without relying on unpredictable annual appropriations.
Opponents argue
Opponents argue that user fees create a structural conflict of interest, as the FDA becomes financially dependent on the very industry it regulates, potentially skewing its priorities toward fee-paying manufacturers rather than independent public health review. They contend that OTC drug oversight is a core government function that should be funded through general appropriations subject to full congressional oversight, rather than through a fee arrangement that may insulate the program from standard budget scrutiny.