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 through fiscal year 2030 the user fee program that funds FDA review of over-the-counter (OTC) monograph drugs, updating the formulas for calculating facility and order request fees. It also adds new provisions allowing use of real-world evidence and non-animal testing alternatives for evaluating topical drug ingredients, creates a formal process for companies seeking to switch prescription drugs to over-the-counter status, and requires new FDA reporting including public minutes of fee negotiation meetings and GAO reports on the OTC drug supply chain.
Who benefits
Manufacturers of OTC monograph drugs (e.g., sunscreens, antacids, cold medicines) who gain more predictable fee schedules and clearer pathways for prescription-to-OTC switches; the FDA, which receives dedicated funding to review OTC drug applications and safety data; consumers who may benefit from faster access to new OTC products and continued safety oversight; and drug manufacturers seeking to use real-world evidence or alternatives to animal testing to support ingredient approval.
Who is hurt
OTC monograph drug facilities, which must continue paying annually adjusted fees (with new one-time workload adjustments possible starting FY2028) that are typically passed through to consumers in product prices; smaller manufacturers may face proportionally higher compliance burdens than large firms; and companies awaiting the sunscreen ingredient order, whose timeline depends on FDA finalizing standards under the bill's new evidence provisions.
Supporters argue
Supporters argue this bill ensures the FDA has stable, industry-funded resources to review the safety and effectiveness of everyday OTC products used by nearly all Americans, preventing a lapse in a program that expired and needs reauthorization. They contend the new provisions—allowing real-world evidence, reducing animal testing, and creating a clearer Rx-to-OTC switch pathway—would speed safe products to market while maintaining rigorous safety standards, citing the decades-long success of similar FDA user fee programs for prescription drugs and medical devices.
Opponents argue
Opponents argue that industry-funded user fees can create conflicts of interest, potentially aligning FDA priorities with the regulated industry's negotiating leverage rather than purely public health goals, even with new transparency requirements for negotiation minutes. They contend that fee increases, including the one-time workload adjustment mechanism for larger facility counts, ultimately raise costs that are passed to consumers of everyday health products, and that loosening evidentiary standards through real-world evidence could weaken the traditional clinical trial threshold for demonstrating safety and effectiveness.
Constitutional context
Congress is exercising its taxing and spending power under Article I, Section 8 to authorize the FDA to collect industry user fees, similar to the framework upheld for other FDA user fee programs; this is a well-established, non-controversial exercise of the spending power that does not resemble the coercion or mandate issues addressed in NFIB v. Sebelius.
Checks and balances
Congress authorizes and periodically reauthorizes the fee structure while delegating fee-setting formulas and guidance issuance to the FDA (executive branch), with new reporting requirements to Congress and public disclosure of negotiation minutes serving as oversight mechanisms.
Historical precedent
This reauthorizes the OTC Monograph Drug User Fee program first established by the CARES Act in 2020, following the long-standing model of similar FDA user fee programs like PDUFA (prescription drugs) and MDUFA (medical devices) that have been periodically reauthorized since the 1990s.