S-2292 — Over-the-Counter Monograph Drug User Fee Amendments

YourVoice.Now Summary

Corporate BenefitsTransparency & AccountabilityTargeted & Unrelated Provisions

Keeps FDA fees on over-the-counter drug makers through 2030 and changes how sunscreen gets judged.

Corporate Benefits

Real-world data allowed for skin drugs — not just clinical trials

When the FDA judges whether an ingredient in a skin product is safe and works, it would have to accept real-world evidence. That means health records and patient databases, used alongside trial data.

Animal-free tests considered for skin drugs — guidance due in one year

The FDA would have to consider lab and computer tests in place of animal tests for skin drugs, including sunscreen. Draft guidance on how companies can use them is due one year after passage.

Clearer rules for moving drugs over-the-counter — guidance within 18 months

Companies can already apply to move a prescription drug to store shelves. The FDA would have to spell out what evidence it expects within 18 months, and could meet with a company to plan its application.

Nonprescription drug makers keep paying fees — through 2030

The fee program for over-the-counter drugs was set to end after fiscal year 2025. It would run through fiscal year 2030 instead, with the money paying for FDA review of these drugs.

Fees rise above inflation — $2.4 million extra in 2026

Each year's fee total starts from the year before and adds inflation. On top of that, the bill adds $2.4 million for 2026, $1.2 million for 2027, and $854,000 for 2028.

One-time fee increase allowed after 2027 — if plants top 1,625

The FDA could raise fees once more in 2028, 2029, or 2030. It could do this only if the three-year average of fee-paying plants tops 1,625 and fewer than 30 percent are behind on payment.

Transparency & Accountability

FDA must post fee negotiation notes — within 30 days

The FDA and the drug industry negotiate these fee levels in private. Written minutes would have to go on the FDA website within 30 days, covering what each side proposed and where they disagreed.

Yearly report tracks unpaid drug fees — starting 2026

The yearly FDA report would have to say, for each plant charged a fee, whether it paid. It would also list plants that registered for the first time that year.

FDA must publish review times yearly — starting fiscal year 2026

Starting with fiscal year 2026, the yearly report would have to show how many requests got proposed and final orders, by type, and how long reviews took. It would also cover reports of harm from these drugs.

Watchdog report on drug supply chain — due September 30, 2027

The Government Accountability Office would have to study how steady the supply of these drugs is. The report goes to two congressional committees by September 30, 2027.

Fee program ends October 1, 2030 — Congress must renew it

The fee rules would expire on October 1, 2030, and the reporting duty on January 31, 2031. Current law ends the program in 2025, so this is a five-year extension with a new deadline for Congress.

Targeted & Unrelated Provisions

Fee bill directs pending sunscreen decision — SPF 15 benefits count

A user fee bill would also set terms for a sunscreen decision the FDA already has pending. That order would have to weigh the safety record of ingredients already sold here and the role of SPF 15 and higher in preventing skin cancer.

More about this bill

The FDA's review of over-the-counter drugs would keep running five more years, paid for by industry fees. Most people would see no direct change in what they pay. The fees fall on plants that make drugs you buy without a prescription. Think pain pills, cold medicine, antacids, and sunscreen. Those plants pay the FDA to review their products, and that fee would run through 2030. The total would rise with inflation each year. Set add-ons would push it higher still: $2.4 million in 2026, $1.2 million in 2027, and $854,000 in 2028. One more increase could be added once, in 2028, 2029, or 2030. It would apply only if paying plants average more than 1,625 over three years. Fees would be owed from October 1, 2025, even if the bill passes later. Two parts would change how these drugs get judged. First, the FDA would have to accept real-world evidence when it reviews ingredients in drugs you put on your skin. That means data from health records and patient lists, not just clinical trials. It would also have to weigh test methods that do not use animals. Draft guidance for drug makers is due within one year. A pending FDA order on sunscreen would have to count the safety record of ingredients already sold here. It would also have to count the role of SPF 15 and higher in preventing skin cancer. Second, the FDA would have to publish guidance within 18 months on moving a prescription drug to store shelves. Drug makers could ask to meet first to plan that application. Public reporting would grow. The FDA would have to post notes from its fee talks with industry within 30 days. Those notes must lay out what each side proposed and where they split. Starting in fiscal year 2026, the yearly FDA report would add order counts and average review times. It would also cover safety follow-up and which plants paid or skipped their fees. A watchdog report on the supply chain for these drugs would be due by September 30, 2027. The whole fee program would end October 1, 2030, so Congress would have to act again.

Congressional Summary

Over-the-Counter Monograph Drug User Fee AmendmentsThis bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA); revises procedures used by the Food and Drug Administration (FDA) to evaluate topical, nonprescription drugs (e.g., sunscreens); and requires the FDA to clarify the process through which a prescription drug may be switched to nonprescription status.Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the FDA, rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective. The bill reauthorizes the collection of OMUFA fees from OTC drug facilities through FY2030 and revises methods for calculating such fees.Separately, the bill requires the FDA to allow for the use of real-world evidence to demonstrate the safety and effectiveness of active ingredients in topical, nonprescription drugs. The FDA must consider nonclinical tests and other alternatives to animal testing in evaluating such drugs.The FDA must also issue guidance to clarify the application process for nonprescription drugs, including applications to switch a prescription drug to nonprescription status. The FDA must plan to engage stakeholders in identifying drugs that are promising candidates for a switch. Moreover, applicants seeking a switch may request to meet with the FDA to develop a plan for the requisite application.Finally, the Government Accountability Office must report on (1) the OTC monograph drug supply chain, and (2) the FDA’s handling of applications to switch a prescription drug to nonprescription status.

Legislative Subjects

Congressional oversightDrug safety, medical device, and laboratory regulationSupply chainUser charges and fees

Details

Congress: 119th
Chamber: Senate
Status: summarized
Action: Reported to Senate
Action Date: 2025-09-08
Date Added: 2026-06-04
Source: Congress.gov →

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