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S. 2292119th CongressHealth
Over-the-Counter Monograph Drug User Fee Amendments
Sponsored by Sen. Jim Banks (R-IN) · 3 active : 1 Republican, 2 Democrats
Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Where it standsBefore the Senate10 senators score as swing votes
Hasn’t passed either chamber
- Senate: next
- House: not yet
- President: not yet
Summary
, via Congress.govOver-the-Counter Monograph Drug User Fee Amendments
This 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.
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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.
Committees and subjects
Committees
- Senate Committee on Health, Education, Labor, and Pensions · SenateReported by · Markup by · Referred to
Subjects
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- Supply chain
- User charges and fees
Model
Directional: count only breaks toward the other partyWhy do scores change?v3default (selected)v2 model swing-v2
How the Senate breaks down
- 10Swing 70–100
- 63Middle 30–70
- 27Entrenched 0–30
Members fall into . All 100 senators have enough data to score.
Key players in the Senate
Ranked by swing score, 0–100 · swing-v3, directional: only movement toward the other party counts, so members who sit further from the center than their party no longer score as swing votes.
Bars show each input from 0 to 100: ideology gap, scorecard gap, , and the . is the seat’s partisan lean, and shows how much of the input data a score has.
Similar past votes, Senate
Earlier behind swing-v3’s inputLoading similar votes
Cosponsors
3 activeShow all 3 cosponsors
- Tim Kaine (D-VA)
- Andy Kim (D-NJ)
- Jon Husted (R-OH)
How the swing score works
Ideology gapHow far a member’s DW-NOMINATE voting score sits from their party’s median in the same chamber.
Scorecard gapHow far their Heritage Action and LCV ratings stray from their party’s average, using the groups’ votes on similar bills where available.
Cross-pressureHow strongly their district or state leans toward the other party, from our own computed partisan lean.
Similar votesHow often they voted against their own party on earlier roll calls about this bill or similar ones.
Committee bonusMembers of the committees handling the bill decide whether it moves, so they get a boost.
Cosponsor checkThe sponsor and active cosponsors have already committed, so they drop toward entrenched.
