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H.R. 4273119th CongressHealth
Over-the-Counter Monograph Drug User Fee Amendments
Sponsored by Rep. Robert E. Latta (R-OH) · 3 active : 1 Republican, 2 Democrats
Latest action: Placed on the Union Calendar, Calendar No. 254.
Where it standsBefore the House75 representatives score as swing votes
Hasn’t passed either chamber
- House: next
- Senate: 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) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.
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Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.
The bill makes certain changes to OMUFA, including by
revising the total facility fee revenue amount to be collected for FY2026-FY2030,
revising due dates for facility fees,
permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, and
requiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.
Finally, the bill adds as a
Tier 2 OTC monograph order request
a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
Committees and subjects
Committees
- House Committee on Energy and Commerce · HouseReported by · Markup by · Referred to
Subjects
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- 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
- 9Swing 70–100
- 62Middle 30–70
- 29Entrenched 0–30
Members fall into . All 100 senators have enough data to score. The bill is not before the Senate right now; these scores show where members would stand.
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
- Dan Crenshaw (R-TX-2)
- Debbie Dingell (D-MI-6)
- Diana DeGette (D-CO-1)
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.
