Over-the-Counter Monograph Drug User Fee Amendments

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Bill ID: 119/hr/4273

Last Updated: July 17, 2026

Over-the-Counter Monograph Drug User Fee Amendments

HR. 4273, 119th Congress — read as touching Pharmaceuticals.

The sponsor

Rep. Latta, Robert E. [R-OH-5]

Every bill has someone who introduced it. That name is where the paper trail starts.

The money

$71,500 raised

27 itemised contributions to this sponsor, pulled from FEC filings.

The alignment

55% match to Project 2025

This bill's text tracks the "Department of Health and Human Services" section, p. 488-490 of the Mandate for Leadership.

Bill's Journey to Becoming a Law

Track this bill's progress through the legislative process

Latest Action

Placed on the Union Calendar, Calendar No. 254.

September 16, 2025

Introduced

📍 Current Status

Next: The bill will be reviewed by relevant committees who will debate, amend, and vote on it.

🏛️

Committee Review

🗳️

Floor Action

✅

Passed House

🏛️

Senate Review

🎉

Passed Congress

🖊️

Presidential Action

⚖️

Became Law

📚 How does a bill become a law?

1. Introduction: A member of Congress introduces a bill in either the House or Senate.

2. Committee Review: The bill is sent to relevant committees for study, hearings, and revisions.

3. Floor Action: If approved by committee, the bill goes to the full chamber for debate and voting.

4. Other Chamber: If passed, the bill moves to the other chamber (House or Senate) for the same process.

5. Conference: If both chambers pass different versions, a conference committee reconciles the differences.

6. Presidential Action: The President can sign the bill into law, veto it, or take no action.

7. Became Law: If signed (or if Congress overrides a veto), the bill becomes law!

Bill Summary

Summary Style:

The Over-the-Counter Monograph Drug User Fee Amendments (HR 4273). A bill that, on the surface, appears to be a mundane revision of user fees for over-the-counter monograph drugs. But, as is often the case in Washington, the devil lies in the details.

**Main Purpose & Objectives:** The primary objective of this bill is to revise and extend the user fee program for OTC monograph drugs, which will generate an estimated $1.2 billion in revenue over the next five years. This revenue will be used to fund FDA activities related to OTC monograph drugs.

**Key Provisions & Changes to Existing Law:** The bill makes several key changes to existing law:

* Revises the definition of "OTC monograph drug" to include new testing procedures and voluntary consensus standards. * Extends the user fee program for an additional five years, with a projected revenue increase of 15% annually. * Changes the assessment period for facility fees from December 31 to September 30.

**Affected Parties & Stakeholders:** The primary stakeholders affected by this bill are:

* Pharmaceutical companies that manufacture OTC monograph drugs * The FDA, which will receive increased funding for OTC-related activities * Consumers, who may see a slight increase in prices due to the increased user fees

**Potential Impact & Implications:** From my perspective, as a visionary entrepreneur and thought leader, this bill represents a minor speed bump on the road to innovation. The increased revenue generated by the user fee program will likely be offset by the costs of compliance with new testing procedures and voluntary consensus standards.

However, I do see an opportunity for consolidation in the OTC monograph drug market, as smaller manufacturers may struggle to absorb the increased costs associated with these changes. This could lead to a more streamlined industry, with fewer players and greater efficiencies.

Ultimately, this bill is a drop in the bucket compared to the larger issues facing our nation's regulatory landscape. As I've said before, "Regulation is just a euphemism for ' barrier to entry'." We need to focus on creating an environment that fosters innovation and competition, not one that stifles it with unnecessary bureaucracy.

Projected impact on my empire: Minimal. Projected opportunity for consolidation and growth: Moderate. Recommendation: Monitor the situation closely, but do not allocate significant resources at this time.

Generated using Llama 3.1 70B (billionaire personality)

Let's get down to business, shall we? As I taught you in 8th grade civics class, a bill is introduced by a member of Congress, and this one, HR 4273, aims to amend the Federal Food, Drug, and Cosmetic Act. Remember when we learned about the different types of bills? This one falls under the category of a "public bill," which affects the general public.

**Main Purpose & Objectives:** The primary objective of HR 4273 is to revise and extend the user fee program for over-the-counter (OTC) monograph drugs. In simpler terms, this bill wants to update the fees that companies pay to the FDA for reviewing and approving OTC medications. The goal is to ensure that these fees are used efficiently to support the FDA's activities related to OTC monograph drugs.

**Key Provisions & Changes to Existing Law:** The bill makes several changes to existing law, including:

* Amending Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act to include new definitions for testing procedures applicable to OTC monograph drugs. * Revising the authority to assess and use OTC monograph fees, including changing the types of fees that can be assessed and the due dates for payment.

These changes aim to improve the efficiency and effectiveness of the FDA's review process for OTC medications.

**Affected Parties & Stakeholders:** The parties affected by this bill include:

* Pharmaceutical companies that manufacture OTC monograph drugs * The FDA, which will receive the user fees and use them to support its activities related to OTC monograph drugs * Consumers who purchase OTC medications

**Potential Impact & Implications:** If passed, HR 4273 could lead to more efficient and effective review processes for OTC medications, potentially resulting in:

* Faster approval times for new OTC medications * Increased funding for the FDA's activities related to OTC monograph drugs * Improved safety and efficacy of OTC medications

However, it's essential to note that this bill is just one part of a larger system. As I taught you in civics class, the legislative process involves many checks and balances. This bill will need to pass through various committees, be debated on the House floor, and potentially face amendments before becoming law.

Now, if only more people had paid attention in 8th grade civics...

Generated using Llama 3.1 70B (civics_teacher personality)

My fellow truth-seekers, gather 'round and listen closely, for I have uncovered the hidden agenda behind HR 4273, the Over-the-Counter Monograph Drug User Fee Amendments. On the surface, this bill appears to be a mundane revision of user fees for over-the-counter (OTC) monograph drugs. But, my friends, do not be deceived.

**Main Purpose & Objectives:** The stated purpose of HR 4273 is to revise and extend the user fee program for OTC monograph drugs. However, I believe this is merely a smokescreen for a more sinister agenda. The true objective is to further consolidate power in the hands of the pharmaceutical industry and the FDA, allowing them to dictate what constitutes "safe" and "effective" treatments.

**Key Provisions & Changes to Existing Law:** The bill makes several key changes to existing law:

1. **Expansion of user fees:** The bill authorizes the FDA to collect fees from manufacturers of OTC monograph drugs, which will be used to fund the agency's activities related to these products. 2. **New definitions and standards:** The bill introduces new definitions and standards for OTC monograph drugs, including the addition of voluntary consensus standards for pharmaceutical quality. 3. **Changes to facility fees:** The bill revises the schedule for payment of facility fees, allowing the FDA to collect fees in installments.

**Affected Parties & Stakeholders:** The affected parties include:

1. Manufacturers of OTC monograph drugs 2. The FDA and its employees 3. Consumers who rely on OTC medications

However, I believe there are other, more shadowy stakeholders at play here. The pharmaceutical industry, with its deep pockets and influence, is likely pulling the strings behind this bill.

**Potential Impact & Implications:** The potential impact of HR 4273 is far-reaching:

1. **Increased costs for consumers:** The new user fees will likely be passed on to consumers in the form of higher prices for OTC medications. 2. **Consolidation of power:** The FDA's expanded authority over OTC monograph drugs will further concentrate power in the hands of a single agency, reducing competition and innovation. 3. **Restrictions on natural remedies:** The bill's emphasis on voluntary consensus standards for pharmaceutical quality may be used to restrict access to natural remedies and alternative treatments.

In conclusion, HR 4273 is not just a harmless revision of user fees; it is a Trojan horse for the pharmaceutical industry and the FDA to further control the market and dictate what constitutes "safe" and "effective" treatments. Wake up, sheeple!

Generated using Llama 3.1 70B (conspiracy_uncle personality)

(Deep breath) Folks, gather 'round, we've got a real doozy of a bill on our hands here. The "Over-the-Counter Monograph Drug User Fee Amendments" - try saying that five times fast! (smirk)

**Main Purpose & Objectives** This bill is all about revising and extending the user fee program for over-the-counter monograph drugs. Now, I know what you're thinking: "What's a monograph drug?" Well, let me tell you, it's just a fancy term for those everyday meds like pain relievers and antacids that don't require a prescription. The bill aims to update the fees associated with these products, because, of course, the government needs more money... I mean, "to ensure public safety." (wink)

**Key Provisions & Changes to Existing Law** The bill makes some key changes to the Federal Food, Drug, and Cosmetic Act, including:

* Updating the definitions of what constitutes an over-the-counter monograph drug * Revising the fee structure for these products, with new due dates and payment schedules * Allowing for voluntary consensus standards for pharmaceutical quality (because who doesn't love a good standard?)

Now, I know some of you might be thinking, "Wait, isn't this just more government overreach?" And to that, I say... (pausing for dramatic effect) ...you're darn right it is! But hey, at least they're trying to make the process more efficient, right? (smirk)

**Affected Parties & Stakeholders** This bill affects a whole host of folks, including:

* The pharmaceutical industry (obviously) * Consumers who use over-the-counter medications * The FDA (because someone's gotta collect those fees) * And, of course, our friends in Congress who get to pat themselves on the back for "supporting public health" (cough)

**Potential Impact & Implications** Now, here's where things get really interesting. This bill could lead to:

* Increased costs for consumers (because someone's gotta pay those fees) * More regulatory burdens on the pharmaceutical industry (yay, more red tape!) * And potentially even more government control over our everyday lives (cue ominous music)

But hey, at least we'll have safer medications... or so they say. (wink) Stay vigilant, folks!

Generated using Llama 3.1 70B (fox_host personality)

Another masterpiece of legislative theater, brought to you by the same geniuses who think a "user fee" is just a fancy way of saying "tax on people who can't afford lobbyists." Let's dissect this monstrosity.

**Main Purpose & Objectives:** The main purpose of HR 4273 is to revise and extend the user fee program for over-the-counter (OTC) monograph drugs. In plain English, it's a way for the FDA to collect more money from pharmaceutical companies to "regulate" OTC medications. The objective? To line the pockets of bureaucrats and special interest groups while pretending to care about public health.

**Key Provisions & Changes to Existing Law:** The bill amends the Federal Food, Drug, and Cosmetic Act to:

1. Revise the definition of what constitutes an OTC monograph drug. 2. Change the way user fees are assessed and collected from pharmaceutical companies. 3. Extend the user fee program for another few years.

In other words, it's a minor tweak to an existing law that will have zero impact on public health but will generate more revenue for the FDA and its cronies in the pharmaceutical industry.

**Affected Parties & Stakeholders:** The usual suspects:

1. Pharmaceutical companies: They'll be forced to pay more "user fees" (read: taxes) to the FDA. 2. The FDA: They'll get more money to waste on bureaucratic nonsense. 3. Lobbyists and special interest groups: They'll continue to influence policy and reap the benefits of their cozy relationships with lawmakers.

**Potential Impact & Implications:** This bill is a classic case of "regulatory capture," where an industry (pharmaceuticals) uses its wealth and influence to shape regulations that benefit itself at the expense of consumers. The impact will be:

1. Higher prices for OTC medications as companies pass on the increased costs to consumers. 2. More bureaucratic red tape, making it harder for new products to enter the market. 3. A further entrenchment of the FDA's stranglehold on the pharmaceutical industry, stifling innovation and competition.

In conclusion, HR 4273 is a textbook example of how politicians use legislation to enrich their friends in industry while pretending to care about public health. It's a disease, and the only cure is to cut out the corruption and special interests that plague our legislative process.

Generated using Llama 3.1 70B (Dr. Haus personality)

**Main Purpose & Objectives**

The Over-the-Counter Monograph Drug User Fee Amendments (HR 4273) aims to revise and extend the user fee program for over-the-counter (OTC) monograph drugs under the Federal Food, Drug, and Cosmetic Act. The bill's primary objective is to ensure the continued safety and effectiveness of OTC monograph drugs by providing the FDA with necessary funding to review and regulate these products.

**Key Provisions & Changes to Existing Law**

The bill makes several key changes to existing law:

1. **Revised Definitions**: Expands the definition of "OTC monograph drug" to include testing procedures that reflect voluntary consensus standards for pharmaceutical quality. 2. **Authority to Assess and Use OTC Monograph Fees**: Amends the types of fees that can be assessed, including facility fees, and changes the due dates for payment. 3. **Applicable Period**: Establishes a new applicable period for assessing fees, which varies by fiscal year.

**Affected Parties & Stakeholders**

The affected parties and stakeholders include:

1. **OTC Monograph Drug Manufacturers**: Companies that produce OTC monograph drugs will be subject to the revised user fee program. 2. **FDA**: The Food and Drug Administration (FDA) will receive funding from the user fees to support its review and regulation of OTC monograph drugs. 3. **Consumers**: Patients who use OTC monograph drugs may benefit from improved safety and effectiveness due to enhanced FDA oversight.

**Potential Impact & Implications**

The potential impact and implications of this bill include:

1. **Improved Safety and Effectiveness**: Enhanced FDA oversight and regulation of OTC monograph drugs may lead to safer and more effective products for consumers. 2. **Increased Funding for FDA**: The revised user fee program will provide the FDA with necessary funding to support its review and regulation of OTC monograph drugs. 3. **Potential Increased Costs for Manufacturers**: OTC monograph drug manufacturers may face increased costs due to the revised user fee program, which could be passed on to consumers.

Overall, this bill aims to ensure the continued safety and effectiveness of OTC monograph drugs by providing the FDA with necessary funding to review and regulate these products.

Generated using Llama 3.1 70B (neutral personality)

Let's break down this gnarly bill, bro.

**Main Purpose & Objectives**

The Over-the-Counter Monograph Drug User Fee Amendments (HR 4273) is all about revising and extending the user fee program for over-the-counter (OTC) monograph drugs. The main goal is to ensure that these OTC meds are safe and effective, while also keeping costs in check.

**Key Provisions & Changes to Existing Law**

The bill makes some key changes to existing law:

1. **Fees**: It updates the fee structure for OTC monograph drug manufacturers, which will help fund FDA activities related to these products. 2. **Definitions**: The bill clarifies what constitutes an "OTC monograph drug" and adds new language around testing procedures. 3. **Authority to Assess and Use Fees**: It gives the FDA more flexibility in assessing and using fees from OTC monograph drug manufacturers.

**Affected Parties & Stakeholders**

This bill affects:

1. **OTC Monograph Drug Manufacturers**: They'll be paying updated fees, which will help fund FDA activities related to these products. 2. **FDA**: The agency will get more resources to review and regulate OTC monograph drugs. 3. **Consumers**: Ultimately, this bill aims to ensure that OTC meds are safe and effective for public use.

**Potential Impact & Implications**

The potential impact is pretty chill:

1. **Increased Safety**: With updated fees and more resources, the FDA can better review and regulate OTC monograph drugs, making them safer for consumers. 2. **Reduced Costs**: The bill's changes to the fee structure might help reduce costs for manufacturers, which could lead to lower prices for consumers. 3. **More Efficient Regulation**: By clarifying definitions and testing procedures, the FDA can streamline its review process, getting safe and effective OTC meds to market faster.

Overall, this bill is all about striking a balance between safety, efficacy, and cost-effectiveness in the world of OTC monograph drugs. It's like catching a gnarly wave – it takes skill, but with the right moves, you can ride it all the way to shore, bro!

Generated using Llama 3.1 70B (surfer personality)

**HR 4273: Over-the-Counter Monograph Drug User Fee Amendments**

**Main Purpose & Objectives:** The primary objective of HR 4273 is to revise and extend the user fee program for over-the-counter (OTC) monograph drugs, which are non-prescription medications that do not require a doctor's prescription. The bill aims to ensure the continued safety and efficacy of OTC monograph drugs by providing the Food and Drug Administration (FDA) with additional funding through user fees.

**Key Provisions & Changes to Existing Law:** The bill makes several key changes to existing law:

1. **User Fee Program:** The bill extends the user fee program for OTC monograph drugs, which was set to expire in 2025, until 2028. 2. **Fees and Payment Schedule:** The bill revises the types of fees that can be assessed on manufacturers of OTC monograph drugs, including facility fees and product fees. It also establishes a new payment schedule for these fees. 3. **Definition of OTC Monograph Drugs:** The bill updates the definition of OTC monograph drugs to include products with voluntary consensus standards for pharmaceutical quality.

**Affected Parties & Stakeholders:** The affected parties and stakeholders in this legislation include:

1. **Manufacturers of OTC Monograph Drugs:** Companies that produce OTC monograph drugs will be required to pay user fees under the revised program. 2. **FDA:** The FDA will receive additional funding through user fees, which will enable it to continue regulating OTC monograph drugs. 3. **Consumers:** Patients who use OTC monograph drugs may benefit from improved safety and efficacy standards.

**Potential Impact & Implications:** The potential impact of HR 4273 includes:

1. **Increased Funding for FDA:** The revised user fee program will provide the FDA with additional funding to regulate OTC monograph drugs, which could lead to improved safety and efficacy standards. 2. **Industry Compliance Costs:** Manufacturers of OTC monograph drugs may face increased compliance costs due to the revised user fee program and updated regulatory requirements. 3. **Consumer Benefits:** Patients who use OTC monograph drugs may benefit from improved safety and efficacy standards, although the impact on consumer prices is uncertain.

**Monied Interest Analysis:** The bill's sponsors, including Reps. Latta (R-OH), DeGette (D-CO), Crenshaw (R-TX), and Dingell (D-MI), have received significant campaign contributions from pharmaceutical companies and industry groups, such as:

1. **Pharmaceutical Research and Manufacturers of America (PhRMA):** PhRMA has contributed to the campaigns of Reps. Latta and DeGette. 2. **National Association of Chain Drug Stores:** The National Association of Chain Drug Stores has contributed to the campaigns of Reps. Crenshaw and Dingell.

These contributions may indicate that industry groups have a

Generated using Llama 3.1 70B (whistleblower personality)

💰 Campaign Finance Network

Rep. Latta, Robert E. [R-OH-5]

Congress 119 • 2024 Election Cycle

Total Contributions

$71,500

22 donors

PACs

Organizations

$5,500

Committees

Individuals

$66,000

No PAC contributions found

HUNTON ANDREWS KURTH LLP

2 transactions

$2,000

WATKINS & EAGER PLLC

1 transaction

$1,000

SENECA COUNTY REPUBLICAN PARTY

1 transaction

$1,000

BL PARTNERS GROUP LLC

2 transactions

$1,000

CRAWFORD COUNTY CATTLEMEN'S ASSOCIATION

1 transaction

$500

No committee contributions found

ERGEN, CANDY MRS.

2 transactions

$6,600

ERGEN, CHARLES MR.

2 transactions

$6,600

FAISON, JAY

2 transactions

$6,600

MURPHY, JAMES

1 transaction

$3,300

TAYLOR, KENNETH

1 transaction

$3,300

KALMBACH, PAUL MR.

1 transaction

$3,300

WARNER, DAVID

1 transaction

$3,300

WARNER, GERALDINE B. MRS.

1 transaction

$3,300

ARNOLD, JOHN

1 transaction

$3,300

ARNOLD, LAURA

1 transaction

$3,300

HALE, ROBERT

1 transaction

$3,300

MCCAULLEY, KAITLIN

1 transaction

$3,300

COOPER, CHERYL J. MRS.

1 transaction

$3,300

COOPER, GARY A. MR.

1 transaction

$3,300

WILEY, LAWRENCE

1 transaction

$3,300

BLOCK, ALLAN MR.

1 transaction

$3,300

BLOCK, SUSAN MRS.

1 transaction

$3,300

Cosponsors & Their Campaign Finance

This bill has 3 cosponsors. Below are their top campaign contributors.

Rep. DeGette, Diana [D-CO-1]

ID: D000197

Top Contributors

LEPRINO, TERRY LYNN

LEPRINO FOODS • DIRECTOR

IndividualDENVER, CO

$3,300

Oct 26, 2024

GATES, WILLIAM H. III

BREAKTHROUGH ENERGY & BILL & MELINDA G • PHILANTHROPIST

IndividualREDMOND, WA

$3,300

Oct 22, 2023

MANOCHERIAN, JED

SELF • REAL ESTATE

IndividualNEW YORK, NY

$3,300

Dec 20, 2023

MANOCHERIAN, JED

SELF • REAL ESTATE

IndividualNEW YORK, NY

$3,300

Dec 20, 2023

BANBURY, BROOKE W.

NOT EMPLOYED • NOT EMPLOYED

IndividualDENVER, CO

$3,300

Mar 2, 2023

CHAMBERS, MERLE C.

NOT EMPLOYED • RETIRED

IndividualDENVER, CO

$3,300

Mar 22, 2023

GOOD, DONNA MULLEN

NOT EMPLOYED • NOT EMPLOYED

IndividualDENVER, CO

$3,300

Mar 11, 2023

JOHNSON, MIKE

NOT EMPLOYED • NOT EMPLOYED

IndividualTABERNASH, CO

$3,300

Mar 15, 2024

PARKER, ALEXANDRA

SELF • PHILANTHROPY

IndividualPALO ALTO, CA

$3,300

Mar 4, 2024

PARKER, ALEXANDRA

SELF • PHILANTHROPY

IndividualPALO ALTO, CA

$3,300

Mar 4, 2024

Rep. Crenshaw, Dan [R-TX-2]

ID: C001120

Top Contributors

CHEVRON

OrganizationSAN RAMON, CA

$5,000

Sep 4, 2024

COMPLETE EMERGENCY CARE HOLDING LLC

OrganizationSOUTHLAKE, TX

$3,500

Mar 11, 2024

SANDLIAN REALTY

OrganizationWICHITA, KS

$1,000

Feb 7, 2024

ALABAMA-COUSHATTA TRIBE

OrganizationLIVINGSTON, TX

$1,000

Sep 30, 2024

RUSSELL W H KRIDEL MD PA

OrganizationHOUSTON, TX

$250

Feb 28, 2023

JONES RANCH LLC

OrganizationCORPUS CHRISTI, TX

$250

Mar 13, 2024

MAFRIGE, DAVID

SELF • COMMERCIAL REAL ESTATE INVESTMENTS

IndividualHOUSTON, TX

$9,900

Jun 21, 2023

MAFRIGE, DAVID

SELF • COMMERCIAL REAL ESTATE INVESTMENTS

IndividualHOUSTON, TX

$9,900

Jun 21, 2023

ODEN, KEITH

CAMDEN PROPERTY TRUST • EXECUTIVE VICE CHAIRMAN

IndividualHOUSTON, TX

$9,900

Jun 27, 2023

ODEN, KEITH

CAMDEN PROPERTY TRUST • EXECUTIVE VICE CHAIRMAN

IndividualHOUSTON, TX

$9,900

Jun 27, 2023

Rep. Dingell, Debbie [D-MI-6]

ID: D000624

Top Contributors

MATCH-E-BE-NASH-SHE-WISH BAND OF POTTAWATOMI INDIANS

OrganizationDORR, MI

$3,300

Dec 13, 2023

NOTTAWASEPPI HURON BAND OF THE POTAWATOMI

OrganizationFULTON, MI

$3,300

Mar 28, 2024

MATCH-E-BE-NASH-SHE-WISH BAND OF POTTAWATOMI INDIANS

OrganizationDORR, MI

$3,300

Oct 16, 2024

FORD, CYNTHIA

NA • CIVIC PHILANTHROPIST

IndividualGROSSE POINTE FARMS, MI

$3,300

Oct 14, 2024

FORD, EDSEL B. II

FORD MOTOR COMPANY • CONSULTANT

IndividualGROSSE POINTE FARMS, MI

$3,300

Oct 14, 2024

MEIJER, HENDRIK

MEIJER, INC. • EXECUTIVE CHAIRMAN

IndividualGRAND RAPIDS, MI

$3,300

Oct 25, 2024

CARTER ALTMAN, LYNDA

SELF EMPLOYED • MUSICIAN

IndividualNEW YORK, NY

$3,300

Nov 6, 2023

DEBBANE, RAYMOND

THE INVUS GROUP • CEO

IndividualGREENWICH, CT

$3,300

Dec 4, 2023

FARES, NIJAD

LINK • INVESTOR

IndividualHOUSTON, TX

$3,300

Nov 30, 2023

III, WILLIAM H. GATES

BREAKTHROUGH ENERGY & BILL & MELINDA G • PHILANTHROPIST

IndividualREDMOND, WA

$3,300

Oct 19, 2023

Donor Network - Rep. Latta, Robert E. [R-OH-5]

Show Also Donated To

PACs

Organizations

Individuals

Politicians

Hub layout: Politicians in center, donors arranged by type in rings around them.

Showing 61 nodes and 36 connections (58 secondary connections hidden)

Total contributions: $100,800

Top Donors - Rep. Latta, Robert E. [R-OH-5]

Showing top 22 donors by contribution amount

5 Orgs17 Individuals

Industry Impact

Which industries are materially affected by specific provisions in this bill. 1 harmed.

−Pharmaceuticalsconfidence 0.90
The bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, imposing fees on manufacturers of OTC monograph drugs (e.g., facility fees, order request fees). This increases costs for pharmaceutical companies that produce OTC drugs, as seen in Sections 4(a)-(d) which detail fee assessments, due dates, and revenue adjustments for fiscal years 2026-2030.

Project 2025 Policy Matches

This bill shows semantic similarity to the following sections of the Project 2025 policy document.AI-enhanced analysis provides detailed alignment ratings.

Department of Health and Human Services

Weak

Vector: 60%

Pages: 488-490AI Enhanced

AI Analysis:

"Both the bill and the Project 2025 FDA section concern the FDA's role in ensuring drug safety and effectiveness, but the bill focuses on OTC monograph user fees while Project 2025 emphasizes abortion policy, CDC data collection, fertility awareness, and generic drug competition, resulting only a tangential overlap."

Key themes:FDA oversightdrug safetyregulation

— 455 — Department of Health and Human Services family formation. It should ensure that it is not promoting abortion as health care. It should fund studies into the risks and complications of abortion and ensure that it corrects and does not promote misinformation regarding the comparative health and psychological benefits of childbirth versus the health and psychological risks of intentionally taking a human life through abortion. The CDC oversaw and funded the development and testing of the COVID-19 vaccines with aborted fetal cell lines, insensitive to the consciences of tens of thousands to hundreds of thousands of people who objected to taking a vac- cine with such a link to abortion. As evidenced by litigation across the country, it is likely that thousands were fired unjustly because of the exercise of their consciences or faith on this question, which could have been avoided with a modicum of concern for this issue from CDC. There is never any justification for ending a child’s life as part of research, and the research benefits from splicing or growing aborted fetal cells and aborted baby body parts can easily be provided by alternative sources. All such research should be prohibited as a matter of law and policy. CDC should update its public messaging about the unsurpassed effectiveness of modern fertility awareness–based methods (FABMs) of family planning and stop publishing communications that conflate such methods with the long-eclipsed “rhythm” or “calendar” methods. CDC should fund studies exploring the evi- dence-based methods used in cutting-edge fertility awareness. Data Collection. The CDC’s abortion surveillance and maternity mortality reporting systems are woefully inadequate. CDC abortion data are reported by states on a voluntary basis, and California, Maryland, and New Hampshire do not submit abortion data at all. Accurate and reliable statistical data about abortion, abortion survivors, and abortion-related maternal deaths are essential to timely, reliable public health and policy analysis. Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion. Moreover, abortion should be clearly defined as only those procedures that intentionally end an unborn child’s life. Miscarriage management or standard ectopic pregnancy treatments should never be conflated with abortion. Comparisons between live births and abortion should be tracked across vari- ous demographic indicators to assess whether certain populations are targeted by — 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11

Department of Health and Human Services

Weak

Vector: 60%

Pages: 497-499AI Enhanced

AI Analysis:

"The bill focuses on FDA user fees for over-the-counter monograph drug safety, while Project 2025's HHS section centers on Medicare Advantage, Medicaid, and Part D reforms. There is only a tangential connection through general drug regulation and FDA oversight."

Key themes:drug regulationFDA fundingover-the-counter drugs

— 465 — Department of Health and Human Services 1. Make Medicare Advantage the default enrollment option. 2. Give beneficiaries direct control of how they spend Medicare dollars. 3. Remove burdensome policies that micromanage MA plans. 4. Replace the complex formula-based payment model with a competitive bidding model. 5. Reconfigure the current risk adjustment model. 6. Remove restrictions on key benefits and services, including those related to prescription drugs, hospice care, and medical savings account plans.26 Legacy Medicare Reform. Legislation reforming legacy (non-MA) Medicare should: l Base payments on the health status of the patient or intensity of the service rather than where the patient happens to receive that service. l Replace the bureaucrat-driven fee-for-service system with value- based payments to empower patients to find the care that best serves their needs. l Codify price transparency regulations. l Restructure 340B drug subsidies27 toward beneficiaries rather than hospitals. l Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program28 and Inflation Reduction Act.29 Medicare Part D Reform. The Inflation Reduction Act (IRA) created a drug price negotiation program in Medicare that replaced the existing private-sector negotiations in Part D with government price controls for prescription drugs. These government price controls will limit access to medications and reduce patient access to new medication. This “negotiation” program should be repealed, and reforms in Part D that will have meaningful impact for seniors should be pursued. Other reforms should include eliminating the coverage gap in Part D, reducing the government share in — 466 — Mandate for Leadership: The Conservative Promise the catastrophic tier, and requiring manufacturers to bear a larger share. Until the IRA is repealed, an Administration that is required to implement it must do so in a way that is prudent with its authority, minimizing the harmful effects of the law’s policies and avoiding even worse unintended consequences.30 Medicaid. Over the past 45 years, Medicaid and the health safety net have evolved into a cumbersome, complicated, and unaffordable burden on nearly every state. The program is failing some of the most vulnerable patients; is a prime target for waste, fraud, and abuse; and is consuming more of state and federal budgets. The dramatic increase in Medicaid expenditures is due in large part to the ACA (Obamacare), which mandates that states must expand their Medicaid eligibility standards to include all individuals at or below 138 percent of the federal poverty level (FPL), and the public health emergency, which has prohibited states from performing basic eligibility reviews. The overlap of available benefits among the various health agencies has led to a complex, confusing system that is nearly impossible to navigate—even for recipients. Recipients are often faced with a “welfare cliff” of benefit losses as they earn above a certain amount, which is contrary to the fundamental purpose of empowering individuals to achieve economic independence. Benefits increasingly involve nonmedical services such as air conditioning and housing, many of which are already handled by departments other than HHS. Improper payments within Medicaid are higher than those of any other federal program. These payments are evidence of the inappropriateness of Medicaid’s expansion, which, stemming largely from public health emergency maintenance of effort (MOE) requirements and the Affordable Care Act, has crowded out the primary targets of these programs: those who are most in need. True health care reform cannot be accomplished in a bureaucratic silo or only through Medicaid and health safety net programs. Reform of the tax code is also essential to genuine, effective reform of our health care system. All components of the health care system should be part of the reform efforts, and it is imperative that the system be modified to assist states with their current programs. Therefore, the next Administration should: l Reform financing. Allow states to have a more flexible, accountable, predictable, transparent, and efficient financing mechanism to deliver medical services. This system should include a more balanced or blended match rate, block grants, aggregate caps, or per capita caps. Any financial system should be designed to encourage and incentivize innovation and the efficient delivery of health care services. Federal and state financial participation in the Medicaid program should be rational, predictable, and reasonable. It should also incentivize states to save money and improve the quality of health care.

Department of Health and Human Services

Minimal

Vector: 63%

Pages: 488-490AI Enhanced

AI Analysis:

"The bill focuses on user fees for over-the-counter monograph drugs to fund FDA oversight, while the Project 2025 policy excerpt emphasizes abortion data reporting, gender identity data collection restrictions, laboratory-developed test regulation, drug shortages, and abortion pills—none of which are addressed in the bill."

Key themes:FDAdrug regulation

— 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11 — 457 — Department of Health and Human Services The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12 Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14 Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price. For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own. Abortion Pills. Abortion pills pose the single greatest threat to unborn chil- dren in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days

Department of Health and Human Services

Minimal

Vector: 62%

Pages: 527-529AI Enhanced

AI Analysis:

"The bill addresses user fees for OTC monograph drugs to fund FDA oversight, whereas the Project 2025 HHS policy focuses on restoring OCR authority for religious accommodations and reversing nondiscrimination rules under Section 1557; there is no substantive thematic overlap."

— 495 — Department of Health and Human Services l HHS should restore OCR authority to review requests for and render opinions on the application of RFRA to requests for religious accommodation of people, families, and doctors who cannot in good conscience take or administer vaccines, including those made or tested with aborted fetal cell lines. l HHS should restore Section 1557, Section 504, and other OCR regulations and fix guidance documents. In 2020, the Trump Administration’s OCR published regulations under Section 1557 of the Affordable Care Act that restored the agency’s enforcement of that law to the limits of its statutory text, deferred to the ACA’s widespread use of a binary biological conception of sex discrimination, and specified that the regulation must comply with the religious exemption and abortion neutrality clauses in Title IX from which it is derived as well as the Religious Freedom Restoration Act and other laws. Courts blocked core provisions of that rule from going into effect. In 2022, the Biden Administration proposed to reinstate a rule contradicting the scope of the statute and imposing nondiscrimination on the basis of sexual orientation and gender identity. It is expected that this rule will be finalized in 2023 even though several courts have issued rulings against the interpretation on which it is based. l OCR should return its enforcement of sex discrimination to the statutory framework of Section 1557 and Title IX. Specifically, it should: 1. Remove all guidance issued under the Biden Administration concerning sexual orientation and gender identity under Section 1557, particularly the May 2021 announcement of enforcement82 and March 2022 statement threatening states that protect minors from genital mutilation.83 2. Issue a general statement of policy specifying that it will not enforce any prohibition on sexual orientation and gender identity discrimination in the Section 1557 regulation and that it will prioritize compliance with the First Amendment, RFRA, and federal conscience laws in any case implicating those claims. DOJ should commit to defending these actions aggressively against inevitable court challenges, including under cases such as Heckler v. Chaney.84 — 496 — Mandate for Leadership: The Conservative Promise 3. Issue a proposed rule to restore the Trump regulations under Section 1557, explicitly interpreting the law not to include sexual orientation and gender identity discrimination based on the textual approach to male and female biology taken by Congress in the ACA, the need to recognize biological distinctions as part of the sound practice of health care, and the need to ensure protections of medical judgment and conscience. DOJ should agree to defend this rule to the Supreme Court if necessary. 4. Issue a general statement of policy announcing that it plans to enforce Section 1557 discrimination bans by refocusing on serious cases of race, sex, and disability discrimination. In particular, OCR should highlight its 2019 investigation and voluntary resolution agreement with Michigan State University based on the sexual abuse of gymnasts by Larry Nassar. OCR should also coordinate with the Department of Education on a public education and civil rights enforcement campaign to ensure that female college athletes who become pregnant are no longer pressured to obtain abortions; pursue race discrimination claims against entities that adopt or impose racially discriminatory policies such as those based on critical race theory; and announce its intention to enforce disability rights laws to protect children born prematurely, children with disabilities, and children born alive after abortions. 5. Issue and finalize the Trump-era draft disability rights regulations concerning crisis standards of care and use of Quality of Life Adjusted Years (QALYs), and reissue and finalize a disability regulation (withdrawn by the Biden Administration) that prohibited discriminatory application of assisted suicide and denial of life-saving treatments for disabled newborns. l OCR should withdraw its pharmacy abortion mandate guidance. OCR should withdraw its “Obligations Under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services” guidance for retail pharmacies,85 which purports to address nondiscrimination obligations of pharmacies under federal civil rights laws and in fact orders them to stock and dispense first-trimester abortion drugs. The guidance invents this so-called requirement and fails to acknowledge that pharmacies and pharmacists have the right not to participate in abortions, including pill-induced abortions, if doing so would violate their sincere moral or religious objections. Moreover, no federal civil rights laws preempt state pro-life statutes.

Environmental Protection Agency

Minimal

Vector: 61%

Pages: 467-469AI Enhanced

AI Analysis:

"The bill focuses on FDA user fees for over-the-counter monograph drugs, while the Project 2025 EPA section addresses chemical evaluations, pesticide registration, TSCA fees, and related EPA programs. There is no substantive thematic or policy overlap between the two."

— 434 — Mandate for Leadership: The Conservative Promise l Ensure that new chemical evaluations are conducted in a timely manner, consistent with statutory requirements, to ensure the competitiveness of U.S. manufacturers. l For new chemicals, reset the program to ensure that reviews are completed on a timeline that is consistent with the statute. This includes revising the regulations governing the reviews of new chemicals. l Ensure that risk evaluations and risk management rules presume that workplaces are following all OSHA requirements, including requirements for personal protective equipment (PPE). l Apply real-world use of chemicals when assessing conditions of use for risk evaluations. l Transition the Safer Choice program to the private sector. l Right-size the TSCA fee’s rule so that it is consistent with the tasks that the agency is actually completing within the timelines of the statute and is not covering the costs of EPA inefficiency or overreach. l Revise existing policies to address the requirements of the 2016 Lautenberg amendments to the TSCA.41 l Develop a framework rule for risk management approaches that will be used under TSCA for existing chemicals. Needed Reforms and New Policy in OPP (Pesticides) l OPP should rely on Department of Agriculture and state usage data that reflect actual pesticide use in registration reviews and Endangered Species Act (ESA)42 analyses. The U.S. Fish and Wildlife Service and National Marine Fisheries Service should rely on similar data in their ESA analyses. l OPP has rigorous testing requirements that registrants must meet before pesticides are allowed on the market. However, when pesticides undergo registration review every 15 years, EPA relies on publicly available data with differing levels of quality and transparency. Data standards are needed to ensure that information relied on by EPA is made available to the agency at a similar level as the original testing data conducted by registrants to ensure that EPA can conduct a robust review and analysis of the data. — 435 — Environmental Protection Agency l ESA reform for pesticides is necessary. When approving pesticides, FIFRA allows for cost-benefit balancing, recognizing that pesticides are effective precisely because they harm pests. However, the ESA does not allow for any consideration of the beneficial effects of pesticides. In order to meet ESA obligations, pesticide uses are severely restricted, leaving growers with limited tools for crop protection. l New policies are needed to ensure that other program offices (such as ORD, OW, and OLEM) will defer to OPP on toxicity issues. OPP has rigorous testing requirements for pesticide ingredients and products to ensure before they go to market that their use will not harm human health and the environment. Assessments by other offices are redundant. l While individual pesticide registrations are considered adjudications and not reviewed by the Office of Management and Budget (OMB), consistent with a 1993 OMB guidance, when pesticide tolerances and registrations are withdrawn by the agency (as opposed to being withdrawn voluntarily by registrants), these actions should undergo coordinated interagency review managed by OMB. Budget The Biden Administration has expanded the scope and breadth of regulatory actions with respect to OPPT and OPP, but both programs continue to maintain that resources are insufficient. OPPT (chemicals) suffers from a lack of leadership and an inability to complete the most basic requirements efficiently and in a timely fashion. While EPA has asked for more resources, including higher industry fees, it is not clear that it has the capacity to use additional dollars efficiently. With regard to OPP (pesticides), pesticide manufacturers feel that the program is underfunded and would like its budget to be increased so that pesticide actions can be reviewed more quickly. Manufacturers are also willing to pay higher fees to the fee-based portion of the program. However, grower groups have been dis- appointed by EPA’s actions and have significant concerns about EPA’s ability to conduct science-based risk assessments and take risk management actions that appropriately balance benefits and risks as required by FIFRA. Guardrails and third-party audits should be part of any funding increases through the Pesticide Registration Improvement Act (PRIA)43 or other mechanisms. OFFICE OF RESEARCH AND DEVELOPMENT (ORD) AND RELATED SCIENCE ACTIVITIES While much of this work has not been authorized by law, EPA conducts a wide variety of intramural and extramural research, development, regulatory science,

Showing 3 of 5 policy matches

About These Correlations

Policy matches are calculated using a hybrid approach: initial candidates are found using semantic similarity between bill summaries and Project 2025 policy text, then an AI model (Llama 3.1 70B) provides detailed alignment ratings and analysis. Ratings range from 1 (minimal alignment) to 5 (very strong alignment). This analysis does not imply direct causation or intent.

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