Fight Illicit Pill Presses Act

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Bill ID: 119/hr/5880
Last Updated: July 27, 2026

Sponsored by

Rep. Hageman, Harriet M. [R-WY-At Large]

ID: H001096

Follow the money

The bill

Fight Illicit Pill Presses Act

HR. 5880, 119th Congress — read as touching Pharmaceuticals.

The sponsor

Rep. Hageman, Harriet M. [R-WY-At Large]

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

The money

$99,500 raised

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

The alignment

70% 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

Forwarded by Subcommittee to Full Committee by Voice Vote.

July 14, 2026

Introduced

Committee Review

📍 Current Status

Next: The bill moves to the floor for full chamber debate and voting.

🗳️

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

Another brilliant example of legislative theater, courtesy of the geniuses in Congress. Let's dissect this masterpiece, shall we?

**Main Purpose & Objectives:** The "Fight Illicit Pill Presses Act" (because who doesn't love a good title?) aims to regulate tableting machines and encapsulating machines used in the production of pills. The supposed goal is to prevent illicit pill presses from churning out fake or dangerous medications. How quaint.

**Key Provisions & Changes to Existing Law:** The bill amends the Controlled Substances Act to require regulated persons (i.e., manufacturers, distributors, importers, and exporters) to identify tableting machines and encapsulating machines by serial number. It also expands the definition of "regulated person" to include those who manufacture or distribute critical parts for these machines. Oh, and let's not forget the obligatory "detailed guidance" on serial numbers for machines manufactured before the bill's enactment. Because, you know, clarity is overrated.

**Affected Parties & Stakeholders:** The usual suspects: pharmaceutical companies, manufacturers of tableting and encapsulating machines, importers and exporters, and (of course) the Attorney General's office, which gets to promulgate new regulations. One can only assume that the lobbyists for these industries have already begun salivating at the prospect of "guiding" lawmakers on the finer points of serial number affixation.

**Potential Impact & Implications:** Ah, now we get to the good stuff. This bill is a textbook example of regulatory capture, where industry interests are cleverly disguised as public safety concerns. The real impact will be to create new bureaucratic hurdles for legitimate manufacturers while doing little to prevent illicit pill presses from operating. After all, criminals tend not to bother with serial numbers or regulations. Meanwhile, the added compliance costs will be passed on to consumers, because who needs affordable medication when you can have more paperwork?

In conclusion, this bill is a masterclass in legislative obfuscation, designed to create the illusion of action while serving the interests of industry insiders. It's a testament to the boundless creativity of lawmakers in crafting bills that sound good but accomplish little. Now, if you'll excuse me, I need to go treat a patient suffering from a bad case of " politician-induced nausea."

Related Topics

Public Health & Pandemic Response
Generated using Llama 3.1 70B (Dr. Haus personality)

💰 Campaign Finance Network

Rep. Hageman, Harriet M. [R-WY-At Large]

Congress 119 • 2024 Election Cycle

Total Contributions
$99,500
21 donors
PACs
$0
Organizations
$99,500
Committees
$0
Individuals
$0

No PAC contributions found

1
CHEROKEE NATION
2 transactions
$6,600
2
PECHANGA BAND OF INDIANS
2 transactions
$6,600
3
SHAKOPEE MDEWAKANTON SIOUX COMMUNITY
2 transactions
$6,600
4
MUCKLESHOOT INDIAN TRIBE
2 transactions
$6,600
5
AK-CHIN INDIAN COMMUNITY OPERATIONS ACCOUNT
2 transactions
$6,600
6
POARCH BAND OF CREEK INDIANS
2 transactions
$6,600
7
SAN MANUEL BAND OF MISSION INDIANS
2 transactions
$6,600
8
THE TULALIP TRIBES OF WASHINGTON
2 transactions
$6,600
9
SHINGLE SPRINGS BAND MIWOK INDIANS
2 transactions
$5,800
10
COW CREEK BAND OF UMPQUA TRIBE OF INDIANS
1 transaction
$5,000
11
PUYALLUP TRIBE OF INDIANS
1 transaction
$3,700
12
MORONGO BAND OF MISSION INDIANS
1 transaction
$3,300
13
HPUL PROJECT OPERATIONS
1 transaction
$3,300
14
MOORETOWN RANCHERIA
1 transaction
$3,300
15
SANTA YNEZ BAND OF MISSION INDIANS
1 transaction
$3,300
16
AQUA CALIENTE BAND OF CAHUILLA INDIANS GENERAL FUND
1 transaction
$3,300
17
PRAIRIE BAND POTAWATOMI NATION
1 transaction
$3,300
18
PASCUA YAQUI TRIBE
1 transaction
$3,300
19
CHOCTAW NATION OF OKLAHOMA
1 transaction
$3,300
20
PUEBLO OF LAGUNA
1 transaction
$3,300
21
ONEIDA INDIAN NATION
1 transaction
$2,500

No committee contributions found

No individual contributions found

Cosponsors & Their Campaign Finance

This bill has 10 cosponsors. Below are their top campaign contributors.

Rep. Stansbury, Melanie A. [D-NM-1]

ID: S001218

Top Contributors

70

1
PUYALLUP TRIBE OF INDIANS
OrganizationTACOMA, WA
$3,700
Jun 10, 2024
2
PUEBLO OF ISLETA
OrganizationISLETA, NM
$3,300
Nov 27, 2023
3
PUEBLO OF SANDIA
OrganizationBERNALILLO, NM
$3,300
Nov 27, 2023
4
PECHANGA BAND OF LUISENO INDIANS
OrganizationTEMECULA, CA
$3,300
Dec 6, 2023
5
PUEBLO OF SANTA ANA
OrganizationBERNALILLO, NM
$3,300
Dec 20, 2023
6
PUEBLO OF SANDIA
OrganizationBERNALILLO, NM
$3,300
Nov 27, 2023
7
PASCUA YAQUI TRIBE
OrganizationTUCSON, AZ
$3,300
Dec 30, 2023
8
AK-CHIN INDIAN COMMUNITY
OrganizationMARICOPA, AZ
$3,300
Mar 29, 2023
9
POARCH BAND OF CREEK INDIANS
OrganizationATMORE, AL
$3,300
Mar 29, 2023
10
FEDERATED INDIANS OF GRANTON RANCHERIA
OrganizationROHNERT PARK, CA
$3,300
Mar 25, 2024

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

ID: C001120

Top Contributors

26

1
CHEVRON
OrganizationSAN RAMON, CA
$5,000
Sep 4, 2024
2
COMPLETE EMERGENCY CARE HOLDING LLC
OrganizationSOUTHLAKE, TX
$3,500
Mar 11, 2024
3
SANDLIAN REALTY
OrganizationWICHITA, KS
$1,000
Feb 7, 2024
4
ALABAMA-COUSHATTA TRIBE
OrganizationLIVINGSTON, TX
$1,000
Sep 30, 2024
5
RUSSELL W H KRIDEL MD PA
OrganizationHOUSTON, TX
$250
Feb 28, 2023
6
JONES RANCH LLC
OrganizationCORPUS CHRISTI, TX
$250
Mar 13, 2024
7
MAFRIGE, DAVID
SELF • COMMERCIAL REAL ESTATE INVESTMENTS
IndividualHOUSTON, TX
$9,900
Jun 21, 2023
8
MAFRIGE, DAVID
SELF • COMMERCIAL REAL ESTATE INVESTMENTS
IndividualHOUSTON, TX
$9,900
Jun 21, 2023
9
ODEN, KEITH
CAMDEN PROPERTY TRUST • EXECUTIVE VICE CHAIRMAN
IndividualHOUSTON, TX
$9,900
Jun 27, 2023
10
ODEN, KEITH
CAMDEN PROPERTY TRUST • EXECUTIVE VICE CHAIRMAN
IndividualHOUSTON, TX
$9,900
Jun 27, 2023

Rep. Harder, Josh [D-CA-9]

ID: H001090

Top Contributors

25

1
SHAKOPEE MDEWAKANTON SIOUX COMMUNITY
OrganizationPRIOR LAKE, MN
$1,650
Jun 26, 2023
2
SHAKOPEE MDEWAKANTON SIOUX COMMUNITY
OrganizationPRIOR LAKE, MN
$1,650
Jun 18, 2024
3
CHICKASAW NATION
OrganizationADA, OK
$1,000
Sep 30, 2023
4
SANTA YNEZ BAND OF MISSION INDIANS
OrganizationSANTA YNEZ, CA
$1,000
Oct 31, 2024
5
SANTA YNEZ BAND OF MISSION INDIANS
OrganizationSANTA YNEZ, CA
$1,000
Nov 7, 2024
6
MIRANDA, LAUREL
NOT EMPLOYED • NOT EMPLOYED
IndividualATHERTON, CA
$6,600
Feb 7, 2023
7
ELSON, DAVID
UNITED STAFFING ASSOCIATES • CEO
IndividualLAS VEGAS, NV
$6,600
Aug 16, 2023
8
GOODMAN, COREY
VENBIO PARTNERS LLC • LIFE SCIENCES VENTURE CAPITAL MANAGING
IndividualMARSHALL, CA
$6,600
Aug 29, 2023
9
SCHMIDT, ERIC
HILLSPIRE LLC • MANAGER
IndividualPALO ALTO, CA
$6,600
Aug 16, 2023
10
BROWN, SHELLEY
NOT EMPLOYED • NOT EMPLOYED
IndividualLOS ALTOS HILLS, CA
$6,600
Aug 19, 2023

Rep. Fry, Russell [R-SC-7]

ID: F000478

Top Contributors

24

1
EASTERN BAND OF CHEROKEE INDIANS
OrganizationCHEROKEE, NC
$3,300
Feb 20, 2024
2
EASTERN BAND OF CHEROKEE INDIANS
OrganizationCHEROKEE, NC
$3,300
Sep 5, 2024
3
RMS LLC
OrganizationHOOVER, AL
$2,500
Sep 5, 2024
4
ROBERT S GUYTON PC
OrganizationMYRTLE BEACH, SC
$1,000
Jun 17, 2024
5
GAMBLE, KATHRYN
UNAKA CO • BUSINESS EXECUTIVE
IndividualDALLAS, TX
$6,600
Jul 15, 2024
6
AUSTIN, ROBERT
UNAKA CO., INC. • BUSINESSMAN
IndividualDALLAS, TX
$6,600
Jul 19, 2024
7
MOORE, KEVIN
R.H. MOORE COMPANY, INC. • CONSTRUCTION
IndividualPAWLEYS ISLAND, SC
$6,600
Aug 20, 2024
8
LOWELL, RANDY
BURR FORMAN • ATTORNEY
IndividualISLE OF PALMS, SC
$3,435
Dec 2, 2024
9
GRUBBS, WESLEY
BEACH FORD • CAR DEALER
IndividualMYRTLE BEACH, SC
$3,435
May 30, 2024
10
WOOTEN, GAIL
RETIRED • RETIRED
IndividualMURRELLS INLET, SC
$3,435
Jun 19, 2024

Rep. Vindman, Eugene Simon [D-VA-7]

ID: V000138

Top Contributors

22

1
LUX FOR VIRGINIA
OrganizationLADYSMITH, VA
$500
Mar 29, 2024
2
LUX FOR VIRGINIA
OrganizationLADYSMITH, VA
$500
Mar 31, 2024
3
FORSTER-BURKE, DIANE
NOT EMPLOYED • NOT EMPLOYED
IndividualCOTTONWOOD HEIGHTS, UT
$4,000
Apr 20, 2024
4
FORSTER-BURKE, DIANE
IndividualCOTTONWOOD HEIGHTS, UT
$4,000
May 5, 2024
5
VON STEIN, THOMSON
IndividualROCKVILLE, MD
$3,500
Aug 7, 2024
6
HULL, MEGAN
SELF • ACTIVIST
IndividualWASHINGTON, DC
$3,300
Nov 2, 2024
7
KAISER, GEORGE
GBK CORPORATION • EXECUTIVE
IndividualTULSA, OK
$3,300
Oct 25, 2024
8
PARSONS, KATHLEEN
NOT EMPLOYED • NOT EMPLOYED
IndividualPOTOMAC, MD
$3,300
Oct 18, 2024
9
STAPLE, HARISE
SELF • MD
IndividualLOS ALTOS, CA
$3,300
Oct 18, 2024
10
HOLMES, LAURA
SELF • REAL ESTATE INVESTOR
IndividualBOCA RATON, FL
$3,300
Oct 22, 2024

Rep. Levin, Mike [D-CA-49]

ID: L000593

Top Contributors

48

1
DIGIDEMS PAC
CONDUIT TOTAL LISTED IN AGG. FIELD
PACLOS ANGELES, CA
$250
Nov 5, 2024
2
SANTA ROSA RANCHERIA
OrganizationLEMOORE, CA
$6,600
Jun 13, 2024
3
SYCUAN BAND OF THE KUMEYAAY NATION
OrganizationEL CAJON, CA
$3,300
Nov 2, 2024
4
AGUA CALIENTE BAND OF CAHUILLA INDIANS
OrganizationPALM SPRINGS, CA
$3,300
Jun 29, 2023
5
SYCUAN BAND OF THE KUMEYAAY NATION
OrganizationEL CAJON, CA
$3,300
Jun 29, 2023
6
FEDERATED INDIANS OF GRATON RANCHERIA
OrganizationROHNERT PARK, CA
$3,300
May 12, 2023
7
FEDERATED INDIANS OF GRATON RANCHERIA
OrganizationROHNERT PARK, CA
$3,300
May 12, 2023
8
POARCH BAND OF CREEK INDIANS
OrganizationATMORE, AL
$3,300
Jun 21, 2023
9
SAN MANUEL BAND OF MISSION INDIANS
OrganizationLOS ANGELES, CA
$3,300
Aug 22, 2024
10
POARCH BAND OF CREEK INDIANS
OrganizationATMORE, AL
$3,300
Jun 13, 2024

Rep. Tran, Derek [D-CA-45]

ID: T000491

Top Contributors

24

1
FEHER, ERICA
FEHER LAW • MARKETING
OrganizationTORRANCE, CA
$3,300
Feb 22, 2024
2
COTCHETT, PITRE & MCCARTHY LLP
OrganizationBURLINGAME, CA
$1,700
Jul 7, 2024
3
BRACAMONTES VLASAK, PC
OrganizationOAKLAND, CA
$1,000
Mar 31, 2024
4
FEDERATED INDIANS OF GRATON RANCHERIA
OrganizationROHNERT PARK, CA
$1,000
Aug 27, 2024
5
SOSNICK, AARON
IndividualRENO, NV
$3,392
Jun 24, 2024
6
ABIR, DANNY
ACTS LAW FIRM • ATTORNEY
IndividualENCINO, CA
$3,300
Oct 2, 2023
7
ABRON, BYRON
BYRON ABRON • ATTORNEY
IndividualLOS ANGELES, CA
$3,300
Oct 2, 2023
8
ARDALAN, PEZHMAN CHRISTOPHER
ARDALAN & ASSOCIATES, APLC • ATTORNEY
IndividualTHOUSAND OAKS, CA
$3,300
Oct 2, 2023
9
AREVALO, KRISTY
MCCUNE LAW GROUP • ATTORNEY
IndividualUPLAND, CA
$3,300
Oct 1, 2023
10
BABBITT, GREGORY
AUTO FRAUD LEGAL CENTER • ATTORNEY
IndividualSAN DIEGO, CA
$3,300
Nov 24, 2023

Rep. Min, Dave [D-CA-47]

ID: M001241

Top Contributors

32

1
SYCUAN BANK OF KUMEYAAY NATION
OrganizationEL CAJON, CA
$3,300
Jun 30, 2023
2
SANTA ROSA RANCHERIA
OrganizationLEMOORE, CA
$3,300
Jun 11, 2024
3
SANTA ROSA RANCHERIA
OrganizationLEMOORE, CA
$3,300
Jun 11, 2024
4
YOCHA DEHE WINTUN NATION
OrganizationBROOKS, CA
$3,300
Sep 25, 2023
5
YOCHA DEHE WINTUN NATION
OrganizationBROOKS, CA
$3,300
Jul 11, 2024
6
BARONA BANK OF MISSION INDIANS
OrganizationLAKESIDE, CA
$2,500
Jun 30, 2023
7
VIEJAS BANK OF KUMEYAAY INDIANS
OrganizationALPINE, CA
$2,500
Jun 30, 2023
8
SYCUAN BANK OF KUMEYAAY NATION
OrganizationEL CAJON, CA
$2,000
Jun 30, 2023
9
SYCUAN BANK OF KUMEYAAY NATION
OrganizationEL CAJON, CA
$1,300
Jun 30, 2023
10
FEDERATED INDIANS OF GRATON RANCHERIA
OrganizationROHNERT PARK, CA
$1,000
Aug 5, 2024

Rep. Kaptur, Marcy [D-OH-9]

ID: K000009

Top Contributors

22

1
HECATE ENERGY LLC
OrganizationCHICAGO, IL
$4,000
Aug 31, 2023
2
RMS INVESTMENT GROUP LLC
OrganizationSHAKER HEIGHTS, OH
$3,300
Jun 28, 2023
3
HOWLEY, JO ANN
NONE • NONE
IndividualVERMILION, OH
$3,500
Oct 15, 2024
4
ANSPACH, ROBERT
ANSPACHLAW • ATTORNEY
IndividualPERRYSBURG, OH
$3,300
Nov 4, 2024
5
BRANDT, JANICE
TIME WARNER • VICE CHAIR
IndividualGREAT FALLS, VA
$3,300
Oct 25, 2024
6
CHOWDHURY, MANIDIPA
BCI INC. • CFO
IndividualMOORESTOWN, NJ
$3,300
Oct 23, 2024
7
CHOWDHURY, SAILESH
BCI INC. • CEO
IndividualMOORESTOWN, NJ
$3,300
Oct 23, 2024
8
CONOVER, CATHERINE M
CATHERINE CONOVER • INVESTOR
IndividualWASHINGTON, DC
$3,300
Nov 1, 2024
9
EGNOR, DANIEL
SELF-EMPLOYED • PROGRAMMER
IndividualOAKLAND, CA
$3,300
Oct 28, 2024
10
HELLMAN, FRANCES
UC BERKELEY • PROFESSOR
IndividualBERKELEY, CA
$3,300
Oct 29, 2024

Rep. Norcross, Donald [D-NJ-1]

ID: N000188

Top Contributors

20

1
DAVIS, MITCHELL
DAVIS & ASSOCIATES • DEVELOPER
IndividualPHILADELPHIA, PA
$4,600
Dec 5, 2023
2
BELLIA, MICHAEL
BELLIA ENTERPRISES • CFO
IndividualWOODBURY, NJ
$3,300
Oct 22, 2024
3
BERNARDES, JULIENE
SELF EMPLOYED • PT
IndividualARLINGTON, VA
$3,300
Oct 29, 2024
4
BIBBS, K. WENDELL
REMINGTON & VERNICK • ENGINEER
IndividualVOORHEES, NJ
$3,300
Oct 24, 2024
5
BIRD, ALLEN
M&A • CONTRACTOR
IndividualARLINGTON, VA
$3,300
Oct 28, 2024
6
CAPOFERRI, ROBERT
ASPHALT PAVING SYSTEMS, INC. • PRESIDENT
IndividualHAMMONTON, NJ
$3,300
Oct 31, 2024
7
CULNAN, DENNIS JR
PHOENIX STRATEGIES • MANAGING DIRECTOR
IndividualMT LAUREL, NJ
$3,300
Oct 30, 2024
8
FORMAN, DONNA R
N/A • NOT EMPLOYED
IndividualCHERRY HILL, NJ
$3,300
Oct 30, 2024
9
LEONARD, THOMAS A ESQ.
OBERMAYER REBMANN ET AL • ATTORNEY
IndividualPHILADELPHIA, PA
$3,300
Oct 30, 2024
10
KRONE, DAVID BRETT
APOLLO MANAGEMENT • PARTNER
IndividualNEW YORK, NY
$3,300
Jan 22, 2024

Donor Network - Rep. Hageman, Harriet M. [R-WY-At Large]

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Organizations
Individuals
Politicians

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

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Showing 70 nodes and 88 connections

Total contributions: $88

Top Donors - Rep. Hageman, Harriet M. [R-WY-At Large]

Showing top 21 donors by contribution amount

21 Orgs

Industry Impact

Which industries are materially affected by specific provisions in this bill. 2 harmed.

  • −Pharmaceuticalsconfidence 0.80

    Section 2(b)(1) requires regulated persons to identify tableting machines and encapsulating machines by serial number, which may increase regulatory burden on pharmaceutical manufacturers.

  • −Medical Devicesconfidence 0.60

    Section 2(a)(3) defines critical parts of tableting and encapsulating machines, which could impact medical device manufacturers that produce these machines.

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

Moderate
Vector: 63%
Pages: 488-490AI Enhanced

AI Analysis:

"The bill aims to curb illicit drug production by regulating pill presses, which aligns with the Project 2025 FDA objective of ensuring drug safety and preventing counterfeit or unsafe medications, though it does not directly address the specific topics (abortion data, gender identity, generic competition, lab tests, drug shortages, or abortion pills) emphasized in the excerpt."

Key themes:drug safetyillicit drug manufacturingFDA regulationpublic healthcounterfeit drugs

— 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

Weak
Vector: 58%
Pages: 491-493AI Enhanced

AI Analysis:

"Both the bill and the Project 2025 HHS section aim to protect public health through drug-related regulation, but the bill focuses on preventing illicit drug manufacturing via pill press controls, whereas the Project 2025 policy addresses abortion pill restrictions, vaccine importation, and NIH bioethics—topics with little direct overlap."

Key themes:drug safetypublic healthFDA regulationcontrolled substances

— 459 — Department of Health and Human Services pro-life states that are trying to protect women, girls, and unborn children from abortion. The FDA should therefore: l Reinstate earlier safety protocols for Mifeprex that were mostly eliminated in 2016 and apply these protocols to any generic version of mifepristone. A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women’s health and safety. l Address weaknesses in the current FAERS (FDA Adverse Events Reporting System). The Administration and policymakers should ensure that health care workers, particularly those in hospitals and emergency rooms, report abortion pill complications. Women who experience complications from abortion pills typically go to an emergency room, not to the abortion pill prescriber, so putting the onus of reporting on the prescriber who typically has no idea that a complication has occurred means that the FAERS is seriously undercounting adverse events. Submitting an adverse event to the database should be a quick and efficient process for busy health care practitioners. Currently, providers report that the process is difficult and convoluted. l Implement a policy of transparency about inspections of the abortion pill’s sponsors, Danco and GenBioPro, as well as facilities that manufacture the pills. The FDA should respond to congressional requests and Freedom of Information Act (FOIA) requests about inspections, compliance, and post-marketing safety in a timely manner. l Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.16 Vaccine Importation. Thousands of Americans of faith and conscience wish to receive various childhood vaccinations for themselves and their families but are not allowed to receive vaccines that are derived through or tested on aborted fetal cells. For example, the chickenpox, Hepatitis, and MMR vaccines in the U.S. are all linked to abortion in this way. There are ethically derived alternatives abroad that have been used safely there for decades, but the FDA makes it exceedingly difficult for Americans to import them. In January 2021, the HHS Office for Civil Rights (OCR) and the FDA jointly announced that HHS was required by the Religious Freedom Restoration Act — 460 — Mandate for Leadership: The Conservative Promise (RFRA)17 to allow bulk importation by doctors of certain Japanese-made vaccines to accommodate religious needs of patients, but the Biden FDA unlawfully revoked this waiver. The FDA should restore the waiver to comply with RFRA and for the obvious public health benefits of increased childhood vaccination by families seek- ing ethically derived alternatives. To avoid future moral coercion of the sort experienced with the COVID-19 vac- cines, the FDA and NIH should require the development of drugs and biologics that are free from moral taint and switch to cell lines that are not derived from aborted fetal cell lines or aborted baby body parts. Conflicts of Interest. A 2018 report in Science found that more than two-thirds of FDA reviewers later ended up at the same companies whose products they had been reviewing while they were working for the government.18 This revolving door is one mechanism by which pharmaceutical companies capture the agencies that regulate them. The FDA should impose a lengthy cooling off period for reviewers, preventing them from working for companies they regulated. In 1997, the FDA relaxed regulations to permit broadcast drug advertisements, after which Big Pharma began routine direct-to-consumer advertising, making the United States and New Zealand the only countries where such practices are legal. Following the 1997 changes, pharma became the largest advertiser for all major media organizations. This buys considerable influence in the newsroom—whether media companies acknowledge this or not—and distorts independent reporting on public health issues. The FDA or Congress should regulate where and how paid advertising is used by pharmaceutical companies more stringently, especially on media outlets. NATIONAL INSTITUTES OF HEALTH (NIH) The National Institutes of Health (NIH) is the world’s largest biomedical research agency and is made up of 27 different components called Institutes and Centers. Despite its popular image as a benign science agency, NIH was respon- sible for paying for research in aborted baby body parts, human animal chimera experiments, and gain-of-function viral research that may have been responsible for COVID-19. Bioethics Reform. Research using fetal tissue obtained from elective abortions is immoral and obsolete. Research using human embryonic stem cells also involves the destruction of human life and should not be subsidized with taxpayer dollars. Good science and life-affirming, ethical research are not mutually exclusive. In fact, ethically derived sources such as discarded surgical tissue and adult stem cells (made pluripotent), not tissue obtained from elective abortions, have contributed the most successful treatments for a variety of ailments. Congress authorized HHS to choose not to fund extramural abortion-de- rived fetal tissue research that fails ethics advisory board review, and in 2019, the

Department of Commerce

Weak
Vector: 57%
Pages: 705-707AI Enhanced

AI Analysis:

"The bill focuses on domestic regulation of pill press machines to combat illicit drug production, while the Project 2025 policy centers on reforming export controls for emerging technologies to protect national security. There is minimal thematic overlap, as the bill does not address export controls, technology transfers, or foreign adversaries like China and Russia."

Key themes:regulatory oversightnational securityexport controls

— 672 — Mandate for Leadership: The Conservative Promise regulate exports of emerging and foundational technologies. Although the scope of such technologies is vast, to date BIS has only controlled just over 40 of these technologies. This does not meet the clear statutory intent of Congress that ECRA be leveraged to ensure that the United States maintains a technological advantage in technologies bearing upon national security interests. Currently, BIS self-identifies technologies that merit control under the EAR with minimal input from other federal agencies. This mechanism should be improved. BIS should create an open, transparent rulemaking process by which any industry participant, private entity, or branch of the government may, at any time, submit nominations for emerging/foundational technologies for control. Then, on a quarterly basis, BIS should make public such recommendations (while holding the identity of the submitter confidential) for public input, followed by an explanation about its ultimate decision to control or not control the items, its reasons, the level of controls applied (stringent or permissive), and the relevant Export Control Classification Number (ECCN) under the Commerce Control List. Commerce should also institute a mechanism whereby its decisions can be challenged, including on a confidential basis. Licensing Procedures: Adjudication and Transparency. Currently, if the Departments of Defense, State, Commerce, and Energy disagree on an export license decision, the disagreement may be escalated to the Operating Commit- tee—and subsequently to the Advisory Committee on Export Policy led by BIS’s Assistant Secretary for Export Administration. The Assistant Secretary does not need to lead the dispute resolution, and this process should be revised by giving lead authority to BIS’s Under Secretary, who is better able to account for diverging views. Moreover, BIS’s authority to overrule other agency votes should be changed. Each agency should have one equal vote and, if a licensing dispute remains unre- solved, the final decision should be elevated to the National Security Advisor and the Secretaries of Defense, State, Commerce, and Energy. Additionally, to improve congressional oversight of BIS’s license adjudication process, BIS should provide specific congressional committees with data from the Automated Export System on a quarterly basis. Electronic files should contain U.S. exporter by name; product description (e.g., harmonized system code and ECCN/U. S. Munitions List designation); end user and destination country; and when a license was required, whether the license was granted or denied. BIS cur- rently denies just 1.2 percent of export licenses. These data reporting requirements can help Congress better determine whether BIS is adequately protecting national security through appropriate use of export controls or whether additional direction from Congress is required. Improve End-Use Checks. The integrity of the export control system may be validated only through adequate end-use checks. BIS must deny export licenses to countries that do not permit adequate end-use checks (e.g., China/Russia) by U.S. authorities. BIS should also strengthen the forensic audit capabilities of its — 673 — Department of Commerce Export Enforcement officers through improved and frequent training so they are able to detect export-control violations. EAR Revisions. The U.S. Government needs a new export control moderniza- tion effort to tighten the EAR policies governing licenses to countries of concern, including China and Russia (specifically, revise and/or reverse the 2008 through 2016 policies). When authoritarian governments explain what they plan to do, believe them unless hard evidence demonstrates otherwise. Case in point: China’s and Russia’s stated civil–military fusion policies demand central government command-and-control style systems in which every private entity serves the interests of the state and is forced to provide technology, services, capacity, and data to the central govern- ment and the military. Through this structure, commercial activities are routinely weaponized by authoritarian regimes that repeatedly identify the U.S. as an enemy. Accordingly, U.S. export control policies must be updated to reflect these realities and the associated threats to national security. Key priorities for EAR modernization for countries of concern should be: l Eliminating the “specially designed” licensing loophole; l Redesignating China and Russia to more highly prohibitive export licensing groups (country groups D or E); l Eliminating license exceptions; l Broadening foreign direct product rules; l Reducing the de minimis threshold from 25 percent to 10 percent—or 0 percent for critical technologies; l Tightening the deemed export rules to prevent technology transfer to foreign nationals from countries of concern; l Tightening the definition of “fundamental research” to address exploitation of the open U.S. university system by authoritarian governments through funding, students and researchers, and recruitment; l Eliminating license exceptions for sharing technology with controlled entities/countries through standards-setting “activities” and bodies; and l Improving regulations regarding published information for technology transfers.

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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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