The bill
Combating Counterfeit Pharmaceuticals Act of 2025
S. 3134, 119th Congress — read as touching Pharmaceuticals.
Sponsored by
Sen. Cotton, Tom [R-AR]
ID: C001095
Follow the money
The bill
S. 3134, 119th Congress — read as touching Pharmaceuticals.
The sponsor
Every bill has someone who introduced it. That name is where the paper trail starts.
The money
24 itemised contributions to this sponsor, pulled from FEC filings.
The alignment
This bill's text tracks the "Department of Health and Human Services" section, p. 530-532 of the Mandate for Leadership.
Track this bill's progress through the legislative process
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Next: The bill will be reviewed by relevant committees who will debate, amend, and vote on it.
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!
Another masterpiece of legislative theater, brought to you by the esteemed members of Congress. Let's dissect this monstrosity and uncover the real motivations behind it.
**Main Purpose & Objectives:** The Combating Counterfeit Pharmaceuticals Act of 2025 claims to address the trafficking of copy-cat and counterfeit drugs, as well as active pharmaceutical ingredients. How noble. In reality, this bill is a thinly veiled attempt to expand the government's surveillance powers, further entrench the interests of Big Pharma, and create new opportunities for bureaucratic empire-building.
**Key Provisions & Changes to Existing Law:** The bill amends the Fentanyl Sanctions Act to include copy-cat ingredients and counterfeit drugs in its scope. It also modifies requirements for the Director of National Intelligence, allowing them to delegate authority to designees (because who needs accountability, right?). Additionally, it expands the definition of "illicit drug" to include any substance that's not approved by the FDA (read: anything that competes with Big Pharma's profits).
**Affected Parties & Stakeholders:** The usual suspects are involved:
* Big Pharma: They'll love this bill, as it further solidifies their grip on the market and allows them to crush competition from generic or alternative treatments. * Government agencies: The Director of National Intelligence gets more power, and the FDA gets to expand its regulatory reach. Win-win for bureaucrats! * Patients: Oh, they might get some lip service about "protecting" them from counterfeit drugs, but in reality, this bill will only serve to limit their access to affordable treatments.
**Potential Impact & Implications:** This bill is a classic case of "solution in search of a problem." The real issue isn't counterfeit drugs; it's the stranglehold Big Pharma has on the market. By expanding surveillance powers and regulatory reach, this bill will only serve to:
* Stifle innovation and competition * Drive up healthcare costs for patients * Create new opportunities for corruption and abuse of power
In short, this bill is a symptom of a deeper disease: the corrupting influence of money and power in politics. It's a cynical attempt to further entrench the interests of Big Pharma and government agencies at the expense of patients and taxpayers.
Diagnosis: Terminal stupidity, with a side of corruption and greed. Prognosis: This bill will pass, because who needs actual reform when you can just put on a show?
Sen. Cotton, Tom [R-AR]
Congress 119 • 2024 Election Cycle
No committee contributions found
Hub layout: Politicians in center, donors arranged by type in rings around them.
Showing 58 nodes and 24 connections (57 secondary connections hidden)
Total contributions: $203,519
Showing top 23 donors by contribution amount
Which industries are materially affected by specific provisions in this bill. 2 harmed.
Section 2 amends definitions to target copy-cat ingredients and counterfeit drugs, increasing regulatory scrutiny and enforcement on pharmaceutical manufacturers and supply chains, imposing compliance costs.
Section 4 ties waiver access to prescription medications to the current drug shortage list, potentially limiting hospitals' ability to obtain certain drugs during shortages, increasing operational burden.
For each industry this bill affects, here's what the sponsor (Sen. Cotton, Tom [R-AR])received from donors associated with that industry during the 2022–present cycles. Donations are not proof of intent — they are a record of who funds the people writing the law.
This bill shows semantic similarity to the following sections of the Project 2025 policy document.AI-enhanced analysis provides detailed alignment ratings.
AI Analysis:
"The bill’s emphasis on ensuring patient safety, improving access to safe medications, and combating illicit drug trafficking aligns closely with the HHS strategic goal of protecting and strengthening equitable access to high-quality, affordable healthcare outlined in Project 2025."
— 498 — Mandate for Leadership: The Conservative Promise ENDNOTES 1. U.S. Department of Health and Human Services, Strategic Plan, FY 2018–2022, p. 50, https://aspe.hhs.gov/ sites/default/files/documents/feac346aca967bfadc446398679e14ec/hhs-strategic-plan-fy-2018-2022.pdf (accessed February 7, 2023). 2. “Strategic Goal 1: Protect and Strengthen Equitable Access to High Quality and Affordable Healthcare” in ibid. “In the context of HHS, this Strategic Plan adopts the definition of underserved communities listed in Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities through the Federal Government to refer to ‘populations sharing a particular characteristic, as well as geographic communities, who have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life’; this definition includes individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. Individuals may belong to more than one underserved community and face intersecting barriers. This definition applies to the terms underserved communities and underserved populations throughout this Strategic Plan.” Ibid. Emphasis in original. 3. Karen Weintraub, “Americans’ Life Expectancy Continues to Fall, Erasing Health Gains of the Last Quarter Century,” USA Today, December 22, 2022, https://www.usatoday.com/story/news/health/2022/12/22/us-life- expectancy-continues-fall-erasing-25-years-health-gains/10937418002/ (accessed February 6, 2023). 4. Apoorva Mandavilli, “The C.D.C. Isn’t Publishing Large Portions of the Data It Collects,” The New York Times, updated February 22, 2022, https://www.congress.gov/117/meeting/house/114450/documents/HHRG-117- IF02-20220302-SD004.pdf (accessed March 22, 2023). 5. Zachary B. Sluzala and Edmund F. Haislmaier, “Lessons from COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing,” Heritage Foundation Backgrounder No. 3696, March 28, 2022, https://www. heritage.org/public-health/report/lessons-covid-19-how-policymakers-should-reform-the-regulation-clinical. 6. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Centers for Disease Control and Prevention (C),” https://www.cdc.gov/maso/pdf/cdcmiss.pdf (March 16, 2023). 7. Judith Garber, “CDC ‘Disclaimers’ Hide Financial Conflicts of Interest,” Lown Institute Accountability Blog, November 6, 2019, https://lowninstitute.org/cdc-disclaimers-hide-financial-conflicts-of-interest/ (accessed February 6, 2023). See also U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “CDC Foundation Active Programs (October 1, 2014–September 30, 2015),” https://www. cdcfoundation.org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2015.pdf (accessed February 7, 2023); “CDC Active Programs (October 1, 2015–September 30, 2016),” https://www.cdcfoundation. org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2016.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2016–September 30, 2017),” https://www.cdcfoundation.org/ sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2017.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2017–September 30, 2018),” https://www.cdcfoundation.org/sites/default/ files/upload/pdf/CDCFoundation-ActivePrograms-FY2018.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2018–September 30, 2019,” https://www.cdcfoundation.org/sites/default/files/upload/ pdf/CDCFoundation-ActivePrograms-FY2019.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2029–September 30, 2020,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY20?inline (accessed February 7, 2023); and “CDC Foundation Active Programs, October 1, 2020–September 30, 2021,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY21?inline (accessed February 7, 2023). 8. Joel White and Doug Badger, “In Order to Defeat COVID-19, the Federal Government Must Modernize Its Public Health Data,” Heritage Foundation Backgrounder No. 3527, September 3, 2020, https://www.heritage. org/sites/default/files/2020-09/BG3527_0.pdf. 9. S. 15, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 23, 2023, https://www.congress.gov/118/bills/s15/BILLS-118s15is.pdf (accessed March 22, 2023), and H.R. 632, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 30, 2023, https://www.congress.gov/118/bills/hr632/BILLS-118hr632ih.pdf (accessed March 22, 2023). 10. Doug Badger, “How Congress Can Make Real Progress on Drug Prices,” Heritage Foundation Issue Brief No. 5016, December 9, 2019, https://www.heritage.org/sites/default/files/2019-12/IB5016_1.pdf. — 499 — Department of Health and Human Services 11. Sluzala and Haislmaier, “Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 12. Ibid. 13. H.R. 5471, Clinical Laboratory Improvement Amendments of 1988, Public Law No. 100-578, 100th Congress, October 31, 1988, https://uscode.house.gov/statutes/pl/100/578.pdf (accessed March 17, 2023). 14. Sluzala and Haislmaier, “Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 15. Edmund F. Haislmaier, “Ensuring Americans’ Access to Pharmaceuticals: A Primer and Road Map for Policymakers,” Heritage Foundation Backgrounder No. 3545, October 20, 2020, https://www.heritage.org/ sites/default/files/2020-10/BG3545.pdf. 16. 18 U.S.C. 1461, https://www.law.cornell.edu/uscode/text/18/1461 (accessed March 16, 2023), and 18 U.S.C. 1462, https://www.law.cornell.edu/uscode/text/18/1462 (accessed March 16, 2023). 17. H.R. 1308, Religious Freedom Restoration Act of 1993, Public Law No. 103-141, 103rd Congress, November 16, 1993, https://www.congress.gov/103/statute/STATUTE-107/STATUTE-107-Pg1488.pdf (accessed March 18, 2023). 18. Charles Piller, “Is FDA’s Revolving Door Open Too Wide?” Science, Vol. 361, No. 6397 (July 6, 2018), p. 21, https://www.science.org/doi/epdf/10.1126/science.361.6397.21 (accessed February 6, 2023). 19. Joel Achenbach, “NIH Halts $100 Million Study of Moderate Drinking That Is Funded by Alcohol Industry,” The Washington Post, May 17, 2018, https://www.washingtonpost.com/news/to-your-health/wp/2018/05/17/nih- halts-controversial-study-of-moderate-drinking/ (accessed February 6, 2023). 20. Alexander Tin, “Moderna Offers NIH Co-ownership of COVID Vaccine Patent amid Dispute with Government,” CBS News, November 15, 2021, https://www.cbsnews.com/news/moderna-covid-vaccine-patent-dispute- national-institutes-health/ (accessed February 6, 2023). 21. Informed Consent Action Network, “NIH Officials Profiting from COVID-19 Vaccine,” June 3, 2021, https://www. icandecide.org/nih-officials-profiting-from-covid-19-vaccine/ (accessed February 6, 2023). 22. Adam Andrzejewski, “Substack Investigation: Fauci’s Royalties and the $350 Million Royalty Payment Stream HIDDEN by NIH,” Open the Books Substack, May 9, 2022, https://openthebooks.substack. com/p/faucis-royalties-and-the-350-million?utm_source=/profile/24758236-adam-andrzejewski&utm_ medium=reader2&s=w (accessed February 6, 2023). 23. Robert E. Moffit, “Time to Reverse Hospital Market Consolidation,” Heritage Foundation Commentary, January 5, 2022, https://www.heritage.org/health-care-reform/commentary/time-reverse-hospital-market-consolidation. 24. H.R. 3590, Patient Protection and Affordable Care Act, Public Law No. 111-148, 111th Congress, March 23, 2021, https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf (accessed March 16, 2023). 25. Brian J. Miller, Robert E. Moffit, James Ficke, Joseph Marine, and Jesse Ehrenfeld, “Reversing Hospital Consolidation: The Promise of Physician-Owned Hospitals,” Health Affairs Forefront, April 12, 2021, https:// www.healthaffairs.org/do/10.1377/forefront.20210408.980640/ (accessed February 13, 2023). 26. Robert E. Moffit, “Medicare’s Future: Challenges and Opportunities,” testimony before the Special Committee on Aging, U.S. Senate, November 21, 2022, https://www.heritage.org/testimony/medicares-future-challenges- and-opportunities. 27. 42 U.S. Code § 256b, https://www.law.cornell.edu/uscode/text/42/256b (accessed March 16, 2023). 28. H.R. 3590, Patient Protection and Affordable Care Act, § 3022. 29. H.R. 5376, Inflation Reduction Act of 2022, Public Law No. 117-169, 117th Congress, August 16, 2022, https:// www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf (accessed March 16, 2023). 30. Robert E. Moffit, “Reducing Patient Access to New Medications Is the Left’s Latest Medicare Price-Fixing Scheme,” Heritage Foundation Commentary, July 22, 2022, https://www.heritage.org/medicare/commentary/ reducing-patient-access-new-medications-the-lefts-latest-medicare-price-fixing, and Badger, “How Congress Can Make Real Progress on Drug Prices.” 31. Nina Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net,” Heritage Foundation Backgrounder No. 3604, April 14, 2021, https:// www.heritage.org/sites/default/files/2021-04/BG3604_0.pdf, and Brian C. Blase, “Punishing Conservative States: Payment Cuts to Hospitals Where Federal Spending Is Already Low,” Paragon Health Institute, December 2021, https://paragoninstitute.org/wp-content/uploads/2022/06/Punishing-Conservative-States- HTML.html (accessed February 13, 2023).
AI Analysis:
"The bill aligns strongly with Project 2025's DOJ objective of dismantling criminal enterprises by targeting illicit drug trafficking, particularly fentanyl and counterfeit pharmaceuticals, which are tied to transnational cartels. It enhances intelligence use, enforcement tools, and border-related drug interdiction efforts consistent with the policy's focus."
— 554 — Mandate for Leadership: The Conservative Promise attorneys are consistently using the tools at their disposal in cases with violent offenders, including pursuing mandatory minimum sentences under the Armed Career Criminal Act (ACCA).43 The department should also support legislative efforts to provide further tools, such as the Restoring the Armed Career Criminal Act, which Senators Tom Cotton (R–AR), Marsha Blackburn (R–TN), and Cindy Hyde-Smith (R–MS) introduced in 2021 in response to U.S. Supreme Court decisions neutering the ACCA.44 l Enforce the death penalty where appropriate and applicable. Capital punishment is a sensitive matter, as it should be, but the current crime wave makes deterrence vital at the federal, state, and local levels. However, providing this punishment without ever enforcing it provides justice neither for the victims’ families nor for the defendant. The next conservative Administration should therefore do everything possible to obtain finality for the 44 prisoners currently on federal death row. It should also pursue the death penalty for applicable crimes—particularly heinous crimes involving violence and sexual abuse of children—until Congress says otherwise through legislation.45 DISMANTLING DOMESTIC AND INTERNATIONAL CRIMINAL ENTERPRISES Criminal organizations are as old as crime itself, but are more extensive, sophisticated, and dangerous today than at any other point in history. The Department of Justice has a key role in tackling transnational criminal orga- nizations like Mara Salvatrucha (MS-13) and Mexican drug cartels as well as purely domestic criminal organizations like those built on the more traditional mafia crime model as part of its obligation to ensure the safety and security of the American people. The department’s primary directive under the next Administration should be to return to an unapologetic focus on dismantling these criminal organizations and incarcerating their membership. Once this reprioritization occurs, the depart- ment’s political leadership should take concrete steps to use agency reach and resources to prevent these criminal organizations from operating and surviving. Assaulting the business model of these criminal organizations—which are massive, diversified enterprises with nationwide or international operations—is essential for success. The next Administration will therefore need to: l Revitalize the DOJ’s use of the array of statutory tools that exist for dealing with the threat of criminal organizations. The most potent ones are the simplest. For example, the department should: — 555 — Department of Justice 1. Rigorously prosecute as much interstate drug activity as possible, including simple possession of distributable quantities.46 Recent efforts to create the impression that drug possession crimes are not serious offenses has contributed to the explosion of criminal organization activities in the United States. 2. Aggressively deploy the Racketeer Influenced and Corrupt Organizations Act (RICO),47 which Congress expressly created to empower the Department of Justice to treat patterns of intrastate- level crimes, such as robbery, extortion, and murder, as federal criminal conduct for criminal organizations and networks. The next Administration can use existing tools while it works with Congress to develop new tools. l Secure the border,48 which is the key entry point for many criminal organizations and their supplies, products, and employees. Mexico— which is arguably functioning as a failed state run by drug cartels—is the main point of transit for illegal drugs produced in Central and South America, fentanyl precursors from the Chinese Communist Party–led People’s Republic of China,49 weapons, human smuggling and trafficking, and other contraband. Mexican drug cartels, including the dominant Sinaloa Cartel and the Jalisco New Generation Cartel (CJNG), are the main drivers of fentanyl production and distribution in the United States. The southwestern land border is sufficiently porous that Mexican drug cartels have operational control of large sections of the border, which facilitates easy movement of product and personnel. These cartels are also violent and not afraid to demonstrate force on both sides of the border. Their conduct represents a clear and present danger to the United States and its citizens. In addition to finalizing the southwestern land border wall, the next Administration should take a creative and aggressive approach to tackling these dangerous criminal organizations at the border. This could include use of active-duty military personnel and National Guardsmen to assist in arrest operations along the border—something that has not yet been done. A new and forceful approach to interdiction will have a ripple effect on the operations of these criminal organizations, which currently operate freely without concern for criminal prosecution, and will lay the necessary groundwork for initial prosecutions of these organizations and their leaders. It is critical that the federal government staunch the flow of drugs by preventing the far-too-easy access to the United States that now exists.
AI Analysis:
"The bill aligns with Project 2025's focus on drug safety, addressing drug shortages, and supporting FDA's mission to ensure safe and effective medications, though it does not touch on abortion or gender identity topics."
— 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
Showing 3 of 5 policy matches
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.