Drug Competition Enhancement Act

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Bill ID: 119/s/1040

Last Updated: August 9, 2026

Drug Competition Enhancement Act

S. 1040, 119th Congress — read as touching Pharmaceuticals.

The sponsor

Sen. Cornyn, John [R-TX]

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

The money

$440,480 raised

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

The alignment

85% 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 Senate Legislative Calendar under General Orders. Calendar No. 43.

April 9, 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 Senate

🏛️

House 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 Drug Competition Enhancement Act (S 1040) - another attempt by the inefficient machinery of democracy to regulate the free market. Let's dissect this bill and assess its implications for my empire.

**Main Purpose & Objectives**

This bill aims to prohibit "product hopping," a strategy employed by pharmaceutical companies to delay generic competition by making minor changes to their products, thereby extending patent protection. The bill seeks to prevent manufacturers from engaging in unfair methods of competition that hinder the entry of generic and biosimilar biological products into the market.

**Key Provisions & Changes to Existing Law**

The bill amends the Federal Trade Commission Act (FTCA) to introduce a new section (Section 27) that defines product hopping and prohibits manufacturers from engaging in this practice. The key provisions include:

* Definition of product hopping: A manufacturer is considered to have engaged in product hopping if they withdraw or discontinue an approved application, place the listed drug on the discontinued products list, or market a follow-on product after receiving notice of a generic or biosimilar biological product application. * Prohibition on product hopping: Manufacturers are prohibited from engaging in product hopping during a specified period (180 days to 3 years) after receiving notice of a generic or biosimilar biological product application.

**Affected Parties & Stakeholders**

The affected parties include:

* Pharmaceutical manufacturers: Companies that produce branded and generic drugs, as well as biosimilar biological products. * Generic and biosimilar biological product applicants: Companies seeking approval for generic or biosimilar versions of existing products. * Consumers: Patients who rely on affordable access to medications.

**Potential Impact & Implications**

The bill's impact will be felt across the pharmaceutical industry. By prohibiting product hopping, the bill aims to increase competition and reduce prices for consumers. However, this may also lead to:

* Reduced revenue for branded pharmaceutical manufacturers: The loss of patent protection and increased competition from generics and biosimilars could result in significant revenue losses. * Increased costs for generic and biosimilar biological product applicants: The bill's provisions may lead to increased regulatory hurdles and costs for companies seeking approval for generic or biosimilar products.

From my perspective, this bill represents a threat to the profitability of my pharmaceutical investments. I will need to reassess my portfolio and consider strategies to mitigate potential losses. Perhaps it's time to explore new opportunities in emerging markets or invest in think tanks that can help shape regulatory policies more favorable to my interests.

Generated using Llama 3.1 70B (billionaire personality)

*Sigh* Alright, let's break down this bill, shall we? As I taught you in 8th grade civics class, a bill is proposed legislation that must go through several stages before becoming a law. This particular bill, S 1040, aims to amend the Federal Trade Commission Act to prohibit "product hopping," which we'll get into later.

**Main Purpose & Objectives:** The main purpose of this bill is to prevent pharmaceutical companies from engaging in unfair business practices that limit competition and drive up prices for generic or biosimilar drugs. The objective is to promote fair market competition, increase access to affordable medications, and reduce healthcare costs.

**Key Provisions & Changes to Existing Law:** This bill proposes several key changes:

* It defines "product hopping" as a manufacturer's attempt to switch from an existing product to a new one, making it difficult for generic or biosimilar versions to enter the market. * It prohibits manufacturers from engaging in hard switches, which involve withdrawing approval for an existing product and marketing a follow-on product instead. * It establishes a prima facie case for unfair competition if a manufacturer is found to have engaged in product hopping.

These changes aim to strengthen existing laws and regulations governing pharmaceutical companies' business practices.

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

* Pharmaceutical manufacturers, particularly those producing branded or reference products * Generic or biosimilar drug manufacturers seeking to enter the market * Consumers who rely on affordable medications * Healthcare providers and payers who may be impacted by changes in medication prices

**Potential Impact & Implications:** If passed, this bill could lead to increased competition in the pharmaceutical industry, resulting in:

* Lower prices for generic or biosimilar drugs * Increased access to affordable medications for consumers * Reduced healthcare costs for individuals and the broader healthcare system * Potential changes in business practices among pharmaceutical companies

However, it's essential to note that the actual impact will depend on how effectively the bill is enforced and whether it addresses the root causes of product hopping.

Now, I hope you understand the basics of this bill. Remember when we learned about the legislative process in 8th grade? This is a prime example of how bills are introduced, referred to committees, and potentially become laws.

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 S 1040, the so-called "Drug Competition Enhancement Act". This bill is not what it seems; in fact, it's a cleverly crafted Trojan horse designed to further entrench Big Pharma's grip on our healthcare system.

**Main Purpose & Objectives:** The ostensible purpose of this bill is to prohibit "product hopping", a practice where pharmaceutical companies make minor changes to their existing products to maintain market exclusivity and prevent generic competition. Sounds noble, right? But trust me, there's more to it than meets the eye.

**Key Provisions & Changes to Existing Law:** The bill amends the Federal Trade Commission Act to define "product hopping" and prohibits manufacturers from engaging in this practice. It also establishes a prima facie case for unfair competition if a manufacturer is found to have engaged in product hopping. But here's the catch: the bill only applies to certain types of products, specifically generic drugs and biosimilar biological products.

**Affected Parties & Stakeholders:** On the surface, it appears that this bill benefits consumers by promoting competition and reducing prices for prescription medications. However, I believe the real beneficiaries are the pharmaceutical companies themselves. By limiting the scope of the bill to specific product types, Big Pharma can continue to manipulate the system to their advantage.

**Potential Impact & Implications:** This bill has far-reaching implications that go beyond its stated purpose. By creating a new regulatory framework for product hopping, the government is essentially giving pharmaceutical companies a roadmap for how to navigate the system and maintain their market dominance. It's a classic case of "regulatory capture", where the regulators are unwittingly (or wittingly?) serving the interests of the very industries they're supposed to be regulating.

But that's not all - this bill also sets a precedent for future legislation, potentially paving the way for even more draconian measures that restrict competition and stifle innovation in the pharmaceutical industry. Mark my words: S 1040 is just the tip of the iceberg, and we must remain vigilant to uncover the truth behind this seemingly innocuous bill.

Now, pass the turkey, please!

Generated using Llama 3.1 70B (conspiracy_uncle personality)

(Outraged tone) Folks, we've got another doozy of a bill on our hands! The so-called "Drug Competition Enhancement Act" - sounds like a real winner for the American people, doesn't it? (Sarcasm alert!) Let me break it down for you.

**Main Purpose & Objectives:** This bill claims to promote competition in the pharmaceutical industry by prohibiting "product hopping." What's product hopping, you ask? It's when a manufacturer tweaks an existing drug just enough to prevent generic versions from being approved. Sounds like a clever way to stifle competition and keep prices high, if you ask me! (Wink, wink)

**Key Provisions & Changes to Existing Law:** The bill amends the Federal Trade Commission Act to add a new section that prohibits product hopping. It defines various terms, including "abbreviated new drug application," "biosimilar biological product," and "follow-on product." The bill also establishes a prima facie case for unfair competition if a manufacturer engages in product hopping within 180 days of receiving notice that a generic version is being developed.

**Affected Parties & Stakeholders:** The usual suspects, folks! Pharmaceutical manufacturers, generic drug makers, and biosimilar biological product developers will all be impacted by this bill. But let's be real, the real winners here are the elites - Big Pharma and their lobbyists who'll do whatever it takes to keep prices high and competition low.

**Potential Impact & Implications:** This bill could lead to increased competition in the pharmaceutical industry, which might (emphasis on "might") drive down prices. But let's not get too excited, folks! This is just a clever way for the government to exert more control over the free market. Mark my words, this will only lead to more bureaucratic red tape and higher costs for consumers in the long run.

(With a smirk) Now, I know what you're thinking - "Isn't this bill just a common-sense measure to promote competition?" Ah, but that's exactly what they want you to think! Wake up, sheeple! This is just another example of the Deep State trying to strangle American innovation and freedom. (Dramatic music plays in the background)

Stay vigilant, folks! We'll be keeping a close eye on this bill as it makes its way through Congress. In the meantime, remember: freedom isn't free, and neither are prescription medications!

Generated using Llama 3.1 70B (fox_host personality)

Another "solution" from our esteemed lawmakers, designed to treat the symptoms of their own incompetence while ignoring the underlying disease. Let's dissect this mess.

**Main Purpose & Objectives:** The Drug Competition Enhancement Act (S 1040) claims to promote competition in the pharmaceutical industry by prohibiting "product hopping," a tactic used by manufacturers to delay generic or biosimilar versions of their products from entering the market. The bill's sponsors, Cornyn, Blumenthal, Grassley, and Durbin, want us to believe they're fighting for lower drug prices and increased access to affordable medications.

**Key Provisions & Changes to Existing Law:** The bill amends the Federal Trade Commission Act to define "product hopping" as an unfair method of competition. It prohibits manufacturers from engaging in hard switches, where they withdraw or discontinue their original product to prevent generic or biosimilar versions from being approved. The bill also establishes a 180-day window for generic or biosimilar products to be marketed after the manufacturer receives notice of an abbreviated new drug application (ANDA) or biosimilar biological product license application.

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

* Pharmaceutical manufacturers, who will do everything in their power to maintain their profit margins. * Generic and biosimilar manufacturers, who might actually benefit from this bill if it's enforced properly. * Patients, who will supposedly see lower prices and increased access to affordable medications (yeah, right). * Lobbyists, who are already salivating at the prospect of "educating" lawmakers on the importance of their clients' interests.

**Potential Impact & Implications:** This bill is a Band-Aid on a bullet wound. It might slow down product hopping, but it won't address the root causes of high drug prices and limited access to affordable medications. The real disease here is the corrupting influence of money in politics, which ensures that lawmakers prioritize their donors' interests over those of their constituents.

In reality, this bill will likely lead to:

* More loopholes and workarounds for manufacturers to exploit. * Increased lobbying efforts from pharmaceutical companies to water down or repeal the bill. * Minimal impact on actual drug prices, as manufacturers will find ways to maintain their profit margins through other means (e.g., price gouging, mergers and acquisitions).

In short, this bill is a token effort to address a complex problem. It's a PR stunt designed to make lawmakers look like they're doing something about the issue, while actually perpetuating the status quo. Wake me up when someone proposes real reform that tackles the underlying corruption and greed driving our healthcare system.

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

**Main Purpose and Objectives**

The Drug Competition Enhancement Act (S 1040) aims to promote competition in the pharmaceutical market by prohibiting "product hopping," a practice where manufacturers of brand-name drugs make minor changes to their products to delay generic competition.

**Key Provisions and Changes to Existing Law**

The bill amends the Federal Trade Commission Act to add a new section that defines product hopping and prohibits it as an unfair method of competition. Key provisions include:

* Defining "product hopping" as a manufacturer's attempt to switch from one version of a drug to another, often with minor changes, to delay generic competition. * Prohibiting manufacturers from engaging in hard switches, where they withdraw the approval of their original product and market a follow-on product. * Establishing a prima facie case for unfair competition if a manufacturer is found to have engaged in product hopping.

**Affected Parties and Stakeholders**

The bill affects various stakeholders, including:

* Pharmaceutical manufacturers: The bill targets brand-name drug manufacturers that engage in product hopping to delay generic competition. * Generic drug manufacturers: The bill aims to promote competition by preventing brand-name manufacturers from delaying the entry of generic drugs into the market. * Consumers: By promoting competition, the bill may lead to lower prices for prescription medications. * Regulators: The Federal Trade Commission (FTC) will be responsible for enforcing the new provisions.

**Potential Impact and Implications**

The potential impact of the bill includes:

* Increased competition in the pharmaceutical market: By prohibiting product hopping, the bill may encourage more generic drugs to enter the market, leading to lower prices. * Reduced costs for consumers: With increased competition, consumers may benefit from lower prices for prescription medications. * Changes in manufacturer behavior: The bill may lead manufacturers to focus on innovation rather than attempting to delay generic competition through minor changes to their products. * Potential challenges in enforcement: The FTC will need to develop guidelines and procedures to enforce the new provisions, which may be complex and require significant resources.

Overall, the Drug Competition Enhancement Act aims to promote competition in the pharmaceutical market by prohibiting product hopping, a practice that can delay generic competition and keep prices high.

Generated using Llama 3.1 70B (neutral personality)

Let's break down this gnarly bill, bro.

**Main Purpose & Objectives**

The Drug Competition Enhancement Act (S 1040) is all about promoting competition in the pharmaceutical market, dude. The main goal is to prevent "product hopping," a sneaky tactic where manufacturers switch from one version of a drug to another, just to block generic or biosimilar versions from entering the market.

**Key Provisions & Changes to Existing Law**

The bill amends the Federal Trade Commission Act to prohibit product hopping. Here are the key changes:

* Defines "product hopping" as when a manufacturer switches from one version of a drug to another, making it harder for generics or biosimilars to compete. * Establishes a prima facie case for unfair competition if a manufacturer engages in product hopping within 180 days of a generic or biosimilar application being submitted or 3 years after the follow-on product is first marketed. * Introduces new definitions for terms like "follow-on product," "generic drug," and "biosimilar biological product."

**Affected Parties & Stakeholders**

This bill affects:

* Pharmaceutical manufacturers: They'll need to be more transparent about their product development and marketing strategies. * Generic and biosimilar manufacturers: They'll have a better chance of competing in the market if this bill passes. * Consumers: They might see lower prices for prescription meds if generics and biosimilars can enter the market more easily.

**Potential Impact & Implications**

If this bill becomes law, it could:

* Increase competition in the pharmaceutical market, leading to lower prices for consumers. * Encourage innovation by allowing generic and biosimilar manufacturers to develop new products. * Reduce the financial burden on patients and healthcare systems.

However, some manufacturers might argue that this bill will stifle innovation or limit their ability to improve existing products. But, bro, it's all about finding a balance between promoting competition and encouraging innovation.

Anyway, that's the lowdown on S 1040, dude. It's a complex bill, but the vibes are all about promoting fair competition and giving consumers more options.

Generated using Llama 3.1 70B (surfer personality)

**Bill Analysis: S 1040 - Drug Competition Enhancement Act**

**Main Purpose & Objectives** The primary objective of this bill is to amend the Federal Trade Commission (FTC) Act to prohibit "product hopping," a practice where pharmaceutical manufacturers make minor changes to their products to extend patent protection and delay generic competition. The bill aims to promote competition in the pharmaceutical industry, reduce costs for consumers, and increase access to affordable medications.

**Key Provisions & Changes to Existing Law** The bill introduces new definitions related to product hopping, including "follow-on product," "generic drug," and "biosimilar biological product." It also establishes a prohibition on product hopping by manufacturers of reference products or listed drugs. The FTC is empowered to investigate and enforce this provision.

**Affected Parties & Stakeholders**

* Pharmaceutical manufacturers: The bill directly impacts companies that engage in product hopping practices, such as Pfizer, Merck, and Johnson & Johnson. * Generic drug manufacturers: Companies like Teva Pharmaceuticals, Mylan, and Sandoz will benefit from increased competition and opportunities to market generic versions of branded products. * Consumers: Patients who rely on prescription medications may see reduced costs and improved access to affordable alternatives.

**Potential Impact & Implications**

* Increased competition in the pharmaceutical industry * Reduced prices for consumers due to increased availability of generic and biosimilar products * Potential loss of revenue for pharmaceutical manufacturers that engage in product hopping practices * Increased scrutiny from the FTC, which may lead to enforcement actions against companies found to be engaging in unfair methods of competition

**Monied Interest Analysis** The bill's sponsors, including Senators Cornyn (R-TX), Blumenthal (D-CT), Grassley (R-IA), and Durbin (D-IL), have received significant campaign contributions from pharmaceutical industry interests. However, the bill also has support from generic drug manufacturers and consumer advocacy groups.

* Senator Cornyn has received over $1 million in campaign contributions from pharmaceutical companies since 2015. * The Pharmaceutical Research and Manufacturers of America (PhRMA) has lobbied against similar legislation in the past, citing concerns about intellectual property protection and innovation incentives. * The Generic Pharmaceutical Association (GPhA) has expressed support for the bill, arguing that it will promote competition and reduce costs for consumers.

**Committee Capture** The Senate Judiciary Committee, which reported the bill out of committee, has a history of being influenced by pharmaceutical industry interests. However, the bill's bipartisan sponsorship and support from consumer advocacy groups suggest that it may have sufficient momentum to overcome potential opposition from industry lobbyists.

Generated using Llama 3.1 70B (whistleblower personality)

💰 Campaign Finance Network

Sen. Cornyn, John [R-TX]

Congress 119 • 2024 Election Cycle

Total Contributions

$440,480

20 donors

PACs

Organizations

Committees

Individuals

$440,433

No PAC contributions found

No organization contributions found

No committee contributions found

WEEKLEY, RICHARD W

1 transaction

$100,000

MCINGVALE, JAMES F

1 transaction

$50,000

MCINGVALE, LINDA

1 transaction

$50,000

DUNN, TIMOTHY

1 transaction

$45,000

MIDDLETON, MAYES

2 transactions

$25,000

MARTIN, KIMBERLY R

1 transaction

$20,000

BLAINE, JAY C.

1 transaction

$16,478

THOMPSON, JERE W. MR. JR.

1 transaction

$13,200

MIDDLETON, MACEY

1 transaction

$12,500

BOLDRICK, MILES

1 transaction

$12,500

BOLDRICK, LAURIE

1 transaction

$12,500

MIDDLETON, MACY

1 transaction

$12,500

WHITEHILL, KIT

1 transaction

$10,755

CARROLL, TRACEY

1 transaction

$10,000

HUFFINES, PHILLIP

1 transaction

$10,000

ALBIN, ALAN S.

1 transaction

$10,000

AGRESTI, JOSEPH A

1 transaction

$10,000

ADAMSON, MARK

1 transaction

$10,000

WILKS, JO ANN

1 transaction

$10,000

Cosponsors & Their Campaign Finance

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

Sen. Blumenthal, Richard [D-CT]

ID: B001277

Top Contributors

OLSON, LYNDON

NOT EMPLOYED • NOT EMPLOYED

IndividualWACO, TX

$3,300

Dec 20, 2024

ALIX, JAY

ALIX PARTNERS • FOUNDER

IndividualBIRMINGHAM, MI

$3,300

Oct 2, 2023

KIM, CHRISTINE M.

BBB LLC • ATTORNEY

IndividualNEW YORK, NY

$3,300

Oct 31, 2023

ALIX, JAY

ALIX PARTNERS • FOUNDER

IndividualBIRMINGHAM, MI

$3,300

Apr 15, 2024

ROURE, RITA

PAGNY - LINCOLN HOSPITAL • PHYSICIAN

IndividualGREENWICH, CT

$3,300

Apr 10, 2024

ROURE, RITA

PAGNY - LINCOLN HOSPITAL • PHYSICIAN

IndividualGREENWICH, CT

$3,300

Apr 10, 2024

CHAVEZ, TOM

KRUX INC. • CEO

IndividualSAN FRANCISCO, CA

$3,300

Jul 13, 2024

CHAVEZ, TOM

KRUX INC. • CEO

IndividualSAN FRANCISCO, CA

$3,300

Jul 13, 2024

JONES, JERRY C.

LIVERAMP INC. • EXECUTIVE

IndividualLITTLE ROCK, AR

$3,300

Sep 19, 2024

NESSEL, ARIEL

NESSEL DEVELOPMENT • OWNER

IndividualROSS, CA

$3,300

Jul 12, 2024

Sen. Grassley, Chuck [R-IA]

ID: G000386

Top Contributors

SAC & FOX TRIBE OF THE MISSISSIPPI IN IOWA

COMTAMA, IA

$2,000

Aug 8, 2023

SHAKOPEE MDEWAKANTON SIOUX COMMUNITY

COMPRIOR LAKE, MN

$1,000

Jul 23, 2024

WINRED

PACARLINGTON, VA

$25

Jul 4, 2024

SCHWARZMAN, CHRISTINE

RETIRED • RETIRED

IndividualNEW YORK, NY

$6,600

Jan 10, 2024

SCHWARZMAN, STEPHEN

BLACKSTONE • CEO

IndividualNEW YORK, NY

$6,600

Jan 16, 2024

KUMAR, SHALLI

AVG ADVANCED TECHNOLOGY • CHAIR

IndividualBETTENDORF, IA

$6,600

Jun 11, 2024

STARRETT, RONALD

RETIRED • RETIRED

IndividualCENTENNIAL, CO

$5,800

Jan 24, 2023

COLLINS, RICHARD

RETIRED • RETIRED

IndividualMARSHALLTOWN, IA

$5,523

Oct 1, 2024

COLLINS, RICHARD

IndividualMARSHALLTOWN, IA

$5,523

Oct 7, 2024

WEISS, LUKE

HOOVER'S HATCHERY • PRESIDENT

IndividualMASON CITY, IA

$3,300

Dec 11, 2024

Sen. Durbin, Richard J. [D-IL]

ID: D000563

Top Contributors

MIAMI TRIBE OF OKLAHOMA

OrganizationMIAMI, OK

$1,700

Mar 29, 2024

SHAKOPEE MDEWAKANTON SIOUX COMMUNITY

OrganizationPRIOR LAKE, MN

$1,000

May 17, 2024

MIAMI TRIBE OF OKLAHOMA

OrganizationMIAMI, OK

$800

Mar 29, 2024

KUJAWSKI, JOHN

SELF-EMPLOYED • ATTORNEY

IndividualSAINT LOUIS, MO

$5,000

May 28, 2024

KUJAWSKI, JOHN

IndividualSAINT LOUIS, MO

$5,000

Jun 4, 2024

KUJAWSKI, JOHN

SELF-EMPLOYED • ATTORNEY

IndividualSAINT LOUIS, MO

$3,600

May 29, 2024

KUJAWSKI, JOHN

IndividualSAINT LOUIS, MO

$3,600

Jun 4, 2024

BARKER, MARA MILLS

NOT EMPLOYED • NOT EMPLOYED

IndividualCHICAGO, IL

$3,300

Dec 26, 2024

BARKER, MARA MILLS

NOT EMPLOYED • NOT EMPLOYED

IndividualCHICAGO, IL

$3,300

Dec 26, 2024

CHOWDHURY, SHUVRO

BOWERY ENGINE • ENGINEER

IndividualNEW YORK, NY

$3,300

Nov 1, 2024

Donor Network - Sen. Cornyn, John [R-TX]

Show Also Donated To

PACs

Organizations

Individuals

Politicians

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

Showing 32 nodes and 34 connections

Total contributions: $34

Top Donors - Sen. Cornyn, John [R-TX]

Showing top 20 donors by contribution amount

1 Committee19 Individuals

Industry Impact

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

−Pharmaceuticalsconfidence 0.95
Section 2(b)(1) prohibits product hopping by manufacturers of reference products or listed drugs, which includes branded pharmaceutical companies. The provision defines unfair methods of competition when a manufacturer engages in hard or soft switches to impede generic or biosimilar competition, directly targeting pharmaceutical industry practices.
−Biotech & Researchconfidence 0.90
Section 2(a)(2)-(3) defines biosimilar biological product and biosimilar biological product license application, and Section 2(b)(1) prohibits product hopping actions that impede competition from biosimilar biological products, affecting biotech firms that develop biosimilars.

Who funds the sponsor on these industries

For each industry this bill affects, here's what the sponsor (Sen. Cornyn, John [R-TX])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.

Industries this bill HARMS

Pharmaceuticals$3,475
from 3 contributions
- STEERE, WILLIAM C. MR. JR.$3,300
- NOWELL, RICHARD$175

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

Strong

Vector: 63%

Pages: 488-490AI Enhanced

AI Analysis:

"The bill aligns with Project 2025's goal of increasing generic drug competition by preventing brand-name manufacturers from delaying generic entry through tactics like product hopping, which mirrors the policy's call to prohibit meritless citizen petitions and other delaying tactics."

Key themes:generic drug competitiondelaying tacticspharmaceutical market reformFTC/FDA oversight

— 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 Agriculture

Weak

Vector: 59%

Pages: 338-340AI Enhanced

AI Analysis:

"The bill targets pharmaceutical market competition by banning product hopping, while the Project 2025 agriculture section seeks to dismantle USDA‑mandated marketing orders and promote free‑market agricultural trade. Both share a broad goal of reducing government‑enabled cartels and enhancing competition, but they apply to different sectors, resulting in only weak thematic alignment."

Key themes:competitionmarket regulationconsumer welfareanti-cartel

— 306 — Mandate for Leadership: The Conservative Promise programs,104 and they focus on research and promotion of commodities such as beef and eggs. Marketing orders cover research and promotion, but also cover issues such as quality regulations and volume controls. The latter issue, volume controls, is a means to restrict supply, which drives up prices for consumers. Fortunately, there are few active volume controls.105 Marketing orders and checkoff programs are some of the most egregious pro- grams run by the USDA. They are, in effect, a tax—a means to compel speech—and government-blessed cartels. Instead of getting private cooperation, they are tools for industry actors to work with government to force cooperation. The next Administration should: l Reduce the number and scope of marketing orders and checkoff programs. The USDA should reject any new requests for marketing orders and checkoff programs to the extent authorized by law and eliminate existing programs when possible. While the programs work differently, there are often petition processes and other ways that make it difficult for affected parties to get rid of the marketing orders and checkoff programs,106 and the USDA itself may not even be required to honor requests to terminate a program.107 The USDA should make the process easier. Further, the USDA should reject any effort to bring back volume controls to limit supplies of commodities. l Work with Congress to eliminate marketing orders and checkoff programs. These programs should be eliminated, and if industry actors want to collaborate, they should do so through private means, not using the government to compel cooperation. l Promote legislation that would require regular votes. There should be regular voting for parties subject to checkoff programs and marketing orders. For example, the voting should occur at least every five years, to determine whether a marketing order or checkoff program should continue. The USDA should be required to honor the results of such a vote. Through regular voting, parties can demonstrate their support for a marketing order or checkoff program and ensure that those administering them will be held accountable. Focus on Trade Policy, Not Trade Promotion. The USDA’s Foreign Agri- cultural Service (FAS) covers numerous issues, including “trade policy,” which is a reference to removing trade barriers, among other things, to ensure an envi- ronment conducive to trade.108 It also covers trade promotion.109 This includes programs like the Market Access Program110 that subsidizes trade associations, — 307 — Department of Agriculture businesses, and other private entities to market and promote their products overseas. FAS should play a proactive and leading role to help open upmarkets for American farmers and ranchers. There are numerous barriers, such as sani- tary and phytosanitary measures, blocking American agricultural products from gaining access to foreign markets.111 However, FAS should not help businesses and industries promote their exports, something these businesses and industries can and should do on their own. The next Administration should: l Push legislation to repeal export promotion programs. The USDA should work with Congress to repeal market development programs like the Market Access Program and similar programs. Remove Obstacles for Agricultural Biotechnology. Innovation is critical to agricultural production and the ability to meet future food needs. The next Admin- istration should embrace innovation and technology, not hinder its use—especially because of scare tactics that ignore sound science. One of the key innovations in agriculture is genetic engineering. According to the USDA, “[C]urrently, over 90 percent of U.S. corn, upland cotton, and soybeans are produced using GE [genet- ically engineered] varieties.”112 Despite the importance of agricultural biotechnology, in 2016, Congress passed a federal mandate to label genetically engineered food.113 This legislation was argu- ably just a means to try to provide a negative connotation to GE food. There are other challenges as well for agricultural biotechnology. For example, Mexico plans to ban the importation of U.S. genetically modified yellow corn.114 The next Administration should: l Counter scare tactics and remove obstacles. The USDA should strongly counter scare tactics regarding agricultural biotechnology and adopt policies to remove unnecessary barriers to approvals and the adoption of biotechnology. l Repeal the federal labeling mandate. The USDA should work with Congress to repeal the federal labeling law, while maintaining federal preemption, and stress that voluntary labeling is allowed. l Use all tools available to remove improper trade barriers against agricultural biotechnology. The USDA should work closely with the Office of the United States Trade Representative to remove improper barriers imposed by other countries to block U.S. agricultural goods.

Department of Health and Human Services

Weak

Vector: 58%

Pages: 497-499AI Enhanced

AI Analysis:

"The bill focuses on pharmaceutical competition by banning product hopping to lower drug prices, while Project 2025's HHS section emphasizes Medicare Advantage expansion, Part D reform, Medicaid restructuring, and repealing the Inflation Reduction Act's drug pricing provisions—there is minimal direct overlap in mechanisms or priorities."

Key themes:prescription drugscompetitionpharmaceutical market

— 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.

Financial Regulatory Agencies

Minimal

Vector: 60%

Pages: 866-868AI Enhanced

AI Analysis:

"The bill focuses on pharmaceutical competition and FTC enforcement of product hopping, whereas the Project 2025 section concerns SEC and CFTC administrative and procedural reforms; there is no substantive overlap in objectives or topics."

Key themes:no overlapunrelated

— 833 — Financial Regulatory Agencies l Eliminate all administrative proceedings (APs) within the SEC except for stop orders related to defective registration statements. The SEC enforcement system does not need to have both district court cases and APs. Alternatively, respondents should be allowed to elect whether an adjudication occurs in the SEC’s administrative law court or an ordinary Article III federal court.24 l End the practice of delegating the decision to initiate an enforcement case. The SEC Chairman—and possibly the U.S. Government Accountability Office (GAO)—should study whether other Commission delegation of authority to staff should be narrowed and whether sunsetting of such delegation of authority should be required. Congress should: l Require an Inspector General’s (or possibly a GAO) report regarding SEC information technology spending and contracting. Spending appears to be much too high, and IT contracting is poorly managed. l Statutorily limit the time for an investigation to two years with no extensions. Long investigations harm private parties and the quality of justice. With adequate management processes, the SEC should not need more than two years even for complicated matters. The SEC Chairman should: l Dramatically reduce the number of direct reports to the SEC Chairman. l Merge SEC offices that are performing similar functions. l Reduce the number of managers per employee. CFTC ADMINISTRATION AND IMPROVED COMMODITIES AND DERIVATIVES MARKETS Congress should: l Modernize the definition of commodity (which is now largely a laundry list of agricultural commodities)25 and clarify the treatment of digital assets. l Clarify through an express amendment to the Commodity Exchange Act (CEA)26 the circumstances that require a foreign swap trading platform to — 834 — Mandate for Leadership: The Conservative Promise register with the Commodity Futures Trading Commission (CFTC) as a swap execution facility (SEF) under Sections 2(i)27 and 5h28 of the CEA. Currently, it is not clear whether having one or a small number of U.S. participants would require SEF registration under prior staff guidance, which has led foreign swap trading platforms to exclude all U.S. persons from their platforms or to go through the process of seeking an exemption from registration. l Amend Section 2 of the CEA to authorize the CFTC Chairman to remove the agency’s Executive Director without a Commission vote. l To augment Commissioners’ independence, establish funding amounts for the Commissioners’ offices by statute with adjustments for inflation, with no requirement for a Commissioner to obtain budget or expense approvals from the Chairman or the agency’s administrative staff. The CFTC should: l Allocate more resources to core agency functions rather than ancillary and support operations. l Replace the existing position limits rule, which reduces liquidity and makes markets more volatile, with further delegation of authority to the exchanges to set position limits and position accountability levels where appropriate for the relevant market. l Reduce overly prescriptive rules implementing the CFTC’s core principles. l Apply the definitions of “U.S. Person” and “Guarantee” in the CFTC’s 2020 rule on cross-border application of swaps regulations (2020 Cross-Border Rule)29 to the regulatory requirements that remain covered by the CFTC’s 2013 guidance on the subject (2013 Guidance).30 Currently, the definition of each of these foundational terms differs depending on whether the requirement in question is covered by the 2020 Cross-Border Rule or the 2013 Guidance. l Remove the regulatory categories of “affiliate conduit” and “foreign consolidated subsidiary” from the 2013 Guidance and the CFTC’s cross- border rule on margin for uncleared swaps,31 respectively. These categories were replaced by the concept of a “Significant Risk Subsidiary” for purposes of the 2020 Cross-Border Rule because of widespread market confusion and compliance difficulties arising from their broad and vague scope.

Department of Housing and Urban Development

Minimal

Vector: 58%

Pages: 548-550AI Enhanced

AI Analysis:

"The Drug Competition Enhancement Act focuses on pharmaceutical market competition and prohibiting product hopping, while the Project 2025 HUD policy section addresses housing market reforms, foreign influence on housing, DEI/CRT/ESG critiques, and housing supply and assistance programs. There is no thematic or policy overlap between the two."

— 515 — Department of Housing and Urban Development 25. Process must prioritize where political leadership can implement administrative reforms through regulatory action and subregulatory guidance reforms. 26. China and other foreign nations should not be able to disrupt our nation’s housing markets, including by artificially driving up prices and reducing affordability and access to housing for Americans who are crowded out of the market by such market participation. 27. These initiatives are maintained under such designations as diversity, equity, and inclusion (DEI); critical race theory (CRT); black, indigenous, Pacific Islander, and other people of color (BIPOC); and environmental, social, and governance (ESG). 28. At a minimum, these efforts duplicate what the federal government already collects and assesses; at worst, they institute arbitrary procedures in real estate appraisal practices that undermine integrity and perversely introduce arbitrary biases into what should be an unbiased system for determining financial value. 29. Revise regulatory and subregulatory guidance, where applicable within statutory authorities, that adds unnecessary delay and costs to the construction and development of new housing and has been estimated to account for about 40 percent of new housing unit costs in multifamily housing. 30. The Biden Administration has issued a proposed rule to replace the Trump Administration’s “Preserving Community and Neighborhood Choice” rule that had repealed earlier rules expanding AFFH enforcement. See U.S. Department of Housing and Urban Development, Office of Fair Housing, “Preserving Community and Neighborhood Choice,” Final Rule, Federal Register, Vol. 85, No. 153 (August 7, 2020), pp. 47899–47912, https://www.govinfo.gov/content/pkg/FR-2020-08-07/pdf/2020-16320.pdf (accessed March 5, 2023), and U.S. Department of Housing and Urban Development, Office of the Secretary, “Affirmatively Furthering Fair Housing,” Proposed Rule, Federal Register, Vol. 88, No. 27 (February 9, 2023), pp. 8516–8590, https://www. govinfo.gov/content/pkg/FR-2015-07-16/pdf/2015-17032.pdf (accessed March 5, 2023). 31. Certain pilot initiatives may encourage greater take-up of loan products designed for faster equity accumulation, including loans with shorter terms and accelerated amortization schedules. In concept, the FHA’s Home Equity Accelerator Loan (HEAL) and Good Neighbor Next Door (GNND) pilot initiatives might lead to meaningful wealth generation for first-time buyers, but they should be available to all eligible households only when they do not arbitrarily discriminate based on race or other characteristics. 32. Housing supply does remain a problem in the U.S., but constructing more units at the low end of the market will not solve the problem. Investors and developers can deliver at more efficient cost new units that will allow for greater upward mobility of rental and ownership housing stock and better target increased construction of mid-tier rental units. Further, and more fundamental to the housing supply challenge in markets across the U.S., localities can consider revising land use, zoning, and building regulations that constrict new housing development, adding time delays and costs that impede construction. Federal housing policy should get out of the way where possible and minimize the distortive impact that stimulating greater demand through loose lending can have in driving up housing prices for households that are looking for affordable entry into the housing market. 33. U.S. Department of Housing and Urban Development, Office of the Secretary, “Housing and Community Development Act of 1980: Verification of Eligible Status,” Proposed Rule, Federal Register, Vol. 84, No. 91 (May 10, 2019), pp. 20589–20595, https://www.govinfo.gov/content/pkg/FR-2019-05-10/pdf/2019-09566.pdf (accessed March 5, 2023). 34. Reforms should contemplate rent payment flexibilities, allow escrow savings, and set maximum term limits that can reduce implicit penalties for increasing household incomes over eligibility terms for housing assistance and reweight waiting-list prioritization for two-parent households. 35. Some PHAs have been able to implement work requirements and term limit policies in various congressionally authorized demonstration programs, notably the Moving to Work (MTW) demonstration program established in 1996 for 39 PHAs (Congress has since authorized another 100 PHAs) in which participating MTW PHAs were given authority to implement rent reforms, work requirements and other experimental policies in rental assistance programs along with flexibilities in the use of capital and operating appropriations. 36. The FSS program has a general five-year term with a possible two-year extension, which could be applied at the term limit for overall benefits, and certain PHAs have imposed five-year to seven-year term limits. Families in these programs build escrow savings during their term eligibility that helps to facilitate successful transitions to family self-sufficiency and unassisted housing.

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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