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S. 1096: Preserve Access to Affordable Generics and Biosimilars Act

The Preserve Access to Affordable Generics and Biosimilars Act aims to improve competition in the pharmaceutical market by prohibiting certain agreements between brand name drug companies and generic or biosimilar manufacturers. These agreements often involve brand name companies compensating generic competitors to delay the introduction of cheaper generic drugs. This practice, known as "reverse payment" settlements, has undermined the initial goals of the Drug Price Competition and Patent Term Restoration Act of 1984, which intended to promote generic drug access and lower healthcare costs.

Key Provisions

  • Prohibition of Reverse Payments: The bill prohibits brand name drug companies from compensating generic drug companies to delay the market entry of generic products. Similarly, it bans compensation from biological product manufacturers to biosimilar manufacturers for delaying the introduction of biosimilars.
  • Antitrust Enforcement: It establishes that such agreements have anticompetitive effects and empowers the Federal Trade Commission (FTC) to take legal action against parties involved in these agreements.
  • Civil Penalties: If parties are found to violate this prohibition, they may face civil penalties that could be up to three times the value received from the anticompetitive agreement.
  • Evidence Presumption: There is a presumption that an agreement has anticompetitive effects if a generic or biosimilar applicant receives anything of value and agrees to limit or forgo research, manufacturing, or sales of the product in question.
  • Exclusions for Unlawful Practices: The bill clarifies certain exceptions, such as legitimate compensation for other goods or services not tied to the settlement of patent claims.
  • Transparency Requirements: Companies entering into relevant agreements will need to report these agreements to the FTC and provide certifications regarding the agreements' nature and terms.

Goals of the Bill

The primary goals of the Preserve Access to Affordable Generics and Biosimilars Act are to:

  • Enhance market competition by preventing practices that limit or delay the availability of generic and biosimilar drugs.
  • Support consumer access to affordable medications by ensuring that price competition is not stifled by anticompetitive agreements.
  • Reinforce the principles of antitrust law within the pharmaceutical industry, ensuring that consumer interests are prioritized.

Background Context

In 1984, the 1984 Act encouraged the entry of generic drugs into the market, leading to lower prices for consumers. However, recent trends show that some brand name companies have adopted reverse payment agreements which undermine competition and result in higher costs for healthcare. The bill responds to these changes, aiming to restore the competitive environment that benefits consumers.

Relevant Companies

  • PFE (Pfizer Inc.): Pfizer may be affected as it could alter how it negotiates with generic manufacturers regarding the release of their generic drugs.
  • ABT (Abbott Laboratories): Abbott could be impacted by changes in its interactions with biosimilars.
  • NVS (Novartis AG): Novartis may experience changes based on how it manages its patented drugs and market competitors.

This is an AI-generated summary of the bill text. There may be mistakes.

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Sponsors

9 bill sponsors

Actions

5 actions

Date Action
Apr. 10, 2025 Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Apr. 10, 2025 Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
Apr. 03, 2025 Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar. 24, 2025 Introduced in Senate
Mar. 24, 2025 Read twice and referred to the Committee on the Judiciary.

Corporate Lobbying

0 companies lobbying

None found.

* Note that there can be significant delays in lobbying disclosures, and our data may be incomplete.

Potentially Relevant Congressional Stock Trades

Estimated excess return of the underlying stock since the transaction
Politician Stock Transaction Filed Traded
Congress pfp
Gilbert Ray Cisneros, Jr. D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $15,001 - $50,000
Apr 07, 2025 Mar 31, 2025 -6.79%
Congress pfp
Byron Donalds R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Apr 14, 2025 Mar 20, 2025 +10.28%
Congress pfp
Byron Donalds R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Apr 14, 2025 Mar 20, 2025 +10.28%
Congress pfp
Carol D. Miller R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Apr 11, 2025 Mar 10, 2025 -10.76%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Apr 10, 2025 Mar 06, 2025 +5.09%
Congress pfp
Bruce Westerman R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $1,001 - $15,000
Apr 16, 2025 Mar 03, 2025 -5.78%
Congress pfp
Bruce Westerman R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Apr 16, 2025 Mar 03, 2025 +3.29%
Congress pfp
Gilbert Ray Cisneros, Jr. D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $1,001 - $15,000
Mar 06, 2025 Feb 26, 2025 -4.70%
Congress pfp
Robert Bresnahan R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $15,001 - $50,000
Mar 27, 2025 Feb 25, 2025 -5.76%
Congress pfp
Jefferson Shreve R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $15,001 - $50,000
Mar 09, 2025 Feb 24, 2025 -5.04%
Congress pfp
Shelley Moore Capito R / Senate
ABT logo
ABT Abbott Laboratories
Sale (Partial) $1,001 - $15,000
Mar 06, 2025 Feb 24, 2025 +8.94%
Congress pfp
John Boozman R / Senate
PFE logo
PFE Pfizer Inc
Sale (Full) $1,001 - $15,000
Mar 06, 2025 Feb 13, 2025 +0.04%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Mar 06, 2025 Feb 13, 2025 +13.08%
Congress pfp
Julie Johnson D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Mar 12, 2025 Feb 12, 2025 -0.29%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Feb 10, 2025 Jan 29, 2025 +15.00%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Feb 10, 2025 Jan 28, 2025 +15.76%
Congress pfp
Gilbert Ray Cisneros, Jr. D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Feb 11, 2025 Jan 24, 2025 -1.70%
Congress pfp
Jared Moskowitz D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Feb 10, 2025 Jan 15, 2025 +29.11%
Congress pfp
Jared Moskowitz D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Feb 10, 2025 Jan 15, 2025 +29.11%
Congress pfp
Jared Moskowitz D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Feb 10, 2025 Jan 15, 2025 +29.11%
Congress pfp
Julie Johnson D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Feb 12, 2025 Jan 15, 2025 -4.34%
Congress pfp
Markwayne Mullin R / Senate
ABT logo
ABT Abbott Laboratories
Sale (Full) $1,001 - $15,000
Jan 31, 2025 Jan 08, 2025 +25.39%
Congress pfp
Emily Randall D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Feb 11, 2025 Jan 06, 2025 +27.50%
Congress pfp
Thomas H. Kean, Jr. R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Jan 22, 2025 Dec 16, 2024 +29.55%
Congress pfp
Markwayne Mullin R / Senate
ABT logo
ABT Abbott Laboratories Common Stock
Sale (Partial) $15,001 - $50,000
Dec 31, 2024 Dec 11, 2024 +28.12%
Congress pfp
Michael T. McCaul R / House
ABT logo
ABT ABBOTT LABS
Sale $15,001 - $50,000
Dec 16, 2024 Nov 19, 2024 +22.66%
Congress pfp
Michael T. McCaul R / House
ABT logo
ABT ABBOTT LABS
Sale $15,001 - $50,000
Dec 16, 2024 Nov 19, 2024 +22.66%
Congress pfp
Michael T. McCaul R / House
ABT logo
ABT ABBOTT LABS
Purchase $50,001 - $100,000
Dec 16, 2024 Nov 04, 2024 +18.95%
Congress pfp
Michael T. McCaul R / House
ABT logo
ABT ABBOTT LABS
Purchase $50,001 - $100,000
Dec 16, 2024 Nov 04, 2024 +18.95%
Congress pfp
Laurel M. Lee R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $15,001 - $50,000
Nov 21, 2024 Oct 21, 2024 -13.66%
Congress pfp
Greg Landsman D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Nov 14, 2024 Oct 15, 2024 -15.59%
Congress pfp
John James R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Sale $1,001 - $15,000
Sep 06, 2024 Sep 04, 2024 +18.92%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Sep 11, 2024 Aug 19, 2024 +22.97%
Congress pfp
Kathy E. Manning D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Sep 04, 2024 Aug 09, 2024 -21.24%
Congress pfp
Scott Franklin R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $15,001 - $50,000
Aug 20, 2024 Aug 06, 2024 -25.31%
Congress pfp
Scott Franklin R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Aug 20, 2024 Aug 01, 2024 -24.73%
Congress pfp
Josh Gottheimer D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Aug 15, 2024 Jul 29, 2024 +28.37%
Congress pfp
Thomas H. Kean, Jr. R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Aug 19, 2024 Jul 23, 2024 +30.96%
Congress pfp
Jared Moskowitz D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Aug 19, 2024 Jul 05, 2024 +31.01%
Congress pfp
Kathy E. Manning D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Aug 16, 2024 Jul 02, 2024 +31.01%
Congress pfp
Kathy E. Manning D / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Aug 16, 2024 Jul 02, 2024 +31.01%
Congress pfp
Tommy Tuberville R / Senate
PFE logo
PFE Pfizer, Inc. Common Stock
Sale (Full) $15,001 - $50,000
Jun 14, 2024 May 03, 2024 -23.35%
Congress pfp
Sheldon Whitehouse D / Senate
NVS logo
NVS Novartis Ag ADR
Sale (Partial) $1,001 - $15,000
May 20, 2024 Apr 09, 2024 +14.32%
Congress pfp
Roger Williams R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Jun 12, 2024 Mar 04, 2024 -17.25%
Congress pfp
Roger Williams R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Jun 12, 2024 Mar 01, 2024 -19.38%
Congress pfp
Roger Williams R / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $1,001 - $15,000
Jun 12, 2024 Mar 01, 2024 -19.38%
Congress pfp
Tommy Tuberville R / Senate
PFE logo
PFE Pfizer, Inc. Common Stock
Purchase $1,001 - $15,000
Mar 15, 2024 Feb 27, 2024 -21.52%
Congress pfp
Earl Blumenauer D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Purchase $1,001 - $15,000
Mar 02, 2024 Feb 12, 2024 -25.05%
Congress pfp
Kathy E. Manning D / House
ABT logo
ABT ABBOTT LABORATORIES
Sale $1,001 - $15,000
Feb 06, 2024 Jan 23, 2024 +6.30%
Congress pfp
Kathy E. Manning D / House
ABT logo
ABT ABBOTT LABORATORIES
Sale $1,001 - $15,000
Feb 06, 2024 Jan 23, 2024 +6.30%
Congress pfp
Thomas R. Carper D / Senate
ABT logo
ABT Abbott Laboratories
Sale (Partial) $1,001 - $15,000
Feb 02, 2024 Jan 17, 2024 +3.49%
Congress pfp
Jared Moskowitz D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Jan 22, 2024 Dec 28, 2023 -33.59%
Congress pfp
Jared Moskowitz D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Jan 22, 2024 Dec 28, 2023 -33.59%
Congress pfp
John Boozman R / Senate
PFE logo
PFE Pfizer Inc
Purchase $1,001 - $15,000
Jan 08, 2024 Dec 20, 2023 -32.38%
Congress pfp
Shelley Moore Capito R / Senate
PFE logo
PFE Pfizer Inc
Sale (Partial) $1,001 - $15,000
Jan 12, 2024 Dec 18, 2023 -29.29%
Congress pfp
Jerry Moran R / Senate
PFE logo
PFE Pfizer, Inc. Common Stock
Sale (Full) $1,001 - $15,000
Jan 17, 2024 Dec 14, 2023 -26.83%
Congress pfp
Kathy E. Manning D / House
PFE logo
PFE PFIZER, INC.
Sale $15,001 - $50,000
Jan 12, 2024 Dec 12, 2023 -35.95%
Congress pfp
Kathy E. Manning D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Jan 12, 2024 Dec 12, 2023 -35.95%
Congress pfp
Kathy E. Manning D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Jan 12, 2024 Dec 12, 2023 -35.95%
Congress pfp
Sheldon Whitehouse D / Senate
PFE logo
PFE Pfizer Inc
Sale (Full) $1,001 - $15,000
Jan 18, 2024 Dec 11, 2023 -36.67%
Congress pfp
John R. Curtis R / House
ABT logo
ABT ABBOTT LABORATORIES
Sale $1,001 - $15,000
Dec 15, 2023 Dec 04, 2023 +9.23%
Congress pfp
John James R / House
ABT logo
ABT ABBOTT LABORATORIES COMMON STOCK
Purchase $1,001 - $15,000
Sep 02, 2024 Nov 10, 2023 +19.86%
Congress pfp
Greg Stanton D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Nov 09, 2023 Oct 24, 2023 -51.57%
Congress pfp
Greg Stanton D / House
ABT logo
ABT ABBOTT LABORATORIES
Sale $1,001 - $15,000
Nov 09, 2023 Oct 24, 2023 +13.82%
Congress pfp
Markwayne Mullin R / Senate
ABT logo
ABT Abbott Laboratories Common Stock
Purchase $1,001 - $15,000
Nov 01, 2023 Oct 03, 2023 +11.82%
Congress pfp
Greg Stanton D / House
PFE logo
PFE PFIZER, INC.
Purchase $1,001 - $15,000
Nov 09, 2023 Sep 26, 2023 -54.87%
Congress pfp
Greg Stanton D / House
ABT logo
ABT ABBOTT LABORATORIES
Purchase $1,001 - $15,000
Nov 09, 2023 Sep 26, 2023 +12.91%
Congress pfp
Pete Ricketts R / Senate
ABT logo
ABT Abbott Laboratories
Sale (Full) $100,001 - $250,000
Oct 20, 2023 Sep 21, 2023 +10.79%
Congress pfp
Sheldon Whitehouse D / Senate
NVS logo
NVS Novartis Ag ADR
Purchase $15,001 - $50,000
Oct 17, 2023 Sep 20, 2023 -12.59%
Congress pfp
John R. Curtis R / House
ABT logo
ABT ABBOTT LABORATORIES
Purchase $1,001 - $15,000
Oct 04, 2023 Sep 13, 2023 +9.63%
Congress pfp
Markwayne Mullin R / Senate
ABT logo
ABT Abbott Laboratories Common Stock
Purchase $15,001 - $50,000
Oct 12, 2023 Sep 13, 2023 +9.63%
Congress pfp
Scott Franklin R / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Oct 12, 2023 Sep 11, 2023 -52.20%
Congress pfp
Lois Frankel D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Oct 10, 2023 Sep 08, 2023 -53.56%
Congress pfp
Jared Moskowitz D / House
PFE logo
PFE PFIZER, INC. COMMON STOCK
Sale $1,001 - $15,000
Aug 21, 2024 Sep 01, 2023 -54.81%
Congress pfp
Tommy Tuberville R / Senate
PFE logo
PFE Pfizer, Inc. Common Stock
Purchase $1,001 - $15,000
Aug 14, 2023 Jul 25, 2023 -55.87%
Congress pfp
Daniel S. Goldman D / House
PFE logo
PFE PFIZER, INC.
Sale $15,001 - $50,000
Aug 13, 2023 Jul 12, 2023 -56.58%
Congress pfp
Daniel S. Goldman D / House
NVS logo
NVS NOVARTIS AG
Sale $50,001 - $100,000
Aug 13, 2023 Jul 10, 2023 -4.96%
Congress pfp
Lois Frankel D / House
PFE logo
PFE PFIZER, INC.
Purchase $1,001 - $15,000
Jul 28, 2023 Jun 28, 2023 -59.20%
Congress pfp
Tommy Tuberville R / Senate
PFE logo
PFE Pfizer, Inc. Common Stock
Purchase $1,001 - $15,000
Jul 14, 2023 Jun 12, 2023 -65.89%
Congress pfp
Zoe Lofgren D / House
PFE logo
PFE PFIZER, INC.
Sale $1,001 - $15,000
Jun 06, 2023 May 26, 2023 -66.52%
Congress pfp
Kathy E. Manning D / House
PFE logo
PFE PFIZER, INC.
Purchase $1,001 - $15,000
May 19, 2023 Apr 28, 2023 -69.73%
Congress pfp
Kathy E. Manning D / House
ABT logo
ABT ABBOTT LABORATORIES
Purchase $1,001 - $15,000
May 19, 2023 Apr 28, 2023 -8.09%
Congress pfp
Thomas R. Carper D / Senate
NVS logo
NVS Novartis AG Common Stock
Purchase $1,001 - $15,000
May 01, 2023 Apr 26, 2023 -22.16%