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S. 1095: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act

The proposed bill, known as the **Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act** or the **Stop STALLING Act**, primarily aims to enable the Federal Trade Commission (FTC) to tackle instances where companies submit false petitions to delay the approval of competing generic drugs or biosimilars. This is intended to enhance competition in the pharmaceutical market and improve the timely access of new generic medications for consumers.

Key Provisions of the Bill

  • Sham Petitions Definition: The bill defines a "sham" petition as one that is objectively baseless and is intended to misuse a governmental process to interfere with a competitor's business.
  • Liability for Sham Petitions: Individuals or entities submitting these sham petitions can be held liable for engaging in unfair competition practices, subject to enforcement by the FTC.
  • Civil Action: The FTC is granted the authority to initiate civil actions against those who file sham petitions, seeking penalties and appropriate relief in federal court.
  • Presumption of Delay: If the Secretary of Health and Human Services determines that a petition was filed mainly to delay approval of a competing application, the FTC can presume that the petitions are sham. The burden of proof would then fall on the defendant to show otherwise.
  • Civil Penalties: Those found liable for submitting sham petitions could face substantial financial penalties based on the revenue generated from the drugs involved during the petition’s review or a predefined daily penalty amount.
  • Application: The provisions of this bill will apply to new petitions submitted after the enactment date.

Enforcement Mechanism

The enforcement mechanism allows the FTC to pursue legal action against companies that engage in these practices. Once the FTC identifies a sham petition, it can take the following steps:

  • Commence a civil action in a U.S. district court.
  • Seek civil penalties based on the revenue generated from the relevant drug products or a maximum daily fine during the period the petition is under review.

Impact on Competition

The main purpose of this legislation is to discourage pharmaceutical companies from obstructing competition through the use of sham petitions. In doing so, it aims to foster a more competitive environment, which may lead to lower drug prices and improved access to medications for consumers. By streamlining the approval process for legitimate generic drugs, the bill is designed to enhance innovation and efficiency in the healthcare sector.

Relevant Companies

  • PFE - Pfizer Inc.: As a major pharmaceutical company, it may be impacted if its competitors could potentially file sham petitions against its products.
  • AMGN - Amgen Inc.: It may face increased competition from generic biosimilars, and should those petitions arise as a means to delay approvals, it could be subject to scrutiny under this law.

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

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Sponsors

7 bill sponsors

Actions

5 actions

Date Action
Apr. 10, 2025 Committee on the Judiciary. Reported by Senator Grassley without amendment. Without written report.
Apr. 10, 2025 Placed on Senate Legislative Calendar under General Orders. Calendar No. 45.
Apr. 03, 2025 Committee on the Judiciary. Ordered to be reported without amendment 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
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
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
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
Jefferson Shreve R / House
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $15,001 - $50,000
Mar 09, 2025 Feb 24, 2025 +1.41%
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
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
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
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
Emily Randall D / House
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Sale $1,001 - $15,000
Feb 11, 2025 Jan 06, 2025 +18.86%
Congress pfp
Virginia Foxx R / House
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $1,001 - $15,000
Jan 06, 2025 Dec 06, 2024 +15.13%
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
Sheldon Whitehouse D / Senate
AMGN logo
AMGN Amgen Inc
Sale (Partial) $1,001 - $15,000
Oct 10, 2024 Sep 17, 2024 -10.17%
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
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $50,001 - $100,000
Aug 20, 2024 Aug 07, 2024 -12.80%
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
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $1,001 - $15,000
Aug 20, 2024 Aug 02, 2024 -15.75%
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
Kathy E. Manning D / House
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $1,001 - $15,000
Aug 16, 2024 Jul 02, 2024 -6.68%
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
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
AMGN logo
AMGN AMGEN INC.
Purchase $1,001 - $15,000
Feb 06, 2024 Jan 23, 2024 -19.12%
Congress pfp
Tommy Tuberville R / Senate
AMGN logo
AMGN Amgen Inc. - Common Stock
Sale (Full) $15,001 - $50,000
Feb 14, 2024 Jan 19, 2024 -19.08%
Congress pfp
Michael C. Burgess R / House
AMGN logo
AMGN AMGEN INC.
Sale $15,001 - $50,000
Jan 22, 2024 Jan 02, 2024 -18.25%
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 $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
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
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
Greg Stanton D / House
AMGN logo
AMGN AMGEN INC.
Sale $1,001 - $15,000
Nov 09, 2023 Oct 24, 2023 -23.91%
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
AMGN logo
AMGN AMGEN INC.
Purchase $1,001 - $15,000
Nov 09, 2023 Sep 26, 2023 -20.14%
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
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
Jared Moskowitz D / House
AMGN logo
AMGN AMGEN INC. - COMMON STOCK
Purchase $1,001 - $15,000
Aug 21, 2024 Jul 14, 2023 +4.69%
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
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
Shelley Moore Capito R / Senate
AMGN logo
AMGN Amgen Inc. - Common Stock
Sale (Full) $1,001 - $15,000
Jul 17, 2023 Jun 12, 2023 +6.19%
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
Josh Gottheimer D / House
AMGN logo
AMGN AMGEN INC.
Sale $1,001 - $15,000
Jun 11, 2023 May 01, 2023 -10.68%
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
AMGN logo
AMGN AMGEN INC.
Purchase $1,001 - $15,000
May 19, 2023 Apr 28, 2023 -11.00%