Legis Daily

Stop STALLING Act

USA119th CongressS-1095| Senate 
| Updated: 4/10/2025
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (6)
Richard J. Durbin (Democratic)Ted Cruz (Republican)Cory A. Booker (Democratic)Peter Welch (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This legislation aims to curb anti-competitive practices in the pharmaceutical industry by empowering the Federal Trade Commission (FTC) to address "sham" citizen petitions. These petitions are often filed to delay the market entry of competing generic drugs and biosimilars, hindering competition and increasing drug costs. The bill seeks to ensure that only petitions raising legitimate public health concerns receive efficient review, while deterring those intended solely for delay. The bill defines a "sham" petition as one that is objectively baseless and attempts to use a governmental process to interfere with a competitor's business, rather than seeking a legitimate outcome. Submitting such a petition, or a series of them, is deemed an unfair method of competition under the Federal Trade Commission Act. The FTC is authorized to initiate civil actions in federal court against individuals or entities found to be in violation. In such civil actions, a covered petition is presumed to be part of a sham series if the Secretary of Health and Human Services (HHS) determines it was submitted primarily to delay approval and refers this finding to the FTC. Those found liable face significant civil penalties, which can be the greater of any revenue earned from the sale of the drug product during the petition's review or $50,000 for each calendar day the sham petition was under HHS review. This measure is intended to provide a strong deterrent against the misuse of the citizen petition process.

Bill Text Versions

View Text
2 versions available

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Timeline

Bill from Previous Congress

S 116-1224
Stop STALLING Act

Bill from Previous Congress

S 118-148
Stop STALLING Act

Bill from Previous Congress

S 117-1425
Stop STALLING Act
Mar 24, 2025
Introduced in Senate
Mar 24, 2025
Read twice and referred to the Committee on the Judiciary.
Apr 3, 2025
Committee on the Judiciary. Ordered to be reported without amendment favorably.
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.
  • Bill from Previous Congress

    S 116-1224
    Stop STALLING Act


  • Bill from Previous Congress

    S 118-148
    Stop STALLING Act


  • Bill from Previous Congress

    S 117-1425
    Stop STALLING Act


  • March 24, 2025
    Introduced in Senate


  • March 24, 2025
    Read twice and referred to the Committee on the Judiciary.


  • April 3, 2025
    Committee on the Judiciary. Ordered to be reported without amendment favorably.


  • April 10, 2025
    Committee on the Judiciary. Reported by Senator Grassley without amendment. Without written report.


  • April 10, 2025
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 45.

Health

Administrative remediesBusiness ethicsCivil actions and liabilityCompetition and antitrustDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Licensing and registrationsPrescription drugsPublic participation and lobbying

Stop STALLING Act

USA119th CongressS-1095| Senate 
| Updated: 4/10/2025
This legislation aims to curb anti-competitive practices in the pharmaceutical industry by empowering the Federal Trade Commission (FTC) to address "sham" citizen petitions. These petitions are often filed to delay the market entry of competing generic drugs and biosimilars, hindering competition and increasing drug costs. The bill seeks to ensure that only petitions raising legitimate public health concerns receive efficient review, while deterring those intended solely for delay. The bill defines a "sham" petition as one that is objectively baseless and attempts to use a governmental process to interfere with a competitor's business, rather than seeking a legitimate outcome. Submitting such a petition, or a series of them, is deemed an unfair method of competition under the Federal Trade Commission Act. The FTC is authorized to initiate civil actions in federal court against individuals or entities found to be in violation. In such civil actions, a covered petition is presumed to be part of a sham series if the Secretary of Health and Human Services (HHS) determines it was submitted primarily to delay approval and refers this finding to the FTC. Those found liable face significant civil penalties, which can be the greater of any revenue earned from the sale of the drug product during the petition's review or $50,000 for each calendar day the sham petition was under HHS review. This measure is intended to provide a strong deterrent against the misuse of the citizen petition process.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-1224
Stop STALLING Act

Bill from Previous Congress

S 118-148
Stop STALLING Act

Bill from Previous Congress

S 117-1425
Stop STALLING Act
Mar 24, 2025
Introduced in Senate
Mar 24, 2025
Read twice and referred to the Committee on the Judiciary.
Apr 3, 2025
Committee on the Judiciary. Ordered to be reported without amendment favorably.
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.
  • Bill from Previous Congress

    S 116-1224
    Stop STALLING Act


  • Bill from Previous Congress

    S 118-148
    Stop STALLING Act


  • Bill from Previous Congress

    S 117-1425
    Stop STALLING Act


  • March 24, 2025
    Introduced in Senate


  • March 24, 2025
    Read twice and referred to the Committee on the Judiciary.


  • April 3, 2025
    Committee on the Judiciary. Ordered to be reported without amendment favorably.


  • April 10, 2025
    Committee on the Judiciary. Reported by Senator Grassley without amendment. Without written report.


  • April 10, 2025
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 45.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (6)
Richard J. Durbin (Democratic)Ted Cruz (Republican)Cory A. Booker (Democratic)Peter Welch (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)

Judiciary Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesBusiness ethicsCivil actions and liabilityCompetition and antitrustDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Licensing and registrationsPrescription drugsPublic participation and lobbying