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Ensuring Timely Access to Generics Act of 2023

USA118th CongressS-1067| Senate 
| Updated: 6/22/2023
Jeanne Shaheen

Jeanne Shaheen

Democratic Senator

New Hampshire

Cosponsors (5)
Mike Braun (Republican)Michael F. Bennet (Democratic)Tammy Baldwin (Democratic)Susan M. Collins (Republican)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Ensuring Timely Access to Generics Act of 2023 This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. ( Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.) Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.

Bill Text Versions

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2 versions available

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Timeline

Bill from Previous Congress

S 116-1169
Ensuring Timely Access to Generics Act of 2019

Bill from Previous Congress

S 117-562
Ensuring Timely Access to Generics Act of 2021
Mar 29, 2023
Introduced in Senate
Mar 29, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
  • Bill from Previous Congress

    S 116-1169
    Ensuring Timely Access to Generics Act of 2019


  • Bill from Previous Congress

    S 117-562
    Ensuring Timely Access to Generics Act of 2021


  • March 29, 2023
    Introduced in Senate


  • March 29, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 11, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • June 22, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.


  • June 22, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.

Health

Related Bills

  • S 118-2226: National Defense Authorization Act for Fiscal Year 2024
  • S 118-1269: INSULIN Act of 2023
Drug safety, medical device, and laboratory regulationPrescription drugs

Ensuring Timely Access to Generics Act of 2023

USA118th CongressS-1067| Senate 
| Updated: 6/22/2023
Ensuring Timely Access to Generics Act of 2023 This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. ( Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.) Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.

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 116-1169
Ensuring Timely Access to Generics Act of 2019

Bill from Previous Congress

S 117-562
Ensuring Timely Access to Generics Act of 2021
Mar 29, 2023
Introduced in Senate
Mar 29, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
  • Bill from Previous Congress

    S 116-1169
    Ensuring Timely Access to Generics Act of 2019


  • Bill from Previous Congress

    S 117-562
    Ensuring Timely Access to Generics Act of 2021


  • March 29, 2023
    Introduced in Senate


  • March 29, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 11, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • June 22, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.


  • June 22, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
Jeanne Shaheen

Jeanne Shaheen

Democratic Senator

New Hampshire

Cosponsors (5)
Mike Braun (Republican)Michael F. Bennet (Democratic)Tammy Baldwin (Democratic)Susan M. Collins (Republican)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 118-2226: National Defense Authorization Act for Fiscal Year 2024
  • S 118-1269: INSULIN Act of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationPrescription drugs