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Expanding Access to Low-Cost Generics Act of 2023

USA118th CongressS-1114| Senate 
| Updated: 6/22/2023
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Expanding Access to Low-Cost Generics Act of 2023 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met. If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved. Additionally, the FDA must inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).

Bill Text Versions

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2 versions available

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Timeline

Bill from Previous Congress

S 116-3092
Expanding Access to Low-Cost Generics Act of 2019

Bill from Previous Congress

S 117-2910
Expanding Access to Low-Cost Generics Act of 2021
Mar 30, 2023
Introduced in Senate
Mar 30, 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. 108.
  • Bill from Previous Congress

    S 116-3092
    Expanding Access to Low-Cost Generics Act of 2019


  • Bill from Previous Congress

    S 117-2910
    Expanding Access to Low-Cost Generics Act of 2021


  • March 30, 2023
    Introduced in Senate


  • March 30, 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. 108.

Health

Related Bills

  • S 118-775: Increasing Transparency in Generic Drug Applications Act
  • HR 118-3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Drug safety, medical device, and laboratory regulationPrescription drugs

Expanding Access to Low-Cost Generics Act of 2023

USA118th CongressS-1114| Senate 
| Updated: 6/22/2023
Expanding Access to Low-Cost Generics Act of 2023 This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met. If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved. Additionally, the FDA must inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).

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 116-3092
Expanding Access to Low-Cost Generics Act of 2019

Bill from Previous Congress

S 117-2910
Expanding Access to Low-Cost Generics Act of 2021
Mar 30, 2023
Introduced in Senate
Mar 30, 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. 108.
  • Bill from Previous Congress

    S 116-3092
    Expanding Access to Low-Cost Generics Act of 2019


  • Bill from Previous Congress

    S 117-2910
    Expanding Access to Low-Cost Generics Act of 2021


  • March 30, 2023
    Introduced in Senate


  • March 30, 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. 108.
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 118-775: Increasing Transparency in Generic Drug Applications Act
  • HR 118-3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationPrescription drugs