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Ensuring Timely Access to Generics Act of 2021

USA117th CongressS-562| Senate 
| Updated: 3/3/2021
Jeanne Shaheen

Jeanne Shaheen

Democratic Senator

New Hampshire

Cosponsors (3)
Bill Cassidy (Republican)Michael F. Bennet (Democratic)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Ensuring Timely Access to Generics Act of 2021 This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar. (The current statute refers to these petitions as citizen petitions , which typically involve requests that the 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 requires the FDA to establish procedures for referring such a delaying petition to the Federal Trade Commission. 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.
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Timeline

Bill from Previous Congress

S 116-1169
Ensuring Timely Access to Generics Act of 2019
Mar 3, 2021
Introduced in Senate
Mar 3, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

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


  • March 3, 2021
    Introduced in Senate


  • March 3, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
Administrative remediesCivil actions and liabilityDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government liabilityPrescription drugs

Ensuring Timely Access to Generics Act of 2021

USA117th CongressS-562| Senate 
| Updated: 3/3/2021
Ensuring Timely Access to Generics Act of 2021 This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar. (The current statute refers to these petitions as citizen petitions , which typically involve requests that the 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 requires the FDA to establish procedures for referring such a delaying petition to the Federal Trade Commission. 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.
View Full Text

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
Mar 3, 2021
Introduced in Senate
Mar 3, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

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


  • March 3, 2021
    Introduced in Senate


  • March 3, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jeanne Shaheen

Jeanne Shaheen

Democratic Senator

New Hampshire

Cosponsors (3)
Bill Cassidy (Republican)Michael F. Bennet (Democratic)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesCivil actions and liabilityDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government liabilityPrescription drugs