S 3014 — Ensuring Timely Access to Generics Act of 2025

Bill Text

• Introduced Introduced in Senate Current html October 16, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends the process and requirements for citizen petitions related to new drug applications, impacting how delays in drug approval are assessed and the procedural requirements for filing civil actions.

• 21 U.S.C. 355(q)(1)(B)

  application and → application or

  Changes the wording from 'application and' to 'application or' to clarify the conditions under which petitions may be submitted.

• 21 U.S.C. 355(q)(1)(B)

  If the Secretary → (i) In general.--If the Secretary

  Introduces a new format for the Secretary's authority, clarifying the general condition for evaluating petitions.

• 21 U.S.C. 355(q)(1)(B)

  the second sentence → (ii) Primary purpose of delaying.--(I) In general.--In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors: ...

  Replaces the original second sentence with a detailed framework for evaluating whether a petition delays drug approval.

• 21 U.S.C. 355(q)(2)

  A person shall submit a petition to the Secretary under paragraph (1) → In general.--A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j)...

  Mandates that individuals submit a petition before initiating a civil action regarding drug application approvals.

• 21 U.S.C. 355(q)(2)

  within 150 days after the date of the petition → within 180 days after the person knew the information that forms the basis of the request

  Extends the time allowed for submitting petitions related to civil actions from 150 days to 180 days.

• 21 U.S.C. 355(q)(2)(C)

  within the 150-day period referred to in paragraph (1)(F), → on or after the date that is 151 days after the date of submission of the petition,

  Modifies the conditions under which the Secretary may approve applications related to pending petitions.

• 21 U.S.C. 355(q)(2)(D)

  Exceptions → Exceptions.--This subsection does

  Revises the heading and introductory clause for clarity in the exceptions to the provisions of this section.

• 21 U.S.C. 355(q)(2)(D)(i)

  the action for failure to exhaust administrative remedies. → the action for failure to timely file a petition.

  Sets stricter dismissal criteria for civil actions that fail to comply with timely petition filing requirements.

• 21 U.S.C. 355(q)(2)(D)(iii)

  if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) → that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2)

  Clarifies conditions under which civil actions related to petitions may be dismissed for lack of final agency action.

• 21 U.S.C. 355(q)(1)(H)

  submission of this petition → submission of this document

  Updates the language to standardize the terminology used for submitting petitions.

Action History

1. October 16, 2025

   Introduced in Senate

2. October 16, 2025

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

• Jeanne Shaheen · Primary
• Susan M. Collins · Cosponsor
• Tammy Baldwin · Cosponsor

Subjects