S 3014 Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.
Ensuring Timely Access to Generics Act of 2025
To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
Summary
The Ensuring Timely Access to Generics Act amends the Federal Food, Drug, and Cosmetic Act to modify the citizen petition process for generic drugs and biosimilars. The bill requires citizen petitions to be filed within 180 days after a person knew the relevant information forming the basis of the petition and establishes specific factors the FDA must consider when determining if a petition was submitted primarily to delay an application. The legislation requires parties to exhaust administrative remedies by filing a petition before pursuing a civil action and establishes procedures to dismiss civil actions that fail to meet these requirements. These changes aim to prevent frivolous petitions from delaying the FDA approval of generic drugs and biosimilar applications.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Shaheen, Jeanne [D-NH] (D-NH)
2 cosponsors
- Sen. Baldwin, Tammy [D-WI] (D-WI)
- Sen. Collins, Susan M. [R-ME] (R-ME)
Actions (2)
- Oct 16, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Oct 16, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Committee action
What happened to this bill in committee — the meetings where it was considered and every recorded vote taken on it.
Meetings where this bill was on the agenda
- Business meeting to consider S.2355, to amend the Public Health Service Act to provide for hospital and insurer price transparency, S.4189, to reduce the price of insulin and provide for patient protections with respect to the cost of insulin, S.4974, to amend the Federal Food, Drug, and Cosmetic Act with respect to food safety, S.5026, to require warning labels on sugar-sweetened foods and beverages, foods and beverages containing high-intensity sweeteners, ultra-processed foods, and foods high in nutrients of concern, such as added sugar, saturated fat, or sodium, to restrict junk food advertising to children, S.1414, to amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy, S.3788, to amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information, S.3794, to amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, S.494, to establish a national plan to coordinate research on epilepsy, S.4110, to revise and extend health workforce programs under title VII of the Public Health Service Act, S.1874, to amend the Public Health Service Act to reauthorize certain nursing workforce development programs, and S.380, to improve obstetric emergency care.
- Business meeting to consider S.1782, to prohibit discrimination on the basis of mental or physical disability in cases of organ transplants, S.3799, to amend the Public Health Service Act to reauthorize the Healthy Start Initiative, S.4109, to reauthorize the Stem Cell Therapeutic and Research Act of 2005, S.2339, to reauthorize the Young Women's Breast Health Education and Awareness Requires Learning Young Act of 2009, S.4472, to amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, S.2658, to require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office, S.3014, to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions, and S.1954, to improve the requirements for making a determination of interchangeability of a biological product and its reference product.
Full text
IN THE SENATE OF THE UNITED STATES
October 16, 2025
Mrs. Shaheen (for herself and Ms. Collins) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Ensuring Timely Access to Generics Act of 2025”.
SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.
Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)) is amended—
(1) in paragraph (1)—
(A) in subparagraph (A)(i), by inserting “, 10.31,” after “10.30”;
(B) in subparagraph (E)—
(i) by striking “application and” and inserting “application or”;
(ii) by striking “If the Secretary” and inserting the following:
“(i) In general.—If the Secretary”; and
(iii) by striking the second sentence and inserting the following:
“(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: “(aa) Whether the petition was submitted in accordance with paragraph (2)(B), based on when the petitioner knew the relevant information relied upon to form the basis of such petition. “(bb) When the petition was submitted in relation to when the petitioner reasonably should have known the relevant information relied upon to form the basis of such petition.
“(cc) Whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.
“(dd) Whether the petition was submitted close in time to a known, first date upon which an application under subsection
(b)(2) or (j) of this section or section 351(k) of the Public Health Service Act could be approved. “(ee) Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition. “(ff) Whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, including if the subsequent submission follows such response from the Secretary closely in time. “(gg) Whether the petition requests changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards the Secretary has determined to be applicable to the listed drug, reference product, or petitioner’s version of the same drug. “(hh) The petitioner’s record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay.
“(ii) Other relevant and appropriate factors, which the Secretary shall describe in guidance.
“(II) Guidance.—The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (I).”;
(C) by striking subparagraph (F);
(D) by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and
(E) in subparagraph (H), as so redesignated, by striking “submission of this petition” and inserting “submission of this document”;
(2) in paragraph (2)—
(A) by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively;
(B) by inserting before subparagraph (C), as so redesignated, the following:
“(A) 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) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence.
“(B) Timely submission of citizen petition.—A petition and any supplement to a petition shall be submitted within 180 days after the person knew the information that forms the basis of the request made in the petition or supplement.”;
(C) in subparagraph (C), as so redesignated—
(i) in the heading, by striking “within 150 days”;
(ii) in clause (i), by striking “during the 150-day period referred to in paragraph
(1)(F),”; and
(iii) by amending clause (ii) to read as follows:
“(ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.”;
(D) by amending subparagraph (D), as so redesignated, to read as follows:
“(D) Dismissal of certain civil actions.—
“(i) Petition.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection
(b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph
(A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.
“(ii) Timeliness.—If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (B), the court shall dismiss with prejudice the action for failure to timely file a petition.
“(iii) Final response.—If a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has taken final agency action on the petition within the meaning of subparagraph (C), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.”; and
(E) in clause (iii) of subparagraph (E), as so redesignated, by striking “as defined under subparagraph (2)(A)” and inserting “within the meaning of subparagraph (C)”; and
(3) in paragraph (4)—
(A) by striking “Exceptions” in the paragraph heading and all that follows through “This subsection does” and inserting “Exceptions.—This subsection does”;
(B) by striking subparagraph (B); and
(C) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly. <all>
Comments