What does Preamble of Ensuring Timely Access to Generics Act of 2025 do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act regarding citizen petitions.

What does SHORT TITLE. of Ensuring Timely Access to Generics Act of 2025 do?

This bill is formally titled the Ensuring Timely Access to Generics Act of 2025.

What does ENSURING TIMELY ACCESS TO GENERICS. of Ensuring Timely Access to Generics Act of 2025 do?

This section amends Section 505(q) of the Federal Food, Drug, and Cosmetic Act. It modifies procedures related to citizen petitions concerning drug applications, aiming to ensure timely access to generics. The Secretary is given factors to consider when determining if a petition was submitted with the primary purpose of delaying an application, including the timing of submission relative to when relevant information was known. A person must submit a citizen petition before filing a civil action seeking to delay or prevent approval of a drug application. Petitions and supplements must be submitted within 180 days after knowing the information forming the basis of the request. Civil actions filed without complying with petition requirements may be dismissed. Exceptions to certain procedures are modified.

Back to bills

Ensuring Timely Access to Generics Act of 2025

Last updated: 10/16/2025 · Introduced: 10/16/2025

Author: Jeanne Shaheen (D-NH)

TL;DR (AI)

This bill amends the Federal Food, Drug, and Cosmetic Act to streamline procedures for citizen petitions related to drug applications, with the goal of accelerating generic drug approvals.
To prevent delays, the bill requires parties seeking to delay drug application approval to first submit a citizen petition within 180 days of obtaining relevant information.
Civil actions attempting to delay or prevent drug application approval without prior submission of a compliant citizen petition may be dismissed by a court.

119th Congressin committeeS. 4189(In Committee)Official page

Verified Votes

No verified votes yet.

Community Votes

No community votes yet. Be the first!

Voting as guest · Sign in for verified votes

Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

Click "Show details" to explore individual sections. Use the community vote above or visit All Sections to vote per section.

Read official text

Want the full experience?

Create a free account to cast verified votes on each section, get a personalized summary, and track your voting history.

Create Free Account