We have received text from S. 3014: Ensuring Timely Access to Generics Act of 2025. This bill was received on 2025-10-16, and currently has 2 cosponsors.
Here is a short summary of the bill:
This bill, titled the
Ensuring Timely Access to Generics Act of 2025
, aims to modify certain aspects of how citizen petitions are processed under the Federal Food, Drug, and Cosmetic Act. The main goal of the bill is to prevent the misuse of citizen petitions that could unnecessarily delay the approval of generic drugs. Here are the key provisions of the bill:
Modifications to Citizen Petitions
The bill proposes amendments to Section 505(q) of the Federal Food, Drug, and Cosmetic Act concerning how citizen petitions can affect the approval of drug applications. The relevant changes include:
- Factors for Delay Assessment: The Secretary of Health and Human Services will now have additional factors to consider when determining if a citizen petition was submitted with the main intention of delaying a generic drug's approval. These factors include:
- The timing of the petition relative to when the petitioner knew the relevant information.
- Whether the petitioner has submitted multiple petitions raising similar issues.
- Whether the petition raises more stringent standards than previously established.
- A record of previous petitions deemed intended to cause delays.
- Timeliness of Submission: Petitioners are required to submit their petitions within 180 days after learning about the relevant information supporting their claims.
- Requirement Before Civil Action: Individuals must submit a petition before they can file a civil lawsuit that seeks to delay or block the approval of a drug application. The petition must include all arguments and evidence that would support relief in a civil action.
- Dismissal of Civil Actions: Courts are mandated to dismiss lawsuits seeking to challenge delays in approvals if petitioners have not complied with the new requirements outlined in this bill.
Impact on Drug Approval Process
The overall impact of the bill is to streamline the process of approving generic drugs, reducing delays that can arise from citizen petitions that are not based on substantial claims. By establishing clearer guidelines and timelines for submitting these petitions, the bill seeks to foster a more efficient drug approval landscape, thereby potentially improving access to generic medications for consumers once the petitions are processed.
Relevant Companies
- PFE (Pfizer Inc.): As a large pharmaceutical company, Pfizer could be impacted by the fast-tracking of generic drugs that compete with its branded medications.
- SNY (Sanofi): Similar to Pfizer, Sanofi may face competition from generics which could affect its revenue from existing branded products.
- ABBV (AbbVie Inc.): The company may experience shifts in market dynamics as generics enter, particularly in relation to its blockbuster drugs.
Senator Jeanne Shaheen Bill Proposals
Here are some bills which have recently been proposed by Senator Jeanne Shaheen:
- S.3014: Ensuring Timely Access to Generics Act of 2025
- S.2657: STOP China and Russia Act of 2025
- S.2648: Protecting Public Naval Shipyards Act of 2025
- S.2627: A bill to require the United States Postal Service to designate a single, unique ZIP Code for Swanzey, New Hampshire.
- S.2611: Safeguarding the Integrity of the Human Rights Reports Act of 2025
- S.2592: Supporting Ukraine Act of 2025
You can track bills proposed by Senator Jeanne Shaheen on Quiver Quantitative's politician page for Shaheen.
Senator Jeanne Shaheen Net Worth
Quiver Quantitative estimates that Senator Jeanne Shaheen is worth $7.8M, as of October 23rd, 2025. This is the 126th highest net worth in Congress, per our live estimates.
Shaheen has approximately $0 invested in publicly traded assets which Quiver is able to track live.
You can track Senator Jeanne Shaheen's net worth on Quiver Quantitative's politician page for Shaheen.
Senator Jeanne Shaheen Stock Trading
We have data on up to $315.0K of trades from Senator Jeanne Shaheen, which we parsed from STOCK Act filings.
You can track Senator Jeanne Shaheen's stock trading on Quiver Quantitative's politician page for Shaheen.
This article is not financial advice. See Quiver Quantitative's disclaimers for more information.
