S. 3014: Ensuring Timely Access to Generics Act of 2025

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.