S. 3134: Combating Counterfeit Pharmaceuticals Act of 2025

This bill, known as the Combating Counterfeit Pharmaceuticals Act of 2025, aims to address the issues surrounding counterfeit drugs and copy-cat pharmaceutical ingredients. Here is a summary of its main points:

Short Title

The legislation can be referred to as the "Combating Counterfeit Pharmaceuticals Act of 2025."

Definitions

The bill introduces new definitions for two key terms:

• Copy-cat ingredient: This refers to an ingredient in a drug that imitates or claims to be a component of a legitimate prescription drug but is made differently or does not meet the quality expected of that drug.
• Counterfeit drug: This term retains its existing legal definition as outlined in federal drug law.

Changes to the Fentanyl Sanctions Act

The legislation aims to update the Fentanyl Sanctions Act with several amendments, including:

• Changing references from "opioid" to "illicit drug" in multiple sections to broaden the scope of the law to include all illicit drugs, not just opioids.
• Adding provisions for identifying and addressing counterfeit drugs and copy-cat ingredients as part of the overall drug trafficking strategy.

Director of National Intelligence

The bill allows for the Director of National Intelligence to delegate certain authorities concerning the identification and reporting of foreign drug traffickers, enhancing the coordination on combating drug trafficking.

Prescription Medication Access Waivers

There is a provision for a waiver related to accessing prescription medications during drug shortages. This aligns access with the current drug shortage list maintained by health authorities.

Technical Amendments

Several technical and conforming amendments are proposed to ensure that the language used in the Fentanyl Sanctions Act is consistent with the updates made by this legislation, particularly focusing on the illicit drug terminology.

Impact on Intelligence Reporting

The bill also seeks to streamline the briefings and reporting on drug trafficking and enforcement measures related to narcotics, ensuring that intelligence resources can better target illicit drug operations.

Implementation and Compliance

The modifications will require compliance across various federal agencies involved in drug enforcement and public health, ensuring that efforts to combat counterfeit pharmaceuticals are prioritized and effectively managed.

Relevant Companies

• PFE (Pfizer Inc.): As a major pharmaceutical company, it may face increased scrutiny or regulatory requirements related to the use of copy-cat ingredients in medications.
• MRK (Merck & Co., Inc.): Similarly, as a leading provider of pharmaceuticals, it could be impacted by new regulations addressing counterfeit drugs.