Combating Counterfeit Pharmaceuticals Act of 2025
Summary
The Combating Counterfeit Pharmaceuticals Act of 2025 amends the Fentanyl Sanctions Act to target the trafficking of counterfeit drugs and copy-cat ingredients. It broadens the scope of the original act to include all illicit drugs, not just opioids. The bill also modifies requirements for the Director of National Intelligence, allowing delegation of certain responsibilities, and includes a waiver for access to prescription medications on the drug shortage list.
Expected Effects
This act is likely to increase efforts to combat the spread of counterfeit drugs, potentially reducing harm to individuals who unknowingly consume them. It may also lead to increased scrutiny and regulation of pharmaceutical ingredients and supply chains. The delegation of authority from the Director of National Intelligence could streamline intelligence operations related to drug trafficking.
Potential Benefits
- Enhanced public safety through reduced availability of counterfeit drugs.
- Improved access to needed medications during shortages.
- Streamlined intelligence operations by allowing delegation of authority.
- More comprehensive approach to combating illicit drug trafficking beyond just opioids.
- Clearer definitions of 'copy-cat ingredient' to aid enforcement.
Potential Disadvantages
- Potential for increased regulatory burden on legitimate pharmaceutical manufacturers.
- Possible delays in access to certain medications due to increased scrutiny.
- Risk of unintended consequences from broadened definitions, impacting legitimate generic drug production.
- Increased costs associated with enforcement and regulation.
- Delegation of authority could reduce accountability if not properly managed.
Constitutional Alignment
The Combating Counterfeit Pharmaceuticals Act of 2025 appears to align with the Constitution's broad goals of promoting the general welfare (Preamble) by aiming to protect public health and safety. Congress's authority to regulate interstate commerce (Article I, Section 8, Clause 3) provides a basis for federal legislation addressing drug trafficking and pharmaceutical regulation. The Act does not appear to infringe upon any specific constitutional rights or limitations.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).