H.R.1060 - Modern Authentication of Pharmaceuticals Act of 2025 (119th Congress)
Summary
H.R.1060, the Modern Authentication of Pharmaceuticals Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act. The goal is to modernize the authentication methods for controlled substances within the pharmaceutical distribution supply chain. This involves incorporating physical chemical identifiers on individual doses of solid oral dosage form controlled substances manufactured five years after the Act's enactment.
Expected Effects
The Act will mandate the inclusion of physical chemical identifiers on certain controlled substances. This will enhance the ability to verify the authenticity of these drugs and reduce the risk of counterfeit medications entering the market. The changes also redefine 'product identifier' and 'verification' within the context of the Act to accommodate the new authentication methods.
Potential Benefits
- Enhanced patient safety through reduced risk of counterfeit drugs.
- Improved supply chain security for controlled substances.
- Modernization of authentication methods using advanced technology.
- Increased confidence in the integrity of pharmaceutical products.
- Better tracking and tracing of controlled substances to combat illegal activities.
Most Benefited Areas:
Potential Disadvantages
- Increased manufacturing costs for pharmaceutical companies.
- Potential delays in the production and distribution of affected medications during the initial implementation phase.
- Possible challenges in developing and implementing standardized physical chemical identifiers.
- The five-year delay before implementation may prolong the risk of counterfeit drugs in the interim.
- The Act focuses solely on solid oral dosage forms, potentially neglecting other forms of controlled substances.
Constitutional Alignment
The bill appears to align with the Constitution's Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce, including the regulation of pharmaceuticals. The bill aims to ensure the safety and efficacy of drugs distributed across state lines, which falls under the purview of interstate commerce regulation. There do not appear to be any violations of individual rights or freedoms as protected by the Bill of Rights.
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).