H.R.3162 - Affordable and Safe Prescription Drug Importation Act of 2025 (119th Congress)
Summary
H.R.3162, the Affordable and Safe Prescription Drug Importation Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to allow wholesale distributors, pharmacies, and individuals to import more affordable prescription drugs from countries like Canada, the UK, and members of the EU. The bill establishes a framework for certified foreign sellers and importers, setting criteria for drug safety, labeling, and supply chain security. It also includes provisions for penalties against online sales of adulterated or counterfeit drugs and emphasizes that the act does not preempt existing state or federal laws.
Expected Effects
The bill, if enacted, is likely to lower prescription drug costs for American consumers by increasing competition and providing access to drugs sold at lower prices in other developed countries. It will also create a regulatory framework for safe drug importation, including certification processes for foreign sellers and quality control measures. The FDA would have increased oversight and enforcement responsibilities.
Potential Benefits
- Reduced prescription drug costs for consumers.
- Increased access to needed medications.
- Establishment of safety and quality control measures for imported drugs.
- Potential for increased competition in the pharmaceutical market.
- Codification of existing enforcement discretion regarding personal importation.
Potential Disadvantages
- Potential risks of counterfeit or substandard drugs entering the supply chain.
- Possible challenges in ensuring the safety and quality of imported drugs.
- Potential for increased burden on the FDA for oversight and enforcement.
- Possible negative impact on the domestic pharmaceutical industry.
- Risk of supply chain disruptions or shortages.
Constitutional Alignment
The bill aligns with the Constitution's general welfare clause (Preamble) by attempting to provide affordable prescription drugs to citizens. Congress's authority to regulate interstate and foreign commerce (Article I, Section 8, Clause 3) provides the basis for federal regulation of drug importation. The bill includes provisions for due process and equal protection under the law (5th and 14th Amendments) through its regulatory framework and enforcement mechanisms.
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).