H.R.3546 - Prescription Drug Price Relief Act of 2025 (119th Congress)
Summary
H.R.3546, the Prescription Drug Price Relief Act of 2025, aims to lower prescription drug prices in the United States by ending government-granted monopolies for manufacturers charging higher prices than the median prices in other countries. The bill mandates the Secretary of Health and Human Services to identify excessively priced drugs based on international reference pricing and other factors. It allows for the waiver of exclusivities and the granting of open, non-exclusive licenses for generic drug manufacturing.
Expected Effects
The likely effect of this bill is a reduction in prescription drug prices for American consumers. This would be achieved by increasing competition through generic drug manufacturing. The bill also establishes a public database for tracking drug prices and manufacturer reporting requirements.
Potential Benefits
- Lower prescription drug costs for patients.
- Increased access to life-saving medications.
- Greater competition in the pharmaceutical market.
- Transparency in drug pricing through public databases.
- Potential savings for government healthcare programs.
Potential Disadvantages
- Potential reduction in pharmaceutical company profits, possibly impacting R&D investment.
- Possible legal challenges from pharmaceutical companies.
- Risk of drug shortages if generic manufacturing cannot meet demand.
- Complexity in determining 'reasonable royalty' rates for licenses.
- Potential for unintended consequences in international trade relations.
Most Disadvantaged Areas:
Constitutional Alignment
The bill's alignment with the US Constitution is primarily rooted in the Commerce Clause (Article I, Section 8), which grants Congress the power to regulate commerce among the several states and with foreign nations. By addressing drug pricing and international comparisons, the bill seeks to regulate aspects of interstate and international commerce.
Additionally, the bill's provisions related to intellectual property and patents could be viewed in light of Article I, Section 8, Clause 8, which empowers Congress to grant patents and copyrights. The bill does not violate this clause as it provides for reasonable royalties to patent holders.
However, potential legal challenges could arise under the Fifth Amendment's Takings Clause if pharmaceutical companies argue that the waiver of exclusivities constitutes a taking of their property without just compensation.
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).