340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2025; 340B PATIENTS Act of 2025
Summary
H.R. 4581, also known as the "340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2025" or the "340B PATIENTS Act of 2025", aims to ensure the accessibility of drugs furnished through the 340B drug discount program. The bill clarifies that drug manufacturers must offer discounted prices to covered entities regardless of where the drugs are dispensed. It also prohibits manufacturers from placing conditions on covered entities' ability to purchase drugs at discounted prices through contract pharmacies.
Expected Effects
This bill will likely increase access to discounted drugs for patients served by covered entities, particularly those who rely on contract pharmacies. It may also lead to increased financial stability for hospitals, clinics, and health centers participating in the 340B program. However, it could potentially decrease profits for drug manufacturers.
Potential Benefits
- Increased access to affordable prescription drugs for patients, especially those with chronic or life-threatening conditions.
- Enhanced financial stability for covered entities, allowing them to provide more comprehensive services to their communities.
- Clarification of the rules governing the 340B program, reducing uncertainty for covered entities and manufacturers.
- Support for contract pharmacy arrangements, which are often the only means by which covered entities can access vital specialty drugs.
- Potential reduction in drug price increases due to the inflationary penalty provisions under section 340B of the Public Health Service Act.
Potential Disadvantages
- Potential decrease in profits for drug manufacturers, which could lead to reduced investment in research and development.
- Possible increase in drug prices for non-340B purchasers to offset the discounts provided to covered entities.
- Risk of increased oversight and regulation to prevent abuse of the 340B program.
- Potential for unintended consequences due to the complex interactions within the pharmaceutical supply chain.
- Could lead to disputes between manufacturers and covered entities regarding compliance with the new regulations.
Constitutional Alignment
The bill appears to align with the General Welfare Clause of the U.S. Constitution, as it aims to improve public health by ensuring access to affordable prescription drugs. Congress has the power to regulate commerce, including the pharmaceutical industry, under Article I, Section 8. The bill does not appear to infringe on any specific constitutional rights or liberties.
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).