Drug Shortage Prevention Act of 2025
Summary
The Drug Shortage Prevention Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act to improve notification procedures regarding potential drug shortages. It requires manufacturers to notify the Secretary of Health and Human Services about discontinuances, interruptions, or increased demand for critical drugs. The bill also mandates more detailed reporting on supply chains, including information on active pharmaceutical ingredient suppliers.
Expected Effects
This act will likely lead to earlier warnings about potential drug shortages, allowing healthcare providers and patients more time to prepare and find alternatives. Enhanced supply chain transparency could also help identify and address vulnerabilities that contribute to shortages. The changes should improve the overall stability and reliability of the drug supply chain.
Potential Benefits
- Early Warning System: Provides earlier notification of potential drug shortages.
- Improved Transparency: Requires more detailed reporting on drug supply chains.
- Better Preparedness: Allows healthcare providers and patients to prepare for shortages.
- Enhanced Supply Chain Stability: Helps identify and address vulnerabilities in the drug supply chain.
- Public Health Protection: Ensures continued access to critical medications.
Potential Disadvantages
- Increased Burden on Manufacturers: May increase reporting requirements for drug manufacturers.
- Potential for Over-Reporting: Manufacturers might over-report potential issues to avoid penalties.
- Limited Enforcement: The effectiveness depends on the enforcement capabilities of the Secretary.
- Cost Implications: Increased reporting and compliance could lead to higher drug costs.
- Voluntary Reporting Loopholes: Voluntary reporting may not capture all relevant supply chain issues.
Constitutional Alignment
The Drug Shortage Prevention Act aligns with the Constitution's general welfare clause (Preamble). Congress has the power to regulate interstate commerce (Article I, Section 8), which includes the manufacturing and distribution of drugs. The Act does not appear to infringe on any specific constitutional rights or freedoms.
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).