On April 2, 2024, the Department of Health and Human Services (HHS) released a white paper highlighting steps HHS has taken to prevent and mitigate the drug shortages millions of Americans have experienced while providing solutions to address the mounting issue. HHS has partnered with several federal departments, such as the Food & Drug Administration and the Federal Trade Commission, to monitor and improve pharmaceutical supply chain issues. HHS has specifically established a new coordinating role to strengthen and enhance supply chain transparency for pharmaceuticals and other medical products. The white paper focuses on generic sterile drugs; however, the challenges and solutions that have been laid out impact various other medical products. Key highlights include:
- Drug shortages have negatively impacted the healthcare system for decades, which impacts stakeholders from manufacturers to pharmacies. Critical issues include a lack of transparency, pricing concerns, and power imbalances in the supply chain.
- Policy solutions should include collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program (MRAP) and a Hospital Resilient Supply Program (HRSP) to increase transparency in the market.
- HHS’s progress in addressing drug shortages should be paired with long-term solutions, such as additional statutory authorities and funding to resolve underlying causes.
Read more about the white paper “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States” here.