As part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra today announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures.
President Biden will issue a Presidential Determination broadening HHS’ authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages.
“To ensure Americans always have the essential medicines and other critical medical products we need, we must have more control over our supply chains,” HHS Secretary Becerra emphasized this afternoon at the inaugural convening of the White House Council on Supply Chain Resilience. “In addition to having the necessary data and insights for visibility into supply chain disruptions, we need to be better positioned to help our partners in the private sector mitigate supply chain disruptions. The actions we have taken today, and will continue to take, accomplish these goals.”
Following the issuance of the Presidential Determination, HHS will begin using the newly delegated Title III authorities which will be managed by the Administration for Strategic Preparedness and Response (ASPR). HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines. This will help ensure the United States has all the tools and resources necessary to prepare for, respond to, and recover from future pandemics, biological threats, and other public health emergencies.
Additionally, ASPR and the U.S. Department of Commerce are partnering to conduct assessments of the U.S. Public Health Industrial Base supply chain, which will inform requirements to design, build, and sustain long-term capabilities in the United States to manufacture supplies and devices for public health emergencies. The assessments will identify and address points of failure in the U.S. Public Health Industrial Base supply chain with a focus on supplies critical for the manufacturing of the influenza vaccine, FDA-designated essential medicines, and high-consequence biological medical countermeasures.
“The actions announced today will give ASPR additional flexibility to promote the onshoring of essential manufacturing capabilities through the DPA, which will further strengthen our response to public health emergencies,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Our partnership with the Department of Commerce is an important extension of this work which will highlight potential gaps in the supply chain of raw materials, active pharmaceutical ingredients, and essential medicines.”
In addition to the Department’s new DPA efforts and the assessments it’s conducting with the U.S. Department of Commerce, HHS will designate a new Supply Chain Resilience and Shortage Coordinator responsible for coordinating efforts across the Department that advance the resilience of medical product and food supply chains and accelerate the Department’s response to related shortages. Institutionalizing this coordination across the Department will help HHS meet its long-term supply chain resilience and shortage mitigation goals.
“The coordinator and their team will leverage extensive experience coordinating cross-HHS initiatives and conducting research on the supply chains of medical products,” said Principal Deputy Assistant Secretary for Planning and Evaluation Rebecca Haffajee. “This new role will strengthen synergies in HHS’ coordination and implementation of evidence-based policies and strategies to strengthen America’s supply chains.”