As of last week, the Biden Administration announced the 100-day supply chain assessment findings and its global vaccine assistance plan. In addition, the FDA issued a series of guidance documents for the Drug Supply Chain Security Act (DSCSA). Please see details for these and other supply chain developments below:
- On May 31, the heads of the International Monetary Fund (IMF), World Health Organization (WHO), World Bank Group, and World Trade Organization (WTO) jointly announced a new commitment for vaccine equity, covering financing, manufacturing, and trade elements.
- On June 3, the FDA issued two guidance documents and two draft guidance documents to promote compliance with the DSCSA requirements.
- Guidance: Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers provides drug manufacturers and repackagers with further clarification on the requirement to put product identifiers on drug packages.
- Guidance: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification assists manufacturers and certain trading partners in identifying suspect products of illegitimacy entering the pharmaceutical distribution supply chain and clarifies the process to notify the FDA.
- The revised Draft Guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act lays out the FDA’s current understanding of the terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution.”
- Draft Guidance: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act intends to provide recommendations for supply chain stakeholders, particularly trading partners, to comply with the DSCSA requirements for enhanced drug distribution security, which will become effective on November 27, 2023.
- On June 3, the Biden Administration announced that it will work with U.S. manufacturers to increase vaccine production for the rest of the world and support global supply chains to assist other countries expand their own capacity to produce vaccines. The Administration also announced its framework for sharing at least 80 million U.S. vaccine doses globally by the end of June and the detailed plan for the first 25 million doses.
- On June 3, the White House COVID-19 Response Team announced that more than 63 percent of adult Americans had received at least one shot of vaccine, and more than 52 percent of adult Americans had been fully vaccinated.
- On June 8, the Biden Administration released the findings report for the 100-day supply chain assessments for four critical products under Executive Order 14017. For pharmaceuticals and active pharmaceutical ingredients (APIs), the Administration pointed out the heavy reliance on foreign supplies and concluded that “[a] new approach is needed to ensure more resilient supply chains that includes improving transparency, building emergency capacity, and investing in domestic production.”
The Administration also announced immediate actions to address supply chain issues, including:
- Establishing a public-private consortium for advanced manufacturing and onshoring of domestic essential medicine production.
- Developing novel platform technologies to increase domestic manufacturing capacity for API.
Please do not hesitate to contact us if you have any questions about these developments.