In the past week, both the executive and legislative branches acted to address medical product supply chain issues. President Biden further increased his vaccine supply goal, invoked the Defense Production Act (DPA) for the first time, and is seeking funds to build two vaccine manufacturing facilities. Meanwhile, the House Committee on Energy and Commerce Subcommittee on Health held a hearing to discuss the concern of overreliance on foreign medical supplies. Please see details for these and other supply chain developments below:
- On January 29, the FDA updated its August 2020 Guidance: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. Most updates in the guidance are administrative in nature, but notably, the guidance states that the FDA has implemented interim processes to communicate with manufacturing facilities about issues identified following a review of records or other information requested in advance of or in lieu of a pre-approval or pre-license inspection. Responses from the facility about these issues will, as feasible, be considered before the FDA takes action on a pending application.
- On February 2, President Biden announced Increased Vaccine Supply, Initial Launch of the Federal Retail Pharmacy Program, and Expansion of FEMA Reimbursement to States in order to increase weekly vaccine supply to states, tribes, and territories to 10.5 million doses nationwide for the next three weeks, representing a 22% increase since President Biden’s inauguration on January 20.
- On February 3, the House Committee on Energy and Commerce Subcommittee on Health held a hearing, “Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain.” During the hearing, a number of House members raised concerns of overreliance on foreign countries for medical product supplies and questioned witnesses on possible government approaches to boost domestic production.
- On February 3, an analysis of President Biden’s $160 billion direct pandemic relief request shared by Protect Our Care revealed that the President is seeking $4 billion to build and equip two manufacturing facilities with the capacity to produce 100 million COVID-19 vaccine doses per month; $1 billion to create a stockpile of essential raw materials and ancillary supplies for vaccines; $3 billion to expand domestic manufacturing capacity for additional supplies, including personal protective equipment (PPE), gloves, and testing consumables; and $2 billion for onshore manufacturing of test kits and related supplies for COVID-19 and emerging biological threats.
- On February 4, Johnson & Johnson announced the submission of its Emergency Use Authorization (EUA) application for the single-dose Janssen Biotech COVID-19 vaccine. The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss the EUA on February 26.
- On February 5, the White House’s COVID-19 Response Team announced the Biden Administration’s first use of the DPA. The Response Team revealed that the Administration is using the DPA to give Pfizer priority access to supplies it needs to make its vaccine, including filling pumps and tangential flow filtration units, and has also taken other DPA-related actions for COVID-19 tests and PPE. The Response Team added that there will be more DPA announcements coming in the next few weeks. See the C-SPAN recording here.
- On March 29 and 30, the FDA will host a Public Workshop: Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation. The workshop will address nitrosamines detected as impurities in drugs, nitrosamine pharmacokinetics, carcinogenesis, mutagenesis, (Q)SAR, and health risk assessment and mitigation. Registration is required for online attendance.
Please do not hesitate to contact us if you have any questions about these developments.