In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO issued a report on the FDA’s inspection challenges. Please see details for these supply chain developments below:
- On March 2, President Biden announced that Johnson & Johnson and Merck will cooperate to expand the production of the Janssen vaccine, and the Administration invoked the DPA to equip two Merck facilities to meet the standards necessary to manufacture the vaccine. He added that the Administration will continue to use the DPA to expedite critical materials in vaccine production, such as equipment, machinery, and supplies. He projected that the U.S. is on track to have enough vaccine supply for every adult in the U.S. by the end of May.
- On March 3, the GAO released Drug Safety: FDA’s Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog as written testimony before a hearing of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the House Committee on Appropriations. The report states that the FDA’s foreign inspections declined in recent years and then mostly stopped due to the COVID-19 pandemic. The GAO further reported that the FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. The report concludes that the FDA should utilize lessons that it has learned during the COVID-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and plans to address its growing backlog of inspections.
- The subcommittee’s hearing “FDA’s Foreign Drug Inspections Program” has been rescheduled to 10:00AM ET, March 9.
- On March 5, the FDA issued emergency use authorizations (EUAs) for two COVID-19 tests. The Cue COVID-19 Test developed by Cue Health Inc. is the first molecular test authorized for at-home use without a prescription. The T-Detect COVID Test developed by Adaptive Biotechnologies is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
Please do not hesitate to contact us if you have any questions about these developments.