Daily Report | ‘I Don't Think That's Going to Fly’: 3 Vaccine-Related Arguments Litigators Might Want to Avoid

This week, Congress passed a bill raising the nation’s debt limit to avoid a potential default and CMS issued a final rule rescinding COVID-19 vaccine requirements for facilities participating in Medicare and Medicaid. 

This week, the COVID-19 PHE expired, and DEA issued a final rule that provides a six-month extension of PHE flexibilities that allow the prescription of controlled substances via telemedicine.

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference for Pfizer-BioNTech and Moderna vaccine boosters. The new recommended Tris vaccine buffer leads to greater stability and requires no dilution. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in teens 16 and 17 years of age. The Administration Port Action Plan continues to improve the supply chain backlog. The FDA released an update to the Resiliency Roadmap for Inspections. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain employers. Also, the State Department updated its rules for passengers entering the United States. Please see details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.