Bloomberg Law | Vaccine Mandates at Work Set for Uptick after Full FDA Approval

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. 

OSHA withdrew its emergency temporary standard, which required a mandatory vaccination policy for large private employers. The FDA extended its pause on non-mission-critical domestic surveillance inspections to February 4, and the Biden Administration announced that it was making at-home test kits available to the American public. Robert Califf previewed his priorities, if confirmed as commissioner of the FDA, to the Senate HELP Committee. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug Evaluation and Research released its annual report. This week, the Senate HELP Committee approved the nomination of Dr. Robert Califf for commissioner of the FDA. Senators introduced legislation that would require certain foreign establishments to register with the FDA. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

This week, CMS issued the CY 2023 Medicare Advantage and Part D Proposed Rule. 

Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11 years of age. The FDA released draft guidance for manufacturers of medical devices marketed under EUAs or policies of enforcement discretion to assist them with transitions to traditional approvals at the end of the public health emergency. The Administration convened the Supply Chain Disruptions Task Force for an update on its progress. The FDA released guidance for laboratory staff and manufacturers on technical considerations for new strains in development of COVID-19 tests and reading results for current tests. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.