FDA’s New Emergency Authorizations, CMS Reinstates Vaccine Mandate
The FDA fast-tracked a new drug and COVID-19 test to prepare for a surge in cases, CMS has reinstated a vaccine mandate for half the country’s healthcare workers, and the Supreme Court revisits an Epic Systems ruling
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By - CMS has issued a revised COVID-19 vaccine mandate for healthcare workers. The new mandate requires that healthcare workers in 25 states be vaccinated by the end of February 2022.
In a series of December decisions, the FDA has approved emergency authorizations for Roche’s COVID-19 test and Merck’s antiviral Molnupiravir. Both approvals came after the products were shown to be effective in clinical trials. Additionally, the FDA acted last month when it issued a warning to Medtronic’s diabetes facility.
Meanwhile, the Supreme Court will hear a case that could reverse a 2018 decision that supported Epic Systems’ use of arbitration to settle a work-related claim.
Supreme Court Case Revisits Epic Systems Ruling
The Supreme Court’s upcoming hearing of Viking River Cruises, Inc. versus Moriana may affect the 2018 ruling of a case between Epic Systems and one of its employees. Epic won the case in 2018 which affirmed the company’s right to use class action waivers in the case of work-related claims.
“A favorable ruling for California employers could change the landscape by allowing employers to implement and enforce arbitration agreements with Private Attorney Generals Act (PAGA) waivers,” the National Law Review stated. “In short, it would allow arbitration agreements to control PAGA claims on parity with all other statutory employment claims under state and federal law.” READ MORE.
FDA Emergency Authorization for At-Home COVID-19 Test
The FDA has approved Roche’s new at-home COVID-19 test. The test approved last week is shown to have 95 percent sensitivity and the ability to detect positive cases for all strains of the virus. To receive approval, Roche participated in the NIH Rapid Acceleration of Diagnostics’ Independent Test Assessment Program. Roche’s tests will be available to consumers beginning this month. READ MORE.
Medtronic Receives FDA Warning
Medical device company, Medtronic, received a formal warning from the FDA last month after inspections showed inadequate quality systems at the company’s Northridge, California facility. The FDA cited failures in risk assessment, device recalls, compliant handling, and reporting of adverse events. In response to the FDA’s warning, Medtronic representatives emphasized their commitment to improving the quality of their California facility. READ MORE.
Merck’s Molnupiravir Granted Emergency FDA Authorization
The antiviral drug approved last month is shown to reduce death and hospitalization among those infected with COVID-19. Emergency authorization for the drug applies to adults 18 years or older with high risk of disease who would either not benefit from or have access to other forms of treatment. The drug will not be administered as a prophylactic or to individuals already hospitalized with COVID-19. READ MORE.
CMS Reinstates COVID-19 Vaccine Mandate
CMS has reinstated the COVID-19 vaccine mandate for healthcare workers and set a new deadline for a first dose. Healthcare staff in 25 states will need to receive two doses of an approved vaccine by February 28, 2022, or risk losing their jobs. Still to come, the Supreme Court will hear oral arguments concerning the vaccine mandate on January 7, 2022. READ MORE.
