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Medical Products Supply Chain Week Review – November 2021 # 2 | Alston & Bird

Last week, the president chose Dr. Robert Califf to be the commissioner of the FDA. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements have been issued by OSHA and CMS for some employers. In addition, the State Department has updated its rules for passengers entering the United States. Please see details of these and other supply chain developments below:

  • On November 4, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced a new Temporary Emergency Standard (ETS) that requires companies with 100 or more employees to develop a vaccination policy. against COVID-19. Requirements include that companies check the immunization status of each employee, require proof of vaccination, and keep records. Additionally, unvaccinated employees would be subject to weekly testing, early notification of a positive COVID-19 diagnosis, and a quarantine strategy. Employers have 60 days to comply with all of the requirements. In the meantime, lawsuits have been filed with the United States’ Courts of Appeals for the Fifth, Sixth, Seventh, Eighth, Eleventh and DC Circuits to review the legality of the order. While the Fifth Circuit has granted an emergency motion to suspend the OSHA HTA, cases will be consolidated and transferred to one circuit through a lottery system. The complainants argue that OSHA does not have the specific legislative authority to establish this rule and is in violation of the doctrine of non-delegation. For more information, see Alston & Bird’s Labor and Employment / Healthcare advisory, “What You Need to Know About OSHA’s ETS for Employee Vaccination Requirements” .
  • On November 4, the Centers for Medicare & Medicaid Services (CMS) issued emergency regulations requiring the full immunization of some health facility staff by January 4, 2022. The agency’s data collection determined that these requirements have not led to a critical shortage of personnel from the widespread resignation of essential personnel. For any non-compliant entity, CMS has committed to use its executing authority to take further action.
  • On November 6, Congress passed the Infrastructure Investment and Jobs Act. The law will provide funding for large infrastructure projects to “strengthen our supply chains and avoid the disruptions that have caused inflation.” The 10-year plan provides for $ 17 billion in funding for the modernization of port infrastructure and $ 25 billion in funding for US airports. The bill awaits the president’s signature.
  • On November 9, Pfizer and BioNTech submitted a request to change their Emergency Use Authorization (EUA) for the booster dose of the COVID-19 vaccine. The amendment would allow the booster dose to be authorized for all persons 18 years of age and over. The claim is based on data from a Phase 3 clinical trial which demonstrated the booster to be 95% safe and effective.
  • On November 10, the Administration announced action plans to improve the flow of goods through the supply chain and the progress made so far. The amount of cargo that passed through the ports of Los Angeles and Long Beach reached an all-time high. The Administration plans to facilitate the movement of goods by working with key stakeholders to operate the ports 24/7, including removing fees for truckers who collect cargo overnight and on weekends. , reducing rail rates for shipping to ports on weekends and encouraging retailers to use off-peak weekend hours for supply chain activities.
  • On November 12, President Biden will appoint Dr. Robert Califf as FDA commissioner. Califf previously served as commissioner during the Obama administration and is expected to receive bipartisan support. The announcement is expected today.
  • The FDA has issued “Product Specific, Interim and Revised Guidelines” to help manufacturers develop bioequivalence studies to use in their Abbreviated New Drug Application (ANDA) submissions. The guidelines and draft guidelines will apply to the products explicitly listed. The deadline for submitting comments is January 2, 2022.

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Joan J. Dean

The author Joan J. Dean