Medical Products Supply Chain Week in Review November 12, 2021

Medical Products Supply Chain Week in Review – November 11, 2021

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 below:

  • On November 4, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced a new emergency temporary standard (ETS) that requires companies with 100 or more employees to develop a COVID-19 vaccination policy. The requirements include that companies ascertain the vaccination status of each employee, require proof of vaccination, and maintain records. Additionally, unvaccinated employees would be subject to weekly testing, prompt notification of a positive COVID-19 diagnosis, and a strategy for quarantine. Employers have 60 days to comply with all requirements. In the interim, lawsuits have been filed in the U.S. Courts of Appeals for the Fifth, Sixth, Seventh, Eighth, Eleventh, and DC Circuits to review the legality of the order. While the Fifth Circuit granted an emergency motion to stay OSHA’s ETS, the cases will be consolidated and transferred to one circuit through a lottery system. The plaintiffs argue that OSHA does not have specific legislative authority to make this rule and is in violation of the nondelegation doctrine. For more coverage, see the Alston & Bird Labor & Employment / Health Care 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 full vaccination of certain health care facility staff by January 4, 2022. Data collection by the agency has determined that these requirements have not led to a critical shortage of personnel from widespread resignation of essential staff. For any entity not in compliance, CMS has vowed to use its enforcement authority to take further actions.
  • On November 6, Congress passed the Infrastructure Investment and Jobs Act. The Act will provide funding for major infrastructure projects to “strengthen our supply chains and prevent disruptions that have caused inflation.” The 10-year plan provides $17 billion in funding for upgrades to port infrastructure and $25 billion in funding for U.S. airports. The bill awaits the President’s signature.
  • On November 9, Pfizer and BioNTech submitted a request to amend their emergency use authorization (EUA) for the COVID-19 vaccine booster dose. The amendment would allow authorization of the booster dose to all individuals 18 years of age and older. The request is based on data from a Phase 3 clinical trial that demonstrated the booster is safe and 95% effective.
  • On November 10, the Administration announced action plans to improve the movement of goods within the supply chain and the progress made thus far. The quantity of freight that has moved through the ports of Los Angeles and Long Beach has reached a record level. The Administration plans to facilitate movement of goods by working with key stakeholders to operate the ports 24/7, including waiving fees for truckers who retrieve freight on nights and weekends, reduced rail rates for shipping from ports on weekends, and encouraging retailers to utilize off-peak weekend hours for supply chain business.
  • On November 12, President Biden will nominate Dr. Robert Califf to serve as commissioner of the FDA. Califf previously served as commissioner during the Obama Administration and is expected to receive bipartisan support. The announcement is expected today.
  • The FDA published “Product-Specific Guidances and Draft and Revised Draft Guidances” to aid manufacturers in developing bioequivalence studies to be used in their submissions of abbreviated new drug applications (ANDAs). The guidances and draft guidances will apply to those products explicitly listed. The deadline to submit comments is January 2, 2022.

    Please do not hesitate to contact us if you have any questions about these developments.
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