Medical Products Supply Chain Week in Review May 18, 2021

COVID-19 Medical Products Supply Chain Week in Review – May 18, 2021

In the past week, the FDA authorized the Pfizer/BioNTech COVID-19 vaccine for adolescent use and updated its inspection guidance again. In addition, President Biden announced that the U.S. had reached the 250 million vaccine shot milestone. Please see details for these and other supply chain developments below:

  • On May 10, the FDA expanded the emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to include adolescents 12 through 15 years of age. On May 12, the CDC adopted its Advisory Committee on Immunization Practices’ (ACIP) recommendation for the use of the Pfizer COVID-19 vaccine in adolescents.
  • On May 10, the FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene a virtual meeting on June 10, 2021 to discuss COVID-19 vaccines for adolescents and children less than 12 years of age.
  • On May 11, the FDA issued Guidance: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annexes. The annexes supplement ICH Guideline Q12 adopted in November 2019 to provide “a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes in a more predictable and efficient manner.” In particular, the annexes provide examples of when a regulatory submission is needed for a postapproval change and a structured approach for analytical procedure changes. 
  • On May 12, the CDC revealed that it was allowing coadministration of COVID-19 and other vaccines. The Pink Sheet reported that many ACIP members had expressed concerns about the lack of data for this policy change.
  • On May 12, the FDA published the meeting minutes for the April 22, 2021 FDA-Industry GDUFA Reauthorization Meeting. During the meeting, the agency and the industry agreed to end the Site Engagement Program, a voluntary program that offers identified sites an additional opportunity to communicate quality issues with the FDA to avoid drug supply disruptions. 
  • On May 13, President Biden announced that COVID-19 vaccination shots had exceeded 250 million.
  • On May 17, the FDA again updated Guidance: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (originally issued in August 2020; last revised in January 2021 as we reported in a previous issue). Notably, the guidance: 
    • Refers to the agency’s new tool of “remote interactive evaluations,” which we have analyzed in a previous advisory.
    • Adds more examples of factors for the agency’s assessment of whether an inspection is “mission-critical,” including whether a product is on the drug shortage list.
    • Provides more details on the agency’s plans for applications when relevant sites cannot be inspected because of travel restrictions.
    • Reveals that the agency intends to take a risk-based approach to prioritize inspections as travel restrictions are eased or lifted.

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

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Nicholas Clarke
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Phone: 212.210.1222

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