Medical Products Supply Chain Week in Review – October 2021 #2

Alston & Bird

Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for over-the-counter (OTC) hearing aids. The ports of Los Angeles and Long Beach went to 24 hours a day, seven days a week operations to help alleviate supply chain congestion. Please see details for these and other supply chain developments below:

  • On October 13, President Biden remarked on the Administration’s effort to address the bottlenecks in the global transportation supply chain. Through the infrastructure bill and the Build Back Better Act, the President hopes to make a billion-dollar investment to move supply chain operations forward. In the interim, the ports of Los Angeles and Long Beach will be operational 24 hours a day, seven days a week to move goods from ports to their terminal destination. Home Depot, Walmart, Target, and Samsung have committed to increase their efforts to move products from ports to stores, particularly in off-peak hours. UPS and FedEx have also committed to allot more resources toward overnight distribution. 
  • On October 14, the Center for Devices and Radiological Health issued draft guidance, “Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.” This draft guidance provides proposed updates to the FDA policy on global identification (label) requirements for Class I devices. The public comment period ends on December 13, 2021.
  • On October 14, the FDA announced that the Antimicrobial Drugs Advisory Committee is meeting on November 30 to discuss the EUA submitted by Merck and Ridgeback Biotherapeutics for molnupiravir. The drug, which is administered orally, would be the first authorized COVID-19 antiviral for self-treatment in a home care setting. The intended use is for those with mild to moderate COVID-19 disease and a high risk for progression to severe disease.
  • The FDA announced a public meeting, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA),” scheduled for November 16, 2021. The purpose of the meeting is to provide stakeholders with the opportunity to discuss with the FDA the state of their progress toward meeting the system and data requirements of an interoperable tracking system for prescription drugs. The deadline for registration is October 26, 2021. The FDA will accept individual comments on the meeting until January 18, 2022. 
  • On October 19, the FDA proposed a new rule to establish a new category of OTC hearing aids. The rule would apply to certain air-conduction hearing aids intended for adults 18 years of age and older who have perceived mild to moderate hearing loss.
  • On October 20, the FDA amended the EUAs for Moderna and J&J’s COVID-19 vaccines to allow for booster doses. The indication for the Moderna booster is administration six months after completion of the initial series of vaccination doses for people 65 years of age and older, those 18 to 64 years of age with risk factors for severe disease, and those whose occupations put them at risk of exposure. For the J&J booster, the indication is for administration two months following an initial vaccination for all individuals 18 years of age and older. The FDA also authorized mix and match administration of doses from different manufacturers.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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