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

Last week, the Administration’s COVID-19 Response Team reported that the case numbers continue to rise in low-vaccination states, with most infections as a result of the Delta variant. Vaccination rates, however, are starting to improve, particularly in low-vaccination states. Please see details for these and other supply chain developments below:

  • On August 3, the President addressed misinformation related to the COVID-19 vaccines. While case rates continue to increase nationally, he noted that of the deaths due to COVID-19, 99% were unvaccinated. The President also continues to encourage the 90 million unvaccinated Americans to receive their first dose. 
  • On August 3, the President announced the U.S. has donated 110 million doses globally. This fulfills the commitment of 80 million doses, with more shipments of Pfizer doses anticipated to commence this month. The Administration considers risk-based, apolitical factors in determining which nations receive doses: COVID-19 case rates, hospitalizations, death rates, current vaccination rates, responses to surges, and logistical factors. The President reiterated the Administration’s commitment to COVAX and support for other organizations representing vulnerable populations.
  • On August 6, the FDA announced that certain lots of the AstraZeneca COVID-19 vaccine are acceptable for export overseas. The vaccine, while not authorized for use in the U.S., is an option for communities worldwide. The decision came after review of testing and facility records.
  • On August 6, the FDA published the medical device user fees for fiscal year 2022, which runs from October 1, 2021 through September 30, 2022. The registration fee will be $5,672 for all medical device establishments required to register, a 2.3% increase over the previous year. User fees for applications vary depending on whether the entity is certified as a small business by the Center for Devices and Radiological Health.
  • CDER has published findings related to a citizen’s petition that alleges that ranitidine contained N-nitrosodimethylamine (NDMA) and further, when ingested, converts to high levels of NDMA in the human body. As a result of preliminary FDA investigations that NDMA levels were above acceptable limits and levels increase over time, ranitidine products were removed from the U.S. market in April 2020. While the product approvals were not withdrawn, the FDA may allow them back on the market if NDMA can be shown to be stable. 

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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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