Medical Product Supply Chain Week in Review – August 2021 #2 | Alston and bird
Last week, the administration’s COVID-19 response team reported that case numbers continued to rise in low-vaccination states, with most infections due to the Delta variant. Vaccination rates, however, are starting to improve, especially in states with low vaccination rates. Please see details of these and other supply chain developments below:
- On August 3, the president addressed misinformation related to COVID-19 vaccines. As case rates continue to rise nationwide, he noted that among COVID-19 deaths, 99% were unvaccinated. The president also continues to encourage the 90 million unvaccinated Americans to get their first dose.
- On August 3, the president announced that the United States had donated 110 million doses worldwide. That fulfills the 80 million dose commitment, and more Pfizer dose shipments are expected to begin this month. The Administration considers apolitical risk-based factors to determine which countries receive doses: COVID-19 case rates, hospitalizations, death rates, current vaccination rates, surge responses, and logistical factors. The President reiterated the administration’s commitment to COVAX and its support of other organizations representing vulnerable populations.
- On August 6, the FDA announced that certain lots of the AstraZeneca COVID-19 vaccine are acceptable for overseas export. The vaccine, although not licensed in the United States, is an option for communities around the world. The decision was made after reviewing the facility’s tests and records.
- On August 6, the FDA released 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 facilities. medical devices required to register, an increase of 2.3% over last year. Application usage fees vary depending on whether the entity is certified as a small business by the Center for Devices and Radiological Health.
- CDER has released findings related to a citizen’s petition alleging that ranitidine contains N-nitrosodimethylamine (NDMA) and further, when ingested, converts to elevated levels of NDMA in the human body. Following preliminary investigations by the FDA indicating that NDMA levels were above acceptable limits and that levels are increasing over time, ranitidine products were removed from the US market in April 2020. Although approvals products have not been withdrawn, the FDA may allow them to return to the market if the NDMA can be shown to be stable.