As of last week, more than half of U.S. adults are fully vaccinated, and the FDA has reconsidered its approach to COVID-19 vaccine Emergency Use Authorization (EUA) requests. In addition, the FDA’s submitted 2022 budget involves various medical product supply issues. Please see details for these and other supply chain developments below:
- On May 25, the White House COVID-19 Response Team announced a milestone that more than 50 percent of U.S. adults had been fully vaccinated.
- On May 25, the FDA updated its Guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19. Notably, the agency revealed that it may decline to review new COVID-19 vaccine EUA requests other than those whose developers have already engaged the agency for their products.
- On May 26, the FDA issued an EUA for GSK’s COVID-19 monoclonal antibody therapy sotrovimab for high-risk patients.
- On May 28, the FDA announced that its 2022 budget request includes medical product safety investments to strengthen and monitor the supply chain and additional investments to increase inspections. The agency also submitted a package of legislative proposals, including efforts to:
- Expand the FDA’s authority to manage medical device shortages to increase domestic supplies.
- Explicitly authorize the FDA to “request records or other information in advance of or in lieu of inspections” to secure medical product supplies when inspections are not advisable.
- Improve the FDA’s ability to assess “pharmaceutical critical infrastructure.”
- Expand the FDA’s authority to require a drug sponsor to label a product with the longest possible expiration date.
- Extend current provisions related to counterfeit drugs to include medical devices.
Please do not hesitate to contact us if you have any questions about these developments.