Post-COVID Checkup: Current FDA Due Diligence Considerations

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives. As the public health emergency in the United States and elsewhere has ended, it is critical that life science companies, and their investors and lenders, consider the changing FDA regulatory and compliance landscape.

During the pandemic, the FDA focused its resources and priorities on issues related to COVID‑19. In many cases, the pandemic paused important agency activities, such as inspections of manufacturing establishments. In other cases, the FDA applied its enforcement resources to combating fraudulent COVID-19 “treatments” or ensuring the quality of hand sanitizers used by millions of Americans. Now that the pandemic is subsiding and the public health emergency orders have ended, FDA inspection and enforcement patterns are returning to more traditional patterns. The FDA is once again conducting on-site inspections at manufacturing facilities and issuing Warning Letters at a rate that is more commensurate with past practice. But it would be wrong to think that the pandemic has not also affected the FDA’s approach and practice. And these effects have important implications for both healthcare investors and lenders in the life sciences and healthcare sectors.