Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19). At the time of this writing, FDA has not offered specific recommendations on measures that regulated industries should take. However, good manufacturing practice (“GMP”) requirements and the Federal Food, Drug and Cosmetic Act (“FDCA”) impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety. Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.
The Centers for Disease Control (CDC) have provided general recommendations for businesses, which include encouraging sick employees to stay home, taking precautions before travelling and maintaining routine cleaning, these fall well short of the steps required under FDA regulations.
Husch Blackwell’s FDA practice has developed a framework comprehensive report for FDA-regulated clients on managing COVID-19. This specific guidance is based on communications from health officials, government agencies and news outlets and is consistent with existing FDA regulatory requirements. Husch Blackwell LLP stands ready to offer a report tailored to a client’s business needs to assist with the navigation of the applicable laws and regulations governing this rapidly changing situation. For specific, tailored consultation regarding your response to the COVID-19 outbreak, contact the head of Husch Blackwell’s FDA practice, Seth Mailhot, at 202.378.2306.