The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented.  Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic.  The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused on identifying and alleviating drug shortages before they happen.  The FDA also is using emergency measures to provide access to diagnostic tests and other medicines that would not otherwise be available to the public.

Looking back on 2019, we saw a shifting regulatory landscape for certain high-profile products under FDA’s purview—cannabis, e-cigarettes, and artificial intelligence (AI).  Public opinion on cannabis changed dramatically, and companies are seeing its effects—both in the workplace and in the marketplace.  FDA’s reaction has been slow and steady as it gathers scientific and medical data on cannabidiol (CBD), the active ingredient in cannabis derived from the hemp plant.  We also saw a shifting regulatory landscape for e-cigarettes, which FDA not long ago considered to be safer alternatives to traditional combustible cigarettes.  FDA changed course in 2019 and reacted quickly to the outbreak of lung illnesses associated with vaping by enforcing against companies manufacturing and selling kid-friendly e-cigarettes.  Finally, we saw the agency take an innovative approach to regulating medical device software powered by AI.

Looking ahead to 2020, drug pricing will continue to be a priority, as FDA reacts to clear demands from the White House to lower prescription drug prices.  We also likely will continue to see scrutiny on the global supply chain, including enforcing data integrity practices at ex-US manufacturing facilities.  Hear about these issues, and predictions for 2020, in Sheppard Mullin’s Note Bene podcast series.  For an in-depth discussion, listen to Allison Fulton on Episode 71 of Sheppard Mullin’s Nota Bene podcast.

For more legal insights visit our Coronavirus (COVID-19) page.