From Emergency Medical Products To Chicken Nuggets: What Manufacturers And Distributors Need To Know During COVID-19

Published date24 June 2020
Subject MatterFood, Drugs, Healthcare, Life Sciences, Coronavirus (COVID-19), Food and Drugs Law, Operational Impacts and Strategy
Law FirmThompson Coburn LLP
AuthorMs Mackenzie Salenger, Carl J. Pesce and Booker Shaw

As the country and the world continue to adjust to the ever-changing 'new normal' of COVID-19, the need for essential products, ranging from emergency medical products to critical food supplies, is at an all-time high. Over the last two months, this country has watched the exceptional efforts of businesses in every industry come together to lend a helping hand to save lives. Pharmaceutical and biotech companies are innovating to develop vaccines and antiviral medicines to target this novel and potentially life-threatening virus. Automotive companies have switched gears to manufacture ventilators. Fashion designers have altered patterns to manufacture face masks. Meat processing plants have been full steam ahead to keep critical food supply chains operating for all Americans. And doctors, nurses, medical students nearing graduation, and even retired medical professionals have stepped up to the plate to work long hours to save those in dire need of help.

As this nation faces the uncertainty of what the next several months will look like, it is critical that manufacturers and distributors of essential products understand what their country may ask of them and whether their actions now will protect them from legal repercussions in the future. Below, we analyze the legal implications of the Defense Production Act of 1950 (the 'DPA'), 50 U.S.C. ' 4501 et seq., and the United States Department of Health and Human Services' Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (the 'Declaration'), 85 Fed. Reg. 15198.

Defense Production Act of 1950

Over the last few weeks, the DPA has received considerable media attention and even more speculation as to if and when President Trump will invoke it in response to the global pandemic. The DPA generally confers powerful, emergency authority to the President to enlist private businesses to aid in meeting demands of a national emergency.

Broad grant of authority

Historically, the DPA was enacted to allow the President to mobilize the nation's industrial base during wartime. 50 U.S.C. ' 4502. Since the 1950s, the DPA has been expanded beyond war and military preparedness to a broader definition of national defense that now includes national emergencies and emergency preparedness activities. 50 U.S.C. ' 4552. The DPA's powerful grant of authority over the 'national defense' encompasses the following:

  • Programs for military and energy production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling space, and any directly...

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