In the article, “When Pandemic Ends, EUA Recipients May Face Litigation And Enforcement Actions,” Pink Sheet Informa Pharma Intelligence outlined key takeaways from the Food and Drug Law Institute (FDLI)’s Enforcement, Litigation and Compliance Conference session titled “The Future of EUAs: What Happens Post-Crisis,” for which product liability and mass torts partner Adrienne Busby served as a panelist.
Busby and fellow panelists discussed how the manufacturers that have benefited from regulatory flexibilities that allowed them to get COVID-19 products to the market quickly, could face government enforcement actions and litigation once the public health emergency ends and emergency-use authorizations (EUAs) for their products are terminated.
Busby highlighted that public perceptions of companies receiving EUAs may change when the crisis passes and the surge of goodwill fades. “I think there’s a culture to some degree of agency mistrust, so the actions of an agency allowing an emergency use of these drugs and devices may ultimately play out in a different way in a court down the road,” she said. “We also have to think down the road there may be an element of pandemic fatigue.... Five, ten years down the line, will the jurors look at this and remember the circumstances that we found ourselves in with the EUA? That remains to be seen.”
The full article is available for Pink Sheet Informa Pharma Intelligence subscribers.