How the FDA bent its rules to prevent drug shortages during pandemic

The pandemic caused the FDA to bend regulations in 110 instances to ease drug shortages, according to a report published July 7 by the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis. 

During the pandemic, the FDA has expedited more than 100 new drug applications for COVID-19-related products. The agency has approved 48 of those applications. 

The FDA also used regulatory flexibility 45 times to increase supplies of COVID-19 drugs, including heparin, albuterol and propofol.

The agency began lessening drug supply disruptions in January 2020 by reminding drugmakers of notification requirements, according to the center.

Presidential and congressional actions have allowed the FDA to prevent and manage more shortages. The Coronavirus Aid, Relief, and Economic Security Act, which took effect Sept. 23, allowed the FDA to prioritize and expedite drug applications and inspections and requried drugmakers to provide more information about potential supply disruptions. 

Find the center's full report here

 

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