Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies. The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here).
In discussing the types of challenges that may be faced, the FDA notes:
“For example, challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19. In addition, the process of interrupting and restarting bioequivalence studies for ANDAs may require protocol revisions and impact the collection of information needed to establish bioequivalence.”
The primary objective is to protect study participants enrolled in the study, as well as the personnel that must conduct and monitor such studies. The statement provides suggestions for ANDAs already submitted, as well as those where either the study is underway or is about to be started. With other issues, like FDA changing its bioequivalence recommendations a number of times over the course of ANDA lifecycle either before or after approval, throwing the potential COVID-19 issues into the mix can result in even more confusion. The Agency will need to have greater flexibility in these crazy times. At least FDA is asking people with questions to contact them about what to do and how to handle various situations that arise.
