Falsification of at-home isotretinoin pregnancy testing during the COVID-19 pandemic: A case series and proposal of mitigation strategies

Abstract

In response to the COVID-19 pandemic, the US Food and Drug Administration changed the guidelines for existing Risk Evaluation and Mitigation Strategies on March 22, 2020, to reflect the increased need for self-isolation and social distancing. The update allowed for greater flexibility with laboratory testing and imaging requirements for drugs subject to a Risk Evaluation and Mitigation Strategies program.1 As a result, adjustments were made to the iPLEDGE program, a Risk Evaluation and Mitigation Strategies program created to manage the risks of isotretinoin, a highly teratogenic medication used for severe nodulocystic acne.