An Unofficial Legislative History of Over-the-Counter Monograph Reform

Elizabeth Guo, Richard Kingham & David Spangler


On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the COVID-19 pandemic in the United States. Title III, Subtitle F of the CARES Act enacted major reforms to FDA’s regulatory system for over-the-counter (OTC) drugs. This Article discusses the history of OTC monograph reform and explains the OTC monograph provisions in the CARES Act. Section I provides background and the history of nonprescription drug regulation in the United States until 1972, when FDA established a rulemaking process to classify OTC drugs as Generally Recognized as Safe and Effective (GRASE) and not misbranded (“OTC Drug Review” or the “Review”). Section II describes the challenges of the OTC Drug Review and provides historical context on the impetus for OTC monograph reform. Section III describes the growing interest in OTC monograph reform and initial discussions around what OTC monograph reform would look like. Section IV describes the legislative and stakeholder process between 2016, when Congress released the first discussion draft for OTC monograph reform, and 2020. Section V describes the provisions of OTC monograph reform, as enacted in the CARES Act. As Section VI explains, the history of the OTC Drug Review and the legislative history show how OTC monograph reform was a consensus, born out of the challenges of the Review and enacted after many years of discussions among stakeholders—including the Food and Drug Administration (FDA), Democrats and Republicans in the House and Senate, industry, physician associations, and consumer groups.