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April 2, 2020

The Over-the-Counter Monograph Safety, Innovation, and Reform Act Is Enacted: Top Five Takeaways for Manufacturers of OTC Drug Products


On March 27, 2020, President Trump signed into law the Over-the-Counter Monograph Safety, Innovation, and Reform Act (OTC Monograph Reform Act), as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This ends a multiyear legislative effort to reform the monograph system for over-the-counter (OTC) drugs and to introduce new mechanisms for OTC product changes and innovation.

From 2015 to 2017, the US Food and Drug Administration (FDA) held a series of meetings with industry representatives to discuss how to reform the OTC monograph process. These meetings culminated in the drafting of the Proposed OTC Monograph User Fee Program Performance Goals and Procedures (FY 2018-2022) (Performance Goals), which were transmitted to Congress on June 7, 2017. On September 13, 2017, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock testified before the US House of Representatives Energy & Commerce Subcommittee on Health on the Performance Goals, explaining that the current monograph process has "not kept up" and emphasizing the need for monograph reform to streamline processes and provide user fees to address resource challenges.

During the 115th and 116th Congresses, legislation reflecting the Performance Goals was introduced in both chambers. Although the OTC Monograph Reform Act had wide bipartisan and bicameral support, it stalled amid disagreements regarding various aspects of the bill, including whether (and how long) to provide market exclusivity and the structure of the user fee program.

Now that the OTC Monograph Reform Act has been enacted, we have prepared this Advisory to highlight the top five takeaways that should be on the radar of OTC drug manufacturers.

© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.