On March 27, Congress passed Over-the-Counter (OTC) monograph reform as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. These provisions represent a sea-change in FDA’s regulation of OTC drug products, including moving to an administrative order process rather than the longstanding monograph rulemaking process, opening a pathway for migration of certain products to OTC monographs, offering a way out of the New Drug Application requirements for some OTC products, and allowing for the assessment of user fees. During this panel, speakers will address these provisions as well as other aspects of the reform, including whether the lingering sunscreen review problems have been fixed, potential changes to FDA’s OTC enforcement authority and procedures, and the new 18-month exclusivity period for certain OTC drugs, which will lead to new competitive opportunities, risks, and litigation in this space.
James N. Czaban, Partner, Loeb & Loeb LLP and Co-Chair, FDLI 2020 Annual Conference
Deborah L. Livornese, Director, Hyman, Phelps & McNamara, PC
Theresa Michele, Director, Office of Nonprescription Drugs, CDER, FDA
David C. Spangler, Senior Vice President, Legal, Government Affairs, and Policy, Consumer Healthcare Products Association (CHPA)