Overview
The CARES Act was implemented in 2020 and has modernized the regulation of the OTC Drugs Monograph to improve efficiency, timeliness, and predictability in the process. This webinar will provide an overview of how the CARES Act has reformed the OTC drug review process and updates on what the FDA has done thus far regarding implementation. It will also explore: 1) Over-The-Counter Monograph Drug User Fee Program (OMUFA) and where the FDA is in meeting statutory deadlines, as well as its performance goals and procedures in fiscal years 2018-2022; 2) Address the OTC/ Nonprescription Drugs Guidances as well as the recently issued draft guidance on “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”; 3) discuss the OTC Monographs@FDA portal that provides a resource for the public to view proposed, final, and interim final orders for OTC drugs monograph; 4) how OTC Monograph Reform can advance efforts to address healthcare disparities; and 5) what industry can expect over the next 12 months.
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Speakers
Ann M. Begley, Partner, Wiley LLP
Elizabeth Guo, Associate Chief Counsel, Office of Chief Counsel, FDA
David C. Spangler, Senior Vice President, Policy, and General Counsel, Consumer Healthcare Products Association (CHPA), and Member, FDLI Board of Directors
Moderated by Jessica P. O’ Connell, Partner, Covington & Burling LLP
ANN M. BEGLEY is Chair of the Food & Drug Practice at Wiley Rein LLP and counsels clients facing legal and regulatory challenges involving products regulated by the FDA. As it concerns her food practice, Ann’s expertise ranges from advising on and facilitating access to regulatory approvals and notifications associated with new food, feed, and dietary ingredients to advising on labeling and advertising requirements for conventional foods, medical foods, and dietary supplements. She regularly advocates on behalf of clients addressing compliance matters, including regulatory inspections, recalls, import detentions and alerts, agency warning letters and other agency enforcement actions. In addition to her significant experience representing clients before the FDA, she also represents clients before the United States Department of Agriculture (USDA), and the Federal Trade Commission (FTC).
ELIZABETH GUO is an Associate Chief Counsel at the US Food and Drug Administration (FDA). She counsels the agency on matters involving FDA-regulated products, particularly drugs, and advises the agency on regulations, guidance documents, responses to citizen petitions, and draft legislation, among other matters. Prior to government service, she was an associate in the Food, Drug, and Device group at Covington & Burling. She received her JD from Harvard Law School, a Master of Public Health from the Harvard TH Chan School of Public Health, and a BA from Harvard College.
DAVID C. SPANGLER is Senior Vice President, Legal, Government Affairs & Policy at CHPA where he leads the association’s team of eight across legal, government affairs, and policy functions. Mr. Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president’s office, project management, international affairs, and, after completing law school in 1995, the association’s legal department. Mr. Spangler responsibilities were expanded to his current role in 2019. Mr. Spangler is a member of the DC Bar as well as the American Society of Association Executives. He authored the chapter on OTC medicines in “Modern Pharmaceutical Industry: A Primer” (Jacobsen and Wertheimer, eds., 2009) and has served on a range of committees and working groups for the Food and Drug Law Institute and the Global Self-Care Federation. Spangler earned his Certificate in Organization Management in 1991 from the US Chamber of Commerce’s Institute for Organization Management. He received his AB from Miami University (Ohio) and his JD from George Washington University National Law Center.
JESSICA P. O’CONNELL is a partner in Covington & Burling’s Food and Drug practice group in Washington, DC. She advises companies and trade associations on complying with US regulatory requirements enforced by FDA, USDA, FTC, and state regulators for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of all FDA and USDA-regulated products. Before joining Covington, she was an Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on legal issues primarily related to cosmetics, foods, and dietary supplements. Jessica received a bachelor’s degree in biology and physics from the University of Virginia, an MPH from Johns Hopkins, and a JD from Georgetown University Law Center.Virtual Learning FAQ
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