ACI’s Advanced Legal, Regulatory and Compliance Forum on OTC Drugs, January 23 – 24, 2024, New York, NY — Featuring HPMer and Former FDAer Deborah Livornese

January 5, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount.

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

HPM is ably represented by seasoned drug product development and authorization attorney—and former FDA counsel—Deborah Livornese.  Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.  Prior to joining HPM as a Director, Deb spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, and development of the OTC monograph reform.

Deb along with fellow panelists Kyle Y. Faget, Partner, Foley & Lardner LLP and Amy Replogle, Director, Rx-to-OTC Switch, Bayer will present a must-attend panel focusing on:  FDA’s recent efforts to enhance accessibility to OTC drug products that has set the stage for a wave of approved switches in the industry — a development being warmly embraced by non-prescription drug companies. This panel will analyze the recent high-profile switches shaping the OTC industry landscape, including:

  • Opill
  • Naloxone
  • Explore what FDA has considered in approving the latest switches and hurdles industry may face in obtaining future switches
  • Assessing the significance of the Opill switch and its implications on new opportunities for RX-OTC switches, particularly in the area of women’s health

Make your plans today to meet and benchmark with present and former FDA and FTC enforcers, NAD representatives and leading OTC industry stakeholders.  Attend and walk away with an enhanced understanding of how to navigate the current OTC legal and regulatory environment.

This year’s Keynote Speaker will be Dan Brum, PharmD, MBA, BCPS, Chief of Project Management, Office of Nonprescription Drugs, Food and Drug Administration (FDA).  Also on the federal side is Jennifer Santos, Attorney, National Advertising Division (NAD).

To obtain a copy of the conference brochure and to register for the event, please visit ACI’s website – here.

FDA Law Blog is a conference media partner for this event.  As such, we can offer our readers a special 10% discount off the current price tier for the event.  The discount code is:  S10-826-826L24.S.  We look forward to seeing you at this important conference.