Food, Drug & Cosmetic Law Section 2024 Spring Meeting

8:00 a.m. – 8:10 a.m. 

Welcome and Introduction

8:10 a.m. – 9:00 a.m.

AI in Drug Development

Moderator:

Brian Malkin, Esq., Associate General Counsel, Regulatory Law, Teva Pharmaceuticals

Panelists: 

Mathew Chun, Patent Agent, Fish & Richardson, JD Candidate, Harvard Law School

Eran Harary, MD, SVP, Global Clinical Development, Head, Innovative Medicines R&D, Teva Pharmaceutical Sciences

Huanyu Zhou, Senior Director, Head of AI Science, Teva Pharmaceutical Industries

Mati Gill, CEO, AION Labs, Tel Aviv-Yafo, Israel 

Tala Fakhouri, PhD, MPH, Associate Director for Policy Analysis, U.S. Food and Drug Administration, CDER, Office of Medical Policy

Stefanie Kraus, JD, MPH, Senior Regulatory Counsel, U.S. Food and Drug Administration, CDER, Office of Regulatory Policy

1.0 Credits in Areas of Professional Practice 

9:10 a.m. – 10:00 a.m.

Supreme Court Review of the Mifepristone Decision and the Future of Standing and Administrative Deference

Moderator: 

Janet B. Linn, Esq., Tarter, Krinsky & Drogin

Speakers: 

Professor Rachel Rebouche

Dean and Peter J. Liacouras Professor of Law

Temple University, Beasley School of Law

Brianne Bharkhda, Esq.

Partner, Covington & Burling LLP

Washington, D.C.

Kendall Burchard

Covington & Burling LLP

Washington, D.C.

1.0 Credit in Areas of Professional Practice 

10:00 a.m. – 10:10 a.m.

Break

10:10 a.m. – 11:00 a.m.

FTC Health Products Compliance Guidance

We will review Federal Trade Commission (FTC) staff's guidance document, published in December 2022 to update and replace Dietary Supplements: An Advertising Guide for Industry, issued in 1998. This document provides guidance on how to ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.  

Since 1998, FTC has settled or adjudicated more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products. This update draws on the issues raised in those cases to illustrate how FTC identifies the express and implied claims conveyed in advertising and how the agency evaluates the scientific support for those claims. The same legal principles in the original guides now apply to the marketing of any health-related product

Speaker: 

Thomas A. Cohn, Esq., Senior Director and Counsel, Marketing and Product, Hello Fresh

1.0 Credit in Areas of Professional Practice

11:00 a.m. – 11:50 a.m.

Drug Pricing Wars: Trends, Politics and Policies

Speakers: 

Ron Lanton III, Esq., Lanton Law, PLLC

Casandra Lanton, Lanton Law, PLLC

1.0 Credit in Areas of Professional Practice 

11:50 a.m. – 12:00 p.m.

Break

12:00 p.m. – 12:50 p.m.

Florida’s Gamble to Lower Prescription Drug Prices with Canadian Imports: Will Other States Follow or Will It Backfire?

Moderator:

Brian Malkin. Esq. Associate General Counsel, Regulatory Law, Teva Pharmaceuticals

Panelists:

Dorothy Charach, Partner, McCarthy Tetrault, Toronto

Samantha Wasserman, Associate, McCarthy Tetrault, Toronto

David L. Rosen, BS Pharm., JD, Foley & Lardner LLP, FDA Practice Group Leader, (Former FDA/CDER Senior Official)

1.0 Credit in Areas of Professional Practice

12:50 p.m. – 1:00 p.m.

Adjourn