Food, Drug & Cosmetic Law Section

Event Overview

Thursday, January 16, 2025

8:00 AM – 1:00 PM – CLE Program

Food, Drug & Cosmetic Section 2025 Annual Meeting Topics

Avoiding Antitrust Liability When Settling Hatch-Waxman Litigation
Forty years since the enactment of Hatch Waxman legislation and ten plus years since the Supreme Court in FTC v Actavis called for review of “reverse payment” settlements of Hatch -Waxman litigation under the Rule of Reason, the courts are still defining the provisions in these settlement agreements that violate antitrust law. The panel will discuss recent decisions clarifying what the courts require at the pleading stage in reverse payment cases, and using the decisions as guidance in structuring Hatch Waxman settlements.

FDA 2025: What to Expect After the Election
Commissioner Robert M. Califf, M.D. reportedly will step down regardless of who wins the Presidential Election. President Joe Biden took over a year to appoint Dr. Califf as the FDA Commissioner during a national pandemic situation with COVID. When our new President is sworn into office on January 20, 2025, who will be nominated as the new FDA Commissioner and what will be the hot issues on their plate?  This panel will take a fresh look at where we stand in 2025, as well as a retrospective look at Dr. Califf as FDA Commissioner.

Moderator:
Brian Malkin, Associate General Counsel – Regulatory Law, Teva

Panelists:
Eva Temkin, Washington DC, Arnold & Porter
Michael Varrone, Washington, DC, Sidley & Austin
Maarika Kimbrell, Washington, DC, Morgan Lewis

AI and Healthcare: How is the government regulating AI in the Healthcare industry?
AI is an incredible tool in the healthcare industry. But, what happens when the idea of AI and policymakers clash?

This presentation will tackle the following:

• Discuss how AI is actually affecting healthcare
• Review state and federal legislation/regulation
• Overview of the possible ramifications of the use of AI in healthcare
• Articulate the advantages of AI and how policymakers could better balance risks and rewards.

FDA Impact of Loper Bright and Chevron Reversal
This panel will take a look at recent litigations against the US Food and Drug Administration where the reversal of Chevron or Loper Bright have been cited as support for why an FDA decision/deference should not be provided in the first instance by a court.

Moderator:
Brian Malkin, Associate General Counsel – Regulatory Law, Teva

Panelists:
Danielle Desaulniers Stempel, Washington, DC, Hogan Lovells
Sonia W. Nath, Washington, D.C., Cooley LLP
Brian Stimson, Washington, D.C., Arnold Golden Gregory

FTC oversight of PBMs: Boundary crossing or within the agency’s purview? Who should regulate?
This panel will consider the FTC’s recent investigations, reports, and challenges over the PBM industry, and whether the FTC is the appropriate agency to tackle these issues. Is there a better agency for the job?  Congress calls for agency action daily, but query as to whether they must legislate in order to address their concerns.

Highlights and Objectives:

• Understand how the election, potential legislation, and recent case precedent may impact FDA regulatory authority.
• Understand how technology and agency action is shaping the healthcare and pharmaceutical industries in ways that legislation and regulation have not predicted.

Food, Drug & Cosmetic Section Chair:
Larissa Bergin

Program Chairs:
Ron Lanton, Larissa Bergin, and Janet B. Linn