Event Overview
Thursday, January 16, 2025
8:00 AM – 1:00 PM – CLE Program
Food, Drug & Cosmetic Section 2025 Annual Meeting Topics
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.
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 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.’’
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
General Registration Fee
Required for all Annual Meeting attendees.
| NYSBA Members | $250 |
| Non-members | $350 |
+plus…
$150 Program Registration Fee
Food, Drug and Cosmetic Law 2025 Annual Meeting Program
Food, Drug, and Cosmetic Law Section
New York Hilton Midtown
1335 6th Avenue (between 53rd & 54th Streets), New York, NY 10019
Thursday, January 16, 2025
CLE Program: 8:00 a.m. – 1:00 p.m.
Nassau West, Second Floor
5.0 MCLE Credits: 5.0 Areas of Professional Practice
This program is transitional and is suitable for all attorneys including those newly admitted.
8:00 a.m. – 8:10 a.m.
Introduction – Program Chair or Section Chair
8:10 a.m. – 9:50 a.m.
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.
Speaker
Eva Temkin | Washington DC, Arnold & Porter
Michael Varrone | Washington, DC, Sidley & Austin
Maarika Kimbrell | Washington, DC, Morgan Lewis
Moderator
Brian Malkin | Associate General Counsel – Regulatory Law, Teva
2.0 MCLE Credit in Areas of Professional Practice9:50 a.m. – 10:00 a.m.
Break
10:00 a.m. – 10:50 p.m.
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.
Speaker
Janet Linn | Counsel, Tarter Krinsky & Drogin, New York, NY
Richard Kurz | Partner, Haug Partners LLP, New York, NY
Ethan Litwin | Partner, Shinder Cantor Lerner LLP
1.0 MCLE Credit in Areas of Professional Practice10:50 a.m. – 11:45 a.m.
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.
Speaker
Danielle Desaulniers Stempel | Washington, D.C., Hogan Lovells
Sonia W. Nath | Washington, D.C., Cooley LLP
Brian Stimson | Washington, D.C., Arnall Golden Gregory
Moderator
Brian Malkin | Associate General Counsel – Regulatory Law, Teva
1.0 MCLE Credit in Areas of Professional Practice11:45 a.m. – 12:00 p.m.
Break
12:00 p.m. – 12:50 p.m.
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.
Speaker
Larissa Bergin | Partner, Jones Day, Washington D.C.
1.0 MCLE Credit in Areas of Professional Practice