Date: Thursday, January 30, 2020


Meeting Program: 11:50 p.m. - 5:30 p.m. | Gibson Room, 2nd Floor | 5.0 MCLE  Credits 


Food and Drug Hot Topics with a Look at Corporate Responsibility 

[This program is transitional and is suitable for all attorneys including those newly admitted.] 


11:50 a.m. - 12:00 p.m.   Welcome and Introduction

Chair: Brian J. Malkin, Esq., Arent Fox LLP, Washington, D.C. 


12:00 p.m. - 1:40 p.m.  Drugs and Biologics Update (2.0 Credit in Areas of Professional Practice) 

  • Patent invalidating agreements and overboard claims (Helsinn v. Teva; Idenix v. Gilead)
  • Avoiding invalidity under Section 101, will the Supreme Court weigh in? Claiming natural ingredients (National Alternatives v. Creative Compounds) and method of treatment/dose adjustment (Hikma v. Vanda and Endod v. Teva)
  • Recent case precedent impacting the FTC’s ability to obtain monetary remedies (FTC v. Shire ViroPharma, Inc.)
  • State and federal policy trends with biologics/biosimilars as well as pertinent litigation

Speakers: Larissa Bergin, Jones Day, Washington, D.C.; Ronald W. Lanton, Lanton Strategies & Lanton Law, Boston, MA; Janet Linn, Tarter Krisnky & Drogin, New York, NY 


1:40 p.m. - 1:50 p.m.    Break 


1:50 p.m. - 2:40 p.m.    Corporate Responsibility in Cosmetics and Other Regulated Products (1.0 Credit in Areas of Professional Practice) 

  • Animal testing/ Cruelty-free/ Vegan
  • Packaging / Environmental
  • Use of sustainable ingredients
  • Truth in advertising / Transparency
  • Free-from claims / Revealing potential toxicities
  • Certifications / Seals

Moderators: Thomas Cohn, New Avon Company, New York, NY; Jennifer Orendi, Dalimonte Rueb Stoller, Washington, D.C. 

Speakers: Jamie Lee Mattison, Senior Manager, Climate Change and Sustainability Services, Ernst & Young LLP, New York, NY; Alphonse Iannuzzi, Jr., Ph.D., Vice President, Sustainability, Global Corporate Citizenship &  Sustainability, The Estée Lauder Companies, New York, NY


2:40 p.m. - 3:55 p.m.   Tobacco/Deeming Rule Update (1.5 Credit in Areas of Professional Practice) 

  • ENDS products
  • Federal v. State Laws
  • Vaping, Lawsuits, and Regulations

Moderator: Anne Pierson Allen, King & Spalding LLP, New York, NY

Speakers: David Dobbins, JD, MPH, Chief Operating Officer, Truth Initiative, Washington, D.C.; Morenike Fajana, Esq., Special Counsel, Executive Division, NYS Office of the Attorney General, New York, NY; Kim Kessler, JD, Assistant Health Commissioner, Bureau of Chronic Disease Prevention & Tobacco Control, NYS Department of Mental Health & Hygiene, New York, NY


3:55 p.m. - 4:10 p.m.   Break 


4:10 p.m. - 5:00 p.m.   Keynote

Speaker:  Douglas Stearn, Deputy Director for Regulatory Affairs Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Washington, D.C.


5:00 p.m. - 5:25 p.m.   Off Label Promotion Update (0.5 Credit in Areas of Professional Practice) 

  • Medical practice/oncology protocols
  • IVDs in hospital settings/practice of medicine
  • Promotion of CBD following Epidiolex for Rx, OTC drugs and other products
  • Legal implications of vitamin E enhancement in cannabis products 

Moderator: Brian Malkin, Esq., Arent Fox LLP, Washington, D.C.

Speaker: Jeffrey B. Chasnow, Esq., Senior Vice President & Associate General Counsel, Pfizer, New York, NY; Steve Shapiro, Esq., Of Counsel, Rivkin Radler, New York, NY


5:25 p.m. - 6:35 p.m.  Business Meeting (Elections)  

 

Reception: 5:40 p.m. - 7:00 p.m. | Off-site at Arent Fox LLP | 1301 Avenue of the Americas, 42nd Floor New York, NY 10019


Section Chair: Brian J. Malkin, Esq., Arent Fox LLP, Washington, D.C. 



FOOD, DRUG AND COSMETIC LAW SECTION SCHEDULE

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