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Food, Drug and Cosmetic Law Section Home


Thursday, January 30, 2020
11:50 AM - 5:30 PM
Gibson Room, 2nd Floor


5.0 Credits
5.0 Areas of Professional Practice 
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.     Drug and Biologics Update

Larissa Bergin, Jones Day, Washington, DC
Ron Lanton, Esq. Lanton Strategies & Lanton Law, Boston, MA 
Janet Linn,  Tarter Krinsky & Drogin,  New York, NY 

  • Patent invalidating agreements and overbroad claims (Helsinn v. TevaIdenix 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 Endo v. Teva)

    Interactive Q and A on Drug and Biologics litigation and legislation 
    Discussion of state and federal policy trends with biologics/biosimilars as well as pertinent litigation. 
    o  Examination of currently approved biosimilars
    o  Discussion of the IPI, the Biosimilar Action Plan and other relevant FDA policies
    o  Pending biosimilar legislation
    o  Sneak peak into PBM/payor formulary policies

    (2.0 Credit in Areas of Professional Practice)

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 

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

Moderators: Thomas Cohn,Esq., New Avon Company, New York, NY
Jennifer Orendi, Esq., Dalimonte Rueb Stoller, Washington, DC

o  Animal testing/ Cruelty-free/ Vegan
o  Packaging / Environmental
o  Use of sustainable ingredients
o  Truth in advertising / Transparency
o  Free-from claims / Revealing potential toxicities
o  Certifications / Seals 
 (1.0 Credit in Professional Practice) 

2:40 p.m.– 3:30 p.m.         Tobacco/Deeming Rule Update

Moderator: Anne Pierson Allen, Esq. New York, NY


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, J.D. 
Assistant Health Commissioner
Bureau of Chronic disease Prevention & Tobacco Control
NYS Department of Mental Health & Hygience
New York, NY

o  ENDS products
o  Federal v. State Laws
o  Vaping, Lawsuits, and Regulations 
(1.0 Credit in Areas of Professional Practice) 

3:30 p.m. - 3:40 p.m. Break 

3:40 p.m. – 4:30 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.  

4:30 p.m. – 5:20 p.m.         Off label Promotion Update

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

Jeffrey B. Chasnow, Esq. 
Senior Vice President & Associate General Counsel
New York, NY

Steven Shapiro, Esq. 
Of Counsel, Rivkin Radler
New York, NY

o   Update on FDA and Off-label Promotion
o   Promotion of CBD following Epidiolex for Rx, OTC drugs and other products 
(1.0 Credit in Areas of Professional Practice) 

5:20 p.m. - 5:30 p.m.         Business Meeting (Elections) 

5:40 p.m. – 7:00 p.m.        Reception, Arent Fox LLP, 1301 Avenue of the Americas, NYC 

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


Under New York’s MCLE rule, this program has been approved for a total of 5.0 credits (5.0 areas of professional practice). This program is transitional and is suitable for NY MCLE credit for both newly-admitted attorneys and experienced attorneys. Further information about the NY CLE Rules is available at To receive credit in other jurisdictions, a uniform MCLE certificate can be issued.

Tuition Assistance | Discounts and Scholarships: Any attorney experiencing financial hardship, may apply for tuition assistance to attend this program.  Tuition assistance applies to the educational portion of the program only. Requests for financial assistance must be received via email by Monday, January 6, 2020. For further information, please visit

Accommodations for Persons with Disabilities:  NYSBA welcomes participation by individuals with disabilities. NYSBA is committed to complying with all applicable laws that prohibit discrimination against individuals on the basis of disability in the full and equal enjoyment of its goods, services, programs, activities, facilities, privileges, advantages, or accommodations. To request auxiliary aids or services or if you have any questions regarding accessibility, please contact Cindy O’Brien at [email protected]  

For overnight room accommodations, please contact the New York Hilton Midtown at 1-800-445-8667 and identify yourself as a member of the New York State Bar Association.  You can book your room online at The rate will be based on room selection (single/double occupancy) and arrival/departure dates with additional taxes and hotel fees. The discounted rate for January 26th and January 27th is $179 per night. The discounted rate for January 28th through February 1st is $229 per night. Reservations must be made by December 22, 2019. 

For questions about this program, please contact Lisa Bataille, Section Liaison at 518-487-5680 or lbataille To register by phone, please call the Member Resource Center at 1-800-582-2452.

Register Online |


Thursday, January 30, 2020
5:40 PM - 6:45 PM
Offsite at Arent Fox LLP | 1301 Avenue of the Americas, 42nd Floor

Register for the 2020 Annual Meeting Here or Download the Registration Form Here.


Welcome to the Food, Drug and Cosmetic Law Section 

More than 70 years ago, the Food, Drug and Cosmetic Law Section became one of the first sections to be formally organized by the New York State Bar Association. During the ensuing years, this group - the first organization in the country to be composed of in-house, law firm, government and trade association attorneys practicing food and drug law - has been a focal point for practitioners in this specialty. We welcome you to our expanded website! 

Why Join the NYSBA Food, Drug and Cosmetic Law Section?

Want to improve your professional skills and knowledge? It's easy when you join the Food, Drug and Cosmetic Law Section. Whether it's through meetings, good old-fashioned networking, participating in MCLE programs, professional resources, or legislation, Section activity is the key to keeping you informed on the latest developments in the food, drug and cosmetic law field. The Section also acts as a resource for business, civic and governmental groups.

View Section's Brochure for Membership Benefits

Join Online Now!

To join this Section by phone, call the Member Resource Center at (800) 582-2452 during business hours.

How much are Section dues? Very affordable with NYSBA membership. View the price list here (scroll down for Section dues). 

Are you interested in volunteering for a Section Committee?  Please email your staff liaison to indicate the committees you wish to join.  Thank you!