Food, Drug & Cosmetic Law Section Meeting

Thursday, January 25, 2018
9:00 AM - 5:00 PM
Total MCLE Credits: 7.00 (Professional Practice 6.00, Ethics 1.00)
Nassau West, 2nd Floor


Hot Topics in Food, Drug & Cosmetic Law

January 25, 2018 | New York Hilton Midtown | NYC
7.0 Total Credits: 1.0 Ethics 6.0 Professional Practice (Non-Transitional)

Program Flier

Program: 8:30 a.m. - 5:00 p.m. | Nassau West, 2nd Floor

Register Here or Download The Registration Form Here.

Brian J. Malkin, Esq.
Arent Fox LLP
Washington, DC

8:30 a.m. - 8:35 a.m. Introduction - Brian J. Malkin, Section Chair              

8:35 a.m. - 9:00 a.m. Tobacco Law
Embracing the Continuum of Risk: CTP Builds Policy on Product Standards and Tobacco Flavoring, and Reassesses Regulatory Priorities in Aftermath of the Deeming Rule

  • The feasibility and impacts of FDA’s decision to delay regulatory deadlines for newly deemed products while undertaking rulemaking and eliminating the sunset provision
  • The complications and potential public health benefits and harms related to FDA’s proposed product standards for nicotine levels, tobacco flavors, and re-evaluation of premium cigars
  • Analysis of FDA’s request for input on most efficient use of its resources and review of provisional substantial equivalence reports

Brian J. Malkin, Esq.
Arent Fox LLP
Washington, DC

Anne Pierson Allen, Esq.
King & Spalding (former FDA Office of Chief Counsel (OCC) representative to the Center for Tobacco Products (CTP)
New York, NY

Christina Young, Ph.D.
King & Spalding (former Chemist to the FDA’s CTP)
New York, NY 

9:05 a.m. -  9:55 a.m. Animal Health Law
Are All Human Drugs Actually Animal Drugs Waiting to Be Developed?  What it Take to develop a New Animal Drug and Other Animal Health Considerations

·         In-Licensing Human Drug Products For Development in Animal Health—A Cautionary Tale

o   Structuring the deal and financial expectations
o   Managing risks
o   Case study:  Analysis of the Aratana Deal Model
Compounders versus Drug Manufacturers

·         Update on Compounding for Use in Animals v. Drug Manufacturers

o   Food Animals versus Companion Animals
o   Offlabel Use

Janet Linn, Esq.
Eaton & Van Winkle 
New York, NY

Manya Deehr, Esq.
Cooley LLP
New York, NY

Nancy E. Halpern, D.V.M., Esq.
Fox Rothschild LLP
Princeton, NJ

10:00 a.m. - 10:25 a.m. Food Law
From Farm to Table – The Future of GMO Plants and Animals  

  • An update on the rulemaking the US Department of Agriculture (USDA) is undertaking to implement the Bioengineered Food Disclosure Law
  • The status of regulatory proposals relating to the regulation of plant and animal products of biotechnology proposed by USDA and FDA, respectively
  • Other emerging issues related to the regulation of plant and animal products of biotechnology

Suchira Ghosh, Esq.
Axinn Veltrop Harkrider LLP
New York, NY

Karen Carr, Esq.
Arent Fox LLP
Washington, DC

Kristin Landis, Esq.
Deputy General Counsel, Agriculture & Environmental, Biotechnology Innovation Organization (BIO)
Washington, DC

10:25 a.m. - 10:40 a.m. Coffee Break

10:40 a.m.  - 12:00 p.m. Biologics Law 
Gene Therapies Now FDA-Approved for Use: What You Need to Know to Address Safety and IP Considerations - Plus an Update on Biosimilars

  • FDA Discusses New Gene Therapy Approval and Safety Considerations for REMS for Gene Therapy
  • IP Considerations for Patenting Gene Therapies – When and How Do You Do It?
  • Update on Biosimilar Approvals: The Legal Pathway After the Supreme Court Ruling in Sandoz v. Amgen and Marketing Challenges

April Polikoff, Esq. 
Associate Director & Counsel
Akorn Pharmaceuticals
Amityville, NY 

JP Ahluwalia, Ph.D.,
Medical Officer, FDA, Center for Biologics Evaluation and Research
Analytic Epidemiology Branch
Silver Spring, MD Janet Linn, Esq., 
Eaton & Van Winkle
New York, NY

Janet Linn, Esq.
Eaton & Van Winkle 
New York, NY 

Vicki Malia-Piekarz, Esq.,
Senior Counsel, New York Genome Center 
New York, NY

12:00 p.m. - 1:30 p.m. Lunch on Your Own

1:30 p.m. - 2:20 p.m.  Ethical Considerations on How an Attorney Balances the Duty to Represent the Client Zealously with the “Greater Good” of Early Access to Investigational Drugs and the “Right to Try” that Benefit Patients?

Moderator and Speaker: 
David S. Weinstock, Esq.
Weston, CT

Anne Pierson Allen, Esq.
King & Spalding
New York, NY

Ilene Wilets, Ph.D.
Institutional Review Board Chair
Program for the Protection of Human Subjects -  Icahn School of Medicine at Mount Sinai
New York, NY 

2:25 p.m. - 3:40 p.m. Drug Law
Opioid Drug Crisis: Measures to Control
Do Laws Mandate Drug Company Collaboration: A look at recent public meetings, held by FDA and US Federal Trade Commission (FTC), and recent rulemaking efforts to increase competition and reduce Rx prices?Using Sovereign Immunity as a Competitive Tool: Allergan’s patent assignment to the St. Regis Mohawk Tribe

Larissa Bergin, Esq.
Jones Day
Washington, DC

Professor Michael Carrier
Distinguished Professor of Law, Rutgers Law School
Camden, NJ

Lisa Landau, Esq. 
Chief, Health Care Bureau
New York State Office of the Attorney General
Albany, NY

James Klaiber, Esq. 
Hughes Hubbard & Reed
New York, NY

Michael Knight, Esq. 
Jones Day (Former Assistant Director, FTC Bureau of Competition)
Washington, DC

James Major, Esq. 
Lucas & Mercanti, LLP
New York, NY

3:40 p.m. - 3:55 p.m. Coffee Break

3:55 p.m. - 4:45 p.m. Medical Devices  
Innovation and Regulation of Emerging Technologies:  Safety and Data Security 

  • Updates in FDA device and software regulation following the 21st Century Cures Act
  • Practical guidance on when my software is regulated by FDA
  • Data transfers as a treatment tool
  • Privacy and security risks and regulation

FDA's Evolving Policy on Personalized Medicine Tests

  • Direct-to-Consumer genetic health tests
  • Update on Laboratory Developed tests
  • Developments in pharmacogenomics tests

Christopher C. Palermo, Esq.
Bleakley Platt & Schmidt, LLP
White Plains, NY
Nancy L. Perkins, Esq. 
Arnold Porter Kaye Scholer LLP
Washington, D.C.

Mahnu Davar, Esq. 
Arnold Porter Kaye Scholer LLP
Washington, D.C.

Nancy K. Stade, Esq. 
Sidley Austin LLP
Washington, D.C.

4:45 p.m. - 5:00 p.m.  Section Business/Elections 

5:30 p.m. - 7:00 p.m.  Off-Site Reception 
Arent Fox LLP 
1675 Broadway
New York, NY 10019

Thank You to Our Reception Co-Sponsors: Arent Fox |  Axinn, Veltrop & Harkrider | Sanchez Devanny!

Under New York’s MCLE rule, this program has been approved for a total of 7.0 credit hours (6.0 Areas of Professional Practice and 1.0 credit hours in Ethics). This program will NOT qualify for credit for newly-admitted attorneys because it is not a basic practical skills program. Discounts and Scholarships: New York State Bar Association members and non-members may apply for a discount or scholarship to attend this program, based on financial hardship. This discount applies to the educational portion of the program only. Under this policy, any member of our Association or non-member who has a genuine basis for their hardship, if approved, can receive a discount or scholarship, depending on the circumstances. Request for discounts or scholarships must be received prior to January 12, 2018. For more details, please contact Lisa Bataille in writing at New York State Bar Association, One Elk Street, Albany, New York 12207 or

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 Lisa Bataille at 518-487-5680.

For overnight room accommodations, please call the New York Hilton Midtown at 1-800-445-8667 and identify yourself as a member of the New York State Bar Association or on the web 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 21st and January 22nd is $179 per night. The discounted rate for January 23rd through January 28th is $229 per night. A rate of $209 will be offered to those with overlapping dates. Rates and availability are not guaranteed after December 29, 2017.

For questions about this specific program, please contact Lisa Bataille at 518-487-5680. For registration questions only, please call the Member Resource Center at 800-582-2452. Fax registration form to 518-463-5993.