Food, Drug and Cosmetic Law Section Home

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    Welcome to the Food, Drug and Cosmetic Law Section
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    Food, Drug & Cosmetic Law Section Annual Meeting Program
  • Events
    • Food, Drug and Cosmetic Law Section Annual Meeting Offsite Reception

      *FOOD, DRUG & COSMETIC LAW OFF-SITE RECEPTION

      Thursday, January 25, 2018 
      5:30 PM - 7:30 PM
      #nysba18

      Register Here or Download The Registration Form Here.

      Arent Fox LLP
      1675 Broadway
      New York, NY 10019

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

    • Food, Drug and Cosmetic Law Section Meeting

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

      Register Here or Download The Registration Form Here.

      Program Flier

      SECTION & PROGRAM CHAIR 
      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

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

      Speakers: 
      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 
      ·         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

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

      Speakers:  
      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

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

      Speakers: 
      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

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

      Speakers: 
      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

      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 Zeaslously 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 

      Speakers:
      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 

      Moderator: 
      Larissa Bergin, Esq.
      Jones Day
      Washington, DC 

      Speakers: 
      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


      Moderator: 
      Christopher C. Palermo, Esq.
      Bleakley Platt & Schmidt, LLP
      White Plains, NY
       
      Speakers: 
      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 lbataille@nysba.org.

      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 www.nysba.org/am18accomm. 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.

                                             

  • Welcome to the Section

    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! 


  • Section Programs
  • Join the Section

    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 this Section.

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

    The 2014-15 New York State Bar Association Annual Report is now available online. View a brief overview of the Food, Drug & Cosmetic Law Section’s accomplishments, activities and events this past year. 

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