Pre-Conference Workshop

Animal Health Boot Camp: An Intense Guide to the Laws and Regulations Governing Medicines, Therapeutics, Food and Feed for Companion Animals and Livestock

Sep 13, 2016 2:00pm – 5:30pm

Speakers

Joseph W. Cormier
Attorney
Hyman, Phelps & McNamara, P.C. (Washington, DC)

Diane J. Romza-Kutz
Partner
Thompson Coburn LLP (Chicago, IL)

Day 1 - Wednesday, September 14, 2016

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Analyzing the NOOH Process and Its Importance in the Animal Drug Arena
8:45
FDA Enforcement Activity in the Animal Health Industry: A Year In Review
9:30
From Glofish to Frankenfish: Understanding How the Approval of Transgenic Animals May Impact Animal and Human Food and Drugs
10:15
Morning Coffee Break
10:30
Exploring the Continuing Controversy of Antibiotic Use in Livestock
11:15
Establishing Protocols for The Next Wave of FSMA Rule Implementation for Animal Feed, Pet Food and Animal Drug Manufacturers
12:00
Networking Luncheon
1:00
Non-Economic Damages for Animal Loss: Assessing the Legalities, Realities as well as Economic Consequences of Such Awards for the Animal Health Industry
1:45
Animal Biologic Development: The Continuing Debate Between Cure and Cost
2:30
Afternoon Refreshment Break
2:45
Dietary Supplements for Animals: Cause and Controversy
3:30
Creative Leveraging of IP to Ensure Protection of Animal Drugs and Therapeutics
4:15
New Considerations for Advertising and Promotion of Animal Drugs and Animal Foods
5:30
Conference Adjourns to Day Two

Day 2 - Thursday, September 15, 2016

7:15
Continental Breakfast
8:15
Co-Chair’s Opening Remarks and Recap of Day One
8:30
Pet Prescription Portability: An In-Depth Look at the Proposed Fairness to Pet Owner Act
9:15
Revisiting the Animal Drug Compounding Debate
10:00
Morning Coffee Break
10:30
Exploring New Controversies in Bioequivalency Studies for Animal Drugs
11:15
Safe Guards for Third Party Clinical Studies in the Animal Health Arena
12:00
Conference Ends (Luncheon will be served immediately following the conference for Post-conference Workshop Attendees only.)

Day 1 - Wednesday, September 14, 2016

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks

Judith Weinstein
Associate General Counsel
Phibro Animal Health Corporation (Teaneck, NJ)

Jeannie M. Perron
Partner
Covington & Burling LLP

8:15
Analyzing the NOOH Process and Its Importance in the Animal Drug Arena

Judith Weinstein
Associate General Counsel
Phibro Animal Health Corporation (Teaneck, NJ)

Jeannie M. Perron
Partner
Covington & Burling LLP

An FDA Notice of Opportunity for Hearing “provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action…before a presiding officer designated by the Commissioner.” The panelists will discuss the FDA Notice of Opportunity for Hearing (NOOH) process and procedures in the context of Animal Health.

8:45
FDA Enforcement Activity in the Animal Health Industry: A Year In Review

Ashish Talati J.D., M.S., RAC

Amin Talati & Upadhye, LLC (Chicago, IL)

CVM’s Office of Surveillance and Compliance has responsibility for and “monitors marketed animal drugs, and veterinary devices to assure their safety and effectiveness…[and] is also is responsible for animal food safety programs including the approval of food additives, monitoring the safety of animal feed and administering the medicated feed program.” This panel will explore this office’s enforcement activity and hotspots for industry in the last year. Points of discussion will include:

  • Post-marketing surveillance of animal drugs
  • Adverse events
  • Animal feed and pet food safety measures
  • Advertising and promotional review
  • Notable Alerts and Warning Letters

9:30
From Glofish to Frankenfish: Understanding How the Approval of Transgenic Animals May Impact Animal and Human Food and Drugs

Joseph W. Cormier
Attorney
Hyman, Phelps & McNamara, P.C. (Washington, DC)

GMO Salmon was approved for human consumption last fall via a New Animal Drug Application. This panel will explore the controversial nature of this approval as well as its wider implication for animal and human food and drugs.

  • Review and analysis of the approval process for transgenic animals through use of a NADA
    • understanding why a potential food is approved as an animal drug
  • Glofish exemption v. AquAdvantage NADA Approval
    • differences and controversies
  • Implications for what new animal drug approval for transgenic animals such as AquAdvantage salmon will have on animal and human foods chain
  • Exploring the labeling controversy for AquAdvantage salmon and other GMO foods in both the animal and human food industries

10:15
Morning Coffee Break
10:30
Exploring the Continuing Controversy of Antibiotic Use in Livestock

John F. Kuckelman
General Counsel
Elanco Animal Health (Greenfield, IN)

In June 2015, the FDA issued its Veterinary Feed Directive (VFD) final rule which together with Directives 209 and 213 call for tighter controls of antibiotic use in livestock, effective January 2017. This session will explore these Directives and their controversial implications for animal feed and drug manufacturers as well as the public.

  • Overview the Veterinary Feed Directive Final Rule and Directives 209 and 213
  • Medically important use vs. minor use
  • Defining “judicious” antibiotic use
  • Exploring the implications of the bar on promotional use claims relative to animal growth
  • Examining expanded veterinary oversight of certain antibiotic feed additives which were previously available OTC and its impact on animal food and drug manufacturers
  • Viewing industry and manufacturer pledges for antibiotic use phase out vis-vis new regulations
  • Assessing safety concerns relative to antibiotic use of livestock
    • residue evaluation of certain antibiotic products
  • Evaluating future of livestock safety and implications to human health in view of new antibiotic restrictions
    • analyzing other recent antibiotic controversies Carbonox and Notice of Opportunity of Hearing controversy
      • politics vs. science
    • FDA Final Rule on Antibiotic Sales Estimates
  • Survey of international protocols and laws governing antibiotic use in livestock

11:15
Establishing Protocols for The Next Wave of FSMA Rule Implementation for Animal Feed, Pet Food and Animal Drug Manufacturers

Jason W. Sapsin
Counsel
Faegre Baker Daniels LLP (Denver, CO)

Diane J. Romza-Kutz
Partner
Thompson Coburn LLP (Chicago, IL)

  • Establishing protocols for the implementation of a comprehensive FSMA compliance program
  • Devising implementation strategies specifically tailored for the individual needs of animal food manufacturers vs. animal drug manufacturers
  • Review and analysis of the final (FSMA) Preventive Controls for Animal Food Rule
    • cGMP implementation
    • risk-hazard analysis and preventative controls
    • supply chain program requirements
    • defining farm and feed mills
  • Understanding the requirements of the Final Rule on Sanitary Transportation of Human and Animal Food
  • Review of other applicable FSMA requirements for animal foods
    • Foreign Supplier Verification Programs

12:00
Networking Luncheon
1:00
Non-Economic Damages for Animal Loss: Assessing the Legalities, Realities as well as Economic Consequences of Such Awards for the Animal Health Industry

Phil S. Goldberg
Partner
Shook Hardy & Bacon L.L.P. (Washington, DC)

Dr. Kent McClure
General Counsel
Animal Health Institute

Bonnie Lutz
Shareholder
Klinedinst PC (Santa Ana, CA) (Chair of the American Bar Association’s Animal Law Committee)

At time of press, an appeals court in Georgia is reviewing a matter in which a pet owner is seeking non-economic damages for the loss of a pet. This is an area replete with controversy. While some argue that contrary to established law, pets are more than property and chattel, other argue that should that classification change, the social and economic consequences of such an award would do more harm than good to animal care. This panel will explore this issue and line of cases which seek to compensate for loss of animal companionship. Points of discussion will include:

  • Analysis of Georgia case and other similar court matters and dispositions
  • Animal health industry position on non-economic damages
  • Evaluating just compensation to pet owners vs. cost of animal care in future and other trickle down affects

1:45
Animal Biologic Development: The Continuing Debate Between Cure and Cost

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Hans Draayer MS
Chairman of the Board
Edge Veterinary Vaccines Consulting Group, LLC (Ames, Iowa)

We live in an age, where biologics for humans have brought tremendous advancements in the cure for disease. This in turn leads to the question about the development of such therapies for animals and the cost effectiveness debate. There are also questions of ethics coupled in this debate concerning animal testing in the development of these products. This panel will explore these controversies. Points of discussion will include:

  • Advances in animal biologics from the routine to the highly sophisticated
  • Cost effectiveness and financing debate
  • Understanding how the development of animal biologics fits into the “one health” initiative movement
  • The ethics of advance biological use in animals
    • position of Industry Animal Welfare Groups

2:30
Afternoon Refreshment Break
2:45
Dietary Supplements for Animals: Cause and Controversy

Michael Uckele
Owner, President & CEO
Uckele Health & Nutrition (Blissfield, MI) (Chief Executive Officer, Board Member, National Animal Supplement Council)

  • Status and classification of dietary supplements for animals — food, drug or something else?
  • Deciphering the DSHEA controversy relative to animal dietary supplement classification
  • Understanding FSMA applicability to dietary supplements for animals
  • Assessing how FSMA might allow for FDA regulation for dietary supplements for animals

3:30
Creative Leveraging of IP to Ensure Protection of Animal Drugs and Therapeutics

Elizabeth A. McGraw
General Patent Counsel, Elanco Animal Health Sr Dir., Assistant General Patent Counsel
Eli Lilly and Company (Greenfield, IN)

  • Exploring IP usages beyond basic patent protections to position and protect animal drugs and therapeutics in the marketplace
  • Assessing strength of design pattern and process patents to position products to best economic advantage
  • Identifying and evaluating use of IP protections to prevent product counterfeiting
  • Employing trade secret use to protect and position products in marketplace

4:15
New Considerations for Advertising and Promotion of Animal Drugs and Animal Foods

KS Reagan
Partner
Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

Evangelia C. Pelonis
Partner
Keller and Heckman LLP (Washington, D.C.)

  • Establishing best practices for claim substantiation by examining governing agency and FTC warning letters and enforcement actions
  • Drawing parallels between human drug and food and animal drug and food promotional activities
  • Assessing the impact of Amarin and Pom on animal drug and food advertising and promotion
  • Addressing social media and website concerns relative to animal drug and food promotion and advertising

5:30
Conference Adjourns to Day Two

Day 2 - Thursday, September 15, 2016

7:15
Continental Breakfast
8:15
Co-Chair’s Opening Remarks and Recap of Day One

Judith Weinstein
Associate General Counsel
Phibro Animal Health Corporation (Teaneck, NJ)

Jeannie M. Perron
Partner
Covington & Burling LLP

8:30
Pet Prescription Portability: An In-Depth Look at the Proposed Fairness to Pet Owner Act

Clint Vranian
Vice President and General Counsel
VitalPet (Indianapolis, IN)

Eric J. Steiner
Director, U.S. Government Affairs
Elanco Animal Health (Washington, DC)

This past April, a Congressional hearing took place on the merits of the proposed Fairness to Pet Owners Act which in the eyes of its advocates would allow for prescription portability — as well as more economical option for pet owners to purchase pet medicines outside the traditional means of obtaining such medicines through a veterinarian’s office. The Act’s opponents believe that choice already exists at the state level and that this legislation would interfere with the veterinarian’s role in pet care. This panel will discuss this potential legislation and the views of both sides of the debate. Points of discussion will include:

  • Overview of the Proposed Fairness to Pet Owner Act
  • Examining distribution channels for pet medicines
    • perceived restrictions on these channels
  • Exploring antitrust concerns and FTC’s position on the matter

9:15
Revisiting the Animal Drug Compounding Debate

Theodore M. Sullivan
Partner
Quarles & Brady LLP (Washington, DC)

Rachael G. Pontikes
Partner
Duane Morris LLP (Chicago, IL)

Moderator:

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

The animal drug compounding controversy continues. While, FDA issued a draft guidance on the matter last year. There still is no specific Federal law or Amendment to the Food Drug and Cosmetic Act regulating the practice. In this federal vacuum, various states are now chiming in with their own proposed legislation. In this session, our panelists will continue the discussion from last year and revisit the pros and cons of compounding as well as new compounding controversies. Points of discussion will include:

  • Status of the FDA draft guidance on animal drug compounding
  • Review of various state laws attempting to regulate animal drug compounding
  • Use of controlled substances in animal drug compounding
  • Veterinarian input in the animal drug compounding controversy

10:00
Morning Coffee Break
10:30
Exploring New Controversies in Bioequivalency Studies for Animal Drugs

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Elizabeth A. McGraw
General Patent Counsel, Elanco Animal Health Sr Dir., Assistant General Patent Counsel
Eli Lilly and Company (Greenfield, IN)

Bioequivalency studies are a key requirement of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), the animal drug equivalent to the Hatch Waxman Act governing human drug brand and generic market access. This panel will explore new concerns relative to bioequivalency in animal drugs and therapeutics.

  • Evaluating concerns with bioequivalence studies in all major species
  • Understanding when it is necessary to exclude certain species to procure a more accurate bioequivalency study, e.g., felines
  • Exploring benefits of invitro bioequivalency studies

11:15
Safe Guards for Third Party Clinical Studies in the Animal Health Arena

Ann R. Donoghue DVM, MS
VetDC, Inc. Authorized Representative
Regulatory Affairs (Fort Collins, CO)

Gary Yingling
Partner
Morgan, Lewis & Bockius LLP

  • Overview of clinical trial requirements for animal drugs and therapeutics
  • Examining the use of third parties such as CROs in conducting clinical trials for animal drugs
    • addressing legal and regulatory concerns relative to such contracting and outsourcing
  • Working with outside organizations such as CROs to design studies that show desired results and satisfy FDA protocols
  • Drafting contracts with third parties for clinical research that ensure IP protection of your product and subsequent findings and discoveries
  • Ensuring protection of study publication rights when working with a third party organization

12:00
Conference Ends (Luncheon will be served immediately following the conference for Post-conference Workshop Attendees only.)