I attended the first ever Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics, “a comprehensive guide to the latest developments affecting drugs for companion animals and livestock,” held in New York City by the American Conference Institute, on September 10-11.

Attendees and speakers were the who’s-who of this area of law, affecting animals, their owners, veterinarians, pharmaceutical companies, the biomedical research community and more.

Topics discussed, as listed on the agenda (©ACI Agenda) included:

The Policy and Politics of Animal Health: Understanding How Certain Legislative‚ Political and Grassroots Initiatives May Impact the Animal Health Industry’s Future;

Consolidation in the Animal Health Industry: Understanding How Mergers‚ Acquisitions and Spinouts Are Reshaping the Legal‚ Regulatory and Economic Landscape of Veterinary Medicines;

Animal Medicines -The Approval Process;

Drug Compounding in the Animal Drug Industry: Assessing Fair and Foul Practices;

Patents and Veterinary Medicines: Exploring the Delicate Balance Between Brand Name and Generic Animal Drug Products and New Controversies;

Making A Name and Setting a Mark: Appreciating the Importance of Trademarks and Trade Names for Animal Medicines;

Exploring the Relationship Between Veterinary Medicines and Animal Feed and Pet Food;

Exploring Legal‚ Regulatory and Economic Concerns Associated With the Development of Advanced Biological Drugs for Use in Animals;

Navigating the Regulatory Maze of Advertising and Promotion in the Animal Medicines Industry;

Understanding the Importance of Current Good Manufacturing Practices in The World of Animal Drugs;

Establishing Best Practices for Adverse Event Reporting and Recalls in the Animal Health Space; and

Survey of Class Action Lawsuits in the Animal Drug Industry.

The panel on compounding was most entertaining.

Brian Malkin, Senior Counsel, McGuireWoods LLP, served as umpire (literally) for Rachel G. Pontikes, Partner, Duane Morris, who represents compounding pharmacies and veterinarians, and Theodore M. Sullivan, Counsel, Buchanan Ingersoll & Rooney PC who served up a full-fledged rally, with no clear winner, except for the audience, appreciative of the passionate presentation.

Amongst other points, the panel debated:

  • whether FDA has the authority (as it asserts) to prohibit veterinary compounding from bulk drug substances, under the umbrella of “new animal drugs” which FDA is clearly authorized to regulate; or
  • whether animal compounding remains governed by state laws; and
  • if FDA does not currently have that authority, will it have to obtain authorization from Congress, by way of statutory amendment, as it did to obtain authority over compounding in the human area.

The panelists also debated the meaning of the district court’s holding in U.S. v. Franck’s Lab, Inc., 816 F. Supp. 2d 1209 (M.D.Fla. 2011), namely, that FDA was not authorized to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances,” since the appeal that followed that decision was dismissed as moot.

In May, 2015, FDA issued Draft Guidance #230 titled, Compounding Animal Drugs from Bulk Drug Substances, which “Contains Nonbinding Recommendations”  (the panelists also debated whether FDA’s guidance documents are binding or not).

It remains to be seen whether and to what extent those recommendations are binding, or will be challenged as another unauthorized overreach by FDA into the governance of the practice of compounding medicines for animals, historically a state-governed fundamental aspect of veterinary medicine.

More to come about the other topics discussed during this historic conference.