On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview and a post-conference session working with FDA, the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which included a mock meeting with the FDA’s Center for Veterinary Medicine (CVM).
Kicking off the main conference were Dr. Kent McClure, General Counsel, Animal Health Institute, and Clinton Vranian, General Counsel, North America, Elanco Animal Health. Vranian provided an overview of the history of animal health products including how there were historically few “ready-made” products, where veterinarians could operate and own their own pharmacies to fill the pharmaceutical needs for animals. In addition, unlike human medicines, there has been no third-party payor model (resale only). At the heart of treatment models for animals is the veterinary client patient relationship (“VCPR”), linking animal prescription products for exclusive distribution practices. Every year, an act similar to the Fairness to Pet Owners Act of 2015 is introduced but not passed that aims to require veterinarians to write prescriptions, even if they fill them in their own offices, except while delivering acute care. The Federal Trade Commission, Vranian explained, has expressed interest in the mergers and acquisition movement in the animal health industry, which is “evolving naturally” and including more competition and with startups across all product lines and categories, which he thought should not be compared to the single class of contact lenses (a common comparison model).
McClure addressed how animal welfare and animal rights get blurred, where the goal is to look for proper care and responsible use of animals in research, as well as appropriate compensation for companion animals harmed in negligence cases. McClure noted the increasing perceived issue concerning antibiotic use in animals, as well as the impact and proper use of animal compounding, particularly when compounded from bulk active ingredients, alongside the growing animal pharmaceutical industry.
Next, Gregory Helzer, Partner, McDermott Will & Emery LLP, looked at consolidation in the animal health industry. Heltzer noted that there tends to be very detailed analyses for animal health transactions when challenged, which is generally when a market has a smaller ratio of players. In general, Helzer noted more aggressive antitrust enforcement in the current administration, where both onlabel and offlabel uses of products have been considered.
What followed was a general overview of the approval process for animal medicines by Ann Donoghue, DVM, MS, Donoghue Consulting, LLC; Dr. Gareth Harris, AVP, Global Regulatory Affairs, Merck Animal Health, and Jennifer Spokes Johansson, J.D., Senior Vice President, Regulatory Policy and Counsel, Putney, Inc. and Chair, Generic Animal Drug Alliance (GADA). Johansson noted that some suitability petitions for generic animal drugs have been harder to get than others, e.g., the change from a suspension to a tablet is often difficult to obtain via this route. She also noted that since the 1988 statutory provisions were enacted, FDA has offered no guidance for hybrid applications that are similar to 505(b)(2) NDAs. Donoghue described how FDA has been using its conditional approval process (conditional new animal drug applications (“cNADAs”), which requires a complete pivotal efficacy study within 5 years of cNADA approval, and had been a popular program. While there is an indexing process that utilizes a qualified expert panel for drugs intended for animal species too rare or varied to be used in traditional safety and effectiveness process, the process has been infrequently used (about only 10 products) e.g., fish, rodents, ferrets, or raptors. Finally, pesticides may be regulated by EPA or FDA, depending on federal and state laws, which often involves a risk assessment. Harris explained how biologics are regulated by USDA or FDA.
Following lunch, an explosive panel addressed the contentious issues surrounding drug compounding for animal medicines. Brian Malkin, Senior Counsel, McGuireWoods LLP, moderated and delievered an overview of FDA’s regulation of animal drug compounding, with Rachael Pontikes, Partner, Duane Morris LLP, providing the view of animal compounders, and Theodore Sullivan, Counsel, Buchanan Ingersoll & Rooney PC, providing the view of the animal pharmaceutical industry including GADA. What became clear from the debate is that animal compounders believe that they fill a valuable void for customized medicines that need to be developed for the diversity of animal species and sizes, whereas pharmaceutical manufacturers believe that compounders go too far, competing with approved animal medicines. Caught in the middle is FDA, which has been attempting to regulate animal drug compounding without clear statutory authority in some cases, where it has sought to use guidances and test cases as a bridge rather than regulations.
Then the concept of a “patent thicket,” coined by panelist Dr. Judy Jarecki-Black, Esq., Global Head, Intellectual Property, Merial, was then explored in the context of veterinary medicines. The panel compared veterinary patent litigations and reviews to those under the Hatch-Waxman Act, finding similarities and differences. While there have been statutory modifications to the Hatch-Waxman Act since 1984, including such refinements as certifying to patent listings, for animal drugs the procedures have remained largely the same since the 1988 statutory provisions. For example, FDA simply lists patents submitted by reference listed product holders in the Green Book (FDA Approved Animal Drug Products) without such certifications. And the safe harbor provisions for patent infringement include a curious carve-out for biologic veterinary products, the panel noted.
Other discussions in the first day included animal medicine trademarks and trade names, as well as the relationship between veterinary medicines, animal feed, and pet food.