Here continues Part Two of our coverage of the American Conference Institute (ACI’s) inaugural Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics Conference held in New York City on September 10-11, 2015. For Part One, see here.
The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA regulating biologics, which have confounded many in the industry. USDA’s Center for Veterinary Biologics (CVB) generally regulates biologics with an immunological process for treating disease, e.g., antibodies, immunomodulators, and immunostimulants. FDA’s Center for Veterinary Medicines (CVM), on the other hand, regulates certain veterinary vaccines and biologics, where the mechanism of action is not immunological, e.g., monoclonal antibodies that control pain or have other nonimmunological functions, recombinant proteins, gene and stem cell therapies, cytokines, and interferons. This agency split of authority is explained in a USDA-FDA Memorandum of Understanding. Some examples of USDA CVB’s licensed products include monoclonal antibodies developed by Aratana Therapeutics (“Aratana”) to treat canine lymphoma, and Merial’s Oncept®, which uses DNA and recombinant bacteria vaccines to treat animal cancers and predates similar products for humans. FDA’s CVM includes cyotokines, certain monoclonal antibodies, e.g., Nexvet Biopharma’s (Nexvet’s) monoclonal antibody to control pain associated with neurodegenerative diseases in dogs or cats, and Nexvet’s recombinant proteins to treat canine inflammatory diseases, such as atopic dermatitis, or Aratana’s stem cell therapy Regeneus Cryoshot® Canine to treat canine osteoarthritis. Brake opined that many industry members believe it is better to be regulated by USDA’s CVB rather than FDA’s CVM, because there are generally lower research and development costs and eased manufacturing guidelines—both leading to faster regulatory approval times with continuous submission reviews. Natasha Leskovsek, Partner, Cooley LLP, then provided additional input regarding post-approval concerns, such as immunogenicity, which has also been seen with biosimilars.
In a post-discussion question by Brian Malkin, Senior Counsel, McGuireWoods LLP, on petitioning for changing from FDA to USDA or vice versa, McClure suggested that companies may use their labeling claims and intended use to help direct their biological veterinary products to FDA or USDA, depending on the perceived mechanism of action. Linda Rhodes, VMD, Ph.D., Chief Scientific Officer, Aratana, who co-chaired the afternoon’s post-conference workshop, provided an example where an immunocontraceptive for deer initially appeared to be regulated by FDA, which was petitioned later to be reviewed by the EPA as the more appropriate agency. This case suggests that companies may have an impact in determining the reviewing agency for new product categories, which is an important product development issue. And yet other attendees noted confusing examples where seemingly similar biological classes of products were either regulated by FDA or USDA without apparent clear lines regarding immunological action, further indicating that companies should stay on top of this issue.
Next, the topic turned to advertising and promotion for animal medicines. Jennifer Harmer, Director, Regulatory Affairs North America (Pharmaceuticals), Merial, Inc., explained the challenges of complying with three different regulatory bodies for approval and labeling (FDA, USDA, and EPA) along with one general advertising enforcer (FTC) with several private enforcement mechanisms, including the National Advertising Division (NAD) and Lanham Act Litigations. For example, only FDA requires promotional materials at time of promotion and only EPA requires pre-approval of all promotional claims, and the FTC focuses specifically on deceptive advertising. NAD is a private, self-regulatory group that investigates advertising and gives advertisers a mechanism for resolving disputes voluntarily, which is faster than the litigation route via the Lanham Act. While the Amarin decision is interesting (see related blog here), Harmer cautioned to “not go overboard with it,” because FDA likely views it as an unusual case and not many animal health companies appear to be engaging in offlabel claims.
The main conference then concluded with discussions on good manufacturing practices (cGMPs), adverse event reporting, and class action lawsuits in the animal drug industry. As with the other presentations, the complexity of dealing with products regulated by FDA, USDA, or EPA plays in these activities. Given the success of the program, ACI indicated that the program was likely to be continued next year.