Regulatory challenges top of mind at inaugural ACI animal health forum

About 60 animal health executives were in attendance for the first American Conference Institute (ACI) Forum on Animal Health and Veterinary Drugs and Therapeutics, where industry experts covered a range of topics related to challenges involved in navigating the USDA, FDA and other regulatory agencies. The two-day event, held in New York City, was so popular ACI hopes to repeat it next year, according to ACI representatives on site. (FierceAnimalHealth was a media sponsor of the event.)

In addition to reviewing the approval process for animal medicines, speakers at the forum discussed the environment for mergers and acquisitions in the industry, patent issues and regulations related to the advertising of veterinary drugs. The attendees also participated in a lively debate about fair and foul practices in drug compounding.

The second day of the event kicked off with a discussion about the development of biotech drugs for animals. David Brake, founder and principal of BioQuest Associates, a Connecticut-based consultancy, explained the sometimes confusing process by which drugs are assigned to either the FDA or USDA for approval.

Generally speaking, the USDA regulates any biologics that act via immune pathways in the body, such as vaccines, while the FDA handles everything else, Brake explained. But the advent of products that fall into the "gray area"--such as vaccines that are used to treat diseases rather than prevent them, and stem cell treatments--has left some companies scrambling to figure out which agency to approach to begin the regulatory process.

Brake predicted that the explosion of new animal drugs in the R&D pipeline would prompt further clarification of which agency has jurisdiction over which products. "This is an evolving area," Brake said.

Although seeking approval from the USDA is often easier and less expensive than the FDA route for companies, one audience member at the conference commented that public perception might favor products that are approved by the FDA. Brake advised the attendees to keep a close eye on the regulatory scene going forward. "Historically, the perception was that USDA-regulated products were not as good, but I think that's changing," he said. "I think the USDA has upped its game."

The forum featured legal and regulatory experts from several of the leading companies in animal health, including Merial, Merck ($MRK) Animal Health and Eli Lilly's ($LLY) Elanco Animal Health division.

- access the conference agenda here