FDA CVM lays out innovation plan for new animal, veterinary products

Addressing drug shortages and bringing innovative products to market are priorities in its Animal and Veterinary Innovation Agenda

Much hope exists in veterinary medicine, animal industry, and food production sectors, where new technologies hold great promise, says Tracy Forfa, director of the Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM). At the same time, global markets, climate change, and increased disease threats mean the food system and animal industries need to become more creative and resilient.

In addition, drug shortages caused by supply chain issues, including penicillin, potentially harm patients’ health and wellbeing, according to a paper published in JAVMA in January by the AVMA Committee on Antimicrobials.

Dr. Tristan Colonius, chief veterinary officer and deputy director for science policy at the FDA CVM, recently provided AVMA leadership an overview of the Animal and Veterinary Innovation Agenda, the center’s plan to support the development of safe and effective new products, spur innovation, and adopt smart improvements to regulatory pathways for new animal and veterinary products to reach the marketplace.

Medical researcher looks through a microscope in a laboratory
The Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) announced its Animal and Veterinary Innovation Agenda last fall. As part of this effort, the FDA CVM intends to launch a Gene Editing Regulatory Science Council comprising experts from the FDA’s human, animal, and plant programs.

Speaking during the AVMA House of Delegates regular winter session, held January 5-6 in Chicago, Dr. Colonius referenced the FDA’s recent approval of two new breakthrough treatments for sickle cell disease, one of which is the first medicine to be approved in the U.S. that uses the gene-editing tool CRISPR-Cas9. 

“We at FDA are incredibly excited about the innovative technologies out there, from gene editing to cellular therapies,” he continued. “We’re equally aware of some storm clouds on the horizon, about low margin products that may be made by a single manufacturer that may lead to higher risk of shortages.”

Published in September 2023, the agenda describes FDA CVM’s ongoing commitment to taking smart, risk-based regulatory approaches that keep pace with technological innovation and support and spur progress in the U.S. animal health, animal food, and animal agricultural industries.

Key objectives of the FDA CVM agenda are supporting technologies and products that address high-priority needs; aligning regulatory pathways to the modern landscape; enhancing the agency’s One Health workforce for the future of innovation; and identifying and addressing gaps specific to new technologies and emerging health threats.

Ways in which these goals will be realized include fast-tracking certain products, such as biotechnologies, by offering scientific assistance to developers and finding ways to offer faster review times to speed innovative products to market. The FDA CVM will also explore modernizing regulatory pathways to create smart and agile frameworks that support and spur innovation, Dr. Colonius said.

He referenced the Minor Use Minor Species Act (MUMS), explaining that after discussions with minor species groups, the act hasn’t been as successful as hoped.

“We need to interrogate MUMS to determine what would make a difference in that space— what's worked, what hasn't worked, and what we want the next 20 years of minor use and minor species work to look like so we can deliver more tools into the hands of those who need them,” Dr. Colonius said.

The FDA CVM intends to launch a Gene Editing Regulatory Science Council comprising experts from the FDA’s human, animal, and plant programs to look at common emerging science in this space and ways to address risks, such as off-target effects. He said doing so would truly put One Health into action and bring more products to market that address critical animal and human health needs.

Additionally, the innovation program calls for recruiting, retaining, and continuing to develop world-class scientific and technical talent and the creation and implementation of an FDA One Health Code of Practice. The FDA CVM will develop specific, measurable actions to adapt the center’s operational practice, risk prioritization, and strategic planning to integrate human, animal, and environmental scientific areas of focus to address complex public health problems.

The FDA CVM will form an Innovation Exploration Task Force to work across the center to develop and implement methods of monitoring emerging technologies from all sectors—including biomedical products and novel food ingredients for both animals and humans—that can impact the FDA CVM’s regulatory work.

And finally, the FDA CVM will research emerging technologies that will allow the center to better align its work with the attributes of those technologies.

“We see an incredibly bright future for veterinary medicine in the space that we regulate. But we've got real challenges. Some of these are unique to veterinary medicine … but we’ve got to figure out how to address these, and we're going to need a coalition to do it,” Dr. Colonius said.