A new innovation agenda released by the Food and Drug Administration's Center for Veterinary Medicine outlines how CVM plans to address hot-button issues such as approvals of zootechnical feed additives and coordinate on regulating the use of gene editing in animals.
“We want our industry, scientific, community and public partners to all know that we really embrace exciting new technologies. We’re not afraid of them. We’re staffing up for them,” said CVM Director Tracey Forfa in an exclusive interview with Agri-Pulse ahead of the announcement. Forfa said the innovation agenda includes what CVM is already doing and lays out its vision going forward.
Specifically, the agenda identifies the following objectives:
- “Support technologies and products that address high-priority needs.
- Align regulatory pathways to the modern landscape.
- Enhance our One Health workforce for the future of innovation.
- Identify and address gaps specific to new technologies and emerging health threats.”
As a lawyer and the first non-veterinarian to head up CVM, Forfa said she recognized that FDA would not have the authority to regulate new zootechnical technologies without some “additional tweaks to our underlying authorities.”
FDA has been working with industry and congressional partners on the Innovative FEED Act, which "will introduce new approval pathways for zootechnical animal food substances (novel food ingredients that function in the gut of the animal to affect qualities like feed efficiency, reduced waste output, or reduced pathogens in food products made from the animal)," FDA said in a news release.
The Innovative FEED Act, which has cleared a Senate committee, is widely supported by industry stakeholders. FDA has been criticized for not acting quickly or transparently to approve feed additives designed to promote feed efficiency and reduce methane emissions.
Similar to other countries around the world, Forfa said FDA's new agenda provides the balance to ensure rigorous oversight while also allowing for technological advancements. “This framework creates a pathway to market that takes the specific circumstances of the unique substances which I think we're going to be seeing more of into consideration while requiring a complete evaluation of safety,” Forfa said.
The agency is also expanding its Veterinary Innovation Program (VIP), which was established in 2018 as a forum to work with sponsors and developers of animal products derived from novel technologies. In the agenda, CVM noted that in July, FDA had over 50 products enrolled in the VIP.
The new VIP-Plus is planned to launch later this year, FDA said. Biotechnology and gene-editing animal researchers have criticized FDA on the delayed timeline and even asked for FDA to allow USDA to oversee animal biotechnology product approvals.
CVM plans to implement what it calls “VIP Sci-Assist” to help standardize how regulators evaluate the genome editing process. Forfa said she encourages developers to talk with the agency early in the process.
“I think there’s a prevailing kind of misunderstanding out there that every biotechnological product that is presented to us has to go through a whole animal drug review process,” Forfa said. “But we’re a risk-based scientific agency,” she said, and evaluates whether products are high- or low-risk.
She said the process for biotech animal reviews is “not a one-size-fits-all,” although FDA does have timeframes it must strictly adhere to. “It is striking that balance between time to market, but also to make sure that any genetically altered animal or biotech product is safe to the animal and safe to anyone who eats the food,” she said.
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A second action the agenda outlines is a “VIP Fast-Step project to identify components of CVM’s VIP review process for which CVM can commit to abbreviated timelines.” Another action item is to form an Accelerating the Development of Veterinary and Animal Needs Program – ADVANce – to establish partnerships to address the most critical priorities. CVM also plans to invest in data modernization.
CVM also will create a Regulatory Modernization Task Force and identify potential improvements throughout the regulatory process. It will also establish a Food Innovation Hub in the Office of Surveillance and Compliance.
In recognizing the importance of One Health, the innovation agenda also said CVM plans to work with FDA’s Office of the Chief Scientist to share information between human and animal health scientists. “FDA, in sort of a One Health approach, is taking a really progressive look at how we can make sure these innovative products move forward in the most safe manner possible,” she said.
“We really want to collaborate not just across FDA, but across the entire government and with all of our stakeholders to make sure that we are leaders in spurring and supporting innovation on, because it really is an exciting time. And we want to make sure that we are good partners,” Forfa said.
Jesse Sevcik, Elanco executive director of government affairs, said the company appreciates FDA’s commitment to modernize the regulatory framework.
“We need to modernize the pathway that keeps FDA in the center, continuing to ensure safety and efficacy while speeding tools into the hands of farmers. Ultimately this is about creating value and ensuring competitiveness for American farmers,” he told Agri-Pulse.
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