The Food and Drug Administration's has responded to concerns about how it would regulate gene editing in animals.
Last week, the FDA's plan was roundly criticized by the National Pork Producers Council.
The NPPC is focused on the importance of gene editing in animal agriculture and how FDA oversight would hamper progress of the technology and put U.S. livestock producers at a competitive disadvantage globally.
NPPC says the technology holds enormous promise in addressing many of the issues facing animal agriculture, such as the need for disease-resistance pigs, but contends FDA’s approval process would be impractical, lengthy and expensive.
The organization wants regulatory oversight transferred to USDA, which oversees genetic changes in plants along with FDA and EPA.
FDA’s draft guidance on the issue states an intentional genomic alteration — known by the initials IGA — meets the definition of a drug because it affects the structure and function of the animal.
That means the descendants of the edited animal will be subject to regulation as animal drugs in perpetuity, Dan Kovich, NPPC director of science and technology, said in his “Meat of the Matter” paper on the issue.
But Anna Abram, FDA deputy commissioner for policy, legislation and internal affairs, said FDA’s science- and risk-based approach is flexible.
“FDA does not intend to enforce investigational and approval requirements for IGAs in animals that pose minimal risk,” she said.
FDA does not regulate animals as a drug but instead evaluates IGAs based on the risk they pose to the animal and human health, she said.
“We acknowledge that the nomenclature hasn’t been optimal to capture the spirit of what we’re doing and how we are regulating these products,” said Dr. Steven Solomon, director of FDA’s Center for Veterinary Medicine.
FDA does have statutory authority to regulate these IGAs. However, it has the option to exercise enforcement discretion and not enforce approval requirements for products that pose minimal risk — and already has for several products, he said.
“This is why we encourage developers to come to us early in the process, so we can help advise in generating the appropriate safety data from the beginning — potentially expediting the process,” he said.
For products that do need to go through the approval process, FDA offers a phased review process and the opportunity to request participation in the Veterinary Innovation Program, he said.
“The promise of this technology is advancing all the time, and we want to innovate with it,” he said.
That’s why FDA has built a tremendous level of scientific expertise to be able to help biotechnology firms efficiently develop the data they need to either support an approval or demonstrate that the agency can practice enforcement discretion, he said.
Kovich said FDA is currently requiring significant numbers of at least three generations of descendants of gene-edited animals to be reared to adulthood and evaluated as part of the approval process.
That approval process would take at least five years for pigs for every gene edit proposed and at least 10 years for cattle, he said.
Once an edit has been approved, FDA has signaled it is only approved for the lineage of the animal that has gone through the approval process and not for the species generally, he said.
FDA has heard these and other criticisms in public comment responses to its draft Guidance for Industry 187, Solomon said.
“We’re now revising our guidance document and plan to be responsive to these concerns by clarifying many of these points,” he said.
For instance, where it is not feasible or practical to provide data on multiple generations of animals, sponsors can use an alternative means to demonstrate that the genetic alteration they are making is durable — that the claimed change, such as disease resistance, persists in subsequent generations, he said.
“What we want to have at the end of the day is a science-based approach with sufficient flexibility to demonstrate the safety of the IGA to the animal, safety for people eating products from the animal and that the IGA does what it’s supposed to do,” he said.