The Food and Drug Administration announced plans Tuesday to clarify and speed up the regulatory path for new gene-edited traits in both plants and animals.

In its new Plant and Animal Biotechnology Innovation Action Plan, the agency declared broadly that it will “clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and our public health mission.”

The initiative is focused on facilitating regulatory approvals for animal biotech advances and products:

  • A Dec. 3 webinar on “the current science, promising uses . . . (and) the potential risks” of gene editing in animals;
  • “A comprehensive policy framework for . . . intentionally genetically altered animals and the food and drug products derived from them . . . to help usher in new, beneficial and safe products to consumers and animals;” and
  • “We’re also piloting a new Veterinary Innovation Program (VIP) for developers of intentionally genetically altered (IGA) animals and animal cells, tissues and cell- or tissue-based products (ACTPs) that are seeking the FDA’s approval.”

With its VIP, the agency promises developers “intensive assistance for developers . . . enhancing certainty in the regulatory process . . . and supporting an efficient and predictable pathway to market for . . . animal products."

For each new animal biotech product, the agency says, the process will include an FDA Center for Veterinary Medicine review team and regular contact with CVM project managers who will help the product developer “in understanding the regulatory process, planning for submissions, and ensuring you have the information necessary to prepare high quality submissions” for regulatory approval.

Daniel A. Kovich, DVM, technology director for the National Pork Producers Council, says those are helpful changes in livestock biotech regulation, and he likes FDA’s commitment to adopt a more “staged, risked-based approach.”

However, he said the pork industry is disappointed the FDA announcements “have not addressed a fundamental issue . . . of treating the genome of the animal as the animal drug.” That approach by FDA, Kovich said, prevents any new animal genetic change approved by FDA to be applied to the other animals of the same species.

Thus, he said, progress in adopting such gene editing advances is stymied. FDA “can address that (problem) in the future, and we certainly hope they do,” but the announcement this week did not address it, he said.

In the plant biotechnology arena, meanwhile, FDA expects to also publish guidance soon "to clarify our regulatory approach for plant biotechnology products for human and animal food.”

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