The Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan, which provides an overview of FDA’s efforts to develop a comprehensive policy framework for the oversight of animal biotechnology products, including food and drug products derived from intentionally genetically altered animals and plants.

In a draft Guidance document released in 2017, the FDA indicated that it will likely require premarket approval for every intentional alteration to animal DNA, stating, “…each specific genomic alteration is considered to be a separate new animal drug subject to new animal drug approval requirements”. The FDA received stakeholder feedback on this draft guidance, and will be holding a webinar on December 3, 2018 to open the public dialogue regarding this risk-based regulatory approach.

You can register for the webinar here: “Center for Veterinary Medicine Public Webinar: Genome Editing in Animals on Monday, December 3, 2018 1:00:00 PM EST - 3:00:00 PM EST”. During registration, you will have the option to submit any questions you have regarding genome editing in animals and regulation of animal biotechnology.

The FDA also announced plans to:

• Release guidance documents on FDA’s regulatory approach to animal gene editing and publish draft guidance explaining how FDA’s currently regulatory policy for foods applies to genetically engineered plants, both in 2019.

• Release draft guidance for industry to establish an alternative type of file as a repository for information exchanges with the FDA’s Center for Veterinary Medicine (CVM) for products that are in early development or research stages that may never progress to a marketable product.

• Start a new pilot program - the Veterinary Innovation Program (VIP) - to provide technical and programmatic assistance to those developing genetically engineered animal or cell products related to human or animal health, or food production.

• List on its website the specific animals or categories of animals for which the FDA has made a risk-based determination to exercise regulatory premarket approval requirements.

• Begin updating existing procedures for voluntary premarket consultations with industry for genome editing of food crops.