FDA clarifies approach to genomic changes in animals

FDA and USDA Establish Memorandum of Understanding to Clarify Roles and Responsibilities for Regulation of Intentional Genomic Alterations at Animals

SILVER SPRING, Md., May 1, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency. In addition, the agency has established a Memorandum of Understanding (MOU) with the U.S. Department of Agriculture (USDA) to clarify roles and responsibilities for regulating IGAs in animals.

“We recognize that innovations in animal biotechnology offer enormous opportunities for advancing human and animal health, and that as an agency we must keep our regulatory approach up to date with evolving science,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine. “These have been updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety. These technologies hold promise for many public and animal health applications and benefits, such as resistance to animal diseases, control of zoonotic disease transmission, improved livestock husbandry, and increased food production and quality.”

IGAs in animals can be made using modern molecular technologies, including random or targeted changes in the DNA sequence, including nucleotide insertions, substitutions or deletions, or other technologies that introduce specific changes into the animal’s genome. IGAs in animals have many different intended uses, including applications in human health (e.g., reduced allergenicity; “biopharmaceutical” animals that produce substances, typically in their milk or eggs, for use in the production of human therapeutics; animals used used to model human disease), in improved animal health, welfare and husbandry practices (e.g. disease resistance, heat tolerance) and in improved production and food quality (e.g. faster growth, feed efficiency, nutritional benefits).

The two documents released today, the final Guidance for Industry (GFI) #187A, “Herited Intentional Genomic Alterations in Animals: Risk-Based Approach,” and the revised draft GFI #187B, “Hereditary Intentional Genomic Alterations in Animals: the Approval Process” are intended to help the industry understand existing legal and regulatory requirements as they apply to IGAs in animals, and to inform the public about the FDA’s process for regulating them.

The guidance documents are in line with the objectives of the FDA’s Animal and Veterinary Innovation Agenda (AVIA)which aims to promote the development of safe, innovative products and implement smart, risk-based approaches to regulating modern animal and veterinary products, while protecting human, animal and environmental health.

The FDA first issued final guidance on the regulation of certain IGAs in animals in 2009 January 2017Due in part to the evolution in the science of IGA technologies, the agency has clarified the scope of its guidelines to include animals with intentionally altered genomic DNA, developed through the use of genome editing technologies, in the updated draft of GFI #187 , “Regulation of Intentionally Altered Genomic DNA in Animals.”

Final GFI #187A outlines the FDA’s overarching policy for regulating all IGAs in animals and describes the agency’s risk-based regulatory approach to the oversight of hereditary IGAs. This final GFI also describes how FDA determines when it is appropriate to exercise enforcement authority over certain products. The types of products that may be eligible for enforcement power have been expanded since the 2017 draft to include IGAs for food-producing animals, such as SLICK livestock, in circumstances where they have been modified to be equivalent to animals of the same species that already exist and have a history of safe use. In a supplemental document, Draft GFI #187B, we describe how the FDA approval process applies to hereditary IGAs in animals.

The FDA is committed to working with its regulatory partners within the federal government to ensure that approved IGAs are safe for the animal, safe for humans, and that the product does what it claims to do. On April 18, 2024, the FDA and USDA have signed an MOU governing the FDA’s activities related to IGAs in animals that are also subject to certain USDA authorities. The MOU establishes policies and procedures to improve the exchange of information among the agencies, describes the agencies’ regulatory functions, and promotes the coordination of regulatory responsibilities in a manner that enables an efficient, seamless regulatory process. No legal requirements for developers are changed or added. Additional details can be found here.

The FDA encourages developers of animal IGAs to approach the agency early in their research and development phase to discuss the specific risk profile of the proposed product and the appropriate route for commercialization. For eligible products, the agency recommends participation in the Veterinary Innovation Program (VIP)which aims to assist developers of innovative veterinary products, including certain animal IGAs, by providing intensive technical and programmatic support throughout the approval process to make it as efficient as possible.

The FDA will continue to work with its domestic and global partners as the agency implements an appropriate risk-based regulatory approach, based on sound science, that facilitates the development of safe, innovative products and ensures consumer confidence. This action also aligns with the goals of Executive Order 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.

The agency is now seeking public comment on GFI #187B for 90 days May 2, 2024. To ensure that FDA considers comments before beginning work on the final version of GFI #187B, members of the public should submit comments by July 312024.

Extra information:

Media contact: Veronika Pfaeffle310-301-2576
Veterinary and consumer questions: (email protected)800-835-4709

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration