The U.S. Food and Drug Administration (FDA) took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. FDA says the updated guidance underscores 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. The agency also established a memorandum of understanding (MOU) with USDA to clarify roles and responsibilities for regulation of IGAs in animals.
“We recognize that innovations in animal biotechnology offer tremendous opportunities for advancing human and animal health, and that we as an agency need to keep our regulatory approach current with the evolution of the science,” Tracey Forfa, director of the FDA’s Center for Veterinary Medicine, said in a release. “These updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety. These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality.”
FDA clarified that IGAs in animals can be made using modern molecular technologies, which may include random or targeted DNA sequence changes, including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. IGAs in animals have many different intended uses, including applications in human health (e.g., reduced allergenicity; “biopharm” animals that produce substances, generally in their milk or eggs, for use in the production of human therapeutics; animals used to model human disease), in improved animal health, well-being, and husbandry practices (e.g., disease resistance, heat tolerance), and in enhanced production and food quality (e.g., faster growth, feed efficiency, nutritional benefits).
The two documents released on May 1 include:
- final Guidance for Industry (GFI) #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach”
- draft revised GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process”
Both of these documents are intended to help the industry understand the existing statutory and regulatory requirements as they apply to IGAs in animals and to inform the public about the FDA’s process for regulating them, FDA said.
“The guidance documents align with the goals of the FDA’s Animal and Veterinary Innovation Agenda (AVIA), which aims to foster 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,” FDA wrote.
The FDA first issued final guidance on the regulation of certain IGAs in animals in 2009. In January 2017, due in part to evolution in the science of IGA technologies, the agency clarified the scope of its guidance to include animals with intentionally altered genomic DNA developed through use of genome editing technologies, in updated draft 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 heritable IGAs. It also describes how FDA determines when it is appropriate to exercise enforcement discretion over certain products. In Draft GFI #187B, FDA describes how the FDA approval process applies to heritable IGAs in animals.
“The FDA is committed to collaborating with its regulatory partners across the federal government to ensure that approved IGAs are safe for the animal, safe for people, and that the product does what it claims to do. On April 18, the FDA and USDA signed an MOU that applies to the FDA’s activities involving IGAs in animals that are also subject to certain USDA authorities,” FDA wrote.
The MOU establishes policies and procedures that not only enhance the exchange of information between the agencies, but also describe the regulatory roles of the agencies, and promote coordination of regulatory responsibilities in a manner that will enable an efficient regulatory process. It does not change or add regulatory requirements for developers, FDA noted. Additional details can be found here.
The FDA said it encourages developers of IGAs in animals to approach the agency early in their research and development phase to discuss the specific risk profile of the proposed product and the appropriate pathway for commercialization. For products that qualify, the agency recommends participation in the Veterinary Innovation Program, intended to assist developers of innovative veterinary products, including certain IGAs in animals, by providing intensive technical and programmatic assistance throughout the approval process in order to make it as efficient as possible.
The agency requests public comment on GFI #187B for 90 days starting on May 2. To ensure the FDA considers comments before it begins work on the final version of GFI #187B, members of the public should submit comments by July 31.
