Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health. Promising new technologies that can edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity and food security. New forms of biotechnology allow modification of living organisms, such as plants or animals, in order to produce a new product, such as a novel pharmaceutical, new food variety or disease-resistant crop. These are just some of the new plant and animal-based biotechnology innovations that are opening up new opportunities to improve public health.
The Action Plan works to address questions we regularly receive from biotechnology stakeholders, including developers of these products and public health interest groups. This new plan identifies priorities in three important areas: 1) advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways; 2) strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology; and 3) increasing engagement with domestic and international partners on biotechnology issues.
As a first step, the FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.
This modern, flexible framework will advance the agency’s commitment to safety while promoting innovation in this space. Our shared goal is to help usher in new, beneficial and safe products to consumers and animals as quickly and safely as possible.
In addition, the FDA’s Center for Veterinary Medicine (CVM) intends to hold a public webinar on Dec. 3, during which we’ll discuss the science behind genome editing in animals, the promising uses of this technology in animals and the potential risks, and information about CVM’s flexible risk-based approach to the regulation of intentional genomic alterations to animals. CVM will also address some of the common misconceptions about the FDA’s regulation of these products. At this webinar, the FDA’s Center for Biologics Evaluation and Research will also provide information about genome editing used in producing human products, including those for use in xenotransplantation, and how these products will be regulated.
Another key focus of our Action Plan is a robust communications and engagement strategy designed to continue collaborations with a wide range of stakeholders to understand their views on how the FDA can best support safe innovation in plant and animal biotechnology while addressing and appropriately considering any potential risks. Such outreach is crucial to help ensure that the FDA is fostering innovation while at the same time helping the agency uphold its mission of protecting and promoting public health.
The Action Plan is intended to help the agency ensure the safety of plant and animal biotechnology products, foster continued public confidence in the FDA’s regulation of these products, and avoid unnecessary barriers to future innovations that align with our mission.
