FDA’s New Plan to Advance Plant, Animal Biotechnology

The FDA recently announced its new Plant and Animal Biotechnology Innovation Action Plan. The plan is intended to advance policy priorities that the FDA will pursue to clarify its science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and its public health mission.

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 to produce a new product, such as a new food variety or disease-resistant crop.

The Action Plan works to address questions FDA regularly receives from biotechnology stakeholders, including developers of these products and public health interest groups. This new plan identifies priorities in three 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 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.

The agency intends to publish two guidance documents over the next year to provide more clarity on how the FDA is applying its regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various products.

FDA is 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 of a new animal drug application. The program will provide assistance for developers of IGA animals or ACTPs that benefit human or animal health, animal well-being, or food production.

FDA also intends to publish guidance to clarify its regulatory approach for plant biotechnology products for human and animal food. The agency has evaluated the safety of food from more than 180 varieties of genetically engineered plants. The guidance will provide the clarification to help small and medium size firms understand their responsibilities under FDA’s regulatory framework so that they’re better able to bring safe plant biotechnology products to market.