WASHINGTON — The U.S. Food and Drug Administration on Oct. 30 unveiled a Plant and Animal Biotechnology Innovation Action Plan, which addresses policy priorities that the agency will pursue to clarify its science-and-risk-based approach for product developers. Scott Gottlieb, M.D., commissioner of the F.D.A., and Anna Abram, deputy commissioner, said the Action Plan further aims to ensure unnecessary barriers to innovation in plant and animal biotechnology are avoided even as the F.D.A. advances its public health mission.
The plan identified three priority areas: 1) advancing human and animal health by promoting innovation and applying modern, efficient and risk-based regulatory pathways, 2) strengthening public outreach and communication regarding the F.D.A.’s approach to plant and animal biotechnology, and 3) increasing engagement with domestic and international partners on biotechnology issues.
“As a first step, the F.D.A. 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,” Dr. Gottlieb and Ms. Abram said. “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 as safely as possible.”
As part of the effort, the F.D.A. said it intends to publish two guidance documents over the next year that will provide more clarity on how the agency applies its regulatory oversight to evaluate new animal biotechnology products based on their risk profile.
Dr. Gottlieb and Ms. Abram said the F.D.A.’s Center for Veterinary Medicine will hold a public webinar on Dec. 3 to discuss the science behind genome editing in animals, the promising uses of the technology in animals and the potential risks, and information about C.V.M.’s risk-based approach to the regulation of intentional genomic alterations of animals.
The F.D.A. also will launch a new pilot program, the Veterinary Innovation Program, for developers of intentionally genetically altered animals (I.G.A.s) and animal cells, tissues and cell- or tissue-based products (A.C.T.P.s) that are seeking the agency’s approval of a new animal drug application.
“The program will provide intensive assistance for developers of I.G.A.s or A.C.T.P.s that benefit human or animal health, animal well-being or food production,” Dr. Gottlieb and Ms. Abram said. “The goal of the Veterinary Innovation Program is to facilitate advancements in the development of innovative animal products by enhancing certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to market for certain innovative animal products.”
Dr. Gottlieb and Ms. Abram said the F.D.A. under the Action Plan also intends to publish guidance to clarify its regulatory approach for plant biotechnology products for human and animal food.
“The F.D.A. has evaluated the safety of food from more than 180 varieties of genetically engineered plants,” they said. “Many of these products are consumed by Americans every day. The guidance will provide the clarification necessary to help small and medium-size firms understand their responsibilities under our regulatory framework so that they’re better able to navigate the regulatory pathway toward bringing safe, innovative plant biotechnology products to market.”
Communication and engagement are two other priorities identified in the Action Plan. The F.D.A. said it will collaborate with stakeholders to understand their views on how the agency may best support safe innovation in plant and animal biotechnology while addressing and considering any potential risks.
“Such outreach is crucial to help ensure that the F.D.A. is fostering innovation while at the same time helping the agency uphold its mission of protecting and promoting public health,” Dr. Gottlieb and Ms. Abram said.
The final element in the Action Plan is the F.D.A.’s commitment to work with domestic and international partners “to foster efficiency and regulatory cooperation and enhance regulatory science.”
In a statement issued Nov. 1, the Biotechnology Innovation Organization said, “BIO applauds the F.D.A.’s commitment, as part of its recently announced Action Plan, to invest agency time and energy in establishing a fresh approach to biotechnology regulation that empowers American ingenuity and spurs consumer access to health, nutrition and environmental solutions.”
Andrew W. LaVigne, president and chief executive officer, American Seed Trade Association, added, “We’re encouraged by F.D.A.’s announcement that the agency is moving forward on a plan to provide clarity and foster future innovation around evolving plant breeding methods. To ensure U.S. agriculture remains at the forefront of innovation and maintains its leadership role globally, it’s critical that we have clear, consistent and science-based federal policies around new and emerging plant breeding methods.”