FDA Works to Improve Plant and Animal Biotechnology Guidelines
The plan has three priority areas: advancing public health by promoting innovation; strengthening public outreach and communication; and increasing engagement with domestic and international partners.
The first two steps in implementing the plan include a Public Webinar on Genome Editing in Animals that will focus on the current science and potential risks. The second is a Veterinary Innovation Program (VIP), a new pilot program.
In a statement, FDA Commissioner Scott Gottlieb said, “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.”
The agency plans to publish two guidance documents over the next year, which will clarify what the FDA plans to do and how it plans to apply it oversight processes in evaluating new animal biotechnology products.
The FDA’s Center for Veterinary Medicine (CVM) will hold the public webinar on December 3. In addition to discussing the current technology, the webinar will, according to Gottlieb, “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.”
The Veterinary Innovation Program (VIP) is for developers of intentionally genetically altered (IGA) animals and animal cells, tissue and cell- or tissue-based products (ACTPs) that are looking for FDA approval of a new animal drug application. Gottlieb states, “The goal of the VIP 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.”
At the same time, the agency will publish guidance on its regulatory approach to plant biotechnology products for human and animal food. This appears to be focused on genetically-modified plants or animals used in food. Gottlieb noted that the agency had evaluated the safety of food from more than 180 varieties of genetically engineered plants already.
Gottlieb points out that the agency is interested in communications and engagement with all stakeholders, not just large corporations, but small and medium companies.
“As the final element of our Action Plan,” Gottlieb stated, “the FDA remains committed to efforts with domestic and international partners to foster efficiency and regulatory cooperation and enhance regulatory science.”
To do so, the agency expects to “engage in a dialogue” about biotechnology techniques such as genome editing and how it might be used to address vector-borne diseases like Zika virus.
And because so much of this new Action Plan will focus on possible food products, cooperation with the United States Department Of Agriculture (USDA) will be involved, as well.