The US Food and Drug Administration announced its Plant and Animal Biotechnology Innovation Action Plan last fall, outlining the agency’s priorities for regulating plant and animal biotechnology products. On April 25, the Agency will host a webinar to discuss intentional genomic alterations in animals and address common misconceptions about FDA’s approach to regulating these technologies—signaling the Agency’s commitment to implementing the Action Plan following the departure of FDA Commissioner Scott Gottlieb.
The Action Plan is intended to clarify the agency’s science- and-risk-based approach to regulating such products with the stated goals of fostering innovation, enhancing public communication and outreach, and increasing coordination between FDA and its federal and international counterparts.
The agency’s first priority will be creating “a comprehensive framework for the development and regulatory oversight of animal biotechnology products, including intentionally genetically altered animals and the food and drug products derived from them” and it announced two concrete actions that it is taking to this end:
The Veterinary Innovation Program — a new pilot program for certain intentionally altered genomic DNA in animals and animal cells, tissues, and cell- or tissue-based products seeking FDA approval via the new animal drug application pathway.
A Public Webinar hosted by FDA’s Center for Veterinary Medicine — a live-cast webinar intended to provide an overview of the current science, and the promising uses for, and potential risks of, intentional genomic alterations in animals and address common misconceptions about FDA’s approach to regulating these technologies. The webinar will also feature speakers from FDA’s Center for Biologics Evaluation and Research, who will provide information about genome editing used in producing human products, including those for use in xenotransplantation, and how these products will be regulated. Rescheduled from its original date last year, the webinar will be held on Thursday, April 25, 2019 from 1:00—3:00 PM EDT. Advance registration is required and available here.
In its announcement of the Action Plan, FDA also noted that it plans to issue several guidance documents over the next year in the area of animal biotechnology, including a guidance document clarifying how FDA will evaluate new animal biotechnology products based on their risk profile. The agency also announced that it is planning to publish draft guidance explaining its policy for regulating human and animal foods produced through modern molecular plant breeding techniques.
FDA’s Action Plan is part of the larger effort (reported previously here and here) initiated in 2015 by the White House Office of Science and Technology Policy to examine and clarify federal oversight of biotechnology-derived products to address advances in biotechnology. Neither the Action Plan nor any of FDA’s related announcements indicate whether its approach to regulating animal biotechnology products will differ from the approaches outlined in draft guidance published during the previous administration. But the decision to schedule the webinar following the announcement of the departure of Commissioner Gottlieb seems to suggests that the Agency will continue moving forward with its implementation of the Action Plan.