FDA Signals Move To Modernize Oversight of Plant and Animal Biotech

FDA says it is making progress on modernizing its approach to regulating plant and animal biotechnology and intends to increase stakeholder outreach and update guidance for developers.The agency on Tuesday (Oct. 30) released its "Plant and Animal Biotechnology Innovation Plan," outlining priorities for how to clarify and revamp its review of biotech products in a manner that encourages developers but ensures safety.The six-page action plan is short on specifics but generally suggests the agency is bullish on the potential benefits from both plant and animal biotechnology and is keen to promote development with a "science- and risk-based approach" to regulation.Biotechnology offers "tremendous opportunities for advancing public health," FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram said in a joint statement. "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 food varieties and disease-resistant crops are some of the key biotech products that can help improve human health, the FDA officials said.The plan lays out priorities across three areas: promotion of product innovation and the use of "modern, efficient and risk-based regulatory pathways"; strengthening public outreach and communication; and increasing engagement with domestic and international partners.Key to the revamp of FDA's regulatory oversight will be the release of new industry guidance for developers of animal biotechnology – sometime next year – to clarify the agency's requirements for product developers.