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FDA Sketches Out Approach to Regulating Genome-Edited Products

NEW YORK (GenomeWeb) – The US Food and Drug Administration announced the first specific details of how it plans to regulate genome-edited food and therapeutic products.

In an FDA Voice blog post attributed to outgoing Commissioner Robert Califf and Senior Policy Advisor Ritu Nalubola, the agency said it will take a product-specific, science- and risk-based approach to regulation.

Specifically, the FDA said, applications of genome editing technologies apply to three product classes under its purview: human medical products, foods derived from genome edited plants, and genetically engineered animals.

"Human medical products that apply gene editing to exert their therapeutic effect are regulated under our existing framework for biological products, which include gene therapy products," Califf and Nalubola noted in their blog post. Existing programs at the FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine should adequately address the latter two product categories, they added, but the agency is also taking steps to "clarify" its position and is seeking more data on whether foods — for both humans and animals — derived from edited plants pose additional risks compared to "traditionally bred plants."

Regarding genome-edited animals, the FDA made a determination that the intentionally modified portion of the genome is considered a drug.

"It is intended to alter the structure or function of the animal and, thus, subject to regulation under our provisions for new animal drugs," Califf and Nalubola wrote. The agency has issued a draft guidance as a revision to existing guidance on the regulation of genetically engineered animals, which is open for public comment.

This plan has been announced as a new anti-regulation administration is set to take over the White House, adding uncertainty to a years-long review of biotechnology policy in the executive branch of the US government. In 2015, President Barack Obama ordered a review of Coordinated Framework for the Regulation of Biotechnology, involving the FDA, the US Department of Agriculture, and the Environmental Protection Agency.

The FDA blog noted that those agencies released the 2017 Update to the Coordinated Framework on Jan. 4.

Since the advent of CRISPR/Cas9 genome editing, the FDA has been publicly silent on how it might approach regulating genome-edited products, especially therapeutics. The agency sent representatives to the December 2015 International Summit on Human Gene Editing, and is co-sponsoring a so-called "consensus study" that came out of that meeting.

In their post, Califf and Nalubola noted several developments since then, including clinical trials using genome editing as part of cell therapy for HIV and cancer, animals with engineered traits like hornless cattle, and alterations to non-animal foods like browning-resistant mushrooms.

While each agency may take its own approach in forming policies, "Under the [Coordinated Framework] Update, interagency coordination and cooperation will continue, including on appropriate terminology, identification of hazards, and approaches to addressing risks, within the constraints imposed by regulatory paradigms for different product areas," they wrote, adding that the FDA also has a collaborative relationship with the National Institutes of Health and its Recombinant DNA Advisory Committee.