New FDA Plan Focuses on Plant and Animal Biotechnology

The FDA has unveiled an action plan that outlines key priorities for the agency in supporting innovation in plant and animal biotechnology. According to the FDA’s announcement, the overarching goal of the Plant and Animal Biotechnology Innovation Action Plan is to ensure the safety of plant and animal biotechnology products while averting unnecessary barriers to future innovation.

“Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health,” FDA Commissioner Scott Gottlieb, MD, 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. This new plan identifies priorities in 3 important areas:

• Advancing human and animal health by promoting product innovation and applying modern, efficient, and risk-based regulatory pathways
• Strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology
• Increasing engagement with domestic and international partners on biotechnology issues.”

Several action items in the plan may be of interest to the veterinary industry.

Veterinary Innovation Program

The FDA’s Center for Veterinary Medicine (CVM) launched a pilot of this program on October 30 to provide technical and programmatic assistance to developers of innovative veterinary products, including biotechnology products. The program offers tools meant to guide sponsors through the regulatory process, as well as options for developing alternative strategies for generating necessary evidence, pre-submission reviews of data packages, and cross-disciplinary and coordinated FDA review.

The FDA says the purpose of the innovation program is to enhance regulatory predictability and efficiency, improve agency responsiveness, and enable early, sustained interactions with innovators.

Genome Editing in Animals

On December 3, the CVM, along with representatives from FDA’s Center for Biologics Evaluation and Research, will host a public webinar to discuss the FDA’s regulatory approach. Registration for the webinar is required and attendees are encouraged to submit questions upon registering. This webinar is said to be the FDA’s initial step in helping innovators better understand how the agency’s regulatory oversight applies to their products.

“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,” 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 safely as possible.”

FDA Guidance Documents

As part of its effort, the FDA plans to publish guidance documents over the next year in 2 key areas of animal biotechnology:

• FDA’s regulatory approach and clear criteria and data requirements for each risk-based category
• Use of genome editing techniques to produce new plant varieties for use in human or animal food.

“Another key focus of our Action Plan is a robust communications and engagement strategy designed to continue collaborations with a wide range of stakeholders to understand their views on how the FDA can best support safe innovation in plant and animal biotechnology while addressing and appropriately considering any potential risks,” Drs. Gottlieb and Abram explained.

One crucial area of collaboration that the FDA will address with domestic and international partners is how transformative biotechnology tools, such as gene drives, may eventually strengthen measures to address vector-borne diseases.