On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation. Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities:
- Advancing public health by promoting innovation;
- Strengthening public outreach and communication; and
- Increasing engagement with domestic and international partners.
The statement includes an indication that FDA will be seeking public input in the coming year. Once input is received, the first step in implementing the new action plan will be the adoption of “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.” According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019. The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products. In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.