“FDA and One Health” Presentation with One Health Experts, including Dr. Solomon, CVM Director, and Dr. Namandjé Bumpus, the new Chief Scientist.

On September 27, 2022, the Alliance for a Stronger FDA held a webinar on FDA’s involvement its One Health Initiative. This far reaching event included presentations from several senior FDA personnel, including FDA’s new Chief Scientist, Dr. Namandjé Bumpus.

Dr. Steven Solomon, DVM, MPH, the Director for FDA’s Center for Veterinary Medicine (CVM), provided the history, current state, and vision for One Health at FDA. The One Health concept and strategy is described as “…a worldwide strategy [that] helps FDA analyze and identify solutions to resolve health disparities in clinical trials, research, and treatments of infectious, chronic, and debilitating diseases for humans and animals” that involves multiple Departments and Agencies, including FDA.

Dr. Namandjé Bumpus, PhD, FDA’s new Chief, explained how the Office of the Chief Scientist supports One Health at FDA. She spoke about strategies for cross-cutting leadership in science to broaden the depth of understanding across species and the environment.

Dr. Brianna Skinner, DVM, MPH, the Senior Regulatory Veterinarian in the Office of the Chief Scientist, addressed ongoing One Health collaborative efforts with other government agencies. She provided four examples of work, including the OSTP-NSTC Bio incident Research Working Group and the Global Coalition for Regulatory Science Research collaborating with multiple countries and organizations.

Tracey Forfa, JD, the Deputy Director of CVM, introduced vignettes from across the Agency with representatives from other FDA Centers: Dr. Jim Gorny, PhD, the Senior Science Advisory for Produce Safety at CFSAN, Dr. Suzanne Fitzpatrick, PhD, DABT, the Senior Advisor for Toxicology at CFSAN, and Judith Arcidiacono, MS, Regulatory Scientist at the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER).

Dr. Gorny spoke about FDA’s One Health Approach to produce safety. He provided examples of work being done in California and Arizona to minimize foodborne illness based in a One Health approach, in collaboration with USDA’s Food Safety and Inspection Service (FSIS), the Animal and Plant Health Inspection Service (APHIS), and the Agricultural Marking Service (AMS).

Dr. Fitzpatrick highlighted microphysiological systems and alternative methods for food safety. She described new approach methodologies and the path towards next-generation risk assessment, work being jointly done by FDA and the European Food Safety Agency (EFSA).

Finally, Ms. Arcidiacono offered FDA’s perspective on xenotransplantation, a procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from an animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. She described the work underway with pigs, which thus far includes preclinical animal studies, pig kidney transplants into brain-dead humans, and pig heart transplants into humans.

In her closing remarks, Tracey Forfa summarized the presentations by saying that there is a lot of work going on, but what was presented in this webinar is only a small section. She said she hoped to help colleagues at FDA and outside of FDA to understand the One Health program, including using seminars/webinars to help educate the public. Ultimately, she hopes to devote resources to set up a One Health Center of Excellence.

During the question and answer period, issues raised by webinar attendees included: CVM’s long-time work in One Health before its formal creation and how it is now different; an elaboration on CVM’s insights from COVID and dealing with animal pathogens going forward; and how to foster greater collaboration across agencies.