91Â鶹¾«Æ·

The Honorable Bill Cassidy, M.D. 455 Dirksen Senate Office Building Washington, D.C. 20510

The Honorable Bernie Sanders 332 Dirksen Senate Office Building Washington, D.C. 20510

Dear Chair Cassidy and Ranking Member Sanders:

On behalf of the American Society for Microbiology (ASM), thank you to the Senate Health, Education, Labor, and Pensions Committee for the opportunity to submit comments for the record regarding the hearing titled “The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients.” Established in 1899, 91Â鶹¾«Æ·is one of the oldest and largest single life science societies, with more than 38,000 members in the U.S. and around the world. Our mission is to promote and advance the microbial sciences.

As established in the National Security Commission on Emerging Biotechnology’s (NSCEB) , biology is the basis of innovation that extends far beyond the laboratory. While biotechnology shows tremendous promise, microbial innovation in biotechnology is currently stifled by a complex regulatory environment, threats to research funding and an environment often mistrustful of the biological sciences.

Despite this, microbiome research has captured the attention of the public and has generated a booming demand for microbiome-based therapeutics, inoculants and supplements. In humans, probiotics, fecal/microbiome transplants and engineered bacterial therapies hold tremendous potential to improve clinical outcomes and reduce health care costs; these benefits extend to animal and environmental health through microbial amendments to land, water and feed. As scientists continue to explore the connection between microbiomes and human, animal and environmental health, as well as the applications of microbiome research to pressing societal issues like food production, antimicrobial resistance and a changing environment, we request that you carefully consider the current funding and policy landscape for microbial innovations.

Streamline Regulation

Thanks to federal investment in microbiome research, including the Human Microbiome Project, we now know that microbial diversity highly impacts organismal functions and efficiency. For example, a Fecal Microbiome Transplant, which is a medical procedure where healthy bacteria from donor stool are transferred to the gastrointestinal tract of a recipient, can be an effective treatment for certain gastrointestinal conditions, such as Clostridioides difficile infection (CDI), inflammatory bowel disease and irritable bowel syndrome. CDI alone approximately 500,000 patients annually in the U.S., and around 30,000 patients will die without proper care. Due to advances in microbiome research from the NIH federally funded microbiome research contributed to the development of 2 U.S. Food and Drug Administration (FDA) approved biotherapeutic products for treating adult recurrent CDI. However, the road to FDA approval was complicated and costly, serving as a deterrent to future commercialization and creating unnecessary barriers to groundbreaking treatment. 91Â鶹¾«Æ·urges the FDA to work with the biomedical research community to clarify and streamline microbial product regulations.

Effective microbiome therapeutics are also highly valued in the agricultural sector. The use of these products in food production can reduce antibiotic use and combat the rising problem of antimicrobial resistance (AMR). Microbiome therapeutics, such as prebiotics and probiotics in the food animal sector, also improve livestock feed efficiency to enhance nutrient digestion, absorption and overall animal health. By manipulating the microbiome of soil and plants, we can improve crop health, yield and stress resistance while reducing the need for synthetic pesticides and fertilizers, leading to decreased costs for farmers and ranchers while also improving the rural economy.

91Â鶹¾«Æ·supports the NSCEB’s recommendation to simplify pathways to market and avoid duplicative regulations. Coordinated strategies are essential to attaining this goal. The U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the FDA play a key role in ensuring the safety of biotechnology products through the Coordinated Framework for the Regulation of Biotechnology. Regular updates and revisions to the Coordinated Framework are necessary to keep up with biotechnological innovation. We encourage the committee to consider exploring potential synergies in the regulation of microbe-based products that may have applications across human and animal health.

Support Research

Support for biotechnology research and coordination at the National Institutes of Health (NIH), the National Science Foundation (NSF), the Department of Energy (DOE) Office of Science and other federal agencies will increase innovation and human, animal and environmental health. The 2016 Interagency Strategic Plan for Microbiome Research was a promising step forward for microbiome research and commercialization, but federal investments and coordination have not followed. We urge the committee to capitalize on the current interest in biotechnology to create a sustainable commitment to supporting microbial innovation and to encourage the Executive Branch to update the Interagency Strategic Plan for Microbiome Research.
 
To deepen our understanding of the role of microbes, we encourage Congress to avoid overly broad bans on gain-of-function research. In addition to driving fundamental discoveries for disease prevention and treatment, basic research on the function of bacteria and viruses, which could be considered gain-of-function research, leads to innovations in agriculture, aquaculture and environmental health. The recent Executive Order  has led to the suspension of research long recognized as essential to human health. While 91Â鶹¾«Æ·supports the strengthening of biosafety and biosecurity systems, we urge Congress and the White House to work with stakeholders to develop guidelines that do not arbitrarily stifle innovation and the development of lifesaving cures.

Increasing the body of evidence regarding microbes and how they interact with their environment, including with other microbes, will provide federal science and regulatory agencies with the necessary evidence to make informed decisions regarding applications for human, animal and environmental health as well as clarify potential pathways to commercialization for microbial products. 91Â鶹¾«Æ·strongly urges you and your colleagues on the Senate HELP Committee to support microbial innovations. Please reach out to JR Kane, Government Relations Manager, at jkane@asmusa.org if you have any questions.

Sincerely,

Amalia Corby
Director of Federal Affairs
American Society for Microbiology