ºÚÁÏÕýÄÜÁ¿

Dr. Jay Bhattacharya Director National Institutes of Health 9000 Rockville Pike Bethesda, Md. 20892

Dear Dr. Bhattacharya,

On behalf of 40 organizations, representing the scientific community and biosafety and biosecurity stakeholders, we write to share our concerns regarding federal science agency implementation of the “Improving the Safety and Security of Biological Research” Executive Order 14292. We are alarmed by the recent suspension of dozens of grants under the EO, including research long recognized as essential to public health. These suspensions hamper our ability to develop treatments and diagnostics for infectious diseases, making the U.S. more vulnerable to infectious disease threats at a time when our public health challenges are more complex than ever before.

Researchers, institutions and governments recognize the need to manage biosafety and biosecurity risks. However, research currently covered by the gain-of-function pause is already subject to a high level of review and scrutiny to protect the public and the scientists conducting the work. NIH’s recent actions ignore this existing infrastructure and expertise, and in doing so, threaten to drive researchers out of scientific fields and further cede U.S. leadership in biomedical research and biosecurity. As one researcher shared in the Washington Post, “We live with the viruses every day. Nobody would want their staff or their students to get infected.”

Initial reports from NIH and USDA grantees confirm that the scope of agency actions under EO 14292 is far broader than intended and risks paralyzing critical areas of biomedical research. For example, stop work orders from NIH have included experiments that have been standard practice in tuberculosis research that has been conducted safely for more than 40 years, halting the development of new drugs, diagnostics and treatments for tuberculosis.

Further, the handling of GOF research reflects a troubling lack of clarity and coordination within the federal government. Reports of internal disagreement among agencies and staff about how to interpret and apply EO 14292 only further underscore the confusion researchers are facing on the ground. This uncertainty has resulted in the abrupt and arbitrary halting of longstanding, peer-reviewed and biosafety-approved research. It is clear the absence of consistent guidance continues creating unnecessary disruption across the U.S. research enterprise, further undermining U.S. leadership in science and public health preparedness.

Maintaining strong biosafety and biosecurity systems requires continued federal investment, not arbitrary research suspensions and indiscriminate funding cuts. We urge the Administration to commit to transparent, evidence-based policymaking that safeguards public health, strengthens biosecurity and supports continued scientific innovation. This includes robust funding to support state-of-the-art lab safety and training programs.

Thank you for your consideration of these requests. We welcome the opportunity to further discuss our concerns regarding the implementation of EO 14292. Please contact Amalia Corby, Director of Federal Affairs at the ºÚÁÏÕýÄÜÁ¿ at acorby@asmusa.org to arrange a conversation.

Thank you,
ºÚÁÏÕýÄÜÁ¿
American Academy of Allergy, Asthma & Immunology 
American Association for Anatomy
American Association of Immunologists
American College of Neuropsychopharmacology
American Institute of Biological Sciences
American Pediatric Society (APS)
American Society for Investigative Pathology
American Society for Virology
American Society of Tropical Medicine and Hygiene
American Statistical Association
American Thoracic Society
Association of American Medical Colleges
Association of Independent Research Institutes
AVAC
Biophysical Society
Camenzind Solutions LLC
Families Fighting Flu
Foundation for Sarcoidosis Research 
Gerontological Society of America
Global Health Technologies Coalition 
HIV Medicine Association 
IDSA
International Bipolar Foundation
Let's Talk UTI, Inc
Marymount University 
National Foundation for Infectious Diseases
North American Vascular Biology Organization
Pediatric Infectious Diseases Society
Peggy Lillis Foundation
Penn State College of Medicine
Society for Pediatric Research (SPR)
Society of Toxicology
Stony Brook University
Stop TB USA
TB Alliance
Texas Biomedical Research Institute
Texas Healthcare & Bioscience Institute 
Treatment Action Group
Veterans for Common Sense
wAIHA Warriors

For further reading, see ASM's factsheet on gain of function research.