Washington, D.C. - House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) sent a letter today to Food and Drug Administration (FDA) Commissioner Robert Califf following up on previous questions related to its funding of gain-of-function research.
The information in question stems from a Jan. 19, 2022, letter to the FDA that requested a list of all research work in the area of coronaviruses-especially SARS CoV-2-or viruses related to SARS, MERS, or SARS CoV-2. The FDA responded to the letter. However, it did not address a key question about whether any listed experiments involved certain concerning activities associated with gain-of-function research.
KEY EXCERPT:
“After Republican Committee staff followed up, the FDA staff acknowledged in a Jan. 31, 2023, email response that some FDA research studies did involve virus manipulation, passaging of a virus, genetically modified animals, or making any mutations to a virus:
To your question about viral manipulation in the referenced studies - standard techniques in molecular biology, including manipulation of viral sequences and use of animal models, were used in some studies to better understand differences in disease pathology caused by the different SARS-CoV-2 strains (Wuhan and Omicron) that arose naturally. None of the research studies were undertaken to make the virus intentionally more virulent.
“However, the FDA did not provide further specifics about these studies. To put these studies in context and to be able to assess the adequacy of FDA’s oversight of potential risks in such experiments, we are requesting additional information."
The Chairs requested answers to the following questions by April 10, 2023:
1. Please provide a list of all coronavirus research studies referenced in the Jan. 31, 2023, email.
2. What is the biosafety level of the facility being used for these experiments? What bio containment measures are being taken with these experiments?
3. Have FDA laboratories introduced any mutations or insertions of genes associated with pathogenesis or transmission into SARS CoV2? If so, what were the studies? What was the purpose for such studies? Can such insertions contribute to increasing pathogenesis or transmission? If so, please explain.
4. Have FDA laboratories introduced mutations or insertions of genes that encode for resistance to medical countermeasures, or increase pathogenesis or transmission in influenza virus or other respiratory viruses or human pathogens? If so, what were they? What were the reasons for such study?
5. Do all laboratory research studies undergo Institutional Biosafety Committee (IBC) or Dual Use Research of Concern (DURC) review at the FDA? If not, why not? How many studies have undergone IBC review since the inception of the process? How many studies have undergone DURC review since the inception of the process? For the studies referenced in the Jan. 31, 2023, email, please identify the studies and specify whether the study (1) underwent IBC review, and/or (2) underwent DURC review.
6. Please provide a list of all studies that have undergone IBC review at the FDA since Oct. 1, 2013.
7. Please provide a list of all studies that have undergone DURC review at the FDA since Oct. 1, 2013.
8. Who at the FDA oversees the FDA IBC and DURC process? When were the DURC review processes instituted? Please provide the policies and/or procedures related to the IBC and DURC processes.