E&C Republicans to FDA: Turn Over Documents on FDA-Funded Risky Research or Face Subpoena
Washington, D.C. — In a final warning to the Food and Drug Administration (FDA), House Energy and Commerce Committee Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, threatened to issue a subpoena for documents related to risky research conducted at FDA facilities. The letter follows two previous requests for documents regarding experiments involving virus manipulation, which the FDA has acknowledged occurred in some of its research studies. November 9, 2023 The Honorable Robert M. Califf, M.D., MACC Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 Dr. Califf, The Committee sent the U.S. Food and Drug Administration (FDA) a letter on March 27, 2023, regarding FDA-funded research that may pose significant biosafety or biosecurity risks. Following the FDA’s insufficient response on May 26, 2023, we sent a follow up letter on June 29, 2023. To date, the FDA has only produced 29 pages of the charter documents for the Institutional Biosafety (IBC) and the Dual Use Research of Concern (DURC) review panel, which were not sent until October 20, 2023. Having not received an adequate response to our follow-up letter, we are sending a formal document request to obtain information needed for our oversight that we requested in the June 29 letter. Pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by November 28, 2023: All coronavirus research studies referenced in the January 31, 2023, email. All studies that have undergone Institutional Biosafety Committee (IBC) review at the FDA since October 1, 2013, and all documents related to the IBC reviews of these studies. All studies that have undergone Dual Use Research of Concern (DURC) review at the FDA since October 1, 2013, and all documents related to the DURC reviews of these studies. All policies and/or procedures related to the IBC and DURC processes. In the May 26, 2023, response letter, the FDA stated that the Center for Biologic Evaluation and Research (CBER) research studies involving coronaviruses and viral manipulation of SARS-CoV-2 “underwent applicable Institutional Biosafety Committee (IBC) review, including attestation by the principal investigator (PIs) regarding Dual Use Research of Concern (DURC) screening.” The FDA added “[n]one of these studies rose to the level of DURC review.” Please provide all documents related to these statements. In the May 26, 2023, response letter, the FDA stated that a Center for Drug Evaluation and Research (CDER) laboratory performs studies to monitor and evaluate seasonal influenza virus resistance to clinically relevant antivirals. Please provide all documents related to these studies, including the IBC and DURC applications and approvals. In the May 26, 2023, response letter, FDA stated that FDA requires “any research associated with hazardous biological agents and toxins (HBATs) be subject to full IBC review.” Please provide all documents since October 1, 2013, associated with HBATs, including documents related to full IBC review. In the May 26, 2023, response letter, the FDA stated that “[s]ince September 2015, and prior to the establishment of the DRP, the FDA’s IBC application process required the attestation of all PIs concerning the nature of their work as it related to DURC policies.” Please provide a copy of the IBC application with the attestation requirement, and all documents related to the establishment of the attestation requirement. All documents related to all extramural research that have gone through the FDA IBC and/or DURC review since September 1, 2015. Thus, to carry out our Constitutional responsibilities of oversight, if the FDA does not produce the requested documents by November 23, 2023, it will be necessary to issue a subpoena for documents since the FDA has delayed its response and the committee has a right to obtain these materials to aid in its legislative activities and to ensure that the Executive Branch is complying with the law. If you have any questions, please contact the Majority Committee staff at (202) 225-3641. Thank you for your attention to this request. CLICK HERE to view the letter. CLICK HERE to read the March 27, 2023. letter. CLICK HERE to read the June 29, 2023, letter.