The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in regulatory decisions and oversight activities in the United States.
On June 21, 2024, FDA issued a Warning Letter due to objectionable conditions observed during an RRA of Massachusetts Institute of Technology's ("MIT") Committee on the Use of Humans as Experimental Subjects ("COUHES") Institutional Review Board ("IRB"). This marks FDA's first use of an RRA to assert a domestic entity is in potential violation of the Food, Drug, and Cosmetic Act ("FDCA") and its implementing regulations for purposes of taking an enforcement action.
An RRA is an examination of a FDA-regulated establishment and its records, conducted without FDA staff visiting the site. In January 2024, the FDA issued revised guidance on RRAs, which explained what RRAs are and how they may be used. The FDA conducted this RRA under the Bioresearch Monitoring Program, which is designed to review IRB operations for clinical investigations.
The Warning Letter states that the IRB's informed consent forms ("Consent Forms") were deficient because they failed to include a disclosure of appropriate alternative procedures that may be advantageous to the subject. Additionally, the IRB failed to require that its Consent Forms disclose whether any compensation is available if an injury occurs for clinical investigations involving more than a minimal risk. Finally, the Consent Forms also failed to include a statement that the FDA may inspect the records.
The Warning Letter additionally states that the IRB failed to maintain adequate documentation of its activities, including detailed meeting minutes, actions taken by the IRB, and summaries of discussions of controversial issues and their resolution.
The Warning Letter states that the IRB's written response to the RRA observations failed to provide sufficient details, descriptions, and documentation regarding how the IRB would bring their protocols and documentation into compliance. Of note, the Letter stated that deficiencies identified during the 2023 RRA were the same as those identified in investigations in 2002 and 2012, and the recurrence of failures signals inadequate management and oversight of the IRB process—illustrating that FDA is willing to tag back "failures" to inspections occurring more than 10 to 20 years ago.
RRAs facilitate oversight of FDA regulated facilities—thus both domestic and foreign establishments should take care to ensure full compliance with the FDCA.
