/>iFDA Official Says FDA Plans to Issue Guidance as Normal Despite “10-1 Executive Order”
- Senior FDA officials recently signaled that the agency does not anticipate major disruptions to the issuance of guidance documents, even as federal agencies brace for the impact of Executive Order 14192, “Unleashing Prosperity Through Deregulation” which, as previously reported, mandates that federal agencies eliminate 10 regulations for every new regulation issued (the “10-1 Executive Order”).
- Quoted in an article by Inside Health Policy, Grace Graham, Deputy Commissioner for Policy, Legislation and International Affairs at FDA, stated at the Drug Information Association’s annual conference last month that “I think if you look at the executive order, it’s very broad, a number of things can qualify as deregulatory and so we are still working on it and looking at it, but you will continue to see guidance come out of the agency, as you would have in the past.”
- Further, citing the 10-1 Executive Order, among others, the Department of Health and Human Services (HHS) published a Request for Information (RFI) in the Federal Register on May 14, 2025 inviting public comment on regulations and guidance that should be revised, withdrawn, or repealed. The comment deadline on the RFI is next Monday July 14, 2025.
- Keller and Heckman will continue to track developments surrounding the 10-1 Executive Order and its potential implications for FDA.
