FDA and SEC Sign Information-Sharing MOU — Agency Records (Including CRLs) Now Flow to Securities Regulators
The FDA and the SEC have signed a memorandum of understanding establishing a formal framework for exchanging nonpublic information about FDA-regulated companies — a quiet but consequential escalation of scrutiny over how life-sciences companies talk about their FDA interactions. Per Sidley Austin's Sept 15, 2026 analysis, the MOU (on file as mou-between-sec-us-fda-083126.pdf, i.e., effective on signature Aug 31, 2026) runs three years, terminable on 30 days' notice, and creates no binding obligations — but its plumbing matters.
The MOU's stated purpose is "to facilitate the exchange of information … related to FDA-regulated products and activities" and to "establish a framework to support the parties' respective regulatory and enforcement responsibilities and otherwise enhance cooperation." The key operative bit: FDA may generally provide SEC with "any FDA record otherwise exempt from public disclosure" under FOIA — meaning FDA correspondence, meeting minutes, and complete response letters that companies summarize only at a high level publicly can now inform SEC review. SEC's designated points of contact sit in both the Division of Enforcement and the Division of Corporation Finance's Disclosure Review Program, so the information can feed routine filing reviews and comment letters, not just enforcement cases.
Sidley's read on why this lands hard, in context: "Companies should also read the MOU alongside FDA's July 2025 decision to publish complete response letters… The MOU gives SEC a comparable, and broader, nonpublic record." The firm also notes FDA has repeatedly notified companies that their investor-focused press releases were "false, misleading, or otherwise problematic" — and "Public companies should expect that FDA will be notifying SEC in these situations."
What it means: this builds on the CRL-transparency policy track (FDA Plans Proposed Rule to Formally Codify Complete Response Letter Public Disclosure Policy). Public claims about FDA feedback, "alignment" with the agency, or confidence in approval can now be tested by SEC staff against the full nonpublic FDA record — and the enforcement environment for FDA-related disclosure misstatements remains active even amid a broader SEC enforcement pullback. Expect tighter corporate discipline on earnings-call scripts and press releases describing regulatory interactions.