Leadership1 publisher2 min readPublished
A three-year FDA pact opens the agency's nonpublic file to SEC reviewers
Securities staff now have an agreed route to the FDA's nonpublic record of a company's regulatory interactions and inspections. They can use it during a routine filing review, before any investigation is open.
The Board Room · Leadership desk
What happened
- The FDA and the SEC announced a three-year memorandum of understanding on August 31, 2026 governing how they exchange nonpublic information about FDA-regulated products, activities and companies.
- The agreement expressly permits the SEC to use FDA information both in reviews of public-company filings and in enforcement investigations, proceedings and civil actions.
- FDA's Office of the Chief Counsel will lead referrals of potential violations, and the SEC will maintain designated points of contact in its Divisions of Enforcement and Corporation Finance.
- No new statutory power is created: FDA transfers rest on 21 C.F.R. 20.85, which already lets the agency share records exempt from public disclosure with another federal agency under trade-secret protections.
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Why it matters
- constraint A company's account of an FDA interaction can now be tested against the agency's contemporaneous record at low staff cost, so what the FDA wrote down is the binding constraint on how the event is described.
- exposure The flow runs both ways, so information a company provides to the SEC can reach FDA staff on a showing of need and appropriate confidentiality assurances.
- decision Debevoise recommended in 2018 that significant regulatory disclosures pass through securities, FDA, scientific and investor-relations review; companies now decide whether that becomes standing practice or stays event-driven.
- precedent With standard operating procedures and model requests contemplated, pulling the FDA file becomes an ordinary step available to a filing reviewer, and issuers can expect the comparison as a matter of course.
The right to share this information predates the memorandum. In 2004 the two agencies adopted measures that included a centralized FDA procedure for referring possible securities-law violations to the SEC, designated FDA points of contact for SEC requests, technical assistance to the Division of Corporation Finance, and continued sharing of nonpublic information [9]. Twenty-two years on [15], Paul Rubin, Paul Rodel and Melissa Runsten of Debevoise & Plimpton wrote that the new MOU "formalizes and operationalizes that relationship" [14][11].
Formalizing changes the practice. A request has to describe the information sought and its intended use, and it has to carry restrictions on further disclosure [6]. That is a form to fill in. A staff reviewer who can ask a defined question through a defined channel will ask it in cases that would not previously have justified the effort.
On authority, the 2004 measures already allowed all of this. The comparison now happens more often. A drafting process built for one comparison a decade now meets a comment letter every cycle.
The disclosures at issue are the ones these companies make constantly: clinical trials, FDA interactions, product approvals, manufacturing and inspection developments, and other regulatory matters that may be material to investors [2]. The SEC emphasized the market significance of FDA-related public-company disclosures when it announced the agreement [13].
For this quarter the question is narrower than the memorandum. It is whether the person drafting a trial update or an inspection disclosure can see the company's own contemporaneous record of what the FDA said, in the words the FDA used. Where meeting minutes and information requests sit in regulatory affairs and reach the securities team as a summary, the two accounts begin to diverge before anyone drafts a sentence. Two checks need no change in law: where FDA correspondence is logged, and who signs off on how a meeting outcome is characterized.
The agreement runs three years. Counting from the August 2026 announcement, that takes it into 2029 [16].
What to watch
- The first SEC comment letter or enforcement action that visibly draws on FDA-sourced material.
- Whether trade-secret and confidentiality objections narrow what the FDA actually transfers in practice.
- Any indication that information moving from the SEC to the FDA bears on a pending application or inspection.