FDA-Regulated Companies Take Note: FDA and SEC Formalize Bilateral Information-Sharing Agreement

On August 31, 2026, the Securities and Exchange Commission (SEC) and Federal Food and Drug Administration (FDA) entered into a Memorandum of Understanding (MOU) to strengthen cooperation, information-sharing, and enforcement related to FDA-regulated companies, particularly where FDA-related developments may affect public-company disclosures and financial markets. The three-year, nonbinding agreement converts a 2004 FDA-to-SEC, disclosure-focused cooperation arrangement into a formal, bilateral information-sharing system supporting both agencies’ regulatory and enforcement work. The MOU does not create a new disclosure obligation for FDA-regulated companies, but it meaningfully changes the enforcement landscape, so life sciences companies should take notice.

Key Changes

Two-way information flow. The 2004 framework was principally FDA-to-SEC: FDA provided technical assistance and nonpublic information to support SEC filing reviews and enforcement matters. The new MOU expressly creates a bilateral framework under which either agency may share appropriate information with the other, subject to applicable law and confidentiality protections. As a result, nonpublic SEC information may now flow to FDA as well—not just the reverse—for the first time under this formalized framework, subject to the applicable requirements.

SEC information may create FDA-side exposure. The bilateral framework creates a pathway for nonpublic information developed or obtained by the SEC to reach FDA, where the applicable requirements for sharing are satisfied. That could allow FDA to learn of documents, testimony, or other information surfaced in an SEC matter that is inconsistent with representations made to FDA. An inconsistency alone is not necessarily unlawful, but information suggesting that a company knowingly made materially false statements to FDA, or otherwise violated the Food, Drug, & Cosmetic Act, could create separate FDA or criminal enforcement exposure. Knowingly and willfully making a materially false statement in a matter within FDA’s jurisdiction can carry criminal liability under 18 U.S.C. § 1001, and conduct that also constitutes a prohibited act under the FD&C Act can carry criminal penalties under 21 U.S.C. §§ 331 and 333, including enhanced penalties where a violation is committed with intent to defraud or mislead.

Explicit Division of Corporation Finance access. The MOU says FDA information can be used to “inform any public company filing review.” The agencies were already doing this—the SEC previously reported that its Division of Corporation Finance “frequently” requested FDA information—but the new MOU is designed to make the process faster and more standardized. The practical result: Division of Corporation Finance staff reviewing a 10-K, 10-Q, 8-K, or registration statement have a more standardized channel for requesting FDA information where that information may lawfully be shared, using it to assess whether an issuer’s disclosures are consistent with information FDA possesses.

FDA referral process formalized. The MOU gives FDA’s Office of the Chief Counsel a defined role as FDA’s lead on referrals to the SEC of potential violations, including when an SEC matter proceeds to civil or judicial adjudication. It also requires dedicated points of contact and mechanisms for receiving and securely transmitting information requests and contemplates Standard Operating Procedures and templates to facilitate nonpublic-information requests. Unlike FDA’s 2004 announcement, the MOU omits any statement that FDA personnel are not expected to routinely monitor public-company statements. Although the MOU does not direct FDA personnel to police issuer disclosures, it further formalizes and operationalizes the pathway for potential issues identified within FDA to reach the SEC.

Trade secrets preserved. The MOU does not override statutory restrictions on FDA disclosure of trade secrets and other protected confidential commercial information. At the same time, FDA may share with the SEC certain nonpublic FDA records that are exempt from public disclosure where § 20.85 permits doing so. Thus, the MOU does not give the SEC unrestricted access to regulatory application files, but information in an NDA, BLA, PMA, or other nonpublic FDA file is not automatically shielded from the information-sharing framework either.

Insider-Trading Implications. The bilateral framework may also heighten insider-trading detection risk for life sciences companies and their personnel. By facilitating the exchange of nonpublic information concerning FDA-regulated activities, the MOU may make it easier for the SEC to investigate trading activity around significant nonpublic regulatory developments. Companies should therefore review and reinforce insider-trading policies, blackout windows, and Material Non-Public Information (MNPI) training, with particular attention to employees and consultants who have access to FDA-related information such as clinical trial results, Complete Response Letters, inspection or compliance developments, and approval decisions. Companies may also wish to ensure that these policies address prediction-market activity: the Commodity Futures Trading Commission (CFTC) has recently emphasized that its antifraud authority can reach insider trading involving event contracts, creating potential risk where employees or consultants use confidential company or regulatory information to trade on prediction markets.

What You Should Do

The practical message is that consistency has become more important. Counsel should assume it is increasingly easy for SEC staff to compare what a company says publicly with what the company told FDA. In particular:

• Cross-check FDA and SEC communications. Companies should cross-check current SEC filings against FDA submissions and meeting records, with particular attention to disclosures about the tenor or outcome of FDA meetings; whether FDA has “agreed” with a development or regulatory strategy; clinical trial results and FDA’s reaction to them; the status or likelihood of approval; Complete Response Letters, deficiencies, and requests for additional studies; inspection and compliance developments; and potential discrepancies between investor-facing descriptions and representations made in regulatory submissions.
• Coordinate regulatory and disclosure functions. Companies should ensure that their disclosure controls give their employees responsible for SEC filings visibility into significant FDA communications and that company personnel interacting with FDA are coordinating, as appropriate, with attorneys and other personnel responsible for SEC disclosures, capital markets matters, and public statements.
• Prepare for greater cross-agency scrutiny. Companies should prepare for enhanced Division of Corporation Finance scrutiny through comment letters that may cross-reference FDA information and should assume that, where legally permitted, information provided to or obtained by one agency may be shared with the other.
• Review insider-trading controls. As discussed above, companies should revisit insider-trading policies, blackout windows, and MNPI training in light of the heightened detection risk this framework creates.