Quick Hits
- On August 31, 2026, the SEC and the FDA signed an agreement to enhance cooperation on regulatory and enforcement activities.
- The agencies will share information related to FDA-regulated products and companies that sell FDA-regulated products.
- The MOU signals enhanced interest by the SEC related to potential misstatements to investors by companies in the drug and medical device approval process.
- The agreement will remain in place for at least three years.
The SEC and the FDA agreed to expand information-sharing to enhance market oversight and legal compliance in the industries they regulate. Under the agreement, the SEC may use nonpublic information received from the FDA to inform any public company filing review to ensure compliance with the federal securities laws and in connection with any enforcement investigation or civil action within the SEC’s jurisdiction.
The MOU specifically mentioned situations where a company “may have disseminated false or misleading statements to the investing community, such as representations about the status of FDA review, product approvals, clinical trial results, or other matters within the FDA’s regulatory authority that could affect investors’ decisions.”
This is an important development because it shows that the SEC and the FDA will be focused on potential misstatements made in public statements related to new drug and medical device offerings or other issues that may impact both the FDA and the SEC. This development, in conjunction with the FDA previously publishing complete response letters for approved and unapproved drugs and devices, shows the Trump administration’s focus on transparency in this area and the potential for increased enforcement risk.
Key Takeaways
The MOU raises several takeaways:
- Company hotlines are important sources of information: Many times, robust internal reporting channels catch issues early. In at least one other SEC/FDA matter, internal whistleblowers alerted a company’s board to disclosure issues, and the company was able to take prompt remedial action, resulting in no SEC civil penalty for the company.
- Prompt internal investigations pay off with regulators: A company that conducts a prompt and robust internal investigation and shows a clear and thorough response to an internal tip will be better situated to self-correct and have a defensible position, if regulators or law enforcement become involved.
- Statements related to FDA correspondence, actions, and review timelines: Decisions frequently need to be made regarding what, if, and when to communicate to investors regarding the FDA review process or other interactions with the FDA. With the new MOU in place, any disclosures about the FDA review process likely will receive close attention, so companies will want to ensure they are accurate. Companies may want to especially consider statements that downplay bad news, as the SEC may view them as being materially misleading or reflecting omissions of material information. With the new MOU in place, the SEC likely will be privy to communications from the FDA to the company and will compare it to the public statements and disclosures.
- Proper disclosure controls and training: Companies may wish to consider whether they maintain disclosure controls and procedures designed to ensure that information the company discloses is accurate. Misleading statements can be found in any public statement, such as investor documents, SEC filings, press releases, speeches, website updates, etc. Companies may want to consider training for management and directors related to disclosure controls and procedures because they may be liable for misstatements made by management and directors.
Ogletree Deakins’ Financial Services Industry Group and Healthcare Industry Group will continue to monitor developments and will post updates on the Ethics/Whistleblower and Healthcare blogs as additional information becomes available.
This article and more information on how the Trump administration’s actions impact employers can be found on Ogletree Deakins’ Administration Resource Hub.
Jane A. Norberg is a shareholder in Ogletree Deakins’ Washington, D.C., office. She is the former Chief of the Office of the Whistleblower and a Senior Officer in the Division of Enforcement at the SEC.
This article was co-authored by Leah J. Shepherd, who is a writer in Ogletree Deakins’ Washington, D.C., office.
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