SEC, FDA Sign Three-Year MOU to Share Nonpublic Information

The SEC and the Food and Drug Administration ("FDA") entered into a three-year memorandum of understanding ("MOU") establishing formal channels for the two agencies to share designated nonpublic information regarding FDA-regulated companies and their products.

In the MOU, the agencies stated the collaboration aimed to enhance their respective missions of protecting public health and ensuring the integrity of financial markets. The framework established a process for the SEC to more readily obtain FDA information to verify whether a company's public statements about regulatory interactions, clinical trial results, or product reviews were accurate. The agreement also tasked the FDA's Office of the Chief Counsel with referring potential securities law violations to the SEC.

Under 21 CFR 20.85, which governs the FDA's side of the exchange, FDA records otherwise exempt from public disclosure may be disclosed to the SEC. The FDA will not share trade secret or confidential commercial information barred by 21 U.S.C. 331(j), 360j(c), 360ll(d), 360nn(e), or 387f(c). The SEC's sharing is governed by 17 CFR 240.24c-1 ("Access to nonpublic information"). The rule lets the SEC provide nonpublic information at its discretion, on a showing that the information is needed and with confidentiality assurances the Commission deems appropriate. Access is limited to authorized FDA and SEC officials, employees, and contractors who need it for their official duties. The SEC may not disclose FDA nonpublic information to anyone outside that group without the FDA's written permission.

The MOU follows a run of enforcement actions built on FDA-regulated information. In January 2026, the SEC charged three brothers with two market manipulation schemes. It charged the brothers and three friends with a separate insider trading scheme that allegedly generated roughly $41 million in combined profits (see prior coverage). According to the complaint, two of the brothers impersonated physicians to steal confidential information about a pharmaceutical company's clinical trials. They then allegedly stole the identities of breast cancer patients on online forums to publish falsified trial results. The case is ongoing. Also in January 2026, the SEC settled cease-and-desist proceedings against an Associate Director of Immunology at a clinical-stage biotechnology company (see prior coverage). The SEC found he bought put options roughly 52 minutes after learning the FDA would not approve the company's bladder cancer therapy by the target date. He bought more the next day, according to the SEC. Under the SEC order, he paid $41,008 in disgorgement, $4,133.85 in prejudgment interest, and a $41,008 penalty. On the criminal side, the DOJ announced in June 2026 that four defendants were sentenced for trading ahead of a $3.2 billion pharmaceutical acquisition. A board member of the acquired company received 40 months in prison, the longest sentence of the four, and a $1 million fine, per the DOJ.