Media Coverage
Source: Fierce Biotech
Media Coverage
Press Contacts: Erik Cummins, Matt Hyams, Taina Rosa, Olivia Meyer
09.14.26
The SEC and the FDA have signed a three-year memorandum of understanding (MOU) to step up cooperation and information-sharing capabilities, aiming to improve each organization’s regulatory and enforcement missions.
Pillsbury partner David Oliwenstein, a former senior counsel in the Market Abuse Unit of the SEC’s Division of Enforcement, told Fierce Biotech that the MOU is “a potential tool to help the SEC garner real-time information from the FDA about drug trials and other information, so that the SEC staff can compare it with what biopharma companies are telling their investors.”
He noted that the MOU broadcasts to the industry that the SEC intends to keep a close eye on biopharma insider trading. “Biopharma has always been a space that the SEC enforcement staff has focused on in relation to insider trading in advance of clinical trials,” he said. “The existence of this MOU is designed to signal to the market that the SEC is closely watching this space, and this is designed to act as an additional deterrent to misuse of confidential clinical trial information,” he said.
Additionally, Oliwenstein noted that the volume and technical nature of clinical trial data present unique hurdles to the SEC staff when investigating, and the agreement will allow more communication between the organizations to make investigations more efficient.
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