On August 31, the Securities and Exchange Commission and the Food and Drug Administration signed a memorandum of understanding to formalise cross-agency sharing of non-public information.
The agreement places particular emphasis on non-public information concerning FDA-regulated products and the industries that surround them, marking a significant shift in interagency cooperation.
The MOU establishes dedicated points of contact at both agencies, creating secure and formalised channels through which sensitive information can be exchanged between the SEC and FDA.
Each agency will designate a principal point of contact specifically tasked with facilitating information requests between the two regulatory bodies.
Under the terms of the agreement, both agencies commit to sharing “appropriate information” related to FDA-regulated products, activities, and the persons and firms who manufacture, distribute, and sell those products.
Strict confidentiality controls are built into the framework, with non-public information shared under the MOU prohibited from further disclosure without written permission from the providing agency.
The agreement also includes detailed protocols governing how each agency must respond to Freedom of Information Act requests, subpoenas, and congressional inquiries involving shared data.
Legal experts at Barnes and Thornburg have described the MOU as reflecting a broader trend of increased and formalised interagency cooperation, carrying broad implications for FDA-regulated industries and their disclosure practices.
Companies operating in FDA-regulated sectors should now anticipate heightened scrutiny of their public disclosures regarding FDA-related matters following the signing of this agreement.
There is also an increased risk that inaccurate or misleading public statements could trigger a cross-agency investigation involving both the SEC and FDA working in coordination.
The MOU places renewed emphasis on the importance of consistency across communications at various regulatory touchpoints, a factor that will be critical for both companies and their legal counsel.
FDA-regulated companies are being urged to review their existing disclosure practices and strengthen coordination between their securities compliance and regulatory compliance teams without delay.
Legal advisers are also recommending that affected businesses prepare operationally for a greater likelihood of cross-agency inquiries as a direct consequence of this new formal framework.