SEC and FDA Sign Memorandum of Understanding to Share Information on FDA-Regulated Products
核心洞察
The SEC (搜索) and FDA entered into a Memorandum of Understanding effective August 31, 2026, establishing a framework for information sharing relevant to both agencies' missions.
The agreement facilitates the exchange of non-public information on FDA-regulated products and activities, including clinical trial results and product approval status, to support market oversight.
SEC (搜索) Chairman Paul S. Atkins (搜索) emphasized that FDA-related disclosures by public companies significantly impact markets, while Acting FDA Commissioner Kyle Diamantas (搜索) highlighted enhanced transparency across the life sciences sector.
The Securities and Exchange Commission (SEC (搜索)) and the Food and Drug Administration (FDA) announced on August 31, 2026, that they have entered into a Memorandum of Understanding (MOU) designed to assist the agencies in carrying out their respective missions of ensuring the integrity of the financial markets and protecting public health. The agreement establishes a framework for enhanced cooperation in regulatory and enforcement responsibilities, with the stated goal of improving market oversight and compliance.
"FDA-related disclosures by public companies have a significant impact on our markets," SEC (搜索) Chairman Paul S. Atkins (搜索) said in the announcement. "The FDA is a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws, and I look forward to further strengthening our partnership through the MOU."
"We are proud to partner with the SEC (搜索) to enhance transparency across the life sciences sector," Acting FDA Commissioner Kyle Diamantas (搜索) said. "Streamlining our information-sharing helps protect both the patients who rely on FDA-regulated products and the public trust that drives healthcare innovation."
Scope of the Agreement
According to the text of the agreement, the agencies intend to facilitate the exchange of information related to FDA-regulated products and activities. The MOU states that the collaboration is expected to bolster informed decision-making, improve the effectiveness of the parties' oversight and compliance efforts, and ensure that information relevant to public health and the integrity of financial markets is appropriately shared in accordance with applicable laws and policies.
The document describes the FDA's authority to enforce the Federal Food, Drug, and Cosmetic Act, under which the agency directs its activities toward ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices, and radiological products, as well as the safety and security of foods and cosmetics, and the regulation of the manufacturing, marketing, and distribution of tobacco products.
The SEC (搜索)'s mission, as described in the MOU, is to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation. The commission oversees broker-dealers, investment companies, investment advisers, clearing agencies, transfer agents, and credit rating agencies, among others, and is responsible for reviewing the disclosures and financial statements of all public companies in the United States.
The MOU states that this oversight includes situations where a firm engaged in FDA-regulated activities 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.
Information-Sharing Protocols
Under the agreement, each party intends to share appropriate information related to FDA-regulated products and activities, and to persons and firms that manufacture, distribute, and sell FDA-regulated products, where practicable. Each party will establish a mechanism, such as a mailbox, for receiving requests for information from the other party, and a mechanism to provide non-public information, such as via secure file transfer. The MOU defines non-public information as information that is not generally available to the public and that is provided, received, or otherwise shared between the parties in connection with the agreement, whether communicated orally, electronically, in writing, or in any other form.
The Food and Drug Division of the HHS Office of the General Counsel, also known as the FDA Office of the Chief Counsel, advises the FDA on legal issues relating to the MOU, serves as the FDA lead for referrals to the SEC (搜索) of potential violations, and serves as the FDA lead when an SEC matter is in civil or judicial adjudication. Each party will establish and maintain at least one principal point of contact. The FDA will have at least one from its Office of the Chief Counsel, while the SEC will have at least one from its Division of Enforcement and at least one from its Division of Corporation Finance.
The initial contacts named in the MOU are Gabriel Eckstein, associate director of the Division of Corporation Finance's Disclosure Review Program, and Frank Correll, assistant chief counsel in the Division of Enforcement's Office of Chief Counsel, for the SEC (搜索); and Shannon Singleton, deputy chief counsel for litigation in the FDA's Office of the Chief Counsel, and Elizabeth Miller, associate commissioner in the FDA's Office of Inspections and Investigations, for the FDA.
Confidentiality Provisions and Terms
Information sharing under the MOU is governed by existing regulations. When the FDA shares information with the SEC (搜索), the exchange is governed by 21 C.F.R. 20.85, under which the SEC may use non-public 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, proceeding, or civil action within the SEC's jurisdiction. The SEC cannot provide non-public information received from the FDA to any person who is not an officer, employee, or contractor of the SEC without the FDA's written permission.
The SEC (搜索)'s sharing of information with the FDA is governed by 17 C.F.R. 240.24c-1, under which non-public information may be provided upon a showing that it is needed and provided the FDA gives assurances of confidentiality that the SEC deems appropriate. The MOU further states that the FDA will not share trade secret or confidential commercial information whose disclosure is prohibited by specified statutory provisions except as those provisions allow.
The agreement sets out procedures for handling Freedom of Information Act requests for shared information, for notifying the providing party of third-party attempts to obtain shared non-public information through compulsory process, and for responding to requests from duly authorized committees of the United States Congress. The parties intend that sharing non-public information under the MOU will not constitute public disclosure or a waiver of confidentiality or any privilege.
The agreement states that it is not for use in sharing public information, requesting testimony, or responding to a subpoena for records or testimony, and that it applies only to requests for information made after its effective date. The document also states that it does not create binding, enforceable obligations against either party, that activities under it are subject to the availability of personnel, resources, and funds, and that it does not affect or supersede any existing or future understandings or arrangements between the agencies.
The MOU became effective upon the signature of both parties, with the signatures of Atkins and Diamantas each dated August 31, 2026, and it will continue in effect for a period of three years. It may be extended, modified, or terminated by the parties' mutual written consent, and it may be terminated by one party upon 30 days' advance notice to the other.