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FDA and SEC Work to Enhance Public's Protection from False and Misleading Statements

The Food and Drug Administration (FDA) is announcing new measures designed to improve the manner by which FDA assists the Securities and Exchange Commission (SEC), whose primary mission is to protect the investing public and maintain the integrity of the securities market. In addition to implementing administrative improvements to make FDA technical and scientific support of the SEC and its staff more efficient, FDA is for the first time establishing a centralized procedure for FDA personnel to use in referring to the SEC statements by FDA-regulated firms that may be false or misleading.

"The SEC and its staff have primary responsibility for enforcing the rules requiring truth in the securities market, which is essential for its proper functioning," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. "Unfortunately, companies sometimes violate the public trust by issuing false or misleading statements about FDA-related issues, such as the progress of FDA's premarket review. When we identify suspected misstatements, we have a new process to bring them to the attention of the SEC staff as quickly and efficiently as possible."

Under the new referral procedure, any FDA employee who believes a publicly held, FDA-regulated firm has made a false or misleading statement to the investment public concerning a matter within FDA's authority can initiate a process for referring the matter to the SEC Division of Enforcement. FDA's mission is to promote and protect the public health, and FDA employees will not be expected routinely to police statements by publicly held, FDA-regulated companies. However, FDA can be in a position to identify statements that may be of interest to the SEC and its staff, and FDA employees will now have a centralized procedure to make SEC referrals if, in the normal course of their activities, they come to believe that a company may have made a false or misleading statement to the investing public.

In addition to establishing this new referral procedure, the FDA is implementing the following administrative measures to improve the assistance it provides to the SEC and its staff:

1. FDA Contacts. FDA has identified a liaison officer as well as specific contacts within the agency's principal operational components for the SEC and its staff to use in requesting information from FDA.
2. Training. FDA is working with the SEC and its staff to identify opportunities for the two agencies to engage in training in areas of mutual interest.
3. Electronic Communication. FDA will use electronic media when possible, e.g., to provide information or technical support to the SEC or its staff, receive requests from the SEC for non-public information, and review statements in annual reports and other SEC filings made by FDA-regulated firms.
4. Non-Public Records/Information. FDA will provide specified FDA employees a "blanket" authorization to enable them to share non-public information with the SEC or its staff, rather than executing such authorizations on a case-by-case basis. FDA and SEC staff have agreed to continue identifying additional measures that might be implemented to improve the process by which FDA shares non-public information with the SEC and its staff in accordance with FDA's laws and procedures.

The FDA has been providing support to the SEC and its staff for many years. FDA assists SEC staff by assessing the accuracy of statements in SEC filings relating to FDA issues. FDA officials routinely provide technical and scientific information and expert advice to the SEC to assist in their investigations of possible violations of federal securities laws. FDA's new initiative aims to strengthen this cooperation, and make it more effective and efficient.

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Letter from FDA
Letter from SEC
SEC Press Release

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