SEC-FDA cooperation foreshadows scrutiny of life sciences company disclosures

The memorandum of understanding (MOU) builds upon a foundation of existing, informal cooperation between the SEC and the FDA. The two agencies previously announced cooperation efforts in 2004, and the SEC’s Enforcement Manual has long described procedures for SEC staff to request information from the FDA in connection with enforcement investigations. The Division of Corporation Finance also has historically had a point of contact at the FDA and informally consulted with the FDA to inform routine filing reviews. The MOU formalizes these channels with a written bilateral framework, standing points of contact and standardized procedures for requesting, transmitting and protecting nonpublic information. 

Filing reviews can lead to enforcement referrals, creating an additional pathway by which discrepancies between a company’s public statements and the FDA record could reach the SEC. Under existing regulation, the SEC may use nonpublic FDA information to inform public company filing reviews and in connection with any enforcement investigation, proceeding or civil action — and the MOU now creates the operational infrastructure to facilitate that access.

The MOU does not override statutory restrictions on what the FDA can disclose, and clarifies that the FDA will not share trade secret or confidential commercial information prohibited from disclosure under specified statutory provisions. 

The MOU initially has a three-year term and applies to information requests made after August 31, 2026.

Recent enforcement backdrop

While there have been relatively fewer enforcement actions overall under the current administration (see our most recent client update on the topic), the SEC has continued to pursue FDA-related disclosure claims. Recent actions illustrate the types of charges the MOU’s information-sharing framework could facilitate:

• In September 2025, the SEC settled charges against a public company arising from false and materially misleading statements about the safety results of a product candidate. The company’s then-CMO directed undisclosed post-hoc changes to stratification factors — made after the underlying data had been unblinded — that made results appear to show superiority to existing treatment, when the pre-specified factors had shown only non-inferiority. The CMO also represented on an earnings call that the FDA had agreed to the statistical approach when no such discussion had occurred. 
• In January 2026, the SEC charged a public company’s former CEO and CFO for misleading disclosures about the status of an FDA new drug application. The FDA had informed the company that the FDA’s own analysis showed the primary efficacy endpoint was not met. Despite this, the company’s 10-K and earnings calls continued to state the trial had achieved the ‘primary objective as specified in the protocol’ without disclosing the FDA’s efficacy concerns or the FDA’s independent analysis. 

Both cases turned on the gap between the company’s public disclosures and the reality underlying FDA communications. 

SEC enforcement actions have also targeted insider trading based on material nonpublic information tied to FDA communications with a company, and the SEC has touted these actions including in its recent enforcement results update for 2025, signaling continuing focus on both disclosure accuracy and insider trading by individuals with access to nonpublic FDA feedback. 

We expect the MOU to facilitate the Enforcement Division’s ability to bring charges against companies in the healthcare and life sciences space and their insiders.

SEC comment letters

The SEC routinely issues comment letters to life sciences companies focused on characterizations of their product candidates in their disclosures, including on questions of safety and efficacy, the precise stage of clinical trials, or more broadly the characterization of FDA feedback, review process and timing of meetings relating to the design or results of clinical trials or resolution of any FDA concerns. 

The MOU sharpens the Division of Corporation Finance staff’s ability to gain ready access to information that will allow it to more effectively examine and verify public company disclosures as measured against nonpublic information learned directly from the FDA.

Key takeaways

Public companies in the life sciences space already have in-house personnel and/or outside advisors who vet regulatory disclosures. While the MOU does not change any disclosure requirements, it serves as a reminder for those companies (as well as life sciences companies seeking to go public) to ensure that their FDA-related disclosures are appropriately supported, are not speculative, and do not ignore or omit material FDA feedback.

• Disclosure processes should be calibrated to evaluate statements about FDA-regulated matters not only for literal accuracy but for whether they fairly and completely convey the substance of a company’s communications with the FDA.
• Affirmative statements about what the FDA has agreed to, endorsed or communicated should be confirmed against the underlying agency correspondence before inclusion in SEC filings, earnings calls or press releases.
• Business descriptions, risk factors and management’s discussion and analysis that address FDA-regulated matters should continue to be stress-tested against the company’s full regulatory file.

The MOU formalizes existing interagency cooperation between the SEC and the FDA. While it does not create new legal obligations, it makes information-sharing more systematic and increases the practical likelihood that discrepancies between public statements and the underlying FDA record will be identified.