September 17, 2026

SEC Proposes to Rescind Rule 14a-8 & Leave More Shareholder Proposal Determinations to State Law

The long-awaited proposal to rescind Rule 14a-8 was announced yesterday. Here’s the 228-page proposing release and the 1.5-page fact sheet. Statements were issued by Chairman AtkinsCommissioner Peirce and Commissioner Uyeda. The fact sheet explains:

The proposing release discusses the scope of the Commission’s authority under Section 14(a) of the Exchange Act and explains that Rule 14a-8 should be rescinded because it exceeds the Commission’s statutory authority. The Commission also has independent policy reasons for proposing to rescind the rule. First, many of the justifications that were originally provided to support adoption of Rule 14a-8 either have not been substantiated in practice or are less compelling today.

In addition, Rule 14a-8 also has had, and will continue to have, certain unintended consequences that further undermine any justification for retaining the rule:

  • Rule 14a-8 has become a mechanism for influencing the interactions between companies and their shareholders in ways that are inconsistent with the rule’s original purpose.
  • The existence of Rule 14a-8 places the Commission in the position of making judgments about the application of state law that are best left to other actors.
  • The presence of a federal rule has inhibited the development of state law and private ordering.

The proposal would also amend Rule 14a-4(c) to address the issues companies face related to discretionary authority when a shareholder proposal isn’t included in a company’s proxy statement, which may be more common after the repeal of Rule 14a-8. The proposing release says:

[I]f current Rule 14a-4(c)(2) were to remain in effect, more companies may feel compelled to include a proponent’s proposals in the company’s own proxy materials to obtain proxy voting authority from shareholders on the proposals [. . .] Under the proposed amendments, a proponent’s proxy card could include the company’s nominees, management proposals, and the proponent’s proposals, while the company’s card could solely include the company’s nominees and management proposals. The company could then exercise discretionary voting authority to vote proxies it receives against the proponent’s proposals, other than for proxy cards the company receives on which shareholders have checked the proposed [. . .] check box [. . .] that would provide shareholders an option to prohibit the company from exercising discretionary voting authority on proposals omitted from the company’s proxy card.

This Goodwin Public Company Advisory Blog sums up the practical effect of the proposed changes to Rule 14a-4(c) as follows:

A proponent’s independent solicitation would no longer prevent the company from exercising discretionary voting authority over all proxies it receives. Instead, each shareholder would decide whether to allow the company to vote that shareholder’s shares on the omitted proposal.

Without Rule 14a-8, determining when companies must include shareholder proposals in their proxy materials would be left to state law and potentially companies’ governing documents, and “the transition period may be bumpy,” as Commissioner Peirce acknowledges in her statement. That’s because, as the fact sheet notes, “the presence of a federal rule has inhibited the development of state law and private ordering.” Gibson Dunn has discussed this in detail, saying “many state corporate law aspects of shareholder proposals remain unclear or unsettled,” including in Delaware, and different states may take different approaches.

As Goodwin notes, frameworks will eventually be developed governing “who may submit proposals, which matters are permissible for a shareholder vote in those proposals, and when inclusion in a company’s proxy statement is required” through private ordering and state law. Meanwhile, hearing words like “bumpy” and “unclear or unsettled law” makes me think of the Wild West. It may get worse before it gets better. Saddle-up!

The comment period will be open for 60 days following publication in the Federal Register.

Side note: We were pleased to see one of our blogs and remarks from the 2024 Proxy Disclosure & Executive Compensation Conferences cited in the discussion of Rule 14a-4(c). Special thanks to our former editorial colleague, Emily Sacks-Wilner, for pointing this out while I was still digesting yesterday’s fact sheets! She is so on top of things!

Meredith Ervine 

September 17, 2026

SEC Proposes to Modernize the Proxy Solicitation Rules

The SEC approved another proposal yesterday to modernize the proxy solicitation process that we had been expecting since it was submitted to OIRA. Here’s the 152-page proposing release and the 2-page fact sheet. The accompanying statement by Chairman Atkins also has an excellent summary of how the proposal would “modernize the rules to reflect technological advancements and changes in shareholder communications.”

– Annual Report to Security Holders. The Commission proposed to eliminate the requirement in Rule 14a-3 that a company must deliver a separate “annual report to security holders” even if it has already filed a Form 10-K. Today, shareholders receive essentially the same information from both the annual report required by Rule 14a-3 and the Form 10-K. Accordingly, the proposal would, if adopted, reduce costs to companies arising from preparing and delivering an annual report, without sacrificing investor protection and access to timely information.

– Incorporation by Reference Waiting Period. The Commission proposed to eliminate the requirement in Schedule 14A and Forms S-4 and F-4 to send a proxy statement or prospectus to shareholders at least 20 business days prior to the date of a shareholder meeting if the document incorporates information by reference. This 20-business-day requirement predates companies filing on EDGAR Schedule 14A, Forms S-4 and F-4, and incorporated documents. Today, this requirement no longer serves any investor protection considerations because shareholders can quickly and efficiently access those documents on EDGAR. The proposal would, if adopted, provide companies with greater flexibility in planning their shareholder meetings or business combination transactions, without sacrificing investor protection and access to timely information.

– Notice of Exempt Solicitation. The Commission proposed to eliminate the requirement in Rule 14a-6(g) for a shareholder owning more than $5 million of a company’s securities to submit on EDGAR a notice for its exempt solicitation with respect to that company. The notices no longer serve their intended purpose and, in recent years, the substantial majority of these notices have instead been submitted voluntarily by shareholders owning less than the requisite amount. The proposal would, if adopted, eliminate an unnecessary filing requirement and help ensure that EDGAR cannot be misappropriated to become a platform that prominently communicates views not required to be publicly disseminated, as such outcome may confuse shareholders and hinder their access to a company’s required filings.

– Broker Search Period. The Commission proposed to reduce Rule 14a-13’s timeframe for initiating a broker search in connection with a shareholder meeting from 20 business days before the record date to five business days. The current timeframe, which the Commission adopted in 1983, has become outdated with technological advancements. The proposal would, if adopted, provide companies with greater flexibility in planning their shareholder meetings, while continuing to ensure that companies accurately identify their beneficial owners for a shareholder meeting.

Comments on this proposal are also due 60 days from publication in the Federal Register.

Meredith Ervine 

September 17, 2026

Update on Section16.net: Announcing Our New Senior Editor and a New Look!

Here’s an update Alan Dye shared yesterday on Section16.net:

New Senior Editor – Danielle Benderly. Since Peter retired a few years ago, I have been largely solo in drafting most of the content for Section16.net, at least the blogs and the answers to questions posted on the Q&A Discussion Forum and the “printed” Section 16 publications, which are accessible on the website. These publications include the Section 16 Forms and Filings Handbook and (for subscribers who choose to subscribe to it) the Section 16 Treatise and Reporting Guide. (Many other members of the CCRcorp team, of course, work behind the scenes to post content on the website and make sure it stays up to date.)

As the need to create more content and update publications accelerated in recent years, it became clear that we needed to expand our editorial bench to allow us to continue to add new content and update existing resources. At the same time, we needed creative minds to redesign the website to make it easier for practitioners to navigate to all of the resources on the website (or on a specific topic), without changing the depth, clarity, or timeliness of the content. To help undertake those efforts, I am pleased to announce that Danielle Benderly has joined me as a Senior Editor of Section16.net.

Section16.net and our various print and online publications have always been grounded in the knowledge that Peter and I developed through our initial research for our publications and the application of that knowledge in our practice. After that work in the early years, staying current and providing updated guidance on a timely basis was our primary objective, eventually leading to Section16.net. Danielle brings more of the same knowledge and the same objective. She has deep knowledge of Section 16 and related areas, including EDGAR (which has never been my strong suit), which she developed during her 30 years in private practice. She also shares our commitment to digesting complex rules (and staff interpretations) and lengthy court decisions into understandable, practical guidance. Danielle and I are continuing to try to provide a user-friendly roadmap for practitioners to access that guidance. (Coincidentally, Danielle also happens to be great at website design and has been spearheading the new look of the website, which, as discussed below, will be launched on September 21).

While Danielle has been working with me behind the scenes over the last year, going forward you’ll be seeing Danielle’s byline alongside mine as we continue to collaborate. Every blog, update, Model Form, and Q&A Forum response will reflect that collaboration. Unfortunately, despite my plan to present alongside Danielle for the Section 16 session at the upcoming NASPP conference in Orlando, regrettably I now am unable to attend, but Danielle will represent us well along with my usual co-presenter, Barbara Baksa, the NASPP’s Executive Director.

Updating Section16.net. Danielle has been a “superfan” of Section16.net and, as I said above, oversaw our revamping of the website to make it easier and more intuitive to navigate to our online resources. The key tools you have always relied on are exactly where they were — we just removed excess text and added better visual navigation tools. Members who want a more gradual transition can still access the “classic” version of our homepage through the end of 2026, but we think you will like the new look.

The revamped homepage will appear on Monday, September 21. After that, we expect to add improvements incrementally, likely every few weeks.

As always, all of us at CCRcorp appreciate our loyal subscribers.

So happy to have Danielle on the team, and can’t wait to use the revamped Section16.net homepage!

Public Service Announcement: In private practice, I was a long-time Section16.net subscriber and superuser, and at some point I realized I didn’t get updates from Alan Dye’s Section16.net Blog by email. If that’s you, here’s your PSA that you can sign up to get those blogs delivered directly to your inbox too!

Meredith Ervine 

September 16, 2026

Extended Trading Hours: NYSE Also Expands Trading Halt Rule to More Corporate Actions

One of the things that needs to be addressed as trading hours expand is how to handle corporate actions that have to be processed during a nontrading window. Over on Cooley’s CapitalXchange blog, Liz recently shared that Nasdaq was addressing this by expanding the mandatory trading halt framework that already exists for reverse stock splits – extending it to eight specified categories (changes to symbol/ticker or CUSIP, large dividends, splits, de-SPACs, spinoffs, security-type changes and mergers/similar share exchanges). She also noted that “[o]ther primary listing exchanges will implement substantially identical trading halt rules.” NYSE is now also out with a proposed rule change to address this, and the notice of filing and immediate effectiveness has been posted on the SEC’s website. 

In the context of 23/5 Trading, the Exchange has determined—based on discussions both internal and with industry participants, including the other Primary Listing Markets—that, similar to reverse stock splits, certain other corporate actions require a clearly defined and transparent pause in trading to facilitate their coordinated processing by the Exchange and other market participants before orderly trading may resume in the affected security [. . .] Although the Exchange does not currently plan to extend its own trading hours, the Exchange is a Primary Listing Market whose listed securities may trade on any venue, including NYSE Arca and other exchanges that opt to offer 23/5 Trading. Under the current market structure, the Exchange processes corporate action-related changes and updates for its listed securities during overnight hours. Other market participants, including broker-dealers, likewise use that overnight period to process corporate action-related information and adjust quotes, orders, and related instructions accordingly.

Under 23/5 Trading, however, trading in the Exchange’s listed securities will resume on other markets at 9:00 p.m., only one hour after the close of trading at 8:00 p.m. Consequently, there will no longer be a substantial non-trading window during which the Exchange and market participants can process such corporate actions without potentially impacting overnight trading on other markets. These corporate actions require coordinated updates across Exchange and market-participant systems—including adjustments to orders, quotes, and related instructions—to ensure orderly trading and accurate pricing and execution in the affected security. With only a one-hour pause between trading days, neither the Exchange nor other market participants would have sufficient time to process and incorporate corporate action-related information—such as adjustments to systems, orders, quotes, and related instructions—without the risk that trading could occur in the affected security based on incomplete or inconsistent information [. . .]

The Exchange proposes to build on the framework established under Rule 7.18 for reverse stock splits by extending that rule’s mandatory regulatory halt requirement to additional corporate actions [. . .] As proposed, under 23/5 Trading, if a security is affected by any of the corporate actions enumerated in the proposal, the Exchange would implement a mandatory regulatory halt in that security before the start of overnight trading on other markets at 9:00 p.m. ET, and trading would resume with a Trading Halt Auction after 9:30 a.m. ET.

Similar notices of filing and immediate effectiveness have been posted for NYSE American, NYSE Arca and NYSE Texas. All would become operative at the commencement of 23/5 Trading. As John and Liz have noted, these changes will impact timelines, checklists and existing processes for corporate actions.

Reminder: The SEC’s roundtable on preparations for 24-hour trading is happening tomorrow from 10 am to 4 pm ET at the SEC’s headquarters and streaming live on SEC.gov.

Meredith Ervine 

September 16, 2026

Big Week for Primary Listings on the Texas Stock Exchange

The Texas Stock Exchange (TXSE) began trading in July with a phased rollout, initially allowing equity securities of companies listed on other exchanges to trade on the TXSE as “unlisted trading privileges.” Now, the stock exchange is moving up in the world. Bloomberg reports:

Texas Capital Bancshares Inc. will switch its primary listing to the Texas Stock Exchange from Nasdaq, making it the fifth company in a week to jump to the upstart marketplace.

The Dallas-based financial services provider expects to begin trading on the new exchange on Oct. 8, according to a company statement Monday. The announcement came four days after pipeline operator Energy Transfer LP and three related companies said they would shift to the TXSE.

Those three related companies are Sunoco LP, SunocoCorp and USA Compression Partners LP. The article says Texas Capital’s CEO, Robert Holmes, serves on a TXSE advisory board, and Energy Transfer’s chairman, Kelcy Warren, is a backer of the exchange’s parent company, so all have some connection to the TSXE. But still, five companies just this week!

Hot tip for when you’re having conversations about this: TSXE is pronounced “TEX-ee”!

Meredith Ervine 

September 16, 2026

If You’ve Registered for Our “Proxy Disclosure & Executive Compensation Conferences,” Watch Your Email!

Important information for attendees of our Proxy Disclosure & 23rd Annual Executive Compensation Conferences!

Be on the lookout for an email from us (CCRcorp) via no-reply@events.ringcentral.com (our conference platform and app provider) in the coming days. This email confirms your registration and contains your unique link to access the conference platform. (If you’ve never attended a RingCentral event before, you will also receive a second email confirming that a RingCentral account has been created for you.)

That unique link will give you instant access to the platform, where you can view the detailed conference schedule, location information, hotel maps, course materials and CLE forms. Our virtual attendees will also use this platform to join the conference livestream. It also has a chat feature that both in-person and virtual attendees can use to ask questions anonymously. We recommend accessing the platform either through the RingCentral Events app, which is available for download on both iOS devices or Android devices, or on a desktop browser. Virtual attendees are encouraged to stream the live conference on a desktop browser for the best experience.

If you haven’t registered yet, the clock is ticking! We’re less than one month out. Visit our online store, email info@ccrcorp.com or call our team at 800-737-1271 today. There’s so much to talk about, and with the pace of change, no doubt there will be even more to discuss by October. Our experienced speakers will be covering all the latest & greatest!

– Meredith Ervine 

September 15, 2026

Prediction Markets: Data on Public Company Policy Updates

Companies have started addressing prediction markets in their corporate policies to manage the risk of employees trading on prediction markets on the basis of nonpublic information. (See Dave’s article for the July-August 2026 issue of The Corporate Counsel, “Prediction Markets: What Should Companies Do Now?”) Because prediction markets often do not involve “securities,” this may not be as simple as adding a line to your insider trading policy.

While there may not be a one-size-fits-all solution because each company will have to consider its existing policies to determine whether and how to revise them to reflect prediction market insider trading risk, data on what other public companies are doing can be helpful to have in your back pocket. To that end, this O’Melveny quarterly newsletter shares how companies have addressed prediction markets in their policies this year.

In 2026 through September 2, 2026, 54 companies (including 12 large companies) updated their publicly available codes of conduct and 30 companies (including 12 large companies) updated their insider trading policies to include prediction markets language.

Companies typically took a more restrictive approach to prediction markets than that which it applied to securities transactions generally, although this was more common in codes of conduct (81% of companies with prediction markets language in their codes of conduct) than in insider trading policies (69% of companies with prediction markets language in their insider trading policies).

– Prohibition on engaging in any prediction market transaction involving the company. Approximately 24% of companies that included prediction markets language in their codes of conduct restricted employees from engaging in any prediction market transaction involving the company. A similar number of companies included that prohibition in their updated insider trading policies, but due to the smaller number of filed policies containing prediction markets language, this constituted 41% of insider trading policies.

– Application of a lower standard for restricting participation in prediction markets. Approximately 56% of companies that included prediction markets language in their codes of conduct restricted participation based on a lower standard of information (possession of confidential or nonpublic information, rather than material nonpublic information), while 14% of companies that included prediction-markets language in their insider trading policies applied this lower standard. One company took a different approach in its insider trading policy and prohibited trading by individuals in event contracts where they had the ability to affect the outcome of the contract.

Of the 54 companies addressing event contracts in their publicly available codes of conduct, nearly half (46%, or 25 companies) included language regarding prediction markets in the section of their codes of conduct covering insider trading, while one-third of companies (33%, or 18 companies) included the language in the section of their codes of conduct covering confidentiality obligations. A significant minority of companies (15%, or 8 companies) included language regarding event contracts as a standalone section of their code of conduct. Companies also included prediction market language in the sections of their codes of conduct covering conflicts of interest (9%) or compliance with laws (4%).

Meanwhile, more than three-quarters of companies (76%, or 22 companies) that addressed prediction markets in their insider trading policies described trading in event contracts as distinct from trading in securities, often acknowledging that such trading may not be covered by traditional securities restrictions. Many of these companies included restrictions on trading in event contracts in the same section as other prohibited transactions, such as hedging and pledging of securities or entering into derivatives contracts.

The report emphasizes that this is an emerging and evolving risk area, so companies should monitor developments and may want to adjust their practices in response.

Meredith Ervine 

September 15, 2026

Summary & Update on Shareholder Proposal Exclusions Challenged in Court

I had a hard time mentally keeping track of the litigation over the exclusion of shareholder proposals from proxy statements this proxy season (even though we were sharing updates here and on The Proxy Season Blog). So I was pleased to find this chart in the O’Melveny quarterly newsletter I shared in my first blog today covering all the litigation – with updates (even reflecting the vote on the shareholder proposals for those that were ultimately submitted to shareholders).

There is also litigation alleging that the change to SEC Staff’s involvement in the Rule 14a-8 process violated the APA. The newsletter has an update on that too:

The lawsuit is still at the motion for summary judgment stage. Although briefing was initially expected to be completed by the end of October 2026, on September 3, 2026, the court granted the parties’ joint motion to hold the litigation in abeyance while they determine how to proceed in light of Corp Fin’s August 2026 decision to permanently withdraw from its participation in the Rule 14a-8 no-action process.

Meredith Ervine 

September 15, 2026

Human Capital: Income Statement Disaggregation is Coming

Here’s something Liz recently shared on CompensationStandards.com:

It’s been a couple years since I’ve blogged about FASB’s initiative to require companies to quantify labor costs and other income statement expenses. Even though the SEC hasn’t moved forward with detailed human capital disclosure requirements, “public business entities” are still going to need to start providing employee compensation info in the notes to financials in response to FASB Accounting Standards Update 2024-03, which was adopted in November 2024. This Deloitte guide explains what ASU 2024-3 will require and what in-scope companies should do to prepare. Here are a few key takeaways (also see this FASB alert):

The DISE standard introduces new requirements related to disaggregating certain income statement expense captions within the footnotes to the financial statements. These disclosures are required for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027.

The ASU does not change the expense captions an entity presents on the face of the income statement or the recognition and measurement principles of other GAAP standards; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements.

An expense caption presented on the face of the income statement within continuing operations is considered relevant and therefore subject to disaggregation if it includes any of the following natural expense categories:

(1) purchases of inventory;

(2) employee compensation;

(3) depreciation;

(4) intangible asset amortization; and

(5) depreciation, depletion, and amortization (DD&A) recognized as part of oil- and gas-producing activities or other types of depletion expenses.

Entities will need to disaggregate relevant expense captions into these five natural expense categories (the “required expense categories”) in a tabular presentation. The tabular disclosure for each relevant expense caption will also include certain other expenses and gains or losses that must be disclosed under existing U.S. GAAP (the “tabular integration of other disclosures”), expense reimbursements, and other expenses when applicable. The ASU does not change or remove existing expense disclosure requirements; however, it may affect where that information appears in the notes to financial statements because the ASU requires entities to include certain current disclosures in this tabular format.

The requirement applies to “public business entities,” which the standard defines as entities:

– Required by the SEC to file or furnish financial statements, or does file or furnish financial statements (including voluntary filers), with the SEC (including other entities whose financial statements or financial information are required to be or are included in a filing).

– Required by the Securities Exchange Act of 1934 (the Act), as amended, or rules or regulations promulgated under the Act, to file or furnish financial statements with a regulatory agency other than the SEC.

– Required to file or furnish financial statements with a foreign or domestic regulatory agency in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer.

– That have issued, or is a conduit bond obligor for, securities that are traded, listed, or quoted on an exchange or an over-the-counter market.

– That have one or more securities that are not subject to contractual restrictions on transfer, and it is required by law, contract, or regulation to prepare U.S. GAAP financial statements (including notes) and make them publicly available on a periodic basis (for example, interim or annual periods). An entity must meet both of these conditions to meet this criterion.

An entity may meet the definition of a public business entity solely because its financial statements or financial information is included in another entity’s filing with the SEC. In that case, the entity is only a public business entity for purposes of financial statements that are filed or furnished with the SEC.

The ASU does not apply to a not-for-profit entity nor an employee benefit plan.

The Deloitte guide points out that in-scope companies should prepare now for these disclosures, because they may need to collect underlying data may not currently be readily available beginning in 2027 (for calendar year companies) – and companies may need to consider estimates, information systems and reporting changes, and adjustments to processes and controls. The nature and extent of new information required are expected to vary by entity and industry – as illustrated in this separate Deloitte alert for consumer products and retail companies.

From a governance standpoint, this update obviously affects audit committees – and hopefully they are already discussing it. But as Meredith recently blogged, human capital is still on the agenda for many compensation committees as well. Comp committees may want to think ahead about how this new data will be presented and used – by the committee itself as well as other stakeholders.

Meredith Ervine 

September 14, 2026

More on the SEC & FDA MOU: What’s New & What’s Not

When the SEC announced that it had entered into a cooperative Memorandum of Understanding with the FDA to facilitate information sharing to improve the agencies’ regulatory and enforcement responsibilities, I think many practitioners were wondering whether this was a formalization/codification of current practices or an expansion of cooperation, how the MOU would change the agencies’ current communication in practice and what it means for life sciences companies. This Goodwin alert gives us the lowdown.

Interagency cooperation between the SEC and FDA is not new. In 2004, the agencies announced a collaboration to make referrals and exchanges of nonpublic information more efficient, relying on designated contacts and existing statutory and regulatory authorities. The SEC Enforcement Manual (the “Manual”) describes the resulting process. Staff considering a request to the FDA were expected to consult supervisors, notify the Division of Enforcement’s FDA liaison, and assess the statutes governing FDA disclosure. The Manual cautions, however, that requests should be tailored, that substantial time should be allowed for FDA review, and that the company’s consent to further disclosure of its confidential commercial information should be sought early.

The MOU does not “create enforceable rights or obligations” but should improve consistency by establishing certain contacts and procedures to be followed when sharing nonpublic information

Standing channels and accountable contacts. Each agency is to establish a mechanism to receive requests and a secure means to transmit nonpublic information. The SEC’s principal contacts include representatives from the Division of Enforcement and the Division of Corporation Finance; the FDA’s include a representative from the Office of the Chief Counsel.

A defined request-and-response process. A request must describe the information sought and its intended use, be signed by an authorized official, and, for SEC requests, include the required nondisclosure assurance. The agencies commit to timely responses and may develop standard operating procedures and model templates.

Express use in filing reviews and enforcement matters. The MOU confirms that the SEC may use nonpublic FDA information in public company filing reviews and in enforcement investigations and resulting enforcement actions. Including the Division of Corporation Finance is significant: FDA information may influence disclosure review before or apart from an enforcement investigation, and a filing-review issue can lead to an enforcement referral.

Two-way sharing with confidentiality safeguards. Consistent with statutory and regulatory limitations on the ability of the SEC and the FDA to share information with other agencies, the MOU provides that both agencies must restrict access to personnel who need the information, preserve applicable privileges, and coordinate on third-party demands. The providing agency retains a central role in responding to Freedom of Information Act requests, subpoenas, and other efforts to obtain shared material, and the SEC must also obtain permission from the FDA before sharing non-public materials obtained from the FDA with third parties.

Important limits remain. Although the FDA may refer potentially violative conduct to the SEC, the MOU does not authorize the FDA to share with the SEC information that governing statutes prohibit it from disclosing. For example, Section 301(j) of the Federal Food, Drug, and Cosmetic Act restricts disclosure of proprietary manufacturing methods or processes contained in drug applications or FDA inspection materials. The MOU also does not cover public information, testimony requests, or subpoenas, and it does not govern requests made before August 31, 2026.

While I bet most life sciences companies were aware or assumed that the Division of Enforcement was able to get nonpublic information from the FDA, I also bet that more life sciences companies were not aware that Corp Fin is part of this information-sharing process and that information provided by the FDA may result in a comment during a filing review by the Disclosure Review Program. That doesn’t necessarily change things for public companies — this MOU does not create any new public company obligations, and most life sciences companies already have disclosure controls in place to validate their public statements against regulatory correspondence to ensure their disclosure is accurate, complete and not misleading — but it’s good to be aware of.

On the enforcement side, the alert highlights an important point about the Wells process. As it notes, the SEC has recently worked to improve transparency in the Wells process, but that transparency may not always be able to extend to information provided to the Enforcement Staff by the FDA.

Under the MOU, the SEC may more easily obtain nonpublic FDA information, but it may not disclose that information outside the agency without the FDA’s written permission. The MOU provides that the FDA will respond promptly to permission requests, but obligates the FDA to grant permission only when disclosure is compelled by law or judicial order. The result is a potential information gap at the most important pre-charge stage. The SEC staff may know that the FDA record undercuts a company’s public account while the Wells recipient sees only a description of the evidence, selected nonrestricted material, or documents already in the recipient’s possession. The problem may be most acute for individuals who do not control the company’s complete FDA file, or when FDA records contain third-party information or require extensive review before the agency will authorize access.

The MOU also does not specify how the SEC should proceed if the FDA declines or delays permission, whether the SEC staff should segregate FDA materials from the Wells file, or how much detail staff should provide about information it cannot share. Counsel representing life sciences companies and their executive officers should raise access issues early: Identify the FDA materials likely to be relevant, ask what FDA-originated information the staff considered, and request that the SEC promptly seek FDA permission to share materials in the Wells file.

Meredith Ervine