On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) announced a memorandum of understanding. This agreement facilitates the sharing of non-public information between the two agencies. The information pertains to FDA-regulated public companies.
The details
The memorandum of understanding was signed on August 31, 2026. It establishes formal channels for exchanging non-public information. The agreement is for a three-year period, according to finance.biggo.com. This pact allows the SEC to access nonpublic FDA communications, according to McDermott Will & Schulte. The shared information relates to FDA-regulated public companies.
Why it matters
The agreement opens nonpublic FDA communications to SEC enforcement staff, according to McDermott Will & Schulte. This development may heighten disclosure and insider-trading risks for life sciences companies. The SEC and FDA pact aims to accelerate insider trading probes in biopharma, according to finance.biggo.com. The SEC recently created a Financial Reporting and Accounting Unit (FRAU), according to Freshfields. This unit signals a focus on disclosure integrity, accounting fraud, and audit oversight. Bloomberg Law News states that the SEC's accounting unit is seen as a core fraud enforcement engine. Public companies and auditors may face more SEC investigations and enforcement suits, according to Bloomberg Law News. Cases may become bigger and more complicated.
What to watch
No specific next disclosure, filing, print, or date is identified in the provided sources.
Sources
- SEC and FDA Sign Memorandum of Understanding to Share Non-Public Information on FDA-Regulated Public Companies — JD Supra
- SEC-FDA agreement heightens disclosure and insider-trading risks for life sciences companies — McDermott Will & Schulte
- SEC and FDA Forge Three-Year Pact to Accelerate Insider Trading Probes in Biopharma — finance.biggo.com
- SEC Returns to Its Accounting Enforcement Roots: New Financial Reporting and Accounting Unit Signals Focus on Disclosure Integrity, Accounting Fraud, and Audit Oversight — Freshfields
- SEC’s Accounting Unit Seen as Core Fraud Enforcement Engine — Bloomberg Law News
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