SEC and FDA Expand Cooperation: What Life Sciences Companies Need to Know

The FDA now has a formal channel to tell the SEC what a company told the FDA.
On August 31, the two agencies signed a three-year Memorandum of Understanding establishing information-sharing protocols across the life sciences sector.

Under it, the FDA may share non-public information with the SEC — excluding trade secrets and confidential commercial data — and the SEC may use what it receives in reviewing filings and in enforcement matters.
 

Why it matters. Biotech, pharma, and device companies make statements about trial results, submissions, and review status that move prices. The FDA holds the underlying data. The gap between what a company tells its regulator and what it tells its investors was previously hard for the SEC to see. It is less so now.
 

The practical step is unglamorous: reconcile your disclosure language against your regulatory correspondence before the next release. Timelines, endpoint characterizations, and descriptions of agency feedback are where inconsistencies appear — rarely on purpose.

What the SEC-FDA Agreement Changes

The new MOU establishes formal procedures for the SEC and FDA to exchange information relevant to their regulatory and enforcement responsibilities. This includes mechanisms for sharing certain non-public information involving FDA-regulated products, companies, and activities.

Why This Matters for Public Companies

FDA developments can have a significant impact on the market value of life sciences companies. The SEC may use information received from the FDA when reviewing public company filings or investigating whether statements concerning matters such as FDA review, product approvals, or clinical trial results comply with federal securities laws.

Life Sciences Companies Could See Closer Disclosure Scrutiny

Public companies operating in pharmaceuticals, biotechnology, medical devices, and other FDA-regulated industries should pay particular attention to the agreement. Greater information sharing may make it easier for regulators to compare statements made to investors with information available to the FDA.

What Companies Should Review Now

Life sciences companies should review their disclosure controls and internal processes for communicating regulatory developments to investors. Legal, compliance, investor relations, and regulatory teams should be aligned on statements involving clinical trials, FDA submissions, regulatory review, and product approvals.

Keep Regulatory and Investor Communications Consistent

Companies should carefully review whether public filings, earnings materials, investor presentations, and other market communications accurately reflect significant FDA-related developments and the information available internally.

What to Watch Next

The MOU took effect when it was signed on August 31, 2026 and is scheduled to remain in effect for three years unless modified, extended, or terminated. Companies should monitor whether increased SEC-FDA coordination results in additional filing scrutiny, investigations, or enforcement activity involving FDA-related disclosures.

How SJKP Can Help

SJKP's corporate and securities attorneys can assist public companies and life sciences businesses with securities compliance, disclosure reviews, corporate governance, and regulatory risk. Companies affected by FDA developments can work with counsel to review investor communications and disclosure procedures and assess how regulatory events may affect their securities-law obligations.