Day 27

The shutdown has now reached Day 27, making it the longest lapse in FDA funding since the user-fee era began. While the visible symptoms—silent websites, frozen comment periods, suspended outreach—have persisted for weeks, a quieter crisis is now emerging: the slow depletion of review momentum and the near-total halt of new user-fee submissions.

FDA: The User-Fee Engine Winds Down

According to the FDA’s official contingency page, the agency does not have legal authority to accept new submissions that require user-fee payments for FY 2026 during the funding lapse.
(FDA.gov, 2025)

This means no new:

• NDAs, BLAs, ANDAs, or Supplements under the Prescription Drug or Generic Drug User Fee Acts;
• 510(k)s, PMAs, or De Novo requests under the Medical Device User Fee Amendments;
• Animal Drug, Tobacco Product, or Biosimilar submissions tied to user-fee triggers.

Carryover user-fee funding is sustaining limited review work for existing submissions—but even that support is finite. Internal reports indicate a gradual slowdown in active reviews as cross-office coordination and contractor support diminish.
(Hogan Lovells, Oct 2025)

Industry observers note that the backlog is forming now, not after reopening. Each week of delay represents a compounding loss of synchronization between reviewers, sponsors, and advisory support teams—time that cannot be instantly recovered once funding resumes.
(BioWorld, Oct 2025)

Shrinking Pipeline, Growing Queue

The practical result is an empty pipeline of new filings paired with a swelling queue of pending reviews. Submissions awaiting pre-review triage are idle in electronic inboxes, while statutory review clocks for most active applications are technically paused.

For regulated entities, this dynamic carries three key risks:

1. Compression Risk – When appropriations return, the agency may attempt to restart hundreds of reviews simultaneously, creating an unmanageable surge in workload.
2. Priority Distortion – “Critical” filings—especially those tied to unmet medical needs or safety concerns—will be fast-tracked at the expense of lower-priority programs.
3. Fee Realignment – There is potential for fee structure adjustments or carryover reallocations if shutdown losses materially affect fiscal-year revenue projections.

For sponsors in drug, device, or biologics development, the next 60 days may determine the shape of review timelines well into 2026.

USDA & Imports: Fragmented Recovery

The U.S. Department of Agriculture’s partial reopening of 2,100 field offices has stabilized some farm-aid programs, but regulatory continuity remains thin. APHIS, FSIS, and organic certification offices continue to operate under limited contingency staffing. Import clearance delays persist for FDA-USDA dual-jurisdiction commodities, particularly perishable goods and ingredients requiring multiple approvals.

Operationally:

• Expect 3-5 day additional port delays on FDA/APHIS holds.
• Renewals for veterinary biologics and plant-health permits remain unprocessed.
• Organic certification renewals requiring inspection remain paused.

The “Silent Zone” Widens

Beyond submissions, the shutdown has effectively created a regulatory blackout:

• No updates to DailyMed, Federal Register FDA dockets, or Guidance document archives.
• No public access to inspection classifications, recall databases, or enforcement trends.
• No response capacity for FOIA or stakeholder inquiries.

The lack of current regulatory data is now forcing manufacturers, importers, and consultants to rely on outdated information—a subtle but growing compliance hazard.

Strategic Outlook: Preparing for Restart Shock

When the shutdown finally ends, the FDA and USDA will not restart from zero; they’ll restart from a deficit. The cumulative backlog, staff fatigue, and revenue shortfall will likely reshape how both agencies prioritize reviews, communications, and enforcement for the rest of FY 2026.

Recommended actions:

• Document all attempted submissions and communications during the shutdown, including timestamps and receipts.
• Prioritize “mission-critical” filings—those tied to safety, supply continuity, or essential labeling.
• Anticipate slower non-PDUFA interactions, such as pre-IND meetings or CDRH consultations.
• Prepare for selective reactivation, as agencies triage review categories based on available resources.

By Day 28, it’s clear the shutdown has shifted from a budgetary standoff to an institutional stress test. The FDA’s submission freeze marks a turning point: regulatory time is no longer merely paused—it’s evaporating.

FDA Atty will continue monitoring FDA and USDA communications, import performance data, and legislative negotiations as the agency backlog—and its legal implications—grow.