Day 35 Shutdown Update

A Record-Breaking Shutdown—And No End in Sight

Today marks Day 35 of the federal government shutdown—tying the longest in U.S. history. What began as a short-term funding dispute has evolved into a full-scale breakdown of regulatory continuity.

Across FDA, USDA, and related agencies, internal coordination, submission review, and enforcement work are running on fumes. User-fee carryover funds that kept some FDA activity alive are now nearly depleted, and the economic ripple effects are visible throughout the food, drug, device, tobacco, and veterinary sectors.

FDA: The Backlog Deepens

The Food and Drug Administration remains legally barred from accepting new submissions that require user-fee payments. That restriction applies to:

• NDAs, BLAs, ANDAs, and Supplements (PDUFA / GDUFA);
• 510(k)s, PMAs, and De Novo requests (MDUFA);
• Biosimilar, Animal Drug, and Generic Animal Drug submissions (BsUFA / ADUFA / AGDUFA);
• Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) reports under CTP.

FDA’s carryover funds were sufficient to maintain core safety-critical reviews through October, but senior-staff briefings suggest that cross-center communication has slowed sharply as unpaid administrative teams step back. Expect new and supplemental applications to face months-long restart lag even after appropriations return.
(FDA FY 2026 Lapse Plan)

CTP and CVM: Quiet Centers, Growing Risks

Center for Tobacco Products (CTP)

• No new PMTA or SE submissions are being accepted.
• Warning-letter follow-ups and import enforcement remain frozen.
• Analysts project that by year-end, the total PMTA backlog could exceed 250 pending applications, many already past statutory decision dates.

Center for Veterinary Medicine (CVM)

• Only emergency animal-drug safety activities remain operational.
• ADUFA/AGDUFA review work is paused; pet-food ingredient consultations and feed-additive petitions are on hold.
• Veterinary-product imports and medicated-feed clearances continue to face 4–8-day delays.

Both centers are likely to require staggered reopening schedules, prioritizing health-risk reviews before routine commercial filings.

USDA: Food-Aid Suspension Now Real

The U.S. Department of Agriculture confirmed that SNAP benefits were not issued on November 1, affecting millions of households and generating downstream strain on food manufacturers, retailers, and logistics networks.
(NBC Chicago, Oct 28 2025)

Meanwhile, FSIS and APHIS remain on contingency staffing, restricting inspections and permit reviews. Export certificates for meat, produce, and veterinary biologics are delayed, complicating supply-chain documentation.

Courts and Compliance: Secondary Systems Faltering

• Federal courts have begun furloughing clerks and limiting hearings, slowing FOIA and administrative litigation.
• Imports under FDA + USDA jurisdiction are clearing slowly, with rolling delays at Los Angeles, Savannah, and Newark ports.
• DailyMed, Regulations.gov, and Enforcement Report databases remain static, forcing regulated entities to rely on outdated data for compliance decisions.

The Economic and Legal Toll

According to the Congressional Budget Office, the ongoing shutdown could erase $7 to $14 billion in permanent GDP if it lasts another month. The direct regulatory cost is harder to quantify: every suspended submission, missed renewal, or delayed import adds to the post-shutdown backlog that will define FY 2026.

For FDA-regulated businesses, this means increased contract-performance risk, delayed product launches, and heightened exposure to inadvertent non-compliance.

What Industry Should Do Now

1. Document Every Attempted Submission
Retain all timestamps, payment confirmations, and correspondence for later validation.

2. Audit Import and Renewal Dependencies
Identify which facilities, permits, or certificates rely on active federal verification.

3. Prepare “Restart-Ready” Filings
Pre-assemble complete resubmission packages now—agencies will triage by completeness once the funding bill passes.

4. Track Public-Health Priorities
Expect FDA to restore enforcement (inspections, recalls, warning letters) before resuming lower-risk administrative work.

5. Communicate Early
Inform distributors, contract manufacturers, and labelers that documentation delays are expected through December 2025.

Outlook: The Second Month, The Long Shadow

As the shutdown ties the 2019 record at Day 35, the regulatory system’s resilience is being tested to exhaustion. FDA’s review clock has stopped; USDA’s safety oversight is fragmenting; and CTP and CVM are running on minimal life-support functions.

The longer agencies remain unfunded, the harder the restart will be—not just in lost time, but in institutional synchronization. The second month will determine whether the recovery is measured in weeks or quarters.

FDA Atty will continue to monitor congressional appropriations, FDA center communications, and import activity data for the next update.