The FDA’s operations are uniquely positioned during a shutdown due to its reliance on User Fee Act carryover funds. This funding source allows a portion of the agency to continue functioning even without appropriated congressional funds.

How FDA Staffing is Affected by the Shutdown

At the onset of the shutdown, the FDA categorised its staff based on funding and mission-critical needs.

• 14% of FDA staff are furloughed.
• 86% of FDA staff continue to work, with: 66% supported by User Fee Act carryover funds.
• 19% exempted due to work on activities addressing “imminent threats to human life.

It is important to note that staff not covered by user fees may be working without pay, which can gradually impact overall operational efficiency over time, potentially causing indirect delays in FDA review timelines.

What the FDA Shutdown Means for Your Submissions

The most immediate impact of the government shutdown on drug approvals is the clear division between ongoing and paused activities.

Activities That Continue:

Review of pending drug, biologic, and medical device applications already submitted and supported by user fees.

Activities That are Paused:

• The FDA will not accept any new applications that require a fee. This includes:
  • New Drug Applications (NDAs)
  • Biologics License Applications (BLAs)
  • Biosimilar Applications

IND Activity and Clinical Development

While certain Investigational New Drug (IND)-related activities may continue, the FDA’s ability to manage these reviews efficiently could be hindered by staff shortages and reallocation of personnel to urgent public health priorities.

Companies may also face delays in scheduling or holding meetings with the FDA Agency, particularly for programs not deemed time sensitive.

Broader Uncertainties, Implications and Strategic Considerations

An additional unknown is whether ongoing political rhetoric — including threats of further federal workforce reductions — might affect FDA staffing in the weeks ahead. Any such action could further disrupt regulatory timelines and deepen uncertainty for ongoing development programs.

Conclusion

For the biotech and pharmaceutical industry, the 2025 U.S. government shutdown underscores the vulnerability of regulatory processes to political gridlock. While User Fee Act funding provides temporary buffer for key FDA activities, the inability to submit new applications and the strain on Agency resources could slow innovation and delay critical therapies from reaching patients.

Companies should maintain proactive communication with their regulatory affairs teams, track FDA updates, and prepare contingency plans for potential delays in IND interactions and submission timelines.

The next few weeks will be pivotal in determining whether this disruption remains a short-term inconvenience — or evolves into a significant drag on U.S. biopharmaceutical progress.

Stay Informed with Enimera RegsPlus

To stay ahead of regulatory developments and understand how FDA policy shifts may affect your IND and product development strategies, visit Enimera RegsPlus who has Regulatory FDA experience.

Our regulatory strategy team tracks real-time FDA activity and provides actionable insights tailored to the biotech and pharma sectors.

Contact Enimera RegsPlus for a Regulatory Strategic Consultation.

Stay informed. Stay compliant. Stay ahead.

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