Critically, the critical public health mission and user fees are the buffer for FDA when a shutdown occurs.

Below, we will delve into how a shutdown may look for the FDA under the Trump administration.

Staff:

In the case of a shutdown, the FDA estimates it would maintain around seventy-seven percent of its staff. This number is expected to have changed since it was reported in December 2024 due to recent staffing cuts throughout the Agency.

Of the estimated seventy-seven percent of FDA staff retained, sixty-fix percent (12,878 employees as of December 17) are termed “exempt staff” who support activities reliant on supplemental funding, rather than appropriations. Critically, these staff are maintained until their source of supplemental funding slows down. To prolong funds and make sure they are spent on the highest priority activities expect FDA to “triage programs and closely manage spend-downs of cash.” The Alliance for a Stronger FDA suggests that “ongoing activities and staff levels performing user fee activities” will likely “grow smaller in stages.” Supplemental funding sources throughout the FDA include carryover user fees, Working Capital Fund, and COVID-19 supplemental funding. We know as of the end of FY 2024, the FDA had enough carryover funding to support an estimated 9.82 weeks ($270,834,409) of PDUFA regulated activities. While there is no way of knowing exactly where these staff are positioned throughout the FDA, we do know that the estimated sixty-fix percent include:

  • The entirety of the FDA’s Tobacco Center, which is funded entirely by user fees (1,303 FTE as of FY 2024).
  • 622 Public Health Service Commissioned Corps Officers.

The other twelve percent of protected staff, termed “excepted staff,” support activities that are either 1) necessary to address imminent threats to the safety of human life or the protection of property or 2) or ‘necessarily implied’ from the authorized continuation of other activities. Again, while we do not know exactly where these staff are positioned throughout the FDA, we do know that the estimated twelve percent include:

  • 363 Public Health Service Commissioned Corps Officers.

The remaining twenty-three percent of staff would be placed on administrative furlough. During the 2018-2019 government shutdown, many furloughed employees continued working without pay, anticipating the possibility of back pay, which was later secured through the Government Employee Fair Treatment Act of 2019. This may not be the situation this time around.

Typically, furloughed staff include:

  • Individuals involved in the development of regulations or the conduct of administrative or policy work.
  • A significant portion of Food program staff, apart from import inspectors, individuals working on recalls, and other front-line employees needed to address essential duties that protect human and animal safety.

Agency activity:

Drug and device product review programs are not entirely paid for by user fees; in 2018, the Alliance for a Stronger FDA estimated that about “30% of the drug review process is paid for by appropriations.” While this number has likely changed, any dependence on appropriations during a shutdown will slow the review process, even with the widespread use of user fees.

Expect staff working on products not covered by user fees to face furlough during a government shutdown. In 2018, the FDA paused:

  • Non-emergency work on whole blood, blood components for transfusion, allergenic extracts, and HCT/Ps regulated solely under section 301 of the PHSA.
  • The approval of products under ANDA and 351(k) biosimilar BLA.
  • The approval of OTC monograph drugs, besides OTC products approved under NDAs.

Below is a series of tables including activities to expect to continue, come under threat, or halt during a lapse of appropriations.

Activities that CAN continue during an FDA shutdown include:

Activity Notes
FDA activities funded through user fees, including the regulation and testing of human drugs and medical devices
  • Includes the approval of new medical products (through review of biologics license applications (BLAs), new drug applications (NDAs), and premarket approval applications for medical devices, which have been submitted and their user fees paid prior to the lapse in appropriations).
  • It is uncertain whether review times could be affected by a shutdown, but anecdotally, depending on the length of a shutdown there may be delays.
  • The review of requests to conduct important clinical research.
  • The issuance of guidance.
  • Other necessary activities to help patients have access to new therapies.
Investigational new drug (IND) submissions
  • During the FY 2019 shutdown, then-FDA Commissioner Scott Gottlieb indicated that FDA could use carry over funding to accept submissions for which no fee is required, such as investigational new drug (IND) applications and supplements to NDAs and BLAs that qualify for fee exemptions. However, with no confirmed FDA Commissioner to lead these decisions, it is unclear what FDA/HHS leadership’s current position will be.
  • Includes new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed, even for products that are not covered by a user fee program.
Meetings with FDA
  • User-fee-funded meetings on specific applications can continue with exempted staff.
    • During the 2013 shutdown, some sponsors reported pre-IND meetings were postponed.
  • Advisory Committee meetings can be held.
    • Per a recent communication with Peter Marks, he informed us that, “Since influenza vaccines are PDUFA products, the Advisory Committee meeting would proceed in the event of a shutdown.”
    • In 2013, already-scheduled advisory committee meetings were held.
All vital FDA activities related to imminent threats to human health or life:
  • Surveillance of adverse event reports for issues that could cause human harm.
  • The review of import entries to determine potential risks to human health.
  • For-cause and surveillance inspections of regulated facilities.
    • In 2019, then-Commissioner Gottlieb stated in testimony to a Congressional subcommittee, “Our field force continued to perform inspections of foreign and domestic high-risk food and medical product facilities.”

 

Activities that CANNOT continue during a government shutdown include

Activity Notes
Any activity under new user fees
  • Commissioner Scott Gottlieb stated on Twitter in FY2019, “Many asked if #FDA can accept new product applications. The #FDA can’t collect FY2019 user fee payments during the shutdown, which means we can’t accept new applications for products under our user fee programs.”xi,
  • (This refers to marketing applications, e.g., BLAs and NDAs).
  • Per FDA guidance, “FDA cannot accept new applications for which required user fees were not paid prior to the lapse in appropriations.  This means that, for purposes of receipt of such new applications, the government is considered not to be open for business during a lapse in appropriations. For that reason, even if document rooms are open during the lapse period, those rooms will not be considered to have received physical submissions of such new applications during that period.”
  • “Similarly, for ESG (electronic submission gateway) submissions, new applications for which required user fees were not paid prior to the lapse in appropriations will not be received until the lapse ends.”
    • It is unclear whether user fees are processed and considered paid as soon as payment is submitted.
Meetings funded by appropriations
  • Notably, this disproportionately affects policy-focused meetings, including certain Advisory Committee meetings, workshops, and Agency webinars.

Activities at HIGH RISK during a government shutdown:

Activity Notes
Inspections not deemed “necessary” for public safety.
  • Commissioner Scott Gottlieb reported that during the lapse period, the Agency had to delay “nearly 500 food and feed domestic inspections and roughly 355 food safety inspections.”

While the Agency’s reliance on user fees does provide it some protection when it comes to a federal lapse in appropriations, no shutdown comes without a cost.

We will be keeping our eyes on the news for the next few weeks – and we believe you should be too.