Are Workforce Cuts Slowing Down the FDA? Here's What Our Consultants Are Seeing

Anecdotes from the field reveal a complex, uneven picture of how FDA’s internal upheaval is playing out in practice at the moment.

FDA Commissioner Marty Makary just told Congress that the agency is “on track to meet all of our user fee targets”—even after more than 3,000 staff exited the agency this spring through layoffs and early retirements.

“The trains are running on time,” he said during his first Senate hearing as commissioner, clarifying that scientific reviewers and inspectors were not among those let go. “We’re going to operate more efficiently.” (Read his full written testimony here.)

This message comes amid growing concerns across the life science industry, with Sens. Susan Collins and Patty Murray both citing reports of delayed approvals and inspections following the April 1 cuts. While Makary didn’t directly address delays in drug or device facility inspections, he reiterated that drug approvals would not be impacted.

That assurance aligns with what some of our consultants are seeing. Others, however, are observing frictions—especially in informal communications, smaller administrative functions, and inspection dynamics.

To get a clearer view from the ground, we polled our network of FDA-facing consultants to learn how the agency’s internal disruption is (or isn’t) affecting real-world timelines and interactions.

What follows is a snapshot of field intelligence, gathered just this past week. We’ll update it as we gather more feedback.

Before you scroll on—tell us what you’re seeing! If you’re actively working with FDA—on submissions, inspections, meeting requests, or compliance issues—we’d love to hear from you. Send your observations to thefdagroup@substack.com. We’ll keep your responses confidential and be sure to anonymize all responses included in a future newsletter feature.

What the commissioner just told Congress

Before we jump into the anecdotes from our consultants, it’s worth starting with what Makary just relayed to Congress about cuts and any delays stemming from them.

He offered his first public reassurance in front of lawmakers last week: despite more than 3,000 departures, user–fee–driven reviews for drugs and devices are not being delayed.

Makary noted that approximately 1,900 employees were let go under the Trump administration’s reduction-in-force, while another 1,200 took early retirement. He emphasized that no scientific reviewers or inspectors were part of the layoffs—though some scientific researchers were among those cut.

Makary’s key message: the agency had become bloated.

“Did we need 125 travel coordinators? Or 13 strategy offices?” he asked, framing the staff cuts as a move toward a leaner, more efficient agency.

Still, some senators were not reassured. Sens. Susan Collins (R-ME) and Patty Murray (D-WA) cited field reports of missed inspections and delayed approvals—concerns Makary did not fully resolve.

When asked how many inspections FDA had missed since the April 1 firings, Makary acknowledged that “some” had been missed but didn’t provide a percentage. He also avoided directly commenting on drug or device facility inspections.

A note on industry risk

Makary’s written testimony included a reminder about the “trigger” mechanism built into the user fee system. If the FDA underspends its congressional budget for medical product reviews, the biopharma and device industries could claw back user fee payments. This could fundamentally disrupt the current user fee framework and adds pressure for the agency to meet its obligations without shortfalls.

Looking forward, Makary also promised more aggressive use of technology, including AI-assisted scientific reviews across the agency by June 30, as part of his broader plan to “operate more efficiently” and deliver faster, more scalable approvals.

“We’re going to be ahead of schedule and under budget on meeting that goal,” he told lawmakers.

In the meantime, one high-profile delay—Stealth BioTherapeutics missing its April PDUFA date for a rare disease treatment—has raised quiet concerns that the agency’s internal strain may be showing in isolated cases.

Now, here’s what our consultants are saying about what they’re actually seeing in the field.

“Some review offices are nominally responsive. Others are totally non-responsive.”

A senior device regulatory consultant and former FDA manager:

“We’ve seen total silence on one Real-Time PMA, despite having status granted months ago and a positive working relationship with the review division. Internally, FDA morale is low—mass layoffs were abrupt, desk-sharing has created chaos at White Oak, and even small administrative processes are in disarray.”

This consultant, who spent more than a decade in senior management at the FDA, describes a concerning internal environment: experienced reviewers departing, infrastructure strain, and a dramatic drop in informal communication efficiency.

“No slowdown at CDER, CDRH, or DMF—timelines are holding.”

A pharmaceutical and device regulatory consultant:

“Based on recent interactions, FDA is getting back to applicants within the expected timeframe. I haven’t observed any delays in drug or device-related communications.”

Not everyone is seeing problems. This regulatory advisor, who works across drugs and devices, reports business-as-usual conditions—even amid broader concerns.

“I’ve not seen inordinate delays.”

A GxP compliance consultant:

“I’ve not directly seen or heard from any company I’m supporting of inordinate delays by FDA.”

“A client expecting expedited review got a one-year PDUFA date.”

A quality and compliance auditor:

“I was auditing a firm earlier this year and the team was shocked to see their submission assigned a 12-month review timeline instead of six—especially given the product’s eligibility for expedited review.”

This anomaly raises questions about how consistently expedited designations are being honored, or whether reviewer availability is impacting prioritization in subtle ways.

“No issues here—inspections and approvals seem unaffected.”

A seasoned medical device compliance consultant:

“So far, I haven’t seen any changes. FDA inspections are proceeding as usual, and approvals are coming through without delay.”

This viewpoint reflects the experiences of some who work heavily in compliance and field-based programs, where timelines appear to be more stable.

“Everything is dragging—especially small business processes.”

A dental device regulatory specialist:

“510(k) reviews are running up to the limit. Small business designation approvals are taking nearly the full 60 days. We’re also seeing increased scrutiny over documentation rights and reviewer questions are getting more granular.”

“Things are moving on the device submission side. Don’t wait—it could backfire.”

A 510(k) submission consultant:

“If your submission is complete and solid, submit now. FDA has mandated timelines it’s still meeting. The bigger risk is waiting with everyone else and contributing to a quiet backlog.

I haven’t seen major 510(k) delays—but I’ve seen companies put themselves at a disadvantage by hesitating.

FDA reviewers don’t have time to guess what your device does. If your materials aren’t crystal clear, they’ll pass over it and move on—or come back with questions that slow you down anyway.

Especially for small companies, the business risk of waiting is real. Delaying could mean lost revenue, delays in getting to market, and getting leapfrogged by competitors who were willing to move forward.”

This consultant, who works primarily on 510(k) submissions and pre-subs, advises moving forward if your submission is ready. He also noted that the most common weak points he sees are unclear device descriptions, shaky substantial equivalence arguments, and inconsistent testing documentation.

Observations from our account team: hesitation, project paralysis, and quiet backlogs

Beyond consultant insights, we’ve been tracking behavior on the client side. Here’s what we’re observing over just the past few weeks: