In early 2025, the U.S. Department of Health and Human Services eliminated more than 15,200 jobs across agencies, including the FDA, CDC, and NIH, as part of the Trump administration’s effort to reduce the federal workforce.
While the effects are being felt government-wide, the FDA’s role as a gatekeeper for medical products makes the impact especially acute for the life sciences sector, introducing new pressures into the regulatory environment.
As review capacity tightens and timelines come into question, companies will need to adapt their strategies accordingly. What follows is a closer look at how these changes are unfolding and what they mean for drug and device developers in the months and years ahead.
Scope of the layoffs at the FDA
Layoffs at the FDA included as many as 3,500 full-time positions, cutting across critical functions, from policy staff who draft guidance and regulations, to project managers who coordinate review and communicate with industry, to scientists and communications teams who support regulatory standards and public outreach.
The cuts also reached personnel responsible for reviewing drug and medical device submissions, including staff funded through industry-paid user fees. While these fees were established to support timely reviews, the removal of fee-funded staff raises concerns about the sustainability of this model and the agency’s capacity to meet user fee performance goals.
Initial attempts to rehire affected employees were followed by further administrative changes that reversed some of those rehirings, compounding operational uncertainty both inside the agency and across the life sciences sector.
Early signs of regulatory slowdowns
While the FDA hasn’t formally revised its review targets, recent data suggests a slowdown in medical device approvals for high-risk and novel devices. Applications are rising, but decisions aren’t keeping pace.
For example, between January and mid-June 2025, the FDA issued only 11 De Novo classification decisions, compared to 22 during the same period in 2024, a 50% drop that underscores mounting delays in lower-risk device evaluations.
Higher-risk hardware typically undergoes a more rigorous premarket approval (PMA) process. So far in 2025, the FDA has granted eight original PMA approvals, down from 12 over the same period last year.
FDA approvals & clearances for medical devices: De Novo, PMA, and HDE
Fig. 1 – Number of FDA market authorization decisions for novel medical devices from January 1 to June 12 in 2024 and 2025, including De Novo classification requests, original Premarket approvals (PMAs), and original Humanitarian Device Exemptions (HDEs). Source: Definitive Healthcare analysis of FDA Medical Device Databases. *Partial-year data through June 12.
In the agency’s drug review division, several target action dates have slipped. The FDA did not meet its April 1 deadline to decide on full approval of Nuvaxovid, Novavax’s protein-based COVID-19 vaccine. Although the agency ultimately approved the shot in May, the label was narrower than requested.
Other recent delays include GSK’s application to expand Nucala into chronic obstructive pulmonary disease, as well as Stealth BioTherapeutics’ investigational therapy elamipretide for Barth syndrome. In the latter case, the FDA notified the company on the April 29 decision date that it would not meet the target and ultimately rejected the therapy in late May, prompting Stealth Bio to cut 30% of its staff to save cash for resubmission.
Taken together, the delays point to slower throughput and a regulatory environment that’s becoming less predictable, raising planning challenges for companies approaching development and launch milestones.
User fees program faces growing uncertainty
A key piece of the FDA’s regulatory machinery is the user fee program, funding nearly half of the FDA’s overall budget and about 70% of its drug review budget through programs like PDUFA. These fees, paid by pharmaceutical and device companies, are meant to ensure timely reviews of new products.
But the system relies on a balance: User fees are only fully accessible if Congress provides a baseline level of funding through annual appropriations. If that threshold isn’t met, the FDA could lose access to the remaining user fee funds.
Ongoing contract terminations, layoffs, and voluntary departures have raised internal concern that one or more of the FDA’s drug and device user fee programs could breach that threshold before the end of the fiscal year.
The loss of the agency’s senior staff, including negotiators for the 2027 user fee reauthorization, adds to the strain. Some preparatory meetings with industry groups have already been canceled amid the downsizing.
Since these programs must be reauthorized by Congress every five years, any disruption could impact the FDA’s operational budget and, by extension, the pace and consistency of product reviews in the years ahead.
Implications for life science companies
The full impact of the FDA’s staffing changes is still playing out, but early signs point to a resource-constrained regulatory environment and slower reviews. Companies should expect uneven impacts depending on submission type, therapeutic area, and regulatory complexity. What companies may see:
- Extended review timelines for NDAs, BLAs, and PMAs, particularly for novel or first-in-class products.
- Increased variability in regulatory interactions and enforcement activity, as remaining staff are stretched across growing caseloads.
- Reduced agency guidance and feedback, with fewer updates on applications and slower issuance of new regulatory guidelines.
- Delays in market entry, which could shift commercialization strategies, affect launch timing, and impact access to reimbursement.
The companies that come out ahead will be those that anticipate challenges, move decisively, and plan for disruption in the regulatory landscape.
Strategic planning in a shifting regulatory landscape
Here's how medical device and drug developers can proactively respond to the current regulatory slowdown and build resilience into their development timelines. Key imperatives for the months and years ahead include:
Build timeline flexibility into development plans
Extended review timelines, even if not formally communicated, are likely. Firms with near-term PDUFA, MDUFA, or key submission dates should model alternative approval timelines and consider how delays could impact financing, partnerships, and launch plans.
Why it matters: Unexpected regulatory delays can disrupt commercial strategies and funding milestones. Early modeling allows teams to adapt without derailing broader business objectives.
Anticipate and adapt to market shifts
Approval delays can lead to missed market windows. First-mover advantages may diminish, reimbursement policies could change, and competitors might gain ground by bypassing FDA bottlenecks.
Why it matters: Anticipating market shifts helps companies protect competitive positioning and recalibrate commercialization strategies to evolving conditions.
Manage capital and resources strategically
Regulatory delays should now be a part of capital planning. Companies may need to extend cash runways, raise additional funds, or adjust development milestones to reflect a slower regulatory cadence. This is particularly relevant for early-stage biotech firms and startups reliant on capital tied to clinical and regulatory progress, while larger pharma organizations with diversified portfolios may absorb delays more easily.
Why it matters: Maintaining operational continuity through regulatory slowdowns requires deliberate financial planning. Without it, companies risk falling short on funding at critical moments.
Reprioritize portfolios based on complexity
Assets with high regulatory complexity may face more friction. Companies should evaluate whether current risk-reward profiles still align with revised development timelines.
Why it matters: Prioritizing programs with clearer pathways or with flexibility to navigate longer review cycles can help manage risk.
Strengthen pre-submission dossiers
As mid-review and pre-submission meetings are increasingly canceled or reduced to written responses, companies must ensure their documentation is as clear and self-contained as possible. That means comprehensive clinical data summaries, well-supported risk analyses, and clear justifications for safety and efficacy.
Why it matters: In a slower, more limited regulatory environment, incomplete filings and avoidable errors carry greater consequences. With fewer opportunities for direct dialogue and real-time clarification, making a complete and precise initial submission is more important than ever.
Diversify regulatory pathways
Consider pursuing approvals or clearances outside the U.S. in parallel. The European CE Mark process, Health Canada, Australia’s TGA, and Japan’s PMDA may offer more predictable timelines or better alignment with certain therapies and technologies.
Why it matters: Reducing reliance on a single regulatory pathway can mitigate launch risk and demonstrate global traction to investors or partners.
Communicate transparently with stakeholders
Delays and shifting expectations can unsettle investors and partners. Communicate proactively with investors, board members, and commercial partners about the evolving FDA situation. Setting expectations early and backing them up with contingency planning can help preserve confidence during uncertainty.
Why it matters: Proactive communication protects credibility and supports continued access to capital and strategic alignment. Transparency reduces the risk of over-promising and under-delivering.
Monitor FDA communication channels closely
Stay current with FDA communications, Federal Register updates, CDRH guidance documents, and industry alerts. Regulatory consultants can help track review division backlogs and emerging patterns.
Why it matters: Understanding shifting priorities within the FDA can inform strategic decision-making.
Engage regulators early and often
Maintaining open lines of communication remains critical. Early and consistent engagement, both directly with the agency and through internal or external regulatory experts, can help clarify shifting expectations and reduce the risk of delays. Advisors with FDA experience can be valuable for interpreting feedback and anticipating emerging issues.
Why it matters: With submission standards rising and timelines less predictable, expert guidance and early regulatory engagement can help navigate moving targets.
Work together to support FDA rebuilding
This isn’t a challenge any one company can solve alone. Industry groups and advocacy organizations can play an important role in keeping attention on the FDA’s staffing issues, pushing for long-term solutions, and helping create a path for reauthorization of user fee programs.
Why it matters: Staying engaged with policymakers and regulators now can help shape efforts to rebuild the agency and keep the approval system moving.
Make smarter moves in the regulatory landscape
In today’s changing healthcare environment, having a clear view of the landscape is more critical than ever, from the people delivering care to the data behind where and how that care happens.
That’s where Definitive Healthcare comes in. Our healthcare data and analytics give pharma and medical device companies insights into treatment trends, key opinion leaders, strategic opportunities, and much more. Start your free trial today.
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