You Don’t Know What You’ve Got ’til It’s Gone: Regulatory Strategy for a Strained FDA

By Nathan Downing

The U.S. Food and Drug Administration went through rapid staffing changes in early 2025. That is old news. But the downstream effects industry is feeling today continue to be noteworthy. They have real consequences, not just for industry, but for the patients we serve.

The layoffs were a shock to many at FDA and in industry alike. After seeing some of the impacts, the government started to rehire employees to restore lost capabilities. While that is a positive sign, rebuilding to full capacity has been challenging. FDA continues to promote its job vacancies as it seeks qualified candidates even as the upheaval of the past year and a half may give some prospective applicants pause.

What’s the Damage? FDA Staffing, Review Delays, and Deficiencies

Regulatory requirements have not been lifted or reduced, nor should they be, and a robust agency is essential for bringing medical products to market. But FDA’s own workforce data show that rebuilding the agency remains a substantial undertaking. GAO reported in late 2025 that FDA acknowledged staffing constraints affecting medical-device recall oversight, and CDRH itself said in its 2025 annual report that one of its 2026 priorities was strengthening its resilience to "staffing changes." At the beginning of FY2025, the Center for Drug Evaluation and Research had 6,044 employees and the Center for Biologics Evaluation and Research had 1,373. As of June 30, 2026, those figures stood at 4,895 and 1,095, respectively, even as hiring began to accelerate. 

Those numbers have implications for regulatory capacity, and the staffing changes have also drawn congressional attention. At a July 2026 House Energy and Commerce hearing on biomedical innovation, Thomas Bollyky of the Council on Foreign Relations testified FDA staffing remained below 2025 levels despite renewed hiring and that the agency had lost experience and expertise. Other testimony at the hearing highlighted inconsistency and unpredictability in FDA review as additional sources of uncertainty and delay. Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, reported similar concerns from stakeholder convenings, including sponsors losing months trying to determine FDA expectations, differences in evidentiary expectations among review divisions, and the need for greater access to FDA and earlier engagement.

FDA remains subject to timing commitments under programs such as MDUFA and PDUFA. Those commitments establish decision dates, not approval dates, which can create problems when FDA does not have the time to adequately evaluate a submission. In such circumstances, as FDA incorporates artificial intelligence into its review processes, clear and well-organized submissions become increasingly important. Recently, some review interactions have resulted in more extensive deficiency requests, including questions whose answers are already included in the submission itself. A lack of time and human touch has resulted in unclear deficiencies that are either difficult to address or already addressed through provided data. We have seen simple meeting minutes take months to finalize, review teams acknowledge they do not have the time for a full review, and simple pre-submissions result in numerous poorly defined comments that make a meaningful conversation difficult. 

Medical products are complex, and consistent communication is a key to FDA understanding them and to industry relaying their stories. Fewer touch points lead to misunderstandings, unnecessary mistakes, and delays. Those delays not only hurt industry, but also impact the very patients the system is designed to benefit.

Added time and resource demands hurt companies of all sizes but disproportionately impact smaller entities without the capital to withstand delays. That pressure will limit innovation and push industry to weigh product optimization against limiting product complexity in exchange for greater regulatory predictability. We are seeing these conversations play out in practice all the time. 

“When FDA lacks the capacity for meaningful review and communication, companies do not just lose time. They burn resources, face harder decisions about product development, and may have to choose regulatory predictability over innovation. Ultimately, those consequences can reach the patients waiting for better products.”

Nathan Downing, Managing Attorney

At the same time, FDA continues to meet many of its statutory and user-fee commitments, and staffing pressures do not affect every center, review division, or submission in the same way.

A Long Road Ahead: Regulatory Strategy for a Resource-Constrained FDA

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. Getting FDA back to full capacity may take months or years. Companies should continue to utilize all channels of communication as much as possible and continue partnering with FDA. The dilemma is not a result of apathy, but a lack of hours.

Companies also need to understand how to write for AI-assisted review software by clearly identifying each requirement and the information that addresses it. Clear, well-organized submissions are increasingly important as FDA experiments with AI-assisted review. Some companies are using their own AI tools to test submissions and tailoring their writing to both human and artificial audiences. Writing for both a human and computer audience, while making use of available tools, is becoming an imperative.

Industry must also approach FDA interactions with an eye toward preserving the record for a potential appeal. Records should be bolstered with all applicable information regarding the law and the applicable facts. If an erroneous decision is made and FDA does not have the time to adequately address it, an appeal may be the better path forward rather than a new submission. Companies should continue to rely on FDA’s treatment of similar devices and least burdensome principles, with a focus on the standards applicable to them. When pressed, the best response is fully understanding your rights and being prepared to assert them.

Hopefully, FDA is able to address its hiring and resourcing needs so we can return to a more predictable regulatory environment, with the agency working with industry to address public health. In the meantime, speak with your industry contacts, involve yourself in feedback on issues such as the current MDUFA process, and know your rights. 

How Gardner Law Can Help

FDA is operating under unusual staffing and technological conditions, and companies may need to update how they prepare submissions, communicate with review teams, and evaluate escalation. Gardner Law can help companies develop and implement regulatory strategies that account for these conditions while keeping the focus on the applicable science, evidence, and legal standards. Science continues to progress, expanding the clinical possibilities for patients, and the regulatory landscape needs to keep pace.