Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

By Marcelo Trevino, independent expert

Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political, technological, and economic pressures to modernize, deregulate, and restructure regulatory oversight. Under both the Biden and Trump administrations, differing but significant policy directives have reshaped the FDA’s strategic and operational framework, bringing new challenges, risks, and opportunities for stakeholders across the medical device, pharmaceutical, and biotech industries.

Today’s FDA operates at the intersection of rapidly evolving science, political intervention, deregulation mandates, and digital transformation. As the agency embraces new technologies, policy paradigms, and organizational restructuring proposals, regulatory affairs and quality leaders must remain highly agile and forward-thinking. Navigating this evolving landscape has become essential for long-term compliance, risk management, and business sustainability.

Policy Shifts: Gold-Standard Science Meets Regulatory Budgeting

At the core of the FDA’s evolving regulatory philosophy lies its continued commitment to “gold standard science,” a policy focus that reinforces the FDA’s role as a science-driven agency. Regulatory decision-making is grounded in robust empirical evidence, clinical validation, and risk-based evaluation to ensure patient safety and product efficacy. This foundation remains central to the FDA’s public health mission.

However, layered onto this scientific rigor is an increasingly influential regulatory budgeting framework. Under this model, introduced by executive orders across administrations, federal agencies, including the FDA, are required to balance new regulatory burdens against existing ones, often requiring net reductions in regulatory cost or burden. The most ambitious proposals call for agencies to eliminate multiple regulations for every new rule introduced.

This dual mandate creates significant operational complexity. FDA regulatory personnel must conduct not only robust scientific assessments but also detailed economic impact analyses. This dual-layered evaluation often introduces delays in guidance development, rulemaking, and policy advancement. For industries focused on Software as a Medical Device (SaMD), digital therapeutics, AI-driven solutions, and cell and gene therapies – where innovation cycles move rapidly – the mismatch between regulatory science and bureaucratic processes creates significant strategic friction.

The regulatory budgeting model also has reshaped internal FDA resource allocation. Guidance development pipelines are reprioritized, with some guidances delayed or deprioritized indefinitely if they cannot meet the required cost offset thresholds. This leaves companies in emerging drug and technology sectors navigating gaps in regulatory clarity while operating under evolving and sometimes outdated frameworks. For regulatory affairs leaders, proactive intelligence gathering, scenario planning, and early engagement with regulators are critical to navigating this policy environment.

Deregulation And Enforcement Discretion: Strategic Flexibility Or Uncertainty?

Deregulation remains a powerful theme shaping FDA oversight. Executive orders driving broad deregulatory mandates have placed greater emphasis on agency discretion, cost-benefit analysis, and efficiency. The Unified Agenda of Regulatory and Deregulatory Actions continues to signal agency priorities, timelines, and anticipated deregulatory activities.

One of the most heavily used tools within this climate is enforcement discretion – the FDA’s authority to delay, limit, or modify enforcement of certain regulations on a temporary basis. While enforcement discretion offers industries temporary operational flexibility, it simultaneously introduces long-term uncertainty. Companies may delay compliance investments only to face sudden enforcement shifts later. These shifting regulatory sands require RA/QA leaders to view enforcement discretion as a temporary opportunity, not a license to delay compliance readiness. Building robust internal alignment, early implementation strategies, and proactive risk assessments is critical as companies navigate ambiguous regulatory horizons.

The broader deregulation agenda also has led to the rescinding or modification of previously proposed rules and guidances. The withdrawal of the FDA’s Diversity Action Plan Guidance, for example, reflects broader policy shifts away from previously prioritized initiatives, often resulting from evolving public health philosophies or political recalibrations.

A New Paradigm: Policy From The Podium

Under Commissioner Marty Makary’s leadership, the FDA has embraced a notable shift in how regulatory priorities are communicated, sometimes referred to as "policy from the podium." Instead of relying exclusively on Federal Register notices or formal guidance releases, Makary has leveraged media interviews, public forums, podcasts, and industry conferences to unveil regulatory philosophies, enforcement direction, and agency priorities.

While this approach enhances transparency for the public and enables faster agency communication, it introduces new challenges for RA/QA professionals. Informal statements, even when delivered by the commissioner, do not carry binding regulatory authority, yet they often signal imminent policy shifts that can prompt significant corporate adjustments.

Organizations must invest in strengthened regulatory intelligence capabilities that extend beyond monitoring formal agency publications. Active tracking of media statements, conference speeches, industry roundtables, and real-time public communications is now a critical aspect of proactive regulatory strategy. Engagement with trade associations, policy advisory groups, and advocacy organizations also becomes increasingly important to validate interpretations and prepare for impending regulatory shifts.

AI And The FDA: Promise, Performance, And Transparency

Artificial intelligence has become one of the most transformational developments in the FDA’s regulatory practice. The launch of the FDA’s internal AI platform, Elsa, marks a major step toward operational modernization.

Elsa operates as a generative AI platform, deployed across multiple FDA centers, and designed to streamline time-consuming review functions such as protocol reviews, adverse event analyses, label comparisons, and summarization tasks. Hosted in a secure GovCloud environment, Elsa ensures that regulated industry data remains protected and confidential by avoiding any AI training based on industry-submitted data sets.

The agency envisions Elsa as a cornerstone of regulatory efficiency, accelerating the pace of submission reviews, enabling more focused resource deployment, and enhancing consistency across reviewers and departments. Early feedback suggests Elsa has already contributed to faster inspection targeting and submission triage activities.

However, Elsa’s deployment raises profound questions around transparency, auditability, and accountability. Industry stakeholders remain uncertain about the scope of AI involvement in their specific submissions, the extent to which AI-generated assessments influence final decisions, and what avenues exist to challenge or audit AI-generated evaluations. The absence of public guidance outlining these AI governance structures introduces risks of regulatory opacity.

The FDA will need to implement clear AI governance frameworks, disclosure protocols, and third-party oversight to ensure continued public trust and industry confidence in AI-assisted reviews. Companies, in turn, will need to build internal expertise to align submission formats with AI-readability standards, while advocating for appropriate transparency as AI adoption expands.

Financial Leverage: User Fees And Policy Influence

User fees remain a cornerstone of FDA funding, but their strategic role continues to evolve. The FDA’s financial reliance on MDUFA (Medical Device User Fee Amendments), PDUFA, and other industry-paid user fee programs has drawn growing political scrutiny regarding potential conflicts of interest between financial sustainability and regulatory impartiality.

The recent MAHA Report has reignited debates on whether the FDA’s financial models should be decoupled from industry payments to preserve long-term scientific independence. As reauthorization cycles for user fees approach, the potential exists for heightened Congressional intervention or new conditions imposed on fee structures.

Negotiated rulemaking sessions and public hearings scheduled for MDUFA reauthorization represent a pivotal moment for industry engagement. Regulatory leaders must remain actively engaged in these processes to advocate for fee structures that continue to support innovation and public health, while resisting political pressures that could distort the FDA’s scientific mission.

Shifts in user fee structures could also introduce volatility in resource allocation, potentially impacting review timelines, staffing levels, and review quality if funding gaps emerge. Companies must actively monitor these debates as part of their long-term regulatory risk assessments.

Emerging Focus Areas: Advertising, APA Changes, And Pediatric Oversight

Several emerging regulatory domains are rapidly evolving:

1. Direct-to-Consumer Advertising (DTC)
The FDA is evaluating enhanced restrictions on pharmaceutical and device marketing, particularly for off-label communications and pre-approval promotion. Potential reforms may require pre-submission of advertisements, standardized disclaimers, and limitations on scientific claims for unapproved indications. Companies must tighten internal review procedures for promotional materials and anticipate additional regulatory scrutiny.

2. Administrative Procedures Act (APA) Reform
Proposed changes to the APA could shorten comment periods for proposed rules and restrict opportunities for industry engagement. While accelerated rulemaking may facilitate policy responsiveness, it risks reducing stakeholder input on highly technical regulations. Companies should build coalitions through trade organizations to amplify advocacy during compressed consultation timelines.

3. Pediatric Drug and Device Oversight
The FDA is expanding scrutiny around pediatric psychotropic drug approvals and long-term safety monitoring for pediatric populations. Enhanced post-market surveillance, labeling revisions, and stricter clinical trial data requirements are expected to follow. Pediatric innovators should proactively enhance pharmacovigilance systems and real-world evidence collection capabilities to stay ahead of evolving expectations.

FDA Reorganization: Consolidation Or Compromise?

Proposals to consolidate FDA product centers into a single Office of Product Evaluation and Regulation have triggered serious debate across the regulatory community. While positioned as an efficiency initiative, such a sweeping reorganization raises multiple risks:

• Dilution of Specialized Expertise: Highly specialized product centers such as CDRH (devices), CDER (drugs), and CBER (biologics) possess deep scientific and clinical expertise tailored to specific industries. Centralization may erode these competencies, weakening review quality.
• Crisis Response Delays: Integrated review-compliance teams have proven effective in rapid public health responses, such as the Opana ER opioid case. Fragmenting these structures could hamper the FDA’s responsiveness to emerging threats.
• Administrative Complexity: Large-scale reorganization may inadvertently introduce new bureaucratic layers, slowing decision-making and diluting accountability.
• Cultural Disruption: The FDA’s distinct organizational cultures risk destabilization if centralized without sufficient planning or support.

A more balanced reform model would prioritize IT infrastructure modernization, cross-center interoperability, and structured knowledge-sharing without dismantling product-specific scientific specialization.

Commissioner Makary’s Vision: A Smarter, Faster FDA

Commissioner Makary’s modernization agenda presents a bold vision for the FDA’s future, balancing innovation, public trust, and regulatory excellence:

1. Proactive Public Health Oversight: Reemphasizing FDA authority over chronic disease contributors, including nutrition, food dyes, and environmental exposures.
2. Accelerated Access Models: Promoting adaptive trial designs, rolling submissions, and pre-submission engagement to expedite patient access to novel therapies.
3. Accessible Innovation Pathways: Creating clearer regulatory pathways for startups and smaller innovators while preserving robust conflict-of-interest protections.
4. AI Integration and AI Regulation: Deploying AI tools like Elsa for regulatory efficiency while modernizing AI-enabled product approval frameworks.
5. Nutritional and Ingredient Reforms: Pursuing U.S. alignment with global ingredient safety standards and restricting hazardous additives.
6. Data-Driven Oversight: Leveraging real-world data, cloud computing, and advanced analytics for proactive safety surveillance and decision-making.
7. Affordability and Global Access: Supporting global reference pricing, biosimilar development, and streamlined generics access to address healthcare cost disparities.

Makary’s vision reflects a modernized, technologically enabled FDA, positioning the agency as an active public health partner while safeguarding scientific independence and regulatory integrity.

Commissioner’s National Priority Voucher Program: Accelerating Reviews Aligned With Public Health Priorities

The FDA has launched the Commissioner’s National Priority Voucher (CNPV) program, a strategic initiative designed to accelerate the review of drug applications that align with specific public health priorities. Although promoted as a new mechanism, the CNPV program largely repackages features from existing expedited pathways such as the Real-Time Oncology Review (RTOR), Split Real Time Application Review (STAR), and the Coronavirus Treatment Acceleration Program (CTAP). Selected companies — not individual products — may receive vouchers granting a significantly shortened one- to two-month review timeline. To qualify, applications must support national priorities such as addressing U.S. health crises, unmet medical needs, innovative cures, or increasing domestic drug manufacturing of critical medicines.

The program emphasizes early submission of key sections like chemistry, manufacturing, and controls (CMC) and proactive engagement between sponsors and the agency, requiring sponsors to maintain rapid response capabilities throughout the review process. While the approach aims to reduce FDA “review days” by front-loading assessments, concerns have been raised about the lack of objective criteria for awarding vouchers and the potential for perceived subjectivity. Additionally, limitations may apply to complex products, such as those requiring Risk Evaluation and Mitigation Strategies (REMS) or novel therapies unfamiliar to reviewers.

Ultimately, the CNPV program reflects Commissioner Makary’s push to align regulatory incentives with national health strategy, increase review efficiency, and avoid the need for new Congressional authority, by building on proven frameworks already familiar to industry stakeholders.

Conclusion: Navigating Complexity, The Leadership Imperative

The FDA stands at one of the most consequential inflection points in its history — where accelerating innovation, shifting political agendas, deregulation pressures, emerging technologies, and evolving public health priorities converge. For regulatory affairs and quality leaders, this environment demands far more than technical compliance. It requires a strategic leadership mindset that anticipates disruption, navigates ambiguity, and transforms regulatory uncertainty into opportunity. To succeed in this evolving landscape, organizations must:

• Continuously monitor both formal policy actions and informal political signals that increasingly shape FDA direction.
• Embed adaptive regulatory strategies capable of responding quickly to evolving agency priorities, guidances, and enforcement discretion windows.
• Strengthen participation in policy development through active engagement in comment periods, industry associations, public workshops, and collaborative advocacy.
• Elevate regulatory intelligence functions with advanced analytics, horizon scanning, and proactive risk assessments.
• Invest deeply in technical and scientific expertise to maintain product-specific excellence amid any potential FDA structural realignments.
• Leverage opportunities in digital transformation, from AI-enabled submissions to real-world evidence generation to align with the FDA’s own modernization trajectory.

Ultimately, while regulatory complexity may be intensifying, so too is the opportunity for companies that proactively engage, modernize their compliance systems, and align strategically with the FDA’s evolving vision. In this new era, regulatory affairs and quality professionals are enterprisewide business partners, risk navigators, and drivers of innovation. Those who lead with foresight and agility will help define the next generation of healthcare innovation and regulatory excellence.

About The Author:

Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.