FDA in Flux — June 2026 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

High Flux: Leadership Transformation Across FDA Resolves Some Uncertainties but Presents New Questions

After the widescale firings and instability of 2025, FDA has experienced an unprecedented rate of leadership turnover since the beginning of 2026. 

• The last couple of months alone have seen the departure of Vinay Prasad as Director of CBER (April 2026), Marty Makary as FDA Commissioner (May 2026), Tracy Beth Hoeg as Acting Director of CDER (May 2026), and Jeremy Walsh as Chief AI Officer (May 2026) — the latter a newly created position that now seems rudderless. Today the agency has an Acting Commissioner (Kyle Diamantas) and Acting Directors of CDER (Michael Davis), CBER (Karim Mikhail), the Human Foods Program (Don Prater), and the Center for Tobacco Products (Bret Koplow).
• There also are a large number of acting or vacant Office Director and Deputy Director positions throughout the Centers and within the Office of Inspection and Investigation (OII), which leads inspections and law enforcement activities on the ground and manages industry recalls. OII itself is led by an agency veteran, Associate Commissioner Elizabeth Miller.
• The Center for Devices remains steady under the dedicated leadership of Director Michelle Tarver. 

The recent leadership changes coincided with an immediate shift in the agency’s tone toward more carefully measured statements about current and developing programs. This may be related to the Acting Commissioner’s background as an attorney rather than a surgeon like Dr. Makary; these two men almost certainly have completely different risk tolerances. Mr. Diamantas also appears less interested in being in the spotlight and taking credit for all agency developments. Whereas agency press releases from April 2025 to April 2026 generally would include at least one statement from former Commissioner Makary, more recent announcements feature quotes from a wider range of agency leadership. The volume of announcements from the FDA newsroom has also noticeably declined since mid-May. 

Further, more recent actions by FDA’s leadership show some pullback from Dr. Makary’s pedal-to-the-metal approach to implementing new initiatives and pilot programs, which created a constantly shifting regulatory landscape for the drug and biologic industries. For instance, the former Commissioner’s race to develop multiple reforms to Phase 1 clinical trials, including real-time clinical trials (a topic in our May 2026 edition), appears to be on a longer timeline under the new leadership, as evidenced by FDA’s decision to extend the comment period on a pilot program to optimize early-stage clinical trials through the use of AI. 

A move back toward deliberate and evidence-based regulatory decision making, along with some procedural norms such as advisory committee meetings, should be welcome news to industry stakeholders. At the same time, however, FDA’s acting leadership is significantly different in terms of experience and credentials compared with previous administrations. Significant vacancies throughout leadership and line positions at the agency, coupled with the reduction of experience/institutional knowledge due to the dismissal and departure of many long-term career officials over the past 18 months, will continue to pose challenges for FDA. There are bound to be many uncertainties going forward about the new Acting Commissioner’s and Center Directors' approaches to ongoing and future agency initiatives and priorities. 

Where Some of Makary’s Initiatives Stand Now that He Is No Longer Commissioner

This June 2026 edition happens to be the first anniversary of FDA in Flux, which we launched last year in response to the rapid changes Commissioner Marty Makary was overseeing across all functions of the agency, from medical products to food, tobacco, and cosmetics, from reviewing applications to altering safety surveillance systems. In just over 13 months as FDA Commissioner, Dr. Makary initiated and drove forward significant new policies and programs, especially in the drug and biological product space. In some cases, he did so without adhering to typical procedural norms or legal requirements, potentially creating risks for FDA, while in others he worked more clearly within the scope of his/the agency’s authorities (such as when he kicked off the consolidation of multiple adverse event report databases into a single user interface). It is probably safe to say that everyone will have their own views of the positives and negatives when it comes to Dr. Makary’s tenure atop our beloved agency. 

So, ironically perhaps, this anniversary edition also happens to coincide with the shake-up in FDA leadership and the corresponding changes to “tone and tenor” from the top. As the dust begins to settle following the former Commissioner’s abrupt resignation in mid-May, we thought it could be helpful to review some of the major initiatives he spearheaded and to consider where they started, where they are now, and where they might be going.

Commissioner’s National Priority Voucher (CNPV) Pilot Program

The CNPV was one of Dr. Makary’s earliest creations, originally announced in June 2025 and rolled out to drug developers exceptionally quickly in the subsequent months. At the time of its initial reveal, the agency indicated that it would give a “limited number of vouchers to companies aligned with US national priorities” — suggesting that number would likely be five. Since then, at least 22 vouchers have been awarded; an internal procedural guidance document for FDA staff on the program was not issued until January 2026, further contributing to the overall confusion associated with the CNPV pilot program. 

Due to these and other unusual features, stakeholders continue to request additional clarity and transparency with respect to product eligibility and all procedural aspects of the CNPV program, including at a June 4 public hearing where agency officials participated in “listening mode” only. At the same time, some members of Congress continue to strongly criticize the program as being rife with conflicts of interest and political interference, with apparently little engagement from former Commissioner Makary’s office in response to congressional inquiries. 

Whether new agency leadership makes material changes to the program remains to be seen as the public hearing took place very recently and written comments continue to be accepted. Post–Makary’s departure, public reporting suggested that the program’s name was changed to merely “National Priority Voucher,” but FDA’s online information does not yet reflect such a name change nor did agency remarks at the brief June 4 hearing. 

Interested parties may submit written comments on the CNPV program through June 29, 2026 (Docket No. FDA-2026-N-2366). 

Clinical Trial and IRB Process Reforms

As mentioned above, Dr. Makary’s tenure was marked by consistent statements regarding the need to reform both FDA’s procedures for regulating clinical trials, especially early-stage and first-in-human trials, and the country’s institutional review board (IRB) system for overseeing human research. Just before his resignation, Makary and former Chief AI Officer Jeremy Walsh had announced an aggressive push for a “real-time clinical trial” (RTCT) pilot program. Stakeholders had many questions about the former leaders’ ideas, some of which were answered during an Industry Day virtual presentation on RTCTs. 

Perhaps in recognition of the fact that the primary architects of this pilot program are no longer at FDA and that obtaining more stakeholder feedback may prove to be valuable to, at a minimum, provide needed systemic buy-in, the agency recently extended the comment period on this initiative to June 29, 2026 (Docket No. FDA-2026-N-4390). 

But because the original deadline for public comments was May 29 and the extension came at the eleventh hour, many stakeholders have already submitted their thoughts on the topic of AI-enabled early-phase clinical trials. Our review of the comments submitted to date indicate that in general, stakeholders broadly support the initiative, including RTCTs, but only with robust guardrails to protect procedural rigor (especially with respect to safety) and minimize harmful biases.

Separately from the RTCT initiative, changes may be brewing for FDA’s long-standing investigational new drug (IND) regulations and procedures for reviewing and authorizing initial INDs — with or without Dr. Makary in the Commissioner’s office. As of June 3, the White House Office of Management and Budget (OMB) is considering a request for information submitted by FDA that is apparently related to an “expedited” IND pilot program; interested stakeholders can meet with OMB to share their views while this review is pending. At some point in the future, if cleared by OMB, the public will see the agency’s proposal and the scope of this new RFI. 

At the legislative level, Congressman Jake Auchincloss is collecting input on a discussion draft of a bill that would make changes to FDA’s authorities for Phase 1 trials as well as more extensive reforms across the clinical research ecosystem (see here). Representative Auchincloss’s office is accepting comments on the discussion draft though June 30. 

Accelerating the Adoption of New Approach Methodologies 

Concerns about an over-reliance on animals to conduct nonclinical research have existed in the national psyche for decades, and the emergence of complex in silico modeling platforms and other technologies has reignited debates about whether the biomedical industry needs to sacrifice as many rodents, rabbits, dogs, pigs, and primates (etc.) as it has historically, given rapidly evolving scientific frameworks. International harmonization activities to reduce duplicative animal testing are underway; Congress also made its desires known in December 2022 when it amended FDA’s two governing statutes to remove language that required animal study results to be included in new drug and biologic marketing applications.

Within days of assuming the agency’s top job in April 2025, Dr. Makary announced the release of a “roadmap” to reduce animal testing, which kicked off with monoclonal antibody products and encouraged the inclusion of data from new approach methodologies (NAMs) in investigational new drug applications. He also emphasized these initiatives frequently in public appearances and remarks, highlighting their importance to his broader plans to modernize the agency’s historical approach to assessing the potential safety of experimental therapies. Makary also touted progress in the space with an April 2026 “year one progress” report that can be found here.

In more recent months and in alignment with the roadmap, FDA has released multiple guidance documents addressing various aspects of how to incorporate NAMs into the drug development process and limit reliance on animal studies. These include a March 2026 draft guidance on “General Considerations for the Use of New Approach Methodologies in Drug Development” and one led by the Oncology Center of Excellence called “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products” released on May 29 (the latter with an open comment period until July 30). 

At the same time, transitioning toward NAMs exclusively presents certain challenges that stakeholders have repeatedly pointed out; for example, multiple comments on the draft guidance from March request more clarity on how to validate and qualify novel NAMs for specific uses, editorials (e.g., see this one and also points made here) highlight emerging research areas that may suffer if animals are phased out too quickly, and at least one company has sued FDA for requiring long-term animal toxicity data after the company had submitted non-animal data it considered sufficient to characterize potential risks.

Although it may take some time for animal studies to be phased out, the congressional mandate driving both FDA and industry to further integrate NAMs into drug and biological product development and the scientific complexity associated with such a fundamental paradigm shift ensure that these issues will remain a high priority for the agency in a post-Makary environment. 

Agency Implements Another December 2022 Congressional Mandate via Expanded Industry Guidance 

What is happening: In addition to adjusting FDA’s authorities to make clear that animal data for investigational therapies should be optional rather than required, the December 2022 omnibus legislation known as the Food and Drug Omnibus Reform Act (FDORA) amended the FD&C Act to ensure that the ability to share health care economic information (HCEI) about approved products with payors and other sophisticated entities extended to medical device developers. It also created an explicit safe harbor for drug and device developers to discuss certain information about unapproved medical products with those audiences, codified at 21 U.S.C. § 352(gg).

FDA recently released a revised draft guidance on payor communications that will replace an older document that predated FDORA’s changes to the relevant provisions in the law; comments are being accepted through August 3, 2026 at this docket. 

Why it matters: The revised guidance takes into account the various statutory amendments from FDORA and now discusses the scope of the government’s HCEI policies across the board for “medical products” rather than distinguishing separate legal frameworks for drugs and devices. It also outlines how companies can comply with the terms of the Section 352(gg) safe harbor when communicating with payors, formulary committees, and other such entities about an investigational drug or device (or about unapproved uses for an authorized product). Among other things, companies are required to include prominent disclosures about the unapproved nature of the product/use that is being presented to payors and to affirmatively provide updated information to those audiences if what was previously shared becomes “materially outdated.” 

These guidance updates should provide more certainty and comfort to the industry when engaging in certain types of payor communications, as we speculated at the time of FDORA’s enactment. Compared with previous vague assurances of enforcement discretion, FDA’s explicit acknowledgement of the new language codified into the FD&C Act provides a much stronger foundation for building a compliant communication program. Moreover, in a political environment hyper-focused on the price of health care, it may be a savvy move on FDA’s part to give medical product companies more confidence in structuring their product-specific outreach to payors and formulary committees.

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