Key Points
- Drug developers face new regulatory uncertainty because the status of a number of ambitious changes to FDA’s review processes are in doubt following the departure of Commissioner Marty Makary and many of his senior managers.
- Makary had favored informal policy changes without formal rulemaking and lengthy notice and comment procedures. As a result, his initiatives could easily be revised or reversed under a successor or a new administration.
- Programs with uncertain fates include Makary’s priority voucher system to expedite reviews for products in some categories, a reduction in the number of studies required for drug approvals, shortened plant inspections and real-time clinical data reporting.
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The resignation of Food and Drug Administration (FDA) Commissioner Marty Makary on May 12, 2026, and the cascade of senior departures that followed, have created more regulatory uncertainty surrounding the agency. Many of the initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press release, podcast or at public events.
With their principal champions now gone, FDA-regulated companies are asking what will happen to these programs, as well as what the overall tenor of the agency will be under new leadership.
The Policy Durability Problem: ‘Podium Policy’ and Its Limits
Makary made extensive use of what is known as “podium policy”: announcing significant regulatory changes through informal channels rather than through the formal notice-and-comment rulemaking process. Where FDA once channeled its most consequential shifts through Federal Register notices, formal guidance documents and rulemaking, the Makary FDA made many major policy pronouncements via press releases, journal articles, podcasts and social media.
The practical consequence is significant: Policies adopted outside of formal pathways are more vulnerable to reversal by future administrations and less likely to withstand judicial scrutiny. Without an administrative record, the durability of these policy changes is uncertain.
With Makary’s departure and the exit of nearly all of his senior deputies, these informal initiatives carry a heightened risk of reversal or legal challenge, a factor that regulated companies may wish to weigh in their regulatory planning.
Makary Programs That May Change Under New Leadership
National Priority Voucher (NPV) Program
The NPV pilot program (formerly the CNPV program, but the “Commissioner’s” designation dropped after Makary’s resignation), launched in June 2025, offers expedited one- to two-month reviews for selected drug products aligned with five national health priorities. The program has awarded 22 vouchers to date and approved seven designated products.
However, nearly every seat on the NPV review council is now either held by an acting official or vacant, including the positions of principal deputy commissioner as well as chief medical and science officer. The five national health priorities could be redefined entirely, or a new commissioner may decide that the program is not an appropriate use of agency resources and disband it.
It appears unlikely that products already selected for the program will not get the benefits bestowed, but FDA may eventually choose not to award more vouchers or rely on existing expedited pilots that were negotiated with industry under user-fee programs.
Single Clinical Trial Standard
In February 2026, Makary announced in a two-page New England Journal of Medicine article his decision to make a single pivotal trial the default evidence standard for most drug approvals, a change that upended decades of regulatory precedent. This announcement was not accompanied by formal guidance or rulemaking.
With Makary gone and the co-author of that article — Vinay Prasad, former director of FDA’s Center for Biologics Evaluation and Research — also departed, this initiative has lost its two most prominent advocates.
It was already unclear when this approach could be used and when two trials would still be expected for approval. It is now possible that FDA will revert to requiring two trials in most cases, with exceptions for qualifying programs. Given this uncertainty, a formal meeting request to obtain agency agreement on development plans remains the most reliable path for companies seeking drug approvals.
One-Day Inspection Pilot
During what turned out to be his final public appearance on May 6, 2026, Makary announced a pilot program allowing abbreviated, one-day “screening inspections” at manufacturing facilities identified as low-risk. FDA recently indicated that 46 one-day assessments had already been completed and that the program would continue through fiscal year 2026.
The agency has provided limited information on how facilities are assessed for the low-risk classification beyond saying that FDA is using artificial intelligence (AI) to do so.
Real-Time Clinical Trials (RTCT) Initiative
The RTCT initiative, involving real-time reporting of clinical data signals to FDA during ongoing trials, was announced in late April 2026 and was still nascent at Makary’s departure. It also was only described in a press release and an agency request for information. Who will lead the initiative, and whether it will retain institutional support, is unknown.
As with most of Makary’s ambitious agenda, the initiative likely will be implemented in some form, but current program materials are best read as indicative rather than authoritative.
Integration of AI Into FDA Processes
Now that FDA’s first and only chief AI officer has departed, it is unclear how integrating AI tools into FDA processes, including the RTCT initiative and traditional application reviews, will proceed. FDA likely is still interested in adopting AI, but the timeline, scope and practical expectations for the industry are less certain.
Companies have begun moving to AI-enabled regulatory tools in anticipation of FDA using similar products, which is likely still a valid strategy. But FDA’s AI revolution may be slower than previously thought.
Acting Commissioner and White House/HHS Influence
Kyle Diamantas, formerly deputy commissioner for human foods and one of the few commissioners to not hold an M.D. (Diamantas is a lawyer by training), is now acting FDA commissioner.
He is closely tied to the current administration, so the Department of Health and Human Services (HHS) and the White House are unlikely to disengage from FDA policy. Any FDA initiatives with political salience, including those touching on abortion medication, vaccine policy and drug pricing, are likely to attract heightened administration scrutiny. However, Diamantas has pledged to minimize political interference at FDA and listen to career scientists.
Thus far, there has been a stabilizing dimension to the current transition. Many of the officials who have departed were more tied to Makary’s informal policy agenda than to the agency’s traditional scientific review processes, and Diamantas has received positive feedback from current and former staff with respect to how he handles issues as well as his level of thoughtfulness and preparedness.
Diamantas has signaled a deliberate intent to reorient FDA around its career scientific workforce. Especially for companies with development programs in the rare disease and vaccine spaces — areas that were the focus of extreme deviations from the normal scientific practice under Makary — the reemergence of a more stable and science-driven regulatory partner may be a welcome change.
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.