This is the most consequential FDA leadership story since Makary took office. On Friday afternoon, the Wall Street Journal reported that President Trump was planning to fire FDA Commissioner Marty Makary. Bloomberg, Reuters, STAT, and Politico confirmed with their own sourcing within hours. Reuters reported that two White House advisers said the decision was “not final,” while a third source close to the White House said the commissioner “is done” and Trump “signed off.” Makary has served approximately 14 months after being confirmed in March 2025. Whatever you think of his tenure, Makary moved fast. The CNPV program approved Foundayo in 50 days, followed by Otarmeni and Bizengri. The Expedited IND pathway proposed in the FY2027 budget could reshape Phase 1 access. The Real-Time Clinical Trial initiative launched with AstraZeneca and Amgen. Psychedelic CNPVs were issued. The RP1 rejection signaled a higher bar for single-arm oncology studies. All of these decisions were driven by Makary’s office. His departure raises immediate questions: does the CNPV program continue? Does the Expedited IND pathway survive without its champion? Does the RTCT pilot proceed this summer? The triggers for Makary’s ouster were reportedly political, not pharmaceutical—but the industry’s regulatory initiatives may be the casualty.
Top Story: Trump Approved a Plan to Fire FDA Commissioner Makary
What Happened: On Friday May 8 at approximately 3:30 PM ET, the Wall Street Journal reported that President Trump was planning to fire FDA Commissioner Marty Makary. Bloomberg, Reuters, STAT, and Politico confirmed with their own sourcing within hours. Reuters reported that two White House advisers said the decision was “not final,” while a third source close to the White House said the commissioner “is done” and Trump “signed off.”
The Political Triggers
STAT reported that Makary’s tenure had been “tumultuous, marked by personnel drama, departures of longtime staff, and controversy over political pressure impeding the FDA’s scientific process.” Two specific issues appear to have precipitated the decision.
Flavored e-cigarettes: Trump reportedly rebuked Makary over the weekend of May 2 to 3 for not approving flavored e-cigarettes quickly enough. This was a product category Trump pledged to protect during the 2024 campaign. The conflict reflects the tension between the FDA’s public health mission and the political priorities of the administration it serves.
Mifepristone: Makary’s handling of mifepristone angered anti-abortion groups and some Republican lawmakers, who felt he was “slow-walking” the FDA’s own safety review of the drug. The FDA has been conducting a REMS review of mifepristone since July 2025 and has not yet issued a determination.
Neither trigger is related to pharmaceutical drug development policy. The irony is sharp: Makary may be removed for political reasons while his most significant pharmaceutical initiatives—the CNPV, the Expedited IND, the RTCT—were generating widespread industry support and bipartisan interest.
The Succession Picture
The White House is considering naming Kyle Diamantas, currently FDA Deputy Commissioner heading the food group, as acting commissioner. Potential nominees for the permanent role include Stephen Hahn (FDA commissioner 2019 to 2021, oversaw COVID vaccine emergency use authorizations) and Brett Giroir (former acting commissioner and assistant HHS secretary).
The agency is already operating with significant leadership gaps. Both CDER divisions are headed by acting directors. Tracy Beth Høeg is acting director of CDER. Former FDA Chief Scientist Jesse Goodman said there is “a vacuum that has created a lot of gaps in expertise and experience.”
The choice of acting commissioner matters enormously for the near term. Diamantas runs the food group and has no known track record on drug development policy. His appointment would likely mean a holding pattern on drug-side regulatory initiatives while the White House identifies a permanent nominee. A permanent commissioner requires Senate confirmation, which could take months—months during which the CNPV program, the Expedited IND, and the RTCT pilot would operate without their institutional champion.
What Makary Built in 14 Months
The scope of Makary’s regulatory activity during his tenure is extraordinary by any measure. His departure puts every initiative at varying degrees of risk:
The CNPV program approved three new molecular entities in under two months: Foundayo (orforglipron, obesity, 50-day review), Otarmeni (gene therapy for hearing loss, April 23), and Bizengri (zenocutuzumab, bile duct cancer, May 9). Three psychedelic therapy CNPVs were issued on April 24. Revolution Medicines and Lilly (Foundayo T2D) have CNPV filings planned or in progress.
The Expedited IND pathway was proposed in the FY2027 budget as a risk-based alternative to traditional INDs using validated non-animal testing methods. The proposal was explicitly framed as a competitive response to China’s faster regulatory timelines.
The Real-Time Clinical Trial initiative launched on April 28 with AstraZeneca and Amgen running proof-of-concept trials. The public comment period closes May 29. A broader pilot was planned for this summer.
DTC advertising authority was proposed as new statutory enforcement power over drug ads, including compounded drugs.
Domestic manufacturing incentives included a $9 million PreCheck program and a one-month Paragraph IV head start for U.S.-based generic manufacturers.
The RP1 second CRL maintained a high evidentiary bar for single-arm oncology studies, establishing a precedent that the FDA would not lower its approval standards regardless of physician advocacy or breakthrough designation.
What Happens to Companies with Active CNPV Filings
The most immediate practical question is what happens to companies that have CNPV filings planned or in progress. Revolution Medicines intends to file daraxonrasib under the CNPV in H2 2026. Lilly plans to submit Foundayo for type 2 diabetes under the CNPV by end of Q2. Both companies built their regulatory strategies around the assumption that the CNPV program would continue to operate with the same speed and commitment that characterized the first three approvals.
If the CNPV program stalls during a leadership transition—even temporarily—regulatory timelines extend. A standard NDA review takes 10 to 12 months. The CNPV compressed that to weeks. The difference between a functioning CNPV and a paused one could mean the difference between a 2026 approval and a 2027 approval for programs that are ready to file.
The program itself has bipartisan support and industry buy-in. It has delivered three NME approvals and three psychedelic fast-tracks with no safety controversies. The institutional infrastructure exists. But without a commissioner actively championing the program—assigning review teams, prioritizing applications, and protecting the program from bureaucratic resistance—momentum could dissipate.
Our Pro brief analyzes the five regulatory initiatives at risk, how each potential successor (Hahn, Giroir, Diamantas) would shape FDA direction differently, and what the leadership vacuum means for companies with active CNPV filings. [Details below.]
What to Watch
The acting commissioner announcement is the immediate catalyst. If Diamantas is named, watch whether he makes any public commitments to continuing drug development initiatives or focuses exclusively on food safety. The permanent nominee will take months to identify and confirm—Stephen Hahn’s original confirmation in December 2019 took several months from nomination to Senate vote. During that interval, every company planning a CNPV filing, every sponsor participating in the RTCT pilot, and every biotech relying on the Expedited IND pathway needs to assess whether their regulatory strategy still holds.
The institutional knowledge loss matters beyond the commissioner’s office. STAT reported that both CDER divisions are already headed by acting directors and that longtime career staff have departed throughout Makary’s tenure. An FDA operating with acting leadership at multiple levels simultaneously—commissioner, CDER divisions, and key review offices—has fewer institutional champions for any single initiative. Programs survive leadership transitions when they have deep institutional support across the organization. Programs that were driven primarily from the commissioner’s office are more vulnerable.
The SCOTUS mifepristone stay expires today (May 11). The full Court must decide whether to extend the stay or let the 5th Circuit ruling take effect. The coincidence of the mifepristone deadline and the Makary departure creates a moment where both the FDA’s leadership and its regulatory authority are simultaneously in question—an unprecedented convergence that has no recent parallel in the agency’s history.
Corporate Developments
Odyssey Therapeutics IPOs at $304M as 2026 Biotech Wave Continues
Odyssey Therapeutics debuted on Friday via an upsized $304 million IPO. BioPharma Dive noted that nine of the 11 biotechs to go public in 2026 have raised at least $250 million in their initial stock sales, the most in a single year since 2021. Total 2026 biotech IPO proceeds now exceed $3.2 billion, following recent debuts from Seaport Therapeutics and Hemab Therapeutics.
Why This Matters: For context, full-year 2025 biotech IPO proceeds were approximately $1.8 billion. 2026 has already nearly doubled that through May. The IPO window is the most open since 2021. The key driver is strong M&A premiums (which give public market investors confidence in exit optionality) combined with a deep pool of clinical-stage companies seeking capital. The durability of this window may now depend on whether the FDA leadership transition disrupts the regulatory clarity that has been a tailwind for biotech valuations throughout 2026.
Angelini Pharma Acquires Catalyst Pharmaceuticals
Italy’s Angelini Pharma announced a definitive agreement to acquire Catalyst Pharmaceuticals for $31.50 per share in cash. Catalyst markets Firdapse (amifampridine) for Lambert-Eaton myasthenic syndrome, a rare neuromuscular disorder. The deal continues the trend of European pharma companies acquiring U.S. rare disease assets—joining Chiesi/KalVista and the broader cross-border consolidation pattern that has characterized 2026. For European acquirers, U.S. rare disease assets offer high per-patient pricing, long IP runways, and established commercial infrastructure in the world’s largest pharmaceutical market.
FDA Approves Bizengri Under CNPV — Third NME Before Makary’s Departure
The FDA approved Partner Therapeutics’ Bizengri (zenocutuzumab) for adults with a rare form of bile duct cancer on May 9, under the CNPV program. This is the third new molecular entity approved under the CNPV after Foundayo and Otarmeni. The approval occurred just hours before reports of Makary’s planned departure emerged, underscoring the program’s continued output right up to the moment the commissioner’s future came into question. The three approvals collectively demonstrate the CNPV program’s applicability across therapeutic areas: metabolic disease (Foundayo), gene therapy (Otarmeni), and oncology (Bizengri). That breadth is part of what makes the program’s potential disruption during a leadership transition so consequential for the industry.
Strategic Themes
1. The CNPV Program Is the Most Important Regulatory Initiative at Risk
Three NME approvals in under two months. Three psychedelic fast-tracks. Revolution Medicines and Lilly T2D filings in the pipeline. The CNPV transformed FDA review from a 10-to-12-month process into a weeks-long process for qualifying therapies. No single regulatory innovation in years has had a more direct impact on the speed at which drugs reach patients. If the program stalls during the leadership transition—even temporarily—the consequences ripple through every company that built its filing strategy around accelerated review.
2. The Political Triggers Have Nothing to Do with Pharma—But Pharma Pays the Price
Makary is not being removed because of his pharmaceutical regulatory decisions. He is being removed because of flavored e-cigarettes and mifepristone. But the pharmaceutical industry’s most important regulatory reforms—the CNPV, the Expedited IND, the RTCT—were all built under his leadership. The departure threatens programs that have nothing to do with the political conflicts that caused it. For pharma executives, the lesson is that FDA regulatory stability is never guaranteed, regardless of how well a commissioner’s drug development initiatives are performing.
3. The Leadership Vacuum Compounds an Existing Institutional Gap
The FDA is already operating with acting directors in both CDER divisions. Former Chief Scientist Goodman has identified “a vacuum” in expertise. Adding a commissioner departure—and potentially an acting commissioner from the food side of the agency—extends that vacuum to the highest level of the organization. For an agency responsible for regulating 20% of U.S. consumer spending, the combination of leadership gaps at multiple levels simultaneously is without recent precedent.
4. The Biotech IPO Window May Depend on Regulatory Continuity
$3.2 billion in biotech IPO proceeds through May, with nine of 11 companies raising $250 million or more, reflects investor confidence in the biopharma regulatory environment. If the FDA leadership transition creates uncertainty about the CNPV program, the Expedited IND, or the approval bar for key therapeutic areas, that confidence could erode. The IPO window that has been open since late 2025 is not guaranteed to stay open through a prolonged period of regulatory uncertainty.
Frequently Asked Questions
Is Makary officially fired?
Not yet. Multiple outlets (WSJ, Bloomberg, Reuters, STAT) reported that Trump approved a plan to fire him. Reuters said two advisers called the decision “not final” while a third said he “is done” and Trump “signed off.” The announcement has not been made official as of Monday morning.
Why is Makary being fired?
Two reported triggers: Trump rebuked him for not approving flavored e-cigarettes fast enough, and anti-abortion groups were angry about his handling of the mifepristone safety review. Neither trigger is related to his pharmaceutical drug development initiatives.
Who could replace him?
Kyle Diamantas (FDA Deputy Commissioner, food group) is being considered as acting commissioner. Stephen Hahn (FDA commissioner 2019 to 2021) and Brett Giroir (former acting commissioner and HHS assistant secretary) are potential permanent nominees. A permanent appointment requires Senate confirmation.
What happens to the CNPV program?
The program has institutional infrastructure and bipartisan support. Three NMEs have been approved under it. But without a commissioner actively championing it, new applications could slow during a transition. Revolution Medicines and Lilly both have CNPV filings planned. The program could continue operating at a reduced pace or pause during the leadership gap.
What regulatory initiatives did Makary launch?
The CNPV program (three NME approvals, psychedelic fast-tracks), the Expedited IND pathway (Phase 1 access using non-animal methods), the Real-Time Clinical Trial initiative (AstraZeneca and Amgen pilots), DTC advertising enforcement authority, domestic manufacturing incentives (PreCheck, Paragraph IV head start), and a higher bar for single-arm oncology approvals.
How does this affect companies planning CNPV filings?
Revolution Medicines intends to file daraxonrasib under the CNPV in H2 2026. Lilly plans to submit Foundayo for T2D under the CNPV by end of Q2. If the program stalls, standard NDA review timelines (10 to 12 months) would apply instead of the weeks-long CNPV review. The difference could mean 2027 approvals instead of 2026.
What is the SCOTUS mifepristone status?
Justice Alito’s administrative stay expires today (May 11). The full Court must decide whether to extend the stay, let the 5th Circuit’s in-person dispensing requirement take effect, or take the case on the merits. The expiration coincides with the Makary departure news, creating a moment where both FDA leadership and regulatory authority are simultaneously in question.
What was the Bizengri approval?
The FDA approved zenocutuzumab for a rare form of bile duct cancer on May 9 under the CNPV program—the third NME approved under the program after Foundayo and Otarmeni. The approval occurred hours before reports of Makary’s planned departure emerged.
BioMed Nexus Pro — What Institutional Subscribers Are Reading Today
Five Initiatives at Risk. We assess the CNPV program, Expedited IND pathway, Real-Time Clinical Trial initiative, DTC advertising authority, and domestic manufacturing incentives against the leadership transition—rating each by risk level and modeling what stalling, continuation, or reversal would mean for drug development timelines across the industry.
Commissioner Succession: Three Paths. We analyze how Diamantas (food-side acting), Hahn (institutional continuity), and Giroir (politically aligned) would each shape FDA regulatory direction differently, and what each scenario means for companies currently relying on Makary-era programs.
IPO Wave and Regulatory Risk. We assess whether the $3.2 billion in 2026 biotech IPO proceeds is sustainable through a prolonged FDA leadership transition, and how regulatory uncertainty could affect the investor confidence that has kept the window open.
Plus: SCOTUS mifepristone timeline, Bizengri CNPV approval analysis, Odyssey/Angelini deal coverage, Daiichi Sankyo tariff earnings, and the updated catalyst calendar through ASCO and H2 2026.
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