The FDA Is Rudderless And Clinical Trials Are Left Adrift

By Denise N. Bronner, Ph.D., fractional chief strategist, Empactful Ventures

Leadership vacuums are expensive. They can impact internal morale and external optics, as well as actual dollars, delayed timelines, and decisions that never get made because nobody with authority will make them. In pharma, when a program loses its executive champion, it stalls, budgets freeze, and teams go into a holding pattern.

Now imagine that happening at the FDA.

The agency responsible for every drug approval, every trial standard, every evidentiary threshold in the United States currently has no confirmed commissioner, a gutted senior staff, and a queue of regulatory decisions that sponsors have been told to keep waiting on. This new operational reality will have direct consequences for clinical pipelines, trial participants, and companies that built their next five years around regulatory predictability that no longer exists. The instability did not start with Marty Makary's resignation, because the challenges that forced his exit have been building for quite some time.

What Just Happened

FDA Commissioner Marty Makary, MD, resigned on May 12, 2026, following months of mounting pressure from pharmaceutical executives, anti-abortion activists, vaping industry lobbyists, and political allies of the administration.¹ The decision to remove him was made by HHS Secretary Robert F. Kennedy Jr., according to a senior administration official, and subsequently approved by the White House.² Kyle Diamantas, the FDA's deputy commissioner for food and a lawyer without a medical background, stepped in as acting commissioner.³ His appointment could take many months, given outstanding vacancies at the CDC and surgeon general's office competing for the same limited confirmation bandwidth.

To be clear about what that means in practice: The agency that governs clinical development in the world's largest pharmaceutical market has no confirmed leader, no permanent deputy commissioner, and no permanent leadership at two of its most consequential divisions, the centers overseeing drugs and biologics. For an industry that makes decade-long bets on regulatory predictability, this is catastrophic.

When Predictability Disappears

Sponsors and CROs operate in a world built on regulatory predictability. Investment decisions, trial designs, endpoint selections, and commercial timelines all rest on the assumption that the FDA's evidentiary standards are consistent and knowable. Under Makary, that assumption eroded.

Makary and his deputy Vinay Prasad overruled career staff scientists on decisions ranging from vaccines to rare disease medications, repeatedly asserting they were restoring "gold standard science" while bypassing the agency's own review processes.⁴ Speaking at AACR in San Diego in April 2026, Richard Pazdur, MD, was direct about what this looked like from the inside: "The FDA began announcing policy changes through press releases without consulting career staff."⁵ Instead of convening independent advisory committees, the administration assembled panels that critics described as rubber stamps for a predetermined agenda.⁵

Many of the reforms initiated during Makary's tenure, including the shift to single-trial approval pathways and the real-time trial pilot, lack formal rulemaking, meaning they can be reversed, reinterpreted, or simply abandoned by the next commissioner without legal consequence.⁶ The baseline sponsors are now operating from is one without regulatory certainty, consistent standards, or a clear signal about which initiatives will survive the transition.

The Pazdur Question: Is He The Right Person In The Wrong Political Moment?

Within days of Makary's departure, a coalition of nearly 400 biotech CEOs, investment partners, financial analysts, and patient advocates signed a letter to President Trump recommending a single candidate to restore order at the FDA:  Pazdur, the agency's former top oncology regulator who stepped down in December 2025 after 26 years of service. The letter, organized by advocacy group No Patient Left Behind, argued that "decisional volatility, staff exodus, missed deadlines, and eroding scientific predictability at the FDA have created a crisis of confidence in America's ability to remain a leader in biomedical progress."⁷ Pazdur, the signatories contended, has the scientific credibility, institutional knowledge, and operational track record to reverse that crisis — and to send an unambiguous signal to global markets that the United States still takes regulatory leadership seriously.

There is only one problem: Pazdur has made clear he will not serve under this administration.

Pazdur left the FDA in December 2025 citing "promises made, promises not kept" and departed weeks into his role as CDER director after clashing with leadership over political interference in the drug review process.⁸ At a keynote at RBC Capital Markets' global healthcare conference following Makary's resignation, he declined to formally put his name forward for the commissioner role, though he did outline what he believes the next leader must bring: concrete plans with timelines to restore confidence, a commitment to preserving the agency's science-driven culture, and a bottom-up approach to rebuilding an organization hollowed out from the top.⁹

On the erosion of scientific independence, he put it plainly at AACR: "Prior to this administration, I never really had a discussion with a commissioner about whether a drug should be approved." That norm, built over decades, is now gone.

When the person the industry most wants for the job will not take it, that is not a personnel problem. It is a systemic indictment of the conditions in which the FDA currently operates.

The Patient Toll That Headlines Miss

Industry commentary on the FDA's leadership crisis has focused, understandably, on sponsors, investors, and regulatory timelines. Those are legitimate concerns, but the population absorbing the highest cost of this instability is in a clinic, a trial site, or a waiting room.

On March 18, 2026, more than 100 advocates, families, and caregivers affected by mucopolysaccharidoses staged a funeral outside FDA headquarters, dressed in black and carrying a real coffin, to draw attention to children with rare metabolic disorders whose treatments continued to be rejected despite mounting clinical evidence.¹⁰ "No one should be playing politics with our children's lives," said one mother whose teenage son has Hunter syndrome. "Every day the FDA delays is a day a child loses: skills, health, time."

Compounding this, a peer-reviewed study published in JAMA Internal Medicine found that 383 NIH-funded clinical trials lost grant funding between February and August 2025, which affected more than 74,000 trial participants.¹¹ Patients who enrolled in good faith, disclosed their health histories, and accepted the risks of experimental treatment found themselves in studies without the infrastructure to complete them. As one researcher put it: "Clinical trials aren't light switches. You cannot just flip them off without consequences."¹¹

Waiting for regulatory certainty is not a viable strategy. The FDA's leadership void may resolve in weeks or in many months and even when a new commissioner is confirmed, rebuilding institutional trust and operational consistency will take longer still. The industry's responsibility in the interim is not to pause but to operate with greater rigor and intentionality than the regulatory environment currently demands.

The Question That Remains

The FDA's leadership crisis is a story that converges on governance, commercialization, and, above all, science. And all of this impacts patients. The agency was established to protect people, to ensure that the drugs reaching them are safe, that the evidence behind them is real, and that the process producing that evidence is insulated from politics.

The Pazdur paradox crystallizes the moment we are in. The biopharma industry's most credible candidate for restoring the FDA's integrity will not serve under the administration doing the hiring because of what he witnessed from inside the agency he spent 26 years building.

The question facing every sponsor, CRO, patient advocate, and clinical research professional right now is not whether the FDA will eventually stabilize. The question is what we build and who we protect in the meantime.

References:

1. Makary M. Resignation as FDA Commissioner. May 12, 2026. As reported by CNBC. https://www.cnbc.com/2026/05/12/trump-fda-commissioner-marty-makary-out.html
2. Marty Makary resigns as FDA commissioner following industry and White House backlash. CNBC. May 12, 2026. https://www.cnbc.com/2026/05/12/trump-fda-commissioner-marty-makary-out.html
3. FDA Commissioner Marty Makary Resigns, Kyle Diamantas Steps In as Acting Head. HCPLive. May 2026. https://www.hcplive.com/view/fda-commissioner-marty-makary-resigns-kyle-diamantas-steps-in-as-acting-head
4. Sharfstein J. Marty Makary misunderstood something fundamental about the FDA. STAT News. May 16, 2026. https://www.statnews.com/2026/05/16/marty-makary-fda-commissioner-administrative-power/
5. Pazdur R. Remarks at industry partnering event, American Association for Cancer Research (AACR) Annual Meeting, San Diego, CA. April 2026. As reported by Fierce Biotech. https://www.fiercebiotech.com/biotech/fda-veteran-pazdur-bemoans-state-agency-warns-political-influence
6. Murr R, et al. One and Done: FDA's New Single-Trial Default and What It Means for Drug Developers, Investors, and Counsel. Gibson Dunn Biotech Briefings. March 16, 2026. https://biotechbriefings.gibsondunn.com/one-and-done-fdas-new-single-trial-default-and-what-it-means-for-drug-developers-investors-and-counsel/
7. No Patient Left Behind. Letter to President Trump Recommending Dr. Richard Pazdur as Commissioner of the U.S. FDA. May 14, 2026. As reported by BioSpace. https://www.biospace.com/fda/biotech-leaders-pitch-pazdur-as-next-fda-chief
8. Pazdur R. "Promises made, promises not kept." As reported by STAT News and Epoch Times. January 2026. https://www.theepochtimes.com/us/top-fda-drug-regulator-discloses-why-he-resigned-5970840
9. Pazdur R. Keynote remarks at RBC Capital Markets Global Healthcare Conference. May 2026. As reported by BioSpace. https://www.biospace.com/fda/pazdur-declines-to-announce-candidacy-for-vacated-fda-commissioner-role
10. National MPS Society. MPS Families Carry Coffin to FDA to Mourn Children Losing Their Lives Due to Regulatory Delays. March 18, 2026. https://mpssociety.org/en/news/march-for-rare/
11. Patel VR, et al. Clinical Trials Affected by Research Grant Terminations at the National Institutes of Health. JAMA Internal Medicine. November 17, 2025. As reported by CBS News. https://www.cbsnews.com/news/national-institues-health-clinical-trial-funding-cuts-cancer-research/

About the Author:

Denise N. Bronner, Ph.D., has 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch, and storytelling refinement, and identifying business opportunities within pharma. Beyond her professional endeavors, she is passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a bachelor’s degree in biological sciences from Wayne State University, a Ph.D. in microbiology and immunology from the University of Michigan - Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures, which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.