How to Succeed as an FDA Commissioner: Lessons from a Failed Tenure

Introduction

Becoming the commissioner of the Food and Drug Administration is one of the most consequential roles in public health. Over the past quarter-century, appointees have navigated crises, scientific breakthroughs, and political pressures. Yet the tenure of Marty Makary, who resigned under pressure, stands out as a cautionary tale—not for what he accomplished, but for how systematically he undermined his own effectiveness. His approach offers a clear blueprint of what not to do. This guide extracts hard-learned lessons from that experience, turning them into actionable steps for any future commissioner or leader in a similar high-stakes regulatory environment.

How to Succeed as an FDA Commissioner: Lessons from a Failed Tenure — Source: www.statnews.com

Disclaimer: This guide is based on reported facts about a specific individual’s performance and is intended for educational and reflective purposes only.

What You Need

Deep understanding of FDA’s mission: Protecting public health by ensuring the safety, efficacy, and security of drugs, biologics, and medical devices.
Regulatory science literacy: Familiarity with clinical trial design, biostatistics, risk-benefit analysis, and the legal framework of the Federal Food, Drug, and Cosmetic Act.
Political acumen: Ability to navigate Congress, the administration, media, and public opinion.
Leadership humility: Willingness to listen to career staff who possess institutional knowledge.
Strategic patience: Understanding that meaningful reforms take time and consensus-building.
Team stability: A plan to retain experienced senior leadership and fill vacancies with qualified, independent experts.
Commitment to evidence: Willingness to make decisions based on science, not political expediency or personal wins.

Step-by-Step Guide

Step 1: Fully Understand the Role and Its Responsibilities

Before accepting the position, invest significant time in learning the breadth of the FDA’s work. The commissioner oversees not only drug approval but also food safety, tobacco products, and medical devices. Makary’s fundamental lack of understanding of the nature of the role—especially the delicate balance between speed and safety—set the stage for failure. To succeed, you must appreciate that the FDA is both a scientific agency and a regulatory one; its decisions affect millions of lives and billions of dollars. Study past commissioners’ successes and failures, meet with division directors, and read the Food, Drug, and Cosmetic Act. This step prevents the isolation and disjointed priorities that plagued Makary’s tenure.

Step 2: Retain and Empower Senior Leadership

One of Makary’s most detrimental moves was allowing too much of the senior leadership to leave or be removed. The FDA’s senior scientists and administrators carry decades of experience. Losing them weakens institutional memory and regulatory consistency. As a new commissioner, immediately meet with each senior leader, learn their priorities, and publicly affirm their value. Create incentives for them to stay—such as clear career paths and autonomy in their areas. If you must replace anyone, ensure the new hires are as knowledgeable and respected, not political loyalists. A stable leadership team provides a buffer against rash decisions and maintains morale across the agency.

Step 3: Uphold Rigorous Standards—Don’t Weaken Them

Makary’s tenure saw a weakening of standards, which undermined the FDA’s credibility. The agency exists to ensure that products are safe and effective; lowering the bar erodes public trust and can lead to dangerous outcomes. Instead, focus on improving efficiency without sacrificing rigor. For example, the original text notes that Makary’s ideas about using AI, speeding drug review by reducing dead time, and accelerating clinical trials were strong—but they must be executed carefully, with guardrails. Anchor to this step should serve as a reminder: innovation is welcome, but never at the expense of the gold standard of evidence. Maintain transparent criteria for approval, involve advisory committees, and resist pressure to rush products that lack robust data.

Step 4: Actively Listen to Your Staff and Their Expertise

Ignoring staff who understand both the science and the political art of regulation was a critical error. The FDA employs top-tier scientists, epidemiologists, and policy experts. As commissioner, you must create channels for open dialogue—town halls, anonymous feedback systems, and regular meetings with rank-and-file reviewers. Makary reportedly dismissed staff input, leading to a culture of fear and disengagement. Instead, treat your staff as partners. When a reviewer raises a concern about a new drug, take it seriously. When a team proposes a more efficient workflow, pilot it. Listening builds trust and surfaces problems before they become crises.

Step 5: Avoid Isolation and Focus on Substantive Wins

Toward the end of his tenure, Makary seemed isolated and obsessed with notching “wins” that often amounted to very little. Isolation prevents you from gauging the real impact of your decisions and from building coalitions. To avoid this, maintain a diverse advisory group—including career staff, industry representatives, patient advocates, and academics. Set specific, measurable goals that align with the FDA’s mission, such as reducing review times for truly innovative therapies without compromising safety, or improving post-market surveillance. Celebrate actual achievements, not just press releases. Remember that a “win” in public health is a product that safely reaches patients—not a political headline.

Tips for Long-Term Success

Prioritize transparency: Document your decisions and reasoning. The more transparent the process, the more trust you build.
Balance innovation with caution: Embrace technological advances like AI and real-world evidence, but establish clear validation protocols first.
Build bipartisan bridges: FDA commissioners serve administrations, but public health is nonpartisan. Seek input from both sides of the aisle.
Plan for handoffs: Ensure that when you leave, the agency is stronger than when you arrived. That means training successors and preserving institutional knowledge.
Stay connected to patients: Regularly hear from those who use FDA-regulated products. Their stories provide perspective that data alone cannot.
Never stop learning: The science evolves, and so must you. Attend conferences, read journals, and engage with the scientific community.

By following these steps—learned from one of the most challenging tenures in FDA history—you can avoid the pitfalls that led to failure and instead lead the agency with integrity, competence, and respect.

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