Ex-Pharma CEO George Tidmarsh Named Head of FDA Drug Program/ Newslooks/ WASHINGTON/ J. Mansour/ Morning Edition/ The FDA has named Dr. George Tidmarsh, a pharmaceutical industry veteran, to lead its drug oversight division. Tidmarsh replaces acting director Dr. Jacqueline Corrigan-Curay amid a wave of staff departures and structural changes. His role includes overseeing key drug safety reviews and advancing regulatory reforms under the Trump administration.
FDA Drug Program: Quick Looks
- George Tidmarsh appointed to lead FDA’s drug center, replacing outgoing acting director
- Tidmarsh is a former pharmaceutical CEO and adjunct professor at Stanford University
- He will oversee drug safety, approvals, and regulatory changes under Commissioner Marty Makary
- FDA staff cutbacks threaten drug review operations, with 2,000 layoffs and widespread turnover
- Key focus areas include abortion pill mifepristone and other long-standing medications
- Tidmarsh’s role is pivotal amid growing scrutiny from Trump and RFK Jr.’s health agenda
- Appointment reflects shift toward industry-aligned leadership within FDA’s top ranks
- Makary’s FDA is pushing faster approval programs and a reassessment of pandemic-era policies
- Dr. Vinay Prasad recently appointed to vaccine division, continuing leadership shakeups
- FDA’s tobacco and vaccine centers also undergoing changes, with senior directors ousted
Ex-Pharma CEO George Tidmarsh Named Head of FDA Drug Program
Deep Look
WASHINGTON (AP) — In another major leadership shift at the Food and Drug Administration, Dr. George Tidmarsh, a seasoned pharmaceutical executive and cancer specialist, was named Monday as the new director of the Center for Drug Evaluation and Research (CDER) — the largest branch of the FDA responsible for overseeing all U.S. drug approvals and safety.
FDA Commissioner Dr. Marty Makary, appointed under President Donald Trump, announced Tidmarsh’s appointment during a press briefing in Washington, citing his extensive industry experience and background in pediatric oncology and pharmaceutical innovation. The appointment follows last month’s retirement of Dr. Jacqueline Corrigan-Curay, who had been serving as the acting director.
Dr. Tidmarsh previously founded and led several pharmaceutical companies, including Horizon Pharmaceuticals, which developed widely used anti-inflammatory treatments for arthritis. He also served as an adjunct professor at Stanford University, balancing his industry roles with academic contributions.
A Critical Appointment Amid Institutional Upheaval
As director of CDER, Tidmarsh will manage a division with nearly 6,000 employees and critical oversight of new drug applications, safety monitoring, and regulatory compliance for existing medications. The post is among the most influential in global pharmaceutical policy and is typically held for many years — often bridging multiple presidential administrations.
However, Tidmarsh steps into the role at a moment of intense turbulence. Since January, the FDA has experienced an unprecedented leadership exodus, including the departures of vaccine chief Dr. Peter Marks and tobacco division head Brian King. Many of these exits were triggered by either forced removals or administrative leave orders from the Trump administration, with Health Secretary Robert F. Kennedy Jr. overseeing the restructuring.
In total, the FDA has lost more than 3,000 employees in recent months, including 2,000 layoffs and over 1,000 early retirements or buyouts. These cuts have reportedly slowed regulatory functions and left critical positions unfilled — including permanent directors for several FDA centers.
Key Priorities for Tidmarsh
Dr. Tidmarsh’s top tasks will include overseeing ongoing reviews of controversial drugs such as the abortion pill mifepristone, a flashpoint in U.S. culture wars, and longstanding medications like antidepressants and hormone therapy drugs. These reviews are part of broader health policy reforms directed by Makary and RFK Jr., both of whom have challenged legacy FDA positions on multiple fronts.
“George Tidmarsh brings a wealth of medical and entrepreneurial knowledge to a position that demands both scientific rigor and leadership under pressure,” said Makary. “His vision aligns with our commitment to make the FDA more responsive, transparent, and accountable.”
Critics, however, worry that the appointment of former pharmaceutical executives to high-level regulatory roles could tilt the agency too far toward industry interests. Tidmarsh’s close ties to biotech firms have already drawn scrutiny from public health watchdogs and some Democratic lawmakers.
FDA’s Leadership Realignment Under Trump
Tidmarsh’s appointment is the latest in a series of reshuffles within the FDA. In May, Makary appointed Dr. Vinay Prasad, a prominent critic of COVID-era vaccine policies, to head the Center for Biologics Evaluation and Research (CBER) and serve as FDA’s Chief Medical Officer. Dr. Prasad replaced Peter Marks, who had been removed earlier amid criticism of the agency’s pandemic responses.
Other key leadership roles at the FDA remain unfilled or are currently held by acting directors, leaving the agency in a transitional phase just as it confronts growing demands for reform from Capitol Hill and the White House.
“We are witnessing a restructuring of the FDA unlike anything in its modern history,” said one former agency official. “It’s clear that this administration wants full alignment between regulatory decisions and its political health agenda.”
Looking Ahead: Reform and Risk
The appointment of Tidmarsh comes at a time when the FDA’s credibility and functionality are being tested. With massive personnel losses, uncertain political direction, and a growing list of regulatory overhauls, the agency faces both operational challenges and ethical questions.
Still, Tidmarsh expressed confidence in the FDA’s mission during Monday’s announcement, stating:
“I’m honored to serve at this pivotal time and committed to ensuring that the drugs approved in this country meet the highest standards of safety and efficacy. I believe in patient-first innovation and integrity in science.”
As the U.S. prepares for a new wave of drug development and public health scrutiny, Tidmarsh’s leadership will help define the FDA’s role in this evolving landscape, with major implications for everything from cancer research to consumer drug access.
You must Register or Login to post a comment.