Dive Brief:

• The Food and Drug Administration on Monday appointed George Tidmarsh, a Stanford University physician with long experience in the pharmaceutical industry, as director of the Center for Drug Evaluation and Research.
• An adjunct professor of pediatrics at Stanford, Tidmarsh served as CEO of La Jolla Pharmaceutical from 2012 to 2019. He previously founded Horizon Pharma, which, many years later, was bought by Amgen for $28 billion, and Threshold Pharmaceuticals, according to his Stanford biography.
• “Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — from bench to bedside,” said FDA Commissioner Marty Makary in an agency statement.

Dive Insight:

Tidmarsh’s appointment helps to solidify the top ranks of the FDA’s leadership under Makary. CDER is the agency’s principal drug review office and has been run on an acting basis by Jennifer Corrigan-Curay after the departure of the last permanent director, Patrizia Cavazzoni, before the Trump administration took office.

The FDA’s other main drug review office, the Center for Biologics Evaluation and Research, is run by Vinay Prasad, a physician researcher and longtime critic of the agency who Makary appointed in May.

Like Prasad, Tidmarsh is a prolific contributor to academic literature, authoring more than 140 scientific publications and patents, according to the FDA’s statement. He holds an M.D. and a Ph.D. from Stanford, where he is the founding director of a program designed to help students and researchers advance their laboratory discoveries.

“I look forward to working with him to strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public,” said Makary.

Also like Prasad, Tidmarsh has been a vocal critic of past FDA leaders, authoring an April editorial in Real Clear Policy that castigated Prasad’s predecessor at CBER, Peter Marks, as someone who “catered to industry and hurt patients.” In particular, Tidmarsh criticized Marks’ decisions on COVID-19 vaccines, a now-discontinued Alzheimer’s disease drug and Elevidys, a gene therapy that’s now at the center of an FDA dispute. 

As CDER director, Marsh will have significant influence over large swathes of the agency’s regulation and approval of new medicines. He’ll also likely play a role in helping Makary carry out a number of his new initiatives, such as phasing out requirements that drugmakers conduct toxicology tests in animals.

CDER, like other arms of the agency, has been destabilized by the widespread layoffs across the Department of Health and Human Services that the Trump administration ordered in April. While some critical laid-off staff have since been hired back, the FDA’s workforce is thousands of employees smaller now than it was at the end of last year.

The cuts have raised worries about the FDA’s smooth functioning, although so far there have been apparently few disruptions in the agency’s drug reviews.

Corrigan-Curay was set to retire from the agency this month, Endpoints News, Stat News and other publications reported in June.

Tidmarsh stepped down from a position on the board of directors at Revelation Biosciences in May, citing plans to work closely with the federal government.