FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009.
Jason Reed | Reuters
The Food and Drug Administration said on Monday it has appointed former biotech executive George Tidmarsh as the agency’s top drug regulator.
Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University’s School of Medicine, Fpauswill lead one of the biggest and most crucial divisions of the FDA, which reviews the vast majority of new drug applications.
The Center for Drug Evaluation and Research, or CDER, regulates over-the-counter and prescription treatments, including biologic therapies and generics. The acting head of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring.
Tidmarsh will step in as the FDA and its regulatory process face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued deep staff cuts across HHS and, in some cases, brought in new employees who either lack relevant scientific and medical experience or share his skepticism of vaccines.
But Tidmarsh’s extensive background in the industry and involvement in the development of seven now-approved drugs is likely a sigh of relief for the pharmaceutical industry. His previous comments signal that he could take a more hardline approach to regulating drugs.
In an opinion piece in April, Tidmarsh slammed regulatory decisions made by a key official pushed out of the FDA under Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen’s ill-fated Alzheimer’s drug, Aduhelm, and overruling FDA staff to expand approval of Sarepta Therapeutics‘ Duchenne muscular dystrophy treatment Elevidys.
Last week, the FDA asked Sarepta Therapeutics to halt all shipments of Elevidys after three patients died from liver failure after taking it or a similar treatment. The company later said it would not stop shipments to treat patients with the condition who can still walk, saying data show “no new or changed safety signals” within that group.
In an interview with CNBC on Friday, before the Tidmarsh appointment was announced, Marks said his previous decisions on the gene therapy were “made on the best available knowledge at the time.” At that time, the debate centered around efficacy, not safety, he said.
Marks said he doesn’t think it’s “unreasonable” to ask Sarepta to pause shipments until “you do a real review of everything that is going on.”
Tidmarsh will likely have a say on that controversial accelerated approval process and the FDA’s approach to prescription drug advertising. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma, the latter of which he founded before Amgen bought it for $28 billion. Tidmarsh also founded Threshold Pharmaceutical, and held senior positions at other biotech companies.
“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 Dr. Marty Makary, in a statement. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”
— CNBC’s Angelica Peebles contributed to this report
