File Photo: The US Food and Drug Administration (FDA) headquarters will be seen on November 4, 2009 in Silver Spring, Maryland.
Jason Reed | Reuters
The Food and Drug Administration said Monday that former biotech executive George Tidmarsh has appointed agency top drug regulator.
Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University School of Medicine, leads one of the largest and most important departments of the FDA, which reviews most of the new drug applications.
The Center for Drug Evaluation and Research (CERDER) regulates over-the-counter and prescription treatments, including biological and generics. Jacqueline Corrigan-Curay, acting chief for Cer, announced in June that she had left the company.
Tidmarsh has pursued deep staff cuts across the HHS as the FDA and its regulatory processes face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy, and in some cases brought in new employees who lack relevant scientific and medical experience or shared vaccine skepticis.
However, Tidmarsh’s extensive background in the industry and its involvement in the development of seven currently approved drugs is a relief sigh for the pharmaceutical industry. His previous comments show that he can take a stronger approach to drug regulation.
In an opinion article in April, Tidmarsh condemned the regulatory decisions made by key officials pushed out by the FDA under Kennedy, Peter Marks. This includes support for accelerated approvals of biogen’Expanding approval to overturn unlucky Alzheimer’s, Adelm and FDA staff Sarepta Therapeutics‘Duchenne muscular dystrophy treatment Elevedi.
Last week, the FDA asked Sarepta Therapeutics to stop all shipments of Elevidi after three patients died from liver failure or liver failure after receiving similar treatment. The company later said that the data would not stop shipping to treat patients who are still able to walk, saying that within the group “no new or changed safety signals have been changed or changed.”
In an interview with CNBC on Friday before Tidmarsh’s appointment was announced, Marks said his previous decision on gene therapy was “made based on the best knowledge available at the time.” At the time, he said the debate was focused on effectiveness rather than safety.
Marks said he doesn’t think it’s “irrational” to ask Salepta to suspend shipments until “actually review everything that’s happening.”
Tidmarsh will have a say in its controversial accelerated approval process and the FDA’s approach to prescription drug ads. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma. amgen I bought it for $28 billion. Tidmarsh also manufactured thresholds and held senior positions at other biotech companies.
“Dr. Tidmarsh is a skilled physician scientist and leader with experience extending to a complete arc of drug development from the bench to bedside,” FDA Commissioner Dr. Marty McCurry said in a statement. “His appointment to lead CDER brings exceptional scientific, regulatory and operational expertise to the institution.”
-CNBC’s Angelica Peebulls contributed to this report.
