Folder photo: The headquarters of the US Food and Drug Administration (FDA) is seen in Silver Spring, Maryland on November 4, 2009.
Jason Reed | Reuters
The Food and Drug Administration said on Monday that it had appointed the former director of biotechnology George Tidmarsh as the best drug regulator of the agency.
Tidmarsh, auxiliary professor of pediatrics and neonatology at the School of Medicine at the University of Stanford, will lead one of the largest 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 biological therapies and generics. CDER’s actor chief Jacqueline Corrigan-Curay announced in June that she was retiring.
Tidmarsh will then intervene that the FDA and its regulation process should face massive upheavals under the Secretary of Health and Social Services, Robert F. Kennedy Jr. Kennedy, continued cuts of deep personnel through HHS and, in some cases, brought new employees who lack relevant scientific and medical experience.
But the in -depth history of Tidmarsh in industry and participation in the development of seven drugs now approved are probably a sigh of relief for the pharmaceutical industry. His previous comments point out that he could adopt a harder approach to regulate drugs.
In an opinion article in April, Tidmarsh criticized the regulatory decisions taken by a key official pushed outside the FDA under Kennedy, Peter Marks. Which includes support for accelerated approval of Biogene ‘s unhappy Alzheimer’s drug, aduhelm, and prevail over the FDA staff to extend the approval of Sarepta Therapeutics“Treatment of Duchenne elemented muscular dystrophy.
Last week, the FDA asked Sarepta Therapeutics to stop all Elevedys expeditions after three patients died of liver failure after taking it or similar treatment. The company later said that it would not stop shipments to treat patients with the condition that can still work, claiming that data show “no new or modified security signals” within this group.
In an interview with CNBC on Friday, before the announcement of the appointment of Tidmarsh, Marks said that his previous decisions on gene therapy was “taken on the best knowledge available at the time”. At that time, the debate was focused on efficiency, not on security, he said.
Marks said he did not think it was “unreasonable” to ask Sarepta to suspend expeditions until “you will do a real examination of everything that is happening”.
Tidmarsh will probably have his say on this controversial accelerated approval process and the FDA approach to advertising on prescription drugs. He was CEO of the Jolla Pharmaceuticals and Horizon Pharma, the latter which he founded before Amgen I bought for $ 28 billion. Tidmarsh also founded Threshold Pharmaceutical and held management positions in other biotechnology companies.
“Dr. Tidmarsh is an accomplished doctor -scientist and a leader whose experience extends on the full arc of drug development – from the bench to bedside,” said FDA commissioner, Dr. Marty Makary, in a statement. “His appointment to direct CDER brings an exceptional scientific, regulatory and operational expertise to the agency.”
– Angelica Peebles of CNBC contributed to this report.