FDA taps biotech exec George Tidmarsh as RFK Jr.’s top drug regulator
File Photo: The center of the US Food and Pharmaceutical Administration (FDA) is seen on November 4, 2009 at Maryland Silver Spring.
Jason Reed | Reuters
Food and Pharmaceutical Administration on Monday appointed Former Biotechnology Manager George Tidmarsh as an Agency best drug regulator.
Tidmarsh, Fpauswill, a professor of pediatric and neonatology at Stanford University Faculty of Medicine, directs one of the biggest and most important parts of FDA, which reviews the majority of new drug applications.
Drug Evaluation and Research Center or CDER regulates the counter and prescription treatments, including biological treatments and generic. CDER player Jacqueline Corrigan-Curay, announced He retired in June.
Tidmarsh, FDA and the regulatory process will face a major uprising under the Secretary of Health and Human Services, Kennedy Jr. Kennedy has made deep personnel deductions throughout HHS and brought it to new employees who lack the relevant scientific and medical experience or share their skepticism into gaps.
However, Tidmarsh’s comprehensive history in the sector and its participation in the development of seven drugs currently approved is probably a comfort for the pharmaceutical industry. Previous comments indicate that they can adopt a harder approach to regulate drugs.
One part of the idea In April, Tidmarsh hit the regulatory decisions taken by a key authority pushed from FDA under the direction of Tidmarsh, Kennedy, Peter Marx. This includes support Accelerated confirmation conjunctive Biogen ‘Expansion of malicious Alzheimer’s medicine, aduhelm and FDA personnel approval conjunctive Sarepta therapeutics‘Duchenne muscle dystrophy therapy elevidys.
Last week, FDA asked Sarepta Therapeutics to stop all posts of Elevidys after died of liver failure or similar treatment after receiving three patients. The company later said that the data did not show “new or changing security signals” within this group, and that the treatment of patients will still not be stopped.
In an interview with CNBC on Friday, before the announcement of the Tidmarsh appointment, Marx said that his previous decisions on gene therapy were “on the best information available at that time.” At that time, he said the debate was gathered around the event, not security.
Marks said he didn’t think it was “unreasonable” to ask him to pause the posts until Sarepta made a real examination of everything that was “from Sarepta.
Tidmarsh will probably have a say about the controversial accelerated approval process and FDA’s approach to prescription drug advertising. He worked as the CEO of La Jolla Pharmaceuticals and Horizon Pharma. Amgen I bought it for 28 billion dollars. Tidmarsh also established threshold drugs and received high -level tasks in other biotechnology companies.
FDA Commissioner “Dr. Tidmarsh is a successful doctor-science man and leader,” Dr. Tidmarsh, his experience, “Dr. Tidmarsh,” He said. “The appointment of the CDER to lead the CDER, the agency brings extraordinary scientific, regulatory and operational expertise.”
– CNBC’s Angelica Peebles contributed to this report
