FileToto: The headquarters of the US Food and Drug Administration (FDA) can be seen in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
The Food and Drug Administration said on Monday that it had appointed the former biotech manager George Tidmarsh the best drug regulator of the agency.
Tidmarsh, extraordinary professor of pediatrics and neonatology at Stanford University School of Medicine, will lead one of the largest and most important departments in the FDA that the vast majority of the new drug applications check.
The Center for Pharmaceutical Assessment and Research or Cder regulates over -the -counter and prescription treatments, including biological therapies and generics. The reigning director CDS, Jacqueline Corrigan-Curay, announced in June that she retired.
Tidmarsh will be exposed to the FDA and its regulatory process under massive upheavals in the context of the health and human service -secretary Robert F. Kennedy Jr.
Tidmarsh's extensive background in the industry and participation in the development of seven drugs that have now been approved is probably a sigh of relief for the pharmaceutical industry. His earlier comments signal that he could pursue a more difficult approach to regulating medication.
In an opinion in April, Tidmarsh struck regulatory decisions of an important civil servant who was pushed out of FDA under Kennedy, Peter Marks. This includes the support of the accelerated approval of Biogen 'S Unhappy Alzheimer's drug, Aduhelm and Repfuling FDA employee to expand the approval of Sarepta therapeutics'Duchenne muskeldystrophy treatment elegen.
Last week, the FDA asked the Sarepta therapeutic agent to stop all deliveries of ELEDYS after three patients died of liver failure after taking or similar treatment. The company later said that there would be no shipments to treat patients with the disease who can still run, and the data show that “no new or changed security signals in this group”.
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In an interview with CNBC on Friday, before the Tidmarsh appointment was announced, Mark said that his earlier decisions about gene therapy were “made the best available knowledge at this time”. At that time, the debate about effectiveness, not on security, revolved, he said.
Marks said that he does not think that it was “unreasonable” to ask Sarepta, paused programs until “they checked a real evaluation of everything that is going on”.
Tidmarsh will probably have a say in this controversial accelerated approval procedure and the FDA's approach to advertise prescription drug advertising. He was CEO of La Jolla Pharmaceuticals and Horizon Pharma, from which he had previously founded Amgen Bought it for $ 28 billion. Tidmarsh also founded the threshold pharmaceutical and had leading positions at other biotech companies.
“Dr. Tidmarsh is an accomplished medical scientist and leader, whose experience extends the full arc of drug development from the bank to the bed,” said FDA commissioner Dr. Marty Makary in an explanation. “His appointment as head of Cder brings exceptional scientific, regulatory and operational expertise to the agency.”
– Angelica Peebles from CNBC contributed to this report.
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