File photo: The headquarters of the United States Drug and Food Administration (FDA) is seen in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
The Food and Medicines Administration said Monday that it appointed former Biotechnology Executive George Tidmarsh as the main drug regulator in the agency.
Tidmarsh, an attached professor of pediatrics and neonatology at the Stanford University School of Medicine, will direct one of the greatest and most crucial divisions of the FDA, which reviews the vast majority of the new drug applications.
The Drug Evaluation and Research Center, or CDER, regulates free sale treatments, including biological and generic therapies. The interim chief of Cder, Jacqueline Corrigan-Curay, announced in June that he retired.
Tidmarsh will intervene when the FDA and its regulatory process in front of a massive agitation under the Secretary of Health and Human Services, Robert F. Kennedy Jr. Kennedy, has remained deep staff cuts and, in some cases, brought to new employees who lack relevant scientific and medical experience or share their skepticism of vaccines.
But Tidmarsh's extensive experience in industry and participation in the development of seven medicines now approved is probably a relief sigh for the pharmaceutical industry. His previous comments indicate that he could adopt a harder line approach to regulate drugs.
In an opinion article in April, Tidmarsh criticized regulatory decisions taken by a key official expelled from the FDA Bajo Kennedy, Peter Marks. Which includes supporting the accelerated approval of Biogen 'S Alzheimer's Drugst Therapeutic Sarepta'Duchenne Elevidys muscle dystrophy treatment.
Last week, the FDA asked Sarepta Therapeutics to stop all Elevidys shipments after three patients died from liver failure after taking it or similar treatment. Later, the company said it would not stop shipping to treat patients with the condition they can still walk, saying that the data shows “there are no new or changed security signs” within that group.
In an interview with CNBC on Friday, before Tidmarsh's appointment was announced, Marks said his previous decisions about gene therapy “took the best knowledge available at that time.” At that time, the debate focused on efficacy, not security, he said.
Marks said he does not believe it is “unreasonable” to ask Sarepta to pay them until “you do a real review of everything that is happening.”
Tidmarsh will probably count on that controversial accelerated approval process and the FDA approach for advertising of prescription medications. He served as CEO of the Jolla Pharmaceuticals and Horizon Pharma, the last of which he founded before Amgen I bought it for $ 28 billion. Tidmarsh also founded Urreshold Pharmaceutical, and occupied senior positions in other biotechnology companies.
“Dr. Tidmarsh is a consummate medical-scientific and leader whose experience covers the complete arc of medication development, from the bank to the bed,” said FDA Commissioner, Dr. Marty Makary, in a statement. “His appointment to lead Cder provides an exceptional scientific, regulatory and operational experience to the agency.”
– Angelica Peebles de CNBC contributed to this report.
