FDA faucets biotech exec George Tidmarsh as RFK Jr.’s prime drug regulator 

The Meals and Drug Administration stated Monday it has appointed former biotech government George Tidmarsh because the company’s prime drug regulator.

Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford College’s Faculty of Medication, will lead one of many greatest and most important divisions of the FDA, which opinions the overwhelming majority of latest drug purposes.

The Heart for Drug Analysis and Analysis, or CDER, regulates over-the-counter and prescription remedies, together with biologic therapies and generics. The performing head of CDER, Jacqueline Corrigan-Curay, introduced in June she was retiring. 

Tidmarsh will step in because the FDA and its regulatory course of face large upheaval beneath Well being and Human Providers Secretary Robert F. Kennedy Jr. Kennedy has pursued deep workers cuts throughout HHS and, in some instances, introduced in new workers who both lack related scientific and medical expertise or share his skepticism of vaccines. 

However Tidmarsh’s intensive background within the business and involvement within the growth of seven now-approved medicine is probably going a sigh of aid for the pharmaceutical business. His earlier feedback sign that he may take a extra hard-line strategy to regulating medicine. 

In an opinion piece in April, Tidmarsh slammed regulatory choices made by a key official pushed out of the FDA beneath Kennedy, Peter Marks. That features supporting the accelerated approval of Biogen’s ill-fated Alzheimer’s drug, Aduhelm, and overruling FDA workers to increase approval of Sarepta Therapeutics‘ Duchenne muscular dystrophy therapy Elevidys.

Final week, the FDA requested Sarepta Therapeutics to halt all shipments of Ele­vidys after three sufferers died from liver failure after taking it or the same therapy. The corporate later stated it could not cease shipments to deal with sufferers with the situation who can nonetheless stroll, saying information exhibits “no new or modified security indicators” inside that group.

In an interview with CNBC on Friday, earlier than the Tidmarsh appointment was introduced, Marks stated his earlier choices on the gene remedy had been “made on the very best obtainable information on the time.” At the moment, the talk centered round efficacy, not security, he stated.

Marks stated he does not suppose it is “unreasonable” to ask Sarepta to pause shipments till “you do an actual evaluate of the whole lot that is occurring.”

Tidmarsh will possible have a say on that controversial accelerated approval course of and the FDA’s strategy to prescription drug promoting. He served as CEO of La Jolla Prescribed drugs and Horizon Pharma, the latter of which he based earlier than Amgen purchased it for $28 billion. Tidmarsh additionally based Threshold Pharmaceutical, and held senior positions at different biotech corporations. 

“Dr. Tidmarsh is an achieved physician-scientist and chief whose expertise spans the total arc of drug growth—from bench to bedside,” stated FDA Commissioner Dr. Marty Makary, in an announcement. “His appointment to steer CDER brings distinctive scientific, regulatory, and operational experience to the company.”

— CNBC’s Angelica Peebles contributed to this report.