FDA taps biotech industry veteran as RFK Jr.'s top drug regulator 

The Food and Drug Administration said connected Monday it has appointed erstwhile biotech enforcement George Tidmarsh arsenic the agency's top cause regulator.

Tidmarsh, an adjunct prof of pediatrics and neonatology astatine Stanford University's School of Medicine, Fpauswill pb 1 of the biggest and astir important divisions of the FDA, which reviews the immense bulk of caller cause applications.

The Center for Drug Evaluation and Research, oregon CDER, regulates over-the-counter and medicine treatments, including biologic therapies and generics. The acting caput of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring. 

Tidmarsh volition measurement successful arsenic the FDA and its regulatory process look monolithic upheaval nether Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued heavy unit cuts crossed HHS and, successful immoderate cases, brought successful caller employees who either deficiency applicable technological and aesculapian acquisition oregon stock his skepticism of vaccines. 

But Tidmarsh's extended inheritance successful the manufacture and engagement successful the improvement of 7 now-approved drugs is apt a suspiration of alleviation for the pharmaceutical industry. His erstwhile comments awesome that helium could instrumentality a much hardline attack to regulating drugs. 

In an opinion piece successful April, Tidmarsh slammed regulatory decisions made by a cardinal authoritative pushed retired of the FDA nether Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen's ill-fated Alzheimer's drug, Aduhelm, and overruling FDA unit to grow approval of Sarepta Therapeutics' Duchenne muscular dystrophy attraction Elevidys.

Last week, the FDA asked Sarepta Therapeutics to halt each shipments of Ele­vidys aft 3 patients died from liver nonaccomplishment aft taking it oregon a akin treatment. The institution aboriginal said it would not halt shipments to dainty patients with the information who tin inactive walk, saying information amusement "no caller oregon changed information signals" wrong that group.

Tidmarsh volition apt person a accidental connected that arguable accelerated support process and the FDA's attack to medicine cause advertising. He served arsenic CEO of La Jolla Pharmaceuticals and Horizon Pharma, the second of which helium founded earlier Amgen bought it for $28 billion. Tidmarsh besides founded Threshold Pharmaceutical, and held elder positions astatine different biotech companies. 

"Dr. Tidmarsh is an accomplished physician-scientist and person whose acquisition spans the afloat arc of cause development—from seat to bedside," said FDA Commissioner Dr. Marty Makary, successful a statement. "His assignment to pb CDER brings exceptional scientific, regulatory, and operational expertise to the agency."