By Kamal Choudhury
May 1 (Reuters) – The U.S. Food and Drug Administration has named Katherine Szarama as the acting director of its vaccines and biologics unit, a Health and Human Services official told Reuters on Friday, replacing Vinay Prasad, whose turbulent tenure came to an end this week.
The appointment comes days after FDA Commissioner Marty Makary said no decision had been reached on Prasad’s permanent successor and that he expected an announcement “in the coming weeks.”
Szarama will lead the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies and the blood supply.
Prasad left the agency after a term marked by controversy, including several high-profile decisions on rare disease drugs and vaccines.
The news was first reported by Politico.
Before joining the agency, Prasad, an oncologist, was known for his vocal criticism of U.S. drug and vaccine policies, especially concerning COVID-19 mandates.
His time at CBER was marked by repeated clashes, most notably the FDA’s rejection of a Huntington’s disease gene therapy from Dutch drug developer UniQure.
The U.S. drug regulator called for a new study to support the approval of the company’s treatment for the rare brain disorder.
However, UniQure and patient advocates said the request was too lengthy and onerous on patients, while the HHS accused the company of misleading the public about regulators’ requirements.
Prasad had previously resigned abruptly in July last year, saying he did not want to become a distraction. He was reinstated a little more than a week later.
Szarama, who holds a PhD, worked at the Centers for Medicare and Medicaid Services from 2016 to 2019, then moved to the Emerson Collective and Arnold Ventures. She joined the FDA in December as CBER deputy director, reporting to Prasad.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shreya Biswas and Maju Samuel)
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