Sept 8 (Reuters) – The U.S. health department on Tuesday appointed the acting heads of the FDA’s drug and biologics review centers to permanent roles, formalizing leadership at the two key units responsible for regulating medicines, vaccines and other biologic products.
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HHS said Michael Davis and Karim Mikhail, who were serving as acting heads of the units, will take over as directors of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, respectively.
The agency also named Jared Seehafer as its first deputy commissioner for technology and artificial intelligence and named acting head Bret Koplow as director of the Center for Tobacco Products.
Last month, U.S. President Donald Trump named White House policy aide Heidi Overtonto lead the Food and Drug Administration, turning to an “America First” ally to steady an agency shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
The FDA has faced numerous challenges in Trump’s second term, including an exodus of experts and top talent and plummeting morale after Health Secretary Robert F. Kennedy Jr. fired thousands of people across the health department.
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The agency, which is responsible for regulating and approving all drugs, treatments and vaccines, has lost more than 3,000 staff over the past year, including division heads, and is under pressure to rebuild confidence among industry and public-health groups.
Davis was CDER’s deputy director for about a year before taking over as acting director in May. Mikhail had been working at the FDA as an adviser before taking on the role of acting director at CBER.
According to a CNBC report, the U.S. plans to have two FDA deputy commissioners, with one to focus on technology, including healthcare and AI, and the other to oversee drugs.
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(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid)
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