FDA names permanent chiefs for drugs, vaccines and tobacco centres

The US Department of Health and Human Services (HHS) has announced the permanent appointment of four senior officials at the Food and Drug Administration (FDA), ending a period of instability that saw several high-profile resignations earlier this year.

Dr. Michael Davis will now lead the Centre for Drug Evaluation and Research, the FDA's largest division. Davis, who previously headed the agency's psychiatric drug unit and later worked at a nonprofit focused on psychedelic therapies, had been serving in an acting capacity since the departure of Dr. Tracy Beth Hoeg in May.

His new role places him at the centre of upcoming reviews of psychedelic compounds such as psilocybin, MDMA and LSD, which are being studied for psychiatric conditions. Both President Donald Trump and Health Secretary Robert F. Kennedy have called for faster evaluation of these therapies.

Karim Mikhail, a pharmacist and former pharmaceutical executive, has been confirmed as the permanent director of the FDA's vaccines centre. He steps into the role vacated by Dr. Vinay Prasad, who resigned in March amid disputes over vaccine policy and the approval of gene therapies.

Prasad had introduced stringent requirements for updated COVID-19 vaccines, including lengthy new studies before tweaked shots could be approved for healthy adults and children. His tenure was marked by criticism from biotech executives and patient groups over the handling of rare-disease drugs.

The agency has also named attorney Bret Koplow as director of the Centre for Tobacco Products. Koplow had been acting in the role since the previous director was removed early in the administration. His appointment comes after the FDA cleared several new nicotine pouches and e-cigarette products following the resignation of former Commissioner Dr. Marty Makary, who faced pressure over the agency's slow action on flavoured vapes.

In a fourth appointment, Jared Seehafer will take up a newly created position overseeing artificial intelligence and technology at the agency.