WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month. 

Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products. 

The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes. 

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Residue and stains plastered on production walls, floors, and manufacturing equipment. Corrosion on a product line. An employee wearing open-toed sandals.

These were among the unsanitary conditions found last April by a Food and Drug Administration inspector during a visit to Shoolin Pharma in Gujarat, India, where the company makes active pharmaceutical ingredients for more than a dozen medicines, including erectile dysfunction and anti-convulsant pills, that are sold to compounding pharmacies in the U.S., according to the agency.

The concerns about filth and possible contamination in the production and packaging areas — as well as incomplete laboratory testing records — prompted the agency last month to halt all product shipments by the company into the U.S., the FDA disclosed in an Aug. 18 warning letter that was posted on the FDA web site last week.

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In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 

Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma. 

In the trials, tozo reduced COPD exacerbations — any sudden worsening of the disease requiring medical care, whether a severe cough or breathlessness — by about 30% across all patients over a year, according to data presented at the European Respiratory Society’s annual conference in Barcelona and published in the New England Journal of Medicine. That finding makes tozo competitive with other COPD treatments that have reached patients in recent years, but notably, the tozo trials included participants not eligible for the other new drugs. The benefits seen in those patients could give AstraZeneca a large segment of the market to itself.

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