Three people are dead from a rare hantavirus that has surfaced on a cruise ship carrying passengers from 23 countries. Eight cases have been confirmed or suspected, all linked to the same cruise ship. The WHO is coordinating an international response.

And the US agency responsible for regulating diagnostics and therapeutics just lost its leader.

Marty Makary resigned Tuesday as FDA commissioner after 13 months marked by mass layoffs, senior departures, and policy clashes with the White House, Congress, and the pharmaceutical industry. His replacement, at least temporarily, is Kyle Diamantas — a corporate lawyer with no medical or scientific degree who previously represented infant formula manufacturer Abbott Laboratories and is described by watchdog group Public Citizen as a hunting companion of Donald Trump Jr.

A virus with unusual reach

On May 2, the WHO was notified of a cluster of severe acute respiratory illness aboard a Dutch-flagged cruise ship that departed Ushuaia, Argentina, on April 1. The vessel stopped at Antarctica, South Georgia Island, Tristan da Cunha, Saint Helena, and Ascension Island before reaching Cabo Verde.

Laboratory testing confirmed Andes virus, a hantavirus with two troubling characteristics: a case fatality rate that can reach 50 percent in the Americas, and the rare but documented ability to spread between humans. Of eight reported cases, three have died. WHO has assessed the global risk as low. The CDC warns that patients with suspected hantavirus can deteriorate rapidly, with severe respiratory cases killing roughly 38 percent.

The CDC dispatched a team to the Canary Islands on May 7 to assess exposure risk among American passengers, and is working with partners to repatriate them to a specialized facility in Nebraska. The agency has also issued guidance to clinicians nationwide on case identification and testing.

Coordinating the diagnostic and therapeutic response to such an event falls squarely within the FDA’s remit. The agency is now doing so under interim leadership — with a lawyer at its head.

The replacement

Diamantas joined the FDA in February 2025 to lead its food division after stints at Jones Day and Baker Donelson. He received his law degree from the University of Florida in 2013. He does not hold a medical or scientific credential — a qualification typically expected of FDA commissioners.

“Diamantas is an attorney with no scientific or medical credentials,” said Robert Steinbrook, health research director at Public Citizen. “The American people deserve an acting FDA Commissioner with deep expertise in the agency’s many responsibilities. Diamantas’ background inspires no confidence that he will ensure the FDA’s full independence from Pharma and political interference.”

Diamantas told Politico in December he had agreed to recuse himself from companies he previously represented for one year after entering government.

A purge in slow motion

Makary’s departure was months in the making. According to Politico, HHS Secretary Robert F. Kennedy Jr. made the final call and the White House signed off. Trump described Makary as “a great guy” who “was having some difficulty.”

The Johns Hopkins surgeon’s tenure was turbulent from the start. He arrived at FDA headquarters in March 2025 days before Kennedy laid off 3,500 FDA workers through the Elon Musk-led Department of Government Efficiency. Senior career officials departed in quick succession. Oncology chief Richard Pazdur resigned, citing concerns that political imperatives overrode career regulators’ evaluations. Vinay Prasad, a controversial appointee, cycled through and out of the agency twice.

In his final weeks, Makary faced pressure from anti-abortion Republicans demanding he restrict access to mifepristone — Senator Josh Hawley called him “uniquely destructive to the prolife movement” — and from Trump himself, who pressured him to authorize fruit-flavored vaping products after a meeting with tobacco company R.J. Reynolds. The FDA approved the vapes. Makary resigned one week later.

In a resignation text shared by Trump on Truth Social, Makary touted 50 major FDA reforms and said it had been “the honor of a lifetime.”

The vacancies multiply

The FDA is not the only health agency without stable leadership. The CDC’s leadership has turned over repeatedly in the past year, with NIH director Jay Bhattacharya temporarily running both agencies. A fifth planned director, Erica Schwartz, has yet to be confirmed. Trump’s third pick for surgeon general, Nicole Saphier, has yet to face a confirmation hearing.

Peter Lurie, a former FDA associate commissioner now leading the Center for Science in the Public Interest, described the situation as “endless chaos.” Janet Woodcock, a former acting commissioner, has said the agency demonstrated a pattern of suppressing vaccine safety research.

The FDA regulates roughly a quarter of the world’s pharmaceutical market. Its decisions on drug approvals, diagnostic standards, and safety monitoring shape medical practice globally. When the agency loses its leader, sheds thousands of career staff, and installs a corporate lawyer with no scientific background — all while a novel viral outbreak demands coordinated international response — the consequences do not stop at the US border.

Sources