FDA names Richard Pazdur as top drug regulator

The FDA yesterday said it has chosen Richard Pazdur, its longtime head cancer regulator, to lead its drug center, replacing George Tidmarsh.

Pazdur founded the agency's Oncology Center of Excellence (OCE). His appointment signals an effort to bring stability to a crucial part of the FDA that's been wracked by declining morale and staff departures, my colleague Lizzy Lawrence writes. Read more.

My colleague Matt Herper also weighed in, writing that Pazdur's appointment is "the best news" for the agency, patients, and drug companies. More on why here.

regulation

Two FDA officials are quietly upending vaccine regulation

My colleague Lizzy Lawrence also has published an in-depth investigation this morning on two FDA officials who are trying to reshape vaccine regulation: one who's widely known, Vinay Prasad, and the other who's been largely out of the public eye, Tracy Beth Høeg, a lieutenant to Commissioner Marty Makary.

Prasad and Høeg both believe that the FDA's methods for determining the safety and efficacy of vaccines, both before and after they hit the market, are inadequate. They're focused most closely on Covid-19 shots, but are also looking at other vaccines more broadly.

After speaking with more than 20 sources and reviewing internal documents, Lizzy has also learned that Prasad and Høeg have seized control from career scientists who run the FDA's vaccine surveillance programs and are rapidly changing procedures with little input from career staff.

politics

Yancopoulos and other biotech leaders set to attend exclusive MAHA event

Regeneron science chief George Yancopoulos, CRISPR Therapeutics CEO Sam Kulkarni, and biotech entrepreneur Alexis Borisy are scheduled to speak today at an invitation-only MAHA summit in Washington.

Officials including health secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and Vice President JD Vance are also included on the agenda of the event, which has not been publicly disclosed by administration officials or event organizers.

Attendees will be able to participate in "exclusive networking" with these officials, according to a copy of the invite viewed by STAT.

The event raises questions about which groups get access to top officials, even as Kennedy has promised "radical transparency" and decried the close relationship between former policymakers and industry leaders.

Read more from STAT's Daniel Payne and Allison DeAngelis.

pharma

Why is Eli Lilly worth nearly $1 trillion?

From my colleague Damian Garde: The short answer, according to CEO Dave Ricks, is that his company has a blockbuster GLP-1 drug and all but one of its competitors do not. The longer one involves Eli Lilly's chance to fundamentally change how the pharmaceutical business actually works.

So Ricks explained over a pint with a pair of winsome Irishmen made fabulously wealthy by starting the payments company Stripe. During a two-hour video podcast, in which Ricks neither split the G nor finished his Guinness, Lilly's leader extolled the virtues of LLMs ("I have at least one or two AIs running every minute of every meeting I'm in.") and bemoaned the sluggishness of clinical trial recruitment ("If Taylor Swift can sell out a concert in a few seconds, why can't I fill an Alzheimer's study?").

Somewhere around the 100-minute mark comes the big question: Why, at a time of escalating pressure on the world's largest pharmaceutical companies, is Lilly worth nearly $1 trillion?

Pharma is a cyclical business, but there's a theory, held by Lilly's most ardent supporters, "that perhaps this cycle could be different," Ricks said. Thanks to LillyDirect and the demand for novel weight loss medicines, the company has the potential to break the industry model and "create much more of a self-pay, branded business that has staying power beyond a patent cycle," he said. "And I think so far, the evidence is pointing that way."

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