Administration infighting over the national stockpile

The health department's preparedness office overseeing national stockpiles of emergency medical gear is trying to cement its Covid-era power — and meeting with congressional skepticism.

The Administration for Strategic Preparedness and Response has seen demands for protective gear and therapies rapidly expand between the Covid-19 pandemic, the 2022 mpox outbreak, and now the spread of avian flu among cows. But its management of the nation's medical stockpile — and its efforts to replenish depleting stock — are under fresh scrutiny from lawmakers. In particular, Republicans want answers on the $850 million that Congress clawed back from ASPR's budget, and on why that cash wasn't spent if the stockpile needed it so badly, my co-author Sarah Owermohle reports.

The problem, health officials and congressional staff familiar with the dispute say, is that the pandemic office tried to use those funds — and White House budget officials held up spending plans. The holdup is the latest in a long-running battle over emergency supply spending and who should spearhead federal efforts to provide essential medical supplies in emergencies. More from Sarah.

agencies

Clinical trial diversity guidance on deck

After a five-month delay, the FDA will finally be putting out guidelines for drug and device makers on how to include people of color in the clinical trials that test whether products are safe and effective, my colleague John Wilkerson writes.

"It should be a matter of days before we issue guidance," Patrizia Cavazzoni, head of FDA's drug center, said in a congressional hearing Wednesday.

Lawmakers had required companies to give FDA their plans to diversify their clinical trials.

influence

Pharma's losing bet in New Jersey

It's been a while since pharma CEOs have taken out their wallets to support a particular political candidate, but another round of campaign donations cropped up earlier this year when a few CEOs gave thousands of dollars to Tammy Murphy, the then-candidate for New Jersey's seat in the U.S. Senate. The problem? The state's first lady dropped out just a few weeks later.

The seat is currently occupied by Sen. Bob Menendez (D-N.J.), a longtime pharma industry ally who is facing corruption charges.

The CEOs who donated were:

Merck CEO Robert Davis: $6,600 on Jan. 27
Pfizer CEO Albert Bourla: $3,300 on Feb. 23
Bristol Myers Squibb CEO Chris Boerner: $6,600 on Feb. 26

lobbying

Shakeup leaves BIO reeling

My colleague John Wilkerson and I have been making some calls following BIO's big layoffs earlier this week. Here are some of our takeaways.

Member companies are taking more of a wait-and-see approach to see how CEO John Crowley's pivot plays out. Some members of the group's executive committee were given a heads up, but not all of them.
In a notable change from the group's 2020 ambitions to be focused on social justice, STAT has heard that a diversity, equity, and inclusion manager was laid off as part of the restructuring. A BIO spokesperson said the group can't comment on specific individuals, but insisted that health equity continues to be a priority. "Specifically, BIO intends to direct significant new resources to an initiative in women's healthcare. And BIO will continue to invest to ensure we continue to have a diverse and inclusive workforce internally and well as through our important Board Committee on DE&I."
Most of the layoffs were focused on BIO's international team and marketing department, with some targeted to industry research and policy as well.
Another top executive was let go: Eric Weaver, who was the organization's chief human resources officer.

devices

A Senate challenge to FDA

Win McNamee/Getty Images

The FDA at long last finalized its plans to regulate lab-developed tests this spring. Republicans on Capitol Hill have griped about it being agency overreach, but one lawmaker has taken things a step further.

Sen. Rand Paul (R-Ky.) last week introduced a joint resolution under the Congressional Review Act that would void the policy.

However, the odds of that resolution passing aren't looking good so far. Currently the resolution has no co-sponsors. Per the Congressional Research Service, CRA resolutions have to have majority support to pass, which isn't a likely thing in a Democratic-controlled Senate.

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