at the fda

There’s a new acronym coming to town 

Drug and food world, meet the FDA Office of Inspections and Investigations. The agency is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products — and that includes a name change, three people familiar told me. 

The new moniker makes more direct reference to the department’s duties, which came under scrutiny last year amid baby formula shortages and congressional probes of FDA food oversight. The reorg could also have ramifications for drug and device manufacturers, as FDA shuffles people into different divisions and consolidates labs. 

Other changes slated to be announced include an additional clinical branch in the vaccine division of CBER, aimed at spreading out first-line reviewers among more supervisors, one official said. CBER is also “undoing” a reorganization of the Office of Blood Research and Review that was announced as part of its major reorganization last June, the official said. More from me.

budget battles

A little breathing room for a brewing HHS budget fight

While House lawmakers managed to pass a continuing resolution this week that would push a government shutdown till January, that was about all they could do. Support for the actual 2024 budget proposals quickly fell apart on the House floor Wednesday, with conservatives tanking their own spending bills — and then everyone heading home. 

But some notable health amendments latched onto the HHS bill before things stalled, including a U.S. ban on gain-of-function sponsored by Rep. Thomas Massie (R-Ky.), which passed by voice vote. It’s unclear how that will play in the Senate, but Republicans there (Rand Paul and Roger Marshall) are also pushing for gain-of-function bans. Others have argued that the controversial research is essential for vaccine development and understanding pathogens. But no defenders were in the room Tuesday. 

Another amendment slipped in by voice vote would prevent Medicaid from fining drugmakers that do not provide timely and accurate pricing information. And the bill still includes language barring federal funding of gender-affirming care, a poison pill for the Democrat-controlled Senate.

But with the House back home until after Thanksgiving, the budget could be in for major revisions and a new fight. Just not at Christmas, please. Read more from me on this, too.

insurance intel

STAT reporting triggers class action lawsuit

If you haven’t already read my colleagues’ stellar reporting on UnitedHealth’s problematic algorithms, here is another reason to: Lawyers filed a class action suit late Tuesday, citing Casey Ross and Bob Herman’s investigations. 

The lawsuit is filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan. It alleges that the insurer’s subsidiary, NaviHealth, has illegally used an algorithm to deny rehabilitation care to serious ill patients, even though the companies know the algorithm has a high error rate.

Casey and Bob’s reporting uncovered internal documents showing that NaviHealth managers set a goal for clinical employees to keep patients rehab stays within 1% of the days projected by the algorithm. But don’t let me explain it to you — read the full investigation here.