The next steps in the abortion pill battle

By now, you've heard: Texas Judge Matthew Kacsmaryk's Friday night ruling effectively banning mifepristone could upend abortion access and throw the FDA's authorities into legal limbo. A Washington ruling that same night, ordering the FDA to keep the abortion pill on the market, just made it more confusing.

But what actually happens now? Legal experts and abortion access advocates are blasting the Trump-appointed judge's reasoning while mulling arguments for the FDA to ignore enforcement and for drugmakers to submit new applications. Reproductive rights activists are tentatively optimistic that an appeals court will issue a stay, but that hasn't stopped multiple left-leaning states from stockpiling thousands of pills.

My colleague Ed Silverman and I waded through some of the biggest questions in the wake of the dueling mifepristone decisions, like why the Washington ruling might help FDA buck enforcement and what has other drugmakers nervous. Read more from us here.

Drugmakers

Where is PhRMA in this fight?

The Texas decision could have major ramifications for any controversial FDA approval, especially products mired in political fights. But so far, the industry's biggest organization is staying on the sidelines, as Rachel Cohrs writes.

PhRMA, which is the top-spending lobbying group in the health care sector and is known to be litigious itself, still hasn't put out a press release on the decision. Instead, when asked by reporters, it issued the same statement it sent STAT in February before the decision came down, calling FDA the "gold standard" but noting it's not part of the ongoing legal fight.

That's in stark contrast to BIO, whose interim president and CEO Rachel King issued a statement calling the ruling "an assault on science," and a "dangerous precedent" that will have negative effects on drug development. But while PhRMA and BIO share several major members like Pfizer, Sanofi, and Novartis, their makeup and D.C. allies aren't quite the same. More from Rachel here.

CONGRESS

Timing is tight on Senate health committee markup

The Senate health committee markup of a hodge-podge of also-ran health care measures might slip from the April 19 date that's been reported, according to two lobbyists tracking the markup who spoke to John Wilkerson.

A markup on April 19 (next Wednesday) would require senators to file bills and amendments almost immediately upon return from the two-week spring recess, my colleague John Wilkerson reports, and at least right now, it's not totally clear what bills the Senate health committee plans to mark up, the lobbyists said.

The markup is part of a plan by Senate Majority Leader Chuck Schumer to package health care bills from the health, Judiciary and Commerce committees for a floor vote. The details of that plan are vague, but lobbyists expect the overall package to contain measures on a commercial market insulin-cost cap, generic drug competition, left-over FDA user fee measures and reforms to pharmacy benefit managers. However, the Senate Finance Committee, which has primary jurisdiction over PBM reforms, does not seem to be in the mix.

MEDICARE

It's IPPS o'clock

Medicare's proposed rule for the inpatient prospective payment system landed late Monday, starting the annual slog to parse out how much hospitals will get paid next year for seniors' treatments and procedures.

Mercifully, my colleague Bob Herman has already outlined some of the policies he is looking for in the 500+ page document. As always, the agency's baseline payment rates are a focal point – and hospitals are unhappy with the slight bump in Monday's rule. Providers saw a payment bump with the 2023 rule but have argued for years that payments aren't matching rising costs.

Federation of American Hospital President and CEO called next year's increase"disappointing" in a statement. "Hospitals aren't immune to inflation. They are contending with rising labor costs combined with the growing challenges of a deepening caregiver shortage, drug price increases, and supply chain breakdowns, among other inflation challenges."

CORONAVIRUS

The White House is finally kicking off its own Operation Warp Speed

A long-awaited effort from the White House to support next-generation vaccines and treatments for Covid-19 is finally kicking off, the Washington Post first reported.

The targets of development include creating monoclonal antibody treatments that are effective against current variants, nasal vaccines, and pan-coronavirus vaccines. Commercial development of new treatments that are effective against the evolving Covid-19 virus has stalled.

The initiative was in the works for months — the White House told STAT in July 2022 that officials aimed to launch the effort, but they hadn't gotten it funded. The White House is now putting $5 billion behind the effort, despite claiming for more than a year that the Covid-19 response was out of money. HHS used "funds intended for coronavirus testing, personal protective equipment and other priorities," the Post reports.

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What we're reading

UnitedHealth's physician buying spree continues with takeover of Crystal Run, STAT
Next abortion battles may be among states with clashing laws, The Associated Press
Questions about Marc Tessier-Lavigne unanswered by the Genentech investigation, STAT
Johnson & Johnson's $8.9B bankruptcy settlement is 'unworkable,' talc plaintiff lawyer says, Fierce Pharma