HHS' new efforts to tie drug prices to what other countries pay

When the Biden administration first secured an agreement from Regeneron to guarantee that the U.S. would get a better price for its latest Covid-19 treatment than any other developed country, the big question was how widely HHS would apply that idea.

With an announcement this morning, we have a better idea. ASPR announced it has negotiated best-price provisions with three more vaccine makers involved in Project Next Gen: CastleVax, Gritstone Bio, and Codagenix. And in the future, a senior administration official said, "pricing will be a factor in all of [ASPR's] contract negotiations going forward."

It's a big deal for the drug pricing world, but with one big caveat: this won't apply to NIH-funded research, so the impact is still limited. Here's more from us on the Regeneron deal.

reproductive rights

FDA's authority gets a SCOTUS test

ZCSRL53ETBLISK2L4WLB67Q3TM-1600x900

SHURAN HUANG/THE NEW YORK TIMES

A controversial legal case over access to a commonly used abortion pill is going all the way to the Supreme Court, my co-author Sarah Owermohle writes.

It's set up to be an election-year brawl — oral arguments will happen in the spring, with a decision by this summer. The case could have big implications for the FDA's regulatory authority, and could open up the floodgates for challenges to the agency's decisions.

A lower court in Texas ruled against the FDA, but the decision is stayed and access remains unchanged as the legal process plays out. Read more from Sarah.

STAT also looked at the life of an abortion provider who, after Dobbs, shuttered his clinic and took his mission on the road. More here.

health tech

Regulators eye AI in health care

Federal regulators finalized new rules aimed at placing guardrails around a new generation of AI models gaining rapid adoption in hospitals and clinics around the country yesterday, my colleague Casey Ross reports.

Companies who develop the tools for health care settings are going to have to disclose more technical details about how they train, develop, and test AI models.

Want an example of how an AI model developed by an electronic health records company can go wrong? Read some of Casey's prior reporting on algorithms developed by Epic that delivered inaccurate information on seriously ill patients.

influence

Hospitals to Congress: Throw PBMs under the bus

After Monday's House health care vote, one prominent hospital lobbying group is trying to throw PBMs under the bus.

At issue is how to pay for a package of health programs that currently expire on Jan. 19, including funding for public health programs and efforts to delay cuts to community health centers and safety-net hospitals. The House's plan includes a $3 billion hit to hospitals to offset those items.

The Federation of American Hospitals, which represents for-profit hospitals, this week publicly endorsed the Senate's plan which, you guessed it, takes a bigger hit out of the PBM industry instead. It's normal for a group to oppose a bill they don't like — less common for them to publicly endorse a competing package that originally passed a Senate panel five months ago. For the record, PBMs don't really like either plan.

More around STAT

Check out more exclusive coverage with a STAT+ subscription

Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

A new law regulating the cosmetics industry expands the FDA's power but fails to ban toxic chemicals in beauty products, Inside Climate News
Health records don't always show when patients are dead. One researcher is trying to change that, STAT
Contraception is a winning issue, conservative strategists tell GOP, Politico
Gene therapy offered this 7-year-old freedom. The price: a grueling year, STAT