Finance joins the drug pricing fun

The Senate health committee has generated buzz for its early work putting together a bipartisan health care policy package, and a new panel is getting in on the action, my colleague Rachel Cohrs reports from the Capitol.

Senate Finance Chair Ron Wyden (D-Ore.) told reporters Monday that he and his Republican counterpart Mike Crapo (R-Idaho) are working to put together a package addressing pharmacy benefit managers — and he's already talked to Ways & Means Chair Jason Smith (R-Mo.) about health care.

"You gotta go to where the major expenditures are in terms of the federal government. That's our committee," Wyden said.

A Senate aide said the hope is to develop bipartisan legislation on prescription drug policy with a focus on PBMs, and to engage across the committee and in the House, as well. This area of interest wouldn't be new or surprising, as Wyden has introduced a package of PBM reforms in the past and the Finance committee recently held a markup on the issue.

LONG TERM CARE

Biden orders home care improvements

President Joe Biden today will release an executive order designed to vastly improve long-term care — from plans to implement nursing home staff ratios to potential Medicaid and Medicare payment tweaks to keep people in the home care workforce, and encourage more to join. And while the administration is asking for nearly a trillion to see his sweeping care plan realized, officials insist some of these changes can happen without a spending bump. That could be a small nod at the reality in Congress, where Republicans have promised to nix spending increases that push the deficit.

The administration is hoping the bulk of these plans will be funded through the proposed 2024 budget — including $600 billion over a decade for universal preschool. Biden also is instructing HHS to "build on" the minimum staffing requirements for nursing homes and "condition a portion of Medicare payments on how well a nursing home retains workers," per a White House fact sheet.

"If you look at something like ensuring a greater share of Medicaid spending actually reaches homecare workers who are doing the work, that's not about new dollars, it's about … lining up the incentives so that these are better jobs," said one senior official. That said: "We are absolutely continuing to call for more resources," another added.

SCOTUS

The midweek abortion pill decision

Maybe don't make plans: A U.S. Supreme Court justice's Friday move to pause limits on abortion pills sets us up for a decision on their fate – and broadly, the authority of the FDA – this Wednesday by midnight. Anti-abortion advocates have until noon today to file their responses after the order by Justice Samuel Alito, who last summer penned the court's decision overturning Roe v. Wade.

Alito's stay gives the court time to consider arguments about mifepristone and the amicus briefs that poured in this past week from dozens of pharmaceutical executives, legal experts, and late Friday, the industry lobby PhRMA (which had initially tread lightly as other industry groups blasted the Texas decision that set off this firestorm). But his order is no indication that the conservative-majority court could side with the FDA on the decades-old mifepristone approval.

PhRMA in their brief argued that last week the Ninth Circuit Court of Appeals made the right move by restoring mifepristone access during the legal battle but "did not go far enough" because it barred FDA-cleared options like mail-order mifepristone. The lobby also warned that the appeals court "endorsed a sweeping theory of standing that would potentially invite limitless court challenges to FDA-approved drugs based on the mere possibility of future purported harms that are commonplace in the medical field," echoing other briefs that argued this decision could "chill" development of new drugs.

Read more: I'll be on standby all week (and at all hours) for new documents to drop. But in the meantime, read about how the patchwork of abortion policies and politics have already divided a Virginia-Tennessee border town struggling with accessible health care, from my colleague Eric Boodman.

E-CIGS

A lawsuit that could be really, really embarrassing for the FDA

Tomorrow, lawyers for the FDA and the e-cigarette company Juul will spar before a federal judge in Washington — not over some scientific issue or a compliance dispute — but over whether the FDA has to disclose a previously secret memo discussing Juul's application, my colleague Nick Florko reports.

Nick is the first to admit he's a bit too obsessed with public records, but there aren't many FDA lawsuits that get the heart pumping quite like this one. For the uninitiated, Juul filed a FOIA lawsuit last September as part of its ongoing fight with the FDA over the agency's attempts to ban its products. This is where things get interesting: That lawsuit successfully uncovered that the FDA had drafted two memos discussing Juul's application, but only one was made public – the second one wasn't even stored in the FDA's actual document archive and FOIA officers didn't know it existed.

Juul appears to believe the second, yet-to-be-released memo would bolster the case for why its product should be authorized, though it's impossible to know for sure what it actually says (since the FDA refuses to release it.) The FDA, for its part, says it shouldn't have to disclose the second memo because it was essentially a work-in-progress and disclosing it would make it harder for FDA scientists to do their jobs, especially since Juul's application is still being reviewed.

Regardless of what the memo says, and whether it actually is as positive as Juul predicts, Wednesday's hearing is yet another eyebrow raising moment in what's already been a drawn out and pretty embarrassing saga for the FDA. (And if I may editorialize for a second, it's also yet another example of why public records laws are so cool.)

HOUSE OVERSIGHT

Panel takes up Covid-19 origins, unaccompanied minors

The GOP-led House Oversight Committee has a packed schedule this morning, starting with a 9 am subcommittee hearing on the origins of the coronavirus pandemic followed by a midmorning hearing on how HHS's Office of Refugee Resettlement has followed through with unaccompanied minors placed in homes — sometimes without family — after they cross the border.

Both hearings hit at messaging challenges for the Biden administration, which has largely downplayed theories that Covid-19 leaked from a lab (though the president didn't fight a bill from Congress demanding intelligence reports about the virus' origins) and weathered flak for reports that unaccompanied minors were falling into dangerous home situations and illegal labor after leaving border care.

The Covid-19 hearing also comes one day after Republicans in the Senate released a full report suggesting that the virus leaked from a Wuhan, China, lab rather than spreading naturally from animals to humans at a food market. U.S. agencies and world health regulators have come to conflicting conclusions or more commonly, no definitive one, as they've probed the start of the pandemic.

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