The FDA's priority review vouchers are an under-the-radar health program that would need to be reauthorized in December, with research into drugs to treat rare pediatric diseases on the line if it doesn't happen, Victoria reports.

Why it matters: Patient advocates and pharmaceutical companies say a missed deadline could jeopardize the benefits of the program, which gives drugmakers incentives to develop drugs for rare pediatric diseases by allowing streamlined FDA product evaluations.

• But others argue that the program is a handout to drug manufacturers.

What they're saying: The voucher program encourages drug companies "to take on the financial and scientific risks associated with developing treatments for diseases that have historically been overlooked," Terry Wilcox, cofounder of Patients Rising, a pharma-affiliated patient advocacy group, told Victoria.

• If the program is allowed to expire, Wilcox said, "we jeopardize the progress we've made in giving patients and families hope for lifesaving therapies."

State of play: The program was due to expire Sept. 30 but was extended in the latest government funding continuing resolution. The new deadline is Dec. 20, the same day the CR expires.

• In September, the House passed legislation by voice vote that would reauthorize the program so the FDA could continue issuing vouchers through 2029.
• Sens. Bob Casey and Markwayne Mullin introduced a bipartisan reauthorization bill in the Senate this summer that would extend the program through 2030.

PAHPA, the pandemic preparedness bill, whose own reauthorization has been stalled since last year, had been seen as a potential vehicle for priority review vouchers to ride on.

• Last year, HELP Ranking Member Bill Cassidy was pushing for a five-year voucher extension to be included in PAHPA. Cassidy's office told Victoria the lawmaker still supports extending the program.
• Now it seems more likely that the priority review measure will have to ride on an end-of-year package, if one does materialize, or be extended in the short term in another continuing resolution into next year.
• One point in favor of the program is that a previous estimate by the CBO has put it as costing a minimal amount, and most of the cost is just for administration.

Friction point: But one obstacle could be current HELP Chair Bernie Sanders, who has previously opposed the priority review voucher program, viewing it as a handout to pharmaceutical companies.

• Sanders' office didn't respond to a request for comment.
• During the Energy and Commerce committee's markup of the House bill, Ranking Member Frank Pallone questioned whether the program actually motivated pharmaceutical companies to create drugs for rare diseases. But he still voted to approve the legislation.

Biden administration officials say they're getting around the congressional ban on Medicare coverage of anti-obesity medications by "reinterpretation of the statute," Victoria reports.

• They'd view treating obesity as addressing a chronic condition rather than weight loss.

Why it matters: The administration's announcement today of a proposed rule that would allow Medicare to cover anti-obesity medications could trigger a backlash if lawmakers think the administration is going beyond its authority.

• The proposed rule would also require Medicaid programs to cover anti-obesity medications. They're currently covered only as an optional benefit, and coverage varies by state.

What they're saying: "I have heard from countless people about how this coverage exclusion is a barrier preventing people from treating obesity and living healthier lives," CMS administrator Chiquita Brooks-LaSure said today in a call with reporters.

• "That's why we're proposing to revise our interpretation of the law and provide coverage of anti-obesity medications for the treatment of obesity."

By the numbers: The officials said they estimate about 3.4 million people in the Medicare program and 4 million in Medicaid would become newly eligible for obesity treatment.

Yes, but: The proposed rule could be reversed or altered by the incoming Trump administration.

What we're watching: At least one lawmaker had protested the move as of this morning: Rep. Lloyd Doggett, ranking member of the Ways and Means health subcommittee. So we're watching to see if others will join in.

• "Compelling Medicare and Medicaid to offer medications, whose prices they cannot now negotiate, will only bloat spending — costing taxpayers billions, raising premiums, and threatening the long-term security and promise of Medicare," Doggett said in a statement.

1. Omnibus or CR? It's probably going to be a CR, which would last through late February or early March, per Axios' Stephen Neukam, Juliegrace Brufke and Stef Kight.
2. RFK Jr.'s power: He could use his new HHS leverage by issuing more requests for vaccine safety data and appointing like-minded individuals to advisory panels, Axios' Adriel Bettelheim and Tina Reed report.
3. And his takeover: Trump's other health care nominees will be helpful to Kennedy's goals of disrupting health care agencies and raising doubts about vaccines, Axios' Caitlin Owens reports.
4. Ramaswamy vs. FDA: Vivek Ramaswamy still owns stock in the company he founded, Roivant Sciences, which is pursuing studies for three drugs that the FDA might review while he's in a position to reshape the agency, the Washington Post reports.
5. Sanofi's new 340B policy: The drugmaker, following J&J, plans to implement a policy that would give rebates rather than upfront drug discounts to 340B providers, the Wall Street Journal reports.