Where expiring ACA subsidies currently stand

The Senate last week voted down competing healthcare proposals aimed at addressing enhanced ACA subsidies that are slated to expire at the end of the year, leading the House to tee up a series of other healthcare votes this week.

Both Senate proposals needed 60 votes to pass. The Senate Democratic proposal, which would have extended the enhanced ACA subsidies for three years, failed 51–48. The Senate Republican proposal, which wouldn't have extended subsidies but instead would have provided payments between $1,000 and $1,500 into health savings accounts for some ACA enrollees, also failed 51–48.

Senate Majority Leader John Thune (R-S.D.) has said he's open to continuing bipartisan talks on a healthcare package, however both parties are skeptical that a deal can happen. Senate Democrats have been pushing a three-year extension of the ACA subsidies without any modifications, arguing that many Republican-backed changes to the subsidies aren't feasible with little time remaining before the start of 2026.

Meanwhile, many Senate Republicans have been opposed to any kind of extension of ACA subsidies, arguing the subsidies are wasteful spending that benefit health insurance companies. Of note, four Republicans — Sens. Susan Collins (R-Maine), Josh Hawley (R-Mo.), Lisa Murkowski (R-Alaska), and Dan Sullivan (R-Alaska) — voted in favor of the Democratic proposal. Just one Republican, Sen. Rand Paul (R-Ky.), voted against the Republican proposal.

The House this week plans to take up a series of healthcare votes; however, House leadership plans to bring up a set of proposals that don't include extensions of the ACA subsidies. Instead, the plan includes several other measures including transparency requirements for pharmacy benefit managers and measures to help small businesses purchase health coverage.

House Speaker Mike Johnson (R-La.) said that he won't call a vote on extending the ACA subsidies. "There's about a dozen members in the conference that are in these swing districts who are fighting hard to make sure they reduce costs for all of their constituents. And many of them did want to vote on this Obamacare Covid-era subsidy that Democrats created," Johnson said. "We looked for a way to try to allow for that pressure release valve, and it just was not to be. We worked on it all the way through the weekend, in fact. And in the end there was not an agreement — it wasn't made."

However, on Wednesday, four House Republicans — Reps. Brian Fitzpatrick (R-Pa.), Mike Lawler (R-N.Y.), Robert Bresnahan (R-Pa.), and Ryan Mackenzie (R-Pa.) — signed onto a discharge petition filed by House Minority Leader Hakeem Jeffries (D-N.Y.) that includes a clean three-year extension of the ACA subsidies and was backed by all 214 House Democrats.

The support of the four House Republicans brings the petition to 218 signatures, which means the House will have to have a vote on the measure. House leadership has seven legislative days to bring it up, meaning they could punt the vote until January.

(Sullivan, Axios, 12/15; Sullivan, Axios, 12/11; McCaskill/Cowan, Reuters, 12/12; Kapur et al., NBC News, 12/16; Santaliz/Solender, Axios, 12/17)

FDA considered putting 'black box' warning on COVID-19 vaccines

Some FDA officials recommended putting a "black box" warning on COVID-19 vaccines, the most serious warning FDA places on medicines that's designed to warn about risks like death or life-threatening or disabling reactions. However, agency leaders, including director of the agency's Center for Biologics Evaluation and Research (CBER) Vinay Prasad, didn't feel the move was necessary, according to FDA Commissioner Marty Makary.

Trump signs executive order classifying fentanyl as 'weapon of mass destruction'

President Donald Trump on Monday signed an executive order designating fentanyl as a "weapon of mass destruction" that is "closer to a chemical weapon than a narcotic" and could potentially be weaponized for "concentrated, large-scale terror attacks by organized adversaries."

In an Oval Office event to award the Mexican Border Defense Medal to members of the military who were sent to assist with efforts to crackdown on southern border crossings, Trump signed the order and warned against the "scourge" of fentanyl.

"No bomb does what this is doing," Trump said, attributing between 200,000 and 300,000 deaths per year to the drug.

Drug deaths have steadily declined since 2023 but are still elevated, with around 76,000 Americans estimated to have died of an overdose in the 12-month span ending in April.

However, some drug policy experts said Trump's claims about fentanyl lack evidence.

There is only one documented instance of fentanyl being used as a biological weapon. In 2002 during a hostage crisis in Moscow, Russian security services released gas believed to contain an aerosolized fentanyl analogue into a theater, which succeeded in killing the 40 captors and contributed to the deaths of as many as 132 hostages.

Jonathan Caulkins, a professor at Carnegie Mellon University whose research focuses on drugs, crime, terror, and violence, said the appeal of the designation is apparent, especially since even small amounts of fentanyl could cause overdose in people who don't already use opioids, but simply applying the label regardless of the actual threat level posed cheapens the term.

"I'm inclined to push back against the hijacking of terms that have a specific meaning just to harness the emotional impact," Caulkins said. "By those arguments, cigarettes would be weapons of mass destruction — cigarettes kill more Americans every year than fentanyl does."

(Samuels, The Hill, 12/15; Facher, STAT, 12/15)

Top drug regulator set to leave FDA, top lieutenant to FDA commissioner to replace him

Richard Pazdur, FDA's top drug regulator, has filed papers to retire from the agency at the end of this month, according to two agency sources familiar with the matter who spoke to STAT. A spokesperson for FDA confirmed the news and said Pazdur's decision is final.

"We respect Dr. Pazdur's decision to retire and honor his 26 years of distinguished service at the FDA," the spokesperson said. "As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients."

Pazdur was named director of the Center for Drug Evaluation and Research (CDER) in November, replacing George Tidmarsh, who left FDA earlier that month following accusations that he used his regulatory authority to advance a personal vendetta against a former business associate.

Three sources close to Pazdur who spoke to STAT said that concerns about the legality of a new drug review program, FDA Commissioner Marty Makary and CBER Director Vinay Prasad inserting themselves into drug review decisions, and Makary's efforts to handpick hires for CDER all contributed to Pazdur's decision to leave.

In his place, Tracy Beth Høeg, a top lieutenant to Makary who previously investigated reports of children who died after receiving a COVID-19 vaccine, will lead CDER, according to an announcement from FDA.

"CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective," Høeg said in a statement. "This is an incredible opportunity to serve my fellow Americans."

"Dr. Høeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there," Makary said in a statement.

(Lawrence, STAT+ [subscription required], 12/2; Lawrence/Cirruzzo, STAT+ [subscription required], 12/3)

CDC approves new hepatitis B vaccine recommendation

CDC on Tuesday approved the recommendation from its Advisory Committee on Immunization Practices (ACIP) to delay when most babies receive a vaccine against hepatitis B.

Earlier this month, ACIP voted 8-3 to approve the recommendation for mothers who test negative for hepatitis B during their pregnancy. The recommendation specifically states that these mothers should discuss with their doctors whether to give the hepatitis B vaccine at birth, or at all, and those who choose to give their child the vaccine should wait until their baby is at least two months old.

The recommendation doesn't change the policy for babies born to mothers who tested positive for hepatitis B during pregnancy or whose hepatitis B status isn't known. These babies should still receive a dose of a vaccine within 12 hours of birth and a dose of hepatitis B immune globulin.

The recommendation also won't affect insurance coverage for hepatitis B shots, nor will it affect coverage through the Vaccines for Children Program.

(Payne, STAT, 12/16)