An FDA advisory panel's recommendation to pull an early birth drug from the market is only the latest controversy surrounding a popular program aimed at getting promising new treatments to patients faster, Axios' Caitlin Owens writes.

Why it matters: Critics — including the FDA itself — say the program lacks appropriate guardrails, putting expensive, unproven treatments in consumers' hands while drugmakers often delay proving the drugs' effectiveness.

Driving the news: Wednesday's recommendation that the FDA pull Makena, a drug owned by Covis Pharmaceuticals marketed as preventing pre-term births, came after years of tension between the company, the agency, consumer protection groups and medical associations.

The big picture: Accelerated approval began drawing policymakers' attention after it was used last year to approve Aduhelm, a controversial Alzheimer's drug that an FDA advisory panel recommended the agency not approve. The manufacturer Biogen later largely gave up marketing the compound.

• The more routine issue with the program is that drugmakers frequently miss deadlines for completing confirmatory trials, yet their products remain on the market.
• Both the House and the Senate have proposed reforms to the program, and the FDA asked specifically for more authority to ensure confirmatory studies "progress in a timely manner."
• Lawmakers punted on legislative reforms when they debated a must-pass FDA bill last month. The issue could resurface during a post-election lame-duck session.

By the numbers: A report by HHS's internal watchdog found nearly 40% of the 278 drug applications granted accelerated approvals from 1992 to the end of 2021 haven't completed their confirmatory trials.

What we're watching: The FDA will now officially decide whether to pull Makena from the market, likely ending this particular saga.

• The question then becomes whether Congress will enact reforms to the program after the midterms, and how far those reforms will go.

The panel's recommendation to pull Makena from the market could leave one fewer option for a health care segment that's customarily overlooked by researchers and drugmakers.

Why it matters: Treatments to reduce maternal mortality or reduce pre-term births — problems that disproportionately impact women of color — are few and far between. And experts say there isn't much energy directed at building a pipeline.

What they are saying: "There is a dearth of research into women's health, into peripartum and immediate postpartum health and there's a dearth of good high-quality preventative treatments," Megan Ranney, academic dean at the Brown University School of Public Health, told Axios.

• "Although the removal of this product makes absolute sense, it leaves those at highest risk with even fewer options," she said.

Go deeper.

Pandemic-era policies to expand telehealth haven't increased the number of patient services that Medicare pays for, a new claims analysis from consulting group Teus Health suggests, Axios' Maya Goldman writes.

Why it matters: The findings could counter concerns that continuing telehealth flexibilities beyond the COVID-19 public health emergency is too expensive.

Details: The number of virtual and in-person patient visits Medicare covered in 2021 remained below 2019 levels.

• In-person and virtual care had almost identical rates of repeat visits for the same medical issue, at just over 20%. The study also found consistent rates between chronic and emergent conditions.
• But the rate of repeat visits varies with diagnoses, and more research is needed to understand why the variation happened, said the Alliance for Connected Care, the industry group that commissioned the analysis.

Reality check: Congress has already authorized extending telehealth waivers and other favorable policies for five months after the end of the emergency designation. The Congressional Budget Office predicted the extension could cost the government $663 million.

• Though a pro-telehealth lobbying group commissioned the research, other studies show similar findings.
• Nature published a study in September that found little change in primary care visits between 2019 and 2021 as telehealth became increasingly popular.

Almost 40% of Americans are willing to split their ticket and vote for a candidate from the opposing party who made a top priority of lowering health costs, according to a Gallup/West Health poll published today, Axios' Victoria Knight writes.

Why it matters: Though candidates haven't been talking much about medical costs in the run-up to the midterms, the issue remains enough of a priority that it could erode straight party-line voting.

By the numbers: 87% of Americans polled said a candidate's plan to reduce the cost of health care services was very or somewhat important in casting a vote.

• The issue cut across partisan lines, with 96% of Democrats and 77% of Republican respondents saying a candidate with a health care costs plan was an important factor.
• 86% also said a plan to lower prescription drug prices is very or somewhat important. That's especially true for seniors.

Of note: Democratic voters were more likely than Republicans to say they would cross party lines because health costs are a top priority. 4 in 10 Democrats said they were likely to do so compared to about 1 in 5 Republicans.

💉 The FDA issued an emergency use authorization for Novavax's COVID-19 vaccine as a booster shot for all adults in the U.S., including those who initially received Pfizer's or Moderna's shots. (Axios)

👀 COVID-19 contributed to a quarter of maternal deaths in the first two years of the pandemic, according to an oversight report to Congress released on Wednesday. (Axios)

👉 The National Academy of Medicine published a call-to-action for workforce well-being (Modern Healthcare)