Three appeals in a pod

Three judges on the U.S. Court of Appeals for the Third Circuit interrogated lawsuits brought by Bristol Myers Squibb, Johnson & Johnson, and AstraZeneca against the Inflation Reduction Act's Medicare drug negotiation program. It's the first appellate court hearing on drugmakers' suits. A district court judge ruled against the companies.

The issues the judges asked about included:

How much notice companies would have to give to leave the negotiation program
Whether the government can tie drug products made by the same company together in purchase negotiations
Why Congress didn't just set the prices in statute themselves
Whether Medicare serves as both a regulator and a buyer of the medicines
Whether terms in a government contract can count as a violation of free speech rights.

If circuit courts ultimately split in their rulings, it makes it more likely that the Supreme Court could take the case.

election 2024

Presidential candidates make closing arguments on caregiver support

In the final sprint to Election Day, both VP Harris and former President Trump are promising to provide relief to family caregivers, an estimated 53 million voters and growing.

Trump once again brought up tax credits for long-term caregivers during a North Carolina rally on Wednesday, after unveiling the proposal at his Madison Square Garden event over the weekend, DCD co-writer Sarah Owermohle notes.

He said Harris "copied" him when she, too, promised caregiver support during a Washington D.C. event Tuesday night. But what Harris seemed to be referring to was her own "Medicare at home" plan, launched earlier this month. That proposal would offer Medicare coverage for at-home care on a sliding scale, based on seniors' needs and incomes. Harris suggested the program (conservatively projected to cost $40 billion a year) would be funded by letting the Medicare program negotiate prices for more drugs. (Trump hasn't yet discussed who would be eligible for his plan, or how it'd be funded).

But both candidates have reasons to vie for the votes of a huge and growing share of the U.S. population, dubbed the 'sandwich generation,' faced with caring for aging family members. In key battleground state Pennsylvania, for instance, AARP polling suggests a third of voters identify themselves as caregivers. In North Carolina, where both candidates rallied Wednesday, 1 in 4 voters say they are caregivers and most over-50 voters say they'd pick a candidate with a support plan.

influence

Chiropractors for RFK

The Make America Healthy Again movement has a new super PAC, called the MAHA Alliance, and one group dominates the committee's early donors: chiropractors.

In the group's first campaign finance reports, 26 out of the 51 initial donors were chiropractors. Robert F. Kennedy Jr.'s campaign nodded to chiropractors as a base of support, even selling "Chiropractors for Kennedy" bumper stickers. Chiropractors have long complained of hostility from the medical establishment, and some leaned into misinformation during the Covid-19 pandemic.

Of the other donors, one was Robert Malone, a physician who gained fame spreading misinformation about Covid-19, and claimed to have a role in the development of the Covid-19 vaccines. Another, Merily Pompa, pleaded guilty to stealing from the trust fund of children she and her husband — also a chiropractor — adopted.

coverage

The ghost of elections past

There's been a firestorm over the Affordable Care Act (again) this week following video NBC obtained of House Speaker Mike Johnson (R-La.) stating that health care reform will be "a very big part of the agenda" for the House GOP next year. The video also shows a confusing exchange between an event attendee and Johnson about whether changes to the Affordable Care Act would be on the table.

First, Johnson was asked some very wonky questions about HSAs and direct primary care. He said the desire for health care reform is not a secret, and that the GOP Doctors' Caucus has given him a laundry list of reform ideas. Spokespeople for the three co-chairs of that caucus didn't provide details of their proposals in response to inquiries from STAT. He talked about taking "a blowtorch to the regulatory state," and decried agencies being weaponized against people.

"No Obamacare?" one attendee then asked. "No Obamacare," Johnson said, rolling his eyes. "The ACA is so deeply ingrained, we need massive reform to make this work."

Some news reports have characterized that exchange as an indication that Johnson wants to get rid of the Affordable Care Act entirely. His office says he was trying to say the opposite.

"Despite the dishonest characterizations from the Harris campaign, the audio and transcript make clear that I offered no such promise to end Obamacare, and in fact acknowledged that the policy is 'deeply ingrained' in our health care system. Still, House Republicans will always seek to reduce the costs and improve the quality and availability of health care for all Americans," Johnson said in a written statement.

Regardless of how you read these off-the-cuff comments, a few pieces of context to consider. Trump's campaign disavowed ACA repeal, and other Trumpworld figures have been clear that repeal and replace is not a top priority. Democrats are also always eager to say the Affordable Care Act in its entirety is under threat, as it's a winning political argument for them.

agencies

The FDA's shortage saga

All the dosages of Novo Nordisk's blockbuster diabetes and obesity treatments are listed as available, which means they could be taken off the agency's drug shortages list, STAT's Elaine Chen reports.

If the drugs are pulled off the shortage list, it's unclear whether the FDA will ban compounders from continuing to make copies of the drug, given the agency got burned by an about-face in a similar situation with Eli Lilly drugs.

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What we're reading

Hassan, Cassidy prep site-neutral framework, Axios
First Opinion: The progressive campaign against biomedical innovation, STAT
Court ruling threatens to curb billions in political 'dark money', The Wall Street Journal
Eli Lilly hits rare stumble, as sales and earnings disappoint, STAT