A Judge Rules Against PhRMA in an IRA Case, But Does It Matter?

CORRECTION: Last week, I flagged a study that looked at prices for generic drugs at a number of “direct to consumer” pharmacies. I noted that the researchers compared the prices at those pharmacies to GoodRx prices. 

But I missed a nuance: the researchers didn’t compare the prices to the discounted prices available using a GoodRx card. They simply used GoodRx as the data source for undiscounted price information. I regret the error.

The first decision in an IRA case is out, and it’s a loss, sort of, for PhRMA. A judge in Texas granted the government’s motion to dismiss a suit filed by PhRMA, the National Infusion Center Association (NICA), and the Global Colon Cancer Association.

The coverage has been pretty spotty. Bloomberg Law is probably the best take so far, but I don’t think any article really gets to the heart of the legal underpinnings (which is that only NICA is based in Texas and can therefore sue in Texas, but NICA is barred from suing for procedural reasons). If you really want to get your head around things, you should probably just read the 14-page opinion. 

As with all things legal, I’m out over my skis on everything I’m about to write, but it seems like there are a few takeaways:

1. This ain’t over. The assumption, I think, has always been that these suits will get appealed at least once (to the circuit court), if not twice (if the Supreme Court takes them up). And PhRMA is “weighing our next legal steps,” which seems like a sign. 

2. This was a procedural decision. For all of the analysis we’ve seen over the past nine months or so about the constitutional questions, this case turned on standing, which is far more boring -- but no less important -- than the big questions.  

3. It’s not clear this decision matters to the other cases. At the heart of the PhRMA case was a government argument that NICA, under the Medicare Act, needed to try to resolve its concerns about the law with CMS first. I look forward to someone clearly explaining the “arise under” standard, but a quick control-F through some of the other lawsuits suggests that the Medicare Act argument is not being deployed elsewhere (I assume because the harm to infusion centers is legally distinct from the harm that manufacturers are alleging). So I don’t think that this should have a huge impact elsewhere. 

In terms of next steps, the only real commentary I’ve seen is Georgetown Law’s Zachary Baron’s comment to Axios that if the Fifth Circuit does back industry on this, it likely just means that the case will be kicked back down to the district court for a round two. 

I’d be shocked if a bunch of big law firms didn’t write up explainers about this decision over the next few days -- sometimes, breaking news journalism is not the best way to capture nuance -- and I’ll share those as I see ‘em.

• It’s not drug pricing, per se, but I’m always interested in pharma industry reputational plays. So I sat up on my couch when I saw the Pfizer Super Bowl ad come on. Reactions have varied. My social feed was filled with lots of praise, but I’m not sure that my peers are representative. The NYT wasn’t a fan. STAT went with a deeper/more objective take. Whatever your thoughts on the commercial itself, if you didn’t love the musical choice, we’re going to have to drop the mitts. 

• When you boil everything else down, the biggest question in health care is “how do we make sure that we’re paying for stuff that delivers high value?” It’s a really hard question (in part because “high value” is, itself, a tough concept to pin down), but this JAMA Health Forum article has some good thought starters, especially as it relates to benefit design. 

• JAMA examined how Americans of different ages view various proposals around Medicare (lowering the eligibility age, offering a public option, “negotiating” drug prices, etc.) and found that once folks hit 65, they’re far less likely to support a public option, and support for other expansion erodes more slowly. One of the authors noted on Twitter that “If Democrats want to expand Medicare, they may have to convince beneficiaries that doing so won’t erode their current benefits. Because otherwise, it’s an uphill battle against one of the most politically engaged groups in America.”

• There’s a STAT First Opinion from former FDA lawyer Dan Troy in which he raises an eyebrow at some early legal successes in a lawsuit that alleges that Gilead slow-walked development of an HIV medicine. 

• Big day for Dan-related op-eds: Dan Leonard from We Work for Health also has a piece out detailing how the IRA is going to hammer biosimilars development by raising the risk that the government’s intervention to drive down costs could destroy the market for lower-cost biosimilars. 

• Maryland’s legislature is trying to expand its PDAB so that the group’s decisions affect all Marylanders, not just those covered by government health plans. WTOP and Maryland Matters both have summaries of the reaction.