More IRA Lawsuits Coming, PhRMA Chief Predicts

Near-Term Programming Note: Cost Curve is off tomorrow, back Friday for AbbVie earnings and whatever other fun befalls us in the next 48 hours.

Long-Term Programming Note: I plan to be at J.P. Morgan in San Francisco this year, and I’d love to meet up.

I found out yesterday that J.P. Morgan won’t credential Cost Curve as media, so if anyone can suggest a Plan B, I’m all ears. I’m willing to give JPMorgan Chase a piece of the Cost Curve IPO, if that would grease the skids.

We have nine pending lawsuits against the IRA, which feels like a lot. But that’s apparently just the tip of the iceberg.

PhRMA CEO Stephen Ubl told Bloomberg Law “There is likely to be a second wave” of legal action, focused not on constitutional issues (as most of the existing suits are) but rather “as-applied” challenges to the implementation of the law itself.

Those future suits might map a little more to the legal efforts by Novo Nordisk and AstraZeneca, which are focused on narrow super-technical -- but critical -- issues such as how CMS has chosen to define terms. How those suits play out may provide a template for assaults to come. (For those tracking closely, HHS is due to respond to the AZ suit next Wednesday.)

That’s not to say that the constitutional challenges can’t work or won’t work. But the one judge to offer any ruling on any suit (the Chamber case) took a fairly skeptical line on the primary argument undergirding the constitutional claims. Add that to a parade of amicus briefs filed in the BMS/J&J case this week -- from academics, from law professors, from wonks, from medical societies, from think tanks -- and it feels like there is an uphill battle for the first wave.

• This is a useful look at the 56 oncology medicines approved between 2008 and 2018 that subsequently won approval for an additional indication. The research, from the folks at NPC, found that 59% of those medicines received an approval in a new cancer, and nearly half received a new indication in another line. It helps quantify the kind of post-approval development that is at risk under the IRA.

• Bernie Sanders isn’t going to vote to confirm Monica Bertagnolli as the director of the NIH, but he’s not pushing anyone to follow his lead. Sanders’ beef was -- and remains -- a concern that Bertagnolli isn’t going to drive hard bargains with drug companies when it comes to licenses.

• Another PBM is adding a Humira biosimilar to its formulary … at parity with Humira. If we’ve learned one thing so far in 2023, it’s that refusing to give preference to biosimilars is not going to lead to uptake. So you can probably ignore this announcement.