- Cost Curve
- Posts
- How to Catch Up Quick on the Merck/IRA Lawsuit
How to Catch Up Quick on the Merck/IRA Lawsuit
Plus ... How the National Raisin Reserve Plays Into IRA Litigation
The Merck lawsuit that led Curve yesterday is still all anyone is talking about. Literally every national outlet covered the story, so if you want to catch up, you have a lot of choices. Here’s how I’d approach things:
First, read the STAT coverage, which probably has the best perspective (and definitely the best kicker). WSJ did a pretty good job, too, as did the Financial Times.
Then check out this highly skeptical Twitter thread from University of Michigan law prof Nicolas Bagley. I suspect that it’s not as cut-and-dried as Bagley suggests. “Never go in against a pharma lawyer when death is on the line” is up there with “never get involved in a land war in Asia” when it comes to life advice. (Apologies to the Princess Bride.)
After that, check out Endpoints’ coverage of the reaction from inside the industry, including the possibility that Biogen will follow Merck’s lead.
And if you still want more -- and you haven’t done it yet -- the actual lawsuit is a great read.
Lawsuits aside, I don’t want to lose the thread around cancer drug development.
I’ve now referenced, a couple of times this week, a PhRMA/Partnership for Health Analytic Research analysis, but I haven’t really dived in. It’s probably worthwhile to pause and do that.
The upshot is that the majority -- 61% -- of small-molecule cancer medicines routinely get cleared for additional uses after their initial approval. About two in every five of those additional uses come seven years or more after the first approval.
Because the Inflation Reduction Act imposes price controls on small molecules after nine years, the PhRMA/PHAR research raises the question of whether companies will continue to do the expensive and painstaking clinical research on medicines subject to government price-setting. What gets shelved? What gets prioritized?
As I mentioned yesterday, Novartis and Genentech have already answered that question, in some ways: larger indications get prioritized. Speed does not.
Shots Fired: the PBM lobby is out with a snark-laden Boston Globe op-ed targeting the BIO attendees flooding Boston. “... despite the clear demand to address prescription affordability, it seems there are a hundred other topics to discuss as a pharmaceutical and biotech sector at this year’s meeting of the minds,” wrote PCMA’s SVP Katie Payne.
Politico ran a piece about how Medicare Director Meena Seshamani says she is all-in on getting patient input around the drug price-setting provisions. A good place for her to start would probably be reading the letter that NORD -- and a hundred other patient groups -- already sent to CMS.
Sen. Bernie Sanders doesn’t want Medicare to pay the current price for Eisai’s Leqembi Alzheimer’s drug, and barring that, he wants HHS to break the drug’s patents.
Nevada published its annual Drug Transparency Report, which is pretty much impossible to parse. Here’s the link. Good luck.
Endpoints published a Q-and-A with GSK’s Emma Walmsley, in which she dodges questions about any GSK-related implications around the Horizon-Amgen-FTC brouhaha.
I’m looking forward to the legal debate around the Merck IRA lawsuit, in no small part because there is a chance we’ll get to hear about the National Raisin Reserve.
It turns out there was -- until recently -- a government agency that took from raisin growers some portion of the U.S. supply to control market prices. In 2015, the Supreme Court ruled that the Reserve violated the takings clause. That spelled the end of the National Raisin Reserve.
That case is frequently referenced when Fifth Amendment claims are debated. That’s at the core of Merck’s argument, so there will soon be -- among lawyers anyway -- a discussion about the similarities between pills and raisins.
(I’m a sucker for weird national stockpiles. Nothing will top my love for the fact that Canada has a maple syrup reserve … and that there was once a heist of millions of dollars worth of syrup from a facility in Quebec.)