Notwithstanding the fact that I found plenty to write about today, my expectation is that the rest of the week is going to be kind of quiet. So I’m going to put Cost Curve on hold until Monday, barring something big and unexpected. I’ll still be at my desk for a portion of Wednesday and Friday, so if you’re looking for some communications consulting, I’d be happy to find some time.
The Orange Book is in the news again, with the FTC amping up pressure on Teva to list its inhaler patents in the Orange Book or else. The mechanism of this pressure is a “civil investigative demand,” which the Washington Post said is basically a subpoena, so I guess it’s good news for … lawyers?
The Washington Post has a link to Teva’s response to a previous Orange Book inquiry from Sen. Elizabeth Warren. It’s worth a read, both because it’s probably the core of Teva’s defense and because it makes clear that industry and the FTC are talking past each other.
Teva’s point is that Orange Book listings are not interfering with competition or generic entry, in part because no drug can have more than one Orange Book-triggered stay of generic competition, no matter how many patents are listed in the FDA’s database.
It also makes a compelling case that this whole brouhaha is meaningless until the FDA sets some standards: “If a company concludes that a patent claims an approved product, the company is required by statute to list the patent in FDA’s Orange Book,” the letter notes. “This is particularly important since FDA has steadfastly refused to tell Teva and other pharmaceutical innovators how to list patents related to components of a drug product, despite repeated requests from industry for this information since at least 2005.”
I have no idea what the outcome of the latest FTC gambit will be, but I’ll be curious to see how — or if — the agency responds to Teva’s reasonable questions here.
(If you want more Orange Book stuff, there is also a STAT op-ed from Sen. Dick Durbin and FTC Chair Lina Khan laying out their thinking on the Orange Book, but that doesn’t really address industry’s concerns, either.)
Leaving my professional biases aside, my heartfelt belief is that if the Democrats were really serious about driving medicine prices down, they would be fighting an all-out, multi-front war. They’d be mad not only at their usual punching bags in pharma, but they’d also be all-in on PBM reform and probably taking shots at hospitals, too, over markups.
In short, it would be “a plague o’ all your houses” kind of approach.
This is a prologue linking to a USA Today op-ed by Bernie Sanders and the President of the United States whining about high drug prices … that is almost entirely just throwing shade at drug companies. No bigger-picture thoughts. No serious policy proposals.
Yes, there is a nod to the weird Biden proposal to expand the IRA to 50 drugs a year, which in itself would have essentially no meaningful impact on anything. Beyond that, it’s the usual Bernie stuff about obesity meds, bolstered by the same dumb study that even the author won’t defend.**
But the real tell here that Sanders and Biden are in this for political reasons is that there’s no effort to take a swipe at PBMs, no nod to others behaving badly. I’m not naive enough to think that Dems would ignore pharma, but there’s not even a hint of other strategies.
Maybe some high-powered strategist has encouraged these guys to “keep it simple” and avoid getting into the confusing vortex of rebates and markups and benefit design. But, again, that speaks to a certain lack of interest in the substance of the drug pricing issue.
Because — let’s be honest here — we’re not going to get to a better system by spending all of our political capital shaming Novo Nordisk, as well that might poll.***
** As an FYI, any time you see a story that mentions there is research that shows that obesity meds can be profitably produced for $5 a month, remember that the author of that study went on live television and dropped some amazing quotes, including “I’m not trying to say, ‘what does it cost Novo Nordisk, today, to manufacture the drug” and “I’m not accounting for innovation. Yes, that’s true.”
*** I assume this polls well. It also had the knock-on effect of driving shares of Novo and Lilly lower today, which — not investing advice — seems silly in the absence of any actual policy proposals.
Today was a good day for PBMs. The Biden/Sanders op-ed ignored them, and there is only one story about people being mad at them: the military press is all over a congressional letter to the Department of Defense raising questions about whether Express Scripts is taking advantage of servicemembers.
This is a nice wrap-up, by the Partnership to Fight Chronic Disease’s Ken Thorpe, of all of the ways that the IRA might boomerang to harm patients with chronic diseases. From Health Affairs Forefront. It was published last week, but somehow fell through the cracks.
The physician voice has kind of been ignored in the IRA process, which is unfortunate, given that the structure of the program includes a lot of thinking on comparators. That makes this Real Clear piece from Mayo hematologist Rafael Fonseca an important read. The core of his argument: “If CMS allows pricing, along with pharmacy benefit manager rebating pressures, to trump clinical nuance and patient-centered care, the damage could be immense.”
Header image via Flickr user e-Magine Art.
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