A List of Would-Be IRA Targets and a List of IRA Legal Deadlines

I should warn all of you that this newsletter contains the word “Shkreli” eight times. That’s probaby eight times more than you would want, but I really can’t help myself sometimes.

This might be a slow month, but there will be IRA-related things every single day until September 1 (or maybe a day or two before!), when the first 10 drugs to be price-controlled are announced.

Today’s IRA-related thing is a Reuters article that summarizes which drugs Wall Street thinks will be on the top 10 list. It’s a broader list of possibilities than this Journal of Managed Care and Specialty Pharmacy piece that gets referenced all the time. The Reuters accounting is a reminder that there is still some uncertainty.

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But I want to contribute an IRA-related thing, too. So here is a list of all of the current deadlines in five of the six IRA related lawsuits (there isn’t a briefing schedule out yet in the Astellas case). For those counting, this means there will, on average, an IRA-related legal filing every nine days until Christmas shopping season.

• August 10, 2023 (PHRMA): Plaintiff’s motion for summary judgment

• August 11, 2023 (CHAMBER): HHS’ opposition to Plaintiffs’ motion for a preliminary injunction

• August 16, 2023 (BMS/JANSSEN): Plaintiffs’ motions for summary judgment (one brief for each plaintiff)

• August 25, 2023 (CHAMBER): Plaintiffs reply in support of their motion for a preliminary injunction and a separate opposition to HHS’ motion to dismiss.

• September 8, 2023 (CHAMBER): HHS’ reply in support of their motion to dismiss.

• September 11, 2023 (MERCK): HHS’ opposition to Plaintiff's motion and cross-motion

• September 29, 2023 (PHRMA): HHS’ motion for summary judgment and opposition to plaintiff’s motion for summary judgment

• October 16, 2023 (BMS/JANSSEN): HHS’ combined opposition and cross-motion for summary judgment

• October 19, 2023 (MERCK): Plaintiff's reply to motion for summary judgment and opposition to cross-motion

• October 26, 2023 (PHRMA): Plaintiff’s reply and opposition to HHS’ motion

• November 10, 2023 (BMS/JNJ): Plaintiffs’ combined replies in support of their motions for summary judgment

• November 17, 2023 (PHRMA): HHS’s reply

• November 21, 2023 (MERCK): HHS’ reply in support of cross-motion

• December 8 (BMS/JANSSEN): HHS’ reply in support of their cross-motion for summary judgment

• Your daily dose of weight-loss drug news comes from STAT, which has a good look at the aggressive ways that payers are cracking down on off-label use of GLP-1 meds.

• Speaking of payers, the American Prospect (more from them below) goes after UnitedHealth. And if you want to stick with the payer theme, STAT has a worthwhile piece on how all the insurance companies are pivoting into primary care.

• Business Insider on pharma’s approach reporting profits: “It is undeniably allowed by the tax law, but it is still an outrage.”

• I wasn’t paying close attention to new 340B reporting requirements in Minnesota and Maine, but Ted Slafsky, the guy behind the 340B Report, says that such efforts are going to be more and more a part of the regulatory landscape. “340B covered entities to be working closely with their federal and state lawmakers to push hard for the enactment of legislation that restores access to contract pharmacies while also determining what type of transparency/good stewardship standards they can live with.”

• I may do a little 340B wrap tomorrow, in which case I’ll repeat this line, which comes from a letter that the National Association of Community Health Centers sent to Senators last week. “Today, more than half of the top 20 companies on the Fortune 500 generate profit from the 340B program.” I mean: whoa.

• Finally, you all know that I’m obsessed with TheracosBio, which is running an ambitious experiment to see there is a cash-pay market for branded drugs. They have new CEO, so … congrats and good luck to Brian Connelly.

I have to admit: this 7,000 word American Prospect story is living rent-free in my head.

On the surface, it’s a great example of an over-reported, under-edited attempted takedown of the orphan-drug market by an advocate-journalist in which some of the more egregious excesses of the pharmaceutical market are loosely tied together in a Grand Unified Theory of Corporate Villany, with Martin Shkreli popping up, Zelig-like, throughout the story.

But it’s the lede that I can’t shake, which has Shkreli engaged in a complicated plot in which he plans to buy a competitor to Acthar Gel and bring it to market at a fraction of Acthar’s price in order to tank the share price of Questcor, Acthar’s manufacturer.

Per Shkreli had shorted Questcor, so -- the article alleges -- his real profit wouldn’t be from marketing a low-priced med, it would be from using his insider information to essentially (and, again, allegedly) manipulate the price of Questcor by destroying the market for Acthar. In the end, the Shkreli plan is foiled when Questcor outbids Shkreli for the competitive product.

Leaving aside (alleged) security violations, this opens up a wild alternative history of drug prices in which Shkreli ends up being the hero who pioneers disruptively low prices rather than the Daraprim villain.

That kind of mind-bending to think about, isn’t it?

And because this is Shkreli, and because this is 2023, we can also get a hot take on the article from Shkreli’s ex-girlfriend.

What a world.