Merck Adds Its Name To A Growing List Of Large Pharmas Suing HHS On 340B Threats Of Fines; Removal

This all-star wrestling match has been brewing for over two years, and we have a quiet, and yet sunny Friday, so let's catch up on it all.

Below are collected a fair number of recent cases in which large pharmas (imaged at right) have sued the federal government, or Health and Human Services, specifically, for threatening action against them if they did not continue to offer so-called 340B discount pricing in on covered drugs.

As Policy & Medicine explains, "Merck is trying to avoid potential fines for cutting off 340B contract pharmacies from receiving discounted prescriptions."

Under the 340B program, pharmaceutical companies offer discounted pills and solutions to certain providers in exchange for Medicare and Medicaid participation. Multinational public company pharmaceutical manufacturers now argue that the HHS program has "gotten too big" (apparently, with no irony intended. . . hilarious!) and so, 340B is no longer benefiting patients. That's the gist of it. And so, in 2021, several companies cut off their sales of 340B discounted drugs -- to various contract pharmacies.

Merck's is the latest of the suits -- and it is in ample, if not necessarily. . . good company:

. . .AstraZeneca Pharms. LP v. Becerra, C.A. No. 21-27-LPS, 2022 WL 484587, at *6 (D. Del. Feb. 16, 2022) (“Because the Violation Letter rests on essentially the same flawed statutory interpretation that the Court already rejected, the Violation Letter cannot stand.”), appeal docketed, No. 22-1676 (3d Cir. Apr. 15, 2022); id. at *6, *9 (stating, on two separate grounds, that the court will vacate and set aside HRSA’s “Violation Letter”); see also Eli Lilly & Co. v. U.S. Dep't of Health & Hum. Servs., No. 1:21-cv-00081-SEB-MJD, 2021 WL 5039566, at *1, *24 (S.D. Ind. Oct. 29, 2021) (stating that the court is “set[ting] aside and vacat[ing] . . . the May 17 Letter” “because HRSA has failed even to acknowledge any change in its position”), appeal docketed, Nos. 21-3128 & 21-3405 (7th Cir. Nov. 15, 2021, Dec. 30, 2021); Sanofi-Aventis U.S., LLC v. U.S. Dep't of Health & Hum. Servs., CV Nos. CV 21-00634 and 21-00806 (FLW), 2021 WL 5150464, at *43 (D.N.J. Nov. 5, 2021) (vacating HRSA’s “Violation Letter” “to the extent that such determinations may depend on the number of permissible contract pharmacy arrangements under the 340B statute”), appeal docketed, Nos. 21-3167 et al. (3d Cir. Nov. 26, 2021). . . .

We will keep a weather eye on this (but I do expect that PhRMA has the upper hand here). We will also keep a weather eye out, in Southern California (where a year's worth of rain may fall in just the next 16 or so hours). . . stay safe one and all -- climate change is. . . a thing.

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