Wednesday, November 29, 2023

We Now Have The Biden Administration's 44 Page Answer -- To Merck's Whining, About Negotiating, On Drug Prices...


We said we'd have it for you tonight -- and now. . . we do. And frankly, Merck's lawyers look rather foolish, when put to their proof.

As Buckminster Fuller was reputed to have said (albeit of. . . Cleveland) "there really is no 'there'. . . there." This is true of Merck's "claims" as well. Heh. [And just for fun, we will run a legacy graphic, the one that accompanied AARP's fine amicus brief in this matter -- from earlier in September 2023.]

In any event, do read it all, but here's a bit of the very well thought out governmental payors' response tonight -- just filed, in DC:

. . .[P]rescription drugs have “long been the source of public concern and the subject of government regulation.” Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1007 (1984). And the Supreme Court has made clear that Congress can require manufacturers of such “dangerous chemicals” to give up some property interest “as a condition [of] receiving a permit to sell those products” -- a “benefit” manufacturers are not inherently entitled to receive. Horne v. Dep’t of Agric., 576 U.S. 350, 365–66 (2015). . . .

[In fact,] as another district court recently recognized when considering a similar constitutional challenge to the IRA, Congress’s authorization for the Secretary to negotiate how much Medicare pays for drugs “cannot be considered a constitutional violation” because drug manufacturers “are not legally compelled to participate in the [Negotiation] Program—or in Medicare generally.” Dayton Area Chamber of Com. v. Becerra, No. 3:23-cv-156, --- F. Supp. 3d ---, 2023 WL 6378423, at *11 (S.D. Ohio Sept. 29, 2023). . . .

[E]ntities “that wish to participate in Medicare and Medicaid have always been obligated to satisfy a host of conditions” that are packaged together as part of one offer, without being able to pick and choose individual conditions they wish to accept or reject. Biden v. Missouri, 595 U.S. 87, 94 (2022). Contrary to Plaintiffs’ suggestion, presenting such all-or-nothing offers is well within Congress’s prerogative to ensure that federal funds are spent according to its view of the “general Welfare.” U.S. Const., art. I, § 8, cl. 1. And Plaintiffs’ attempts to evade this established framework not only misread the underlying legal authorities but also would -- by [Merck's] own admission -- rewrite decades of established law about Congress’s spending powers. Plaintiffs do not come close to justifying this extraordinary result. Drug manufacturers may choose whether they wish to participate in Medicare -- but they do not have a constitutional right to unilaterally dictate how much the government spends on their drugs. . . .

Congress acts pursuant to its spending powers to set terms on which the government will buy products. In those circumstances, the government is not imposing a legal obligation on a private party to hand over property at all, but merely setting conditions on doing business with the government (as one of many buyers). . . .

. . .“Unlike ordinary legislation, which imposes congressional policy on regulated parties involuntarily, Spending Clause legislation operates based on consent: in return for federal funds, the [recipients] agree to comply with federally imposed conditions.” Cummings v. Premier Rehab Keller, PLLC, 596 U.S. 212, 216 (2022) (internal quotes and citation omitted). “[I]f a party objects to a condition on the receipt of federal funding, its recourse is to decline the funds.” Agency for Int’l Dev. v. All. for Open Soc’y Int’l, Inc., 570 U.S. 205, 214 (2013). Accordingly, there is no need to consider whether a party obtained a separate benefit to determine that the government’s conditions are part of a voluntary exchange. . . .


Mr. Davis really ought to let this be dismissed on consent. His purported "claims" lack "any and all. . . there, there."

नमस्ते

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