Without any ado, here in green is the Biden Administration filing with Justice Alito -- at lunch-time -- it is excellent:
. . .To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety -- much less done so after those conditions have been in effect for years. And the lower courts reached that unprecedented result only through a series of fundamental errors that violate black letter Article III and administrative law principles. . . .
FDA’s [23 years of prior] actions were amply supported by an exhaustive review of a record developed over decades of safe use of mifepristone in the United States and around the world. While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the Fifth Circuit swept the agency’s judgments aside in three cursory paragraphs that constituted the sum total of its merits analysis. That brief discussion rested in critical respects on demonstrably erroneous characterizations of the record. . . .
Indeed. And. . . here in blue is the industry request, just made to Justice Alito's chambers this morning, and a bit:
. . .This Court’s settled view is that neither statistical evidence nor chains of discretionary actions by independent third-parties equates to the certain, impending injury required for Article III standing. That is no less true here than in the many cases where this Court has laid down these rule-of-law principles. The Fifth Circuit’s standing analysis flunks those precedents. Worse yet, the panel never even purported to analyze how even those statistics and third-party chains of conduct link to any injury caused by the specific agency actions the panel left enjoined -- FDA’s 2016 REMS modifications and subsequent challenged actions. But courts are required to ensure plaintiffs have standing for each claim they press. Absent facts demonstrating certain, impending injury from those specific FDA actions, distinct from facts about injury related to their separate challenge to the 2000 approval, there was no basis for the Fifth Circuit to conclude Plaintiffs likely have standing to challenge the 2016 REMS modification and its subsequent actions.
The Fifth Circuit’s ruling is equally flawed on the merits. Rather than defer to FDA’s expertise in evaluating data from dozens of clinical trials, which members of this Court have repeatedly said courts should do, the Fifth Circuit held that FDA fails to examine “ ‘an important aspect of the problem’ ” by making a change to a drug’s approval where “zero studies” incorporated all of the exact metes and bounds of the modified approval. App. 35a (citation omitted). The pharmaceutical industry could not have been clearer that such a judicial imposition on FDA of this sort of rigid matching requirement, untethered to anything in the statute or regulations, would be devastating. If that were the rule governing FDA approvals, it would be unlikely that any drug on the market is properly approved. . . .
Leaving the Fifth Circuit’s ruling in place will irreparably harm. . . women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers. . . .
The panel identified no requirement in the FDCA or in any regulation imposing this kind of rigid matching requirement where FDA lacks discretion to approve a drug or a change to a drug absent a specific study containing all of the exact parameters that FDA ultimately concludes are appropriate. The panel ignored the substantial evidence for the agency’s conclusions found in the dozens of studies involving data on tens of thousands of subjects that FDA analyzed. See supra pp. 5-6.
[. . .The] panel found FDA’s 2023 REMS modification lifting the in-person dispensing requirement -- implemented after this lawsuit was filed -- was a final agency action, but did not moot Plaintiffs’ challenges to the 2021 non-enforcement decision, and that Plaintiffs’ challenge to the 2021 non-enforcement decision was timely and exhausted. . . .
This Fifth Circuit nonsense, out of Texas, directly contradicts orders out of Washington State -- by another, co-equal federal court. The Supremes must resolve this open, and contentious split in authorities. Do stay tuned.
नमस्ते
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