In a withering 76-page ruling, a federal judge in Boston today agreed with states, universities, hospitals and medical schools that the current regime can't simply eliminate hundreds of millions of dollars in previously approved indirect research costs just because it feels like it.
US District Court Judge Angel Kelley wrote that without even considering constitutional issues, she was able to issue a preliminary injunction against the diktat because it violated federal laws that require a detailed explanation of the rationale and a chance for the institutions that would be affected a chance to have their say first. And she continued, the edict would destroy lives - both of the people doing the research and the people hoping for health relief from their work:
In short, the Notice fails to consider the impact the Rate Change Notice would have on public health, which is the purpose of the entire regulatory regime. The Notice fails to contemplate the budgets of these institutions, formulated months and years before this Notice's sudden implementation. It fails to contemplate the risk to human life as research and clinical trials are suspended in response to the shortfall. It fails to contemplate the life, careers, and advancement that will be lost as these budgets are indiscriminately slashed. Although reticent to consider together, the Rate Change Notice fails to reflect on the health of those whose hopes rely on clinical trials and the financial investment that will be lost as research is disrupted. It fails to consider that public health will suffer.
She added:
The Plaintiffs' hardship absent a preliminary injunction ... is substantial and ranges from the halting of research and clinical trials, resulting in the loss of life for those of whom are relying on clinical trials as their last hope, to a negative impact on patient health and outcomes, the death of animals that represent years of research, the degradation of infrastructure, the loss of staff who are central to patient care and research activities, brain drain in the healthcare industry, and the delay and potential suspension of future grant applications as institutions are unable to support additional research projects. Thus, in light of these hardships, a preliminary injunction would preserve public health, and by extension, serve the public interest. Additionally, there is "substantial public interest 'in having governmental agencies abide by the federal laws.'"
Kelley wrote that federal lawyers basically waved their legal hands around and blustered that private charities reimburse research institutions at lower rates for such costs as building and lab maintenance, without providing any proof that "bringing the federal government in line with private foundations is actually a good thing.
"NIH's conclusory statements hardly rise to the level of 'reasoned decisionmaking' " required by the federal Administrative Procedures Act, she wrote. "The failure to provide any type of reasoning renders the Rate Change Notice arbitrary and capricious."
She added:
NIH’s proffered "reasons" fail to grapple with the relevant factors or pertinent aspects of the problem and fails to demonstrate a rational connection between the facts and choice that was made. In cutting indirect costs without identifying a countervailing funding stream for such costs of research, the only reasonable outcome will be the discontinuing of research supported by the slashed F&A rates, including ongoing clinical trials. ... The Rate Change Notice seems to have ignored the need for indirect funds in the administration of any and all research. In essence, by cutting indirect funds, NIH is cutting research. There also seems to be a limited rational connection between the facts, particularly the nature of private funding opportunities and their differences from federal funding grants, as well as the limitation on university endowments, and the decision to cut ICRs to bring them in line with private organizations.
Although Kelley hears cases in Massachusetts, she declared her injunction applies nationwide. She noted that 22 states had brought one of the suits, and that colleges and medical schools across the country brought two others.
Absent a nationwide injunction, institutions across the country will be forced to operate with the same uncertainty, resulting in the types of irreparable harm that a preliminary injunction is meant to prevent. In the face of this uncertainty, institutions would almost certainly file many additional lawsuits. The potential patchwork of injunctions would cause administrability problems, not only for the institutions relying on consistency to prevent the harm discussed above but also for NIH as it attempts to comply with varying injunctions across the country.
Government lawyers could appeal her ruling to the First Circuit Court of Appeals in Boston or just try to cut out the middlemen and go directly to the Supreme Court.
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SCOTUS just ruled in a similar case
By perruptor
Thu, 03/06/2025 - 12:02am
The supreme court just ruled against the maga administration in a similar case .
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