A U.S. District Court judge in Massachusetts has issued two temporary restraining orders (TROs) blocking the Trump administration’s new 15% cap on indirect cost reimbursements for recipients of grants from the NIH,  including one in a suit filed by organizations including the American Association of Colleges of Pharmacy (AACP).

A late-in-the-day announcement on Friday, Feb. 7 declared that the NIH would drastically and immediately cut support for indirect research costs paid to its grant recipients. The policy imposes an across-the-board 15% cap on “facilities and administrative” (F&A) costs, also known as indirect costs, linked to research—and means an immediate and massive budget cut to all universities that conduct NIH-funded research.

Currently, the average rates grant pay for those indirect research costs is 30%. By reducing that rate to 15%, proponents of the move believe it would save the NIH billions of dollars.

“This rate will allow grant recipients a reasonable and realistic recovery of indirect costs while helping NIH ensure that grant funds are, to the maximum extent possible, spent on furthering its mission,” noted the statement, issued by the NIH Office of Policy for Extramural Research Administration.

At least three lawsuits were filed against the cuts on Monday, Feb. 10. One of the suits was filed by 22 state attorneys general, who requested a TRO to stop the cuts, referring to them as “unlawful.” They added that “without immediate relief, this action could result in the suspension of lifesaving and life-extending clinical trials, disruption of research programs, layoffs, and laboratory closures.”

District Judge Angel Kelley granted their request for a TRO early on Monday evening, writing that: “Defendants and their officers, employees, servants, agents, appointees, and successors are hereby enjoined from taking any steps to implement, apply, or enforce the Rate Change Notice (NOT-OD-25-068) within Plaintiff States until further order is issued by this Court.”

The order required the NIH to file regular status reports “confirming the regular disbursement and obligation of federal financial assistance funds and reporting all steps that NIH, HHS [Department of Health and Human Services] and their officers, employees, servants, agents, appointees, and successors have taken to comply with the Court’s temporary restraining order.” The administration has until Feb. 14 to respond to the TRO, with a plaintiffs’ reply due by Feb. 18 and an in-person hearing set for 10 a.m. on Feb. 21.

That TRO only applies within the 22 states that joined in the court challenge. But later on Feb. 10, Ms. Kelley also granted a TRO in a suit filed by the Association of American Medical Colleges (AAMC), AACP, Association of Schools and Programs of Public Health, Conference of Boston Teaching Hospitals Inc., and Greater New York Hospital Association, declaring that the NIH is “enjoined from taking any steps to implement, apply, or enforce” the rate change notice “in any form with respect to institutions nationwide until further order is issued by this Court.”

“The Plaintiffs have made a sufficient showing that, unless their Emergency Motion For Temporary Restraining Order … is granted, they will sustain immediate and irreparable injury before there is an opportunity to hear from all parties,” Ms. Kelley wrote.

A third lawsuit also has been filed in the same court, by three groups representing dozens of higher education institutions: the Association of American Universities, American Council on Education, and Association of Public and Land-Grant Universities. At least a dozen individual universities, including the George Washington University, Johns Hopkins University and University of Pennsylvania, also signed on to that suit. No judicial response to that lawsuit had yet been issued when this article was posted.

Pharmacy, Medical Groups Voice Concerns

“Cutbacks in F&A funding for research at our colleges and schools of pharmacy, as well as at our counterparts in colleges of medicine, nursing, dentistry, and other health professions, will immediately compromise their ability to develop new treatments for patients,” said Lee Vermeulen, BSPharm, MS, FCCP, FFIP, the executive vice president and CEO of the AACP, in a statement. “The impact will be felt for years to come, and will cost patients’ lives.” 

In a statement from the AAMC, President and CEO David J. Skorton, MD, and chief scientific officer Elena Fuentes-Afflick, MD, MPH, denounced the cuts, saying they “will diminish the nation’s research capacity, slowing scientific progress and depriving patients, families, and communities across the country of new treatments, diagnostics, and preventative interventions."

“Make no mistake," Dr. Fuentes-Afflick said. "This announcement will mean less research. Lights in labs nationwide will literally go out. Researchers and staff will lose their jobs. As a result, Americans will have to wait longer for cures and our country will cede scientific breakthroughs to foreign competitors. These are real consequences—slower scientific progress, longer waits for cures, fewer jobs.”

Indirect costs have been described to include overhead expenses such as utilities, maintenance, equipment and support staff, but as the AAMC noted in an accompanying fact sheet, operating state-of-the-art biomedical research facilities also requires myriad other much more costly indirect expenses, including:

• high-tech lab structures, equipment and maintenance;
• high-speed data storage;
• security, including export controls, cybersecurity and research data security;
• patient safety protocols such as human subjects protections; and
• radiation safety and hazardous waste disposal.

Organizations including the Infectious Diseases Society of America (IDSA) and HIV Medicine Association (HIVMA) also criticized the NIH funding cuts. The reductions “will eliminate the promise of lifesaving medical treatments for millions of Americans of all ages, topple America’s longstanding role as a global leader in innovation, leave our nation less safe and more vulnerable to disease outbreaks and bioterror attacks, and will hurt our economy,” said IDSA President Tina Tan, MD, FIDSA, FPIDS, FAAP, in a statement issued on Feb. 10.

“The funding slash strikes at the heart of biomedical research infrastructure, which will have ripple effects of halting critical studies, eliminating jobs, driving talent away from the field and hurting efforts to train the next generation of scientists.”

Dr. Tan predicted that the funding cuts will delay the development of vaccines, diagnostics and treatments for emerging threats such as avian flu and other respiratory illnesses; smallpox and other pathogens categorized as posing the greatest risk to national biosecurity; mosquito- and tick-borne diseases, including dengue, Lyme disease, West Nile virus and others; viruses most likely to cause future pandemics; antimicrobial resistant bacteria and fungi; Ebola and other hemorrhagic fevers; and HIV and other sexually transmitted infections that are becoming more common and increasingly resistant to treatment.

“HIV research is one of the most powerful examples of the return on investments made by NIH,” said HIVMA Chair Colleen Kelley, MD, MPH, FIDSA. “It is because of NIH funding that there are incredibly effective options for treating and preventing HIV—discoveries that have improved health for millions of people in the United States and worldwide. These groundbreaking discoveries have made it possible to end HIV as an epidemic and have spurred novel treatments for cancer, viral hepatitis and tuberculosis.”

Research institutions responded with equal fervor. State University of New York (SUNY) Chancellor John B. King Jr. called the cuts “an existential threat to public health,” noting that a preliminary estimate from the SUNY Research Foundation predicts that they will cost SUNY research an estimated $79 million for current grants, including more than $21 million over just the next five months (through June 30).

‘An Attack on Science’

The move will cut research funding to the University of California system by hundreds of millions of dollars annually, UC said in a Feb. 10 press release that also declared its support for the California Attorney General’s participation in the suit seeking the TRO. “A cut this size is nothing short of catastrophic for countless Americans who depend on UC’s scientific advances to save lives and improve healthcare,” said UC President Michael V. Drake, MD. “This is not only an attack on science, but on America’s health writ large. We must stand up against this harmful, misguided action.”