Originally published by our sister publication Pharmacy Practice News

A U.S. District Court judge in Massachusetts has issued a temporary restraining order (TPO) blocking the Trump administration’s new 15% cap on indirect cost reimbursements for recipients of grants from the National Institutes of Health (NIH), after 22 state Attorneys General filed suit on Monday, Feb. 12, to halt the cut, calling it unlawful and saying, in a joint statement, “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.”

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 say 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’s Office of Policy for Extramural Research Administration.

In the order, District Judge Angel Kelley wrote 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.

"Counsel for Defendants shall file a status report with the Court within 24 hours of the entry of this Order, and at biweekly intervals thereafter, confirming the regular disbursement and obligation of federal financial assistance funds and reporting all steps that NIH, HHS 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 am on Feb. 21.

Medical Groups Voice Concerns

In a statement from the Association of American Medical Colleges (AAMC), president and CEO David J. Skorton, MD, and chief scientific officer Elena Fuentes-Afflick, MD, denounced the cuts, saying that 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. 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 such overhead expenses 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, & 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 Disease Society of America (IDSA) and the 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 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.”