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At 6 a.m. on April 1, 10,000 federal health care workers at agencies of the Health & Human Services Department received an email from the Trump administration informing them that they would be eliminated from the payroll. These cuts will be felt very close to home, as now roughly 25% of the staff members serving the National Center for Toxicological Research, an agency of the U.S. Food & Drug Administration, have been removed from their positions.
NCTR has operated in Jefferson (Jefferson County) for 54 years. In a nutshell, NCTR creates innovative scientific tools and generates reliable data used by the regulatory community to make sure our food supply, prescription drugs and new products are not going to harm us (or our pets!).
In a recent confirmation hearing, Dr. Martin Makary, current FDA commissioner, touted FDA’s “gold-standard science.” That reputation is in no small way attributable to NCTR. It’s not hyperbole when you consider NCTR’s key role at the agency and that 20 cents of every dollar that circulates in the U.S. economy is touched by the FDA.
NCTR plays a fundamentally unique role within the FDA and around the world. Primarily, it is in the way it’s set up. Importantly, NCTR does not have a regulatory mission. It has the mission of supporting the regulatory science needs of the agency. That’s a key distinction. This means NCTR stays ahead of the pack as a prolific contributor of interdisciplinary toxicology research solutions in anticipation of future FDA needs. It also organizes multidisciplinary teams to create new approaches for safety assessments. NCTR’s work enables FDA product centers and its new Human Foods Program, which do have regulatory mandates, to be faster and more accurate and economical in the quest to address hazard assessments.
Often, NCTR is better known outside the state than here at home. It sets the foundation of the FDA’s global reputation as the gold standard of regulatory science. This is due to a combination of factors. NCTR collaborates across the FDA, other agencies, the private sector and academia. It leads national and global consortia to help strengthen and harmonize international standards for technologies and policies. Let’s look at some of its recent contributions.
Maternal health is of great concern for Arkansas, and for 40 years, NCTR has conducted regulatory science research addressing critical data gaps on drug safety and environmental exposures affecting pregnant women, neonates and infants. In 2018, Congress established the FDA virtual Perinatal Health Center of Excellence (PHCE), coordinated by NCTR, to fund collaborative research spanning toxicology, computational modeling, clinical studies, bioinformatics and exposure science. PHCE prioritizes projects with wide regulatory impact, including studies on the development of a pharmacology model for fetal cardiac safety, Zika virus biomarkers and perinatal cannabidiol central nervous system activity and toxicity.
NCTR created the AskFDALabel as a secure, inexpensive artificial intelligence framework for adopting large language models to assist with drug labeling review. It provides a more efficient, accurate and reliable solution for extracting relevant information from drug labeling documents, which can be a difficult and labor-intensive aspect of the review process.
NCTR plays an important role in the FDA response to threats to our food supply. For example, NCTR’s unique expertise and capabilities were central to the agency response to the contamination of pet food and baby milk formula resulting from fraudulent adulteration in China. In this context, it is clear that NCTR is not only a fundamental component of the FDA but also of the broader national security infrastructure.
Arkansas rice is safe to eat. However, inorganic arsenic is a contaminant frequently found in rice and rice-based products (including canine feed, foods commonly eaten by infants and children), groundwater, soils and sediments. NCTR created models to strengthen hazard assessments of levels of this potential contaminant. NCTR studies are helping to explain the relationship between arsenic-exposed populations and psychiatric disorders and those devastating neurological diseases that impact our ability to move, swallow, breathe and speak.
NCTR is truly a one-of-kind treasure. It is not only a scientific collaborator, but an important economic driver for Arkansas with a singular partnership not found in any other state. For almost 20 years now, the governor of Arkansas and the FDA commissioner have been parties to a memorandum of understanding. It is the only one of its kind between a state and the FDA. The Arkansas Research Alliance manages the state’s relationship with NCTR through a concurrent partnership intermediary agreement. This relationship has yielded the highly popular Arkansas Bioinformatics Consortium, research grants and contracts, countless scientific collaborations, instrumentation and materials sharing, along with internships, training and talent development.
NCTR is the largest FDA lab outside the D.C. beltway. It is located on 500 acres across a lab complex with 1 million SF under roof near Pine Bluff. As a government-owned and operated facility, this means our tax dollars do not have to pay lofty leases because it owns the land it sits on and has plenty of room for expansion. Hint, hint.
NCTR’s 500-person staff (now cut to 375) — which includes 150 doctoral-level researchers — possesses the breadth and depth of workforce talent in a variety of advanced scientific disciplines using state-of-the art facilities and instrumentation to carry out highly specialized work. They do all this operating on a modest (for a federal entity) $77 million annual budget, one that has not kept pace with increases to its sister product centers. If we use the National Institutes of Health impact multiplier effect ($1 of research funding delivers $2.56 in economic activity), then NCTR generates a return of $197 million annually in economic activity.
Some may not like this overused argument, but it needs to be said: The funding to NCTR is a drop in the FDA bucket. The FDA has 20,000 employees and a fiscal 2024 budget of $7.2 billion. NCTR had 500 staff (a number that has responsibly decreased over the past 20 years) and operates on $77 million. It raises the question: If the science is the gold standard for toxicological research, then shouldn’t it be deemed worthy of continued, if not expanded, investment? The bronze standard isn’t going to protect our health.
The world may thank the FDA for the gold standard in regulatory science, but much of the ore and the smelting process are in Arkansas.
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