How hospitals in Central New York monitor FDA prescribing changes, decide what to change locally and communicate those changes to patients
By Jolene Cleaver
When the U.S. Food and Drug Administration announces a change or an addition to how a prescription drug could potentially be used, whether it is a new box warning, a withdrawal or a revised dosing guideline, it does more than shift federal policy, medical professionals say.
The notice triggers a precise choreography inside hospitals.
Pharmacists check inventory, clinical committees review protocols and medical teams prepare to educate patients and families. Behind the calm, public –facing procedural surface are tight timelines and moments when clinicians must translate dense regulatory language into something a concerned parent can understand.
This story examines how hospitals around Central New York monitor FDA prescribing changes, decide what to change locally, and communicate those changes to patients.
A key question for families in the region is how clinicians are assessing the recent guidance related to leucovorin, which made September 2025 news headlines as the FDA announced it could be a tool in the treatment arsenal for autism, and how they are determining next steps for patients who ask about it.
Bassett Healthcare Network
“Basically, we are going to follow best medical practice. Obviously when there is a new federal announcement or directive we are going to look at that. Our doctors are clinically trained and have experience and are going to follow where the research guides them,” said Bassett spokeswoman Jennifer Steller.
Speaking to the typical diagnostic process for autism, Andrea Karweck, an attending psychologist in the Bassett Network, said, “The way the process works, it is pretty standard,” adding the evaluation includes several steps, beginning with gathering developmental history and information about the mother’s pregnancy along with other key data.
“After we gather that information, the child will come into the office for an evaluation.”
That evaluation may include observation, IQ testing, goal–centered assessments and additional standardized tools. All of the data is then scored, which she said is standard across the country.
Autism can be diagnosed as early as 18 to 24 months, though many diagnoses occur around age 5. Demand for evaluations remains high. Karweck noted that wait times may stretch close to a year because there are not many clinicians in the area who perform these assessments. Most children, she said, are already receiving early intervention services before a formal diagnosis is made.
Karweck’s colleague, Sarah Vaithilingam, a medical doctor who provides psychiatric care and specializes in treatment of children and adolescents, said parents frequently arrive with questions about what is available.
She noted that there was a study showing some children diagnosed with autism may be deficient in folate. Because of that, “ leucovorin could potentially help that. It can help with speech,” Vaithilingam said.
But, she added, “We do not know how effective it is.”
She said leucovorin has a low side effect profile and that she has felt comfortable prescribing it, but emphasized, “The results are not in.”
Upstate Golisano Children’s Hospital
Henry Roane, Ph.D., is the executive director of the Golisano Center for Special Needs and chief of the division of Development, Behavior and Genetics at Upstate Golisano Children’s Hospital, where his work includes assessment and treatment of behavior disorders in individuals with developmental disabilitie aswell as caregiver training and program development.
Speaking to the recent buzz about leucovorin, Roane explained, “it has been used for other conditions and we have had discussion with our geneticists at Upstate. Just like any condition, sometimes that condition is comorbid in a child who has autism spectrum disorder. It certainly can have a beneficial effect.”
Like other medical professionals in the Central New York area, Roane noted there is limited data showing effectiveness.
When guidelines change, he said, clinicians at Upstate review available literature and studies. Hospitals then develop a meta-analysis to understand the landscape for the use of a drug for whatever is being proposed.
“When you build that body of scientific evidence, that starts to underscore the notion that essentially, ‘hey, this might work.’”
Roane said that process is standard for any medication, whether it is used for diabetes, autism or another illness.
“We have seen that there have been some medications that were developed for one thing and end up getting approval for another thing. For example, there is medication to quit smoking that also has effects on mood. So it is labeled for both.”
For autism, he said, available medications address a wide range of underlying symptoms.
When parents evaluate treatment options, Roane advises them to identify the specific issue they hope to address when seeking more information. Some literature suggests leucovorin may aid with language development, but the evidence remains limited, he emphasized.
From the provider perspective, he said the recent news prompted immediate preparation. “When this news first broke, I went to all of our providers who prescribe medications and I said, parents are going to ask for this. Which they have.”
Roane said the responsibility then falls on providers to understand the literature, develop a plan to evaluate effectiveness and communicate clearly with families.
“Autism is a multifaceted presentation.” He cautioned that leucovorin is should not. Be viewed as a cure all.
Mohawk Valley Health System
Lindsay Gymburch, PharmD, pharmacy clinical services manager at Mohawk Valley Health System, said guideline changes prompt team meetings where new information is reviewed and decisions are made about whether local changes are necessary.
When patients have questions, she encourages them to talk to their doctors. “They are full of good information.”
“They will guide you down your own individual path because they also know your medical history.”
She noted that Leucovorin is often used in its IV form alongside chemotherapy treatments. For folate deficiencies, it is taken orally and the dosage levels differ.