FDA Commissioner Blames Adderall Shortage on Stimulant Overuse, Telehealth, Generics

June 4, 2023

The head of the Food and Drug Administration (FDA) blames the persistent ADHD medication shortage, in part, on a surge in stimulant use by people with ADHD, who he suggests may not all truly need the drugs. In a new interview with WebMD’s John Whyte, M.D., FDA commissioner Robert M. Califf, M.D., claims that telehealth providers are largely responsible for driving a “tremendous” increase in ADHD diagnoses and stimulant prescriptions over the last few years and, in his words, not all of them are warranted.

“If only the people that needed these drugs got them, there probably wouldn’t be a [stimulant medication] shortage,” Califf says. “There’s a large amount of use which is on the margins. And this is why we need better clinical standards.”

Califf’s call for “better clinical standards,” purportedly to determine whether a patient with ADHD warrants treatment with stimulant medication, echoes lingering misconceptions about the real and important ways that ADHD symptoms impact the lives of adult patients, in particular. “Adult patients with ADHD deserve high-quality care, and providers likewise deserve authoritative resources that outline effective, evidence-based practices for adult ADHD,” said Maggie Sibley, Ph.D., and Ann Childress, M.D., who are working with the American Professional Society of ADHD and Related Disorders (APSARD) to develop the first-ever guidelines for diagnosing and treating ADHD in adults, set for release later this year.

In addition, Califf’s suggestion that ADHD medication use may be unnecessary and inadvisable for some population of diagnosed individuals contradicts decades of research verifying the necessity and safety of short- and long-term ADHD medication use — and its profound ability to help children and adults focus, control impulsivity, perform better at work and in school, and more. In short, stimulants are considered effective and safe for the vast majority of children and adults. “Moderate to severe ADHD absolutely warrants medication,” said Russell Barkley, Ph.D., a pre-eminent expert in ADHD. “This is the most effective treatment available – bar none.”

William Dodson, M.D., a frequent ADDitude contributor, often cites decades of research affirming the safety of ADHD medication use and the dangers associated with untreated ADHD. “The risk comes from not taking ADHD stimulants,” he said, citing extensive research on the subject.^{1 2 3 4 5} “People with ADHD who didn’t use stimulants had a four-fold increase in severe accidents and substance-use disorders (SUDs), seven times the rate of incarceration, and 10 times the rate of unplanned conceptions compared to people with ADHD who took stimulants.”

ADHD Treatment Rates Still Low

Califf’s suggestion that “a large amount” of individuals are unnecessarily or irresponsibly using stimulant medication is at odds with a study published last month by JAMA Network, which shows that treatment rates for children with ADHD are generally low. It found that only 12.9% of 9- and 10-year-olds with reported ADHD symptoms had taken ADHD medication during the preceding two weeks.⁶

Treatment rates in adults with diagnosed ADHD are also low; only about 4.1% of adults take a stimulant medication.⁷ Evidence of medication misuse among adults is scarce and isolated to reports of over-prescription by certain telehealth providers.

For older children, a different story has been shaping up. The National Institute on Drug Abuse reported a 36% increase in ADHD medication use among 12th graders in 2022 compared to 2021.⁸ It attributed the uptick to “more stress” and to attention issues that were amplified by the pandemic’s lockdowns and remote learning. A recent study from the University of Michigan found that up to one in four middle and high school students reported abusing prescription stimulant medications used to treat ADHD.⁹

Still, stimulant misuse among adolescents is not likely significant enough to explain the rampant, ongoing Adderall shortage that has dramatically affected ADDitude readers’ lives for nearly a year.

ADHD and Telehealth Controversies

In March 2020, the Drug Enforcement Agency (DEA) lifted in-person requirements and allowed practitioners to conduct evaluations and prescribe Schedule-II controlled substance like Adderall (a stimulant) in virtual appointments. The move led to a surge of new ADHD diagnoses in patients seeking telehealth care from 2020 to 2021, especially among women, according to the U.S. Centers for Disease Control and Prevention (CDC). The most common ADHD stimulant prescribed by one telehealth provider, Cerebral, was Adderall.

In 2022, Cerebral, along with other telehealth companies, came under federal investigation after multiple news reports revealed that these companies engaged in “aggressive” and questionable prescribing practices. ADHD specialists, too, have expressed fears that stimulants have been overprescribed of late, partly due to these telehealth companies.

“There’s been a tremendous increase in prescribing, some of it related to virtual prescribing, and that’s caused a number of problems,” Califf says in the interview.

However, no research yet exists to confirm or deny the validity of ADHD diagnoses made by telehealth providers during the pandemic. It’s unclear whether telehealth providers over-diagnosed ADHD and over-prescribed stimulants, or simply caught up to pent-up demand from a population of adult patients who had struggled to access in-person health care prior to the pandemic. Women, as a population, have been notoriously under-diagnosed due to outdated ADHD stereotypes, societal stigma, and provider bias. In addition, many reported to ADDitude that telehealth helped them unlock life-changing diagnoses and care, including stimulant medications for ADHD.

Calls for Reform

Patient advocates and legislators dedicated to solving the Adderall shortage are taking a different tack. Rep. Abigail Spanberger (D-Va.) has called on the FDA to coordinate a response with the DEA that addresses artificially low production quotas for stimulant medication, among other roadblocks to accessing care. Twenty other members of Congress likewise wrote a letter to the DEA, urging it to formulate new telemedicine and prescription rules, to take seriously increases in demand when setting production quotas, and to better map supply chains. And Maia Szalavitz, a leading commentator on substance abuse issues, suggested in a column published in The New York Times that oversight of ADHD medication should be shifted from the DEA, to the Food and Drug Administration.

“We wish that we could fix all these things,” Califf said in the interview with Whyte. “But we don’t make the medicines and we can’t tell someone they must make medicines. There are some things that are out of our control.”

Califf also blames the drug shortage on market disincentives for generic drug manufacturers, saying, “A number of generic drugs are in shortage at any given time because there’s not enough profit for a company to… go into the business of making that drug.’” He notes that quality problems in manufacturing may contribute to distribution challenges but calls the Adderall shortage a “special case.”

The Bottom Line

Califf’s statements regarding the ongoing ADHD medication shortage, and efforts to mitigate it, are disappointing. His statements purporting rampant stimulant over-prescription and overuse are troubling. While the FDA can’t act alone to solve the shortage, Califf, who has used his “bully pulpit” to raise public awareness on other health issues, has missed an opportunity to assure millions of Americans with ADHD – many of whom had a diagnosis and were undergoing treatment well before shortages (and before the proliferation of telehealth) began – that the agency takes ADHD and ADHD treatment seriously.

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