Six months after the FDA first announced a shortage of the ADHD drug Adderall and its generic variations, a steady stream of reports shows patients are still struggling to obtain a medication that can be essential for leading a normal and productive life.
Adderall might seem like just one of many drugs that it’s been increasingly difficult to get. Drug shortages are becoming increasingly common in the United States, and on average, lasting longer. Typically, these shortages are, essentially, a supply chain problem: When one drug company experiences a shortage because of supply problems with raw materials, for example, there is little capacity in the market to make up for that shortfall.
But the explanation for the persistent Adderall shortage is more complicated. While it began with manufacturing problems, the picture has muddied over the past few months. Currently, four different companies are reporting shortages of the drug. Their reasons include a shortage of its active ingredient due in part to the unusual way in which Adderall is regulated, and an increase in demand.
Drug shortages are almost always the result of too little supply, not too much demand. But while artificial limits on supply are undoubtedly contributing to the shortage, the growing demand for Adderall is unique. As the medical science on ADHD has evolved, doctors now better understand how ADHD manifests at different ages and are better able to identify when a patient may be dealing with the disorder and, therefore, when Adderall or another stimulant medication may be an appropriate treatment.
For most medical conditions, an increase in the number of people diagnosed would not create new barriers (other than market constraints) to manufacturing more medications for the people who need treatment. But what’s different about ADHD is that the first-line treatment is a stimulant drug with the potential for misuse or addiction — and so it’s a matter not just for pharmaceutical companies but for law enforcement. The Drug Enforcement Agency has hedged on the side of keeping production of these drugs down to limit the potential for abuse.
The fear is that Adderall would follow the same path as opioid painkillers: careless overprescribing would lead to an epidemic of drug addiction — this time, to stimulants.
The current shortage is the result of rising demand colliding with restricted supply, with consequences for millions of patients.
“People are raising the question, ‘Why is Adderall being put in the same category as the opiates?’” Dr. Max Wiznitzer, who advises the ADHD advocacy group CHADD and practices in the Cleveland area, told me. “It’s not where the science is. They’re so stuck on what it has been, they’re not necessarily asking themselves where the science is pointing now.”
The Adderall shortage could be an opportunity to change how the country at large views this condition and the medication to treat it. But institutional inertia, and the shadow of the opioid crisis, is standing in the way.
How has our understanding of ADHD evolved?
The modern scientific understanding of ADHD is commonly associated with George Still, a British pediatrician who in a series of lectures in 1902 described children who were showing symptoms of hyperactivity, impulsivity, and inattention and referred to their condition as a “defect of moral control.” The children were said to suffer from poor academic performance and other behavioral problems.
In the following decades, medical science’s understanding of the disorder advanced from blaming “moral defects” to brain damage to understanding that a deficit of certain neurotransmitters, particularly dopamine, contributes to the disorder’s telltale symptoms.
“As time went on, we had science tell us, it wasn’t that people were doing something wrong,” Wiznitzer said. “It was a product of how their brains were built.”
As ADHD became more widely accepted as a distinct clinical disorder, rather than a result of poor parenting or a byproduct of another condition, the medical community began investigating more treatments. Ritalin had first been approved by the FDA in the 1950s, but it requires more frequent dosing to have a sustained effect.
Adderall was approved in 1996 and would soon become the most commonly prescribed treatment for ADHD, though Ritalin and several other drugs remain in use. A few years later, an extended-release version of the drug — intended to be less prone to abuse — was put on the market.
According to the Centers for Disease Control and Prevention (CDC), approximately 6 million children ages 3 to 17 (about 9.8 percent of children in the United States) have been diagnosed with ADHD as of 2019. Boys are about twice as likely to be diagnosed with the condition as girls.
National surveys have varied in their estimates of how many US adults have ADHD, with figures ranging from 1 to 4 percent, but the trend is consistent: The share who have been diagnosed is going up. A new estimate published in 2022 by researchers from the Oregon Health and Science University put the percentage of the total US population with ADHD at 3.5 percent.
According to IQVIA, a health care data and analytics company, about 41.4 million prescriptions for Adderall were dispensed in the US in 2021. Not every prescription is for a unique individual, but those data suggest that millions of Americans are relying on the drug to moderate their ADHD symptoms.
But that suddenly became more difficult when, in October 2022, the Adderall shortage began.
How does the federal government limit Adderall production?
The reasons for drug shortages can be difficult to divine. Manufacturers are not mandated to report the reasons for a drug shortage and any public information they do provide can be vague.
That has proven true with the Adderall shortage too. However, experts say that the role of the federal government in regulating one of Adderall’s active ingredients makes this shortage distinct.
One of the active ingredients in Adderall is amphetamine, and therefore the drug is regulated as a controlled substance under federal law. Its potential for abuse has long been recognized, with the cliche example being college students taking the drug to help them study. A 2018 study by federal researchers found that about 5 million Americans misused a prescribed stimulant, of which Adderall is the most common, at least once in the past year; about 400,000 misused stimulant drugs frequently enough to be characterized as having a disorder. (About 2.7 million people in the US report they have an opioid use disorder.)
To mitigate the potential for abuse, the Drug Enforcement Administration sets production limits for Adderall and its generic competitors. In order to produce the drugs legally, pharmaceutical manufacturers must obtain approval from the government and comply with regulations for the medication’s manufacturing, distribution, and dispensing.
The DEA also sets annual production quotas for Adderall, as with other controlled substances that have recognized medical uses, based on estimates of legitimate medical and scientific needs, as well as the potential for diversion and abuse. However, those quotas are not well understood; while the agency announced in 2019 that it was allowing for more production of Adderall, given the apparent growing need in the patient population, we still don’t know exactly how much production has been authorized or the limits set for individual companies.
“The DEA gives the companies a set amount of raw material ‘quota’ to manufacture these products, but we don’t know which company gets how much,” said Erin Fox, a pharmacist at the University of Utah and leading expert on US drug shortages. “Some companies say they’re short, but DEA says that they haven’t used it all, so lots of finger-pointing.”
Indeed, the companies that produce Adderall and its generic version have cited both a shortage of the active ingredients and an increase in demand to explain their ongoing shortages. But another factor, new limits on the dispensing of the drug at US pharmacies, is making the situation worse.
In 2022, drug distributors reached a settlement with most states over their role in the proliferation of prescription opioids that helped create an addiction and overdose epidemic. Bloomberg reported this week that, as part of that settlement, secret limits were placed on the dispensation of controlled substances last July. That has in turn prevented pharmacists from filling the prescription of every patient who comes to their pharmacy with an Adderall order.
According to Bloomberg, in essence, manufacturers are supposed to limit a pharmacy’s supply of drugs covered by the Controlled Substances Act, which includes opioids as well as stimulants. Pharmacists can only fill a certain number of prescriptions over a set period. But there has been widespread confusion over these rules because the pharmacists themselves don’t know what the limits are or when they are approaching them. Sometimes, they won’t know their access to Adderall has been cut off until trying to fill a prescription.
In theory, that information is hidden to prevent anyone from gaming the system. But in practice, it has made it harder for patients to get access to the medicines they need during a six-month shortage.
“I understand the intention of this policy is to have control of controlled substances so they don’t get abused, but it’s not working,” Richard Glotzer, an independent pharmacist in Millwood, New York, told Bloomberg. “There’s no reason I should be cut off from ordering these products to dispense to my legitimate patients that need it.”
Doctors have found workarounds. Certain dosages (such as 7.5mg versus 15) are more plentiful. Some physicians have also opted for immediate-release versions of the drug instead of the extended-release doses that are chiefly in short supply. And for some of those patients, those creative solutions may work. But that may not be true for everybody: Wiznitzer told me that, on the day of our interview, a mother had come into his practice and asked that her child be returned to his older medication, currently still experiencing a shortage, as soon as possible.
Some manufacturers report they expect to have production back on track by the end of April or in May. But the fact that a drug depended upon by millions of Americans could, at best, experience more than half a year of shortages has left experts wondering why more couldn’t be done to provide relief sooner.
How can the government make sure Adderall is available to those who need it?
The ongoing shortage has brought the DEA’s limits on Adderall production under scrutiny. Though the current shortage was officially recognized in October 2022, the agency did not alter its plans for production quotas in 2023 in a December 2022 bulletin, to the bafflement of some outside observers.
Maia Szalavitz, a leading commentator on substance abuse issues, suggested in a column published last month in the New York Times that oversight of the drug should be shifted from the DEA, which approaches the issue through a law-enforcement lens, to the Food and Drug Administration. She advocated specifically for increasing production quotas and for revisiting the opioid settlements that have added to the regulatory red tape that may limit legitimate access to the drug for patients who need it.
These artificial limits on production, however well-intentioned, are at least partly to blame for the persistent shortage of the past six months. Lawmakers are pressing the DEA to do what it can to alleviate the problem. The solution seems simple — allow more of the drug to be produced — though that also has potential downsides.
Illicit use of prescription stimulants is a real problem. Some of the doctors I spoke to did not want to comment on the record about any changes to federal Adderall regulations, given its sensitive nature. There are several hundred thousand people in the US who are abusing stimulants like Adderall habitually. Prescription stimulants can be deadly, though they have historically accounted for a small percentage of all overdose deaths.
Regulations should reflect the relative risks. “Stimulants like Adderall and Ritalin are nowhere near as addictive or lethal as Fentanyl or other opioids,” Linda Schmidt, a child and adolescent psychiatrist at Oregon Health and Science University, told me.
The question is how to calibrate government oversight to balance the risks to public health versus the risks to patients who can’t access the medications they need. Some experts believe the current system is too overloaded toward preventing abuse, and the current shortage is a consequence of that misalignment.
It would certainly be possible to monitor for Adderall diversion without subjecting it to the same restrictions as opioids. Wiznitzer pointed out that, under Ohio laws, physicians are required to check the state’s prescription drug monitoring database once a month for patients who are prescribed opioids, but only once a year for patients who are prescribed stimulants.
Most of the policy discussion during the shortage has focused on questions of how to loosen up the supply of Adderall.
The other factor driving the shortage, the increase in demand, is more complicated. During the pandemic, it became easier for doctors to prescribe controlled substances without an in-person visit. There have been examples, as Vox’s Sara Morrison previously reported, of “sketchy as hell” startups pushing Adderall on social media sites like TikTok. The DEA has proposed new rules to require an in-person consultation before the prescription of a drug like Adderall.
But that plan has been criticized by some as putting patients at risk who may rely on telemedicine for legitimate reasons. Wiznitzer pointed out that a virtual visit, in which a doctor can observe a child in their natural habitat, can be more revealing than an office visit.
This law enforcement mindset is at the heart of the critique from Szalavitz and others. The DEA approaches its role in regulating Adderall as primarily one of law enforcement, with the emphasis being placed on preventing abuse as much as possible. That may be an understandable — if misguided, in the eyes of some — legacy of the opioid epidemic.
“Perhaps in response to its failure to prevent the rise in prescription opioid misuse, the D.E.A. may be trying to avert a repeat crisis by keeping stimulant manufacturing quotas tight,” Szalavitz wrote in the Times.
But the crisis of the past six months has also shown the potential risk of the current approach: In the richest country in the world, desperate patients can’t get a medicine they need.