The tightly regulated ADHD drug has been plagued by supply issues, with little information why.
(Bloomberg) — The Adderall shortages that emerged across the US last year started quietly. Teva Pharmaceutical Industries Ltd., the country’s largest producer of the pills, ran into manufacturing troubles but made no announcement. The Food and Drug Administration, which tracks such problems, didn’t alert the public.
In fact, the news came out almost by accident: In July, a Reddit user posted about their difficulty finding a pharmacy to fill their prescription. They contacted the FDA and received a message saying that Teva expected delays for the next two to three months. The company and the agency later confirmed the supply issues to Bloomberg News.
More than half a year later, there’s been little resolution. Adderall, which treats attention-deficit/hyperactivity disorder and the sleep disorder narcolepsy, remains in short supply, with five companies reporting availability issues, according to the FDA. A recent survey of local pharmacies showed that some 97% didn’t have adequate stock of the medicine.
And for a drug regularly used by millions of Americans to stay focused, the reasons behind the shortage are largely a mystery.
The haphazard way the news of the Adderall issues trickled out is emblematic of the secrecy and confusion that has long existed around the manufacturing and distribution of the pills, classified by regulators in the same category as highly addictive drugs such as oxycodone and fentanyl. As the shortage stretches on, it shows the difficulties of tracking a tightly controlled medicine where any hiccup in the supply chain can lead to chaos. That’s all the more frustrating at a time technological advances and regulatory changes are meant to make it easier for people to fill prescriptions.
Adderall usage has climbed amid growing social acceptance of mental-health conditions and stimulant medications as treatments, along with increased availability through telehealth. But rising demand is only part of the story. Teva says its production problems are fixed. The government and manufacturers haven’t provided enough information to say exactly where the bottleneck is. Some companies have said quotas on a key ingredient contributed to the problem, which the agency that sets those quotas denies. And shortages have been a recurring problem over the past dozen years, indicating deep-rooted issues.
Sreenivas Katragadda, a psychiatrist of 17 years in Manchester, New Hampshire, said he’s seen multiple shortages of ADHD medications and the situation is particularly bad.
“It is a logistical nightmare,” Katragadda said. “I will send the prescription to one pharmacy, which is the usual pharmacy for the patient. They’ll say they don’t have it, and they’ll say, ‘Maybe it is there in Nashua,’” a town that’s about 20 miles away.
“I’ll send it to Nashua, only to realize that before my prescription is filled, somebody else has sent another prescription that got filled first,” he said.
Within the past few months, the University of Utah’s drug information service, which tracks supply, has also reported shortages of other type of ADHD stimulants — methylphenidate drugs, a category that includes popular brands like Ritalin and Concerta. That shortage affects the generic versions, which account for the vast majority of filled prescriptions. It’s unclear if the shortage is caused by patients switching from Adderall to those medicines.
Tightly Controlled
Many of the reasons there is so little information about Adderall are tied to its designation as a Schedule 2 controlled substance by the Drug Enforcement Administration, which means the agency has determined the drug can be addictive and has a high potential for abuse. A government study based on data from 2015 and 2016 estimated that 5 million adults misuse prescription stimulants each year and 400,000 have a prescription stimulant use disorder.Because of the Schedule 2 classification, there are rules that govern just about every step of Adderall’s production, distribution and sale. Scrutiny of such medicines has become even more intense following the opioid crisis, caused by irresponsible drug company marketing and physician overprescribing.
The Wall Street Journal reported in December that a DEA official wrote to Adderall manufacturers last year expressing concern that some of the factors that may be leading to increased demand for ADHD drugs are similar to those that led to “an oversupply of opioids during the prescription opioid crisis.”
This kind of comparison concerns clinicians who say that opioids and ADHD medicines have significant differences. Stimulants like Adderall give people with ADHD improved executive function, the set of cognitive skills involved in focusing, planning, and completing tasks. When used appropriately, they aren’t addictive in the way that high doses of painkillers can be. In fact, stimulants like Adderall reduce substance abuse in people with ADHD, according to published research.
“Many of us are concerned when people simplistically lump the stimulant medication with the opioids,” said Max Wiznitzer, division chief of pediatric neurology at University Hospitals Rainbow Babies & Children’s Hospital in Cleveland, who treats children and young adults with ADHD.
Because of the Schedule 2 classification, obtaining Adderall isn’t as simple as getting birth control or an acid reflux medication. Patients need to get new prescriptions every one, two or three months, and can normally only fill them within a few days of the previous prescription running out. If a pharmacy is out of stock, patients need to contact their clinician and ask them to send the prescription elsewhere. It’s all the more troublesome for a person with ADHD, a condition that makes it difficult to complete complicated administrative tasks.
The FDA doesn’t typically broadcast information about brewing shortages because doing so might lead to hoarding and worsen the situation, which is why the agency didn’t proactively alert the public about Teva’s issues over the summer, a spokesperson said. “Usually, people find out about a shortage when they go to their pharmacy,” said Erin Fox, who runs the University of Utah’s drug information service.
Previous shortages have led to finger-pointing. During a shortage in 2011 and 2012, the FDA blamed the DEA and the DEA blamed the drug companies, according to news reports. In the most recent situation, the FDA listed Adderall as in short supply from September 2019 through May 2022, because of “manufacturing delays” and increased demand, according to the agency spokesperson. The FDA once again declared a shortage in October.
Production Snags
Teva, which made one out of four branded and generic Adderall pills dispensed at US pharmacies last year, has said its supply issues were tied to a dearth of workers on the packaging line, a rapid increase in demand and the federal government’s production limits. The labor problem was caused by “Covid workforce-related” issues, Kare Schultz, Teva’s then-chief executive officer, said in November. That was resolved by August, said Kelley Dougherty, a Teva spokesperson, who declined to comment further on the cause of the labor shortage.
Teva, the sole manufacturer of branded, immediate-release Adderall, said last year that it anticipated that the branded pills would come back in full supply more quickly than the cheaper, more common generic version. By the end of January, all of Teva’s branded Adderall pills were fully available, while all of the generics had constrained supply, according to the FDA. About 87% of prescriptions filled in the US last year were for the generic immediate-release or extended-release versions, data from Symphony Health show.
Dougherty said that both Teva’s generic and branded Adderall production has recovered to its expected levels and allocations, and that “unprecedented demand continues.”
Drug companies can’t always quickly ramp up supply of controlled substances, in part because of a government system that limits how much of the medicine’s raw ingredient each manufacturer can have. These quotas, established by the DEA, are intended to limit the amount of controlled substances produced to ensure that there’s enough to meet medical needs, but not so much that it can leak onto the black market.
But the DEA doesn’t disclose which companies are allotted what amount of Adderall’s raw ingredient, amphetamine, making it hard to figure out the role of quotas in shortages. Companies can request more amphetamine throughout the year.
Teva’s Dougherty said in October that DEA quotas contributed to the shortage. Robert Jaffe, a spokesperson for Lannett Co., which makes generic Adderall and is the drug’s third-largest producer, said in December that the DEA’s quotas prevented the company from meaningfully ramping up production in response to the shortage. Neither company answered questions about whether they requested a quota increase. Novartis AG’s generic-drug unit Sandoz, the second-largest maker, has had some of its requested increases granted and some denied, said spokesperson Leslie Pott. She said the federal agency has been working with the industry.
“We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs,” the DEA said in a statement. “Based on DEA’s information — which is provided by ADHD drug manufacturers — this is not true.”
An agency spokesperson, who asked not to be named because of department policy, said that at the end of 2022, manufacturers of Adderall as well as the drug’s raw ingredients had products on hand with at least 34,980 kilograms of amphetamine — about 83% of the total quota the DEA had allowed to be produced for the year. At the end of last year, companies also had at least 29,700 kilograms left over of methylphenidate, used in drugs like Ritalin or Concerta, equating to around 71% of the quota, the spokesperson said.
The disconnect between what the manufacturers and the DEA are saying shows the challenges to resolving the mess. In the meantime, patients like 7-year-old James Ash in Las Vegas are left struggling.
Ash has ADHD and autism and typically takes generic extended-release Adderall. Without the treatment, he has difficulty focusing in school, and might get aggressive and start hurting himself, his parents said.
Four times over the past seven months, the prescription has been out of stock. At the end of December, Ash’s pediatrician tried to prescribe a different type of ADHD medication, but the family’s insurance declined to pay for it. As recently as Feb. 2, a CVS didn’t have enough pills to fill the prescription.
“It’s very frustrating,” said Jennifer Jolly, Ash’s mom. “I just want to do what’s best for my kid, and it sucks, because there’s nothing you can do.”
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