F.D.A. Confirms Widespread Shortages of Adderall

Health and Biotech

The agency cited Teva’s continuing supply problems as well as those of other drug makers struggling to fill the gap.

The Food and Drug Administration has declared a nationwide shortage of Adderall, a medication used to treat A.D.H.D. that has had surging demand in recent years.

The F.D.A. noted that one maker of the drug, Teva Pharmaceuticals, has had continuing manufacturing delays, and other manufacturers of generic versions or alternatives have also reported periodic problems with meeting demand.

The agency recommended that patients taking Adderall talk to their doctors to find alternative treatments.

Adderall, which contains the stimulant amphetamine, is a controlled substance and highly regulated, so it is difficult for pharmacies to quickly pivot and carry new brands, analysts said. Further muddying the picture is the recent popularity of telehealth services. A crop of telehealth start-up companies flourished during the pandemic, with some prescribing Adderall and other drugs to patients in unknown quantities.

The number of Adderall and generic-equivalent prescriptions has been rising in recent years, according to figures from IQVIA, a data analytics company. Total prescriptions rose by about 16 percent, to 41.2 million last year from 35.5 million in 2019.

Over the years, concerns have been raised about the overprescribing of Adderall for children and young adults with A.D.H.D., and about its abuse as a study aid among college students. The teenage mental health crisis that exploded during the pandemic put a spotlight on sharp increases in some prescriptions, like Adderall.

Dr. David Goodman, director of the Adult Attention Deficit Disorder Center of Maryland, said about 4 percent of adults and 8 percent of children have attention deficit hyperactivity disorder, and large numbers of them go untreated — roughly 70 percent of adults and 40 percent of children. He said growing awareness about the condition appears to be leading to a surge in demand for medications.

In addition, he said, the telehealth start-ups made it cheaper and less time-consuming to get a diagnosis, although he questioned whether all of those were accurate.

“I can understand why there are shortages, because there’s an increased demand of people who are seeking these medications,” said Dr. Goodman, who is also an assistant professor of psychiatry at Johns Hopkins University School of Medicine. He received $18,000 in 2021 as a consultant for drug companies.

While a number of companies make Adderall and generic versions, pharmacies may find it difficult to pivot to other suppliers because of amphetamine’s status as a controlled substance that typically includes restrictions on its use and monitoring of prescription orders. Any given pharmacy might risk raising red flags with the Drug Enforcement Administration by doubling its supply, said Erin Fox, an expert on drug shortages at the University of Utah.

“With a controlled substance, it’s harder for patients to call around and find a pharmacy that has product for them,” Ms. Fox said.

Dr. Goodman said patients report almost every day that they are unable to get prescriptions filled. He said his office has had to reissue them in different dosages to help patients receive treatment. Even then, some come up short and, without their medications, may miss deadlines or forget important tasks if they are working in a high-pressure situation.

There is little data on start-up telehealth companies that have drawn criticism for rapidly prescribing a variety of medications, including Adderall.

One such company is Cerebral, which is based in San Francisco. A former vice president of Cerebral, Matthew Truebe, filed a wrongful termination suit against his former employer, claiming that a company goal was to prescribe stimulants to 100 percent of the company’s A.D.H.D. patients, something he considered “not safe or legal,” according to court records. Mr. Truebe also claimed the company had duplicate patients in its database, suggesting that some were seeking prescriptions to resell.

Cerebral, valued at over $1.2 billion this summer, said in a court filing that Mr. Truebe was not fired as an act of retaliation, but because he was a “poor performer.” The company has received a subpoena from federal investigators reviewing its compliance with the Controlled Substances Act. A Cerebral rival, called Done, is also facing Drug Enforcement Administration scrutiny, The Wall Street Journal reported.

Chris Savarese, a spokesman for Cerebral, said the company had ceased prescribing controlled substances to new patients and had not been accused by any government agency of wrongdoing.