Skip to Main Content
Skip Nav Destination
Prescription pills.

FDA, DEA call on drug manufacturers to address shortages, increase access to ADHD medications

August 1, 2023

The Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) called on drug manufacturers Tuesday to increase production of stimulant prescription drugs to address shortages of medicine used to treat children with attention-deficit/hyperactivity disorder (ADHD) and other disorders.

The letter, signed by FDA Commissioner Robert M. Califf, M.D., and DEA Administrator Anne M. Milgram, said the agencies are aware of the importance prescription stimulants play in treating ADHD, binge eating disorder and narcolepsy.

“This is not a problem that the FDA and DEA can solve on our own,” the letter states. “We are urging all stakeholders to work together to resolve these shortages as quickly as possible.”  

Factors contributing to the shortage include a manufacturing delay experienced by one drugmaker last fall. While the delay has been resolved, its effect coupled with additional factors such as record-high prescription rates of stimulant medication, continue to leave some without access.

From 2012-’21, the dispensing of amphetamine products and other stimulants increased by 45.5% in the United States. According to the Centers for Disease Control and Prevention, the percentages in certain groups increased by more than 10%, particularly during 2020-’21 when virtual prescribing was permitted because of the COVID-19 public health emergency.

While the agencies cannot control how much medication is produced, leaders note that manufacturers are not producing as much as allowed.

Stimulants are controlled substances that have a high potential for abuse, which can lead to addiction and overdose. Therefore, the DEA sets limits on how much can be produced. However, officials said manufacturers did not produce the full amount permitted in 2022.

A DEA analysis of inventory, manufacturing and sales data revealed only 70% of the allotted quota was sold in 2022, and approximately 1 billion more doses could have been produced. Data for 2023 show a similar trend, the letter said.

The agencies are asking manufacturers that do not wish to increase production to relinquish their remaining 2023 allotment so other manufacturers can increase production.

Additionally, the FDA is asking health care providers to take a look at diagnosis and treatment of ADHD, including in adult patients. The FDA awarded a grant to the National Academies of Sciences, Engineering and Medicine to support a scientific meeting on ADHD in adults and considerations for diagnosis and treatment. FDA officials say further research is needed, which may lead to alternative treatments and an understanding of the behavioral and societal issues leading to widespread misuse of these medications in certain groups.

Alternative treatment options, such as a game-based digital therapeutic to improve attention in children with ADHD and nonstimulant medications approved to treat ADHD, also are available. FDA officials will continue to monitor concerns of misuse, addiction and overdose of prescription stimulants.

The agencies also will consider additional actions to prevent nonmedical use and ways to identify efforts to better understand and strengthen the supply of medications.

Close Modal

or Create an Account

Close Modal
Close Modal