FDA, DEA Call For Boosting ADHD Drug Production

United States health agencies say they are working to address the shortage of ADHD drugs, simultaneously calling for more thoughtful prescription of stimulant medications.

In a letter to the public released Tuesday, the FDA and the DEA updated their outgoing actions to address the shortage of stimulant medications.

Stimulant medications, including amphetamines (Adderall) and methylphenidate (Ritalin and Concerta,) are often prescribed to treat children and adults with attention-deficit hyperactivity disorder (ADHD). The condition affects about 4.4% of American adults, with diagnosis rates rapidly increasing.

Stimulants, however, are controlled substances with a high potential for abuse, which can lead to addiction and overdose. Therefore, there are quotas set by the DEA for how much of these drugs can be produced.

The agencies say they have called on drug manufacturers to confirm they are working to increase production to meet their allotted quota amount. Those who do not wish to increase production were asked to relinquish their remaining 2023 quota allotment. This would allow DEA to redistribute that allotment to manufacturers willing to step up the production of the drugs.

The FDA says it is asking professional groups and healthcare providers to accelerate efforts to support appropriate diagnosis and treatment of ADHD, such as further developing additional clinical guidelines for ADHD in adults.

Additionally, the FDA supports the development of alternative treatment options. For instance, in 2020, the agency permitted the marketing of a game-based digital therapeutic to improve attention function in children with ADHD, whereas, in 2021, it granted approval for a new non-stimulant medication.

The shortage of ADHD drugs results from many factors, including a manufacturing delay experienced by one drug maker and record-high prescription rates of stimulant medications, the agencies say. From 2012 to 2021, the overall dispensing of stimulants increased by 45.5% in the U.S. Among certain age groups, prescriptions especially rose during the COVID-19 pandemic, when virtual prescribing was permitted.

Prescription stimulants are widely-misused, as they may increase concentration, cognitive enhancement, and energy. The motives for the misuse may also be social, such as euphoria and social connectedness.