The Drug Enforcement Administration is increasing the production limit of Vyvanse and its generic equivalents by about 24% to address the ongoing global shortage of ADHD medications.
In a notice on Tuesday, the DEA said the raised production quota is in response to a July request from the Food and Drug Administration, which said the overall shortage of Takeda Pharmaceutical's Vyvanse and its generic forms was because of a shortage in its active ingredient, lisdexamfetamine dimesylate.
The federal agency said the adjustment now is to ensure that an "adequate and uninterrupted supply" of the active ingredient is manufactured to meet patient needs domestically and globally because the drug is used "in the prevention or treatment of a debilitating disease or condition."
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The DEA classifies Vyvanse and other prescription stimulants like Adderall and Ritalin as Schedule II controlled substances, meaning there are additional safeguards in their production and prescription due to their potential for abuse.
But in recent years, soaring demand and limited supply, in part due to federal caps on controlled substances, have caused lengthy wait times for the drugs and yearslong shortages.
In 2022, the FDA warned of an Adderall shortage due to supply and manufacturing issues, which led to higher demand for Vyvanse, eventually leading to a shortage of it, too. Then last year, the FDA approved 11 generic versions of Takeda's Vyvanse, which was expected to help alleviate some of the ADHD medication shortage that still exists today.
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And as the supply continues to be bogged down, demand for stimulant medications continues to rise.
Data released by the U.S. Centers for Disease Control and Prevention in May showed that 1 million more kids and adolescents in the U.S. received an ADHD diagnosis — 7.1 million kids total — in 2022 compared to 2016.
Some of the spike was attributed to heightened mental health issues brought on by the pandemic, while other experts say a growing awareness of attention-deficit disorders may contribute to an increase in diagnoses and, therefore, ADHD prescriptions.
