On August 1, 2023, the U.S. Food & Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”) issued a joint letter to all Americans to provide a status update regarding the ongoing shortage of prescription stimulants. Stimulants fall under the purview of both FDA and DEA because they are controlled substance drugs. Both agencies recognize the important role of prescription stimulants when it comes to the treatment of conditions such as attention-deficit/hyperactivity disorder (“ADHD”), binge eating disorder, and narcolepsy.

According to the letter, the agencies are working closely with manufacturers and other members of the drug supply chain to address these shortages, which are the result of two main factors—manufacturing delays and an increased demand for the stimulants.

Increased Demand for Stimulants

With respect to increased demand, per the agencies, between 2012 and 2021, the overall dispensing of stimulants increased by 45.5% in the U.S. alone. During the COVID-19 global health pandemic, with the rise of telemedicine encounters and virtual prescribing, percentages in certain age groups grew by more than 10% each.

Accordingly, FDA is now calling upon professional groups and healthcare providers to accelerate efforts that will support and ensure the appropriate diagnosis and treatment of ADHD, such as the development of additional clinical guidelines to treat ADHD in adults. FDA recognizes that further research into the diagnosis and appropriate treatment of ADHD is needed to understand the behavioral and societal issues that have led to a nationwide misuse of these stimulants. In fact, FDA awarded the National Academies of Sciences, Engineering, and Medicine (“NASEM”) a grant toward a workshop that will examine the diagnosis and treatment landscape of ADHD in adults.

Alternative Treatment Options

FDA is also taking steps to examine and support the development of alternative treatment options (i.e., treatments other than stimulants). For example, in 2020, FDA permitted the marketing of the first game-based digital therapeutic device to improve ADHD in children. This prescription device is indicated to improve attention function and is intended to be used as part of a more holistic approach to ADHD treatment, which could include therapy, education, and/or medications. FDA has also approved three non-stimulants to treat ADHD in children and are an alternative to the more traditional treatment with stimulants.

Supply Chain Management

DEA, on the other hand, is seeking ways to better manage and perhaps redistribute the quotas allotted for stimulants. That is, because stimulants are controlled substances with a high potential for abuse and therefore overdose, DEA imposes limits (i.e., quotas) on how much of these drugs can be produced.

Surprisingly, based on data collected in 2022, it appears that manufacturers only sold about 70% of their allotted   quota for the year, and 2023 is shaping up to be the same. Accordingly, DEA, in conjunction with FDA, is calling on manufacturers to confirm that they can meet increased production demands and, if not, DEA will redistribute the allotment to other manufacturers to be in a better position to meet the increased patient need.

As we await the results of NASEM’s forthcoming study, drug manufacturers and prescribers of stimulants should continue to monitor the steps FDA and DEA take in this space, as it could impact manufacturers’ ability to make the drug and practitioners’ ability to prescribe the drug.

Reed Smith will continue to monitor developments with regard to FDA and DEA regulation of stimulants. If you have any questions on any of the issues raised in this post, please reach out to the author or the other health care lawyers at Reed Smith.