FDA, DEA Address Shortages of Stimulant Medications, Including Mfg
The US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have issued a public letter to provide an update and the actions that they are taking to address the current shortages of stimulant medications, such as those to address attention-deficit/hyperactivity disorder (ADHD) and other disorders.
The agencies report that current shortage of these medicines is the result of many factors. It began last fall (fall 2022) due to a manufacturing delay experienced by one drug maker. While this delay has since resolved, record-high prescription rates and production shortfalls have contributed to current shortages.
Data show that from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5% in the US, with a particular spike in certain patient groups during the COVID-19 pandemic in 2020 and 2021. The agency is calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, “to do all they can to ensure access for patients when a medication is appropriately prescribed,” according to the DEA’s and FDA’s public letter of August 1, 2023.
Stimulants are controlled substances, and their manufacturing is regulated by DEA with DEA setting production quotas overall and for individual manufacturers of controlled substances. For amphetamine medications in 2022, DEA says that manufacturers did not produce the full amount of their permitted production quotas that they were authorized to make. Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70% of their allotted quota for the year (2022), and there were approximately 1 billion more doses that they could have produced but drug manufacturers did not make or ship. DEA says that data for 2023 so far show a similar trend.
DEA and FDA have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount. If any individual manufacturer does not wish to increase production, the agencies have asked that manufacturers relinquish their remaining 2023 quota allotment. This would allow DEA to redistribute that allotment to manufacturers that will increase production. DEA also says it will review and improve its quota process.
With regard to alternative treatments, FDA is asking professional groups and healthcare providers to accelerate efforts to support appropriate diagnosis and treatment of ADHD, such as further development of additional clinical guidelines for ADHD in adults. In recognition of this need, 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 also recognizes that further research is needed into the diagnosis and treatment of ADHD and says that research can help inform the development of alternative treatments and an understanding of the behavioral and societal issues leading to widespread misuse of these medications in certain groups.
FDA says it has already taken steps to support the development of alternative treatment options. In 2020, for instance, FDA permitted marketing of a game-based digital therapeutic to improve attention function in children with ADHD. This device offers a non-drug option for improving symptoms associated with ADHD in children. There are also non-stimulant medications approved to treat ADHD, including one approved in 2021. Additionally, to address continuing concerns of misuse, addiction, and overdose of prescription stimulants, the FDA recently issued a drug-safety communication and required updates to the labeling to standardize prescribing information and inform users of associated risks.