Washington, D.C.—Federal officials recently acknowledged and provided an update on the shortage of stimulant medications, primarily for ADHD.

In a letter to the public, Robert M. Califf, MD, commissioner of the FDA, and Anne M. Milgram, JD, administrator of the Drug Enforcement Administration (DEA), said they were “working closely with numerous manufacturers, agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages.”

The letter said that many factors played a role in the current shortage of stimulant medications. “It began last fall due to a manufacturing delay experienced by one drug maker, Dr. Califf and Mrs. Milgram explained. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.”

The CDC has previously reported that the percentages of prescriptions in certain age groups grew by more than 10%—especially during 2020-2021, when virtual prescribing was permitted on a widespread basis during the COVID-19 pandemic.

“We are 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,” the authors of the letter wrote. “We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly.”

The message pointed out that stimulants are controlled substances with a high potential for abuse, which can lead to addiction and overdose. That means that the DEA has quotas for how much can be produced. “However, for amphetamine medications, in 2022, manufacturers did not produce the full amount that these limits permitted them to make,” the letter stated. “Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend.”

Dr. Califf and Mrs. Milgram wrote that their agencies have requested confirmation from manufacturers that they are working to increase production to meet their allotted quota amount. They also asked manufacturers who do not opt to increase production to relinquish their remaining 2023 quota allotment. Then, the DEA would be able to redistribute that allotment to manufacturers that will increase production. The letter states that DEA is also committed to reviewing and improving the quota process.

At the same time, as the agencies are seeking to increase production; the FDA is requesting that professional groups and healthcare providers step up efforts to support the appropriate diagnosis and treatment of ADHD. Those might include further development of additional clinical guidelines for ADHD in adults, according to the agency, which recently 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 believes 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,” the officials wrote.

The letter advised that FDA had supported the development of alternative treatment options, including, in 2020, allowing the 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,” according to Dr. Califf and Mrs. Milgram.

In addition, a recent drug safety communication addressed ongoing concerns about misuse, addiction, and overdose of prescription stimulants, while also requiring updates to the labeling to standardize prescribing information and clearly inform patients, caregivers, and healthcare professionals of the risks.

The goal, according to the FDA and DEA leaders, is to “assure that those who need stimulant medications can get them based on the best clinical knowledge about when they are effective and avoid them when there is no indication for their use.”

Prescription stimulants are primarily used to treat ADHD but also play a therapeutic role in play binge eating disorder and narcolepsy.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

 « Click here to return to Weekly News.