In a letter addressed to the public, the FDA and Drug Enforcement Agency stated that prescription stimulant drug shortages are impacting patients and their families The agencies are taking a multifaceted approach to mitigate these shortages and find potential solutions.
On August 1, 2023, the FDA and Drug Enforcement Agency (DEA) issued a joint letter to update the public regarding the state of availability for prescription stimulant medications that play a significant role in the treatment of attention-deficit/hyperactivity disorder (ADHD), binge eating disorder, narcolepsy, and other disorders.
Robert M. Califf, MD, commissioner, FDA; and Anne M. Milgram, administrator, DEA, collaborated and signed the letter addressed to the American public, acknowledging the important role these stimulants play in various conditions, and that the lack of availability has been “frustrating” for patients and their families.
The agencies are calling on all stakeholders to resolve the shortages via a multifaceted and collaborative approach. The agencies state in the letter, “This is not a problem that the FDA and DEA can solve” on their own. The agencies are working with several manufacturers and other agencies in the supply chain to not only reduce shortages, but to better understand and prevent them.
According to the letter, several factors have contributed to the current shortage of stimulant medications, such as manufacturing delays and “record-high prescription rates of stimulant medications.” From 2012 to 2021 in the United States, overall dispensing of stimulants increased by 45.5%.
The stimulants have a high potential for abuse, potentially leading to addiction or overdose, reasons why the FDA and DEA state amid the shortages, “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 FDA is seeking accelerated efforts to support appropriate diagnosis and treatment of ADHD from professional groups and health care providers. For example, continued and further development of additional guidelines for ADHD in adults. The organizations are also looking at previous steps taken for alternative treatment options, including ones taken in the pediatric population. For example, the FDA allowed marketing of a “game-based digital therapeutic to improve attention function in children with ADHD,” serving as a non-drug option to improve ADHD-associated symptoms in children. Additionally, there are non-stimulant medications, including the approval of Qelbree (viloxazine extended-release capsules), in 2021.
“We will continue to work together and with all of you to mitigate this drug shortage and provide up to date information,” Califf and Milgram concluded.
Califf RM, Milgram AM. Letter. FDA. August 1, 2023. Accessed August 1, 2023. https://www.fda.gov/media/170736/download?utm_medium=email&utm_source=govdelivery