DEA, FDA Address Prescription Stimulant Shortage in Joint Letter

With the manufacturing delay and shortage of stimulant prescriptions, the FDA and DEA are working to improve accessibility.

In light of the current shortage of prescription stimulant medications, the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) are asking key stakeholders to work together to ensure that patients who need these medications are able to access them.

In a joint letter, the FDA and DEA provide an update on the steps being taken to resolve the shortages, which began last fall because of a manufacturing delay experienced by one pharmaceutical company. This, coupled with record-high prescription rates for stimulant medications has resulted in a continued shortage in supply.

Being controlled substances, the DEA sets a quota on how much stimulant medication can be produced on a yearly basis. According to the agency, manufacturers had not produced the full amount they were permitted to make in 2022 and data from 2023 show a similar trend. In an effort to increase supply, the DEA is asking manufacturers to confirm that they will be working toward increasing production to their allotted quota. Those who do not wish to increase production are being asked to relinquish their quota allotment so that it may be redistributed to other manufacturers.

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.

Reviewing the appropriateness of prescription stimulant use and considering alternatives for certain patients should also be considered, according to the FDA. Additional treatment options available include an FDA-cleared game-based digital therapeutic for children with attention-deficit hyperactivity disorder (ADHD), as well as nonstimulant medication.

Additionally, the FDA recently required manufacturers to update the labeling for prescription stimulants to address continuing concerns of misuse, addiction and overdose. The requested updates were made based on a review of medical literature that showed family members and friends were the most common source of prescription stimulants for nonmedical use.

“We want to make sure those who need stimulant medications have access,” said FDA Commissioner Robert M. Califf, MD and DEA Administrator Anne Milgram in the letter. “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.”

This article originally appeared on MPR


US Food and Drug Administration, Drug Enforcement Administration. Joint FDA and DEA letter to the public on prescription stimulant medication availability. Accessed August 1, 2023.