FDA, DEA Steps to Ease Rx Stimulant Shortage

In an unusual 8/1 “Dear Americans” open letter, FDA commissioner Robert Califf and Drug Enforcement Administration (DEA) administrator Anne Milgram say the current shortage in prescription stimulants is not a problem the two agencies can solve on their own. “We are urging all stakeholders to work together to resolve these shortages as quickly as possible,” the two write.

The letter reviews the multiple causes identified for the shortages and updates the steps the two agencies have taken to resolve them. The pair also acknowledge important issues that “will need to be addressed through long-term coordination by a variety of entities involved in this effort.”

While neither FDA nor DEA manufactures drugs or can require a manufacturer to make a drug, make more of a drug, or change the distribution of a drug, Califf and Milgram say they are working closely with numerous manufacturers, agencies, and others in the supply chain to understand, reduce, and prevent the impact of the shortages of the drugs that are used to treat attention-deficit/hyperactivity disorder, binge eating disorder, and uncontrollable narcolepsy episodes.

The letter traces the shortage initially to a situation in the fall of 2022 when one drug maker experienced a manufacturing delay. “While this delay has since resolved,” it says, “we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications.” Califf and Milgram say that between 2012 and 2021, overall dispensing of stimulants increased by 45.5% in the U.S.

“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 two write. “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 letter says the DEA sets limits for how much of the drugs can be produced, but in 2022 manufacturers did not produce the full amount they were permitted to make. “Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products,” the letter says, “manufacturers only sold approximately 70% of their allotted quota for the year, and there were approximately one billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend.”

Califf and Milgram say they have:

• called on manufacturers to confirm they are working to increase production to meet their allotted quota amount and asked manufacturers to relinquish quotas they don’t plan to use so other manufacturers who will increase production could use them;
• asked professional groups and healthcare providers to accelerate efforts to support appropriate diagnosis and treatment of ADHD; and
• taken steps to support the development of alternative treatment options.

“FDA and DEA will continue to do all we can to prevent drug shortages, limit their impact, and resolve them as quickly as possible,” the letter concludes. “We will consider additional actions to prevent non-medical use and identify efforts to better understand and strengthen the supply chain. We also hope that we can all work together 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.”