DEA, FDA outline steps to mitigate prescription stimulant shortage

The Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) on Tuesday laid out steps they are taking to mitigate the ongoing shortage of prescription stimulants like Adderall.

Prescription stimulants, which are commonly used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy, have been in short supply since last fall, after a major drug maker encountered manufacturing delays.

While the delays have since been resolved, FDA Commissioner Robert Califf and DEA Administrator Anne Milgram noted in a letter to the American public Tuesday that the impacts have lingered and have been exacerbated by a rise in the use of prescription stimulants during the COVID-19 pandemic.

Califf and Milgram said their agencies are calling on drug manufacturers to increase production of prescription stimulants to meet their allotted quotas for the year and urging those who do not want to boost production to relinquish the rest of their allotment so it can be redistributed. 

Pharmaceutical companies, which are limited in the amount of a controlled substance they can produce annually, only sold about 70 percent of their quota last year and appear to be following a similar trend this year.

“The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” Califf and Milgram said Tuesday. “That said, we are working closely with numerous manufacturers, agencies, and others in the supply chain to understand, prevent, and reduce the impact of these shortages.”

The FDA is also encouraging professional groups and healthcare providers to “accelerate efforts to support appropriate diagnosis and treatment of ADHD,” the pair noted. 

“We want to make sure those who need stimulant medications have access,” they added. “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.”

Tags Anne Milgram DEA fda Robert Califf

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