The FDA and DEA are urging drug manufacturers to ramp up production of prescription stimulants, such as Adderall, due to the ongoing shortage that has lasted almost a year.
They indicated in a joint letter that they are working with suppliers, manufacturers, and other interested parties to solve the present shortfall and take precautions against future shortages. The letter acknowledged that the FDA and DEA partnership needed help to solve the problem and urged manufacturers to confirm their efforts to boost production to meet the required quota.
One of the main reasons behind the shortage is the DEA’s yearly limit on amphetamine/stimulant production, with Adderall being classified as a Schedule 2 drug due to its potential for abuse. Last year, amphetamine medications were produced 30% below the total quota, resulting in a shortfall of about 1 billion potential doses. This year, a similar trend is being observed.
Manufacturers unwilling to increase production have been asked to relinquish their remaining 2023 quota allotment, allowing the DEA to allocate it to manufacturers that will increase production.
Both agencies have also called on healthcare providers, payers, and physicians to closely monitor stimulant prescriptions due to their widespread misuse and potential for addiction. The use of amphetamine products and other stimulants saw a 45.5% increase in the U.S. from 2012 to 2021, particularly during the COVID-19 pandemic when virtual prescribing became more prevalent.
The letter emphasised the importance of ensuring access to stimulant medications for those who need them while also taking a closer look at responsible and thoughtful prescription practices.
The shortage of Adderall and other stimulants came to light last summer when major producers reported shortages. The manufacturing disruptions were compounded by a surge in Adderall prescriptions in 2022, attributed to increased diagnoses of attention-deficit/hyperactivity disorder and easier availability through online start-ups.
