The important part:
The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker. While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States. According to a U.S. Centers for Disease Control and Prevention report, particularly during 2020-2021, when virtual prescribing was permitted on a widespread basis during the COVID-19 Public Health Emergency, the percentages in certain age groups grew by more than 10 percent. 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. 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.
Stimulants are controlled substances with a high potential for abuse, which can lead to addiction and overdose. Therefore, there are limits (also known as quotas) set by DEA for how much of these drugs can be produced. However, for amphetamine medications, in 2022, manufacturers did not produce the full amount that these limits permitted them to make. Based on DEA’s internal analysis of inventory, manufacturing, and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70 percent of their allotted quota for the year, and there were approximately 1 billion more doses that they could have produced but did not make or ship. Data for 2023 so far show a similar trend.
We (DEA and the FDA) have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount. If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment. This would allow DEA to redistribute that allotment to manufacturers that will increase production. DEA is also committed to reviewing and improving our quota process.
Sure, because that’s what they can see and what is relevant to them. They have no insight into the manufacturers allotment of production, what that production schedule is, or how much of their production allotment they’ve already used. What you’re seeing in this article is “behind the scenes” look at just how deeply the US Government is involved in Healthcare.