Less than four months after Teva’s Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder (ADHD) treatment, Takeda’s Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration (DEA) has increased (PDF) production quotas on the drug by 24%.
The move comes eight weeks after an FDA request to the DEA to bump up production limits. As Schedule 2 controlled substances, Vyvanse (lisdexamfetamine) and Adderall (amphetamine/dextroamphetamine) are subject to DEA limitations that help prevent them from being abused.
The DEA has raised the aggregate production quota on lisdexamfetamine by 6,236 kilograms, according to a final order set to be published Thursday in the Federal Register. Of that figure, 1,558 kg has been allocated to domestic demand for medications, while the remaining 4,678 kg addresses foreign demand for the products.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA wrote in its notice.
Because the drugs are so tightly controlled, there is a ripple effect when one has a supply issue. Shortages of ADHD drugs have persisted since the summer of 2022 when a labor problem on Teva’s packaging line reduced the supply of Adderall. That issue then triggered increased demand and supply issues with most of the 11 companies making generic versions of Adderall, including Sandoz, Amneal and Sun Pharma.
Then, in June of last year, Takeda reported in a statement on its website that it was experiencing “low inventory” for Vyvanse brought on by increased demand and a manufacturing delay.
In addition, the timing of Vyvanse's shortage raises a question around the economics of producing the medicine in the aftermath of generic launches. Takeda reported its Vyvanse supply shortfall last June, and the first U.S. generics launched two months later. Lawmakers and industry watchers have repeatedly flagged that economic factors can drive drug shortages when companies don't see a potential profit motive in dedicating their manufacturing equipment to low-margin—or even loss-making—products.
Meanwhile, on the DEA's manufacturing allocation, the agency last summer committed to “reviewing and improving” the quota process. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been produced, the FDA and the DEA revealed in a joint letter (PDF).
At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it.