DEA Raises ADHD Med Production Quotas. It Could Just Fix the Shortage.

September 10, 2024

The Drug Enforcement Administration is allowing pharmaceutical companies to produce a higher volume of Vyvanse and its generic versions. The “abuse-deterrent” stimulant, which is approved by the Food and Drug Administration to treat ADHD and binge-eating disorder, went generic in 2023 but has remained only sporadically accessible to patients. This is unlikely to have much impact on the ongoing prescription stimulant shortage, which DEA production caps are essentially causing in the first place.

Vyvanse is the brand name for lisdexamfetamine, a central nervous system stimulant that once metabolized converts to dextroamphetamine (AKA D-amphetamine), the same active ingredient in Adderall. Both are Schedule II controlled substances, and as such the DEA decides how much of it pharmaceutical companies are allowed to produce, and how much pharmacies are allowed to carry.

The DEA unveiled the update in the Federal Registrar on September 5, and the order went into effect the same day. The agency is raising its aggregate production quota (APQ) for lisdexamfetamine by around 24 percent, and raised the APQ for dextroamphetamine by around 18 percent. The latter is only for use as an active ingredient in Vyvanse or generics, not for manufacturing Adderall; the DEA acknowledged that companies wouldn’t really be able to increase lisdexamfetamine production without increased access to the active ingredient.

 

 

Though The New York Times and other outlets have characterized the increase as a “potential solution,” only about 25 percent of the expanded quota is for domestic production; the rest will go to international markets where demand has increased at a faster rate. This means that for patients in the United States, the AQP increase is around 6.5 percent for lisdexamfetamine, and around 4.5 percent for dextroamphetamine.

Different pharmaceutical companies’ production methods, as well as the different individual quotas they each receive from the DEA, are all proprietary, so we can’t be sure exactly how this will math out in terms of supply availability. However, given that the FDA estimated the medical need for Vyvanse and equivalent generics increased 6 percent from 2023 to 2024, we can be pretty sure that the impact will be tiny.

Dextroamphetamine and amphetamine, which together comprise Adderall and its generics, went on backorder in October 2022. The Adderall shortage has resolved for some manufacturers—Teva Pharmaceuticals, which makes the brand-name version along with a generic, expects inventory to be fully recovered by the end of September—but not others. Meanwhile, other ADHD medications also began struggling with “low inventory,” as Vyvanse manufacturer Takeda Pharmaceuticals announced in June 2023. The DEA has previously raised the APQ for methylphenidate (brand names Ritalin, Concerta) but hasn’t yet done so for dextroamphetamine.

Manufacturers of generic Vyvanse all attributing their shortages to caps on the active ingredient.

Vyvanse went generic in August 2023 when Takeda’s patent expired, and nearly a dozen companies now manufacture a generic version. But because the DEA also caps dextroamphetamine for those manufacturers, soon they were reporting shortages too. In July 2024, the FDA advised the DEA that all manufacturers of generic Vyvanse were attributing their shortages to a shortage of the active ingredient.

A few weeks before Vyvanse went generic, the FDA and DEA published a joint letter disclosing that Adderall (and generic) manufacturers were only filling about 70 percent of their quotas.

“This is not a problem that the FDA and DEA can solve on our own,” the agencies wrote. “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.”

For however long the DEA is allowed to exist, it will never be able to make a claim so far-fetched that news outlets don’t just take it at face value. This is how media has sort of arrived at a narrative that includes the DEA trying its best to increase the nation’s supply of popular stimulants while the pharma companies involved are just like, not interested in the idea.

Each year the DEA assigns unilateral, arbitrary restrictions to controlled substance manufacturers that hinder full-scale production, and incorrectly forecasts how much product pharmacies will need to meed demand. It could solve the problem, on its own, by not doing that.

 


 

Top image (cropped) via United Stated Drug Enforcement Administration. Inset graphic via Substance Abuse and Mental Health Services Administration.

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Kastalia Medrano

Kastalia is Filter's deputy editor. She previously worked at half a dozen mainstream digital media outlets and would not recommend the drug coverage at any of them. For a while she was a syringe program peer worker in NYC, where she did outreach hep C testing and navigated participants through treatment. She also writes with Jon Kirkpatrick.