### Vyvanse Shortage: DEA Raises Quota to Tackle ADHD Medication Supply Challenges
Following a prolonged shortage, the availability of Adderall and its generics is finally beginning to stabilize. Now, the Drug Enforcement Administration (DEA) is focusing on another vital ADHD medication: Vyvanse (lisdexamfetamine) and its generic forms.
To tackle rising concerns regarding Vyvanse’s availability, the DEA has recently declared it will **boost the permitted production quota of lisdexamfetamine by 23.5 percent**. This revision elevates the current quota from 26,500 kg to 32,736 kg, an increase of 6,236 kg. Additionally, the DEA has sanctioned a corresponding rise in d-amphetamine, a crucial ingredient for lisdexamfetamine production.
As per the DEA, these modifications are vital to ensure that the United States sustains a sufficient and continuous supply of lisdexamfetamine to fulfill both domestic and international demand.
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### The Function of Quotas in ADHD Medication Supply
Vyvanse is categorized as a **Schedule II drug** under the DEA’s classification criteria, similar to Adderall. This classification indicates it has a substantial potential for abuse yet is recognized for legitimate medical applications. Consequently, the DEA regulates its manufacturing to balance genuine medical requirements against the risk of diversion to illegal markets. The DEA accomplishes this by establishing an **aggregate production quota** for controlled substances such as lisdexamfetamine, which is adjusted periodically in response to demand and other considerations.
In recent years, the DEA’s quota system has faced scrutiny, especially during ADHD medication shortages. Certain medical and industry organizations have criticized the agency for underestimating demand, which they contend has contributed to the supply issues. For instance, the **Adderall shortage** that arose in 2022 was initially triggered by a labor shortage at Teva, the drug’s producer. Nevertheless, even after production resumed, demand surged due to factors including rising ADHD diagnoses and the increased utilization of telehealth during the COVID-19 pandemic.
In a 2024 report, the **American Society of Health-System Pharmacists** identified the DEA’s quotas as a contributing factor that was “exacerbating” shortages. However, the DEA and the **Food and Drug Administration (FDA)** have countered this narrative, asserting that the core issue lies with manufacturers not fully leveraging their allocated production capabilities.
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### Manufacturers and Unutilized Quotas
In an **August 2023 joint letter**, the DEA and FDA indicated that manufacturers of amphetamine-based products, such as Adderall and Vyvanse, had sold only **70 percent of their allotted quota** for the year. This resulted in around **1 billion doses** that could have been produced but were left unmanufactured. The agencies observed a similar trend in 2023, highlighting manufacturers’ inability to achieve their full production potential.
To rectify this situation, the DEA and FDA have committed to collaborating with manufacturers to either boost production or relinquish their unutilized quotas, allowing other manufacturers to meet demand.
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### The Vyvanse Shortage: A Multifaceted Challenge
The existing shortage of Vyvanse and its generics presents a similarly intricate challenge. The DEA’s choice to raise the production quota followed a letter from the FDA in July 2023 that requested the adjustment. However, the shortage had already initiated in **June 2023**, when Vyvanse’s manufacturer, **Takeda**, attributed the low inventory to a “manufacturing delay compounded by increased demand.”
The outlook appeared to improve in **August 2023**, when the FDA approved **multiple generic versions** of Vyvanse after the expiration of Takeda’s patent exclusivity. Nonetheless, despite the release of these generics, supply challenges have continued. In **November 2023**, the **Association for Accessible Medicines** (AAM), representing generic drug manufacturers, sent a letter to the DEA stating that generic makers were encountering difficulties acquiring sufficient raw materials to enhance production, citing the DEA’s quotas as a hindrance.
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### Other Contributors to the Shortage
Several other elements may be influencing the persistent Vyvanse shortage:
1. **Manufacturing Delays and Market Factors**: Industry analysts have pointed to concerns about the timing of Takeda’s manufacturing delays, which happened just months before generics hit the market. With significantly lower profit margins linked to generic and off-patent drugs, there’s speculation that manufacturers might be deprioritizing the production of these medications.
2. **Increased Exports**: The DEA has also noted a rising demand for lisdexamfetamine in international markets. While the FDA projected a **6 percent increase** in domestic demand for lisdexamfetamine between 2023 and
