By Kathryn Stapleton

            For many people with Attention Deficit Hyperactivity Disorder (ADHD), Narcolepsy, or Binge Eating Disorder (BED), medications like Adderall (mixed-salt amphetamine), Vyvanse (lisdexamfetamine), and Dexedrine (dextroamphetamine) are not optional; instead, for many patients, they provide the fortitude to take on daily life. However, since late 2022, both patients and prescribers have faced persistent barriers to accessing these medications. While manufacturing difficulties and swings in demand play a part, the core driver is pure regulatory red tape: the Drug Enforcement Administration’s (DEA) annual production quotas for Schedule II stimulants.[1] These quotas, designed to prevent diversion, now function as a restriction to accessibility. It is time to transform these regulations to safeguard both public health and supply security.

How the Quota System Works and Why It Matters

            Under the Controlled Substances Act (CSA), the DEA must set aggregate production quotas (APQs) each year for every Schedule I and II substance, including amphetamine, dextroamphetamine, lisdexamfetamine, and methylphenidate.[2] The implementing regulation, governs manufacturer-specific quotas and procurement quotas.[3] In 2018, the DEA revised its framework to emphasize diversion risks in quota setting, increasing its discretion to limit supply further.[4] DEA establishes APQs annually and can adjust them mid-year when shortages emerge. In 2024, the DEA issued initial quotas in January. By September, the APQ for lisdexamfetamine (Vyvanse) and d-amphetamine (for conversion) increased after the FDA formally requested an increase based on shortage data.[5] This incident demonstrates that the safety valve can function—but only after supply stress has persisted long enough to trigger pressure from patients, public health officials, and congressional oversight measures.

Human Costs of a Shortage

            The FDA first publicly acknowledged an Adderall shortage in October 2022 and kept patients updated as constraints spilled into other stimulants, especially once Vyvanse demand rose after generics launched in 2023.[6] Meanwhile, the Department of Health and Human Services chronicled record-level U.S. drug shortages more broadly, underscoring that persistent gaps harm access and raise costs overall.[7]

Congress also took notice of the issue and, in 2023, outlined the federal levers for addressing Adderall shortages.[8] Additionally, in 2024, Congress pressed the DEA on how it weighs medical need against diversion in its quota decisions.[9] Policymakers signaled that quota transparency and coordination with the FDA must improve for the benefit of both prescribers and patients.

What the Law Requires and What It Doesn’t

            The CSA directs the Attorney General to set quotas at levels “necessary to meet the estimated medical, scientific, and research needs of the United States.”[10] Regulations even provide measures to set quotas in dosage-form terms to avoid overproduction, shortages, and diversion.[11] So on paper, the regime is supposed to balance access and control. However, in practice, the balance has shifted towards heavy diversion control, characterized by unclear methods and lengthy lags before adjustments hit the market.

            The DEA and the FDA jointly acknowledged this in an August 2023 statement, stating that supply problems stem from many factors, outside of diversion, such as supply chain issues and demand swells. The FDA sees clinical demand, and the DEA controls the legal ceiling on active ingredient production. When those perspectives misalign, patients feel it at the pharmacy counter. While executive agencies do not manufacture drugs or compel output, they must coordinate closely with manufacturers to reduce the impact of shortages.[12]

Where the Current Framework Falls Short

            Current medical-need research is opaque and lacking. The statute’s “estimated medical…needs” language does not specify methodology.[13] Neither DEA’s annual APQ notices nor individual-quota adjudications consistently disclose how prescribing trends, shortage data, and inventory levels are weighted.[14]

            DEA policy gives diversion priority over accessibility. Post-opioid crisis rules elevated “potential for diversion” in quota setting.[15] That makes sense for harm reduction, but stimulants are not opioids, and shortages impose their own health risks, such as school and work impairment, driving hazards for narcolepsy patients, and mental-health setbacks for those dealing with binge eating disorder.

Reforms That Preserve Control and Increase Accessibility

            First, make medical-need findings explicit and data-driven. Congress should amend 21 U.S.C. § 826 to require the DEA to use and publish current-year demand inputs from the FDA (utilization, prescriptions filled, new approvals, pediatric use), along with inventory and backorder metrics.

            Second, formalize the FDA’s role in stimulant quotas. Congress can give the FDA a consultation trigger for Schedule II stimulant APQs and individual quotas, especially during declared shortages under 21 U.S.C. § 356c (drug shortage statute).[16] The 2024 lisdexamfetamine order already reflects de facto reliance on FDA shortage determinations. Thus, the law should make that coordination proactive, not emergency-only.

            Third, improve oversight and public accountability. Congress should continue bipartisan oversight, such as requesting methodology, inventories, and allocation rationales, so that it can see whether rising diagnoses and legitimate prescribing are reflected in quota levels.[17]

Addressing the Diversion Concern

            Yes, stimulant misuse exists. However, quotas are a crass instrument for a limited problem. Targeted tools such as prescription drug monitoring programs (PDMPs), telehealth prescribing standards, and audits of high-risk prescribers directly mitigate misuse while keeping legitimate patients supplied.

            The quota system is a vital guardrail against diversion. However, when that guardrail obstructs access, it leaves classrooms unsettled, workers struggling, and patients rationing medication to stay afloat. The next step is to reform the framework so the response during the subsequent shortage is timely, transparent, and tuned to the real-world demand. The government owes patients responsible oversight that keeps medicine available, so evidence-based ADHD, Narcolepsy, and BED care can continue uninterrupted.

[1] 21 U.S.C. § 826.

[2] 21 U.S.C. § 812.

[3] 21 C.F.R. § 1303.03 (2023).

[4] Controlled Substances Quotas for Drug Enforcement Administration, 83 Fed. Reg. 32784, 32790 (July 16, 2018).

[5] Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 Fed. Reg. 72724 (Sept. 5, 2024).

[6] U.S. Food & Drug Admin., FDA Announces Shortage of Adderall (Oct. 12, 2022), https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall.

[7] Rini Beleche & Allison Kolbe, Medical Product Shortages in the United States: Demographic and Geographic Factors and Impacts, U.S. Dep’t of Health & Hum. Servs., (July 15, 2024), https://aspe.hhs.gov/reports/medical-product-shortages.

[8] Lisa Sacco, Cong. Rsch. Serv., The Federal Role in Addressing the Adderall Drug Shortage (May 4, 2023).

[9] Letter from House Comm. on Oversight & Accountability to DEA Adm’r Anne Milgram (May 13, 2024), https://oversight.house.gov/wp-content/uploads/2024/09/Letter-to-DEA-on-drug-shortages_follow-up.pdf.

[10] 21 U.S.C. § 823.

[11] See 21 C.F.R. § 1303.11(b).

[12] U.S. Food & Drug Admin. & DEA, Joint Letter to the Public on Prescription Stimulant Shortages (Aug. 1, 2023), https://www.dea.gov/sites/default/files/2023-08/DEA%20and%20FDA%20Issue%20Joint%20Letter%20to%20the%20Public.pdf.

[13] 21 U.S.C. § 826

[14] DEA, Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances, 89 Fed. Reg. 67,444 (Sept. 25, 2024).

[15] 21 C.F.R. § 1303.03 (2023).

[16] 21 U.S.C. § 356c.

[17] See Sacco, supra note 8.