Giulia DiPasquale

Associate Editor

Loyola University Chicago School of Law, JD 2027

Since October 2022, the United States has been grappling with an ongoing shortage of Adderall, a cornerstone prescription stimulant for millions of Americans. What began as intermittent shortages due to manufacturing disruptions has evolved into a prolonged supply constraint affecting patients, providers, and regulators. Behind this shortage lies a complex overlap of regulatory frameworks, legal reporting obligations, and compliance risks that are present across the pharmaceutical industry. Thus, the Adderall shortage is not simply a manufacturing hiccup. It is a case study in how overlapping regulatory regimes can collectively constrain supply in ways that neither regulators nor companies can easily fix in real time. Thus, ensuring sustainable access to ADHD medications and promoting proper use will require clearer authority, better data integration, and shared accountability across drug regulators and the Big-Pharma industry. Without these reforms, shortages will remain a recurring crisis to manage, rather than a systemic problem to prevent.

Understanding the regulatory landscape: The FDA’s role in drug shortages

The U.S. Food and Drug Administration (FDA) is the primary federal agency charged with ensuring that safe and effective drug therapies are available to the American public. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA manages drug shortage notifications and works with manufacturers to mitigate supply disruptions. The FDA publicly acknowledged a shortage of both name-brand and generic formulations of Adderall, citing production delays at key manufacturing facilities amongst a surging demand. The FDA attributed the shortage to manufacturing delays at Teva Pharmaceuticals, a major U.S. supplier of Adderall. While other manufacturers have continued producing amphetamine formulations, their collective output has not been enough to offset Teva’s reduced supply amid the increasing nationwide demand for ADHD medications.

To address shortages, the FDA can take a number of regulatory actions. They can require manufacturers to report anticipated supply disruptions, publish and update national shortage lists, and collaborate with manufacturers to expedite approval of additional production lines or raw materials. Importantly, these authorities are reactive, providing transparency and mitigation support, but do not legally compel companies to produce more of a drug, or prevent them from discontinuing a product. Thus, the FDA cannot force a company to manufacture more product, nor can it compel a manufacturer to remain in a market. In the case of Adderall, the FDA acknowledged production delays and rising demand, yet its “toolkit” is fundamentally collaborative rather than coercive. This distinction matters! Public discourse often assumes that when a shortage persists, regulators are failing to act. In reality, the FDA’s legal authority is structurally limited. It can facilitate solutions, but cannot mandate output.

Supply chain complexities, demand surge, and DEA quotas

While the FDA oversees drug availability, the Drug Enforcement Administration (DEA) regulates the supply of controlled substances, such as Adderall. The DEA sets aggregate production quotas (APQs) and individual manufacturer quotas each year, which are statutory obligations designed to balance adequate medical supply and minimize diversion to illicit use. These quotas are legally binding annual limits on the amount of amphetamine base that may be manufactured in the United States.

The rise of Telehealth during the COVID-19 pandemic put a strain on these quotas, accelerating, the quantity of stimulant prescriptions. Although telemedicine modifications have since been rolled back, prescription rates have remained elevated, placing additional pressure on the existing quota system. Critically, DEA quotas are based on prescription and demand data, which may lag real-time market conditions, which can lead to artificial supply constraints. This means that although the demand is increasing, the data may not always be indicative of such need.

Legal reporting obligations and compliance expectations

Under the Drug Supply Chain Security Act (DSCSA) and other FDCA amendments, manufacturers must notify the FDA about significant supply disruptions or discontinuations of critical drugs, which are defined as those with no adequate alternatives and significant patient impact. Failure to comply can trigger enforcement actions and reputational harm.

Compliance failures on any of these fronts expose companies to enforcement actions, including warning letters, civil monetary penalties, product holds, or even criminal liability in egregious cases. Beyond fines, violations can erode trust with regulators and patients, which is also a significant risk.

This regulatory landscape highlights a critical tension: while compliance obligations are essential for patient safety and drug integrity, they can also slow manufacturers’ ability to respond quickly to shortages. In the case of Adderall, overly rigid reporting and quality requirements, though well-intended, interact with DEA quotas and production limits to create a system where even minor delays or reporting gaps can ripple into widespread supply constraints. This underscores the view that pharmaceutical companies must treat compliance not just as a legal checklist, but as a strategic tool: proactive, transparent engagement with regulators can help anticipate shortages, adjust production dynamically, and ultimately protect both patients and the company’s reputation. 

Balancing access and regulation: Where do we go from here?

The Adderall shortage reveals a structural tension at the heart of U.S. drug regulation: safeguarding patient access while preventing misuse. Although the FDA and DEA have taken meaningful steps such as improving shortage transparency, coordinating with manufacturers, and adjusting quotas where possible, their authority remains fundamentally limited. The FDA can require reporting, publish shortage data, and expedite approvals, but it cannot compel a manufacturer to increase production or remain in a market. Its toolkit is collaborative rather than coercive.

This distinction is critical. Public discourse often assumes that persistent shortages reflect regulatory inaction. In reality, the FDA is managing within statutory constraints that prioritize safety and oversight but do not provide direct control over output. As a result, when shortages arise, regulators are positioned to mitigate and communicate rather than to mandate solutions. The Adderall shortage makes clear that without stronger structural tools, particularly greater supply chain visibility and quota flexibility, regulators cannot fully guarantee consistent patient access or effectively address concerns about overprescribing.

Moving forward, solutions must extend beyond reactive transparency. A more resilient system would integrate real-time production data, prescription trends, and quota utilization to detect supply disruptions before they escalate. Improved data integration across manufacturers, regulators, distributors, and pharmacies could enable dynamic quota management, earlier intervention, and fewer bottlenecks. Such an approach would simultaneously support access, reduce diversion risks, and strengthen supply chain stability.

For pharmaceutical companies, this moment also signals a shift in what regulatory compliance must mean. Ultimately, the Adderall shortage is not simply a temporary disruption. Compliance can no longer function as a static checklist; it must operate as an ongoing strategic commitment grounded in real-time monitoring, cross-functional coordination, and proactive engagement with regulators. Companies that invest in robust compliance governance and supply transparency will not only mitigate enforcement risk, but also help stabilize essential medication markets and rebuild patient trust.