When medicines are controlled: How Drug Enforcement Administration rules exacerbate drug shortages

Drug shortages have been a serious, persistent feature of the U.S. pharmaceutical market for more than two decades, affecting essential medicines such as treatments for attention‑deficit/hyperactivity disorder (ADHD), cancer therapies, and saline. These shortages can delay care, force substitution to less effective alternatives, and in some cases require rationing, placing real strain on patients and providers. Shortages can stem from economic forces and natural disasters, but less attention has been paid to the role of federal regulation in the supply of certain controlled substances.

On February 25, the Center on Health Policy at Brookings hosted a panel discussion to examine how Drug Enforcement Administration (DEA) regulations affect the drug supply for Schedule II medicines. These drugs—including widely used oral opioids, ADHD medications, and essential hospital opioids such as morphine—have accepted medical uses in pain management but also a high potential for misuse and abuse, prompting tight production limits to prevent diversion of these drugs for illicit purposes.

Drawing on new research, the panel explored how the DEA’s regulatory framework relying on quotas interacts with manufacturing realities, how it may contribute to or prolong drug shortages, and what reforms could improve the reliability of drug supplies while maintaining appropriate safeguards.

This event is part of a broader Center on Health Policy portfolio on drug supply chains.