The Opioid Epidemic and the Food and Drug Administration: Legal Authorities and Recent Agency Action

Summary

According to the Centers for Disease Control and Prevention (CDC), the annual number of drug overdose deaths in the United States involving opioids has more than quadrupled since 1999. CDC estimates that in 2016, more than 63,000 people died from a drug overdose, and more than 42,000 of these deaths involved prescription or illicit opioids. A report issued in November 2017 by the President's Commission on Combating Drug Addiction and the Opioid Crisis also observed that “[t]he crisis in opioid overdose deaths has reached epidemic proportions in the United States ... and currently exceeds all other drug-related deaths or traffic fatalities.” In combating the opioid epidemic, one central challenge for state and federal regulators is striking a balance between taking aggressive action to fight opioid misuse and addiction, while simultaneously protecting patients who experience severe pain. The Food and Drug Administration (FDA)—the executive agency tasked with protecting the public health by ensuring the nation’s drug supply is safe and effective—has a pivotal role in addressing these issues.

This report focuses on FDA as a key player in federal efforts to curb the opioid epidemic. The report provides an overview of FDA’s role in approving new prescription drugs, including certain challenges presented by the approval and regulation of opioid products. Next, the report addresses FDA’s multifaceted approach in its response to the opioid epidemic, the agency’s use of its existing legal authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), and recent agency action taken to target the misuse of opioid medications. The report concludes with a discussion of selected opioid-related legislation in the 115th Congress that would amend the FD&C Act.