A ccording to the Centers for Disease Control and Prevention (CDC) , "115 Americans die every day from an opioid overdose," and deaths from prescription opioids have more than quadrupled since 1999. The Food and Drug Administration (FDA)âthe executive branch agency tasked with protecting the public health by ensuring the nation's drug supply is safe and effective âhas a central role in confronting drug abuse, including the opioid epidemic. This report focuses on FDA as a key player in these efforts. The report provides a brief overview of FDA's role in approving new prescription drugs, including opioids, and also addresses selected examples of the agency's existing legal authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act) and recent action taken with respect to the opioid crisis. The report concludes with a discussion of selected provisions of the recently enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which amends the FD&C Act. As part of these questions, FDA officials have discussed the importance of striking the right balance between taking aggressive action to fight opioid misuse and addiction, while simultaneously protecting patients who experience severe pain. FDA Authority and Recent Agency Action Related to the Opioid Epidemic

FDA is taking a multifaceted approach in its response to the opioid epidemic.
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 approximately 42,000 of these deaths involved an opioid. 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 access to medication for patients who experience severe pain. The Food and Drug Administration (FDA)âthe executive agency tasked with protecting the public health by ensuring the nation's drug supply is safe and effectiveâhas a pivotal role in addressing these issues.
This report focuses on FDA's role 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 provisions of the recently enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which amends the FD&C Act and provides FDA with new tools to combat opioid abuse.