Which U.S. agency makes the first assessment of a new drug's potential for addiction and/or abuse?

The U.S. Food and Drug Administration (FDA) is responsible for the initial assessment of a new drug's potential for addiction and/or abuse as part of its review process for new drug applications. During this process, the FDA evaluates various factors, including the pharmacological properties of the drug, the data from preclinical studies and clinical trials, and its proposed labeling. This assessment helps determine the appropriate scheduling of the drug under the Controlled Substances Act, which is pivotal in identifying substances that may lead to misuse or dependency.

While the National Institute on Drug Abuse (NIDA) conducts research on addiction and drug abuse, and the Drug Enforcement Administration (DEA) schedules drugs based on the potential for abuse, it is the FDA that conducts the first thorough evaluation during the drug approval process. The Centers for Disease Control and Prevention (CDC) does not typically perform assessments related to drug addiction or abuse potential in the context of new drug reviews. Thus, the FDA's role as the agency that makes the first assessment in this area is critical in the overall pharmacovigilance and regulation of new drugs.