FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

BACKGROUND: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use. METHODS: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.

The FDA's Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity.

The U.S. encompasses a heterogenous mix of people and health disparities exist for various subpopulations, such as minorities, women, people with limited English proficiency, those with low socioeconomic status, and other underserved groups. Differences in health outcomes arise in part due to inequalities and injustices rooted in biological, social, and structural factors. Because the origins of health disparities are multifactorial, the approaches to reduce, or even eliminate them, must be multifactorial as well. The social and behavioral sciences are well poised to address the myriad and complex factors that affect health outcomes, including those at the individual level (eg, individuals' behaviors, attitudes, and beliefs), the neighborhood level (eg, housing), the community level (eg, cultural values and norms), and the policy level (eg, public policies that influence healthcare funding and access to healthcare resources and educational materials). In addition, the social and behavioral sciences (1) help equip government agencies with the perspectives and tools needed to promote health equity and (2) contribute to rigorous, evidence-based solutions for public health issues, such as disparities found in childhood vaccination rates, childhood obesity, tobacco use, and access to health information technology. The FDA, in particular, actively conducts social and behavioral sciences research to guide the Agency's efforts to advance and support health equity.