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M-18: Analysis of Drug Labeling for Information Specific to Geriatric Populations

Poster Presenter

      Jacqueline Chen

      • Student
      • University of Southern California
        United States


To assess adherence to Food and Drug Administration Safety and Innovation Act (FDASIA) for greater clinical trial diversity, particularly in geriatrics, through evaluation of content and specificity of recent novel drug approval drug labels and review documents.



Geriatric use sections of 2015-2017 novel drug approval drug labels from FDA.gov were examined in 4 areas: reporting of clinical trial (CT) involving geriatrics, percentage of CT subjects age 65 and/or 75+, geriatric dosage recommendation, determination of product safety and efficacy for geriatrics.


Of the total 99 drug labels examined, 23% did not reference CT information specific to geriatric populations and 33% indicated there was insufficient evidence to determine the safety and efficacy of the product for geriatrics. 71% of drug labels examined did not provide dosage recommendations for geriatric populations. Of those providing no dosage recommendations, 37% state there were insufficient numbers of geriatric participants in CTs to make any dosage recommendations. Further, 42% of geriatric labels examined did not include information on the number of CT participants ages 75+. For example, a drug label stating: "Clinical studies…did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from patients 18 years to less than 65 years of age" fails to include the number of geriatric CT participants ages 65+ and 75+, geriatric dosage recommendations, and determine product safety and efficacy for geriatrics. Even in cases where geriatric labels referenced CT participation by geriatrics ages 65+, 20% did not specify the number of participants ages 75+. We expected to see increases in new drug labels referencing CT information in geriatric populations following 2014 implementation of Section 907 of the FDA Safety and Innovation Act, which calls for a greater diversity in CT participants and more thorough demographic reporting. Of the four areas examined (as described in methods above), we observed an increase over time in only one area -- the number of labels reporting CT participation by geriatrics (2015: 72%, 2016: 74%, 2017: 83%). However, other areas did not show consistent increases: geriatric labels citing the number of CT participants ages 75+ over time (2015: 62%, 2016: 43%, 2017: 61%); geriatric labels stating product safety and efficacy for geriatric populations (2015: 67%, 2016: 58%, 2017: 71%); geriatric labels providing dosage recommendations for geriatric populations (2015: 28%, 2016: 42%, 2017: 24%)


The results of this analysis demonstrate a lack of understanding in the safety and efficacy of new drugs in geriatric populations. Considering that the average US life expectancy is now 78 years old and the anticipated doubling of the elderly population in coming decades (NIH, 2016), there is an urgent need to include this population in current and future clinical research. The geriatric population, particularly those age 75+, use more than a third of total prescription and over-the-counter medications sold in US (Merck Institute, 2014), but is severely underrepresented in clinical trials. With $35.7 million spent annually on hospitalization from adverse drug reactions in the elderly (Nair et al., 2016), it would be in the interest of multiple stakeholders to find ways to include this special population in clinical trials. The effects of polypharmacy and changes in drug metabolism with age increase the need for specific drug dosage recommendations for geriatrics. The unclear or inadequate language currently found in geriatric drug labels would contribute to a lack of understanding in how these products affect the elderly. As a result, clinicians may face challenges when prescribing these medications for their patients who are in the 65+ or 75+ categories. Understanding how a new drug affects this population can only be gained by increasing their participation in the clinical trial process. The findings from this study reveal that while there is slight improvement in recent years for reporting of CTs involving geriatric populations in new drug labels, progress is still needed. Greater inclusion and reporting of CT participants age 75+ would inform the healthcare providers and patients on the safe and effective use of new drugs in this growing segment of the world's population. While there are regulatory incentives and mandates for CTs in pediatric populations, such measures are lacking for geriatric populations and may be an area for future consideration.