November 16, 2020.
National Center for Health Research’s Public Comments Regarding the Draft Guidance for Geriatric Information in Human Prescription Drug and Biological Product Labeling
[Docket number FDA-2020-D-1621]
We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance regarding geriatric information in human prescription drug and biological product labeling. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
The U.S. population is aging, and people 65 and older are expected to make up 20% of the US population by 2030.1 The Centers for Disease Control and Prevention reports that as people get older, they rely more on prescription drugs, and 85% of adults over 60 took prescription medication within the last 30 days. Since older adults metabolize medications differently than younger adults and may have comorbidities that make them more vulnerable to drug side effects, drug interactions, and other serious health problems, it is essential that drugs be tested on older adults and that labeling clearly indicate whether the benefits of a drug or biologic is proven to outweigh the risks for elderly patients.
The FDA encourages but does not require that elderly patients be included in clinical trials used as the basis of FDA approval. Similarly, the Medicare program provides coverage for any FDA-approved prescription drug indicated for all adults.2 For these reasons, clear labeling that explicitly describes the proven safety and effectiveness of drugs in the older adult population is of utmost importance. Research by the National Center for Health Research has found that many new drugs and biologics are not tested on an adequate number of patients 65 and older, and most drug labels do not include statements regarding either the safety or efficacy of the drug for older patients.
We believe that the FDA should not approve therapeutics for adults over the age of 65 if they are not proven to have benefits that outweigh the risks for patients in that age group. We are confident that more targeted indications would provide the incentive needed to persuade companies to include sufficient numbers of older patients and conduct appropriate subgroup analyses. However, if the FDA is not yet willing to restrict approval based on the age of patients that were studied, we agree that the FDA should immediately develop clear guidelines for labeling that addresses safety and effectiveness of drugs in the geriatric population. The suggested labeling for 4 different scenarios would be improved by requiring the label to explicitly state whether the drug is proven to have benefits that outweigh the risks for older patients, rather than focusing only on whether the benefits or risks differ for older patients compared to younger adults. That’s an important distinction, because drugs could be more effective and have fewer risks for younger patients but still have benefits that outweigh the risks for older patients – or those differences might mean that the risks outweigh the benefits for older patients. Adding that information would provide more useful information to patients and providers about what is known about the safety and effectiveness of the drug in the older adult population.
We also strongly endorse the proposed labeling for cases when clinical studies did not include sufficient numbers of geriatric patients, or did not conduct subgroup analyses to determine if benefits outweigh the risks for older patients. This information is crucial for physicians and patients in order to determine whether older patients respond differently to a drug than younger adult patients and the specific safety and effectiveness for those over 65 is unknown.
1. Martin CB, Hales CM, Gu Q, Ogden CL. Prescription drug use in the United States, 2015–2016. NCHS Data Brief, no 334. Hyattsville, MD: National Center for Health Statistics. 2019.
2. Chambers JD, May KE, Neumann PJ. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain. Health Affairs. 2013;32(6):1109-15.