FDA releases guidance on inclusion of geriatric information in drug labeling
The US Food and Drug Administration (FDA) has issued draft guidance on the content and placement of information specific to geriatric patients in drug and biologic labeling.The guidance document, issued in September 2020, replaces a previously withdrawn guidance document – “Content and Format for Geriatric Labeling” – initially released in October 2001.
The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA can permit drug and biological applicants to omit or revise information that would typically be required in the “Geriatric Use” subsection of product labeling. Geriatric patients are defined as being aged 65 years and older.
The new guidance urges drug sponsors not to think of geriatric patients as a “homogenous group,” since there may be differences in organ function, comorbidities, concomitant drugs, and drug distribution and elimination even among geriatric patients in different age brackets. The geriatric use statements should include information on age subgroups (such as 65-74 years, 75-84 years, and 85 years and older) when important differences exist. (RELATED: FDA finalizes guidance on pediatric information in drug labels, Regulatory Focus, 27 March 2019)
Drug sponsors must include geriatric information in the labeling when there is sufficient information to detect an efficacy and/or safety difference between younger adult patients and geriatric patients, both when there is a difference observed and when there is not. Conversely, if data is insufficient to detect efficacy and safety differences, that should be included in the label.
When a safety and/or efficacy difference is observed, sponsors should include the percentage and/or total number of patients 65 years and older and 75 years and older in clinical studies, typically the trials used for drug approval. Alternative age cutoffs may be permitted by the agency. This information should be included in the Geriatric Use section, as well as other relevant labeling sections such as Dosage and Administration, Contraindications, Warnings and Precautions, Adverse Reactions, and Clinical Studies.
When a difference is not observed or the data are insufficient to observe one, the agency recommends inclusion of the number and percentage of drug-exposed geriatric patients in certain clinical studies.
Geriatric exposure information should typically be placed at the beginning of the Geriatric Use subsection. “However, information on specific risks or safety concerns associated with the use of the drug in geriatric patients and/or recommendations on specific monitoring in geriatric patients may appear before the drug exposure information,” FDA advised.
In general, geriatric information should also be included in other sections of the labeling, as well. For instance, if a drug is approved in adults, including geriatric patients, but the dosage is different for geriatric patients, the different dosing information should appear in both the Geriatric Use and Dosage and Administration sections.
Geriatric information must also be included in the labeling when the drug is approved for a geriatric-specific indication or the drug is indicated only for use in geriatric patients. In that case, the Geriatric Use subsection would contain a summary statement and the more detailed information would be discussed throughout the rest of the labeling.
FDA