November 17th 2020 – On November 16 , the Alliance for Aging Research submitted feedback to the Food and Drug Administration (FDA) on its recently released draft geriatric labeling guidance for human prescription drugs and biological products. The purpose of the guidance is to provide industry with recommendations on the appropriate content, format, and placement of geriatric information on drug labeling for health care practitioners.

Key points in the comment letter include:

• Older adult patients are not a homogenous group, so prescription drug labeling should include information on important geriatric subgroups. Information should also be present in multiple sections of a drug label to help healthcare professionals easily detect important clinical differences studied in a product between different age groups.
• Post-market studies are an important source of information for understanding how drugs work in the real-world for older adults. The FDA should provide clarity on the types of non-randomized clinical trial (non-RCT) data eligible for inclusion in geriatric use subsections of labels. Also, the FDA should provide information on its website to help older adults understand the differences between types of non-RCT data sources.

Read the full letter here.

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Janelle Germanos
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