The Silver Tsunami Quiz: CVD in the Elderly

Adam H. Skolnick, MD


March 10, 2017

Although there are FDA Offices of Pediatric Therapeutics, Women's Health, and Minority Health, there is no office representing the interests of older adults. There is an Assistant Commissioner for Women's Health and a Director for Minority Health, along with a Chair of the Pediatric Advisory Committee, but there is no FDA official charged with overseeing elderly affairs.

The FDA has a Pediatric Labeling Database, and the Pediatric Exclusivity Rule offers patent extensions and market exclusivity to pharmaceutical companies that study medication in children; however, no such data or rule applies to older adults. In response to FDASIA 907 (a summary report of the representation of women, racial minorities, and elderly persons in clinical research), the FDA is developing an action plan to increase representation of diverse populations in research.[13]


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