November 20, 2013
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) that underlies both the FDA report and the Action Plan explicitly mentions sex, age, racial, and ethnic subgroup characteristics, but the use of language like "including" and "such as" in Section 907 of the act clearly indicates that the FDA was not given an exhaustive list to consider when assessing the extent to which clinical trial preparation and safety and effectiveness data take demographic subgroups into account. As such, the FDA's lack of consideration of disability in its recent report is a choice, and it is not a choice that can go unremarked.