Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products August 2013
In 2012, Congress passed a law, The Food and Drug Administration Safety and Innovation Act, which recommended that medical product applications submitted for marketing approval improve their demographic subgroup data’s completeness, quality, and availability. FDA was to investigate how well demographic subgroups are included in clinical trials, and if subgroup specific safety and effectiveness data are available. As a result, the FDA, in 2013, published a report which examined 72 medical products submitted for approval in 2011.
As a result, FDA has created an Action Plan presenting 27 action items focused on these priorities:
- Quality: to improve the completeness and quality of demographic subgroup data
- Participation: to identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation
- Transparency: to improve the public availability of demographic subgroup data.
SGWHC applauds the FDA, and the Congress, for their efforts to not only increase participation of subgroups (especially women), but also for efforts to increase availability of results. As we have been saying for years, health outcomes in women (and other subgroups) are sometimes less than optimal when the supposition is made that results in white males are 100% applicable to women and other subgroups. We will look forward to seeing the results of this Action Plan.