According to FDA, it will use stakeholder perspectives to develop action plans to address: improving the completeness and quality of analyses of data on demographic subgroups in labeling; the inclusion of such information in product labeling; and how to improve public availability of information on demographic subgroups to healthcare providers, researchers and patients.
Development of the action plan, required under the Food and Drug Administration Safety and Innovation Act (FDASIA), follows a report published by FDA in August 2013 that examined the collection, analysis and availability of demographic subgroup data for FDA-approved medical products.
In its August 2013 report, FDA reaffirmed the importance of the Agency’s public health mission of effectively communicating clinically meaningful differences that are observed for certain subgroups (including demographic subgroups) to inform decisions by healthcare practitioners and patients. Accordingly, the upcoming public hearing is part of several FDA initiatives intended to facilitate the development and public release of an action plan for strengthening the availability of such data.
Stakeholders can submit requests to make oral presentations at the hearing, which are due by March 21. FDA will accept electronic or written comments after the hearing, until May 16.
View the Federal Register notice announcing FDA’s public hearing on demographic subgroup data.