FDASIA 907 Meeting: Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
Thank you for the opportunity to speak today. My name is Dr. Tracy Rupp and I am the Director of Public Health Policy Initiatives at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers.
We strongly support efforts to improve the safety and effectiveness of drugs and medical devices for ALL groups of people. We appreciate that FDA is concerned about diversity in clinical trials, but we are concerned that it is NOT affecting the data provided at FDA Advisory Committee meetings. At those public meetings, subgroup analyses by sex, race/ethnicity, or for those 65 and older are sometimes included but it is RARE THAT ALL 3 types of subgroup analyses are conducted. Even when some subgroup analyses are conducted, the data are rarely provided for both safety and effectiveness in the FDA briefing documents or presentations.This clearly sends the message that subgroup analyses are not considered important enough to mention.
To learn more, we scrutinized data for all 2014 FDA Advisory Committee meetings on PMA devices. We found that, of the 15 devices reviewed by Advisory Committees in 2014, 9 (60%) did not include at least 30 African Americans. One had zero and 3 had less than 10. It is, therefore, not surprising that only one third of the 15 devices included subgroup analyses for African-Americans.
And, one-third of the 15 device applications did not even specify how many patients were age 65 and older. 15% of the device applications did NOT include ANY patients ages 65 and older. Add those together and almost half had no information about patients 65 and older. This information is critical for Medicare to make coverage decisions.
Although women were always included when appropriate, most devices that would be used by both men and women did not include a subgroup analysis to determine if the device was safe or effective for both sexes.
The application for the AcuFocus KAMRA Corneal Inlay is an example of how known demographic differences were ignored in a PMA application. This device is implanted in the eye to treat nearsightedness. Out of 508 patients in the study, only 4 were African American. Significant racial differences in the physiology of the cornea have been known for over a decade, as was pointed out by the FDA in their summary of the data (p. 40). Despite this fact, the device was subsequently approved.
The FDA should make it clear that the agency will not approve medical products for all populations if the sponsor has not tested the product for safety and effectiveness on all major demographic subgroups and provided meaningful subgroup analyses. If the Center for Devices doesn’t show how important subgroup analyses are by how they present data at Advisory Committee meetings and by how the failure to have diversity affects approval decisions, the situation will not improve.
Thank you for the opportunity to comment today and we look forward to continuing to work with you to build a healthier future for ALL Americans.