WomenHeart CEO makes presentation at FDA hearing
Thursday, April 03, 2014
The Food and Drug Administration heard oral presentations on April 1, 2014 at a public hearing to "obtain input on the issues and challenges associated with the collection, analysis, and availablility of demographic subgroup data (i.e. sex, race/ethnicity, and age) in applications for approval of FDA-regulated medical products."
WomenHeart CEO Lisa M. Tate (pictured at the far right) attended the hearing to present on behalf of women with heart disease, saying "There is a growing awareness of the many differences between men and women in the safety and effectiveness of drugs, devices and biologics. But the extent of these differences has not been sufficiently studied... Doctors and patients can't assess which treatment is best, if meaningful data for women is unavailable."
The hearing focused specifically on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907, looking primarily at how women, minorities, and the elderly are represented in clinical trials. This is an issue about which WomenHeart — along with patients, physicians, and researchers — has raised many concerns, noting that the differing physiology between men and women make it difficult to be certain how various medications and medical devices will perform, particularly when the clinical trials do not include women.
WomenHeart's recommendations include: that trials enroll women in proportion to the prevalence of the condition among women; that sex and race/ethnicity demographic information be included on all medical product labeling; and that post-marketing studies include results that are made publicly available.
Ms. Tate concluded her presentation with a question as to the terminology of the Act itself, saying "Implementation, and actual enforcement, of the above recommendations would go a long way toward assuring that providers can recommend treatments that are safe and effective for the "sub-group", that is, women. Of course, at 51% of the population, women are not a "sub-group" at all. And that is particularly true for women with heart disease who die in greater numbers and at higher rates than men."
WomenHeart's presentation has been submitted for the public record and a link will be posted to the entire presentation when it becomes available.