Commenting at a public hearing on a proposed rule on an agency plan for the collection, analysis, and availability of demographic subgroup data in applications for approval of regulated medical products, WomenHeart said the extent of differences between men and women in the safety and effectiveness of drugs, biologics, and medical devices has not been studied.
“For more than 30 years, FDA has debated, considered, studied, and reported on this problem,” the group said, “yet the problem has not been fixed.” It urged FDA to commit to the following:
- Enforce existing regulations.
- Finalize its draft guidance on sex-specific analysis issued in 2011 based on workshops held in 2008.
- Issue regulations to require new medical device applications to present safety and effectiveness data by sex, race, and ethnicity.
- Deny approval for products that do not report such data.
In other comments at the hearing, the National Center for Health Research (NCHR) said that more work needs to be done to adequately address the need for greater diversity in clinical trials. “To be successful at persuading companies to conduct safety and efficacy studies relevant to the major subpopulations that will use their products, FDA must be prepared to consistently demonstrate that they believe those data are essential for proving safety and efficacy,” the group said.
“Currently, the main challenge in conducting subgroup analyses is that the sample sizes are too small and get miniscule when age, race, and sex are all considered,” the NCHR said. “We understand that not every ethnic group or age group can be separately analyzed. However, we disagree with the assumption that it is not feasible to power studies to detect subgroup differences. It can be done, and should be done. If FDA required this practice and held companies accountable, companies will find a way to achieve this.”
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of AMBRO/FREEDIGITALPHOTOS.NET]