New research by regulators with the Center for Devices and Radiological Health (CDRH) has found that gender-specific data is not always assessed in postmarketing studies on the safety and efficacy of a device, potentially putting women at risk.
Emphasis on Women
CDRH, the US Food and Drug Administration's (FDA) medical device regulatory division, has been placing an increasing emphasis on the needs of women in recent years.
In December 2011 it released a draft guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies, intended to "improve the quality and consistency of available data regarding the performance of medical devices in both sexes by ensuring appropriate representation by sex in clinical studies of devices, and that data from such studies is appropriately analyzed for sex differences."
That information is useful, FDA said, because there are sex-specific differences in the performance and safety of many products. FDA's draft guidance notes that some of these factors are intrinsic-genetics, hormones, body size and physiology-while others are rooted in culture and the environment. Unlike men, women may also have to pay special attention to the teratogenicity of a product, which could cause birth defects to an unborn child.
The information is also needed to correct what regulators have called the "historic underrepresentation of women in clinical studies."
The guidance, as well as other initiatives under way at FDA, has formed the basis of what FDA is calling its "Health of Women Program." In June 2013, FDA held a workshop at its Maryland campus where it said it wanted to develop a "priority research road map for the HoW device ecosystem" that will in turn allow it to address some of the "unique issues in the regulation of medical devices for use by women."
New Research Prompts Changes at FDA
And by the looks of new research just published in the Journal of Women's Health, FDA hasn't needed to look too hard to find additional evidence of where industry could be doing more to assess the effects of their products on women.
The study, authored by Ellen Pinnow, Naomi Herz, Nilsa Layo-Berrios and Michelle Tarver, looked at medical device post-approval studies (PAS) mandated by FDA as a condition of approval. The study looked at if the study broke down enrollment by sex, and more importantly whether the study analyzed if outcomes differed by sex.
"Since approximately 50% of PMAs and humanitarian device exemptions (HDEs) that were approved since 1995 have had one or more mandated PAS requirements and sex differences can impact the effectiveness and safety of medical device interventions, we conducted a study evaluating the participation of women in post-approval studies mandated by the FDA," the authors explained.
What Pinnow and her colleagues found wasn't exactly comforting. While the overwhelming majority of studies (n=225) included data on the sex of participants (93%), just 14% of studies analyzed the effect of the product on women, and just 4% included a subgroup analysis.
The study also noted that participation in PASs varied widely depending on the type of device studied. Plastic surgery and dental surgery products included women at rates greater than 76%, but for cardiovascular products and others, this rate could be lower than 25%.
Pinnow said FDA has already used the information to make changes. "Prior to this review, FDA did not consistently include an assessment of enrollment by sex in its reviews of PAS reports," she wrote. "Based on this analysis, templates used for the review of PAS reports were updated in October 2011 to include an assessment of enrollment by sex."
Pinnow said FDA would continue to work with applicants to ensure high rates of female participation in PAS trials, and will encourage those companies to use targeted communications and more flexible follow-up schedules to facilitate female enrollment.
Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration