The Food & Drug Administration is a lax enforcer of its own rules on pre-market approval for implantable cardiovascular devices like stents and pacemakers, according to a study published in Circulation: Cardiovascular Quality and Outcomes.
Researchers studied safety and effectiveness data from 78 pre-market approval submissions to the FDA from 2000 to 2007. The PMA protocol is designed to measure the benefits and safety of therapies deemed to be high-risk, such as implanted devices. The data showed that study subjects’ gender wasn’t reported for more than a fourth of the 123 studies examined and that less than half featured "gender-bias comments or analysis," according to the study’s authors.
The federal watchdog agency began requiring the inclusion of gender-related data in 1994.
"We think it’s important that we know that devices, particularly cardiac devices, which are often permanently implanted, are shown to be safe and effective in women as well as in men, because otherwise you [risk] exposing someone to definite harm with no known benefit, and I don’t think that’s something we want to continue," lead author Dr. Rita Redberg told heartwire. "I’m not a legal expert, but I believe the FDA currently has it within its authority to say, you have not met our requirements.
"We think it’s particularly important for devices, because there are substantial data that devices perform differently in women from the way they do in men. A lot of them are implanted, and there are more procedural complications in women, and women have more bleeding in general than men do," Redberg said.
Here are some findings from the study:
- Women constituted, on average, about a third of the patients in the trials examined for the study
- 28 percent of the FDA safety and effectiveness reports didn’t provide the ratio of women to men
- Of those that did, almost half didn’t report it across the entire patient cohort
- Only 41 percent included comments or analysis of gender bias
- Of those that did, only 38 percent provided the related data; 26 percent identified a sex-related difference in device safety or effectiveness
The FDA said the study’s findings are nothing new, according a statement emailed to heartwire from the federal watchdog agency, and the agency has held several workshops over the last several years to examine the issue.
The Center for Devices & Radiological Health plans to issue formal guidance "this year," according to the statement, "with a tailored response (depending on the level of risk, amount of existing information available on potential differences, etc.)."
"Interim policy improvements are already under way, intended to address the need for greater consistency in sex-specific analysis and availability of sex-specific information for approved medical devices. Many of these efforts are being coordinated with general initiatives targeted at improving the quality, consistency, and transparency of the evaluation processes at the FDA," according to the statement.