FDA Action Plan Addresses Gap in Clinical Data for Women and Minorities

August 20, 2014—The US Food and Drug Administration (FDA) announced the publication of the “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data” on their website, which is intended to increase the participation of women, minorities, and the elderly in research trials. The American Heart Association, National Women’s Health Network, Society for Women’s Health Research, and WomenHeart: The National Coalition for Women With Heart Disease all see this as an important step toward closing the health care disparities gap and are urging the FDA to implement the plan swiftly.

In a press release, a spokesperson for the four organizations said, “The ‘FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data’ will not only help boost representation of these population groups in clinical trials, but also will lead to more analyses on how medical drugs and devices affect women and men differently.”

With this plan, the FDA has finalized its guidance on the evaluation of sex-specific data in medical device studies and for establishing a steering committee and website to oversee and track progress on implementing the action plan. 

The FDA’s Action Plan was required by the US Food and Drug Administration Safety and Innovation Act, signed into law in July 2012. The act directed the FDA to review medical product applications to determine the extent to which data on how new drugs and devices affect certain subpopulations is being collected, evaluated, and released publicly. By taking the actions outlined in the plan, the FDA will emphasize the need to look for sex, race, ethnicity, and age differences through medical research; allow subgroup-specific data to be more widely available for use in medical practice; and improve the participation of women and minorities in research trials.

“Guaranteeing greater diversity in research trials will help ensure that patients and their health care professionals have the most up-to-date information needed to make the best decisions about care and treatment,” the four organizations commented. “By carrying out the actions recommended by the FDA plan, we can advance our nation’s efforts to achieve the high quality health care that women and minorities want and deserve.”

In the coming months, the organizations will submit additional comments and recommendations about the FDA Action Plan and will work with the agency and Congress to address continuing areas of concern vital to the health of women, minorities, and elderly Americans.