Published on July 11, 2012 at 2:30 AM
President Obama signed into law the bipartisan Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on July 9. This Act reauthorizes FDA's user fee program, which is critical to the Agency's funding, and also includes a provision that has been long sought by the Society for Women's Health Research (SWHR), the American Heart Association (AHA) and Women Heart: The National Coalition for Women with Heart Disease (WomenHeart) that will require FDA to provide a special report and accounting of trials by sex, race, and ethnicity.
The provision, section 908 of the legislation, has been one of SWHR's key advocacy efforts for over two decades. It requires FDA to publicly report annually on the extent to which clinical trial participation, safety, and efficacy data reported by sex, age, race, and ethnicity are included in applications for FDA approval of new drugs and medical devices. This language builds on a provision of the HEART for Women Act, which has had bipartisan support in Congress for years, and will help to close the knowledge gap, which contributes to substantial inequities in healthcare for women and minorities.
"Having this data appropriately analyzed and reported by FDA has been one of SWHR's main priorities," said Phyllis Greenberger, president and CEO of SWHR. "As the leading voice for women's inclusion in clinical trials and the thought leader in sex differences research, we believe this is a critical first step in fostering personalized medical decisions in the United States, which will ultimately lead to better patient care. We would like to thank the President for his support on this issue."
Numerous studies have found that subgroup-specific data about how new drugs and devices perform in women, minorities, and older Americans consistently remain unavailable to patients and the medical community. Sex-specific research results can, and have, yielded important differences in the way drugs and devices work in women and men.
We want to thank President Obama and congressional leadership for their support of this provision.
Source: The Society for Women's Health Research (SWHR)