Great news for women! FDA Safety and Innovation Act signed into law

We thank Susan Campbell from WomenHeart for this contribution.

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WomenHeart is thrilled to mark the anniversary of the Women’s Health Initiative with great news.  On July 10, 2012 President Obama signed into law a bill that will significantly advance women’s heart health and change the nature of clinical trials reporting.  Knowing how women will be affected by the drugs and devices used in their treatment will lead to better and more informed choices by patients and providers and build on the advances made possible by the ground breaking work of the Women’s Health Initiative. 

The bill, the Food and Drug Administration (FDA) Safety and Innovation Act, requires the FDA to submit a report on the extent to which safety, effectiveness, and participation data by sex, age, race and ethnicity is included in new drug and medical device applications. 

This critical information must be made publicly available, and the Act requires the FDA to develop an action plan for improving the quality and availability of such data by sex, age, race, and ethnicity.

A recent study examined the effectiveness of treatments for cardiovascular disease in women (Archives of Internal Medicine, Gutierrez, J., Columbia University, New York, June 25, 2012) and produced discouraging conclusions about the quality of care women receive compared to their male counterparts.   Researchers stated that “in our study, general cardiovascular care did not appear to be as good in women as it was men, and that needs to be addressed."

The study also raised questions about women and clinical trials.  Due to the inadequate number of women in clinical trials and the lack of sex-specific data reporting, healthcare providers do not have all the information they need to provide the best treatment for heart disease in women. Rita Redberg, MD added that "unless we increase inclusion of women in clinical trials and report sex-specific data, there will never be sufficient data to achieve optimal care of all of our patients."

The bill signed today provides long awaited validation of the importance of sex specific data and the authority to require sex specific reporting.   WomenHeart is grateful to Senator Barbara Mikulski, Dr. Vivian Pinn, their many colleagues for making the Women’s Health Initiative possible, and to advocates and WomenHeart Champions throughout the country for their continued efforts to improve women’s heart health.