U.S. Congress orders FDA to establish standard for reporting breast density

By Staff News Brief

After years of failing to pass legislation mandating disclosure of breast density to women who have a mammogram, the U.S. Congress has ordered the U.S. Food and Drug Administration (FDA) to establish a national minimum standard to include breast density information in mammography reports. The mandate was included in a federal spending bill passed by Congress on Feb. 15, 2019.

The law directs the FDA to develop reporting language and ensure that mammography reports and summaries received by patients and their healthcare providers include information that:

explains the effect of breast density in masking the presence of breast cancer on a mammogram;
provides a qualitative assessment of breast density by the radiologist who interprets the mammogram; and
includes a reminder to patients that individuals with dense breast tissue should talk with their healthcare providers if they have questions or concerns.

In 2013, U.S. Representatives Rosa DeLauro (D-CT) and Steve Israel (D-NY) introduced the Breast Density and Mammography Reporting Act of 2013. Senators Dianne Feinstein (D-CA) and Kelly Ayotte (R-NH) introduced a companion federal breast density notification bill in the Senate. The bills were never passed, nor were similar ones introduced in subsequent Congressional sessions. However, 36 states have passed breast density legislation, according to the non-profit organization DenseBreast-Info.org of Deer Park, N.Y.

The organization’s executive director, JoAnn Pushkin, issued a written statement announcing the mandate. Pushkin said that, “while the state density inform laws encompass about 89% of American women, the laws vary in depth and breadth of notification. More importantly, not all current density inform laws actually require that women be provided information about their own breast density.”

“Implementation of this national law will help to address this disparity, as all imaging facilities that perform mammography screening will be required to provide at least the level of information required by the FDA’s new reporting requirement,” Pushkin added.