Mammography News: FDA Says National Breast Density Notification Rule May Be Published in Late 2022 or Early 2023

In a recent letter to U.S. Rep. Rosa DeLauro (D-CT), the Food and Drug Administration (FDA) said a final rule on amendments to the Mammography Quality Standards Act (MQSA), including an oft-delayed national standard for breast density notification in mammography reporting, may be published in the next couple of months.

A national standard for breast density notification may soon become a reality for the reporting of mammography results.

In a letter to Rep. Rosa DeLauro (D-CT), Katherine Klimczak, the Acting Legislative Director for the Food and Drug Administration (FDA), said the FDA is “optimistic” that the final rule on amendments (including breast density notification) to the Mammography Quality Standards Act (MQSA) will be published before the end of 2022 or in early 2023. Klimczak also acknowledged the FDA missing a previously anticipated publication date of September 2022 for the final rule on MQSA amendments.

According to the FDA, the proposed amendments to the MQSA specific to breast density notification would require that patient-oriented summaries of mammography reports indicate whether the patient has low- or high-density breasts and include a paragraph about the “significance of breast density.” Additionally, radiologists would be required to identify one of four breast density categories for the patient in the mammography report sent to referring providers, according to the proposed MQSA amendments.

Congresswoman DeLauro, who helped enact the Breast Density Mammography Act in 2019, said the legislation required the FDA to develop a national standard for breast density notification.

“After three years, I am pleased that the FDA has finally communicated that they believe they will be able to roll out a rule requiring providers to notify women of whether they have dense breasts, what this means for their risk of breast cancer, and the importance of speaking with a health care provider about breast density,” said Congresswoman DeLauro, Chair of the United States House of Representatives Appropriations Committee.

In a recent video interview, Wendie Berg, M.D., Ph.D., FACR, FSBI, a leading researcher on breast imaging, emphasized the urgent need for a national standard on breast density notification to facilitate timely supplemental imaging. She said the news of a final ruling is a welcome development given the high incidence of dense breasts in women and the increased risk for breast cancer.

"I am delighted Rep. DeLauro has a commitment from the FDA to move forward with a national mammography density reporting standard. The 40 percent of women with dense breasts (heterogeneously dense or extremely dense) are at increased risk, about 40 percent of their cancers will be missed on mammography, and they may benefit from adding supplemental screening with ultrasound or MRI,” noted Dr. Berg, a professor of radiology at the University of Pittsburgh.

(Editor’s note: For related articles on breast density, see “Digital Breast Tomosynthesis and Breast Density: What a New Study Reveals” and “What a New Meta-Analysis Reveals About Breast Density, Mammography and MRI Screening.”)

Joann Pushkin, the executive director of www.DenseBreast.info.org , said a national standard for breast density notification has been in the works for more than a decade. She recalled testifying about the need for improved breast density notification for patients at a 2011 National Mammography Quality Assurance Advisory Committee meeting. Pushkin said improved notification of breast density will go a long way toward facilitating earlier detection of breast cancer in high-risk women.

“The 38 states with existing inform laws provide varying levels of notification. A single national reporting standard would mean all American women receive equal information about the screening and risk implications of dense tissue and provide equal opportunity to discuss supplemental screening leading to earlier detection,” explained Pushkin. “I applaud Rep. DeLauro for her persistence on behalf of American women.”