On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
Currently, under the Mammography Quality Standards Act, which was passed by Congress in 1992, the FDA monitors mammography facilities and practices. If the proposed changes are adopted, the FDA would be in a stronger position to enforce regulations pertaining to the level of safety and quality in mammography facilities, as well as their reporting practices.
The proposed changes are focused on modernizing facilities and technology, and empowering patients to be better informed about their breast healthcare. A primary concern addressed in the new rules is improving the quality of communication between mammography facilities and patients. Among the proposed changes is the implementation of a uniform 3-level classification system to include the category “known biopsy proven malignancy” aimed at avoiding the misidentification of already recognized tumors.
A potential groundbreaking aspect of the proposed changes is the requirement that facilities must report breast density information to patients and their referring physicians. Breast density refers to the proportion of fibroglandular tissue in the breast compared with fatty tissue. It is estimated that 40% of women age 40 and over have dense breasts, which increases the risk for developing cancer. Other screening tests, in addition to mammography, substantially increase the detection of early-stage breast cancer in women with dense breasts.
In February 2019, the FDA was directed by Congress to develop language for mammography facilities to include with their patient and physician reports that would convey appropriate information about breast density. That information is to include, at a minimum, the effect of breast density in masking the presence of breast cancer on a mammogram; an assessment of the patient’s breast density by the interpreter of the scan according to the American College of Radiology Breast Imaging-Reporting and Data System; and a reminder to patients that they should discuss questions about dense breasts with their healthcare provider.
Although 36 states have already enacted legislation regarding breast density information, each state law varies as to the amount of information it requires facilities to release. Federal legislation will ensure that every state makes a minimum level of information about the increased risk for breast cancer associated with dense breasts available to patients.
Regarding the proposed changes announced this week, outgoing FDA Commissioner Scott Gottlieb, MD, said, “Breast cancer is one of the most worrisome health concerns facing women. The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed.” The FDA is rolling out a campaign directed toward making the public aware of the new changes. The website’s consumer page features the proposed changes and offers a primer on mammography.
“We’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” Dr Gottlieb noted.
According to the National Cancer Institute, more than 260,000 women were diagnosed with breast cancer in 2018, and more than 40,920 women died of the disease. Breast cancer is the most common cancer among women and the second leading cause of cancer death in women.