FDA releases new regs intended to help detect breast cancer sooner

The Food and Drug Administration (FDA) announced new regulations on Thursday that would require mammogram providers to notify patients about their breast density in an effort to improve early detection of breast cancer.

Dense breast tissue can make it more difficult to detect cancers on a mammogram and represents a risk factor for developing breast cancer, according to the FDA.

The new rules require providers to inform patients about their breast density, explain how it can influence a mammogram’s accuracy, and, for patients with dense breast tissue, point out that other imaging tests may better help detect cancers.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” Hilary Marston, the FDA’s chief medical officer, said in a statement, adding, “We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

Reps. Rosa DeLauro (D-Conn.) and Brian Fitzpatrick (R-Pa.), who pushed for legislation to require reporting on breast density, touted the newly announced regulations.

“When it comes to surviving cancer, early detection is key,” DeLauro, a survivor of ovarian cancer, said in a statement. “99 percent of women who receive an early breast cancer diagnosis survive it, however, not every woman has the necessary tools or insight to ensure they are being properly screened for breast cancer.” 

DeLauro and Fitzpatrick also vowed to reintroduce the Find It Early Act to ensure that all health insurance plans cover additional screenings needed due to breast density, family history or other reasons. Such tests are often paid out of pocket.

About 297,790 people are expected to be diagnosed with breast cancer in 2023, and about 43,700 will die from the disease, according to the American Cancer Society.