OMB Reviewing Proposed Rule that Aims to Improve Mammography Quality and Provide Patients with Better Information

Statement from American Cancer Society Cancer Action Network (ACS CAN)

October 18, 2018

WASHINGTON – October 18, 2018 – The Office of Management and Budget (OMB) has indicated it is reviewing a proposed rule from the Food and Drug Administration (FDA) that would modernize mammography quality standards and address breast density reporting to patients and health care providers.

A statement from ACS CAN follows:

“ACS CAN is pleased to see the FDA is taking this important step to update guidance around breast cancer screening.

“Breast cancer typically produces no symptoms when the tumor is small and most treatable. Having high breast tissue density – or a greater proportion of breast and connective tissue to fatty tissue – increases a woman’s risk of breast cancer. Dense breast tissue makes it harder for doctors to detect cancer on mammograms because dense breast tissue and breast masses or tumors both show up white on the scans, therefore masking tumors.

“Screening mammography is currently considered the most effective way of reducing breast cancer mortality and increasing the odds of survival. Given the limitations of mammography to detect breast cancer in dense breasts, it is important to provide women with information about the risks of breast density and to support studies that address the gaps in knowledge around breast density.

“We look forward to seeing the details of the updated guidance and working with the FDA to expedite a strong rule that provides women with consistent and appropriate guidance about the potential impact that breast density has in masking breast cancer.”

Breast cancer is the most commonly diagnosed cancer among women  and the second-leading cause of cancer death in women. In 2018, an estimated 266,120 new cases of invasive breast cancer will be diagnosed among women, and approximately 40,920 women are expected to die from the disease.


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