The FDA has proposed regulatory amendments to improve the quality of breast cancer screening by expanding the information provided to patients and physicians, modernizing standards for mammograms, and enabling better enforcement of safety and quality regulations.
"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," commented Scott Gottlieb, MD, Commissioner of the FDA.
The proposal seeks to amend regulations issued under the Mammography Quality Standards Act (MQSA). Passed by Congress in 1992, the MQSA authorizes FDA oversight of mammography facilities and allows for annual inspections and enforcement of standards. No changes have been made to the regulation of mammography facilities in over 20 years.
One of the proposed amendments is the addition of breast density information on the mammography summary letter provided to the patient and on the medical report provided to the patient's referring health care professional. Dense breasts, which contain a higher proportion of fibroglandular tissue compared with fatty tissue, have been identified as a risk factor for breast cancer. Because dense tissue hides signs of cancer and decreases the image's sensitivity, mammograms of dense breasts can be challenging to interpret. The proposal includes specific language explaining how breast density can influence mammography's accuracy and recommending that patients talk with their health care provider about what high breast density means for their cancer risk.
"Given that more than half of women over the age of 40 in the US have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy," stated Amy Abernethy, MD, PhD, Principal Deputy Commissioner of the FDA. "We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer."
Several additional proposed changes seek to improve record keeping and communications about mammography results. The new regulations would codify three additional categories for the assessment of mammograms, including a category titled "known biopsy proven malignancy." To enhance post-examination communications, the proposal would require that reports to health care professionals and lay summary letters to patients contain more detailed identifying information about the mammography facility. Furthermore, the proposal would strengthen record keeping requirements in order to prevent loss of information and improve access to and transfer of patients' mammography records.
In addition, the proposal would modernize mammography quality standards, requiring that facilities only use digital accessory components that are FDA approved or cleared for mammography, or those that otherwise meet the regulations' requirements.
The proposal would position the FDA to better enforce MQSA regulations and hold mammography facilities accountable for violations. The amendments state that if a mammography facility is unwilling to do so, the FDA could notify patients and health care providers directly that a mammography did not meet quality standards.
According to Jeff Shuren, MD, JD, Director of the FDA's Center for Devices and Radiological Health, these amendments are "intended to help ensure important information that could affect decisions about patient care—such as the potential need for further evaluation or a repeat of a mammogram—is communicated as quickly as possible."
Dr. Gottlieb emphasized the importance of the amendments: "Today's proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field."
For More Information
The proposed amendments are available online for public comment until June 26, 2019: Mammography Quality Standards Act
Image credit: Rhoda Baer, National Cancer Institute