ON MARCH 27, 2019, the U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.
For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans. These actions would expand the information mammography facilities must provide to patients and health-care professionals, allowing for more informed medical decision-making. It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.
Scott Gottlieb, MD
“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 screenings to identify breast health problems early, when they can be effectively addressed,” said FDA Commissioner at the time, Scott Gottlieb, MD. “As part of our overall commitment to protecting the health of women, 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 [three-dimensional] digital screening tools and the need for more uniform breast density reporting. We’re committed to making sure patients have access to high-quality mammography. [This] proposed rule would help ensure patients continue to benefit from advances in new tools and robust oversight of this field.”
Proposal to Amend Regulations
THE FDA’S PROPOSAL would amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which Congress passed to ensure quality mammography for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections, and enforcement of standards to help ensure mammography facilities provide quality care.
“We’re committed to making sure patients have access to high-quality mammography.”— Scott Gottlieb, MD
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Among the proposed amendments to improve communication and medical decision-making is the addition of breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring health-care professionals. The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend that patients with dense breasts talk to their health-care provider about high breast density and how it relates to their breast cancer risk.
The proposed amendments also seek to enhance information provided to health-care professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy-proven malignancy,” which would help health-care professionals identify those cases where cancer has been mammographically evaluated for therapy. In addition, under the proposed regulations, both health-care professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in postexam communications.
Proposed Changes
THE PROPOSED AMENDMENTS would also modernize mammography quality standards and better position the FDA to enforce the MQSA regulations and take action when violations are found. Some of these proposed changes include:
- Expressly stating that the FDA can directly notify patients and their health-care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed
- Requiring that only digital accessory components specifically FDA-approved or -cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule
- Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.
“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication.”— Jeff Shuren, MD, JD
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“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health. “While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health-care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies. This is 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.”
The proposed rule is available at www.regulations.gov for public comment for 90 days from publication. ■
