FDA advances landmark policy changes to modernize mammography services and improve their quality

FDA advances landmark policy changes to modernize mammography services and improve their quality

U.S. Food and Drug Administration 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. Today’s 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.

“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,” said FDA Commissioner Scott Gottlieb, M.D. “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 3-D 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. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

According to the National Cancer Institute (NCI), approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Additionally, mammography can be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age.

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.

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. Mammograms of dense breasts—breasts with a higher proportion of fibroglandular tissue compared to fatty tissue—can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image. Dense breasts have also been identified as a risk factor for developing breast cancer. The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.

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 identify for health care professionals those cases where cancer being mammographically evaluated for therapy are already known and identified. 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 post-exam communications.

“The FDA is committed to advancing efforts that improve the health of women. 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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Given that more than half of women over the age of 40 in the U.S. 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. Today’s proposed amendments are part of the agency’s broader commitment to supporting new innovations and methods to prevent, detect and treat cancer. We are dedicated to working across the agency and with stakeholders to provide patients with tools and information to fight breast cancer effectively.”

The proposed amendments would also modernize mammography quality standards and better position 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,” said Jeff Shuren, M.D., J.D., 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 facillities’ 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.”

FDA approves first treatment for postpartum depression

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.”

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.

Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo‑controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.

The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.

FDA approves new device for treating moderate to severe chronic heart failure

The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”

About 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body’s needs. The leading causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes. Treatment for heart failure includes treating the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physical activity difficult. Doctors may prescribe medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta blockers to lower blood pressure and reduce strain on the heart as well as diuretics to reduce fluid buildup in the lungs and swelling in the feet and ankles.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The FDA evaluated data from two randomized, multi-center clinical trials with a total of 389 patients with moderate-to-severe heart failure. All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements on standard assessments to measure heart failure symptoms, such as how much the symptoms affect a patient’s quality of life and how much the symptoms impede daily physical activities compared to those who received only medical therapy.

The Optimizer Smart system is indicated to improve six-minute hall walk distance, quality of life and functional status of certain heart failure patients. These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy. Patients should also have a regular heart rhythm, not be candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction (the total amount of blood pumped out in each heart beat) of 25 to 45 percent, which is considered below the normal ejection fraction of 55 to 75 percent.

Potential complications associated with the use of the device include infection, bleeding, worsened heart failure or problems with the device itself such as a dislodgement or fracture of the leads implanted in the heart.

The FDA granted the Optimizer Smart System a Breakthrough Device designation, meaning the agency provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. All designated devices must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.