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Compassionate use exemption Expanded access to investigational drugs By Richard Klein; Deborah Miller, PhD, MPH, MSN, RN; Colleen LoCicero, RPh; and Peter Lurie, MD, MPH
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he Food and Drug Administration (FDA) has a long history of allowing access to potentially promising new therapies for patients with few therapeutic options. Physicians can submit expanded access requests to FDA concerning the treatment of a specific patient. This article will explain how this process works and describe proposed changes that will facilitate access.
The Center for Community Health Maintaining the zone of mental health stability By Janny Brust, MPH, and Bonnie Brueshoff, DNP, RN, PHN
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ospitals, health plans, local public health departments, and community groups are working together to improve the mental health of Minnesotans. The need to take action to address mental health is important and the momentum to do so is growing. According to a 2011 survey by the Behavioral Risk Factor Surveillance
System (BRFSS), more than 9 percent of Minnesotans report that they have poor mental health. When surveying Minnesota adults by telephone, BRFSS found that respondents reported at least 14 of the last 30 days as bad mental health days. Nationally, nearly one in five adults (43.7 million) had a form of mental illness in 2012. The Center for Community Health to page 16
The purpose of expanded access The purpose of expanded access, sometimes called “compassionate use exemption,” is to provide an investigational drug (or biologic) outside of a clinical trial for treatment purposes. FDA may permit expanded access only when there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat a serious disease or condition, and when the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition. Because the purpose of expanded access is treatment, rather than research, it does not require the systematic collection of data necessary to determine the safety and efficacy of the drug. Compassionate use exemption to page 18