In December 2008, the Food and Drug Administration (FDA) conveneda joint meeting of the Pediatric Advisory Committee, the Pulmonary–AllergyDrugs Advisory Committee, and the Drug Safety and Risk ManagementAdvisory Committee (of which I am a member) to review the risksand benefits of inhaled long-acting beta-agonists (LABAs) forthe treatment of asthma in adults and children. Committee memberswere asked to weigh the public health implications of real andserious but relatively infrequent occurrences of severe asthmaexacerbations and asthma-related death against the symptomaticbenefits of bronchodilation and asthma control. The drugs inquestion included single-agent LABA products . . . [Full Text of this Article]
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Dr. Kramer is an associate professor of medicine and executive director of the Clinical Trials Transformation Initiative at the Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC, and a voting member of the Drug Safety and Risk Management Advisory Committee of the FDA.
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