John Kittelson, PhD, associate professor in the Department of Biostatistics and Informatics at the Colorado School of Public Health, has been appointed to a three-year term on the U.S. Food and Drug Administration’s (FDA) Reproductive Health Drugs Advisory Committee. As a member of the committee, Kittelson advises the FDA on issues related to the marketing and use of drugs targeting reproductive and urologic health.
“Dr. Kittelson’s appointment acknowledges the biostatistical expertise that he brings to the FDA advisory panel in this important area,” said Richard Hamman, MD, DrPH, dean of the Colorado School of Public Health. “His wealth of experience in the design and interpretation of clinical trials brings key expertise to the panel as it evaluates the evidence in support of claims for drug efficacy.”
The 13-member committee is selected based on each member’s knowledge in the fields of obstetrics, gynecology, urology, endocrinology, pediatrics, epidemiology, or statistics. Members are responsible for reviewing and evaluating data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, urology and related specialties and providing recommendations to the FDA.
As a leading biostatistician, Kittelson was appointed to the FDA panel based upon his research on group sequential methods for the design and monitoring of clinical trials. Currently, he is the director of the Colorado Biostatistics Consortium at the University of Colorado Denver and the director of the Biostatistics, Epidemiology and Research Design program of the Colorado Clinical and Translational Sciences Institute. These programs provide biostatistical consultation and collaboration to investigators at partner universities and affiliated hospitals.
Often the work of the committee involves controversial decisions as evidenced in Kittelson’s first meeting earlier this month. On June 17-18, the panel was asked to advise the FDA on the approvals of a new emergency contraceptive and on a new treatment for female sexual dysfunction, popularly known as the ‘female viagra’. Kittelson was honored to participate in the FDA approval process.
“These decisions represent the pinnacle of the evidence base for medical practice in the United States,” Kittelson said. “It is a humbling experience to be a part of these decisions as a member of the advisory committee.”
The FDA uses 49 advisory committees and panels to obtain independent expert advice on scientific, technical and policy matters and generally follows committee recommendations. Current members of the Reproductive Health Drugs Advisory Committee include experts from Brown University, Stanford University and the University of Chicago.
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