A Lupus Voice at the FDA

Kathleen AmstenLupus Research Institute Coalition Member, lupus advocate and activist Kathleen Ann Arntsen has been serving a five-year term as a Special Government Employee (SGE) as the Lupus Patient Representative for the Office of Special Health Issues (OSHI) with the U.S. Food & Drug Administration (FDA). She was originally nominated in 2001 and the FDA has finally moved forward on appointing SGEs to represent additional diseases such as lupus. The position is almost a decade of advocacy work by Kathleen and others from the lupus community to ensure that a lupus patient perspective is represented at the table during the drug approval process.

Kathleen had provided public witness testimony previously on lupus to the Arthritis Advisory Committee regarding a potential treatment in 2002 and The SLE Concept Paper in 2003. This past year, Kathleen participated in her first FDA, Center for Drug Evaluation and Research (CDER), Arthritis Advisory Meeting as the Lupus Patient Representative and a voting member of the panel to discuss the license application for Belimumab. Benlysta® received approval in March after 56 years without lupus drugs being approved and is the first treatment developed specifically for lupus.

Kathleen’s role is to provide the patient perspective, ask questions, and offer comments to assist the advisory committee and FDA in making recommendations on therapies and products. Her insight is invaluable to the committee as both a patient herself and advocacy leader and is an opportunity for her to influence regulatory decisions and for the FDA to learn about patient needs and preferences. At the conclusion of each meeting, she provides OSHI with a brief summary of her experience on the advisory committee and suggestions for enhancing patient representation. In between meetings she participates in monthly lecture series webinars regarding topics relating to her position such as drug shortages, pharmacogenetics, personalized medicine, safety, ethics, and conflict of interest.

Kathleen Ann Arntsen currently serves as President/CEO of the Lupus Foundation of Mid and Northern New York, Inc., one of the members of the Lupus Research Institute Coalition. Having volunteered within the local lupus community for the past 25 years, she has also been very active on both the state and national level as a patient advocate. Kathleen is well recognized throughout the lupus community as a persuasive and passionate ambassador not only for lupus, but also for rheumatologic and autoimmune diseases. She states, “It is an honor to represent the lupus community and be a patient voice at the FDA on lupus-related issues.”

S.L.E. Lupus Foundation Board Member Hope Hetherington Makes Local Headlines for Lupus Appointment: