US Food and Drug Administration Scientist Frances Oldham Kelsey, MD, PhD, passed away on August 7, 2015. Her distinguished career was recognized in an August 8 Washington Post front page article that continued to a nearly full interior page, a tribute worthy of a national public health heroine.
In 2011, at the 50th Anniversary of the Society of Toxicology, she was recognized as an SOT Honorary member “in recognition of her outstanding and sustained contributions to advancing the science and the field of toxicology.” This honor was presented because Dr. Kelsey was “famous for her diligence in evaluating the drug Thalidomide while a medical officer at the US FDA.” Although Thalidomide was used in countries around the globe, “FDA withheld approval of the drug based on her recommendations and the drug was later found to cause birth defects.” For her efforts she was awarded the highest honor given to a civilian in the United States, the President’s Award for Distinguished Federal Civilian Service conferred by President John F. Kennedy.
During her 45 years of service at the FDA, Dr. Kelsey helped to shape and enforce amendments to the FDA drug regulation laws to institutionalize protection of the patient in drug investigations. These regulations required that drugs be shown to be safe and effective, that informed consent be obtained from patients when used in clinical trials, and that adverse reactions be reported to the FDA. In 2005, Dr. Kelsey retired from the FDA at the age of 90.
In a message to FDA employees, Stephen M. Ostroff, MD, Acting Commissioner of Food and Drugs, noted that “In 2010, before hundreds of her FDA colleagues, then-FDA Commissioner Margaret A. Hamburg, MD, conferred the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health on Dr. Kelsey herself.”
Shortly before she turned 100 years of age, Dr. Kelsey wrote about her life and career in a piece called, “Autobiographical Reflections” that is posted on the FDA website. In his statement, Dr. Ostroff encouraged reading “the historical, inspiring, and extremely interesting life story of this amazing woman whose career exemplified the highest standards of integrity and dedication to public service.”