When FDA and CBER created its own Division of Biostatistics and Epidemiology, Ellenberg was selected as its first director, a position she held from 1993-2004. Her work at FDA was characterized by a commitment to vaccine safety accompanied by an insistence on more publications by regulators in professional journals to make clear not only what was known, but also what was not known, about the safety of children’s vaccines.
In 1974 she returned to NIH as the Director of the National Institute of General Medical Sciences, the first woman to hold an institute directorship, and in 1993 she became Deputy Director of NIH, a position she carried out for the next decade.
When Sharon Smith Holston retired as Deputy Commissioner for International and Constituent Relations in 2001, she left a rich legacy of administrative service to the Food and Drug Administration.
Her untiring efforts to engage and acknowledge the activism of women’s groups in support of a new statute bore fruit as women shaped many provisions of the new law passed to replace the Wiley Act: The 1938 Food, Drug, and Cosmetic Act.
Effie Alberta Read, Ph. D., M. D., one of very few women in the FDA’s Bureau of Chemistry when she joined the agency in 1907, was among the best trained analysts when she arrived.
In August, 1965, FDA’s Food and Drug Review announced that the agency had hired its first “woman” inspector, Mrs. Imogene Gollinger.
After being nominated as the first female Commissioner of FDA by President Bill Clinton, she became the first FDA Commissioner to go through the grueling Senate confirmation process in 1999. Supporters of the nomination maintained that given both her medical acumen and administrative talent and experience, she was the most qualified Commissioner FDA had ever had.
Mary Engle Pennington became FDA’s first female lab chief under Harvey Wiley following passage of the 1906 Pure Food and Drugs Act. Her bacteriological research helped revolutionize the food supply, making more safe, fresh foods available at affordable prices, particularly in newly industrialized areas of the country.
Her work on the regulation of generic drugs and products for rare diseases helped make valuable treatments more available.
Dr. Mattie Rae Spivey Fox made substantial contributions to the field of trace nutrient investigations and the work of the FDA in regulating food, and thereby advanced the health and well-being of the public.