On Jan. 17, 1999, Jane E. Henney, M.D., appointed by President Bill Clinton, became the first woman to serve as Commissioner of the U.S. Food and Drug Administration (FDA).

Dr. Henney previously worked at the FDA from 1992 to 1994 as deputy commissioner for operations under then commissioner David Kessler.  She says he “hooked” her with the breadth of the agency’s activities which she discovered first hand as she dealt with issues such as the safety of the blood supply, implementation of user fees, the new food label and the safety of breast implants. She particularly enjoyed working with a team of women for the first time in her career, leading her to conclude that “women’s leadership creates a shift in tone, behavior, and thinking.”

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. FDA’s own makeup was changing as well, and in 2000, she was able to report to a Women’s Health Month audience that 53% of FDA’s 8,800 employees were women including 2 Center Directors, the Chief Counsel, several deputy and assistant commissioners, and 2 regional food and drug directors.

During Dr. Henney’s tenure, the FDA launched reforms in drug and medical device review processes and strengthened the science base of the agency.