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  1. FDA Leadership: 1907 to Today

 Photo of Herbert Ley Jr., M.D.

Herbert Ley Jr., M.D.

7/1/1968 - 12/12/1969

Herbert Ley was born on September 7, 1923 in Columbus, Ohio. He attended Harvard College from 1941-1943, and returned there after WWII, where he received his M.D. degree, cum laude, in 1946. In 1951, he earned an Master's of Public Health degree from the Harvard School of Public Health. From 1951 until 1958, he worked with the Army Medical Service Graduate School in rickettsial disease research, the Office of the Surgeon General, and as an epidemiologist in Korea and Vietnam. In 1958, he accepted a position as Professor of Bacteriology and Chairman of the Department of Bacteriology, Hygiene, and Preventive Medicine at George Washington University. In 1963, he was appointed Associate Professor of Epidemiology and Microbiology at the Harvard School of Public Health, and became chairman of the Department in 1964. In September 1966, Ley took a leave of absence from his position to become Medical Director at FDA. Ley became Commissioner Goddard's choice as a successor, and Ley's takeover from Goddard seemed, in the words of one trade press observer, "to herald a period of quieter, more deliberate regulation."

Ley found himself immediately enmeshed in controversy when the Fountain Committee criticized his ten month delay in removing mislabeled stocks of parenteral chloramphenicol from the market. This experience strengthened his regulatory commitment. In light of recommendations made by the National Academy of Sciences and National Research Council in their drug efficacy review, Ley took a strong and unwavering stance against fixed combination drugs and ordered 49 off of the market. Ley also strongly castigated drug industry practices in general, warning them that "unless there is a major change in the drug industry emphasis on sales over safety, the industry as we know it today may well be buried within the next several years in a grave it has helped dig--inch by inch, overpromotion by overpromotion, bad drug by bad drug."

On October 21, 1969, Abbott Laboratories reported that the artificial sweetener cyclamate (in a saccharin-cyclamate mixture) had caused liver tumors in rats. Cyclamates were removed from the list of Generally Recognized As Safe (GRAS) ingredients at Dr. Ley's direction on October 30, 1969.

Ley resigned his position on December 11, 1969, and declined to accept an offer to serve as Deputy Assistant Secretary for health research, development, and delivery services in HEW. In accepting Ley's resignation, Secretary of HEW Finch praised him as a "gifted scientist and a dedicated public servant," saying that he had "coped strenuously with an unwieldy agency."

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