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Herbert Leonard Ley, Jr. (September 7, 1923 – July 22, 2001) was an American physician and the 9th Commissioner and head of the U.S. Food and Drug Administration (FDA).

Background

Dr. Ley attended Harvard College from 1941-1943, and returned there after World War II, where he received his M.D. degree, cum laude, in 1946. In 1951, he earned an Master 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 director of the Bureau of Medicine of the Food and Drug Administration .On July 1, 1968 he was appointed Commissioner of the Food and Drug Administration by President Lyndon B. Johnson.

As FDA commissioner

Dr. Ley found himself immediately enmeshed in controversy when the Fountain Committee (a House of Representatives committee hearing) 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, Dr. 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."

One major event was the controversy involving the drug company Upjohn and their patented drug Panalba. Panalba was a combination of tetracycline, an inexpensive and effective generic drug, with novobiocin, a more toxic antibacterial with a different spectrum of activity. Although Upjohn had been marketing the drug for 7 years, they had not done any of the required studies on the efficacy of it, however, one study that showed Panalba to be no more effective than tetracycline and they moved to decertify it. Dr. Ley met tremendous opposition from Upjohn

In March 2003 Dr. Charles C. Edwards who replaced Dr. Ley as Commissioner, was interviewed and told his story about his assumption of office. After accepting the Nixon administration’s offer to become FDA Commissioner, Edwards had planned initially to serve as an assistant to HEW Secretary Robert Finch for a short while, in order to get a sense of what was going on in FDA. But two days after he arrived in Washington, the newspapers leaked the story that Edwards would become the new Commissioner—prompting the current Commissioner, Herbert Ley, to resign. Finch then called Edwards and told him, “The job is yours.” Edwards went over to Ley’s office—the two men had never met—which had a long conference table with piles of neatly stacked papers. Edwards recalled: “I asked him what were the major problems of the agency. He pointed to the papers and said, ‘There they are.’ He tossed me a toy football and said, ‘The ball is in your court’”.

Dr. Ley was ousted from his Commissioner post on December 12, 1969, (a year and six months after his appointment) Dr. Ley declined an offer to serve as Deputy Assistant Secretary for health research, development, and delivery services in United States Department of Health and Human Services (which he regarded as "exile in Siberia") and resigned. Dr. Ley denied being fired , telling reporters he preferred the phrase "eased out". Dr. Ley stated that companies had not pressured him regarding decisions about specific products during his tenure.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".

In September 1982, interviewed for the oral history program of the FDA History Office, Maurice D. Kinslow, Chairman of the committee and author of the final draft of the July 1969 "Kinslow report" characterized Dr. Ley as Commissioner : "Since I reported to him as a District Director and subsequently took on the special assignment , I had a lot of personal contact with him. I found him to be a very honest, decent person to work for. I respect Herb Ley; he was very different that either George P. Larrick or James Lee Goddard , but I'm convinced he was dedicated to the best interests of the American public. And indeed, I believe that he got into significant trouble during his last days in the agency during the fall of 1969, in connection with the banning of cyclamates because he did what the Secretary told him to do (to not discuss the matter within the FDA). He was a good soldier."

After the FDA

After his resignation, in an interview to the New York Times, Dr. Ley warned the public about the FDA’s inability to safeguard consumers. People were being misled, he believed “The thing that bugs me is that the people think the FDA is protecting them - it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day,” he said. The agency, in his opinion, did not have the motivation to protect consumers, faced budget shortfalls, and lacked support from the Department of Health,Education, and Welfare . Dr. Ley was critical of Congress, the Administration and the drug industry, he stated that he had "constant, tremendous, sometimes unmerciful pressure" from the drug industry and that the drug company lobbyists, combined with the politicians who worked on behalf of their patrons, could bring “tremendous pressure” to bear on him and his staff, to try preventing FDA restrictions on their drugs. The interview concluded with Ley stating that the entire issue was about money, “pure and simple”. In response to Dr. Ley's comments, one of the representatives mentioned in Dr. Ley's comments stated that the dispute was "an extensive scientific controversy, involving a strong difference of opinion" and suggested that Ley was angry because his firm had "forced Ley to take cyclamates off the market", referring to the artificial sweetener cyclamate, which had been shown to cause cancer in laboratory animals.

In December 15, 1999, interviewed for the oral history program of the FDA History Office, Dr. Ley shared that from the first controversy in his tenure as FDA Commissioner he had a "gut feeling" that his life expectancy at the FDA was probably limited. He said he had done everything by the book, both in the FDA and the Department of Health,Education, and Welfare, and he thinks that what the Administration was really wishing, was that he would stonewall the whole Academy report, because it was goring too many pharmaceutical companies. Regarding his inclusion on the master list of Nixon political opponents, Ley had stated: "I still don't know why I was included in that list. But I had very seriously offended someone in the Administration, and I have no idea who. I was, and still am, registered an Independent. I'm neither a Republican nor a Democrat. I have never participated in any political action group. So I am at a loss to explain why this should be".

Dr. Herbert L. Ley Jr died of cardiovascular disease on July 22, 2001 at his home in Rockville, Maryland. He was 77. Survivors include two children from his first marriage, and a sister.

References

1. The FDA's History Office (December 15, 1999). Oral history of the U.S Food and Drug Administration - Herbert L. Ley M.D. Page 25. Food and Drug Administration. Retrieved september 2, 2013.
2. About FDA/Commissioner's Page (Page Last Updated: 06/04/2009) Herbert Ley Jr., M.D. 7/1/1968 - 12/12/1969 Biography. Food and Drug Administration Retrieved August 25, 2013.
3. (June 07, 1968). NEW HEAD OF F.D.A. IS NAMED BY COHEH; Dr. Ley to Succeed Goddard -- 3 Other Posts Filled"... Dr. Herbert L. Ley Jr., director of the Food and Drug Administration's Bureau of Medicine since 1966.." . New York Times. Retrieved August 25, 2013.
4. National Service Center for Environmental Publications Page 13 . Environmental Protection Agency. Retrieved August 25, 2013.
5. About FDA/Commissioner's Page (Page Last Updated: 06/04/2009) Herbert Ley Jr., M.D. 7/1/1968 - 12/12/1969 Biography . FDA. Retrieved August 25, 2013.
6. The FDA's History Office (December 15, 1999). Oral history of the U.S Food and Drug Administration - Herbert L. Ley M.D. Pages 17-19. Food and Drug Administration. Retrieved August 25, 2013.
7. Alex Gordon (April 29, 2003). The Delicate Dance of Immersion and Insulation: The Politicization of the FDA Commissioner footnote #26 . Harvard University DASH (Digital Access to Scholarship at Harvard). Retrieved August 26, 2013.
8. (December 12, 1969). DR. LEY LEAVING U.S. SERVICE TODAY; Ousted F.D.A. Commissioner Rejects Offer to Remain in New Government Post. New York Times. Retrieved August 25, 2013.
9. The FDA's History Office (December 15, 1999). Oral history of the U.S Food and Drug Administration - Herbert L. Ley M.D. Page 24 . FDA. Retrieved September 2, 2013.
10. About FDA/Commissioner's Page Herbert Ley Jr., M.D. 7/1/1968 - 12/12/1969 Biography. FDA. Retrieved August 25, 2013.
11. Washington Post, Obituaries (August 16, 2001). Herbert L. Ley Jr; Headed FDA in '60s. Los Angeles Times. Retrieved August 25, 2013.
12. About FDA/Commissioner's Page (Page Last Updated: 06/04/2009) Herbert Ley Jr., M.D. 7/1/1968 - 12/12/1969 Biography. FDA. Retrieved September 2, 2013.
13. Oral Histories. FDA. Retrieved August 25, 2013.
14. The FDA's History Office (September 16&18, 1982). Oral history of the U.S Food and Drug Administration - Maurice D. Kinslow, Director, Region IV, U.S. Food and Drug Administration Pages 52-54. FDA. Retrieved August 27, 2013.
15. Jennifer ross-nazzal. “From Farm to Fork”: How Space Food Standards Impacted the Food Industry and Changed Food Safety Standards page 226. NASA History Division. Retrieved August 25, 2013.
16. Richard D. Lyons (December 31, 1969). Ousted F.D.A. Chief Charges 'Pressure' From Drug Industry . New York Times. Retrieved August 25, 2013.
17. Oral Histories. FDA. Retrieved August 25, 2013.
18. The FDA's History Office (December 15, 1999). Oral history of the U.S Food and Drug Administration - Herbert L. Ley M.D. Page 19 & 25. FDA. Retrieved september 2, 2013.
19. Washington Post, Obituaries (August 16, 2001). Herbert L. Ley Jr; Headed FDA in '60s. Los Angeles Times. Retrieved August 25, 2013.

External links

• Official FDA Bio
• FDA History Office. Oral history of the U.S Food and Drug Administration - Herbert L. Ley, M.D.

v t e Food and Drug Administration of the United States
Divisions	Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Tobacco Products Center for Veterinary Medicine National Center for Toxicological Research Office of Criminal Investigations Office of Global Regulatory Operations and Policy
Major acts	Family Smoking Prevention and Tobacco Control Act Modernization Act of 1997 Federal Food, Drug, and Cosmetic Act Food Safety Modernization Act Prescription Drug User Fee Act Pure Food and Drug Act
Title 21 regulations and rules	Administrative law Title 21 of the Code of Federal Regulations (CFR) Federal journal Federal Register (FR) Federal law Title 21 of the United States Code (U.S.C.)
Commissioners	Harvey W. Wiley Carl L. Alsberg Charles A. Browne Walter G. Campbell Paul B. Dunbar Charles W. Crawford George P. Larrick James L. Goddard Herbert L. Ley Charles C. Edwards Alexander M. Schmidt Donald Kennedy Jere E. Goyan Arthur H. Hayes Jr. Frank E. Young David A. Kessler Jane E. Henney Mark McClellan Lester Crawford Andrew von Eschenbach Margaret Hamburg Robert Califf Scott Gottlieb Stephen Hahn Robert Califf
Society and culture	Criticism of the Food and Drug Administration FDA Most Wanted Fugitives History of the Food and Drug Administration Regulation of food and dietary supplements by the U.S. Food and Drug Administration
Commissioner of Food and Drugs

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• 1923 births
• 2001 deaths
• Commissioners of the Food and Drug Administration
• American physicians
• Harvard School of Public Health alumni
• George Washington University faculty