Herbert L. Ley, Jr
|Commissioner of Food and Drugs|
July 1, 1968 – December 12, 1969
|President||Lyndon B. Johnson|
|Preceded by||James Lee Goddard|
|Succeeded by||Charles C. Edwards|
|Born|| September 7, 1923|
Columbus, Ohio, U.S.
|Died|| July 22, 2001 (age 77)|
|Alma mater||Harvard University|
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."
During Ley's tenure, the FDA was admonished by consumer advocates, congressional committees and its own parent agency, what was then the Department of Health, Education and Welfare. Department Secretary Robert Finch accused the FDA in that period of "waffling" on assessments of potentially hazardous substances.
Employees of the FDA recognized the agency had problems. in July 1969, the FDA released the “Kinslow report” commissioned by FDA commissioner Dr. Ley, the study concluded, “the American public’s principal consumer protection is provided by the food and drug administration, and we are currently not equipped to cope with the challenge”. In total, the panel submitted 45 recommendations to the commissioner. Dr. Ley did not have time to implement any suggestions. The New York Times in January 1970 reported in an article that "the HEW has done little to implement the report's suggestions, except to oust the man who set up the panel in the first place, Dr. Ley, Jr., and two of his top aides".
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 an added, more toxic, compound. 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, the FDA had done 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
Another major event in October 1969, was the FDA's handling of tests on artificial sweeteners containing cyclamates, which an agency scientist said caused birth defects in chicken embryos. Rats given high doses also were found to develop bladder cancer. Cyclamates had been used for years but came under renewed scrutiny after a few human deaths related to the food additive. Dr. Ley, who eventually removed cyclamates from the list of Generally recognized as safe (GRAS) ingredients, was criticized for the delay. According to Richard D. Lyons of the New York Times This controversy substantially contributed to the ousting of Dr.Ley as Commissioner
That public setback was compounded by testimony in 1969 before a Senate select committee on nutrition in which Dr. Ley said that monosodium glutamate (MSG) was a safe flavor enhancer for processed baby food. Some studies showed MSG caused eye and brain damage in some animals. Afterward, consumer advocate Ralph Nader said two of the four studies Ley cited did not exist and two others were preliminary. Ley said he made an "inexcusable" error, and leading manufacturers soon announced that they no longer would add MSG to baby food.
Due to the disputes centered in the FDA and a series of congressional hearings embarrassing to him on FDA's internal problems - Robert H. Finch, the Secretary of Health, Education, and Welfare, ordered a study of FDA by the Deputy Undersecretary of HEW Frederic V. Malek. This report's conclusions were that the agency should be reorganized internally and raised in bureaucratic standing. In conjunction with these changes Finch announced on December 10, 1969 that he was replacing Ley and two top associates and named Dr. Charles C. Edwards to the position of FDA commissioner.
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 [as commissioner], telling reporters he preferred the phrase "eased out".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 [Dr. Ley] as a District Director and subsequently took on the special assignment [Kinslow Report], 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 [Previous FDA Commissioners], 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”.
Dr. Ley was included in the master list of Nixon political opponents.
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, Lay 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 [as] 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".
"The thing that bugs me" quote
Dr. Ley's post resignation New York Times interview statement “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,” has been quoted many times usually by alternative health promoters and critics of the medical establishment
Dr. Ley was interviewed at his home by the New York Times journalist Richard D. Lyons. The interview was published in the New York Times on December 31, 1969. But purportedly was also published in the San Francisco Chronicle January 2, 1970. Most quoters seem to associate Dr. Ley's statement with the San Francisco Chronicle.
- Official FDA Bio
- FDA History Office. Oral history of the U.S Food and Drug Administration - Herbert L. Ley, M.D.