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A Perspective on FDA Oral Histories

John P. Swann, Ph.D.[1] 

The idea for an oral history program at FDA goes back to about 1974, when the agency proposed developing a history office staffed with a Ph.D. historian and a professionally trained archivist. The agency's acting historian since 1968, Wallace Janssen, formerly Public Information Officer of FDA,[2] was scheduled to retire, so the Office of the Commissioner planned to formalize the historical function in the agency. Within this office, the archivist would be tasked with principal responsibility for the oral history program. The record does not explain or justify this function; rather, it was assumed that oral history was a typical activity in the office's efforts to document the history of the agency. A hiring freeze the next year curtailed all these plans, and Janssen remained agency historian as a "re-employed annuitant" (the federal government's designation for a rehired retiree).[3]

A renewed impetus for an oral history program emerged in 1976 from officials in the FDA's field operations. Two agency employees from the field with experience dating back to the origins of the FDA's consumer protection functions recently had died. This led Fred Lofsvold, director of a regional office, and his planning officer, Robert Porter--with the agreement of their superiors in Washington--to investigate the systematic collection of oral histories. They argued that this material would be useful for recruiting and training employees, informing journalists and others interested in FDA, and contributing to the kind of esprit de corps that they had enjoyed in the agency. [4] Porter and Lofsvold began conducting oral histories on a part-time basis in April 1977.[5]

Independent of this effort, FDA headquarters recently had contracted with noted food and drug historian James Harvey Young to write a history of the agency. Young and his students at Emory University occasionally had been doing oral histories on subjects related to FDA since the late 1960s, which they deposited in the National Library of Medicine under an agreement with that institution.[6] Young's research interests helped lead Porter and Lofsvold to their initial choices for oral history candidates, and like Young they deposited their transcripts and tapes in NLM.[7] Working on a part-time basis, Porter, Lofsvold, and the two agency retirees that took their place, Ronald Ottes and Robert Tucker, coupled with the interviews generated under Young, have produced approximately 150 oral histories up to the present.[8]

Others within and outside of the FDA History Office at times have taken part in some of the oral histories, but by and large they have been a product of our part-time agency retirees. The success of this program has been due largely to the involvement of experienced employees, people who have spent their entire careers in various program areas of the Food and Drug Administration. By applying their collective experience in the selection of those to be interviewed, these former employees have ensured that the oral histories reflect the depth and breadth of FDA's regulatory and scientific responsibilities. While their colleagues in the History Office sometimes provide questions, the insight and comfortable flow of dialogue in these interviews reflect the fact that they take place between like-experienced if not like-minded colleagues.

Having those with shared experiences conduct the oral histories has produced thoughtful records that help those of us in the office and others interested in FDA in a number of ways. We use them for briefing reports and in our own research projects, as do many outside historians. They can be an enormously valuable asset to get a handle on a complex issue, event, or person in a hurry. Their insight can be documented on several levels, and the following are just a few examples of what the oral histories can teach us about the food and drug experience.

The application of food and drug laws in the field are exceptionally well represented in the oral history collection, due largely to the affiliations of those conducting the interviews. We learn from Sam Fine, a 37-year veteran of the agency, of his experiences investigating Cincinnati's proliferation of illegally sold barbiturates and amphetamines in the late 1940s, a national problem that occupied more agency enforcement time than all other drug regulatory issues combined:


"[Fine:] During this period of time at Cincinnati a major project dealt with the illegal sales of prescription drugs. There was a young woman married in Cincinnati who had become addicted during World War II to barbiturates. Her original prescription was probably for either 12 or 24 Seconals, but she kept getting refills and the store where she was getting the refills was Tishbinds which was the leading ethical pharmacy in Cincinnati. The young woman's mother became so concerned about it that she wrote Harry Anslinger who was then Commissioner of Narcotics. Anslinger wrote her back and said he was sorry the Bureau of Narcotics had no control over illegal sales of barbiturates. So the mother then wrote Harry Truman who was the President. The President's office directed the Food and Drug Administration to investigate this case. . . We ended up we had twenty drug stores in Cincinnati that each had at least one addict that they were maintaining either by illegally refilling or by selling directly over-the-counter. We did the close out on all twenty stores on the same day. . . At the time this attracted a great deal of attention and caused the state of Ohio to enact a rather strict law for those days on the sale of barbiturates. It was one of the triggering incidents that led eventually to the Durham-Humphrey Amendment which came along two or three years later."[9]


Once a field official effected an action, the case was still far from resolved. Here inspector William Hill relates his experiences in trying to build a case against a violative crab operation with a Department of Justice representative:


"[Hill:] We had a case with a crab meat plant down on the Gulf Coast. The fellow had been in operation for several years, had been taken to task previous to that but he had now set up a shop in Palacious, Texas. Star Crab Company was the name of his operation, and he had a real filthy operation. . . . We had Star Crab in court, had the case filed and he was pleading not guilty and I went down to work with the U. S. Attorney assistant who was handling the case to prepare for trial. I had outlined the testimony for all the witnesses, all the government witnesses in the case, but the assistant that had this case wasn't accepting what I had prepared, too much. He wanted to do his own, do his own thing. This assistant, you got to understand a little bit about him; he was a great hulking bear of a man, a former professional football player with the Chicago Bears, I think; a great big man. Sloppy as he could be. If he had on a necktie, it was usually pulled to one side and with stains all over it, his shirt would be dirty, usually it would be gaping open at the bottom and his old hairy belly would be sticking out. Just as sloppy as he could be. He was certainly not the epitome of a well dressed attorney. He had been in the U. S. Attorney's office down there about 20 years, which is unusual too. Assistants don't usually stay around that long but he was there and he had developed into kind of the father of the office. All the young attorneys came to him for advice, guidance and assistance. He was nicknamed "Moose," no doubt from his huge size and all like that.

We sat down in his office on one Sunday afternoon and he's sitting there with an old upright mechanical typewriter, going through the witnesses. He would type in the answers, the questions he was going to ask them and what they were going to answer. Of course, I had already done this for him, but he wanted to do it his way. The main charge was that the contamination in the crab meat was E. coli, bacteria. He'd ask me, 'what does this mean?' I would give him the class book description of E. coli and how it came to be in this product. Fecal contamination, indicative of fecal contamination and therefore was filthy and, he asked, 'how did it get there?' I'd explain, 'Well, people don't wash their hands, they go to the bathroom, they don't wash their hands, they handle things and all.' We went through this, and we'd go on to a few more questions and he'd come back to this. 'Tell me again, what is this E. coli?' And I go through the whole thing again for him. We did this, must have been a half a dozen different times. Finally he said, 'You mean it's got shit in it?' I said, 'Yes, that's a crude way of putting it, but that's the problem.' From then on Moose and I, we understood each other and we could talk."[10]


This snippet likely has a few details not in the paper record of FDA's prosecution of Star Crab. But while William Hill laid bare the "odd couple" contrast in this case between the FDA inspector and the Department of Justice attorney, it should be pointed out that that cultural dissimilarities could be just as striking within the agency's own investigative cadre. When an entity dedicated to the interdiction of LSD, amphetamines, and other dangerous drugs called the Bureau of Drug Abuse Control (BDAC) was carved out of FDA staff, a notable cultural rift ensued. The average food and drug inspector was a college-educated scientist and by no means iconoclastic in appearance or demeanor. The BDAC criminal investigator, on the other hand, had to fit in with the surroundings to function effectively in undercover work, even if that meant arranging inconspicuous drug purchases in the 1960s, from Haight-Ashbury to Greenwich Village. Regular food and drug inspectors often kept their distance from some of their BDAC brethren.[11]

The oral histories also provide a glimpse--likely not found elsewhere in the records--of emotional undercurrents that employees sometimes had to live with, undercurrents directly related to their positions. This can be perceived in the group oral history of scientist-administrators and the unique circumstances they faced in pursuing science and research in a regulatory agency. Quoted in this snippet, in addition to interviewer Fred Lofsvold, are William Eisenberg, a microanalyst who joined FDA in 1937; Robert Roe, whose FDA career began as a chemist in 1925 and culminated as Associate Director of the Bureau of Science; Glenn Slocum, a bacteriologist when he joined FDA in 1930 and the Director of the Division of Microbiology when he retired in 1965; and Frederick Garfield, who arrived at FDA as a chemist in 1939 and then moved into administration of the agency's field components. Each had experience both at the bench and in the administration of science:


"[Eisenberg:] . . . [I]n the old days before Food and Drug hired anybody, I think one of the questions they asked, was the extent of whether you had any . . . whether you were you were squeamish or had any second thoughts about punishment of an individual for violation of the law. In other words, were you police oriented. And if you weren't, they didn't hire you. You had to be willing to go into court and mete out punishment. Now whether we do that today, I don't know.


[Roe:] I never heard of that.


[Slocum:] I never heard of it either.


[Lofsvold:] That, I think was a standard question to investigators, certainly, and inspectors.


[Eisenberg:] And chemists?


[Lofsvold:] And to chemists, because we had a couple of sad experiences where we hired people who finally, after they were well trained, had moral scruples against appearing as a witness to send anybody to jail.


[Frederick Garfield:] When I was Assistant to the Chief in St. Louis, I went out to handle cases, legal cases in courts and I think this is one of the first contested actions that I handled. The case was down in Arkansas; and the defendant was some canner who came in dressed in overalls as though he were a farmer, although he was doing several million dollars worth of business when he appeared, as requested. The court found him guilty and sentenced him to two years, and then later on he placed him on probation, but he [had originally] sentenced him to two years. I had the most uncomfortable feeling I think I have ever had because here I was pushing the case and there was no real help, from Washington. And I was putting this poor old farmer in jail for two years. And I was tremendously relieved to find the court had placed him on probation."[12]


Oral histories provide interesting perspective on policy--from the policy-makers themselves. It can be a daunting task to merely begin to understand the breadth of policy generated within an agency that regulates perhaps 25 percent of the gross domestic product. That's why insights like that of Kenneth Milstead, former special assistant to the Commissioner, are so helpful:


"[Milstead:] The good elements in the industry felt and have always felt very badly about the whole industry taking a beating as a result of the action of a few irresponsible people. That's what bothered [Commissioner George] Larrick about issuing notices of regulatory actions that sometimes hurt the whole industry when it was not the whole industry that was involved. When to take regulatory action and when to rely on voluntary correction are questions that have to be weighed by the Commissioner in the decision-making process. He has to decide what emphasis will be given to the regulatory approach and how much to education and cooperation. There's really not anything inconsistent with these approaches--the emphasis may be a little different. Historically, Food and Drug has always had what is called the 'open door policy.' It has always been the philosophy that industry has a right to know the requirements of the law as interpreted by the administration and should be informed. One of the functions of a regulatory agency is to inform and to answer questions and try to prevent violations.


[James Harvey Young:] But at some time in some political climates, it's easier and more natural to have closer relations between regulators and regulated than it is in other climates, and this was a sort of climate in which the push was to get relations a good deal closer. Wasn't there criticism within the Food and Drug Administration against what some spoke of as 'jawbone enforcement?'


[Milstead:] Oh, yes. I think so. There's no question about it; that term was used. But I think it was used by those who believed in hard enforcement. People who conscientiously believed that enforcement is the only way to bring about correction, but that certainly was not Larrick's view.


[Young:] So that Larrick's own personal view and temperament fit in with the kind of suggestions that were made in the [1962 report of the] second Citizens' Advisory Committee, about expanding the area of voluntary compliance.


[Milstead:] No question in my mind about it. He had no difficulty with that, and I think he very successfully encouraged that type of approach. I believe . . . also, Harvey, that the development of the law encouraged that type of approach. Prior to the New Drug section of the Act--and Elixir Sulfanilamide--where there was no pre-clearance control, we had hard law enforcement, inspection and sampling and bringing regulatory actions. If anybody wanted to talk, yeah, we'd talk to them, you know, but our business was not talking. Our business was getting evidence, sound evidence, and bringing legal actions. It really was. Now, I think the Elixir Sulfanilamide episode and then the amendment of the act started a whole, new type of approach of preventive enforcement--doing something more in the interest of the consumers and in the interest of good business, besides bringing law suits. Law suits are a part of the picture, but it's an ineffective way, an impossible way, to protect consumers in this area.

 


[Young:] And all of the amendments virtually following the 1938 law in one way or another put pre-clearance in, for pesticide residues . . .

 


[Milstead:] In my opinion, the pre-clearance approach encouraged greatly the relationships between the Food and Drug Administration and the regulated industries. The pre-clearance approach encouraged a closer relationship. Industry scientists talk to the Food and Drug scientists, and the whole atmosphere is one of cooperation and working things out. So, I think we can expect that this approach will be extended to other areas through amendments to the act. Experience has now demonstrated that maximum consumer protection probably just cannot come about by enforcement alone."[13]


Finally oral histories are useful in assessing leadership qualities--or lack thereof--but such assessments are not necessarily going to be consistent. Following are snippets from two oral histories by individuals of very different proximity to power. Gordon Wood retired as a field district office director, and offered the following appraisal of the Commissioners who served in the 1950s and 1960s:


"[Wood:] Next in line, Charles Crawford was another dominant individual when he lead business. But, otherwise perhaps a warmer personality than either Campbell or Dunbar. I was not in the echelon which discussed FDA problems with. But, I did sit in a time or two on lesser crises. He would sometimes lean back in his chair, smoke his cigarette, appear to look into space and listen with little participation in the discussion. When he had heard enough, he would make his decision known with minimum explanation, and that was that. I have heard him referred to as a 'little Napoleon' and 'cold as ice.'

George Larrick followed Mr. Crawford. I had known George since my resident days in Salt Lake City when as Chief Inspector of FDA he spent two days with me. He was an energetic, outgoing person, easy to meet and easy to talk with. During his regime as Commissioner, FDA grew up in stature with larger staffs, better facilities in the field districts, more responsibilities and bigger appropriations. To accomplish all of this he must have had persuasive powers with the Committee on the Hill. He was also an eminently successful Commissioner. Upon Mr. Larrick's retirement, the chain of succession from within the ranks of FDA was broken."[14]


Robert Roe, who led a headquarters scientific bureau as mentioned earlier, offered his own perspective on the abilities and style of the FDA commissioners. His Commissioner Crawford seems much more casual than the Napoleonic Crawford that Wood described, and Roe's Larrick comes across more as a nervous publicity seeker, whereas Wood singles out Larrick's commitment to the field force:


"[Roe:] We used to meet informally in Crawford's office every morning. More or less as we wanted to, all of the Associate Commissioners and some of the Division Directors would just drop in and sit around for fifteen or twenty minutes just talking. I think this was helpful to us and to the Commissioner because he'd bring up things kind of informally. We were talking about some aspects of the work or what was developing and this and that. But in a very informal way.


Then Larrick came and well Larrick also held meetings of that sort but not quite with the same informality that Crawford had. Larrick was a little more nervous type and he was, as compared with Crawford I would say that Larrick was more interested in well, the publicity aspect of things. Of getting the story across and did not want to unnecessarily upset industry. He wasn't going to kowtow to them but he was more careful in his approach and contacts. Crawford was a little more direct and a little rougher I thought on some of his handling. I certainly think that all of those Commissioners were very competent and men of integrity on the job."[15]


Twentieth-century historians are fortunate to have access to the participants in the events they seek to understand and relate. Well, fortunate most of the time. Oral histories provide insight into an institution, organization, event, or individual that might not easily be discerned from the official records of that entity. Of course, that insight is accommodated by informed questions from those familiar with the subject. A good oral historian knows what to ask, when to ask it, and when to shut up and listen.

Oral history is by no means a substitute for the published and unpublished primary and secondary record; the paper record remains the first and most important documentary resource for the scholar. However, oral histories, as illustrated by those quoted in this paper, can be an enormously helpful supplementary resource to understand a complex story such as the history of the Food and Drug Administration.


Notes and References

[1] Presented at the symposium, "Oral History and the Public Health Service," annual meeting of the Society for History in the Federal Government, College Park, Maryland, 19 March 1998, and at the annual meeting of the American Institute of the History of Pharmacy/American Pharmaceutical Association, Washington, D. C., 11 March 2000.

[2] James L. Goddard to Associate and Assistant Commissioners, Directors of Bureaus, Divisions, and Districts, 15 March 1968, Herbert L. Ley to Wallace F. Janssen, 27 February 1969, and "Brief on FDA's Historical Program," 2-page typescript, 13 May 1969, files, FDA History Office, Rockville, Maryland [hereafter History Office files].

[3] "Organization Study: Historian (Historical Office)," 8-page typescript plus enclosures, c. 1974, and Gerald F. Meyer to Policy Board Members, 18 June 1975, with enclosure, History Office files. The FDA formally established a history office, situated within the Office of Regulatory Affairs, in 1984, and elaborated the staffing and functions of the office five years later; see Robert C. Wetherell, Jr. and Joseph P. Hile to Mark Novitch, 3 July 1984, and John M. Taylor to Commissioner of Food and Drugs, 24 February 1989, History Office files.

[4] Fred L. Lofsvold to Ronald T. Ottes, 7 December 1976, Donald C. Healton to Regional Food and Drug Director, Region VIII [Fred L. Lofsvold], 13 December 1976, and Fred L. Lofsvold to Donald C. Healton, 11 January 1977, History Office files; and Robert G. Porter, interview by Fred L. Lofsvold, Denver, Colorado, 19 October 1981, transcript, History of Medicine Division, National Library of Medicine, National Institutes of Health, Bethesda, Maryland [hereafter NLM], pp. 77-79.

[5] Robert G. Porter and Fred L. Lofsvold to Gerald F. Meyer and Donald C. Healton, 16 October 1980, with attachment, "Interviews Completed as of October, 1980," History Office files.

[6] Wallace F. Janssen to John T. Walden, 22 July 1975, History Office files.

[7] Fred L. Lofsvold to Donald C. Healton, 24 January 1978, History Office files.

[8] This number is based on the list found in Food and Drug Administration History Office, "Oral History Interviews: Cumulative Index," 145-page typescript, May 2000, pp. 3-14, History Office files, as well as the number of oral histories at various stages of completion.

[9] Sam D. Fine, interview by Robert G. Porter, Austin, Texas, 11 May 1978, transcript, pp. 19-21, NLM.

[10] William C. Hill, interview by Fred L. Lofsvold, San Mateo, California, 15 June 1982, transcript, NLM, pp. 64-66.

[11] John P. Swann, "Drug Abuse Control Under FDA, 1938-1968," Public Health Reports 112 (Nov./Dec. 1996): 83-86.

[12] Robert S. Roe, Glenn G. Slocum, Frederick Garfield, and William Eisenberg, interview by James Harvey Young et al., Rockville, Maryland, 29 June 1978, transcript, NLM, pp. 35-37.

[13] Kenneth L. Milstead, interview by James Harvey Young, Fred L. Lofsvold, and Wallace F. Janssen, Chevy Chase, Maryland, 28 August 1968, 28 July 1969, and 4 February 1982, transcript, NLM, pp. 45-47.

[14] Gordon R. Wood, interview by Robert G. Porter, Pasadena, California, 2 February 1978, transcript, NLM, pp. 48-49.

[15] Robert S. Roe, interview by Fred L. Lofsvold and James Harvey Young, Alexandria, Virginia, 7 February 1982, transcript, NLM, pp. 59-60.

 

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