FDA Oral History Program

Interview with William W. Goodrich
Office of the General Counsel, 1939-1971

Interview Topics:

Interviewers: Ronald T. Ottes (RO) and Fred L. Lofsvold (FL)
Date: 15 October 1986
Place: Rockville, Maryland

FL: This interview is one of a series of oral history interviews on the history of the Food and Drug Administration. We are interviewing today Mr. William W. Goodrich, retired General Counsel of the Food and Drug Administration. The interview is taking place at the Parklawn Building in Rockville, Maryland. The date is October 15, 1986. The interviewers are Ronald T. Ottes and Fred L. Lofsvold.

Mr. Goodrich, to start this off, would you briefly sketch your education, when and where you were born, the background of how you came to FDA, and the jobs that you held in the General Counsel's office?

WG: Certainly. I was born in Marlin, Texas, in 1915. I am now seventy-one years of age. I was educated in the public schools in Texas and I graduated from the University of Texas Law School in 1938 when I was twenty-two years of age. I worked for a year in San Antonio, Texas in private practice, and I came to Washington in June of 1939.

I came to work in the Solicitor's Office of the U. S. Department of Agriculture. At that time, it was run by Mastin White, who was the solicitor, and Ashley Sellers, who was the deputy solicitor. They both had taught at the University of Texas where I was educated, and through a friend of mine, James Russell, who was working at that time in the Solicitor's Office, Food and Drug Division, I became interested in coming to Washington.

When I first got here, I worked on problems of administrative procedures in the Department of Agriculture. There were great issues at that time about how the departments were actually performing their administrative procedures, and there were great criticisms of the department for not having written rules and not having a full understanding of what they were supposed to do under various statutes. Indeed, some of the regulations were not published anywhere but were handed out in pamphlets. The Federal Register was organized about that time, and my first job was working on that.

I worked on the procedures of two or three federal laws, including the Federal Food, Drug and Cosmetic Act, from June of 1939 until early in 1940, when I was transferred from being an assistant to Ashley Sellers to the Food and Drug Division. At that time, I worked on 28 Hour Law cases and the Insecticide Act and a few things like that.

To give you an idea of what it was like in the General Counsel's office in early 1940, the Food Drug, and Cosmetic Act had been passed, as you know, in 1938, and became effective, except for some provisions, a year later in 1939. So the total agency--the General Counsel's office, the agency, everyone--was in a position of change and anticipation of what was going to happen under this new law.

For example, in the Food and Drug Division of the Office of Solicitor, there had been before the law was passed a very small group of lawyers--P. D. Cronin, J. B. O'Donnell, Johny Murphy, Dan Willis, Archibald McNaught, and George Shaw--and that was about it. They were doing notices of judgment and were preparing criminal cases and seizures for reference to the Attorney General. But they were not really very active in administration of the regulations or anything of that sort. The new law coming in had a lot of provisions dealing with administrative procedures, especially the adoption of regulations.

Two important things were happening there. First, the solicitor was employing a lot of new people and changing the nature of the General Counsel's office. And second, they were trying to develop procedures to deal with these various regulations. As we all know, the act calls for general regulations and it calls for some regulations to be promulgated through formal procedures. So at that time, the Solicitor's Office was staffing up for that, without a very clear idea of what it was all about.

J. B. O'Donnell and P. D. Cronin were products of the old times. They'd been around a long time. These were all new to them. So they had, under direction of Ashley Sellers and Mastin White, set about the establishing of hearing procedures and employing new hearing examiners and all that business. They employed three hearing examiners, and they set up procedures for formal rule making. In addition, they employed some older lawyers than I was, like Jimmy Russell, Walter Green and Pat Perritt. They came in and I came in. So we were growing there.

At that time, the first order of business under the Act of 1938 was to deal with a number of drug cases that had been nagging the agency for a long time. That is, cases that involved drugs they thought were dangerous to health, primarily, Marmola, which was desiccated thyroid, and things of that kind which were sold over the counter for weight reduction without any real control. So one of the very first cases brought was the Marmola case, alleging that it was dangerous, and it ultimately was taken off the market.

In addition, there were some cases brought under the drug provisions dealing with false labeling. Prior to 1938, charges of misbranding on drugs had to be based on fraudulent claims. And so there was kind of a premium there for ignorance; that is, the less you knew about the drug, the more you could get by with in the claims. There were a lot of claims around that were first order of business for the agency at that time, and since we had a very good veterinary medicine division, some of the first cases brought were in that field. Dr. Salisbury's Rakos case was one of the first. We were moving into an area where at that time there was great question about whether under the Constitution you could regulate the truth of medical claims, that is, if there was a difference of opinion, you could not regulate. And so we moved into that area.

From my own standpoint, my first, job with Food and Drug, after I got through with the 28 Hour Law and a few things like that, was to work on Food Standards.

FL: Bill, what was the 28 Hour Law?

WG: That's a law that prohibits the carrying of cattle in rail cars for more than twenty-eight hours without letting them out to have feed and water. So that was one of the quarantine laws that we were administering. I also had a problem under the Insecticide Act which was a part of our administration at that time.

FL: FDA had the responsibility for that 28 Hour Law?

WG: No, FDA didn't, but it came under the jurisdiction of the Solicitor's Office of which I was a part. That was under the quarantine provisions of the Department of Agriculture.

Soon after I was transferred full time to the Food and Drug Division, I was assigned to Food Standards. Food Standards had been one of the major goals to be accomplished under the 1938 Act. There had been standards of quality under the McNary-Mapes Amendment, which was adopted in 1930, but that was a standard of quality only. When the '38 Act came in, one of the great centers of controversy was whether the agency should have authority to establish standards for foods. One of the great fears was that they would develop so-called "grade-label" standards, and that's what made it so terribly controversial.

The commissioner at the time was Walter Campbell. Walter Campbell was a very longtime director of the Food and Drug Administration. I think he came into control of the agency soon after Wiley left, sometime in the '20s. He was director of the Food and Drug Services for quite a long time. Campbell was an austere sort of a person, very, very intelligent. He was a lawyer by training. He had gone to work with Wiley early in the development of the Food and Drugs Act of 1906. And by the time I came here, of course, he was the director or the chief, I guess they called it, of the Food and Drug Administration. Paul B. Dunbar was his deputy. Charlie Crawford was the assistant commissioner.

In the development of the 1938 Act, Crawford and Campbell had taken the major lead for the Food and Drug Administration. And in the Secretary's Office, Henry Wallace was secretary, and Rexford Tugwell was undersecretary of Agriculture. Those two people were putting this legislation through as a part of the New Deal, under the direction of President Roosevelt and his people. Tugwell, as we all will recall, was a highly controversial person, and Wallace later became one, but at that time was not. Soon after Roosevelt came in, Mr. Campbell saw an opportunity to bring the Food and Drugs Act up to date. In the annual reports of the agency for years before that, they had been pointing out difficulties that they were having in administering the act and what ought to be done to improve it. So they had a pretty good idea of what ought to be done, at least as they understood the situation then. So they worked on this.

Now, Mr. Campbell worked closely with Senator Copeland, who was from New York. He was a physician and had been a public health officer in New York. So he had a common ground with Mr. Campbell. Mr. Crawford worked closely with the House people, primarily Congressman Chapman from Kentucky. Congressman Chapman was a subcommittee chairman that was concerned with the bill, and the committee at that time was headed by Sam Rayburn, who later-became the Speaker of the House, and was a powerful man there for a long time. So in the development of the law, Crawford and Campbell had worked closely together, and Dunbar was the administrative type that ran the agency.

Crawford became ill about the time of the passage of the '38 Act, and took a leave of absence for about a year. When I got here, he was just back on the job. He had the responsibility for food standards and wanted to move that forward. So this is the area that I worked in. He had the department set up a Food Standards Committee, which involved some outside people, as well as some of its own people, and appointed Joseph Callaway, Jr., as secretary of the thing. Joe Callaway was very intelligent, a longtime employee of Food and Drug, and had a good idea of what he wanted to get done, as did Mr. Crawford.

So early in 1940, we set out on these standard-making operations. The first two important ones were canned fruit and flour and bread. Canned fruit was very important because of the controversy between cane sugar and corn sugar. Wallace, of course, being from Iowa, was a staunch supporter of corn sugar. So the issue in that hearing, which was very, very protracted and very controversial, was 1) should sucrose be the only sweetening agent, and 2) if it was not, how should the corn sugar be allowed, whether as a sweetening agent, and if it were allowed as whole or part, how should it be labeled? Well, that hearing lasted for a long time and involved some very large interests. Very large law firms from New York represented both the cane sugar people and the corn sugar people. That hearing carried on through '40 and '41, up until the time we were transferred over to Federal Security Agency in 1940. FDA had started under the Department of Agriculture, and when I came into it in '40, we were going under the Federal Security Agency.

The flour hearing, which was held the beginning of that summer, was presided over by a fellow named Allen Wilcox, who later became general counsel of the department and worked there for a long, long time. The flour hearing started off as a relatively simple, straightforward, standard-making thing. They just didn't have a very good idea about what ought to be in the standards or what ought to be important. Of course, the moisture of flour was important, and one of the items that was believed to be controversial but turned out not to be very controversial was the bleaching of flour, because that had been a bone of contention with the old Bureau of Chemistry from almost the beginning.

That hearing got underway and went very smoothly for most of the time until the vitamin issue came up. About that time, the concern about pellagra and vitamin deficiencies in the Southeast was still with us. Some of the flour millers had begun to put vitamins, which were then becoming available, in their family flour mixes, particularly self-rising flour and salt flours which were used for biscuits primarily through the Southeast.

When the hearing got underway, we had not proposed any provision for optional ingredients of that sort. We had optional ingredients like brominated flour and self-rising flour and things of that sort. But the idea of putting a nutrient in food was new. So one of the firms was putting Vitamin B1 in, another was putting Vitamin D in, another was putting calcium in, another was putting in this, that, and the other thing, There wasn't any real rhyme or reason to that. Elmer Nelson was in charge of our Vitamin Division. He hit upon the idea of trying to make a reasonable standard for enriched flour. If we were going to have it, make it reasonable in terms of the ingredients that should be there and the amounts that should be allowed. So when he testified that we didn't really have any support for the single ingredients, he thought they ought to be multiple and rational.

The hearing then adjourned, and the Food Nutrition Board was organized by the National Research Council to consider the question. Dr. Russell Wilder was the chief actor in that. And from the millers, standpoint, a man named Hartenburg, who was with one of the Minneapolis millers, I believe Peavey, was the chairman of their group. The Food and Nutrition Board then got up a statement of policy and ultimately endorsed what Elmer Nelson had proposed; that is, to have a standard for enriched flour and bread that would be based on not one, but a combination of B vitamins and iron, which were the things most likely to be deficient in the diets of the people that they were aiming at, the people throughout the Southeast. The argument was that if a person was deficient in one vitamin, he was likely to be in the other two. That is, if he was deficient in B1, he was likely to be deficient in niacin and riboflavin, too. And iron would naturally go with that. So that's the way that standard was proposed.

This led me to my first real important meeting with Crawford and ultimately with Campbell. Crawford saw from the start that made a lot of sense. As a matter of fact, he worked with Elmer in bringing that up. But Campbell had a problem on whether or not we had that authority to specify those ingredients and so forth. When we met with him it was the first time I had really met with him on an important issue. And he came around with it, and we adopted those standards.

As you all know, that then moved onto the Supreme Court through the Quaker Oats case. Quaker, of course, didn't make flour, but they made farina. And in the flour hearing, farina was, of course, described as the middlings of wheat, just ground to a different consistency. Quaker had been adding Vitamin D to their farina. They took the view that we were putting them out of business by making them add Vitamin B1, riboflavin, and niacin. If they wanted to have Vitamin D, it was an optional ingredient under the proposal. So that's the way that thing worked out.

FL: Bill, before we leave the flour, was there any consideration at that time of making enrichment mandatory as part of our standards?

WG: Yes, there was, but there wasn't any real feeling that everybody in the United States needed that, and for that reason, it was a beginning step. Also, there wasn't any clear basis that we could outlaw regular flour if it didn't have these vitamins in it. So we went along with the idea of it being an alternative standard.

FL: Actually two different products: flour and enriched flour.

WG: Right. Of course, the follow up on that, bread standard hearings came in just before the war. The War Food Administration made the enrichment of bread mandatory during the war years. So it did move in that direction.

FL: But not under our statute.

WG: Right. Well, they did it under the power to allocate materials, and that if you didn't enrich, they wouldn't give you any power or other things. [Laughter] So that's the way that worked.

Now, on the canned fruit, that hearing finished, and Food and Drug tended to be in favor of making sucrose the standard sweetening agent and allowing corn sugar, but with a declaration that it was neither corn syrup or dextrose. And the argument that was put up by the other people, of course, was that when they were used in baking they inverted, and when they were used in canning, they were inverted to the same kind of sugar in the can, and therefore there wasn't any difference. If 25 or 33%, one or the other, was allowed, there wouldn't be any taste difference, either. That was proposed. Wallace put out a tentative order before we were transferred over to FSA. And then when we went to FSA, one of the first things Paul McNutt did--he was then the administrator of FSA--was to go ahead and finalize that order. That resulted in an appeal to the Court of Appeals in which the standard was upheld on the grounds that the cane sugar people didn't have standing to challenge because they weren't hurt.

In addition to those hearings, there were several other rulemaking hearings going on. That is, the rules for habit-forming drugs were promulgated; the rules for the certification of colors were developed. Dr. Calvery was the head of Pharmacology at that time, and testified in that hearing. Those rules were put out fairly quickly; that is, soon after the law was passed, and this was the first time colors had been certificated as harmless and suitable for use. Calvery's group developed the format of FDC Red No. 1 The colors had the color index names, of course, beyond that. But he decided that it would be more logical to group them in that order: FDC, D. and C., and External D. and C. and so forth, and that's the way the thing came out.

FL: According to what they could be used in?

WG: Yes. There wasn't any very clear idea then, because it was all supposed to be harmless, and I think Calvery was just looking at them in terms of what was actually being used in various products and going along with the standards for that. There wasn't any great controversy there about it. The color industry wanted to maintain those old color index names, but they were not really meaningful to anybody other than the people in the business. So those rules were passed.

Another large hearing was over special dietary foods. And there I think we probably made a mistake in terms of classifying the vitamins as foods and as special dietary foods. The pharmaceutical industry, of course, opposed that; they wanted the products to be labeled as pharmaceutical items. We, in our innocence, wanted them to be food. The result was, that if they were classed as food, their labels would have to declare all ingredients, inert as well as others, whereas if they'd been drugs, only the active ingredients would have been declared. The idea of the minimum daily requirements were put in, and that, of course, fed the idea that if this was the minimum, three or four pills would be better for you. Those regulations lasted for a long time and probably did as much harm as it did good. But that was the direction they went into.

FL: Was there any pressure from the food industry to ...

WG: No. It was all Food and Drug's idea that they could deal with them better under those regulations as special dietary foods than they could as drug items, because the agency really didn't have much experience with drugs at that time.

[Interruption]

WG: Moving from the food standards work, another operation that was going on in the agency was a greatly expanded campaign against the insanitary conditions in food manufacture and in food storage. This provision, that food held under insanitary conditions would be adulterated, was new in the 1938 Act. And so a major effort was made in the very earliest years to greatly improve conditions of sanitation in both storage and manufacturing. So that occupied a lot of the time of the field force. We had a lot of litigation over tolerances, particularly tolerances for tomato products. Mold and tomato products was one of those nagging things that kept us busy for several years.

In those early days, there weren't any good manufacturing practices on sanitation. Each case was just prosecuted on its own bad features--that is, if it was enough to testify to the court how bad the conditions were in this plant--and it was shown by picture or by explanation.

The field also was active in dealing with some more common poisons in food. The '38 Act had changed the idea that you'd have to prove the food itself dangerous to health if it had a poison in it. And there was a new rule, the so-called "per se" rule, on poisonous and deleterious substances in food. And so, a major campaign was underway in terms of getting at lead in apples and spray residues of that sort and then containers that were contributing poisonous substances to food. But there wasn't much going on in terms of pesticides and the use of chemicals in foods. That was all relatively new. In those days, about the only pesticides used were nicotine and lead arsenic, and some fluoride compounds, but relatively few. We had a lot of litigation over that stuff, with and without tolerances established. We'd try to establish tolerances for those early on, and did, and had a lot of litigation over residues in apple chops and things of that sort, but not any great big operation there.

The end of the war brought on a different problem, which I'll get to when we talk about spray residues in a little while. I left the department to go off to the war in June 1942, and was gone for four years approximately--I came back in January of 1946. Things had changed rather remarkably during that time. Mr. Campbell and Linton were tightfisted with money, and so during the war, when other agencies were growing rapidly, Food and Drug didn't grow because they didn't want to request money that would involve them in hiring people that they didn't think were really up to their standards if that's what was all that was available. There was a lot of availability of people. You know, in 1939, when they were hiring, they had pretty much the run of the mill: a lot of people out of jobs, and a lot of people in the top of their classes came to Food and Drug about that time. So during World War II, the agency didn't grow much. It did some inspection-type jobs for the defense and concentrated its efforts on trying to make food that was going to the military sanitary and those things.

When the war was over, of course, the idea was to try to grow again. And by this time, the money was tight; Food and Drug was a very small organization budget-wise in those years. It was a matter of three or four million dollars. And up to as late as 1955, we were at five million dollars. It was a real small operation; salaries were less and costs were less. So that's the way the agency moved along. The financial squeeze came really in the late '40s and early '50s. When the Eightieth Congress came in--I think that was '48--that's when we really got cut down a lot, primarily as a result of the chairman of the Appropriations Committee's getting sore with the agency about classifying some cut-up beets as not young beets and thought we were wasting our money on that. Therefore, they cut it down, and so the agency was strapped.

Campbell left, retired during the war, before I got back. So when I got back, P. B. Dunbar was the Commissioner. And in the General Counsel's office, Cronin died and J. B. O'Donnell died before the war. J. B. O'Donnell was succeeded by Edward Brown Williams when we moved to Federal Security Agency. He was the first real outsider from the old group brought in there. Ed went off to the war, too. So when I came back the office was headed by Dan Willis, and his deputy was Alvin Loverud. Before the war, Dan was concerned with court trials. He went out on the major trials. He was at the Marmola trial, and he was at the first Koch trial, which was tried during the war in '43. He met Al Loverud in Madison. Al Loverud was assistant U. S. attorney there, and actually tried the Marmola case. So he became interested in having Al come down. He got Al hired, and Al became the deputy. When I got back, Dan was Assistant General Counsel, and Al Loverud was his deputy.

Soon after that, Al went off to try the second Koch case. That came up early in '46. It was a full-time job out at Detroit. I became acting deputy at that time. The trial lasted almost a whole year. During the course of it, Al got sick, and I went out there and spent several months beginning, say, about April up until the thing was over with a hung jury roughly in September. So when I went out there, it was obvious something was seriously wrong with Al--he didn't have any energy and was quiet and so forth. But I came back on the plane with him. He said he had some problems and needed to go to the doctor right away. He told me he thought he had cancer.

So when he got back here, you know, he knew a lot about cancer, having just been through that damn case. As a matter of fact, he had an exam out there that didn't show anything. But when he got back here, he went over to Johns Hopkins and they discovered he had colon cancer. They operated on him. So he was out of commission. He came back to work I'd say in September, and he went over there probably in November and had the operation. No, it was before that, because I took his kids up to school because he was sick. Anyhow, he came back to work about the first of the year. And then he was up and down from there on. He died about a year later. So I became then deputy chief of the division. That was about 1947, and I had that position until I became assistant general counsel in 1952.

FL: When Willis left?

WG: That's right. Willis retired in 1952 and I became assistant general counsel.

FL: A position, then, that you occupied until your retirement?

WG: Right. I had that from January 1952 until August of 1971, when I left. I guess I really retired in March or April, but I stayed here through August, and left in August of 1971.

FL: In those days, the job was called assistant general counsel of the Federal Security Agency or the Food and Drug Division?

WG: Well, when we were in Agriculture, it was the Solicitor's Office. When we went to HEW--it was then Federal Security Agency--it was called assistant general counsel, Food and Drug Division, and kept that title as long as I was here. I believe they changed it to chief counsel after I left here.

FL: Actually, you were not a part of FDA, but were theoretically from the departmental office, assigned to Food and Drug matters.

WG: That's right. By that I mean all the budgeting for our office went through the department, in the Secretary's budget. Of course, that was probably good for us when the squeeze was on in the early '50s, but when Food and Drug began getting more appropriations, then that wasn't all that good. The hard times for Food and Drug, as I said, were those late '40s and early to mid '50s years.

My first experience with Food and Drug legislation was in 1941, when the Insulin Amendment was passed. Insulin had been under control through the patent provisions, and the supervision of the University of Toronto, until the patent began to run out. So when there was a danger of it running out, the manufacturers and the people who were really interested in diabetes were very concerned that they would have the same kind of protection they had had under the patent. So they proposed that the product be certified by Food and Drug. And so we proposed and Congress adopted the Insulin Amendment in 1941. That's the first time I got acquainted with the people up on the Hill, with the committees with whom we worked, and so forth.

Mr. Crawford was well known there and was well involved with the people. He had made friends with Allen Perley, who was by 1941 the legislative counsel of the House of Representatives and was heavily relied upon by the House Committee on Interstate and Foreign Commerce. And Perley, being a friend of Crawford's, relied on Crawford for advice, and in turn gave him entre to the committee for explaining things that needed explanations that he, Perley, wasn't able to do. The way that committee worked at that time, they would call in the House legislative counsel to sit with them and advise them on legislation. The House legislative counsel would then advise them in closed session. If he had questions, he would then either ask Crawford or ask Crawford to come in.

So I began to do that beginning in 1941 with that legislation. When I came back, the first legislation we had after that was some of these antibiotic things. Certification of penicillin was the first. We had been doing that testing and certification during the war because the NIH group on biologics wasn't interested in it and Henry Welch was. So he set up to do the certification, and the Antibiotics Division became a big operation there. Immediately after the war, when penicillin became widely available, that operation grew rather remarkably.

I'm getting ahead of myself on drugs there. I brought that in at this stage primarily because of the effect it had on the budgetary situation of Food and Drug. When Food and Drug was being tightly squeezed by appropriations, they were able to cover some of their expenses through the fees that were earned in this certification. So that became a largely independent source of income and a largely independent source of trouble, as it later turned out to be. [Laughter]

The first really important legislative operation I had was with the so-called Miller Amendment. You'll recall that the court of appeals for the Ninth Circuit held in the Phelps-Dodge case that if food became adulterated while held in storage, the act didn't cover it; it would have to be adulterated when in interstate commerce or it would not be subject to seizure before introduction went in. We had contended in that case that because it was in original packages it was still in interstate commerce, even though it had been in Phelps-Dodge's warehouse in Arizona for a year or two. We lost. So we went back to Congress immediately with the so-called Miller Amendment to have that decision reversed.

This was a proposal that wasn't really controversial at all. Everybody was kind of for it. It was a good experience for me to work on legislation because it was not one of those hot issues, but it later turned out to be. When we were working on that, a man from Denton, Texas--Morrison of Morrison Milling Company--proposed through an Oklahoma Senator, Senator Moore, I believe his name was, that that amendment be supplemented by an amendment which would make prosecution for insanitary conditions depend on intent. His firm had been prosecuted for insanitary conditions, and considered that a great disservice, so he made a crusade out of getting that provision in. And he did get it passed through the Senate, and we ultimately were able to knock that out.

But that amendment, in '47 and '48, introduced me to Perley as a working friend, that is, he was House legislative counsel, and to Kurt. Borchardt, who was the counsel for the committee. That came in very handy in the next two years when the Durham-Humphrey Amendment came along. That amendment was the first real recognition and law of a difference between prescription and over-the-counter drugs. Now, we'd been dealing with that before under regulations. When the first regulations were put out back in '40, if a product was prescription, you could make your own choice. That is, if you thought it was prescription, then you labeled it for a prescription by putting on it: " to be dispensed by prescription." And if you made it over the counter, then you had to have adequate directions for use. And this resulted in a situation in that Vitamin C, for example, sold by Lilly, was labeled to be dispensed on a prescription, and the others were over the counter.

So in about 1942, Crawford devised the idea of amending the regulations to limit to prescription drugs all those drugs that could not be sold safely without prescription, and to require all those that could have adequate directions for use to have adequate directions, trying to draw a sharp line between them. They got into the litigation over sulfathiazole with the Sullivan case during the war. That's when it was being sold over the counter to military people in the Alabama and Columbus, Georgia area, where self treatment was going on. That was considered to be a dangerous thing because the treatment was inadequate, and it was resulting in the spread of more serious venereal disease. So the prosecution of Sullivan started there. We won in the district court, we lost in the court of appeals, and it went to the Supreme Court where we ultimately won. And that was the first really big Supreme Court case. Dotterweich had been decided earlier, dispensing with intent in criminal cases, but Sullivan was decided about that time.

Well, we were still having a lot of litigation over these various drugs--which should be prescription and which not--but more importantly was the issue of the refills. And Crawford put Dunbar up to making a speech to the NARD (National Association of Retail Druggists) on prescriptions, likening the prescription to a check, and saying that once the thing had been cashed, then you couldn't cash it anymore. So you can imagine the consternation that caused among the pharmacists.

The National Association of Retail Druggists was headed by a guy named John Dargavel--a great, big, fat guy, and really a volatile person. He saw red, and swore he was going to get Dunbar fired, and also that they were going to get the law changed to where you didn't make those distinctions, or if you made the distinction, it would not be a crime for a pharmacist to use his professional judgment in filling or not refilling that prescription.

So the stage was set for the Durham-Humphrey Amendment. Mr. Carl Durham was a congressman from Durham, North Carolina. I'm not sure he was from Durham, but he was from North Carolina. He was a registered pharmacist. Then so was Hubert Humphrey. We were able to interest them in it, but only after we had interested Dargavel in coming along and getting some sort of legislation that would make this thing regular. He thought that the pharmacists should have a free run. We thought the pharmacists shouldn't have a free run, and so the stage was set. And ultimately the NARD supported the legislation.

With their support, the Durham-Humphrey Amendment was passed in 1950, making this distinction between prescription and over-the-counter drugs. The big part of that was, in dealing first with classification, it kept the same classification that had been in effect under the regulations, but made that legal classification. Second, it required a label statement: "Caution: federal law prohibits refilling without prescription." We pirated that from liquor bottles, which says they can't be refilled. [Laughter] So we thought that was a good idea to put that right on the container. So that's where that idea came from. And then on the issue of refills, the telephone refill came to play, and so we had to deal both with the written authorizationable refill, and with the oral, the telephone type. That's what the Durham-Humphrey Amendment was all about, and it passed in 1950.

FL: Bill, in all those controversies surrounding that question, where did the medical profession stand?

WG: They stood aside. They ultimately would come along with Dargavel because the National Association of Retail Druggists was a powerful lobbying influence. They had druggists, and they were drugstore owners. And so they had stores in all districts of the United States. They had access to people who knew these congressmen. As a matter of fact, you could know pretty quick what was going on, because one of the members of the House committee would say, "Well, now, I just got word from my district that so-and-so . . ." We'd have to go and answer that. That's where I got well acquainted with the members of the committee, of answering those things. But in the final analysis, NARD and Food and Drug worked together on that legislation. Even though it wasn't what Dargavel wanted, it wasn't completely what we wanted, but we got basically what we wanted

The next legislation I was concerned with was oleomargarine, that is, the proposal to repeal the tax on colored oleomargarine, and to adopt those labeling and sign provisions for oleomargarine. That amendment was passed in 1950. Following that, the Inspection Amendment came in '53. There, you'll recall the Cardiff case that pointed out a difficulty in the original inspection authority. That is, according to the court, you could inspect if you first requested and got permission, but if you didn't do that, you couldn't inspect. So that was unworkable.

FL: But the owner had to give permission or he could be prosecuted. [Laughter]

WG: Right. So we then proposed the Factory Inspection Amendment. That has always been controversial up there. It's amazing that many other laws, particularly in the public health area, provide inspections of various kinds and never are controversial up there. But with us, this was always controversial, and the reason was that the industries that we inspect and regulate are well represented in terms of lobbying effect and in contact with the Hill people. They kind of use the inspection as a specter of some inspector taking advantage of some poor local guy that had to submit to inspection whether he wanted to or not. So that amendment was pretty hard fought through the House Committee.

I will deal with the Delaney hearings, the Pesticide, Food Additive, and Color Amendments later. I think now we need to talk a little bit about drugs and new drugs.

FL: Bill, before you leave the legislation, could we go back to that insulin law? I've always been amazed when reading about the legislative action on that how rapidly it went through. Was it very speedy in the preliminaries also?

WG: Yes. The reason that took place that way was that there were only about four or five manufacturers of insulin. That was Lilly; Merck, Sharpe, Dohm; and one or two others--I forget the names. But they had been under certification control through the patent at the University of Toronto. So they were quite responsive to anything that the Insulin Committee of that group wanted, and Drs. Banting and Best who were the discoverers of insulin owned those patents. So they were in favor of some kind of control and the companies were in favor. The possibility was that insulin would be put out without any certification, so that's what gave that urgency to it, and that's why it passed with such a fast go.

FL: There was no opposition of any kind.

WG: No. As a matter of fact, everybody was much in favor of it, and as a result, the legislation passed, and the regulations were put out within a very few days. I worked on both of those and that set the stage for later legislation on antibiotics, but that was the first of the . . . Well, we'd had certification of colors before, and we kind of patterned that to some extent on certification of colors.

I have talked about the prescription drug legislation. I want to go back, now, to the early days and take up new drugs. The revision of the Food, Drug, and Cosmetic Act passed both houses of Congress in 1936. But there was a dispute that held up final enactment about who should have control over advertising. Chairman Davis of the Federal Trade Commission had been a member of Congress before, and he had great influence up there. He was able to get that authority passed over to the Federal Trade, and Food and Drug then objected. So the bill died in conference committee because of inability to resolve that issue.

In the next Congress, Davis made a fast move and got the Wheeler-Lea Amendment passed in about April of '38, and that made it fait accompli of them having control over advertising before our law was ready for passage in June of that year. So the act passed in June. But in November or in the fall of 1937, the elixir of sulfanilamide episode arose. That was after both houses had passed the bill and nobody had said anything about new drugs, and the whole idea was just brand new. When that episode occurred, the first thing Congress did was ask the department for a report on what there was in the new law that would deal with that problem. And, of course, the answer had to be, very little. So the department sent up a report and sent up a proposal on new drugs in '37. It turned out to be controversial because the drug industry was very much opposed to licensing, and they considered this to be a licensing bill.

Nonetheless, that was a bill whose time had come. Before that, there were very few, if any, drugs that had any real importance as curative agents. Sulfanilamide was the beginning of an era. That was in 1936. The New Drug Provision came in just at the dawn of the era of rational therapeutics. Sulfanilamide itself was exempt because it was on the market before 1938. But most of the important drugs came along after that time.

Now, in the beginning, I'm not sure any of us had a very good idea about what that New Drug Provision was all about. The New Drug unit was headed by Dr. Durrett. He was a pretty powerful, opinionated, sort of a fellow, and he had as his deputies, Ted Klumpp and Robert Herwig. I guess before Durrett came, Larrick was the first head of that unit. And then Durrett came in as the first M. D. and started working at that. The first I became involved with New Drugs was soon after the passage of the act. There was a provision there that if the application wasn't acted on within sixty days, it would become automatically effective. So we, then, held a series of hearings, most of them uncontested--I believe all of them; maybe one was contested--to go through the formal steps of denying approval of the new drug before the sixty days passed.

The real eye-opener on new drugs, though, came in about 1941 when there was a mix-up of the sulfathiazole-phenobarbital tablets at Merck, Sharpe, Dohm. That made us begin to realize that the effective New Drug Application (NDA) had some lasting duration to it. We were arguing that because of a failure of the controls, that was a basis for revoking that application. But you had to do it on the ground that the application contained an untrue statement of material fact. The untrue statement was a representation the firm had made about these controls that would be exercised. We took that to be a continuing promise and proceeded on that basis to take action on that application. That was the first time that it was clear to us that the New Drug Application would be considered as a continuing document, making a commitment to the firm both as to their reports of clinical experience and their reports on controls.

The New Drug operation was kept separate from antibiotics primarily because the antibiotics were considered to be a kind of a laboratory problem rather than a labeling and control problem, and that we had in effect control over the quality of those products through certification and not under New Drugs. So they were allowed to grow in parallel, but on two different routes. The New Drug operation was not supported by fees, and it suffered from financial neglect during those years of its early being. It suffered from that plus, I think, not a complete understanding on anyone's part about the importance of making the New Drug Application a commitment of continuing viability on the part of the manufacturer.

They took the view, once they got the New Drug Application passed, that that was the end of it, and they didn't really have to tell us if they made any changes in the thing, and they didn't tell, by and large. If we learned that a new drug was causing problems, we had the authority to withdraw that, but the original thoughts were that the New Drug Application dealt with safety only. Now, I don't know how we ever got that way, because none of these drugs were really all that safe. I remember Dr. Moskey, who was the head of our veterinary group, used to say, "Well, if it's safe for the chickens, it's okay. But without looking at it beyond that, a man has a right to kill his chickens and his cow. Therefore, it really doesn't make very much difference about whether the drugs do harm to animals."

In the human area, there just wasn't enough of a medical component to Food and Drug to be really in there on that operation, although we did have Durrett, and we did have Klumpp, and we did have Herwig. Durrett quit soon after that and went over to Federal Trade. Klumpp resigned and became president of one of the drug companies. Herwig stayed for a while and ultimately went with American Home Products. So the New Drug operation became somewhat of a paper-shuffling deal, and suffered from neglect. That is, Dr. Nelson was head for a while and Ralph Smith was head several times. We didn't really have any strong medical input to that. Both Doctor Arthur Nelson and Smith were pharmacologists--they were not clinicians--and they were more concerned with the pharmacology of the drug and its behavior than they were of how it was promoted and what was happening out there in clinical experience.

So the new drug thing gradually got out of control. When the budget became tighter and tighter, there were more and more rulings by the New Drug Division. Products were no longer new drugs; that relieved them from having to deal with supplements, and in effect, let other people introduce that same drug without clearance, although we never said that to them. That became the drug companies' understanding of it.

From those years in the '40s after the war was over, when the drugs began to be introduced and promoted in large volume, that grew, and it grew continually through the end of the '40s and up into the '50s. And up into the '50s we began to get these first real problems with new drugs, that is, having to withdraw some of them from the market because they turned out to be dangerous. That led into a lot of investigations by the Fountain Committee and by the Nader Group. They began to ask questions about these drugs and what sort of controls were available, and what the agency was really doing about a lot of them. We took, of course, one step in the Durham-Humphrey Amendment by insisting that at the time of the New Drug Approval, the drug be classified prescription or not and labeled accordingly, and there had to be an official brochure. But there wasn't really any insistence that that brochure be used as the basis for promotion.

Along about 1960, and I'm not dead sure of my date here, but I'm pretty sure, we amended the drug labeling regulations, the 502 f(1) regulations, to require a better pattern of labeling for all drugs, that is, to require that all the promotional material be substantially the same as the official brochure, and that there be full disclosure in this promotion. The biggest basis for promotion, I guess, at that time was the PDR (Physician's Desk Reference), and it was being used, really, as a promotional piece rather than as a source of reliable information. If you look at the 1960-61 PDR, you'd be shocked when you compare that with the next year, which is when we first put in the full disclosure and required essentially a full rewrite of that.

So the 1960 regulations were designed to require that all over-the-counter drugs have adequate directions for use--and it was spelled out what that had to include--and that prescription drugs would be exempt from that only if they had full disclosure to the medical profession. That was the first really important step taken by the agency to improve the quality of promotion of prescription drugs, primarily. We had been concerned with a lot of these cats and dogs drugs like Mrs. Alberty's and some of the others, and even with some unorthodox drugs, but the 1960 regulations were moved in that direction.

From there, we went to the Drug Amendments of 1962. The beginning of the Drug Amendments of 1962 was way back in '59, when they were trying to put the '60 regulations in setting. The first of the Kefauver hearings on prescription drug promotions was December 7, 1959. That's the day the whole thing really started to build. The drug companies came to the hearings saying that everything was hunky-dory, that is, that new drugs were being honestly promoted, not exaggerated, and so forth.

Well, Kefauver started off with an antitrust investigation, that these prescription drugs were too high, and that "he who orders doesn't pay and he who pays can't order." That was the theme of the investigation. First, the pharmaceutical industry responded to that by bringing in some of their big guns, presidents of companies--Frederick Brown from Schering and what's his name from Parke Davis, and Eli Lilly and those companies all sent their big presidents down here to testify. Their testimony was that drugs were high because it cost a lot of money to do the clinical research, it cost a lot of money to promote, it cost a lot of money to advertise, and that they were under an obligation to follow the experience with them and they had a short life .

Well, of course, they stepped right into the bear trap when they did that. That just focused attention on these various phases of new drug development and promotion. First of all, was it really all that expensive? Were they really doing all that kind of research? And anyone who had looked at any of the New Drug Applications knew, as I knew, that that was all baloney, and what they were saying to us in those early days was essentially a bunch of testimonials. The way drugs were investigated, a physician from the company would go out in the community with some samples and say to the doctor, "I've got this new drug for so-and-so. Here's some samples. Try it out and let us know how you like it." And they would get back a letter from him: "I tried it out on eight patients and they all got along fine." That's the kind of stuff that was coming in for the science. Of course, that was completely unsatisfactory, and as soon as people focused on that, that raised the problem.

Then, on promotion, they said that the promotion was educational; they were providing a service to the medical profession. They later took the opposite position, saying none of it was educational--nobody believed it, and therefore, it was no reason to require such a hard line on honesty with it. But the defense that they made--the cost of research, the cost of promotion, the promotion to a limited audience, the doctors' responsibility to choose for the patient and make an economic choice for the patient, and the follow-up--all those things were brought up.

Well, the next year, in '60, the committee focused on Henry Welch and his relationship to Ibanez and his collecting money for reprints for various articles that were used in promotion for the drugs. And also, it had something to do with those antibiotic conferences that had been held during the late '50s, particularly with respect to the unprecedented growth of antibiotic combinations. The idea was that if you had one antibiotic and you added another one, you got a broader spectrum, and it was like a shotgun therapy, starting, really, from the combination of penicillin and streptomycin. The triple sulfas, I guess, were the first of those, and then the combinations of the various antibiotics pressed particularly when tetracyclines came along. When Henry was called to testify, he was not able to testify; he had a heart attack. So they, then, introduced the evidence about his relationship with the drug industry, and it was very bad. Henry about that time retired.

Larrick and Rankin and myself went up on what was wrong with the new drug thing and what needed to be done. Now this was not the first time we had urged Congress to deal with the effectiveness of new drugs. We had asked them to do that before. But we had a pretty well-thought-out idea about all that needed to be done, not completely as it ultimately came out, but a pretty good idea about that. So we presented that.

Then, of course, came the testimony of Dr. Moulton, and about that same time, the people over in pharmacology were publicizing the cyclamate thing. The upshot of it was that the hearings continued through 1960. I'm not sure when Morton Mintz's story came out, but I believe it was either in late '61 or in '62. Maybe it was up in the summer of '62. Because once that came out, the drive to have a New Drug Amendment of '62 was unstoppable.

We first tried to compromise with the committee and made a bad choice on it. That became publicized, and when the amendments were finally passed, they were much better than what we had gone in with, and much better than what we could have hoped for. But we did do the drafting on those amendments and did work with the committee, particularly the House Committee on Interstate and Foreign Commerce, in working up a bill. Kefauver had a bill, too, but it wasn't like the one we ultimately came down with. It was somewhat like it, but not completely. And so out of that arose the Drug Amendments of 1962.

FL: The department was involved in this negotiation too?

WG: Yes. Wilbur Cohen was the assistant secretary for legislation, and Abe Ribicoff was our secretary. Abe Ribicoff testified on this bill in '62 favoring a bill. Then Jerry Sinosky, who was Cohen's assistant on legislative matters, tried to work out a compromise with the Senate staff and did work out one; there was a committee report. But it really didn't come down hard on real proof of effectiveness; it in effect bought their argument that it was impossible to prove absolute effectiveness, and therefore relative effectiveness was about the best you could do, and that they would have a right to claim usefulness of the drug provided they put enough qualifiers in there about the thing. Well, that wasn't very good.

The AMA (American Medical Association) had testified against the bill; they didn't see anything good in the bill. And Austin Smith, who was then president of the PMA (Pharmaceutical Manufacturers Association), finally testified and said that all their drugs were safe and all of them were effective, and that they were strongly in favor of a strong science. So we took him up on that and came up with the provisions in the '62 amendment, the most important of which was the requirement that drugs be proven effective by adequate and well-controlled studies and by new regulations on new drugs, new regulations on record keeping and recording, and the other aspects of the '62 amendment.

[Interview with William W. Goodrich:   Part 1   |  Part 2   |  Part 3 | Part 4 ]

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