Interview Topics:
Interviewers: Ronald T. Ottes
(RO) and Fred L. Lofsvold (FL)
Date: 15 October 1986
Place: Rockville, Maryland
FL: Does that go into the part of the story of how much the department's involvement was, superseding any decisions that were being made in FDA?
WG: Yes, that's what I mean. The whole case is laid out there. Now, it's true that in testifying about the case, ex-Secretary Finch had a very poor recollection of what happened, as did some of the others. But in the final analysis, when everybody was questioned, everything was said and done, the whole picture did emerge, and it's all documented to the last piece of evidence right in that case. So if anyone studying the history of this becomes concerned about that, I strongly recommend that they go to that case, and that the documentation is there.
FL: That was the claim by some of those canners?
WG: By the California Packers and Growers against the department.
There are two or three other classes of drugs that you wanted me to discuss. First, of course, the oral contraceptives. The history of these drugs is really rather unbelievable. This class of drugs was introduced before they were ever available as oral contraceptives for female disorders--menstrual difficulties and so forth. So they were around. The idea of having these as oral contraceptives came to the department and was strongly pressed on the department by the Planned Parenthood Association, who had done some studies in Puerto Rico where there was a real need for population control and where they were giving the drugs to people down there.
The population control group, as I remember the file, urged the department to approve it first for a limited study down there, and then to expand the study. Whoever it was that was responsible for approving the drug--and I don't know who it was; I'd have to look back--made a rather simplicist decision. They made the decision that enough was known about the drug and its safety to justify its being approved for use by a limited population group over a short period of time--six months.
Well, anyone should have looked forward beyond that to say that once you approve something like that, it's going to grow like wildfire; and that's exactly what happened. After the initial approval, the department was pressed almost constantly to expand that, and the use of it expanded, I'm sure, beyond what we had approved. So it first started out with a single drug, Enovid, and before or about the time the Drug Amendments of '62 were operational, there were several of them on the market, all different kinds, and they were all essentially the same.
While there were some differences in theoretical risk, depending on the strength of the active ingredients, the experience with the drugs was such that the agency fairly early on settled on a uniform pattern of labeling to try to control the different competitive pressures that were building in the marketplace about one as against the other, both in confusing the physician and convincing women to shift from one to the other. Some of those early shifts were due to the possibility of getting off one in six months. Some of those early labelings still carried forward that limited idea, and people would simply shift to another drug.
The department, as long as I was there, and maybe they still are, was concerned about the very long range effect of these drugs. I know I was concerned about it, and I know that the experience we had didn't begin to answer what might happen when we were deeply involved in approving those drugs. One thing we did in the '60s was to constantly refer that whole issue to an advisory committee to be sure that there was pressure on us to gather up all the data and get from the advisory committee all the data they had and all the leads they had that would tell us where we should be looking for possible untoward effects from those drugs. So that advisory committee was quite active.
We used the advisory committee to develop the uniform pattern of labeling for them. We used them to help assay the experience that was coming in. Much of it was of statistical nature and wasn't really all that good. You know, you're dealing with an epidemiological problem by then. And there wasn't any way, really, to subject these drugs to a long-term study of the type that would be required to give you reasonable assurance of safety. Using a small patient population in Puerto Rico even for a year's time would give you only the vaguest idea of what might happen with the drugs.
But nonetheless, I think we were lucky in the long run that they haven't turned out to be any more problems than they are. I know Larrick was there when this was approved, and he was concerned, and I know I was concerned, and I know that the Bureau of Medicine was concerned. But it was one of those situations that here was a drug whose time had come, and there wasn't any holding it back from the marketplace. About the best you could do was follow the experience as closely as you could and put out the word on them at very frequent intervals just to keep attention on them and keep attention on the fact that the last word in their safety had not been written.
FL: Was that the first time we'd approved a drug for non-therapeutic use?
WG: I'll be damned if I know, Fred.
FL: I think that statement was made in the press at the time that we approved it. I was just wondering.
WG: I'm sure we had some prophylactic drugs before that, some vaccine and things like that were used for prophylactics long before that.
FL: But those would be aimed at a disease other than a condition.
WG: Right. But these were unique drugs all the way across the board, and as I said, all I can say is that we're quite lucky that we came out as well as we did.
The next group of drugs you asked me to talk about were the so-called drug-abuse drugs. Quite early in the '50s, maybe before that, maybe as far back as the early post-war days, the agency became concerned with the excessive prescribing of barbiturates. The people who were studying narcotic addiction at Lexington, Kentucky made a movie early in those years showing the withdrawal symptoms from barbiturates. It was a very striking film. They were interested in having the barbiturates recognized as a serious habit-former, and in putting them in some kind of a classification like narcotics.
Harry Anslinger was the commissioner of Narcotics at that time, and was absolutely adamant about not getting into any other business on drugs other than narcotics. He was an old-time Narco agent, and he wanted to deal with heroin and the other products of that kind and to have nothing to do with anything like barbiturates. This film was shown in and around the Public Health Service, and ultimately was shown to the House Committee on Ways and Means, which had jurisdiction over narcotic legislation. The chairman of that subcommittee on narcotics, Hale Boggs, who later became majority leader and was killed in an airplane accident up in Alaska, instructed us . . . Well, first we went up there to hear the testimony, and Anslinger testified that he didn't want to do anything about it. So Boggs, recognizing he didn't have any jurisdiction legislatively over Food and Drug, nonetheless pressed Larrick to get together some kind of legislation on barbiturates, and to make them subject to closer control. And this is where the dangerous drug business really began.
We proposed a barbiturate bill. My memory is vague on what happened to it. But meanwhile, we were gaining increasing knowledge about other drug uses outside the medical parameters, particularly amphetamines. Amphetamines were in use on the truck routes and among other drivers, and among entertainment people to a substantial degree. But we had no idea it was anything like what it ultimately turned out to be. Again, Charlie Crawford was concerned about these two classes of drugs doing great danger, and he and Larrick both put in programs to start trying to control the distribution of these drugs outside the drugstores, and to some extent, in the drugstores.
In those years, we spent a very substantial amount of our field effort in running down sales of these drugs, and they were everywhere. For example, Scotty, a black man, who was a messenger in Larrick's office, was one of the most effective guys we had in going out and really making buys. He went out to Detroit and he could make a buy almost anywhere around. I mean, he wasn't suspected, and he could make them anywhere. Now some of the other people that worked in the inspection force were quite good at making those buys. The Atlanta district office went all out on it. John Sanders was really convinced that it was all down through there.
As a matter just of curiosity, I was down in South Carolina fairly recently, and drove through a place called Society Hill. Society Hill was one of the places that had figured largely in those early investigations. That's where this chiropractor-osteopath was that was weighing out the amphetamines on a baby scale, that we caught and prosecuted. But there were a lot of them down there, and when I drove through Society Hill, I remembered that. I don't know what's happened with that since, but those two classes of drugs were in great abuse. Now, the amphetamines, I guess, are off the market, and the barbiturates are under somewhat closer control that restricts their abuse somewhat.
In addition to those, we had a problem after the Drug Abuse Amendments were passed about what to do about some of the drugs that were of use in medicine but were being overprescribed, particularly meprobamate, Librium, and Valium. We had the job to list those drugs as dangerous drugs and subject to all the limitations of the Drug Abuse Amendments. The meprobamate was the hardest because it's probably the least habit-forming of that class, but nonetheless was habit-forming. The physicians who testified in the hearing really classified it as habituating rather than habit-forming, as just a drug that really wasn't quite up to that. But nonetheless, the hearing was held, and we did put meprobamate on the list, and they argued that case to the court of appeals for the fourth circuit in Richmond, where they upheld that. So we were able to move with those drugs to keep them going.
Now, after that, when that problem became large, we did organize a drug abuse division, and transferred some of our people to it and recruited others. That operation, I guess, was later shifted over to the Department of Justice. It's still there and has grown substantially since we had it. But we were the ones who started that, and the whole thing goes back to the barbiturate beginnings.
FL: Before the Drug Abuse Amendments were adopted, we just had to use the general provisions in the statute.
WG: We used the sale without prescription. After the Durham-Humphrey Amendment in '50, of course, they were in violation of that. Before that, we charged that they were sold without adequate directions for use. Of course they were, so there wasn't any great problem. We learned in the course of that where all those drugs were made. We developed a capability through microscopic techniques of identifying those drugs, even with no labeling and them being outside the containers of original sale. Our people became quite good at proving interstate commerce by proving where they were made. If they were found in a state where they were not made, that would do the trick on interstate commerce. That incidentally led to a good deal of litigation on whether that was adequate proof of interstate commerce, but it turned out to be.
FL: Were the Drug Abuse Amendments drafted in FDA?
WG: Yes.
FL: With you involved?
WG: Yes. The whole thing started with the barbiturate and amphetamine bill and was expanded into the Drug Abuse Amendments. Then we had the Bureau of Drug Abuse Control. So that came into being after that law was passed. Then the whole thing was transferred to Justice.
FL: Now the Drug Abuse Amendments also included the . . . That was the statute which includes counterfeit drugs?
WG: That may have been a part of it, but counterfeit drugs was another problem with us. In the early days, Food and Drug didn't give much truck to counterfeit drugs. We considered that to be a competitive problem and a problem for the owners of the copyright to protect their property rights. What was involved was imitation in appearance, and if the drugs had essentially the same strength, we didn't really get involved. But at one stage, Larrick did become concerned about the widespread abuse--and that's when the first counterfeit drug provisions were put into the law.
FL: They also were drafted by FDA?
WG: Yes. Next you asked me about DMSO (Dimethylsulfoxide). This drug was, of course, a solvent, and readily available as a solvent for non-drug use around. We began to hear stories about it that I'm sure everyone else has heard, that people were having these remarkable recoveries from arthritis and other serious diseases by buying this product and painting it on themselves. One characteristic was, if you painted it on your skin, you could taste it in your mouth almost immediately, which convinced them that it was quite a drug to move through the body. We became interested in that, first as its being used as a commercial product for a drug with all the attendant risks that were involved there; and secondly, we were interested in if it was that good a solvent, did it have any potentiality for being combined with other drugs that would translocate those drugs from the point of intake to the point of need for the tissue of drug therapy.
We brought some actions based on seizing DMSO that was being offered by chiropractors and others who had been diverting it from industrial use. And then we ran into the problem of Dr. Jacob at the University of Oregon. Dr. Jacob was a very strong supporter of DMSO, and he had the credibility of the University of Oregon Medical School to that and gave it some semblance of scientific development.
We were not convinced that the drug was being handled as an investigational drug; indeed, we were convinced that it was being promoted way beyond any acceptable investigational use, and that Dr. Jacob was the one responsible for that. He was cited, and of course, that drew the Food and Drug in controversy with the university medical school. The case was very, very difficult to deal with. No criminal case, as far as I know, ever came out of that. But he was cited for diversion of the drug. He and his supporters made a lot of efforts to get legislation passed that would guarantee the continued use of that drug. We resisted that legislation and it was really never passed.
Next, the vitamins. The agency's experience with the vitamins goes back many, many years. Earlier in this discussion, I talked about the introduction of vitamins and minerals in flour and bread. That was a unique experience in using a common food item to increase the use of a nutrient that was health-oriented. The Vitamin B complex had been found to be involved in the prevention of pellagra, and that disease was fairly common in the southeastern part of the United States back in the '30s, but since that time has essentially disappeared, and there are no frank vitamin deficiencies in the United States. But as a result of the enrichment of flour and bread and the popularity that the vitamins got there, combined with a lot of enthusiasm for these products made available when we classified them as special dietary foods rather than as drugs, that made them available to a lot of outlets that otherwise wouldn't have had them. The sale of vitamins mushroomed beyond belief, and the first large reason for the growth was the adaptation of . . .
[Interruption]
WG: The adaptation of house-to-house direct selling sales combined with the pyramid-type method of distribution that was feeding that direct sales technique led to the first big confrontation we had with this problem. Mytinger and Casselberry was the firm involved. Mytinger was a sales-type person and Casselberry was a psychologist or the other way around. One of them was a psychologist and the other one was a salesman. They hit on the idea of creating this pyramid-type distribution pattern and selling a product they called Nutrilite, which was a combination of vitamins and minerals in a base of alfalfa, parsly, and watercress. They put those vegetables in there to make it unique from other products so that they would have a very special product. And they sold the material in strength and double strength at about $19, $20 a month. Now, that was back in the '50s and that was a good deal of money at that time.
But they were very, very successful, first as a result of a book which they wrote called How to Get Well and Stay Well which uses all the psychology techniques; that is, that everybody wants to be well, and if you're sick, first, it hurts, and second, it costs you money. Therefore you want to be well. And the way to get well and stay well is to feed your body right. And if you feed your body right, you take these vitamins and minerals. And if you do that, then you're not going to have these diseases. And if you have the diseases, the vitamins and minerals are going to restore the so-called balance in your body to where the disease can't exist in that kind of an environment. Well, you know the old spiel.
The agency was quite alert to the initial distribution of this product, and they had a citation of Mytinger and Casselberry in Los Angeles on the basis of their first book, How to Get Well and Stay Well. Now, it was a book that didn't pull any punches. That is, it went on and told you that if you had epilepsy or if you had heart disease, this was for you. It didn't make any ifs, ands, or buts about it. It had a lot of testimonials in it. One page had a list of all the diseases you could think of. All those, of course, were supposed to be amenable to Nutrilite Food Supplement.
When they were cited, they hired a lawyer in El Monte, California who was active in representing proprietary medicine people out there. He immediately recommended to them that they come in and say that they were going to rewrite the book, that they understood what the charges were and had no intentions of violating the law, and that they were going to rewrite it. Well, Food and Drug nonetheless went on with the citation, but meanwhile, they perfected the other book. First they had a 48-page book or something like that. And then they pulled out what they called the last part, which had the most exaggerated claims, and replaced that with what they called an epilogue. So they had three or four editions of the book.
After the citation and with the appearance of the new book, Mr. Murray, who was the regulatory person in Food Division, or in the Bureau of Enforcement, I guess they called it then, began citing them right and left for multiple seizures, and began to make seizures. We made some seizures, and his plan was to make enough seizures to where they would have to either do something about the thing, correct the violation, or go to trial. He thought that they were simply dodging. Well, instead of that, they filed suit against the agency for these multiple seizures, and to enjoin FDA from making multiple seizures claiming that they were proceeding in good faith and that the agency was harrassing them and making these seizures to run them out of business before they could have any chance to make the necessary corrections.
They were represented by a lawyer named Charlie Rhyne, who was and, is a prominent Washington lawyer, and was a good lawyer. They sued us for an injunction, and they got a judge over in the district court, Judge Goldsborough, who was very much against Food and Drug to start with. So he issued a temporary restraining order. Then we had a trial. We lost very, very badly, because Goldsborough was adamantly against us, and all he did was adopt Charlie Rhyne's findings verbatim, and that really made it tough on us.
But what I learned in this case was the way people looked at vitamins somewhat differently from other products. We had a physician from Cincinnati Medical School who had written on this subject in the medical journals. His evaluation of it, which I think is right, was that Americans want to believe in tonics; they always have believed in tonics. And the vitamins should be considered as a tonic and are considered as a tonic because they're non-toxic and they're readily available, and if people feel like if they take them, they're doing them some good, whether or not they are, then they really weren't doing an awful lot of harm. And that has made it hard on us on regulating vitamins all the way through.
After that trial that we lost in the district court before a three-judge court--this was a suit to enjoin the enforcement of the law claiming that the multiple seizures were unconstitutional--we then went to the Supreme Court twice. First, we went up before the trial for a writ of prohibition alleging that the three-judge court had no jurisdiction. Although the Supreme Court accepted that case for argument, we lost almost the very first day. I mean, we had the argument one afternoon and got word the next day that we'd lost.
So we had to go to trial, and at the trial, the three-judge court took every slant possible against us, and every piece of evidence that was interpretable any other way, they interpreted it against us. They interpreted things that Crawford, Larrick, and Dunbar had all arbitrarily made these judgments without listening to the facts, and that Murray had a sinister motive in trying to put them out of business and so forth. So we lost.
We then appealed to the Supreme Court both on the jurisdictional grounds which we'd previously lost, and second on the factual matter that these findings had absolutely no support whatever in the record, that they were made up out of whole cloth, and that they should be reversed. Well, it would have been in our interest, I think, if the Supreme Court had gone into that. But they decided this time that the court had no jurisdiction. Now Justice Douglas who had dissented when we went up the first time--we lost 8-1--was the majority judge this time. So we won in that case despite having taken a hell of a beating on the facts in the trial court.
After that, we pursued the investigation of Mytinger and Casselberry. We were able to prove in two ways, one of which was through recordings like this that were put in people's houses just to hear what the house-to-house sellers were saying . . . And they were going wild; they were making every kind of a claim you could possibly make. We knew that was so, and Mytinger and Casselberry denied it under oath and on their word to God that it wasn't happening, but we knew it was. So we did a lot of recordings. We entered people into the sales organization. You know, any pyramid thing like that will take anybody and everybody. In order to make those sales systems work, you've got to have quite a cheerleading operation going on. So they ran a Nutrilite News and they ran a lot of meetings at which they had these inspirational speakers and a lot of prizes. The way you'd make money in that, of course, as in any pyramid, is you would make money not only on what you did, but on the business that the people you sponsored did, and you would become a key representative.
After that was done, after the case was reversed by the Supreme Court, we entered into an injunction with Mytinger and Casselberry which curtailed essentially all those things, but for the first time made us recognize that there were certain claims that were being made and could be made for vitamins that we had to accept, notwithstanding we understood that that was going to be probably misused in the direct selling. That was the flaw in that case, in the final settlement. I believe, though, that the pyramid thing died and that the thing has never been the success that it was at one time. There were a lot of other people that were coming into this direct selling, following the example of Mytinger and Casselberry, and Food and Drug developed out of that its so-called quackery program that Milstead has talked about with you in terms of the various people that were going into these schemes and how they were doing it.
At that time it generated in my mind, and several years later, having lost the case involving dextra-sugar in which vitamins were added, and having problems with the vitamin mineral soda water and other things, I hit on the idea of trying to have a standard for dietary food supplements, and to make the dietary food supplements that had the vitamins in it reasonably complete in all vitamins for which there was any reasonable likelihood that supplementation would have any benefit, and then make all others that were not in that category either irrational supplements, because they were not complete, or drugs, and make them have adequate directions for use.
We had a hearing on that and the biggest problem was we wanted a requirement put on the label that most Americans didn't need this; they could get all the vitamins and minerals from foods and they don't really need it, which was a truthful statement. The hearing went okay and we were able to go ahead with the standard, but the legislature intervened, and through Senator Proxmire and others, put in a statute that took jurisdiction away from us on that. So the vitamins are being terribly abused still, but as a tonic, and I guess that's something that we'll have to learn to live with in spite of the fact that from an economic standpoint, it's a very substantial fraud and a very substantial taking of resources from health budget that could very well be put to better use than some other things.
FL: That legislation, too, was engendered by a massive propaganda campaign by the health industry.
WG: Right. Well, it was started by Clint Miller's outfit. It was a group sponsored by people that were in this area of quackery, and they promoted letter-writing to people who were interested in these tonics, and they flooded the legislature with the proposals to deprive us of jurisdiction. Proxmire got onto it and was adamant about it and put the thing through. There was nothing we could really do to resist it.
FL: Wasn't their attorney, Charles Rhyne, very prominent later?
WG: He was president of the American Bar Association.
FL: Yes, that was my recollection, that he was well-connected politically.
WG: He was a roommate of Richard Nixon at Duke University and very well hooked up with Richard Nixon. And in addition to that, he was active in the American Bar Association and became president. He was a good lawyer, and he did lick us in a big way in the district court. He fortunately had three judges that were really awful from our standpoint. Bennett Champ Clark has been one of our major opponents when the bill was going through Congress; Goldsborough was a long-time Eastern shore Maryland judge that kicked us around all through the years; and Eddie Tamm was just an ex-FBIer and thought the agency had misbehaved.
FL: I always thought, though, that the speed with which we got the review in the Supreme Court was remarkable.
WG: Well, it was. And more remarkable is that we failed there and won on the same grounds when it was heard completely on the merits soon after that. But you've got to expect that. Anything that goes up to the Supreme Court on an extraordinary, expedited appeal basis is likely to be thought out, bounced back, and reserved for another day when they have more time to do it, and you might win the second time around, which we did.
FL: I guess because the attorney general was one of the defendants in the injunction. That probably helped expedite it.
WG: Yes. You asked me about the Abbott and toilet goods cases that led to the current situation with suits against the agency early on as programs are being developed. Historically, all through my early years here, it was a matter of well-recognized law that a person couldn't sue to enjoin a prospective enforcement action. It was premature, and the courts just wouldn't take jurisdiction over that. This is a principle that had very few exceptions. We were sued several times, you'll remember, over artificially colored poppy seed, Elko Products against McNutt. We won that on jurisdictional grounds. We lost an old case, National Remedy against Hyde, way back under the original act, where multiple seizures had been initiated after the government had lost its first case. That was a case of deemed arbitrary action. We thought that was a kind of a legal sport--by that I mean one of a kind. But through the years, we had always been baffled about the difference between 701(a) regulations and 701(e) regulations. The former regulations were promulgated after a formal rule-making and after a hearing. The question of whether they had binding force and effect of law was one of those obscure things, because if you looked into the legislative history, it looked like the people up on the Hill were saying that even after you went through that formal procedure, there'd still be a chance to contest the regulations when it was put into force in the district court. But we took the view right along that those regulations promulgated through the formal procedures would have force and effect of law.
About the time that the toilet goods and Abbott cases were decided, the swing in administrative law tended toward making a difference in these rules. That is, the conventional wisdom up to that time was that if the agency issued an order under its general rule-making authority, that that would be entitled to persuasive effect, but not binding on the court. The court could reverse that if they concluded that it was wrong or was arbitrary--anyhow, was subject to de novo review when it became a factor in enforcement.
But there were two cases primarily coming out--one from the Federal Power Commission and one from the Federal Communications Commission--that led me to believe that that part of the law was changing. One of them, the Federal Power Commission, put out some rules on accounting applicable to natural gas which disallowed automatic escalation for increased costs and gathering costs. In other words, they put in a rule that when the gas pipeline came in for a rate increase, it couldn't automatically take advantage of an escalation in a contract it had with one of the suppliers who were beyond their jurisdiction. And the court held in that case that that rule, having been promulgated after notice and opportunity for comment, had the force and effect of law and was binding.
About that same time, the Federal Communications Commission put out a rule that no company could have more than six television stations. That was the limit. If you had six, you couldn't apply for another one no matter how good you were, how much money you had, or where it was. Six was the limit, and that's all you were going to get. And the Supreme Court upheld that, holding that that was a reasonable thing to do.
So when the drug amendments were passed and the color amendments were passed, we put out some what we called interpretive rules, 701(a) rules. We put them out after opportunity of comment. One of them was--and it's the one involved in Abbott--that wherever a trade name of a drug was used, the generic name would have to be presented in half size in immediate conjunction with that. And that's pretty clearly what Kefauver had in mind. It says in the legislation that wherever the trade name appears, the generic name and so forth. And we said that wherever means everywhere. That was the bone of contention. They contended that the rule was that it didn't have to be everywhere, that it had to be in such conjunction with the trade name that would be noticeable, and it wasn't necessary to do it every time.
Well, our regulation was challenged by them, and in the district court in Delaware, we lost. And we appealed. And in the court of appeals in Philadelphia, they agreed with us that the regulation was an interpretive regulation and didn't have binding effect and would not be subject to injunction prior to enforcement. If we tried to enforce that against a piece of literature, then the company could challenge that. In arguing this case in Wilmington before the judge, he said to me, "You adopted this as a binding rule, and you have every intention to enforce it?" I said, "Yes, that's true." And he says, "Sounds like it has the force and effect of law." I said, "Judge, if you'll rule that, I'll take my hat, leave, thank you, and be satisfied with it." Well, he then hemmed and hawed, and so did the other side. That was a case which I had nothing to lose. If I got a ruling that the 701(a) rules were binding force and effect of law, it was beyond my wildest dream. And so, having said that to the judge--and Judge Gesell was their lawyer again--they about flipped that I would say that. But anyhow, he ruled against me, and didn't touch that issue.
It went up to the court of appeals. The solicitor general was Archibald Cox, who you may remember was the one fired in the Watergate episode. He was a teacher of administrative law at Harvard Law School, and went by the conventional wisdom that we did. And when we recommended the appeal, he said, "Well, I agree with you. That interpretive regulation is subject to these other things, and they have to be challenged in the enforcement." So we appealed and we won there. As a matter of fact, when I argued that case in the court of appeals, I said to him first, "I'm going to argue this case in a kind of a backward way. First, I'm going to argue the merits of the regulation because I think we're clearly right on that, that this is what the law says, this is what it requires, and therefore it's valid no matter how you look at it. Second, I said, that will make it much easier for you to decide the jurisdictional issue. You won't feel like you've let me get off the hook on a jurisdictional issue where I had no merit to my case." So we argued that way, and sure enough, they went with me on the jurisdiction. That agreed with Cox.
Then it went to the Supreme Court, and we argued all these issues: rightness, eminent threat--all the things that would make for those early resolutions. Again, we really had more to win by that by making those regulations a binding regulation than we had to lose. You know, it wouldn't really help us much to open the rules up for challenge at some undefined time, when we could get it all settled and have it as force and effect of law. So I consider the Abbott and toilet goods case, which was on the same principle, as cases that gave us a very strong leg up on making our general regulations have force and effect of law. And as things turned out later, that, of course, has been an important development in administration of the law. And that's how that came about.
FL: By losing, we really won.
WG: By losing, we won. And we knew that from the start and said that to the district judge. That's the way we argued it in the district court. [Laughter] So it didn't come as a great surprise to us.
You asked me about turning the files over to Turner and the other Nader people who came in. The public affairs situation was such at that time as a result of Nader's expose of laziness and poor actions over at Federal Trade Commission, that you really couldn't deny them access to anything without it being implied that you were a bad bureaucrat. So a judgment was made to tell them what we had. I mean, I don't think we really lost anything much by that. Turner's book may have been the thing that saved us. It was so bad, had so many mistakes in it, that it was a joke. We wrote a critique of the book and sent that out, and the book never amounted to anything because of that. You know, he just jumped to all kinds of wild conclusions and cited all kinds of half-truths. That didn't hurt us.
Now, this Mark Green, who's running for Senator in New York now, was one of the investigators who came in. Mark was a bright guy then, and he is now. And he was focusing in on how we were enforcing the new drug and the advertising regulations. He had talked with McCleary, and he knew where those records were of a justice turning down some of the early advertising cases. That's what he was interested in. He was trying to show that somebody or other had let these drug companies off when we had an airtight case against them. It really wasn't quite that simple, so he never did very much with it. But that's why we let him have it. Larrick was under a lot of pressure then, and he was trying to dispel the idea that he was trying to hide something. I felt like, "The hell with it; let them see it."
The way I felt about it, I wouldn't say anything inside here that I wouldn't be willing for people to see. I just don't think we do business like that, and sometimes you'd rather they wouldn't see anything that would tip off something in a case or something like that, or if you've got a going argument about some policy that hasn't been settled. But once it's settled, I don't see any problem with where people were and what the arguments were. I mean, it was all done as far as I was concerned out here; it was all done above board and with no sinister motives. I mean, some of us were more adamant than the others, and some of us were more pressureful than others. But that's why I didn't think there was any great problem there.
FL: At the same time, Agriculture took entirely the opposite tact and . . .
WG: And they've never recovered from it. The implication was that they were an old-line, FTC-type operation and that they were trying to hide something. And they weren't trying to hide anything. And the meat inspection people have never recovered from that.
One of two other items that Fred was interested in was how we got into various cases that ended up by giving us expanded inspectional authority into what were essentially local operations. Of course, with the amendment of the seizure provision after losing Phelps-Dodge, and with the broad scope of a seizure then being the equivalent of the criminal authority under the original act, particularly as amended to cover adulterations as well as misbrandings which occurred while the products were held for sale, those provisions themselves were what expanded our authority, and the upholding of that in Sullivan was the most far-reaching decision that we ever had. That is, it gave the agency the authority to follow a prescription drug down to a package or lack of a package in the hands of the individual user. Now, that is the principle on which all that expanded authority went. The reason we had to get into that is that that was the point of diversion of the drugs, and that was what was causing the difficulty.
In the food field, the Pinocchio Oil case and the Allbrook Frozen Foods cases were cases where the raw material was of interstate origin, and the end product was locally produced. All we were saying there was that if the adulterated raw materials in these frozen strawberries was converted or transformed from a fresh to a frozen product, that didn't do away with our jurisdiction to follow those berries into the food. And that's what the court held. In the case of Pinocchio, the situation was somewhat different. Those were products properly labeled in interstate commerce, and then commingled locally to make a product that was labeled as a major olive oil which had no olive oil. That case, in a sense, is somewhat broader than Allbrook, by dealing with a purely local step that resulted in misbrandings, as against Allbrook, which was a purely local step just changing the physical form of an adulterated product that had been in interstate commerce.
FL: The reason I was interested was that I remember some early cases soon after the first years of the '38 Act where field recommendations for action under circumstances like that were disapproved, and they seemed to be following the old, original packages doctrine.
WG: That's true. The Food and Drug Administration in 1938, and for several years after that, really wasn't all that sophisticated about interstate commerce and how far they could go, and neither were many other federal agencies. I mean, the Supreme Court itself had not really been long since in deciding where the limits of interstate commerce were. Remember the Schechter Chicken case and the other cases there all had thrown some kind of question on it. The original package doctrine was, of course, an old myth or an old arbitrary rule to try to draw a line between where interstate commerce stopped and where it didn't. So there was a lot of feeling in Food and Drug about that. But in terms of the legislation, it had nothing about that; indeed, it had a definition of interstate commerce that was as broad as any possibly could be. That's what led us into these later developments. That, combined with the "held for sale" idea. Again, that was Charlie's idea. He developed that "held for sale" after his shipment in interstate commerce idea on the criminal part, and then didn't put it into the seizure, and we later had to put it into the seizure.
Ron asked me about the GMP (Good Manufacturing Practices) regulations for foods. We didn't have them for a long, long time. We brought a case once involving the Smith Canning Company, which you may remember. Smith Canning Company was a part-time operation out in Utah. By that I mean Smith Canning had this cannery, and the local growers grew the tomatoes around there, and they brought in wetback-type workers to work during the season there, peeling and processing the tomatoes. Then the cannery would close down. I guess it would be open maybe a couple of months during the tomato season.
The conditions at that plant were quite bad; I mean, they were terrible. [Laughter] It was an old, open-air operation out in countryside Utah. In the hot summertime, you had all the problems of that kind of an operation. Not only that, the temporary workers were living around there in camps, and they lived in the most despicable unsanitary conditions that you could think of. They used an old bus for a latrine, and it was open to flies going back and forth. So the conditions were really reprehensible.
We brought a seizure against it. Smith was a very prominent Mormon and later became president of the National Canners Association. So they contested, and they had a state inspector who testified against us in the case. In sum and substance, the case got down to a difference of what our inspector said about it and what he said about it. And the court ruled against us. In terms of deciding that case, the court said that there weren't any provisions for screens, and there weren't any other . . . So the court didn't know what would be better and what would not, and he suggested that the agency would be much more likely to receive the support of the court if we first had regulations which specified what . . . Well, that was an open invitation to us.
But Milstead was in that regulatory staff at the time, and I talked with him about general regulations. He demurred; he thought that there were too many different conditions and different types of operation where it wouldn't be possible to develop GMPs. Well, when we finally did it, we had the Smith dictum to go back on, and it turned out they were a good deal easier to do than we thought. They were just rudimentary things like clean water, and screens, and things like that. So that's where the GMP rules originated, and that's why we took the view that we could adopt them as implementation for a(4) as specifying what would be sanitary conditions as a minimum.
RO: To begin with, we were going to have the general regulations, but later they were going to go back and make specific recommendations.
WG: Well, they abandoned that because it was too much like work. You know, that was following up with what Milstead had said, that there were a lot of individual conditions. But when we got to looking at that, that was more like going into a project that had no end and no real outcome to it, and the best we could do was leave that case by case, and add on those GMPs for the basic rudiments of sanitary conditions.
FL: Even without regulations of that sort, we did, in selecting those cases we went to court with, take into consideration what good manufacturing practices were.
WG: Right, and that was the rule, that either that case or the other case on the seizure said that they were more likely to equate the conditions to the average conditions than . . . Well, that was right down our alley. You know, we knew what the average conditions were better than anybody on earth, and anybody we were going after was a hell of a lot below average. So that was our meat, too. So that part of the opinion didn't bother me at all.
You wanted me to say something about CPEHS (Consumer Protection and Environmental Health Service). Back just before Nixon came into the presidency, as I remember the timing. I'm not sure; do you know the years on that?
FL: Yes. At least, from what I know, in April of 1968 at a meeting that I went to in . . .
WG: Right. That would be when Nixon came in, after Johnson.
FL: No, it was before his election.
WG: That's right, it was just before that.
FL: Yes, that's right.
WG: Okay, that's what I'm talking about. Just before Nixon was elected in the late years of Johnson, I guess, Wilbur Cohen was assistant secretary, and there was a great upheaval on environmental stuff. You know, the Clean Air Act was passed in 1970, and the whole department was kind of gung-ho on environmental things, and consumer activities were very much in the news. About that time, we had had Hazardous Substances Labeling Acts and other consumer acts. So Wilbur hit upon the idea that we should have a consumer protection unit in the Public Health Service, that is, that they had a quarantine, they had a clinical, and they should have a consumer and environmental health protection agency. So he created that. He put in charge of it C. C. Johnson who was a PHS sanitary engineer, a black man. He had risen high in the PHS organization as a sanitary engineer, and was very well thought of. So Wilbur picked him to head the agency. He put in the agency Food and Drug; the Air Pollution Control Administration, which was part of PHS; the Drinking Water operation in PHS . . .
FL: Solid Wastes?
WG: Solid Wastes.
FL: Pesticides?
WG: No, Pesticide was Food and Drug. He put us in there. Let me see. There were one or two others from various parts of PHS.
FL: Radiological Health.
WG: Radiological Health is what I was trying to think of. We were based out here at the Rock. I think all of the agencies were either here or over on Twinbrook, which is fairly close to here. C. C. Johnson had the role of being the head of that agency. Well, he could never quite really get control over those independent people. They had been independent too long. John Middleton, who was the Air guy, and Herb Ley, who was Food and Drug, and the others just simply took it as a necessary evil and never did give full support to it.
Well, it didn't last all that long--I think about a couple of years--and when the new administration came in, one of the first things that Charlie Edwards and the other people did was to take Food and Drug out of CPEHS, and CPEHS very soon died. That is, the Air program and the Solid Waste went to EPA, and the CPEHS died a natural death as a result of that. But it never did really become very functional or very operational.
C. C. [Johnson] tried, but he wasn't a line man; he didn't really have any line authority. All he could do was by persuading these people that really had the authority to send everything up through him, and that way he would have a say as it went to the Secretary's office. Now, that may have been the start of taking away from Food and Drug the authority I got for them a long, long time ago to issue regulations without having to go through the Secretary's office. I got that authority from either Folsom or maybe as far back as Ewing. Because they were looking at a lot of papers, primarily antibiotic papers; all the antibiotic regulations had to clear through there. And so, every time a new Secretary would come in, he'd get one of these damn antibiotic documents which were all graphs or parts of paragraphs that they couldn't make head or tail out of. He'd ring me up on the phone: "Come around and explain this thing." I said, "Geez, I can't explain the damn thing. It's an antibiotic laboratory procedure."
Anyhow, whichever one it was said, "I don't see any reason why I should see these things." And I said, "I don't see any reason why you should, either. I don't see any reason why you should see things like these records." For example, when the Willapoint case was through the administrative process, the record was long and involved, and the Secretary had to read that; he had to be prepared to make a judgment. Well, it took Ewing days. He was a lawyer, and he sat down with that thing and didn't do anything else for two or three days. So when he got through, he was inclined to go along. So I got them to put that regulation in that said Food and Drug would have the authority.
One of the considerations there was whether or not they should have a further provision on there that it be subject to approval by the Secretary. I said, "There's no use putting that in there. If you don't trust these guys to do the job and let them do it, then there's no reason to buck it up here automatically; you'll simply have to go through the review whether you need it or not. Why don't you put out a directive to them, and say, 'I've given you this authority. I want to be damn sure that anything that involves any policy thing is explained and alerted to me."' And I said, "That's really all that's needed." So they agreed.
It went that way until when Flemming got involved with the aminotriazole. He wondered why he hadn't seen some of these documents before, and I explained it to him. He then wanted to put in the same thing. I said, "You don't want to do that. It just invites a political intervention in things that are not political, and it doesn't assure you anything you can't get through proper management of these people that are employees of the Secretary and that won't respond. I know from having worked here a long time and knowing the people, if you tell them to do certain things, they're going to do it. And you can rely just as well on that." And I don't know why they haven't been able to put that across down there now. But anyhow, I had problems with it, but I was always able to hang onto that.
RO: Bill, were you chief counsel for CPEHS?
WG: Yes.
FL: Did you have any contact with Winton Rankin in that particular year before he made his speech to FDLI in which he invited the regulated industry to object to the FDA being submerged under CPEHS?
WG: Oh, I'm sure I talked to him a lot of times on it. I talked to Winton every day. I would never do anything like that because it didn't do any good. You've got to go to Wilbur Cohen or somebody who was responsible for the thing to get it . . .
FL: It cost Winton his career.
WG: Yes, well, you can't invite nonparticipants to go and raise hell with your boss on something that you can't convince him on. But CPEHS really never grew into anything, and it disintegrated when the Environmental Protection Agency got those authorities.
FL: Of course, Goddard expected to get that job that Johnson got, didn't he?
WG: I don't think so.
RO: I was going to ask whether it was coincidental that Goddard left almost the same day that we became a part of CPEHS?
WG: I don't know. I know Goddard got in trouble over that speech he made about marijuana. That was a funny thing, and he should have known better than that. Ted Cron kind of agitated him on that, that marijuana wasn't all that dangerous and people were going ape on it. So Goddard made that statement about his daughter and marijuana and his daughter and a martini several times around. I told him, "You're nuts to talk that way. That's not your concern; why the hell do you want to get involved in it?" But he did. Then he made the statement once out in some university--I forget where.
FL: Minneapolis.
WG: Minneapolis. Some stringer picked it up, and from there on, he had bad press. Up until that point, he had excellent press. And from that point, people began to question his judgment if he talked that way.
FL: Well, then the other statement about the demise of the corner drugstore being something that was probably going to happen was widely quoted and got him into further difficulty.
WG: He was an outspoken enough person to where he could make a lot of powerful enemies in the pharmaceutical industry. He called them a sick industry; I mean, he didn't pull any punches on any of that stuff.
Well, Fred, I think that pretty much covers what I've got to say. If you identify other areas that I might be able to contribute on, let me know. Ron wants me to talk about the role as general counsel, and about all I can say about that--I wouldn't want to be critical of what goes on down there. All I can say is what happened with me. When I first came here, and P. D. Cronin was the general solicitor in charge of the work, the Solicitor's Office was not very active in anything Food and Drug was doing because it didn't have any regulations that amounted to anything. They were having some cases in the courts. They were referred to the Department of Justice and handled by the Justice Department without any further intervention. So about all the office was doing was processing those cases and notices of judgment.
Well, that whole scope changed with the '38 Amendment. As I've indicated in the talk here, there was a large operation of administrative hearings with standards and with regulations and so forth which necessarily got them into that. So the role changed. Then, when we were transferred to Federal Security, Paul McNutt was the administrator of that and Fowler V. Harper was the general counsel They were both from Indiana and both very close friends. So McNutt began to rely on Fowler Harper in helping him understand and cope with a lot of these things, such as the corn sugar issue. So from that point on, the general counsel became more involved in dealing with the top.
Now, as long as you were in the Department of Agriculture, I guess you know that that is a hydra-headed, complex agency. If you deal there from Food and Drug over in the south building, when you went over to the north building, you were in some really different, foreign territory. Campbell dealt with Wallace and Tugwell, and Crawford did to some extent, but not anybody else much. Now, Mastin White did. He was brought in by those people to have a stronger say in the legal part. They had a weak general counsel, and Mastin did have a say there. But he didn't involve the division in direct operations.
We got involved in direct operations through working with Charlie (Crawford) on these administrative things. Then when we began to have court cases, it was clear to me that we were going to lose a lot of them if we didn't get out there and argue them ourselves. If we left that up to an assistant U. S. attorney to argue, it didn't do the briefs, and we were going to hurt for that. Because every time you lost a case, it was like losing an amendment to the law. That's something you had to live with a long time, and there was no way to get out of that, other than to get Congress to change it. So it became important to me to kick in there. So from the very first--the Cordell-Urbeteit cases were very early on, the Atlas case--we wrote all the briefs and argued all those cases. And then we became more and more involved with Food and Drug as these things have unfolded.
I've explained to you what I did in legislation and how I got there. That is, Charlie had handled it early on, and then I began to handle it through contacts he made for me through the House legislative counsel, and through the committee counsel. So we became involved with the legislation both as a persuasive matter with Charlie and as having experience working with the committees. So that's the court business and the legislative business and the administrative business.
Then the Division of Regulatory Management came in and they encouraged more and more assistant U. S. attorneys to request aid, so we came more into that. Then, as we got into cases like Hoxsey and Koch and Krebiozen, those became cases in which you had to be an actor; you couldn't just pass the cases over to the Department of Justice and expect anything good to happen. What happened wasn't all that good, but at least we had a going chance.
Now, we had a staff of about fifteen lawyers, I guess, when I first came back after World War II. That grew up to about thirty, maybe. Then, when the cutback came, we lost several, had some RIFs in our own . . . Some of the best lawyers we had--like Selma Levine and Les Uritz--we lost them. So we were cut back. Then we got to where we were handling a lot of business without all those protracted delays. As a matter of fact, I handled all the regulations that came through. I never farmed those out to anybody, unless there was really someone there to do it. I'd either approve them or buck them back with little buck slips saying this was what was wrong with it. So there wasn't any big delay there. Then I wrote all those beginning regulations, at least an outline of what needed to be in the food additive. And then between Rankin and Checci and myself and Wulfsberg and the others working on that, I would give them an outline of what needed to be done, then they would write them up, and then between the two of us, we would get up a draft and send that on up the process. That's the way it worked. So the number of people we had was smaller than they now have.
When Hutt came in, he brought in a lot more money and lot more people, but to keep them busy, they had to put in all these multiple reviews, and when they got involved with all that labeling business, that fell outside of any Food and Drugger's real interest. So they became the principal actors in that, I guess. I don't know anybody in Food and Drug that was very much interested in all those regulations and the freedom of information business like Hutt was. So that's why it changed that much.
FL: Well, in your time, too, you recognized that a lot of cases you did not have to be involved in, the regular, routine insanitation cases . . .
WG: You ought to have some judgment on when to get in and when not. That's what I'm talking about. I came to the conclusion that all those appeal cases had such a risk for it that we would argue every one of them and write the brief. If we were not going to argue it, we would insist on writing a brief, go sit down with the guy that was going to argue it, be damn sure he knew what he was doing, be sure he was prepared. But, sure, there were a lot of over-the-counter cases, sanitation cases--we wrote trial briefs, provided trial briefs for all that stuff. Just routinely, all the district would have all those briefs that outlined what the issues were; they could give it to the judge. So a lot of stuff was handled there without being individually tailored for each and every case.
[Interruption]
FL: Do you think we need to wind it up now?
WG: I don't have anything more in my notes, Fred, but after you go through the draft, if there's anything that needs clarification, let me know. Or if you find areas that we haven't covered that I could contribute on, I'll try my best. But I've probably told you more than I really know already. [Laughter]
FL: We would appreciate your sort of leaving the record open, Bill, because I'm sure that all of us, when we have a chance to look at the transcript, will think of things that might be embellished, or at other subjects that we might also discuss. Certainly this has been an enjoyable and informative session with you, and we greatly appreciate your taking the time to help us out for this project.
WG: Thank you Fred, it's a pleasure to work with Food and Drug again.
[Interview with William W. Goodrich: Part 1 | Part 2 | Part 3 | Part 4 ]
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