An Interview With Mr. George P. Larrick George P. Larrick devoted bis career to the Food and Drug Administration, becoming an inspector in 1922 and serving as Commissioner from 1954 until bis retirement in 1965. He was Associate Commissioner and Deputy Commissioner during the years of effort to secure legislation which became tbe Durham-Humphrey Amendment of 1951, with which this interview is concerned. Richard J. Hopkins, the interviewer, wrote bis master's thesis at Emory University on the background and enactment of this law. This is an oral history interview with Mr. George P. Larrick, former cODlllissioner of Food and Drugs. The interviewer is Richard Hopkins and the interview is being held in Marathon, Florida, January 12, 1968. The questions will be directed primarily to the Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act. Mr. H.: Mr. Larrick, could you briefly describe the background leading up to the 1948 definition of a prescription refill which changed the whole prescription policy? Mr. L.: During the commissionership of Dr. Paul B. Dunbar, it became in­ creasingly apparent that very valuable drugs when properly used, were being misused for non-medical purposes. Among these were the stimulant amphetamines, and the sedative barbiturates. At the convention of the National Association of Retail Druggists in October, 1948, Paul Dunbar enunciated the principle that drugs of this category should be sold only on prescription. He declared that the Food and Drug Administration would regard their sale for non-medical purposes as illegal. This principle was in­ corporated in regulations of the Food and Drug Administration. Subsequently, it was subjected to review in the courts in an historic case known as the Sullivan Case. One of these drugs 2 had been sold by the pharmacy without a prescription and the validity of the Food and Drug Administration's regulation was challenged. The case was tried in Georgia and the history­ making decision was rendered by Federal Judge T. Hoyt Davis. He had previously been a most capable United States attorney. He had been the prosecutor in a case where it was charged that the defendants had falsely represented "Warm Springs Crystals" as a treatment for disorders such as those experienced by President Franklin D. Roosevelt. Judge Davis was a student of the Pure Food and Drugs Law. The Sullivan Case was appealed to the Circuit Court and to the Supreme Court. There the princi­ ple of dividing drugs into those that could properly and safe­ ly be sold without a prescription and those that could not was upheld. The Department was not satisfied to deal with this growing problem exclusively on the basis of administrative rulings. It was thought that it would be wise to submit the whole question to the Congress so that their will could be ex­ pressed. Congressman Carl Durham of North Carolina and Senator Humphrey of Minnesota sponsored legislation to incorporate into the law the philosophy which was expressed in the Sullivan de­ cision. Congressional hearings were held. All manner of views were expressed. Finally, the legislative proposals, after amendments and careful consideration,were enacted. 3 Mr. H.: The Sullivan Case, which you spoke about, that had a peculiar aspect to it, too, didn't it••that the part of the question in­ volved was intrastate versus interstate commerce••that a federal regulation could cover only interstate movements of drugs? Mr. L.: One of the questions for decision was, "Where does interstate commerce and therefore Federal jurisdiction end?" The decision was that interstate conmerce carried through to the ultimate consumer. Mr. H.: Concerning food substances, I think another Georgia case brought about the norm in only something like six months after the Sulli­ van decision which incorporated that same idea that once it bad moved in interstate co1D1Rerce that then it was fair game for fed­ eral regulations. Mr. L.: I don't recall that case in detail, but broadly I think that's a fair statement of it. The Phelps-Dodge decision, of course, that involved food, bad pretty well destroyed the federal government's control over food once it got to the retail level. These two historic decisions restored the authority of the federal government. 4 I think that you, during the Congressional bearing, the House hearing, in 1951, in your testimony said that there was a good deal of disagreement among legal authorities conceming whether or not the federal government, and the Food and Drug Administra­ tion in particular, did have the authority to separated-rugs into prescription and over-the-counter categories merely by regulation, even taking into account the Sullivan decision. Could you explain F that a little bit more? Mr. L.: The Sullivan decision concerned itself with the particular set of circumstances that surrounded the coD&ercial transactions in that instance. The-drugs involved were so clearly inimicable to the public interest when sold without medical supervision that I think the sympathies of the courts were to protect the public health. Many drugs are extremely useful when properly prescribed. The same drugs may be detrimental to the individual who uses them for non-medical purposes. This was responsible for the decision to separate drugs into the two categories mentioned. The Depart­ ment decided that it would be good to have the Congress of the United States enunciate some broad, general principles upon which the industry could rely and the Food and Drug Administration could depend, in making the rules that would govern the determina• tion of whether a drug should be sold only on prescription or 5 whether it was safe for self-medication. Mr. H.: Shortly after the speech that Dr. Dunbar gave to the National Association of Retail Druggists in October of 1948, when be pro• nounced this idea of a prescription being a cancelled check once it bad been filled, Dr. Robert Fiscbelis, who at that time was the executive secretary of the APbA, charged in several articles in 1949 and 1950, even in 1951, that the Food and Drug Administration really wanted to control amphetamines and barbiturates; that the cases which the FDA had brought involved almost exclusively those two drugs or their derivatives; and that it was really sort of a power grab on the part of the FDA in definini dangerous drugs much more broadly than just "amphetamines" and "barbiturates". Do you think this was at all a valid assessment of the situation? Mr. L.: Well, since I was one of those who would have perhaps been ac­ cused of "power grab," I am not unprejudiced, but the times were changing rapidly. Drugs, previously, largely, bad been palliative drugs, rather than curative drugs. We bad a few curative drugs or drugs that suppressed symptoms to the point that they were prac- ., tically curative. We bad insulin, quinine aad some others. Scien- tific research, speeded by the war, entered the field of drugs. It produced substances that are useful in controlling or curing 6 disease but may be harmful, if misused. While Bob Fischelis' conments that we were using amphetamines and barbiturates pretty largely as a basis for the cases that were brought, the people in the Food and Drug Administration and their advisors saw in the present at that time, and particularly in the future, the develop­ ment of drugs which, if not restricted, would do great harm. That was why they tried to get ahead of the problem or at least to meet it by definitions that would give broad authority to deal with drugs that the ordinary layman couldn't possibly be expected to understand. Mr. H.1 Dr. Fischelis also criticized the FDA officials very, very, strongly, especially in late 1950 and 1951 when the split with the NARD came out into the open••tbe APbl•NARD split-- for announc• ing the refill policy in a speech to the NARD but never putting it into the form of a proposal for regulation in the Federal Register. And be, I think, said point blank a few times that this was just an evasion on the part of the FDA to get around any sort of court challenge to this policy which even, according to Fiscbelis, FDA officials doubted was valid. Once again, do you think this has any validity? Mr. L.: Well, of course, Dr. Dunbar •s commissioner at that time and he 7 made up his own mind as to what he would aay to the National Association of Retail Druggists. And I don't know all of tbe motivating factors that led to his decision. Having worked under him and with him for so many years, my conclusion would be he was invited to give this speech to an important pharmaceutical associa• tion group. He did have in mind some fundamental changes in the procedures of the Food and Drug Administration which would en­ force their activities mightily, and so he thought that the forth­ right thing to do was to tell them about it. He knew, of course, that the whole drug trade press and the daily press, for tm:t mat• ter, covered this association meeting with complete coverage, and I think that be deli~erately determined to enunciate this principle there to give them a chan•e to consider it and make any comment that they cared to. The regulations, as I recall it, were forth• coming at a later date and there was a very substantial period of time given for favorable or unfavorable comment. They were not promulgated until after the time had elapsed. Mr. H.: Are you referring to the APbA attempt in August of 1950 to get Secretary Ewing to issue a regulation? That's the only one that I recall. This is the only regulation which was issued which re­ ferred to the retail problem. 8 Mr. L.: Well, I can't recall dates. That goes back a long time, but I recall very vividly a conference that I had with Secretary Ewing. Mr. Goodrich was there and the General Counsel of the department and that bad to do with the regulations which roughly paralleled the later Durham-Humphrey Amendment. It is bard to remember. Mr. H.: I'd like to come back to that. I think maybe that was the meet­ ing in October of 1950 when Thurman Arnold and Walton Hamilton••- Mr. L.: No. Mr. H.: No? It wasn•t? Well, anyway, I'd like to come back to that meet­ ing a little bit later. I think you were there at that time. Mr. L.: Ob, I was. Mr. H.: I also wanted to ask you about the complete about-face which the NARD accomplished when the refill policy of the FDA was announced in October of 1948. The immediate reaction of the NARD and of the APhA was complete hostility, and the first Durham bill, as I 9 recall, was written so that the FDA would have been deprived of all jurisdiction over prescription refills and prescriptions themselves. But sometime at the end of 1949 or at the begit111ing of 1950, NARD officials did a complete about-face and apparently got together with officials of the FDA and wrote the first Dur­ ham-Humphrey Bill wjicb was introduced in June of 1950. Can you explain why NARD officials did do this--a complete about­ face from complete opposition to cooperation with the FDA on the bill? Mr. L.: In the beginning, in answer to this question, I think there was a very sincere desire by the leadership of the American Pharma­ ceutical Association and by the National Association of Retail Druggists and by tbe Food and Drug Administration to bring about a meeting of the minda of these groups so that legislation could go through the Congress with as little cont~oversy as possible. Historically, many groups oppose change and this certainly was the case when the Food and Drug Administration's proposals on Durham-Humphrey were introduced and made public. There were a number of meetings held between the American Pharmaceutical Association leadership, the National Association of Retail Drug­ gists leadership or their representatives, and the Food and Drug Administration. It became apparent that it would be most unlikely that there would be a complete meeting of minds. There were many 10 factors involved: the question of states' rights; what the federal government's function should be in regulation of retail sales; what the federal government should do and what they should leave to the states. I am very sure that there were developments between the two great representatives of retail pharmacy that we did not know about. As an opinion, I think that one man in the National Associa­ tion of Retail Druggists, who was basically a humanitarian, became convinced that the problem involved was one that did involve nec­ essarily federal control. That man was Herman Waller, and I think that be was responsible for persuading bis principals to go along with the essential principles of the Durham-Humphrey Bill as it was then pending before the Congress. Mr. H.: During the initial controversy over the retail opinion as Dr. Dunbar announced it, this was during 1949 that I am speaking about, Dr. Fischelis announced something called the Joint Conference Com­ mittee on Food, Drug, and Cosmetic Law Problem which was intended to include not only the American Pharmaceutical Association and its various constituent societies but also the NARD, and was intended to talk with FDA officials about various problems includ­ ing the recently-announced refill policy. Fischelis wrote up a meeting in August and he also mentioned one in November, but ap­ parently nothing very substantial happened at these meetings. 11 In other words, both parties agreed to disagree and it was some­ time after this that, according to you, Mr. Waller bad a change of opinion about the whole problem. Is this really the begin­ ning of the open split between the APbA and the NARD? Mr. L.: No, I wouldn't think so. In the first place, perhaps over­ simplification would permit us to say that the NARD had histori­ cally concerned itself primarily with the economic side of pharmacy and the American Pharmaceutical Association prided itself on dealing almost exclusively with the professional side of pharmacy. I find it very difficult to deal with these questions because, one, they're philosophical, rather than strictly factual, and also I'm an hon­ orary member of both groups. But I would think that the personal­ ities of the leadership of the two groups, with their rivalry for leadership of the whole profession was significant. The proposals of the Durham-Humphrey Bills really involve a number of fundamental questions in addition to the drug involvement. States' rights were included; the power of state boards of pharmacy; the individual professional rights of pharmacists. I do:not think that it is un­ usual to expect, under these circumstances, where pioneering new principles are being proposed to deal with matters as important to the public health as drugs were and are, would involve some funda­ mental differences of opinion. Certainly, as things developed, there was a basic cleavage between the NARD and the American 12 Pharmaceutical Association. Just what led the NARD to change its view and join with the Food and Drug Administration is speculative. As I said before, I think it was led by Herman Waller's conclusion that it was in the public interest. Mr. H.: You started to speak, I think, before about the personalities of the two leaders of the Associations. Would you feel free to comment on the possibility of a personality clash, as well as the clash of doctrine, being a factor in the complete split during the Durham-Humphrey controversy? Mr. L.: Well, I think personality clashes in men that are tremendously able leaders is commonplace. Certainly, John Dargavel was a strong man. He built the National Association of Retail Drug­ gists from a position of almost bankruptsy, I've been told, to a position of affluence and certainly of great influence. Dr. Fischelis, likewise, was a man of strong, vigorous personality, and I think that the two men had personalities that were not convivial. Mr. H.: The APhA and the National Drug Trade Conference••tbis was some• thing which I think you touched on a minute ago when you men• tioned the states• rights--the APhA and the National Drug Trade 13 Conference worked throughout the late 1940s to draw up a model pharmacy act, and a bill to pass on to the states to control amphetamines and barbiturates at the state-level rather than to create any sort of situation, as was in fact created, which would require federal control. Of course, 4uring the Durham­ Humphrey controversy, Dr. Fischelis and the APhA and most of the members of the National Drug Trade Conference continued to use this as an argument. In your opinion, was there any possibility that separate state regulation of these dangerous drugs could have been sufficiently close to bave protected the public health? Mr. L.: Well, this pea back a great many years. I would think basi­ cally that any replation that needs to be accomplished and can be accomplished at the level of control closest to the people is the most desirable. I was mildly unhappy to think of the retail pharmacist in some remote state who never would have access to the top administrators of the federal govern­ ment agency that determined what bis course of conduct should be and appraised what it was. If it could ban been done uni­ formly throughout the country by the states whereby administra­ tors are close to the problem, I think that would be better. But as it was and because of the urgency of the problem, it was just completely unfeasible. '.,As of today, I think that as much 14 of the problem as can be assumed of control at the state level, at the city level, at the county level, should be bad, and idealistically the federal government would just pick up where tbe states and cities leave off. Now as a practical matter, re­ gardless of the fact that increasingly the local authorities are taking over a greater proportion of this responsibility, I think the federal government will have to be in on it and will have to grow in it. Mr. H.: Something which I think is related to the struggle between those who wanted state regulation and local regulation as opposed to those who wanted federal regulation may have involved what some joumals in the late 1940s described as a drop in the status of pharmacy as a profession in the United States. There was talk that with the therapeutic or the pharmaceutical revolution, that is, with the major pharmaceutical houses producing pills rather than ingredients which the pharmacist would then compound into a medicine, that this was really pushing the pharmacist into the status of a pill-roller rather than a professional member of the medical team. First of all, do you think there was such a status revolution downward for the pharmacist? And do you think this played a significant part in the opposition of the APhA in parti­ cular to the Durham-Humphrey Amendment? Is that too complex a question? 15 Mr. L.: No. I think that those who saw a problem in the transition of the compounding of drugs from the corner drug store to the phar­ maceutical manufacturing plant were mistaken. I think that it was inevitable that as drugs became increasingly complex and as control procedures and legal techniques became so complicated, few if any retail drug stores could have the facilities to per­ form them. The transfer to the pharmaceutical house from the corner drug store of com.pounding drugs was inevitable and very much in the public interest. The same transition from the com­ pounding of drugs to the dispensing of previously prepared drugs brought about a situation where the average doctor cannot or could not possibly keep abreast of all of the indications, con­ traindications, dangers, hazards, dosages of these new drugs. I think that the professional pharmacist saw that and began to bring about this transition from compounding to dispensing in such a way that be would keep informed in bis mind and in bis files of the latest information dealing with all of these new drugs. Time has shown that the really professional pharmacist today is a person that the doctor calls to get the latest informa­ tion on pharmaceutical products. He can perform a more useful function with drugs that are life-saving and drugs that are cura­ tive than be possibly could by compounding a palliative for the ills that beset mankind. 16 Mr. H.: This brings up another point, too. I think you mentioned that NARD was more concerned with the individual retail drug store, the small retail drug stores, as it were. Dr. Fischelis, on the other band, throughout the controversy kept talking in terms of the cooperation and very close relationship between the physician and the pharmacist, which might seem to have some indication of a sort of a big city type of situation where you have a doctors' building with many doctors' offices and a medical pharmacy there. That is, one of the arguments Fischelis used was that the doctors usually bad an understanding with their pharmacists as to bow to handle prescription refills. Is this at all a valid point of view? In other words, could you say that the APbA and Dr. Fischelis really were representing the larger, more professional pharmacy practioner in the relationship to the large group of doctors rather than the corner druggist? Mr. L.: I would think that during the term of Dr. Fiscbelis' leadership of the American Pharmaceutical Association that their principal ties were with the academic side of pharmacy. They bad and have close ties with the pharmacy colleges. They put great stress on their participation with the undergraduates. Mr. H.: Who actually wrote the first Durham-Humphrey Bill, once the NARD 17 and the FDA minds had met on common ground? I'm thinking es­ pecially of the administrative listing provision which would have empowered the administrator of the act, that is, Adminis• trator Ewing in this particular case, to have listed those drugs which could be sold only on prescription, all the rest obviously being over-the-counter drugs. Was this the brain child of the FDA or was it something that Mr. Waller may have proposed, or how did it come about? Mr. L.: It was an evolutionary process. The originators of the idea were Crawford and his associates. Mr. H.: Are you implying here then that the FDA took the initiative in drawing up this bill and that the NARD merely sat in on the sessions and perhaps gave their approval? Mr. L.: I would say that Crawford was the most articulate draftsman and that he would be extremely patient and would take a suggestion from anybody that was in the conference and reduce it to writing and then make changes in it if and as the two groups agreed; but there was no fundamental difference. It was a matter of getting it down on paper and making sure that it didn't have an ambiguity that could make for trouble in the future. Each group, of course, 18 tried to be sure that the people they represented were not short-changed. Mr. H.: One of the prime arguments, if not the prime argument, that tbe NARD used in supporting tbe administrative listing provision of the bill was this situation of what I think they called mis­ leading, certainly confusing, labeling on the part of drug manu­ facturers where one manufacturer would take a drug which could be sold legally over-the-counter and either label it with the prescription legend or label it with such directions as "Take as directed by your doctor"-•by your physician--wbich contained neither the legend nor the adequate directions that the regula­ tions required. Was this really that much of a problem for the retail pharmacists of the period? Mr. L.: Yea, I would say it was a very serious problem because one drug that would--well, two brands of the same drug, one of them could legally be sold over-the-counter and the other couldn't, and there were chaotic conditions because of that difficulty. Mr. H.: In effect, then, what these various drug manufacturers were doing by using such labeling was, as far as regulation is concerned, pretty much daring the FDA to take every one of these separate 19 drugs to court in a separate case which, under the procedure, had to be done, and knowing full-well that the FDA couldn't possibly do that. Is that a fair statement? Mr. L.: I don.• t think it was general motivation of so many different firms, but I am very sure that there was a strong belief in the legal departments of many of the pharmaceutical houses that the construction that we had placed on the law was invalid. Some of them subscribed basically to the philosophy that the doctors should be given complete freedom in the prescription of drugs. They wanted to challenge the government's view that·· the drug should have either complete 4itections for use that the ordinary layman could follow with reasonable safety and reasonable assurance that it would do the things that the label claimed. Mr. H.: Yes. In late August of 1950 Dr. Fischelis and the other offi­ cials of the American Pharmaceutical Association engaged the firm of Thurman Arnold and Walton Hamilton, a firm of lawyers in Washington, to try to achieve a settlement of the retail con• troversy other than by legislation; and the device which the lawyers came up with was an attempt to force the Federal Security Administrator to issue a regulation which would detail the refill 20 policy of the Administration which then could be tested in court. Do you think that this basically wa• a sincere attempt to find a solution to the refill problem, or was it again part of the rivalry between the APbA and the NARD--remembering that at this period the NARD seemed to have the upper band because it was pushing the new bill? Mr. L.: I wouldn't attempt to diagnose the motivation behind that move. I think at that time that Dr. Fischelis was basically opposed to the extension of federal control and perhaps that was the motiva­ tion. Mr. H.: One possible outcome of this attempt of the APbA was a meeting ( of the NARD and the APbA and the various drug manufacturers with Congressman Durham in February, I think, of 1951, in which they attempte4 to reach some sort of compromise on the administrative listing provision. No compromise was reached. Was this largely because of the FDA's desire to have the drugs listed administra­ tively? Mr. L.: Representative Carl Durham wai himself a pharmacist and was very respected by both groups. And I think this was a genuine at• tempt on bis .,art to bring about a meeting of minds, but the 21 differences were so fundamental that that did not result. The Food and Drug Administration was very anxious to have included a provision that would give them the power under appropriate circumstances and with public hearings and other procedures to list the drug. But looking back on it and the way it has worked, particularly with the new drug provisions becoming increasingly significant in this whole picture, contrary to my view at that time, I don't think that made much difference. Mr. H.: After the House bearings in the early part of May, 1951, on the new Durham-Humphrey Bill which was slightly rewritten, with a mAjor change being the appeal procedure for anybody who objected -- to the listing of the drug, the trial de novo instead of the Administrative Procedures Act, which the federal court system had representatives at the bearings to virtually kill-•After these hearings, there was a good deal of lobbying going on, especially after the House committee reported the bill favorably when it appeared the bill didn't have that much of a chance to come out of committee. The very puzzling part of this whole picture is the sort of enigma of the American Medical Association throughout the whole discussion. The AMA Joumal, for example, said very little. I think there was only one article prior to the enact­ ment of the Durham-Humphrey Amendment, and that was merely a statement of the various positions of the drug manufacturers and 22 the pharmacy associations. On tbe other hand, tbe Council on Pharmacy and Chemistry of tbe AMA did have a meeting in Novem­ ber, 1950, and there was a new chairman of this council, Dr. Robert Stormont, who had gone to the council from the FDA. The rumors in the early part of 1951 were that the council had approved of the bill as it was presented to them, that is, approved of the administratiwe listing and of the efficacy standard. First of all, so far as you know, did the council approve of this? Mr. L.: I don't know whether they formally appro-.ed the bill or not. I do know that a number of individual members approved the bill and advocated it quite strongly. I don't know that these people were acquainted in complete detail with all of the provisions of the bill, but I'm very sure that many of them approved of the general principles that were sought to be enacted. Mr. H.: Various members of the•--excuse me. Mr. L.: I think, though, that Bob Stormont, even though he had been with us,pretty largely acted as a secretary rather than an advocate. He stayed in the background. At least he told me he did. 23 Mr. H.: Several congressmen at tbe House committee bearings expressed surprise that there was no member of tbe AMA, no representative of tbe AMA, wbo bad asked to give testimony at the House bear­ ings in May. In fact, it was not until about mid-June tbat tbe AMA's Legislative Conmittee decided to oppose the bill. Tbe reason that was given was tbat it was a long, involved process. As a matter of fact, I think tbat you gave this reason wben someone, one of tbe congressmen, asked you in the House com• mittee hearings. Was tbis, in fact, tbe case, or was tbe AMA really unsure of what it was trying to do? Mr. L.: No. I think that tbe mechanism of tbe AMA on a major piece of legislation is sucb tbat it has to go to a pretty important body-­ I've forgotten••House of Delegates, I believe, before anyone is empowered to speak for the AMA. I think that is what happened. Mr. H.: After the bill was reported out of coDDittee favorably as it was written, with some re-writing, to be sure, but with the major pro­ visions still intact-•tbat is, administrative listing, efficacy standard, and so fortb--tbe :Proprietary Association of America seems to bave taken tbe lead in trying to kill tbe bill in the House. Most observers, at that time, feeling that the committee 24 vote was so strong in favor of the bill, felt that there was little chance to head the bill off in the House of Representa­ tives--to change the administrative listing provision and the efficacy standard. Did the Proprietary Association lead this lobbying attempt to bead it off? Mr. L.: I think they were strongly opposed to the bill at that time. Whether they took the lead oi whether they didn't is difficult to determine because people who are influential before Congress don't always identify themselves very clearly. Mr. H.1 Once the American Medical Association had decided to oppose the bill, one of the trade joumals in the drug industry reported that the AMA and the lobbyists from the American Pharmaceutical Association worked very closely together in button-holing congress­ men and urging them to vote against the bill, to vote against the efficacy standard and the administrative listing provision, in the House floor debate. Can you give me any more details about what this lobbying was like? Mr. L.: In the first place, I think the American Pharmaceutical Association, as of that date, would insist that they had no lobbyist; they had no one registered. I don't know whether the American Medical 25 Association did or didn't. I know tbat botb of them were opposed to that provision of the bill and I suspect that when they were asked, they expressed that viewpoint quite volubly. Mr. H.: So what you are saying then is that, so far as you know, they did not make an active effort to go up to tbe Hill and make known their opposition to the bill. Mr. L.: That I don't know. Mr. H.: A good deal bas been written in the various histories of federal government about the lobbying done by federal agencies themselves on bills, such as in the 1930s, the Wheeler-Lee Act when the Fed­ eral Trade Commission tried to retain and, in fact, did retain, control over advertising in the drug field. In the 1951 instance, Durham-Humphrey, bow much lobbying did the FDA do? Mr. L.: "Lobbying"is a rather difficult term to define. The FDA from bottom to top is made up of civil servants, and lobbying in the sense--of the initiation of the contact by the agency is strictly prohibited. A great many congressmen would send for representa­ tives of the FDA, myself included, and anytime that they sent for 26 us to answer questions, we would go. During the pendancy of this legislation that you are interested in, there were many, many occasions when congressmen, senators, who were in sympa• thy with the viewpoint of the department would call up and ask for various of us to go up on the Hill and meet with them or meet with some of their collegues. When we got such a request, we would honor it and we would meticulously make a record of the meeting and turn it in to the department. Mr. H.: It seems to me, from reading the Congressional Record, that the strongest argument that the opposition to these two clauses in the bill, the efficacy standard and the listing provision, the strongest argument that the opponents to these clauses bad was the Truman Compulsary Health Insurance Plan and the fact that Oscar Ewing was Administrator of the Federal Security Agency and therefore, of the Food and Drug Act. And the hue and cry was "socialized medicine" and Mr. Ewing, during the House committee bearings had given ammunition to that by admitting that aspirin some day might be put on the list of prescription drugs by some administrator other than himself. Was there any substance to this charge of socialized medicine coming out of this bill, or was it merely demagoguery? Mr. L.: I think it was just a red herring. 27 Mr. H.: But an effective one? Mr. L.: Yes, quite effective. But it just slowed it down. It didn't kill it. Mr. H.: You're referring to the 1965 bill? Mr. L.: Right. Mr. H.: In which the efficacy standard was re-written into the law. Mr. L.1 That's right. There's one basic principle that runs through al­ most all advances in Food and Drug legislation and that's "catas­ trophe." You can take amendment after amendment from the early part of this century clear on through. The programs and the at­ tempts to get them go on and on. Then there comes a major catas­ trophe in the area of the controversy and the Congress and the people are galvanized into action and they pass the amendment. For example, the tbal$dimide episode was an important factor in the enactment of the Kefauver-Harris Amendment to which you just referred. 28 Mr. H.: Such as the Elixir Sulfanilamide disaster in 1938. Mr. L.: That's right--1937. That's a milepost in Food and Drug legisla­ tion and led to the inclusion at the last minute of the new drug provision. Mr. H.: A couple of final questions. First of all, in my researches on the bill, I used the F-D-C Reports, what's colllllOnly known as the "Pink Sheet," which comes out weekly, I think, in Washington, as a major source of information. Generally speaking, how ac­ curate is the "Pink Sheet?" Mr. L.: I'd say, generally speaking, it's very accurate. Mr. H.: Very accurate? So far as you can remember in this period it's very accurate? Mr. L.: Yes. There are, of course, bobbles, but I would say it's very accurate. Mr. H.: And, the second question is1 what is the significance of the 29 Durham-Humphrey Amendment in the subsequent enforcement of the laws in the United States? Mr. L.: I think it was very significant. The start was made in con­ trolling the sale of drugs without prescription. The first ef­ fect was a very general observance of its provision by the bulk of the ethical pharmacists of the country. Before that, you could walk in almost any drug store and buy practically any drug except those restricted by the Federal Narcotics Act. This amendment provided penalties for its violation. These were strictly enforced. I would say that in recent years, as the mis-use of LSD and other drugs has become more publicized, the problem is far from being solved. I think that for many reasons, tbe Durham-Humphrey Law is not an effective instrument to deal with these modern-day problems. But by and large, I think it was an advance. I'm personally unconvinced that by law alone you can solve the problems of the use of drugs for non-medical pur­ poses, particularly if there is widespread publicity about the effects of some of them, as there will be. Mr. H.: And I think you were also mentioning, while we were talking in­ formally, the new drug code of the Food and Drug Act which bas taken over more and more. Is that correct? 30 Mr. L.: Yes, the new drug section gives an opportunity to review the labeling of each drug and the requirement can be made or sug­ gested to the manufacturer that if be wants to sell this drug, be will bave to put it on prescription only. As far as I know, the manufacturers go along with that. Mr. H.: So that as the years have gone by and more and more new drugs, more effective drugs, have come onto the market and the older drugs have faded away, the Durham-Humphrey Amendment bas been less and less significant; is that correct? Mr. L.: Well, it is less and less significant until you come to things like the barbiturates and the amphetamines, which are old drugs, and then it's a tool that can be used along with the new drug section in charging offenses when LSD and the wide variety of things with similar physiological effects are used. 31 Index American Medical Association, 21-25 American Pharmaceutical Association, 5•13, 16, 19, 20, 24, 25 amphetamines, 1, 5, 6, 13, 30 Arnold, Tbunnan, a, 19 barbiturates, 1, 5, 6, 13, 30 Crawford, Charles, 17 Dargavel, John, 12 Davia, T. Hoyt, 2 Dunbar, Paul B., 1, 5, 6, 10 Durham, Carl, 2, 20 Durham-Humphrey bill, 2, 8•11, 13, 14, 16, 17, 21, 23-27, 29, 30 Elixir Sulfanilamide, 28 Ewing, Oscar R., 7, 8, 26 F•D-C Reports, 28 Federal Narcotics Act, 29 Federal Trade Coumission, 25 Fiscbelis, Robert, 5, 6, 10, 12, 13, 16, 19, 20 Goodrich, William, 8 Hamilton, Walton, 8, 17, 19 Humphrey, Hubert, 2 Kefauver-Harris Amendment, 27 LSD, 30 National Association of Retail Druggists, 1, 5-12, 16, 18, 20 National Drug Trade Conference, 10, 12, 13 32 Phelps-Dodge decision, 3 Proprietary Association, 23, 24 Stormont, Robert, 22 Sullivan case, 1-3 thalidomide, 27 Truman, Harry s., 26 Waller, Herman, 10, 11 Warm Springs Crystals case, 2 Wheeler-Lea Act, 25