FDA Oral History Program

Interview with Alexander M. Schmidt
Commissioner of Food and Drugs (1973 - 1976)
(Part 3)

Interview Topics:

Quackery, Laetrile
Vitamin and mineral
supplements
Patient package inserts,
National drug compendium
OTC Review,
DESI Review
Health claims on
food labels
Advisory committees
Dalkon Shield
NCTR, drug
postmarket surveillance
Predicted changes in FDA
Dangerous products
Friday afternoon crises
Science Advisory Board
Press relations

JY: You mentioned Peter Hutt. The kind of impression that I have is that he was a terribly important figure in a rather major shift that occurred. To wit, the nature of regulation within the agency. The lessening of court actions and the rise of the regulatory letter and the recall as techniques of regulation, seemed to me to be more related to him, in his position as general counsel, than to anybody else. Is this so? What did you think of him and his generating ideas while he was a very pivotal figure in the general counsel's office?

AS: Well, I think it's a little more complicated than that. A lot of people tend to oversimplify, I think, what was going on. The most simple way of putting it is that the agency with Billy Goodrich, as general counsel, and Sam Fine being an important person, and so on, was a cop agency. It was an enforcement agency. It enforced the law, and that was about it.

Now going back to some of the things I said earlier about the agency changing. The things that you mentioned are results of the change, but not the change. Charlie Edwards was brought in to change the agency. The cyclamate fiasco really shook HEW, shook FDA; it shook the establishment.

AS: Well, it was a fiasco for several reasons. Now I was not there, but I've talked to a lot of people about what happened, because it very clearly was a turning point in the life of FDA. And if I boil it all down to a pungent sauce and say, "What have I got left?," what it is is that the agency was faced with a modern kind of problem for the first time. The agency now is fairly sophisticated with dealing with residues of pesticides and so on, but that was sort of a first. The agency did not know what to do. And it floundered around. It thought of declaring peaches, or whatever it was, a drug for a while. Some really weird things that just demonstrated to everybody that FDA didn't know how to handle this. The commissioner didn't know how to handle it, and the secretary didn't. The thing became politicized. Of course, Finch, who was then secretary and lost this job over this and a few other things, also didn't know what to do. In a sense, the thing was bungled.

I believe that it shook people's confidence in FDA, and it made a lot of people take a look at FDA and say, "What kind of a beast is it and how should it behave and what should it be doing?" Charlie was brought in to move the agency into the twentieth century, so to speak. He was brought in to institute good management in the agency, put in modern people, modern science into the agency. In essence, to revamp the thing and to bring it into the modern world.

Now, one of the things that was an important question for the agency was, is the agency, by nature, an enforcement agency? Should everybody be wearing a badge and carrying a gun and putting people in jail? It's the old railroad question, what business are you in? If you're in the business of running railroads, in forty years you end up with Amtrak. If you're in the business of transportation, the railroads could be in the airline business, and all of that. And the question for FDA is, what business were they in? And Charlie asked that question. And the answer was not, we're in the business of putting people in jail. The answer to the question of what business is FDA in is, it's a public safety agency. It's insuring safe and effective products on the market. It's not like the FTC; it's not economic regulation. What it is to assure safe and effective drugs, safe and nutritious, clean food supply, and so on.

Now, the question then becomes, what is the most effective, efficient way of insuring safe and effective products. And Charlie's answer was, and a lot of people's answer was, that there were ways other than sticking people in jail. Education, for example. Voluntary compliance with guidelines and with standards, for example. An enlightened, educated society doesn't need to be stuck in jail to do certain things.

Charlie revamped the administration of the agency and was looking for more effective ways of accomplishing the business of the agency, which was to ensure safe and effective products. Charlie brought Peter Hutt into the agency because Peter was a superb expert in administrative law and was capable of doing what Charlie and others, and subsequently I, felt were good things to do. So that the lessening of the putting people in jail--and the increase of the education and the administrative remedies--was a deliberate policy that found in Peter Hutt a superb executor, if you like, of that policy.

The most important thing that happened at FDA while I was there was that I sensed what Charlie and Peter and others thought should be done at the agency and had started to do: the OTC Review, the re-write of all the administrative regulations of the agency, the revamping of the administration and management of the agency. Charlie had set a course and had initiated a number of things. It was clear to me that my job, since I agreed with the directions that they were going was to then take the FDA ship across the sea.

What I think I did of significance to the agency was, number one, to establish the policy board and to have it work; number two, to work with Peter and give Peter the rein and support and, from time to time, the instruction and so on to have him and his enthusiastic and talented colleagues in the counsel's office do what they did to revamp the administration of the agency. Third, I think that my management style for that agency at that time was a happy style. I've had many people, in and outside the agency, describe things that they will remember all of their lives. That had to do with a more collegial style. I've been both accused of and told and complimented concerning the fact that I ran the agency the way those people conceived a university should be run--that is, in a truly collegial style, which is what the policy board was. That was management by consensus of the people who ran the organization, and they loved it.

Somebody, Jake Barkdoll, described it to me once by saying, "When you came . . ." You know, Charlie was a get-it-done type. He was a centralizer and he ran things tightly out of his office. He used personal assistants, and he liked to set up task forces reporting to him. That was a very effective way to change the agency and to shake it up and to get things started. But it was a difficult thing to have over the long haul, because it excluded important people in the agency. And he said, "When you came, there were all kinds of people leaning up against the door with their ear pressed to the door trying to hear what was going on in the inner sanctum. You came and opened the door, and we all tumbled into the room and were embarrassed and surprised and didn't know how to behave. You taught us how to behave with the policy board and we were able then to get going and do the things that we did." These included the colossal changes of the administrative regulations and the re-looking at all of the ways we coerced industry into doing what they should do.

The medical device area, of course, had been a big mess and there had been several attempts at getting medical device legislation written and through. Again, largely due to Peter's superb administrative talents, but also due to the contributions of Paul Rogers and his staff and others, and in the face of all of the changes we were making in the internal workings of FDA, we also got the medical device legislation through, which was, you know, a very large task.

I view these things as the major accomplishments of the agency while I was there. It was in this realm, and to this day, the agency is still working, including the policy board, in the way that I set it up to work, which was not the way Charlie was working it.

JY: That clarifies a lot, also makes me think of a dozen subsidiary questions. One, once I argued before the policy board that what had happened applied to reputable industry, but the ending of the cops-and-robbers approach didn't apply so well to hard-core quackery, which was growing. Using the cops-and-robbers approach toward hard-core quackery might be required in order to stop the new wave, since, on the whole, not too much had been done during the decade of the seventies with regard to that since these other problems were requiring attention and energy. That related, to some extent, to Laetrile, which began to grow during your period.

Crout said, at one point, that it was growing so fast that it was really a jeopardy to the agency and he'd almost rather have Congress pass a law, if the pressure got high enough, to exempt Laetrile. Sort of what they did with saccharin--if that were necessary to save the agency in its basic mission against the kind of retrogressive legislation across the board that might have come in the wake of Laetrile as, in a sense, it did come with that other bill of 1976, the vitamin amendments.

AS: Well, I would make several comments. One is that quackery is something that will always be with us, number one. I remember once quoting H. L. Mencken, who said that quacks should be left alone, that they provided a valuable service by ridding the world of people without good sense. I was being facetious, but I was also telling some of the people in the agency who wanted to devote immense resources of the agency to stamping out quackery, that, in my judgment, what the agency needed to do was to use judgment. If there was something that obviously should be stamped out, then the agency should stamp it out, but not try to eradicate quackery. I kind of took an Old Testament view toward that subject, that it will always be with us and the agency would be foolish to devote more than a reasonable amount to quackery. Yet, while I was there, we kept going after some of the more gross violators in the health food business. We took a number of actions in that area. The Q-Meter . . . Well, we were after the Rodales and some of the more fraudulent aspects of the health food industry.

AS: Oh yes. Some of the black boxes with bells and whistles that flashed, we went after.

JY: Do you think that the old-fashioned court action criminal procedures were sometimes needed in that area, because of the recalcitrance of the quacks? You couldn't persuade them to be good boys by the more gentle regulatory approaches.

AS: Well, I'll remind you that, much more when I was there than now, there were the Sam Fines and others of the agency who not only reminded me, but persuaded me of the importance of the iron fist in the educator's glove. And there is a criminal statute and there are criminals. I had no problem at all with putting people in jail who belonged there. I had a lot of trouble, though, with the way the agency was approaching some of its routine things, which was, to a degree, a little too much like the bullying cop and not like the educator. But I'll remind you that we sent material having to do with Searle pharmaceutical to justice for evaluation for criminal prosecution of people at Searle. We were not reluctant to use the firm approach where it was warranted.

The problem with quackery is that there is just too much of it to go against all of it. You could burn every dollar of the agency's resources going against quackery and not eradicate quackery, because it relates to a very basic human need, which is for hope. The reason that quackery still exists is exactly that, that no one ever wants to be without hope. So that if someone is told that they have cancer and there is not an effective treatment, people will seek for anything that stands any chance, however remote, of helping them. And bang, you're into Laetrile and you're into Krebiozen. And remember that the University of Illinois was the home of Krebiozen, and Pat Ward and I know a lot about that.

The issue isn't so much quackery, in a sense, as it is, did the agency turn soft? Did the agency quit enforcing the law? Some hard-liners viewed attempts at educating industry, attempts at the voluntary compliance programs, viewed FDA's having industry itself set standards as being a sell-out to industry, as being soft on industry. I heartily disagreed with that.

JY: Just one more on the quackery front. You said, at the time that the vitamin amendments were being considered, that if they'd pass, it would be a godsend to quackery or produce a heyday to quackery, or some such thing. I've got a quotation from you on that somewhere. And yet, those bills did pass. The pressure from the health food interest was sufficient to get those bills passed, which did, rather drastically, reduce the agency's authority to police the vitamin and food supplement marketplace. You fought that hard, but that was one that you just got beat on, because of the great deluge of material that the health food interests were able to bring to bear upon the Congress.

AS: You're right, we lost that one. And, in retrospect, I think, probably, it was a loser from the beginning. It was not pressure from the health food industry that beat us; it was pressure from the American people. Now, you can say that's a different way of saying the same thing. But it really isn't. I think we could have beat the health food industry. The most damaging single thing there was was that somebody in the health food industry put out, in flyers, that we were trying to take the vitamins and minerals away from the American people and make them prescription drugs. Now, nothing was further from the truth, and the whole thing was just asinine and ridiculous. But that got around. I believe this to be true--I was told this and it's in print--that Congress got more mail on the vitamin issue than on any other subject, including Watergate. People were more excited about their vitamins and minerals and the possibility of losing them than they were about the cover-up in the White House.

So, you're quite right, we lost that. I think of that once in a while when I see both the ads for and the poisonings from the mega vitamin dosage that's still going on.

JY: Right. In connection with the educational approach, both within industry and with regard to the medical profession and with regard to the broader public, there were certain initiatives that, it seems to me, you yourself had a great role in. Some of which didn't come off in the long run. For example, there was a concept of the national prescription drug compendium, which I took it that you may have been quite in favor of. Am I right about that?

JY: And then the patient package inserts as a way of reaching the public and educating them better to handle their prescription drugs. Both of those seemed to be rather strong initiatives. And yet, in the long run, at least up to this point, neither has come through. The compendium, as run by government, hasn't come through. There are only a couple or three things that have patient package inserts. And a program of enlarging that under FDA auspices was eventually thwarted. I was interested in your reaction to that.

AS: You know, you've got to be skillful, again, about change and about accomplishing some things, and I think that Jere Goyan kind of blew the patient package insert business. What I intended to do with that was, on a drug-by-drug basis, where it was obvious that they were good, to do it. Take, for example, insulin: there's always been a patient package insert, in effect. It's needed and it didn't bother anybody.

With the oral contraceptives, that was a lovely one. As a cardiologist, I thought it'd be neat to have one on digitalis. I think there are probably more patients across the country in trouble with digitalis, either because they're overdosed or underdosed with digitalis, than any other drug used by internists, with the possible exception of Valium or something like that, or antibiotics, which aren't cardiovascular drugs.

But I think if the agency had bided its time and selected drugs one by one when a problem arose or when a problem could clearly be demonstrated and could say, "Well now, here's an example of where we need a patient package insert." Forget the name, package insert. If the name became a problem, just say here's where the patient and physician and pharmacist need to share more information. You know, there's a half a dozen ways of skinning a cat.

There are people in Washington and people in agencies and a new commissioner will come in and they say, "Well, you've got sixty days to make your name." They dangle other people in front of you. And they say, "Well, look at Goddard. Nobody will ever forget Goddard, now You don't want anybody to ever forget you, and you've got to do something." And there's a pressure, you know. Whether Goyan decided upon the patient package inserts because he was a pharmacist . . . I don't know. But all of a sudden the agency had too big a program, doing too much at once without a good reason to do it. And the pharmaceutical industry creamed them. FDA made a mistake by underestimating the costs of the total program. We're talking about $200 million of costs at one point. And the pharmaceutical industry calculated the costs at $2 billion. I mean the spread was between a couple hundred million and $2.5 billion or something like that. And the day I saw that, I said to myself, "The program is dead." I was not personally in favor of every drug having a package insert. The country would be littered with little white pieces of paper. That would be ridiculous.

JY: You knew that there were certain drugs that the patient did need to know more about than he was getting.

JY: And you wanted to edge into it as these major areas of education surfaced.

AS: Sure. In a sense, you see, the FDA lost the patient package insert thing for the same reason I lost the vitamin mineral thing. And that is that the regulatory scheme that Peter and others came up with, I was uneasy with, because it seemed to me we were trying to do much--"bang."

AS: With the regulation of vitamin and mineral supplements and so on. We lost it because it was too much, too soon, all at once.

AS: With vitamins and minerals we tried to revamp the entire use of food supplements. What we did is we define vitamins and minerals in three classes, and the three classes were: a very small use, a sort of food fortification; then supplemental use; and then drug use. And it was the drug use one that killed us, because that's what allowed people to say we were going to make them prescription drugs. All we were going to do is say you can buy them in your local gas station, but they aren't going to be called food supplements. We want you to know that that's a therapeutic level. And mega doses had to be labeled as drugs, because that's what they were.

So, that was too much all at once. Jere Goyan and the agency in putting out a massive patient package insert program were just doing too much all at once. It was too big a bolus for anybody to swallow, and they choked and that killed the program.

Now, the compendium which you mention, that's going to come. That's just a matter of time. How it's going to come is over that tube over there. You're already seeing a move with automated, updated telecommunications sorts of data bases. That's a data base in today's parlance, and I think there will be that kind of a data base available to all physicians by computer and . . .

AS: I don't know where from. It could be FDA; it could be from the National Formulary; it could be anybody. Could be PMA. It doesn't matter who does it. But I think, clearly, at some point that's going to come.

JY: That was part of the debate at the time. There were those in FDA who had the feeling that it needed to be FDA to be, as it were, Simon pure.

AS: Well, I didn't agree with that. And, of course, if you're head of an agency, you've got to be at the head of the agency. If you aren't at the head of the agency, you aren't heading it. You can't be standing here and all your troops are over there.

That is why I always come back to change, because one of the things that I tried to do was to change the agency in such a way that I could stay at its head. The strict constructionists, the old timers, the cops in the agency, knew what their useful tools were. And there aren't very many. It's like the carpenter, in the old days, had a very good saw and he took very good care of his saw, because that was one of his most valuable tools, and there weren't very many.

And FDA had the labeling regulations and, of all of the tools FDA has, one of the most valuable is the labeling regs. The use of those regs became a very fine art. And the people who were sophisticated and good enough to understand the use of the labeling regs, fended off any challenge to the agency's authority to declare what was a proper or an improper label. The compendium issue for a large segment of FDA was that FDA, if it gave up its authority to label, would be giving up the whole ship. Giving to some outside, even quasi-governmental group . . .

AS: USP, whoever. To give up to them the authority to label--which in effect was what the compendium was, it was stating what the labeling was of the drug--would be giving away the ship. Now that was a hard one to counter. It wouldn't have bothered me. I would have run the risk and thought there were other ways of maintaining your authority over labeling, but I won't argue that . . . Since we didn't conduct the experiment, we'll never know.

But we controlled a lot of stuff, including advertising and journals and meetings and educational seminars that took place on ships in the Caribbean. I mean, we did an awful lot of regulating in the name of labeling and controlling labels. What people could or could not say about a drug in what kind of a setting. You see, all that came under that labeling authority. That was what brought down the compendium, in my day, was the labeling question.

JY: Another area of rapid change that had already begun and that was reaching high tide while you were commissioner, was that pair of things that had been generated by the 1962 law: the DESI Review, and then the OTC Review, which you've mentioned, which I think while you were commissioner, had led to its first file report.

AS: The antacid. Someday, if I live long enough and I do what I intend to do, I'm going to write some things. And I think among the funniest things--it would be more fascinating than Pat Ward's Krebiozen, "Belling the Cat"--would be to write one on Alka-Seltzer. You know, this became a national controversy that was entered into by the New England Journal of Medicine. And, Franz Inglefinger, you see, was editor of the New England Journal and was chairman of that panel and was just funny as a crutch about the whole thing. I know things that, in a sense, nobody else knows about that, and what Franz did and didn't do, and what people were saying about that . . .

AS: Someday I intend to write that down. In a way we pushed the antacid panel first because I thought it would be non-controversial and the easiest one to bring to fruition--forgetting about Alka-Seltzer . . .

AS: I mean, my consumption of Alka-Seltzer shot way up during that episode, because I took it because it was a nice way to take aspirin. And both Franz Inglefinger and I used Alka-Seltzer because we both felt that it was a great way to take aspirin. And there it was in the antacid panel. And, of course, aspirin is a lousy way to take an antacid, so we got caught in the horns of that dilemma.

JY: How do you think that the concept of the committees worked out? That's another one of the ventures, it seems to me, which you accepted and strengthened--the use of the advisory committees, kind of across the board in FDA. And here's an example of such committees in use.

AS: Well, both the DESI Review and the OTC Review were ongoing when I became commissioner. The DESI Review had been long standing and is still going on. It's coming rapidly now to a conclusion after all these years. And my views on the DESI Review were that, by the time I really got involved in it, which is probably the last couple of years I was there, in all candor, it was sort of boring. The exciting phases of the program were over and the agency was bogged down in extremely difficult and tedious working through of issues that just took a long time. Nobody understood the complexity of the DESI Review when it got going or the amount of work and time it would take to go through the hearings or the denial of hearings, and get the data that were necessary. Nobody anticipated the number of challenges by the drug industry. I was just sort of grateful to escape major problems with the DESI Review while I was there.

For me, the OTC Review was much more fun because it had just gotten off the ground and was just starting. Here was this thing and the question was, what was it and how do you bring it up and make it work well? It went awfully well, I think, while I was there. The panels that we established were very, very good. They were the best people in the country, or sometimes even from Europe. They did awfully good work.

And the thing was a lot of fun. I was very sorry to see it slow down after I left, in the sense that it was neglected. Recently, there have even been some questions as to whether it should be abandoned without being finished.

Basically, the regulatory scheme is a good one. A little more difficult than we had anticipated, but the central issue from day one of the OTC Review--that got very prominent within the agency while I was still there, and has been with the OTC Review to this day--is, who owns it? Where does it belong in the agency? What kind of an activity is it?

Now, I said earlier that Charlie Edwards was a centralizer and somebody who liked to do things out of his office and to have task forces. That way he was sure he could direct it and get it done. So, what I found was an office in my office, and Gary Yingling was in charge of that when I went there. Later Bob Pinkow and others got involved in that and, in essence, they worked for the commissioner. And the Bureau of Drugs was dead-set against that and fought that the whole time.

AS: The structure. There was a lot of tension within the agency about the placement of the OTC program because early on it got a lot of resources and it was sexy and exciting. Dick Crout resented very deeply that that program was not in the Bureau of Drugs.

Now, Charlie's theory was that the only way to get the goddamn thing going, and so on, was do it out of his office, because if he gave it to the Bureau of Drugs to do, they would never do it. It would get caught up in bureaucracy, and the Bureau of Drugs had more important things to do. Charlie was right. I left that structure in place until, toward the end of my tenure as commissioner, I moved it into the bureau. And the reason I moved it into the bureau was that it was far enough along that it started to have to be legitimate. If you were going to regulate that huge class of drugs then with monographs and so on, and if you were going to make switches between prescription and OTC drugs, and if this was going to become a regular part of the program, it could not be a special pet of the commissioner's.

So I told Dick Crout, "All right, I'm going to put it in the Bureau of Drugs and you can have it, but I want it to be a special activity in the Bureau of Drugs, and the instant that thing starts to slow down, I'm going to pull it out again." And I had a kind of a personal contract with Dick Crout and we agreed and shook hands and I put it in the Bureau of Drugs. And it was all right until I left. When I left and quit protecting the program personally, it started to slow down. It was not a high priority in the Bureau of Drugs, and I think that that was the major reason that it . . .

And then the new commissioners would come in and it wasn't sitting there right in front of them, and it became, then, to later commissioners like the DESI Review was to me.

JY: Right. I see that. Two questions: One, what was your own personal view of a point that was much disputed, and I'm not sure is settled yet, about whether the labeling claims for the different classes of OTC drugs should be rigorously fixed by FDA and literally followed by industry, as against greater flexibility for claims and synonyms that industry could come up with?

And the second questions is, why do you think that the OTC Review seemed to generate a movement of drugs from prescription to non-prescription status that seems to be rolling on today?

AS: Well, with regard to the second question, the reason the switch issue came up was because there were good people on the panel. Again, you see, the question was not a cop-type question. The question of the OTC Review was, what products under what conditions ought to be freely available to the American people?

The way the panels were set up, I think, was clever because the panels were set up almost by disease grouping or by disease category. They were functional panels by problem areas--antacids or hemorrhoids or skin conditions or gastrointestinal conditions or sleep. You know, what kinds of products should be freely available to the American people to help them sleep?

If you've got a group of good people sitting there thinking about this, one of the first things they'll think of is Benadryl or an antihistamine, and say, "Well, that is safer and more effective than some of this garbage that's on the market now." If what you want is a safe and effective thing, you're going to look over the range of things you know makes people drowsy. And some people get drowsy with antihistamines.

AS: Sure. And I think that the switch issue fell, normally and naturally, out of the OTC Review, and I thought it was one of the beneficial by-products, in the sense of the need to regulate that large class of drugs and their ingredients. Then, of course, the fact that there were too many drug products to review--so we chose to review active ingredients--drove people in that same way, because if you are looking at molecules then you think of other molecules. And you say, "Well, you know, what I use this for all the time is X." And somebody would say, "Well, that's a prescription drug." Somebody else would say, "Well, should it be a prescription drug?"

The best example of this was the switch of hydrocortisone cream to OTC status, the ointment. This has been studied by economists and by physicians and by all sorts of people, and everybody agrees that that was just a very happy thing to do, because it made available to people, and readily available, an extremely useful, important, safe, effective way to treat a lot of skin conditions. It cut health care costs and all sorts of things. And there are, I think, many others that could be switched.

So, the switch issue was a neat thing that came out of the OTC Review. I forgot what your first question was.

JY: It had to do with your own judgment about the therapeutic claims in the labeling of these products.

AS: The matter was decided, in a sense, on the wrong issues. The real problem there was that FDA did not control the advertising of OTC drugs. It's interesting, but I think it's a fact, that if FDA had controlled the advertising of OTC drugs, that issue never would have surfaced.

AS: The real problem there was an interagency rivalry between FDA and the FTC. And the FDA does not trust the FTC--never has, never will. If you want evidence of that, I can give it to you from the last month.

AS: Kellogg's health claims on their cereal. FDA thought that was a problem. In the face of FDA's saying, "I think we have problems with that," the FTC people said, "We think it's great." And that made FDA mad as hell.

You're seeing the same squabble now. The FDA is highly indignant that the FTC is making statements about what can and cannot be a health claim. That's FDA's turf.

JY: Because the whole food market is out there waiting to do this kind of thing.

AS: But we're back to what I said a little while ago. Remember I said that if you want to stir FDA up, do something that might challenge its labeling authority. And the FDA does control labeling of therapeutic products. Anything that you make a health claim for is FDA's.

So here's Kellogg's saying their cereal will help prevent cancer because of the fiber in it. This is a health claim that belongs to FDA, and FTC is moving in on that. With the OTC drugs, FDA was afraid that if it did not take the strict constructionist's view of labeling, the FTC would screw it all up. FDA didn't want the OTC Review threatened by some stupid things coming out of the FTC.

Now, this was presented to me and I thought about it. And where I came down on it was, well, there's nothing wrong with starting out tough and then loosening up.

But, to tell you the truth, I thought then and think now that the issue was a little bit dumb, because it is simply a fact that there is a vernacular in our language and it communicates, and there's nothing the matter with using that. And FDA would have allowed the vernacular if FDA, at the same time, could control the excesses in advertising that were sure to follow that loosening up. Because there's no question that the drug companies and advertising agencies would have taken that quickly to the limit.

AS: No. And the reason it isn't, I've just told you, which is that, if anything, the Kellogg breakfast cereal business will make it harder to resolve the OTC thing. One way of resolving it, I suppose, is to give OTC drug advertising to FDA. I was asked once if I wanted it passed by Congress, when I was there, and I said no. And I didn't.

JY: It seems to me that the FTC, historically, has wavered much much more than FDA has, historically, about the intent of its mission.

AS: Oh absolutely. You can just look in the last decade. They were practically abolished at one point.

JY: Exactly. Right. Well, that's great. Now another thing I would appreciate your commenting upon . . .

AS: You brought up something that I've been trying to work in, and you gave me the opportunity, and that is the advisory committee business.

AS: You're quite right that coming into the agency, we said earlier, that I was interested in the application of science in the agency. You looked around the agency, and there were some very good people in it, but it was obvious that you couldn't have one of everything in the agency. We had to have the world's best science brought to the decision-making of the agency, and the logical way to do that was through advisory committees. Remember also that I had spent time at NIH and I'd worked in Jim Shannon's office. I'd been chairman of a study section for regional medical programs, and most people in the academy are well familiar with councils and study sections and advisory committees, so it was not very mysterious why I really seized on the advisory committee structure, which again had been started by Charlie Edwards. I give Charlie just immense credit for setting things up so that when I went into the agency, what I did was put meat on the bones that Charlie had already strung together as a skeleton. That was true also for the advisory committees. I made more of them and made some of them better, and I worked with them more than Charlie had had time to do. But I thought that that was a very important part of the agency.

Again, one of the things I've done since I left the agency, is object vigorously when there were challenges to FDA's advisory committees. I talked personally to secretaries and others as I've done with Secretary Heckler, Secretary Schweiker, and others.

AS: Oh sure. Because when you go in and cut the federal budget, OMB always goes after advisory committees, including some of the NIH committees.

JY: And you knew how, from academia, how to find the experts to go on the advisory committees. Did you play a pretty direct role when lots of these were set up in actual picking?

AS: It was fascinating to me that very good people accepted; the people that you might expect to turn FDA down as being not in the direct line of science, or because the people were too busy with NIH. We would call the best people in the world, and they'd say, "Gee, I'd love to." And we did not have to do a lot of arm-twisting when we were setting up the committees to get the best people there were.

I did three things, I think. One is that when we were going to appoint somebody, I would suggest names and look at the list and approve the list and say, "That's my list." Because then when it went downtown, people knew that I was grouchy, and if they knew that was my list, there was no political interference with the establishment of those advisory committees while I was there. I don't think I was ever given a single person to be on the advisory committees.

And, since I've left, at times some very bad, or if not bad, inappropriate, people have been given to FDA by the department or OMB or the White House. And that sort of thing, if somebody had tried that when I was there, I would have quit.

JY: Here is where the independence of the commissioner, you believe, is just an absolute must.

AS: Ordinarily Dick Crout or somebody in the Bureau of Drugs would call people for the Bureau of Drugs committee. I said, "If I can help you recruit somebody, let me know." But I did not call a lot of people or twist a lot of arms to get people to come on to the advisory committees, because they were pleased to do that.

I've talked to a lot of people since about that. For example, right now the head of dermatology here and our transplant surgeon, Olga Jonasson--she is one of the leading academic surgeons in the country--agreed to serve on the hemorrhoid panel. And I said to her once, you know, "Olga, why in the world would you . . ." And she said, "It's important. I have hemorrhoids." It was fun.

JY: Yes, right. Well I understand that, even from personal experience. It's not only an honor, but it truly can be a major service to the whole public.

AS: I'll say two more things. One is I want to refer to the Fountain hearings on the use of advisory committees. If you want to know my views on that, refer to hearings that the Fountain subcommittee held on FDA's use of advisory committees. That's a full reporting of problems other people had with FDA's use of advisory committees. And my defense and arguments against people's concerns, the concerns being that FDA was not doing its job, that FDA was a cop and you couldn't appoint somebody and all that sort of stuff.

The other thing is that the only time FDA advisory committees and my interaction with them wasn't fun had to do with the Dalkon Shield controversy--what was an extremely difficult and messy situation that goes on to this day. One of the problems was that I had two different advisory committees claiming--at one point three advisory committees--all offering me conflicting advice. And that was difficult.

AS: Well, that was the problem, you see. We had an OTC committee, we had a device committee, and we had in the Bureau of Drugs a contraceptive committee. And then on some of the committees were some very aggressive--sometimes even loud-mouthed--people who wanted to climb up on the top of the hill and shout about it and were not statesmen. The whole thing was a pain in the ass. Serious. But handling it was a pain in the ass.

The other thing I want to be sure to mention, that again was started by Charlie but was an infant that I brought along and took a lot of personal interest in, was the National Center for Toxicological Research in Pine Bluff, Arkansas. The reason that comes to mind now is because it had an advisory committee that was also a pain in the ass, because of some of the people that were on it, and the way they behaved.

But the NCTR was a good effort and was important and was another thing that sort of came along during my tenure. You know, that, and the idea of a campus in Beltsville, and some of these other things are still going and are coming slowly to fruition. I take a quiet pleasure in watching those developments.

JY: In connection with prescription drugs, another thing that still continues relates to the problems of getting the drugs on the market and then what happens. And you suggested making pre-marketing power for drugs easier, which relates to something we talked about yesterday. Partly by providing for more intense post-marketing evaluation and easier removal than the law, up to that point, allowed of drugs from the market when their problems fell short of the severe and imminent hazard standard that the law included. Can you talk about that, both as seen at the time and from your present perspective?

AS: In trying to explain this once, I fell on the use of an equation which was very useful pointing out that there was a relationship between the information that you had to have about a drug, and when you got it, and what you could do about it.

If, after a drug were put on the market, FDA could not discover what it needed to know about the drug, and, once discovering that necessary knowledge, couldn't do anything about it, then what happened was that FDA tried to find out everything it needed to know about that drug before it went on the market.

If the person who put his stamp of approval on that drug and allowed it to go to market didn't want to run a risk of being heavily criticized, if, after use of that drug for a period of time in a lot of people, it turned out the drug had a severe side-effect that you couldn't know until it had been used in two thousand people over a two-year period, then that person would want that drug used in two thousand people over a two-year period before it was approved for marketing. It was obvious to me that the drug lag issue, in my terms, was an issue of how much did you have to know about that drug before it went on the market. And if the answer to that was everything, then we were on a course toward never approving any drug as the ultimate way of protecting the public against drugs. So I said, "Look, we need to know this sort of stuff about a drug: what happens to people who take it over a long period of time; are there rarely occurring but very serious side effects that occur only once in five thousands people or once in two thousand people or even once in a thousand people?"

If, after the drug went on the market, we could do post-marketing studies, Phase IV studies, and if we could take a regulatory action short of declaring it an imminent hazard, the drug approval process, in a sense then, could extend through the first few years of its being marketed, we could obviously let the drug on the market quicker than we do now.

So, I set up an equation that had sort of what you needed to know pre-market and what you needed to know post-marketing and set it all equal to a constant. And obviously, then, if one value changed the other value changed in the equation. Then there came a very useful way of demonstrating this that was picked up by Lou Lasagna and others and has appeared many times in articles and so on.

JY: What's the reason? Why has FDA had such trouble getting feedback from real experience? Adequate feedback.

AS: Oh, I've thought about that a lot and I've talked about that and testified on that subject. What I conclude is that there are so many reasons that it's hard even to list them all. You start with the nature of our society. We're a free society. We are not a regimented society. We don't have the same habits or mores as some other countries where they have good post-marketing surveillance. We don't like to follow rules. If the federal government set up a rule for the American physician that he had to do something, he'd say, "Stick it, I won't do it." So that's one reason.

The second reason is, just look at the lawsuits and the malpractice and so on. No physician, who is now paying $100,000 a year for malpractice coverage, is going to start reporting adverse reactions in his patients because of drugs that he prescribed for them. He'll get sued and his malpractice insurance will be $150,000. So, our litigious society is another reason. So that's the second reason.

Third reason is that basically drug companies don't want it. They feel that the front-end of the process is so expensive and so long and what will happen is that you are going to add Phase IV, that will be additive. It will not replace anything on the front end. Ralph Nader won't permit, the agency, the Washington Post won't permit, Morton Mintz won't permit the agency to ease off on the front end in exchange for something on the back end of the approval process. The pharmaceutical industry opposes it vigorously because they don't trust the agency and they feel it will just be additive. So that's the third reason.

Fourth reason is, it's expensive. Costs money to do that. A good post-market surveillance system for this nation, which is very large, heterogeneous and so on, would be expensive. We are not a little homogeneous country that can do this sort of thing well. We're a big sprawling set of kids that don't behave ourselves. So, there are just so many reasons, that I am very pessimistic that we are ever going to really have a good post-market surveillance system.

Again, you're into the patient package insert problem. Another reason is that, if you're a drug company and you want to kill it, the best thing to do is to keep talking about doing it for all drugs at a cost of $180 billion a year or whatever they're going to come up with. What the agency needs to do is what Peter Hutt and I would have done, and that's to say to a drug company, "We will approve this if you will do that. We want a Phase IV study."

AS: That's right. And I would've done it just the way I did patient package inserts. And then, in three or four or five years, you would've had it, and nobody would have seen it coming, and it would be accepted and the agency would have backed off on the front end quietly, and bingo, it's done, and nobody really knows it.

That, by the way, is one of the prices the agency pays for the tenure of commissioners being one to two years. With the exception of Charlie and me, you had one- to two-year commissioners since Larrick.

JY: That's one of the great watersheds that needs to be explained and analyzed.

AS: Not only that, but the second most important office in the agency, which is general counsel, has become politicized and has been turning over. Right now, since I'm speaking this for history, I'll say that I was in Washington on Monday and learned two things. Since today is--what's today?--March 9, 1985, I'll say that my prediction is that the current commissioner, who's been there only a few months, is going to be taken out of that job within a week or two or three and the general counsel is going to be fired. Now, the deputy just left; Taylor Quinn just retired. I've talked to other people in the agency who are very discouraged and are going to take early retirement, and I think that the current department is doing grievous harm to the agency. But Heckler needs an assistant secretary for health, and Young is an easy choice. And I think that, if she can, she's going to pull Young up into that office and then who is running FDA? Mark Novitch is gone. You've got Paul Hile who, in essence, will be running the agency.

JY: And under the circumstances in Washington, it will be hard to select and get the kind of person that is needed.

AS: Well, you've got a two-year period that you could do something, because things won't fall apart until everybody starts campaigning, which will be about a year and a half before the next election. So, if Young stayed in there and was a good person and all, he could do a lot in the next two years. The next two years would be a time you could get something done. The first year of a new administration is hard; the last year of any administration is hard. The second and third years of a stable administration are when you can get something done.

FDA Oral History Program

Interview with Alexander M. Schmidt Commissioner of Food and Drugs (1973 - 1976) (Part 3)

Interview with Alexander M. Schmidt
Commissioner of Food and Drugs (1973 - 1976)
(Part 3)