Interview Topics:
Interviewers: Ronald T. Ottes
(RO) and John P. Swann (JS)
Date: 12 November 1997
Place: Rockville, Maryland
RO: This is another in a series of FDA oral history recordings. Today we are interviewing Dr. J. Richard Crout, former director of the Bureau of Drugs, currently known as the Center for Drug Evaluation and Research. The interview is being held in the Parklawn Building; the date is November 12, 1997. Present in addition to Dr. Crout is Dr. John Swann and Ronald Ottes. This interview will be placed in the National Library of Medicine and become a part of the Food and Drug Administration's Oral History Program.
Dr. Crout, to start the interview, would you give a brief biographical sketch of where you were born, educated, and any relevant experience prior to FDA, and then what brought you there?
JRC: I was actually born in Portland, Oregon, but my parents moved to the Midwest when I was an infant. So I grew up in a suburb of Chicago and later in Columbus, Ohio. I would say from about the fifth grade on, I knew I was going to be a doctor, but I didn't quite envision myself somehow in practice. I was interested in research. I then went to Oberlin College and Northwestern Medical School and had the good luck to get into the NIH (National Institutes of Health) at a time when everybody interested in academic medicine was going to the NIH.
So I came to the NIH after a year of residency in internal medicine in 1957, and there worked with a couple people, Dr. Albert Sjoerdsma, who's a well-known clinical pharmacologist, Dr. Sidney Udenfriend, who's a well-known famous biochemist, and I ended up in clinical pharmacology. So after another year or so at Harvard Medical School in a fellowship, I went to the University of Texas Southwestern Medical School as my first job in 1963 as head of clinical pharmacology there.
In the late sixties--actually 1970--I got on the Ritz Committee, and you may remember that Dr. Charles Edwards was the newly-appointed commissioner at the time. I went then on that committee as the clinical pharmacologist, and I got interested in the FDA from that experience. And in 1971, when Henry Simmons was the director of the Bureau of Drugs, Charlie Edwards asked me if I would join the agency, the bureau, as the deputy director. He basically said, "You academics come down, write reports, and tell us how to do things. Why don't you come down and see if you can demonstrate your wares?" So I came and became the deputy director of the Bureau of Drugs, an organization at that time that probably had, oh, I would say seven or eight hundred people in it--having previously been in charge of a little clinical pharmacology group that had, you know, six or eight people in it. So I suddenly made that jump.
RO: Dr. Crout, before we go into that, would you mind fleshing out that Ritz Committee a little bit?
JRC: The Ritz Committee was one of a number of committees that looked at science in the Food and Drug Administration. There's always one of those going on it seems, if you look back through history. But that was the purpose: to look at science in the Food and Drug Administration. So I had the opportunity to visit all the labs, go to a number of field labs, talk with a number of people in the agency as part of that experience. I basically wrote the part of that report that deals with drug regulation. There was one representative for every portion of FDA on the committee. I mean, there was a food scientist, a veterinary scientist, a chemist, and so on, so that when we came to writing the report, we divided it up into portions like that.
When I came here, I knew from the Ritz Committee that the Food and Drug Administration--at least the Bureau of Drugs--at that time was a difficult and unhappy place. We got lots of feedback on how terrible things were. The agency had previously been--or the bureau had previously been down on the mall in Washington. I remember, when I was here in about 1960; I had gone down to those temporary buildings left over from World War II and met with Frances Kelsey and some others. That's the first time I ever met her. When those were torn down, the agency had moved to Crystal City in Virginia.
So everybody had moved, gone out to Virginia, and suddenly they were uprooted again and had to come to the Parklawn Building here in Rockville. There was a lot of unhappiness over the move; Parklawn Building was, and still is, an inhospitable place architecturally with its long halls, but it was worse then. I mean, it was absolutely, absolutely barren of anything pleasant, simply the long halls and the many doors.
There was a central records room, for all of the New Drug Applications (NDAs) in the bureau, that you couldn't believe. I mean, it was a huge, single room, files extending to the ceiling, stuff all over, desks with clerks sitting there, and you couldn't . . . Nobody could find anything. If you made a request, it was days before you got things, so that people--that is the reviewing medical officers and other officers--literally fought over their applications. If they got an application to review, they kept it in their office. Never did they put it back in the file room. So there was total chaos on where the files were. The drug industry knew that. We heard all these kinds of complaints.
It was also an unhappy institution personnelwise, disorganized in its documents, understaffed. There were at the time about seventy medical officers. Today there's approaching two hundred, and as we'll recount in a minute, we had a lot more work to do then than they do now. So I knew at the time that there was no place for the agency to go except up. Charlie Edwards knew that, too.
He spent a lot of effort successfully recruiting a lot of good people to FDA. Those of us who came at that time still look back and think that we were the favored few who got a chance to come at a time when the agency was rebuilding, and it was very exciting. Among the people who came at the time were myself, Peter Hutt, Mark Novitch, Sherwin Gardner, Jim Grant as the deputy commissioner . . . And there were some old hands also, of course, that Charlie turned to. Sam Fine was the associate commissioner for Compliance. Billy Goodrich had just retired as the general counsel. So we were inheriting quite a legacy, but from a managerial standpoint, we needed more new people. I've forgotten who Dr. Edwards recruited as the director of the Bureau of Foods, but there was a new director there. Gerry Meyers was also recruited at about that time, and he later was promoted to the head of the office of administration following Mickey Moure. Mickey Moure was head of the administration when I came. So a lot of people came new to the agency and helped create a very exciting era in the 1970s.
The first secretary I had a chance to meet with was Elliot Richardson. If you ask any of the people I mentioned, looking back, the secretary they probably liked the most, it might be him, or maybe Cap Weinberger. To go down to the secretary's office and see these people was fun. Both Elliot Richardson and Cap Weinberger were supporting and trusting. They wanted to know what you were going to do, came down, had good conferences, listened to you, and then said to the commissioner, "OK, do it," and then let Charlie go do it. So the commissioners had a lot of support and probably more freedom than they do now.
I recall this was a time also when the agency signed off on its own regulations. No more . . . None of this review by the department, except in a very perfunctory way, and certainly no review by OMB. So we really could do things and take responsibility for it.
RO: And you were the deputy director then. You spent an awful lot of time to begin with on new drugs, didn't you?
JRC: I was the deputy director for a year. Then I was chomping to kind of do something a little more than just watch all the papers go by. I was also in charge of an administrative effort to improve the documents flow in the bureau. And I was interested in that, but it was hard; it was hard to catch on. Science was more my cup of tea. At any rate, after a year, I traded jobs with Marion Finkel. I went down one step in the bureaucracy and she went up one step, and I was then head of the Office of Scientific Evaluation, as it was called, for about a year.
Now during that year, Charlie Edwards went downtown to be the assistant secretary for Health, and Henry Simmons went down there, too. I had been asked at the time that Henry Simmons left whether I would like to be a candidate for director of the Bureau of Drugs, and this was in that interim moment when we had no commissioner. Sherwin Gardner was serving as deputy commissioner, Dr. Schmidt had not yet been recruited, and I said no, I was happy.
Then as that interim period went on, I found that the lack of leadership in the director's office was bothersome. I mean, there were too many people from the commissioner's office who thought they were director of the Bureau of Drugs. Decision making was harder, and second guessing was going on. So I went back to Sherwin after several months and said I would like to be reconsidered as a director of the Bureau of Drugs. This was in perhaps the middle of '73. I had then been in the agency about two years--one year as deputy director and one year in the Office of Scientific Evaluation.
Dr. Mac Schmidt was recruited to the agency as the commissioner--my memory is in the fall of 1973. And he, I guess on Sherwin's advice, asked me if I'd be director of the Bureau of Drugs, and I said, "OK." So that's how I became director of the Bureau of Drugs. They had been, I suspect, looking. I'm sure they were looking, but nobody wanted the job. I mean, nobody wanted to be director of Bureau of Drugs, actually until the 1990s. It took that long for that job to climb out of its hole and become something anybody good wanted to aspire to.
RO: So when you became the director then, what was one of the first big problems that was faced as far as the Bureau of Drugs? It always had drug lag.
JRC: Setting aside congressional hearings, there were several big issues in drug regulation that were on the platter at that time. One was the regulation of new drugs and the very slow pace of approvals. Approval times were averaging three years, and the number of drugs approved each year was very low. There were some really poor statistics. I remember hearing that Merck didn't have a new drug approved for, I don't know, five years or ten years, something like that. Also no new entity had been approved in cardiovascular for five years. The culture first encountered was one of controversy, slowness in reviewing, and a perceived big mess with the new drug approval system. So that was one issue in front us.
JS: May I ask, were there drugs in the pipeline, in the IND [Investigational New Drug] phase?
JRC: Certainly, yes. Interestingly, INDs were going down in some areas. It was quite clear that the industry was shifting out of certain areas, such as the cardiovascular area. And so that was another issue.
A third issue, one that was really far more important than I think people realize, was DESI. DESI, the Drug Efficacy Study Implementation it was called. Really a bad, very bureaucratic term. [Laughter]
JS: Typical though.
JRC: But DESI was an extremely important exercise. To go back in the history a bit. When the New Drug Amendments were passed in 1962, the agency had been ordered to review all of the drugs previously approved for safety, and now re-approve them if they met the test for efficacy. The new test for efficacy was substantial evidence based upon adequate and well-controlled clinical trials. That was a high standard. And the first thing the agency did after the new drug laws were passed in 1962 was nothing. The Congress gave the agency two years to do this review, and by the end of two years absolutely nothing had happened.
So pressures arose, and the agency--now under Dr. Jim Goddard--went to the National Academy of Sciences to get a review of these drugs. The National Academy set up a set of panels and gave recommendations on all of the drugs that had NDAs on the indications for which they were effective and those indications for which they were less than effective. There was a grading system for the degree of less than effective--probably effective, possibly effective, ineffective--and then there were some special categories for combination drugs.
All these reports had come back to the agency in the late sixties, and they were now being published, beginning around '70 or '71, in the Federal Register with decisions by the agency on these drugs. Manufacturers were being notified, "You've got to either change your labeling by dropping offending claims or provide scientific evidence--that is, adequate and well-controlled studies to defend those claims--or we're going to take your drug off the market." And if you didn't like that, you could seek a hearing.
So this was a tremendously complex exercise in which a number of manufacturers were asking for hearings, other manufacturers were relabeling their drugs, others were conducting studies. If you were conducting studies, that took time. Manufacturers couldn't meet the time limits. So we were progressively falling behind in implementing DESI as well as in approving new drugs.
The agency was sued by the American Public Health Association, among others. The party that sued was Sidney Wolfe. The lawyer working for Sidney Wolfe at the time, interestingly, was Bill Schultz, now a major leader at FDA. They sued the agency and won, of course, and time limits were set for us to meet various goals in DESI. Well, we met some, didn't meet others, we were sued again in the late seventies, by the same parties, new goals were set and so on.
The point is that this was a major administrative exercise. But more importantly out of it came a finished product that current regulators don't have to worry about. The DESI project brought the labeling on all of these old drugs up to modern standards. At the same time, we put out regulations which were written largely, almost entirely by myself, Bob Temple, and Marion Finkel on what a modern package insert for drugs should look like and contain. Those regulations then applied to all of the drugs coming out of the DESI process. So the labeling of all drugs was brought up to snuff, and if you want to see the impact of that, go look at a Physicians' Desk Reference (PDR), of the 1950s, and compare it to one of today to see the improvement in quality in drug labeling.
The second thing that DESI affected was the indications and the ingredients for 75 percent of the products on the marketplace at the time. It was an enormous cleaning up of the past. Modern regulators forget that somebody did that. Well, we did that back in the 1970s, and at the same time we were trying to deal with new drug approvals.
[Interview with J. Richard Crout, M.D.: Part 1 | Part 2 | Part 3 ]
FDA
History Home Page
FDA Home Page
| Search
| A-Z
Index | Site
Map | Contact
FDA
FDA/History
Office
Web page created by clb
2002-FEB-06.