Food and Drug Law: An Academic Adventure
Harvard Law School
To my students during Winter Term 1994, who made the course on Food and Drug Law such a stimulating and rewarding academic adventure.
Contents of Appendix:
I had never before been in a Harvard House or a Harvard room, and thus did not know what to expect. From my own experience and the experiences of my three children at Yale, I vaguely anticipated a wood-paneled sitting room with a small bedroom attached. This was not to be.
Eliot House is located at the corner of Memorial Drive and John F. Kennedy Street, on the Charles River. The main entrance is at the end of Dunster Street. It is a beautiful building, of Georgian brick architecture, with a magnificent white tower and steel dome. Like the Yale colleges, Eliot has entryways that climb vertically, not halls that run horizontally. The Matthiessen Room was in the furthest entryway from the main entrance to the House, denominated Entry C. Within Entry C, it was Room 11, on the first floor. It faced in toward the Eliot House quadrangle, not out toward the Charles River.
Upon entering the Matthiessen Room, there was a narrow hallway. A spacious closet was on the immediate left, then a very large bathroom, and finally the hallway opened into the room itself.
The closet deserves some mention. There was no chest of drawers or other place to store clothes in the Matthiessen Room other than in the closet. At each end of the closet, a plastic "shelf" hung from the closet pole. They looked so flimsy that I never tried to use them. Fortunately, as I later learned, the closet had a stack of extra blankets of various colors. It looked like a typical student's closet, with the accumulated debris from several occupants.
The bathroom was long and narrow. It had the customary college black and white tile floor, which never seemed to rise above freezing temperature. One side was lined with old bookcases filled with plates and eating utensils (along with a few bottles of port and wine). Above it hung a 1945 map of Europe. The bathtub/shower was plastic and had a garish green plastic shower curtain.
The main room was about fourteen feet by eighteen feet. It had two windows which looked out on the central courtyard of Eliot House. Against the wall looking toward the windows was an old brown couch that pulled out into a double bed. It could have been in any of thousands of college rooms, and looked like it had been. The two side walls were lined with locked bookcases built into the walls, filled with Matthiessen's books and memorabilia. Dr. F.O. Matthiessen was a renowned English scholar who obtained his undergraduate degree from Yale, was a Rhodes Scholar, obtained his Ph.D. from Harvard, and taught at Harvard from 1929 until his death in 1950. On the walls above the bookcases hung framed letters from illustrious friends and their photographs. Against the wall with the windows was a green couch and a large round table which held a small television, a clock radio, and the telephone. On one side of the room there was an oak desk with an old typewriter, perhaps the possessions of Matthiessen. On the other side there was a chair that matched the green couch and a vacant space where I ultimately put the Xerox boxes that contained my clothes. On the floor was a nondescript patterned brown rug that was undoubtedly placed there simply to distinguish the room from the undergraduate rooms in the House, which have no rugs.
The Keeper of the Matthiessen Room, Kevin Van Anglen, was not at Eliot House when I arrived, but had left the keys with the guard at the main entrance. I obtained a hand cart from the guard and proceeded to unload the car. I had loaded all the boxes intended for Eliot House in the trunk, and shortly had them out and into the room. My suits and coats hung nicely in the closet. I kept the rest of my clothes in four Xerox boxes in the main room.
From Eliot House, I drove through Harvard Square to the Law School, and parked in the parking area reserved for the International Law Center. Leaving a note explaining that I was moving into Griswold Hall, I set off to find my office. Sue Robinson sent me to Sandra S. Coleman, the Administrative Dean, who gave me the key to my office and informed me that my secretary would be Joe Guberman, located in Room 324 of Langdell West, telephone 495-9962. Joe also served as secretary for Professors Kaufman and Herwitz. Only at Harvard Law School would they give me a secretary located in a different building and who could not answer my telephone. It was obvious that I could use him only for occasional typing.
The secretarial situation did not actually disturb me, however, because I had met the secretary who sat outside my door, Tom Potter, on my visit last December. Tom had been extremely friendly and helpful then, and I was certain that I could count on him. This confidence was later proven to be well-founded on many occasions.
I obtained another hand cart and began unpacking the rest of my things from the car. As soon as I finished putting everything in my office, I drove the car to the nearby National Car Rental office, at 1663 Massachusetts Avenue, just a few blocks away. Right next door was Rosie's Bar and Grille, which had a large sign stating that it had been rated number one by Boston Magazine. It was already 12:00, and I therefore had lunch there. If this was the number one restaurant in Boston, I was in deep trouble for the rest of the month.
From there, I walked back to Harvard Square to shop at the Coop. I bought an Eliot House coffee mug, a Harvard scarf, and miscellaneous supplies. Returning to Griswold Hall, I proceeded to unpack.
My office was quite large – about twelve feet by fifteen feet – with a very nice modern desk and two large picture windows. The wall behind the desk was completely covered by bookshelves, and bookshelves occupied the bottom third of the other two walls as well. I had a lovely view of the back of Langdell Hall. A typewriter on a moveable stand and a huge computer complex were located behind the desk, but I had those out of the room very quickly. I also disposed of more than two hundred books left there by the previous occupant, Anna Maria DeVita, a Visiting Professor from the University of Florence.
The entire afternoon was occupied by unpacking my boxes, rearranging the office, and attempting to locate supplies. I discovered that there were no file drawers reserved for visiting teachers, and I therefore retained all of the files I had brought (predominantly my handwritten speech notes) in their boxes. There appeared to be no particular source of supplies, and I found that most of the items one takes for granted in a large law firm simply did not appear to be available. I considered myself very fortunate to have included a box with several legal pads (large and small), file folders, and pens and pencils, just before I left Washington.
My office was in a complex that included four other teachers – Professor Morton J. Horwitz, the foremost scholar on American legal history in the United States and one of the founders of the Critical Legal Studies movement; Professor Duncan Kennedy, another of the founders of the Critical Legal Studies movement; and Visiting Professor Elizabeth Schneider, from Brooklyn Law School, who was teaching gender discrimination during the Winter Term. Across the hall were the offices of two other teachers – Professor Joseph Singer, who specialized in property law, and Professor Lawrence H. Tribe, one of the foremost constitutional law scholars and advocates in the county. Three secretaries, who worked with all of the other teachers but not with me, sat in what can only be described as disheveled areas in our common outer space. When I went searching in the outer office area for what I thought would be something simple (scotch tape) and could find none, Professor Kennedy came to my rescue. When he later found me looking for a pencil sharpener, he explained (with obvious humor) that at Harvard Law School the professors only work in ink. It took me twenty minutes to locate a pencil sharpener, in the Office of the Registrar.
By the end of the afternoon, I had completely settled into my office. It still looked very bare, with virtually all of the bookshelves empty, but I felt quite at home. Thanks to the large windows, it was very light and seemed quite spacious to me. I knew that I could work there very well indeed.
To celebrate, I walked to Harvard Square and had dinner at the Wursthaus, at 4 John F. Kennedy Street. This is the only restaurant of which I was aware that still existed from my time at Harvard, and it had not changed in the slightest.
Back at my office, I started to work on the course syllabus. On a trip to the west coast in December, I had decided on the following schedule:
January 3. Introduction and History.
January 4. Jurisdiction and Enforcement.
January 5. Human Food (definition and labeling).
January 6. Human Food (nutrient content).
January 7. Human Food (sanitation and safety).
January 10. Human Drugs (definition, labeling, and advertising).
January 11. Human Drugs (investigational new drugs and approval of new drug applications).
January 12. Human Drugs (control of prescribing and regulation of nonprescription drugs).
January 13. Animal Feed and Drugs.
January 14. Human Biologics and Biotechnology.
January 17. Holiday (Martin Luther King Birthday).
January 18. Human Medical Devices (definition and labeling.)
January 19. Human Medical Devices (the Medical Device Amendments of 1976).
January 20. Human Cosmetics and Color Additives.
January 21. Carcinogens.
January 24. Overview
I had not yet found time to prepare a detailed syllabus of assigned reading materials, however, and thus proceeded to begin to do so. My secretary, Joe Guberman, said that he did not wish to work with dictated tapes – my customary way of preparing all written materials for the past thirty-five years. I therefore started work on a handwritten syllabus, a new experience.
At 11:00, I walked back to Eliot House. Because I was unfamiliar with the best route, I decided to walk across Massachusetts Avenue, through Harvard Square, and then to Dunster Street and Eliot House. It proved to be longer and less direct than I had anticipated and took about twenty minutes.
When I reached Eliot House, I discovered that the key they had given me did not work in the front door. I had to use a separate key to get into the Faculty lounge and from there into the quadrangle. When I reached my room, moreover, it was absolutely freezing. I could not tell whether it was colder outside or inside. Obviously, they had cut off all of the heat, keeping it just above freezing, while the undergraduate students were gone. I piled all of the available blankets, about seven, on top my bed and went to sleep.
I woke up at 7:30 almost frozen in spite of all the blankets. The only thing that saved me was a lovely hot shower. I left the room as quickly as possible. Because the Eliot House dining hall was closed until the undergraduate students arrived back in about a week, I left my room, walked directly up Dunster Street and through the familiar surroundings of Harvard Yard (which had not changed at all since I was here thirty-five years ago), across the bridge that spans Broadway (which did not exist in my day), between the Littauer Center (where I did much of my research for my third year paper on federal milk marketing orders) and the Science Center (which did not exist), between Austin Hall and Langdell Hall (where all of our classes were located in those days), and into Griswold Hall. This was to become the route that I would follow every morning and night for the next month. It took about fifteen minutes and was a very reassuring way to go. When I lived at 21 Ellery Street during my days at Harvard Law School, I walked every morning down Harvard Street to Harvard Yard, proceeded diagonally through the Yard, crossed Broadway at exactly the same place (although without the benefit of a bridge), and into the Law School.
I spent the morning completing my handwritten syllabus. It followed the outline I had already prepared, and specified the pages in the casebook that would be covered each day. I concluded to make the casebook "notes" optional reading. There were no references to the statutory provisions that would be covered because I concluded these would be obvious from the assigned casebook materials.
For lunch, I tried a sandwich at the Hark Box, a fast food stand in Harkness Commons. It was quite adequate. I said hello to Professor Frank Sanders, whom I had known for some years because he had obtained from me materials relating to the regulatory history of caffeine in soft drinks for a case study in his legal ethics course. He told me that the case study is still used in the course.
I had been told that it would be essential to obtain a Harvard identification card, but that if I did this through normal channels it would probably arrive long after I had left. I therefore went to the designated office in Langdell Hall, where they immediately took my picture and telephoned the appropriate official in the Holyoke Center on Massachusetts Avenue. I walked to the Holyoke Center, where I was promptly handed my official Harvard ID. The entire process took only an hour, which I was later told set a modern world's record at Harvard.
Upon my return, I tackled the telephone system. Although the telephone did not ring through to any secretary at all, it did put the caller into a phone mail that worked quite well. All I had to do to retrieve the message was to dial 58170 and then my number, 53137 (two numbers that I was never able to memorize). The difficulty was that I could not, even with explicit instructions, change the introductory message in the phone mail system. Finally, Joe Guberman got professional help from a telephone expert and we succeeded in changing it to my name.
I was warned, however, that it would take even longer for my name and telephone number to appear in the Harvard system than it would be to achieve any other miracle. I therefore made a note to give my telephone number to all of the students, so they would be able to reach me. By the time I left four weeks later, the Harvard telephone system was still telling people that I was not there.
The same difficulty arose with placing my name outside the office complex and next to my office door. Tom Potter told me that this would take six months. I therefore took the matter into my own hands, prepared my own handwritten name plates, and put them up with scotch tape. They worked just fine.
After attending to these housekeeping details, I turned back to my academic tasks. I revised and corrected the syllabus that Joe had typed, and then began work on a handwritten outline of the first day of the course. There were a number of important administrative issues relating to the course that I had to resolve in order to prepare this outline, five of which I had gone over in my mind for the past two months and thought to be critical to the success of the course. As I reviewed them again, I kept in mind Sarah's parting admonition to consider everything from the standpoint of what the students would think about it.
First, I had concluded that there should be assigned seats and a seating chart so that I could call each student by name. When I had visited in early December and found grooves in the tables for name cards, I wanted to have these as well. I planned to walk the aisles of the classroom, not to stay behind the podium. It seemed to me much easier to have name cards to which I could refer during the middle of a discussion, rather than relying only on a seating chart that would be located at the podium. My two experts on law school classes – Peter and Sarah – warned me, however, that this might be viewed with some dismay by the students. I therefore decided definitely to stick with the seating chart but to talk to the students about the name cards before I prepared them.
Second, I thought it very important to obtain information on the students. The only way I knew to do this easily was to obtain their resumes. Again, Peter and Sarah said that this might be viewed with suspicion. I could not imagine why students who send out thousands of resumes looking for employment would be concerned about giving their resumes to me, but I decided to make this voluntary rather than mandatory.
Third, both Peter and Sarah told me that students like to know in advance when they will be called upon. On the other hand, I planned an entirely interactive course, where I would call on anyone at any time (as I have done for more than twenty years in my segment of the Civil Liberties Seminar at the University of Virginia Law School). I therefore decided on a compromise. There would be presentations on set topics by designated students each day. The class discussion would then be completely interactive. Although I had not previously thought about it, I decided that the student presentations should be focused on a specific proposition, with one student arguing for it and another arguing against it. I decided to select the students for these presentations randomly ahead of time, without prior knowledge about their background and interests. If an assigned student was absent, I would personally assume that student's place and make the assigned argument.
Fourth, the Registrar had told me that there had to be an examination and could not be written papers. Other people had also counselled against papers. I had tentatively agreed to a three day take home open book examination. On the other hand, I wanted to raise with the students the question of a page limit and to ask whether they would prefer any other form of examination. After all, they were the ones taking the examination, not me. Any form that they chose would be acceptable to me.
Fifth, I wanted to have complete interaction with the students. I was there for them, not for any other reason. I was therefore determined to have entirely open office hours, beginning after the conclusion of class and lasting until I left the Law School late at night. Anyone would be free to see me at any time.
With those main principles in place, I divided up the first day into two segments. The first segment would relate to the course, the examination, and administrative details. It would include a brief summary of my own life, so that the students would know who I was and how I came to be teaching them. The second segment would outline the history of food and drug law and would discuss the structure of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938.
When I completed the outline of the first day, I turned immediately to the issues for student presentations. With the concept firmly in mind and the syllabus completed, the issues were relatively easy to identify. I wanted each of them to raise broad questions on which there could easily be two competing views, involving both statutory and policy considerations. Once the issues were identified, I began randomly to assign students to them. I paid no attention to whether the students were men or women, or second or third year students, except in one instance. I made certain that I assigned two women to the issue whether FDA was correct in permitting breast implants to be used for reconstructive surgery but not for cosmetic purposes. I concluded that it would be inappropriate and unfair to have men debating this issue.
That evening, I had agreed to meet for dinner with Mark Butler, formerly the Deputy General Counsel of Warner-Lambert and now the Chief Operating Officer of Interneuron Pharmaceuticals, Inc. Two other Interneuron officials joined us: Glenn L. Cooper, M.D., the President, and Bobby W. Sandage, Vice President for Research and Development. I had thought that the purpose was to discuss Interneuron regulatory issues, but toward the end of the meeting Glenn asked me to consider becoming a member of the Board of Directors. I said that I would be happy to consider it. We had a very good meal at Rarities at 1 Bennett Street in the Charles Hotel.
When we were finished, at 10:00, it was snowing heavily. I walked back to my Law School office and suddenly realized that my right foot seemed quite wet. I discovered that my shoe had a large hole. From then on, I wore rubbers whenever I was outside.
From 10:00 to 12:00, I continued to work on the student presentations. When I left my office, there was already three inches of snow and it was quite beautiful everywhere.
Fortunately, I had run into Kevin Van Anglen when I was leaving Eliot House that morning. I had casually inquired about the heat, and learned that there were two electric room heaters that I had not noticed. The minute I returned to the Matthiessen Room I found the heaters, placed them on either side of the bed, and turned them on. Within a short while, the bed became much more comfortable. Nonetheless, I kept five blankets on the bed, as well as using the two heaters, the entire night.
I did not set an alarm, and thus woke up at 8:30. It was comfortable close to the heaters, but they did not keep the entire room warm. When I looked out of the windows, I found ten inches of snow on the ground. It was extremely beautiful. I hurried to get up and took a number of photographs of Eliot House in the fresh snow.
With the snow at hand, for the first time I wore the full length sheepskin coat I had purchased for myself at the Overland Sheepskin Company in Santa Fe. It felt extremely warm. I walked my customary route up Dunster Street and through Harvard Yard, taking pictures along the way. I went directly to the Hark Box to buy coffee and donuts, and because of my own carelessness I fell on the ice as I returned to my office. My Buffalo ego was bruised but otherwise I was unharmed. It was the only time I fell the entire month, in spite of treacherous conditions.
That morning I made the final revisions in the syllabus and completed the final list of student presentations. I was quite satisfied with both.
For lunch, I again went to the Hark Box. I completed the outline of the first day, and then dropped in to see Professor Emeritus Clark Byse, one of the best-known administrative law teachers in the country, who was now in his 80s. He immediately reminded me of my luncheon talk in March 1982 in New Orleans to a workshop on teaching administrative law conducted by the Association of American Law Schools. I had begun that talk with the statement that either the professors were not teaching administrative law, or I was not practicing administrative law, because what they taught and what I did every day were completely different. He said that my remarks were right on target, and he has always remembered them. During those remarks, I had said that I mercifully did not recall who taught me administrative law at Harvard Law School. He said that, when he returned from New Orleans, he immediately looked it up and was relieved to find that it was not he.
Professor Byse and I then talked for a few moments about teaching administrative law. He asked me whether I intended to "lecture" or to "teach." I said that I intended to use a format of open discussion, which we called the "Socratic method" when I was at Harvard. It was now in some disrepute because of the movie, "The Paper Chase," and the harsh way in which some teachers have used this technique. He immediately agreed with me that this was the only way to teach.
I walked through the Library, most of which remained unchanged from my days here except that, to my dismay, computers had replaced the familiar card catalogues. I dropped in to see Professor James Vorenberg. He had been the Executive Director of the United States Crime Commission under President Lyndon Johnson, and I had at that time known him quite well because I served as an advisor and consultant on the relationship of alcoholism to the criminal law. I had been forewarned by Sue Robinson that Jim has tragically been stricken with Parkinson's Disease, but we had a wonderful time reminiscing.
Returning to my office, I began the outline for the second day of classes. For the past two months I had been debating, in my own mind, whether I should follow the approach of the casebook and Dick Merrill by plunging directly into regulation of human food, or whether I should begin with one or all of three areas that span all of food and drug law: jurisdiction, enforcement, and FDA practice and procedure. I had tentatively concluded that it was important for students to understand FDA jurisdiction and enforcement, but that the Agency's practice and procedure was far less important and could be left to emerge as part of the substantive discussion during each class. I had, in fact, stated in the catalogue that administrative law was desirable but not mandatory. As I thought through it again, my earlier conclusions were re-enforced.
For the second day, therefore, I outlined a review of FDA jurisdiction and enforcement. It would be a brief overview, but I thought it would be sufficient to set the stage for the substantive discussion of FDA-regulated product areas that would comprise the rest of the course.
By 8:00, I had finished the outline for the second day and was hungry. I returned to Rosie's Bar and Grille for dinner. It was extremely cold, with more snow predicted, but my coat kept me quite warm. Nonetheless, I did not like eating in a restaurant by myself. I have never enjoyed eating alone in a restaurant, and have done it only rarely. I vowed to find a nearby college or law school hangout where it would be more fun.
Returning to my office, I began to work on the outline for the third day, covering the definition and labeling of human food. I called my Mother and my sister, Sally, who found it quite wonderful that, after a thirty-five year absence, I was once again at Harvard Law School and having a thoroughly enjoyable time. At midnight, I walked back through Harvard Yard in the new snow. Although the City of Cambridge seemed to be having difficulty coping with the snow, the Harvard paths were kept quite clear. It was a beautiful sight to see Harvard glistening in the fresh snow.
Again I got up late, at 8:30, and was glad that I had the two heaters. There was fresh snow on the ground. It seemed somewhat warmer as I walked through Harvard Yard, but the radio promised that by mid-day it would be below zero degrees throughout the area.
After stopping for coffee at Au Bon Pain at the corner of Dunster Street and Massachusetts Avenue in Harvard Square, I continued on to my Law School office. I finished the outline for the third day and began the fourth, on regulation of the nutrition value of food. It was obvious that, by working all day Sunday, I would be fully prepared for the entire week. I therefore walked up Massachusetts Avenue, rented a car from the National Rental Car office, and obtained a room in the Charles Hotel. After lunch at the Wursthaus, I bought a new suit at the J. Press sale at 82 Mount Auburn Street. At the Coop, I bought Harvard and Harvard Law School ties. After walking to the Law School, I took a taxi back to the Charles Hotel because it was so cold. On New Year's Eve, I was in a warm room, with modern conveniences, and in bed at 11:30.
Today was my time for exploring Cambridge and Boston. I rightly anticipated that this would probably be the only time during the month that I would have this luxury.
Leaving the hotel, I drove to 21 Ellery Street, where Truman Bidwell and I lived in the second floor rear apartment for our three years at Harvard Law School. It was still painted gray with white trim, and looked absolutely the same. All of the nearby stores on Massachusetts Avenue had changed, however, and even the gas station at the intersection of Massachusetts Avenue and Harvard Street had been converted into the new Inn at Harvard.
I drove along Massachusetts Avenue, over the bridge into Boston, and parked at the Ritz Carlton Hotel. For the next few hours I walked along Newbury Street, stopping in all the shops. I had lunch at Joe's American Bar and Grill, which was terrific. Marblehead Antiques, at 215 Newbury Street, had a number of interesting items, including sets of Harvard and Wellesley plates.
From there, I drove to two antiques malls on Monseigneur O'Brian Highway. Although there were several floors of booths, there was little of interest. After walking along Charles Street to look at the antiques stores there, I returned to the Charles Hotel to watch the football games, have room service, and watch a movie.