Journal

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January 9, 1994 Sunday

The radio awoke me at 6:30, but I did not get up until 7:15. After a brief cup of coffee at Eliot House, I began my customary trip through Harvard Yard to my Law School office. The snow had stopped, and the sun was out in a bright blue sky, but it remained extremely cold and windy. I stopped to obtain danish and a large cup of coffee at Au Bon Pain at the corner of Dunster Street and Massachusetts Avenue in Harvard Square.

Starting at 9:15, I completed my preparation for the seventh day and began the outline for the eighth, on control of physician prescribing and regulation of nonprescription drugs. I called Mother and Sally, as well as the children, to give a full report on the first week.

At 1:15, I called the Three Aces to have them prepare a small pepperoni pizza. In spite of the sun, it was still an extremely cold day as I walked the few blocks to the restaurant. I returned to my office by 2:00, and finished my preparation for the eighth day. By 6:45, I was also finished with my outline of the ninth day, on animal feed and drugs.

For dinner I walked back to the Three Aces for a steak and cheese submarine sandwich. When I returned, I called my daughter, Kathy, an Associated Press reporter, who questioned me intensively about the first week of classes. I decided that I should record the experience that I was having at Harvard Law School this Winter Term in some appropriate form. I therefore dictated the prologue to this journal, summarizing the origin of the casebook and my invitation to teach during Winter Term. I finished it, straightened up the office, and at 11:45 walked back through Harvard Yard to Eliot House. It was still five degrees, with a strong wind. By now, however, I had learned to brace myself as I walked through the wind tunnel on Dunster Street. I was beginning to feel very much at home at Harvard.

January 10, 1994 Monday

The radio informed me that, from the time I got up until I left the Matthiessen Room, the temperature had decreased from seven degrees to six degrees. There was a strong wind as I walked my customary route up Dunster Street and through Harvard Yard. By the time I reached my Law School office, I needed the large cup of coffee I bought at the Greenhouse Cafe.

The class was undoubtedly the best to date. We began with another superb debate on the restrictions that FDA has imposed on disease prevention claims, between Stanford Lin and Peg Bolce. The class was surprisingly supportive of the FDA restrictions. I argued strenuously that the GRAS exclusion from premarket approval should be abolished, and Kimberly Yahr argued very persuasively that it should be retained.

We then discussed food sanitation at length. First, Harry Johnson and Erin Fuller debated whether all food should be labeled with the filth content. The history of the FDA "unavoidable natural defect" (filth) guidelines emphasized to the class what I meant when I talked about "real" administrative law. They agreed that I had no choice but to release those guidelines to the public in 1972. While they agreed conceptually that the public should know about the level of fifth tolerated by FDA, they confessed that on a personal level they would rather not know about it.

Kathleen Flaherty attacked the legality of the Hotlix candy sucker I had provided (which contained what we all described as a very prominent and visible worm which was declared in the label statement of ingredients as "insect larva") and Rob MacRae defended it with equal vigor. In the midst of the debate, Norman Carlin, who had a Ph.D. in biology and taught this subject to graduate students at Harvard, inspected the product closely, announced it was actually a Darkling beetle, probably a mealworm, and provided the proper Latin name: Tenebrio molitor. To add to our knowledge, Alice Arndt, a member of the Culinary Historians of Boston who had come from Houston, Texas, to audit the course, gave a brief summary of the use of rodents and insects as food items throughout the rest of the world. We concluded this part of the discussion by raising the possibility of a chain of fast food stores selling ratburgers.

The second half of the class, which dealt with more conventional food safety issues, was equally intense. I noted that the Harvard Law Review had taken the position that fish with a high level of mercury, that FDA determined to be unsafe, should be available on a physician's prescription, and asked Michael Pompeo (a member of the Review) if he wished to defend that proposition. He declined the opportunity, to the great amusement of the class. In considering the safety standard that should be applied to food ingredients, I posed the following issue to Harry Johnson. I hypothesized a new agricultural product, called P, which was an excellent source of protein, mixed well with other ingredients, had a superb taste, and could be used in a wide variety of processed food products. The only trouble with P was that one person out of between five and ten million people is allergic to it, and can suffer a fatal anaphylactic shock. Harry Johnson and the rest of the class struggled with the issue with no clear resolution, but the consensus appeared to be that it should be banned. When I revealed that I was talking about peanuts, and asked Harry Johnson how he felt about the matter now, he responded simply that "I feel like a fool." We all laughed, and although the class ended at that point, most of the students remained in the classroom discussing the issues of the day, with great animation.

I could definitely feel the cohesion in the class that I had sought from the beginning. There was no person attempting to dominate, no clique that espoused a set ideology, and no fear on the part of anyone to state their own personal views. The entire class was becoming a friendly and spontaneous community, willing to discuss any issue openly and with candor. There was an electricity and excitement that I did not recall from my own Law School classes. I left the class that day knowing that I had fully succeeded in what I had come to accomplish. But I also knew that I could not let up for a minute. I did not want to let it slip away.

After the third class, two students had asked if I would be able to have lunch, and I immediately agreed to do so. At 12:00, I had lunch with Gregory Duhl and William Aaronson, both second year students, at Changsho. I made a mental note that I had now established sufficient confidence and trust with the students that they would not feel it unusual if I were to make a general announcement offering to have meals with them.

Although I had not previously thought about the mundane question of who would pay for lunch, it seemed to me wrong to try to split it up. I did not want students to be concerned about the choice of the restaurant or the food, or even whether they could afford to have a meal with me, and it was therefore a simple decision to pay for the entire meal whenever I was with a student. This was an easy rule to articulate and to follow, and I believe that it contributed to the relaxed and very enjoyable times that I experienced with the students on these occasions.

Most of the afternoon was occupied with talking to students about papers and requesting additional materials to be sent by Beth and Marilynn to help them in their research. I also sent my first tape to Beth by Federal Express. Fortunately, I had Beth prepare for me, before I left Washington, some fifteen Federal Express forms with the Covington & Burling account number and Beth designated as the recipient. This meant that I could send whatever I needed done back to her without difficulty.

Kimberly Jackson, who was writing her third year paper on the Daubert decision by the Supreme Court under a Scholarship from the Food and Drug Law Institute and for her third year paper requirement, asked me to review a first draft. In the course of her discussion, she mentioned the student evaluation of teachers. Until then, I knew nothing about this. We simply did not evaluate teachers during my time at the Law School. She was a member of the Board of Student Advisers, which conducts the evaluation. She promised to get me a copy of last year's compilation.

Last week, I discovered that my former partner, Michael Boudin, who is married to Professor Martha Field and taught part time at Harvard Law School for about a decade while he was still practicing law at Covington & Burling, was teaching in the Spring Term rather than the Winter Term. He was now serving as a judge on the United States Court of Appeals for the First Circuit. I telephoned him, and we agreed that we would have dinner this evening. He then persuaded Stephen Breyer, Chief Judge of the United States Court of Appeals for the First Circuit, and Professor Charles Fried, the Solicitor General under President Bush, to join us, along with their wives. Michael picked up Charles and me at the Law School at 7:20 and drove us through the snowy streets to the Peacock Restaurant at 5 Craigie Circle, where we had a wonderful dinner full of interesting conversation. When I explained how much fun I was having, and how thoroughly I enjoyed the intense three hour format every day, they were somewhat skeptical. Steve Breyer and I had fun recalling that I had been responsible for his being appointed to the Committee on Saccharin of the National Academy of Sciences, which was established at the direction of Congress in the late 1970s. Students had told me that he often refers to this experience in his administrative law course. It was truly a remarkable evening, and as is often true on these occasions I felt honored to be included with these extraordinary individuals.

Michael dropped me off back at the Law School at 10:00. For the next hour, I prepared my lecture for the Harvard School of Public Health, that I would deliver tomorrow. At 11:15, I walked back through Harvard Yard to Eliot House. It seemed somewhat warmer than five degrees, but this may be because the wind was not quite as strong.

January 11, 1994 Tuesday

The radio said it was still five degrees but promised that it would get warmer. On the way to my Law School office I stopped at the Greenhouse Cafe and this time sampled yet another new coffee, which contained cinnamon.

The weekly Harvard Gazette for January 7 appeared this morning. I circled all the articles and announcements that related to food and drug law and read them to the class, simply to illustrate the breath of the subject matter we were studying. There were some ten clinical studies relating to food and drugs, for example, for which various parts of the University were recruiting subjects.

It was another excellent class. The two student presentations focused on patient package inserts and prescription drug advertising to consumers. Jim Nuzzo argued in favor of patient package inserts, and Scott Emery argued against them. In a related area, Michael Pompeo argued that prescription drug advertising to consumers should be prohibited, and Harold Rowe argued that it should be permitted. Each of the presentations was thoughtful and comprehensive, but I did note that they were definitely longer than those of the prior week. When I argued strenuously that a product as dangerous to the unborn fetus as Accutane simply should not be marketed at all, I was met with unanimous opposition from the women in the class who contended that this type of government paternalism was unwarranted. The class tended to favor more information for consumers, rather than less, and that forced me to take the opposite position in order to bring out all the issues. By the end of the session, they adhered to their position but they were far more aware of the complexities involved.

Immediately after class, I walked to Harvard Square and took a taxi to the Harvard School of Public Health. When Professor William Curran retired from the Harvard School of Public Health, a search was made for an appropriate replacement. As part of the selection process I was asked, at the time, to review and comment on the background of the three final candidates. After reading the three resumes, I concluded that it was no contest. Troyen Brennan was by far the outstanding candidate. He was a physician and lawyer and also had a masters degree in public health, all with extraordinary academic achievement. He was, in fact, later selected as Professor of Law and Public Health, and Associate Professor of Medicine, at the School of Public Health. When he learned that I was teaching a course on food and drug law at the Law School, he wrote in August 1993 to ask me if I would talk to the School of Public Health while I was there. I immediately accepted. After several telephone calls, we agreed that I would talk today on the FDA approval process for lifesaving drugs.

I talked on this subject for roughly an hour to an audience of twenty-seven, and then engaged in a spirited discussion with two members of the Faculty (who disagreed vehemently with each other) on whether FDA is too strict or too lenient in approval of new drugs. Troy also arranged lunch with four lawyers who were obtaining a masters degree in public health at the School of Public Health.

My presentation at the School of Public Health was a straight lecture, in contrast to the Socratic style of teaching I used at the Law School. It was much less demanding and satisfying, and I wondered whether I would in the future be able to enjoy my customary lectures throughout the country on food and drug law as much as I have in the past.

At 3:00, I took a taxi back to the Law School with Christine Solt, who is a research assistant for Troy and is also taking my course. She had given a superb presentation on food fortification last Friday, one of the most impressive student presentations to date. Back at the Law School, I saw three more students about their papers.

At 4:45, I walked across the Cambridge Common to Radcliffe Yard and found the Schlesinger library. Last fall, I had informed the Culinary Historians of Boston, of which I have been a member for several years, that I would be in Cambridge during the Winter Term. I was immediately asked to give their January talk. I met Barbara Haber, Curator of the Library, and Joe Carlin, one of the leaders of the organization, in Barbara's office. We walked from there to dinner at John Harvard's Brew House at 33 Dunster Street. I have walked by it every morning and night for the past two weeks, but have never had an opportunity to go inside. It was a thoroughly delightful college pub, and I had a very good meal along with five small samplings of the beer produced in the microbrewery.

We walked back to the Schlesinger Library where, at 7:00, I gave a seventy-five minute presentation on the history of food regulation to about twenty-five people. It was enthusiastically received. I left with them a copy of the article Peter and I published in 1984 on this subject.

Back in my Law School office at 9:30, I went through the materials that Beth had sent me and prepared, as I always did, for the next day. By now, the temperature was somewhat warmer, about fifteen to twenty degrees. As I walked through Harvard Yard at 11:00, students were again playing in the snow. Two groups had made snow forts and were having a snowball fight. I must admit that I have thoroughly enjoyed these nightly walks, during which I feel no time pressure at all. It is really a leisurely stroll through a life of thirty-five years ago, recalling lovely memories.

January 12, 1994 Wednesday

The temperature made it all the way up to twenty degrees during the night. There was a lot of slush, and it was particularly difficult to find a place to cross Massachusetts Avenue without wading through deep puddles of water, but the large mounds of snow that still prevailed everywhere did not seem to be melting. I chose the chocolate-raspberry coffee at the Greenhouse Cafe.

The class today focused on FDA regulation of new drugs under the investigational new drug (IND) and new drug application (NDA) requirements. Reginald Williams argued that the IND phase of human drug development should be deregulated, and Danielle Shelton argued against this proposition. Greg Duhl contended that FDA should loosen the NDA approval requirements for all human new drugs, and James Oliver argued for strict approval requirements. There was near unanimous agreement that FDA should do something to speed up development of new drugs, but they were unable to agree how to reduce FDA controls. I again distributed a large amount of materials received from Beth and Marilynn.

During the first week of classes, I had been reluctant to say that I would be available for lunch or dinner, out of fear that this would be viewed as a command performance. By now, however, I thought that I was over this hurdle. The fact that two students had already asked to have lunch with me seemed a good sign. I therefore said that I would be quite happy to have lunch or dinner with individual students or with groups at any time until I left. I noted that those who chose to do so could also feel good about saving me from the dreaded Three Aces. The response was overwhelming. It appeared that I would have company at every lunch and dinner for the next two weeks.

After seeing a few students about their papers, I went to lunch at 12:45 with Bryan Liang at the Border Cafe, 32 Church Street, in Harvard Square. He is a physician and has a Ph.D in public policy. He has researched blood bank issues previously, but has decided to write his paper on regulation of cosmetic claims. By the time we walked back to the Law School, it was still warmer and Harvard Square was full of slush.

At 2:00, I went to see Sue Robinson. We had a wonderful talk about our days in Kenmore and the current status of Harvard Law School. She was pleased that I was having such a good time. I told her that, if the Law School wished to have me teach the course again, I would certainly consider doing it every two years, but only during Winter Term.

The Office of the Registrar told me that one of the people listed as attending the class, Robert Hahn, who never seemed to be present, had been discovered to be a student at the Kennedy School who intended only to audit the course. Another person, Julia Cohen, was also auditing the course, although I had her sitting with all the rest of the students, frequently asked her questions, and had assigned a student presentation to her.

Back at my office, I again met with students. At 6:00, it began to snow again. I went through Beth's materials until 8:00, when I walked to the Three Aces for a steak and cheese submarine sandwich. I returned to my office and completed straightening out all the papers that were accumulating on my desk. I prepared a revised list of the student presentations, to account for the changes made resulting from the student additions and deletions during the first week. In anticipation of my discussions with students during lunch and dinner, I wrote a list of questions about the course on which I would invite their candid responses. Walking back to Eliot House at midnight through the soft new snow in Harvard Yard, I again paused to watch students building snowmen and engaged in endless snowball fights, working off nervous energy from their freshman examinations.

January 13, 1994 Thursday

The radio woke me at the usual 6:30 with the startling information that the temperature was twenty-six degrees, the highest since I had arrived more than two weeks ago. As I walked through Harvard Yard, the snow did seem to be melting, but certainly not at a fast rate. Once again, I sampled a new coffee, the Harvard Blend, at the Greenhouse Cafe.

My new approach to teaching  – restricting the class to major issues which provoke substantial discussion, and not worrying about covering all aspects of the subject  – was now keeping me on schedule. I was still one day behind, but I had perhaps intuitively kept the last day free for any contingency. At least I was not falling any further behind.

Class today focused on good manufacturing practices and restricted distribution of new drugs. I began with a topic that was not the subject of a student presentation, the requirement of good manufacturing practices for human drugs. The class spent a great deal of time discussing the problems inherent in FDA enforcement of a vague, highly subjective, and constantly changing requirement like good manufacturing practices.

Kimberly Jackson made a presentation for prohibiting all unapproved uses of approved human new drugs, and David Gevertz argued against that position. We discussed at some length the difficulty of regulating unapproved uses of approved drugs. Vernadette Ramirez argued strenuously that FDA should in some way force drug companies to conduct clinical trials to validate or disprove unapproved uses. I kept baiting her, asking her just what FDA could do to force the industry to take this step. Finally, when she realized that there was no practical way for FDA to force industry to undertake this type of testing (because it is not realistic for FDA to threaten to withdraw approval of admittedly safe and effective drugs), in exasperation she threatened not to approve any of the company's new drugs in the future. I immediately shouted "Extortion! Bring in the FBI!" to the great hilarity of both Vernadette and the rest of the class. Without knowing it, Vernadette had instinctively found the one sanction that FDA constantly denies it uses, but that industry fears most of all. For me, it was one of the most extraordinary moments that I have every experienced in any classroom. We concluded the day with a debate between Catherine Dargan and Lisa Baar on whether the FD&C Act should be amended to permit FDA to restrict the distribution of approved human new drugs.

Once again, the presentations were excellent, and I explicitly said so. We have simply not had a bad one yet. We did not reach nonprescription drugs, but I was convinced that we could do this and still cover all of animal feed and drugs on Friday.

I have already noted that the student presentations, which I had originally characterized as a one to three minute summary of the assigned argument, gradually lengthened throughout the first week and reached an average of five minutes by the beginning of the second week. I talked to the students about this. They agreed with me that this was a natural and probably predictable result of the desire of the students to do their best before their peers. Students are not accustomed, in classes at the Law School, to make prepared oral presentations on an assigned topic, i.e., to make an oral argument. None of the students with whom I discussed the matter knew of any class in which this was done. They uniformly praised the idea, and said that they felt it gave them an opportunity to demonstrate their ability in a context quite different from the usual Socratic discussion. The inevitable result, however, was that they wanted to do their very best before their fellow students, particularly in a class where a close relationship had developed among the students, and thus the presentations had lengthened. Students were doing extensive research, and preparing detailed outlines of their presentations, often with footnotes.

Following these discussions, I considered whether I should comment in class on the length of the presentations, or set an arbitrary time limit, or even intrude if an individual presentation was going on too long. I concluded not to do any of these, because the approach was going so well. It seemed to me that the concept of this approach was as important as the substance of the arguments that were made. Lawyers make oral presentations every day, on assigned topics, and this was an unusual opportunity for the students to get a preview of what it was like. Most important, the students were taking great pride in their presentations, as shown by the very high quality of their performances, and I did not want to risk diminishing this in any way. From my own days at the Law School, I knew how rare it was for students to be able to take command of a situation in class, demonstrate comprehensive knowledge about a subject matter, and thus gain their own confidence in their ability and the respect of their fellow students in the process. Although a few students did go to excess, it was a small price to pay for an approach that had so many positive attributes.

After class, I went to see Professor Todd Rakoff, who teaches administrative law. Todd succeeded Professor Daniel Meltzer, who is on academic leave for the year, as Associate Dean and Chair of the Appointments Committee. Sue Robinson had told me that, in his capacity as Chair of the Appointments Committee, he should drop in to see one of my classes. I therefore talked to him about how the course was going and invited him to attend at any time.

As I walked out of Todd's office, I saw Professor Elizabeth (Betsy) Bartholet and stopped to talk with her. I had known her since the mid-1960s, when she had just graduated from Harvard Law School and was working with Jim Vorenberg on the staff of the United States Crime Commission. Later, when I was at FDA, she telephoned me to seek funds to start what became the Legal Action Center in New York City. I told her that FDA had no relationship to alcohol and drug abuse (the matters of chief focus for the Legal Action Center), but introduced her to Robert L. DuPont, Jr., M.D., the Director of the National Institute of Drug Abuse. NIDA gave her a large grant that allowed her to start the Center. I have served as a Board member of the Center since 1976 and as Vice Chairman since 1984. Betsy served as the Center Director until she came back to Harvard Law School in 1977 to teach. We agreed that we would have lunch while I was there.

I had scheduled a lunch for today with Assistant Professor Bruce Hay, who just recently came to Harvard Law School to teach environmental law. Harvard has had a large hole in the Faculty with the loss of Professor Richard Stewart. Dick, who spent his first five years at Covington & Burling, taught administrative law and environmental law at Harvard for many years, but then left. Bruce Hay was obviously intended as his replacement. Because one of his children was ill, however, we had to reschedule lunch for the following week. I therefore went to the Faculty dining room at 12:45 and had a thoroughly delightful lunch with Professors Brudney, Cox, Horwitz, Stone, Vagts, Vorenberg, and Wolfman. We talked about the great university leaders of our generation, without reaching any consensus.

Following lunch, I dropped off four rolls of film at the Coop store located in Harkness Common. As I returned to my office, I met Professor Lawrence Tribe and Professor Joseph Singer. Joe Singer, who is married to Professor Martha Minow (who had been a summer associate at Covington & Burling), teaches conflict of laws and was interested in food and drug law preemption cases and statutory provisions.

Back at my office, additional students came to talk about their papers. Approximately half of the class had now talked to me about a paper, most of them on more than one occasion.

For dinner, Andrew Schmolka and I went to the Wursthaus at 6:30. I walked back to my Law School office, where a student managed to find me by asking a security guard to let her into the building. After 6:30, Griswold Hall is virtually impregnable. When she attempted to telephone me, the Harvard telephone system informed me that I was not listed anywhere. I made a note that I should once again give the class my telephone number, so they can reach me during the evenings and weekends. I filed all the materials sent by Beth and prepared for the next morning. It was colder as I walked back through Harvard Yard to Eliot House at 11:00, but not at all like the terrible temperatures and wind of a week ago.

January 14, 1994 Friday

I got up a little later than usual, at 6:45. When I packed in Washington, I decided to bring a different tie for each day. I put thirty ties on a hanging rack that Sarah gave me for Christmas, and have worn a different tie each day. Today was the day for my blue tie with the white Yale seal.

The radio told me that it was twenty-six degrees and would remain relatively "warm" for the rest of the day, but would then turn cold again. After picking up my customary coffee at the Greenhouse Cafe, I arrived at my office later than usual, at 7:45.

We began the morning with a debate between Trina Hunn and John Giezentanner on the legality of the OTC Drug Review. I explored with the class the role of counsel to the industry in cooperating with FDA to establish a regulatory program for which there is no clear statutory basis. We then turned to a surprisingly interesting and challenging session on animal feed and animal drugs. Rebecca Topol contended that animal feed should be subject to less stringent regulation and human food, and Annette Elton argued that they should be subject to the same requirements. The class seemed inclined to allow less stringent regulation of animal feed than human food, and even Annette Elton wisely conceded, after consultation with her cat (who likes to consume mice), that the issue of filth in animal feed was not of major concern. The role of uncertainty in FDA regulation was paramount in our discussion about the perplexing thirty-five-year debate about the safety of antibiotics in animal feed. Kimberly Miller argued that, as long as there is any uncertainty about safety, antibiotics should be banned from animal feed, but Steve Rabinowitz contended that uncertainty should not always result in a ban.

We returned to the discussion about unapproved uses of approved products, this time in the context of animal drugs. John Gardner argued for prohibiting all unapproved uses of approved animal new drugs, and Donna McGraw argued that these uses should not be prohibited. Whereas a majority of the class favored the authority of physicians to prescribe approved human new drugs for unapproved uses, most opposed giving the same authority to veterinarians for animal new drugs. Once again, I was prompted to remark on the excellence of the student presentations.

After seeing students, I had lunch with Norman Carlin at the Casablanca Restaurant and Bar at 40 Brattle Street. We waded through slush going both ways. Norman was a member of the Board of Student Advisors, and in that capacity asked me to review the case materials prepared by the Board for a moot court argument relating to blood contaminated with HIV.

During the afternoon, I met with students, made various telephone calls, tried to catch up on sorting and filing materials sent by Beth, and sent materials back to Beth by Federal Express with various instructions.

At 7:45, I walked to the Three Aces for a small steak and cheese submarine sandwich. The slush made it difficult to cross the streets. I finished cleaning my desk and made calls to the family.

By the time I walked back through Harvard Yard to Eliot House at 11:15, the weather had again changed dramatically. It was ten degrees, with a strong wind. All of the slush had turned to ice, making the trip treacherous. The late news on TV said that it would get even colder over the weekend.

January 15, 1994 Saturday

The alarm went off at 6:30, because I had forgotten to turn it off, but I went back to sleep for an extra two hours. I got up at 8:30 and stopped in at the Eliot House dining hall for coffee and danish at 9:00. I was determined to meet at least some undergraduates, and therefore sat down and introduced myself to two young women  – Molly from Denver and Sarah from Philadelphia. Sarah had gone to Germantown Friends and was captain of the women's lacrosse team at Harvard. Her sister had gone to George School and was in her third year at Harvard Law School. I felt better that, at long last, I was able to talk to at least two undergraduates.

It was a beautiful day, with a blue sky and bright sun. But the temperature was just about zero degrees, there was a terrible wind, and the paths were all covered with ice.

The Registrar had sent a notice to the Winter Term Faculty stating that all examinations must be handed in on Tuesday, January 18. I had purposely left the preparation of my examination until today.

I began with the instructions. Fortunately, Harvard Law School has traditionally collected and bound all of its examination questions each year, dating back prior to my time. I had obtained a set of the examinations for the prior two years. I therefore began by reading the instructions for most of the examinations administered in second and third year courses during those two years. On the basis of these precedents, I prepared my own set of instructions.

There were only two real issues I had to address. First, because the students who had chosen to begin working on a paper obviously had an opportunity to consult both with me and with others, I concluded that it was only fair to allow all of the students to discuss the examination with others as long as the answer remained solely the personal work of the individual student. Second, I had already set a fifteen page limit for the answer to the examination. As I thought about it, however, I had to add that this excluded endnotes and applied whether the answer was typed, printed, or handwritten. I also specified that each answer was to be double spaced.

The first question was easy  – write an essay on any subject of your choice suggested by the casebook, the class presentations, or the class discussion. We had agreed on this during the first class.

The second question was also easy. The student was established as the chief counsel of a congressional committee and asked to analyze the various statutory standards for food safety in the FD&C Act and to provide recommendations on whether and how they should be changed by Congress.

The third question was originally designed to be a followup to the second, by asking the student now to analyze the drug provisions of the FD&C Act and to recommend whether legislative change should also be made there. When I called Dick Merrill to discuss this approach, however, he thought that the second question was excellent but that the third question was too similar. He was right. I therefore discarded the third question I had prepared and went back to work, pursuing an entirely different approach for the third question. I instead established the student as the new general counsel of a venture capital startup pharmaceutical company, faced with a new compound that can be used both to bolster the immune system in AIDS patients and to diagnose HIV infection at an early stage. The student was requested to prepare a clear regulatory strategy for the company on this product. When I completed the question, I was quite pleased with it.

When I called Dick a second time, to check his reaction to my new third question, his wife, Lissa, answered the phone and talked to me about my teaching experience these past two weeks at Harvard. Hearing my excitement, she remarked very perceptively that Dick and I had obviously done the right thing in diversifying our experience. Dick was just as enthusiastic about his part time private practice at Covington & Burling as I was enthusiastic about my part time teaching at Harvard Law School.

For lunch, I went to the Wursthaus with John Gardner. Although it remained sunny, it was very cold and there was a strong wind and ice everywhere. I had Hungarian goulash, which warmed me up.

When I walked back into Griswold Hall after lunch, I noticed a person who clearly looked older than a student. Following my custom of introducing myself to everyone who looked like a member of the Faculty, I said hello and explained who I was. The person responded that he was Bob Clark, the Dean. I did not recognize him because he had a beard in the pictures that I recalled, and has since shaved it. We had a short discussion, during which I said how extraordinarily pleased I was with the way the course was being received by the students. He said that he would try to talk to me again before I left, but his schedule was very tight.

During the afternoon, I finished revising and editing the examination and rewrote it. I could not dictate it because I did not have a secretary accustomed to transcribing tapes. I finished it late, at 8:45.

After calling ahead for a small pepperoni pizza, I walked to the Three Aces for dinner. No matter what I order, they always say that it will be ready in ten minutes. I sat down in a booth just as Elizabeth Stairs walked in the door. She had been jogging by, noticed I was there, and came in to join me. She had a more sensible salad, and we talked about the course. Elizabeth had a law degree from Canada and is the only lawyer in the Law School masters degree program who was taking the course. I promised to obtain for her names of the very few Canadian attorneys who practice in the food and drug law area.

A bulletin on the Three Aces television said that it was two degrees, with a wind chill factor of lower than minus thirty degrees, and was expected to go lower as the evening progressed. When I walked back to the Law School, there was a bitter cold wind.

I spent the next hour reviewing Kimberly Jackson's paper on the Daubert decision. I made a number of comments in the margin, largely suggesting areas where she could clarify what the Supreme Court said and how the decision would have affected decisions that were handed down in the lower courts before the Supreme Court issued its opinion.

My walk back through Harvard Yard and down Dunster Street to Eliot House seemed to be the coldest yet. It was now below zero degrees, with a wind chill factor below minus forty degrees, and all of Harvard was under a sheet of ice.

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