Journal

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January 16, 1994 Sunday

I was up relatively early, at 7:15. The radio now said that it was minus five degrees, with a strong wind. It looked deceptively nice, with a clear blue sky and a bright sun. I stopped for coffee at the Eliot House dining hall at 8:00, but there were only two other people there and both were reading handwritten notes with a look of sheer panic on their faces. I decided not to disturb them. I therefore continued on to Au Bon Pain, where I bought coffee and danish. On the way through Harvard Yard I took several photographs because it was such a beautiful day.

Both last night and on the way to my office this morning, I had worried about the examination. As I prepared it yesterday, the student who did not choose the first question was to answer both the second and the third questions. I was concerned that these last two questions were too complex to be answered in only seven or eight pages each. I called Dick Merrill, who agreed with me. I therefore changed the instructions to permit the student to answer Question I or Question II or Question III. This was clearly the right approach, and I felt much better.

I did have one remaining issue. I needed to know whether the word "injectable" (which I used in the examination) was properly spelled with an "a" or an "i". There was no dictionary in sight. I concluded that, like pencil sharpeners, dictionaries were beneath the Harvard Law School Faculty.

The rest of the morning was taken up with sending letters to the family. I included a copy of the pamphlet on the Harvard Law School Faculty for 1993-1994, to prove that I was actually there on legitimate business. I also sent a letter to George Burditt, since he had played an important role in making all of this happen.

By noon, I was prepared to turn once again to preparation for the last third of the course. I was not concerned about the time needed for preparation, because Monday, January 17, was a school holiday (Martin Luther King's birthday). I began working on the outline for the eleventh day, covering the first of two sessions on human medical devices. Because I was a day behind, this would actually be covered on Wednesday rather than on Tuesday.

At 2:30, I began to get hungry. With the terrible cold weather, however, I was not looking forward to another trip to the Three Aces. I therefore walked down into the Harvard Law School tunnel and found a vending machine, where I obtained peanut butter crackers and orange juice. With the remainder of the cookies that Beth had given me when I left, it was a satisfactory lunch.

By mid-afternoon, I had finished the outline for the eleventh day and started on the twelfth, which was also on human medical devices. I continued to work on it until it was time for dinner. For both of these sessions, I kept reminding myself to focus on the major issues that presented difficult questions of statutory interpretation, scientific uncertainty, and public policy. Even though I would begin with a brief summary of the regulatory approach embodied in the Medical Device Amendments of 1976, I now knew that it was important to focus on these broad issues and not to be concerned about passing over the smaller details with which practitioners must deal on a daily basis.

It was below zero degrees, and there was a strong wind, as I walked from the Law School through Harvard Yard to the Charles Hotel and Giannino's for dinner. Only my sheepskin coat again saved me. I do not know what I would have done the entire month if it were not for that coat.

Arline Heimart had scheduled this dinner with the new Co-Masters of Eliot House, Steven Mitchell and Kristine Forsgard. When he arrived, Alan Heimart informed me that Arline had abruptly left for New Jersey earlier in the day to attend to a very ill daughter. Nonetheless, the four of us had a thoroughly delightful dinner. Steve Mitchell had grown up in Lewiston, New York, and was astonished to find that my ancestor, Benjamin Barton, had helped found Lewiston. His wife, Kristine Forsgard, was an accomplished scientist who had a pet slime mold and was now working in the public policy area at the Harvard School of Public Health. They were members of the Culinary Historians of Boston. They told me where to look for information on the Matthiessen Room. I explained my disappointment at being unable to interact with undergraduates, and we discussed whether some type of presentation by me at Eliot House might be feasible. When I told about my first night in the room without heat, Kristine was horrified. It was, in short, a thoroughly enjoyable evening.

On the way back to my office at 10:00, I stopped at the same news stand in Harvard Square that was there in my day, to buy a copy of the January issue of Allure magazine. Unfortunately, they did not have a copy of the February issue of Vogue. I wanted to read the articles on a new "thigh cream" for potential use in the three-hour segment of the class on regulation of cosmetics.

I worked for another hour on the outline for the twelfth day, but did not finish it. At 11:15, I walked back through Harvard Yard to Eliot House. It was still below zero degrees and bitterly cold. For first time, I wrapped my Harvard scarf over my face to protect against the strong wind. Now that I knew where to look, I quickly found the information on the Matthiessen Room that Steven and Kristine had described to me. It said that contributions could be made to help fund the room. Because I was only being charged $35 a night, I decided that I would make a $1,000 contribution from my speech fund when I returned to Washington.

January 17, 1994 Monday

The radio woke me up at 6:30, informed me that it was five degrees, and predicted six to twelve inches of snow. I promptly fell back asleep until 7:45. Once again, I stopped for coffee and donuts at the Eliot House dining hall. I sat down with Joe, a former submariner who initially attended the University of Massachusetts and has spent his last two years at Harvard. He is a senior, and therefore about to graduate. Like all seniors, he is concerned about finding a job and thinking about graduate school. As I walked through Harvard Yard to the Law School, it was snowing but there was only a low wind. The snow always seems to make the air warmer. I stopped to buy another cup of coffee at Au Bon Pain and then continued on my way.

In my office, I read the Allure article on the new thigh cream and left it for Joe Guberman to have copies made for the class. Then I finished my outline for the twelfth day.

Lisa Baar and Julie Cohen met me at my office at 12:30 and we walked to the House of Blues at 96 Winthrop Street for lunch. Both of them reported that Griswold Hall was locked tight and I was still not in the Harvard telephone directory. Lisa got my attention by standing outside and waiting for me to look out the window. I had anticipated this problem and therefore saw her immediately. Julie Cohen was in the joint Business School-Law School program. She formerly worked as a stock analyst and hoped to find a job in a venture capital organization in the Boston area. I promised to give her names that might be helpful. Her fiancé worked for Astra Pharmaceutical.

Although Julie was only auditing the course, she had made strong contributions during the first two weeks. I always called on her when I needed the viewpoint of a venture capitalist. She explained that Harvard Business School was now back in session and that she would be forced to miss my classes because of a conflicting class that she was taking for credit at the Business School. Later in the week she paid me an extraordinary tribute, by cutting her Business School class and coming to the food and drug law class instead.

It was snowing when we left for lunch, and there was freezing rain when we returned. I reviewed my outline for the eleventh and twelfth sessions, on human medical devices, and made additions and revisions. Then I began and completed the outline for the thirteenth session, on human cosmetics and color additives. I decided that the thigh cream would be a superb way to bring together not just all of the regulatory requirements for cosmetics, but also to illustrate how FDA issues arise in a real life context. This would be a case study on real research and a real product that was just now being developed and marketed and thus would provide a perfect example for the class. I was somewhat concerned that women might feel offended by the use of this kind of product as an example, but concluded that the class and I had by now established such a strong relationship of mutual trust that they would focus on the important regulatory issues, and the interaction those issues provoke within the industry and among the industry and various governmental agencies, and would not be concerned about the specific product involved. Nonetheless, I made a note to explain at the beginning that anyone who was offended by the subject matter should immediately speak up. It was somewhat risky to take this approach, but it was clear to me that the thigh cream presented an outstanding example for purposes of teaching.

By 6:30, the snow had turned to rain. I walked to Harvard Square and took a taxi from there to Toscano Ristorante at 41 Charles Street in Boston, where I met Rob MacRae and his fiancé, Suzanne, for dinner. Rob's father, James MacRae, was the Deputy Director of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB), and a longtime friend. Rob's sister, Katherine, worked as a paralegal for me during 1987-1988 between Yale and Harvard Medical School. She put together the materials that I ultimately used in preparing the new chapter of the casebook on biotechnology. Rob said that she kidded him that, in effect, this meant that she was helping teach him about food and drug law. Rob and Suzanne will be married on June 11 in Philadelphia, and I promised to be there. We had a thoroughly delightful evening.

At 10:15, Rob and Suzanne drove me back to the Law School in the rain. I spent the next hour reviewing the materials on the AIDS case for the Board of Student Advisers, as requested by Norman Carlin. As I walked back to Eliot House through Harvard Yard at 11:30, it was the warmest evening since I had come to Cambridge. The television news said that it had reached forty degrees. This was the first time since I had arrived that the temperature was above freezing. That night, I left off one of the blankets and did not use the heaters.

January 18, 1994 Tuesday

I was up at 6:30, and quite surprised to find three inches of very wet new snow. The temperature had already come back down to thirty degrees, and the radio predicted it would be in the area of ten degrees this evening. The trees looked beautiful with a coating of pristine new snow that was not yet frozen. As I walked to the Law School, there was so much slush that it was difficult to avoid getting my feet wet, even wearing my customary pair of rubbers. I stopped for my usual coffee at the Greenhouse Cafe in the Science Center, and picked up a copy of the Harvard version of "Editorial Humor." I have enjoyed a similar publication from Duke that Sarah has obtained for me for the past two years.

Over the weekend, I decided to return to one animal drug issue, in order to explore a common food and drug law problem. Some animal drugs are also pesticides and therefore subject to dual regulation by FDA and EPA. I posited to Danielle Shelton that, while she was working in a Chicago law firm last summer, one of her relatives from Iowa, who is a farmer, called her to say that they were having enormous difficulty with this dual jurisdiction and to ask her help in resolving the matter. I suggested that she, in turn, seek further information and assistance from classmates who had worked in the federal government, beginning with Trina Hunn, who had worked for the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA). Because Trina Hunn was absent, I suggested she call Rob McRae, whose father was the Deputy Director of OIRA. When Rob could find no solution, we called John Gardner, who had worked in the White House under President Bush. When he had no answer to the problem, I suggested we call Jim Nuzzo, who had also worked in the White House, as Deputy Director of Policy in the Office of the Vice President, under President Bush. Jim similarly knew of no realistic way to find relief. With no help from the Executive Branch, we then decided to call Roger Sherman, who had been a legislative assistant to Representative Henry Waxman, the Chairman of the Subcommittee with substantive jurisdiction over the FD&C Act. Roger could offer no practical help. Everyone agreed that the federal government is essentially powerless to resolve interagency jurisdictional conflicts and overlaps of this nature, which are found throughout the government and can have a major impact on the private sector. In addition to exploring the issues involved in a matter like this, it also served to illustrate the broad diversity, and remarkable experience, of the students in the class.

The rest of the class was on human biological drugs and biotechnology. Each of the students made a solid presentation. Julia Cohen (who was actually an auditor) argued that the 1902 Biologics Act was redundant and should be repealed, but I argued that it still served as a useful purpose. Roger Sherman contended that FDA should expand its jurisdiction by exercising regulatory control over all organs and tissues used for human replantation or transplantation, but David Witherspoon urged that this would harm rather than help public health. Vernadette Ramirez argued at great length (the longest student presentation to date, approximately fifteen minutes) that FDA approval of a human vaccine should preclude tort liability, and Alan Kim took the contrary position. Johanna Davis took the position that any new product made by biotechnology should be subject to special regulatory requirements, and I argued the opposite position. I had to fill in for two people who had called me to say that they were out with the flu. As part of the discussion on human vaccine tort liability, both Vernadette Ramirez and the rest of the class were perplexed when I contended that mandatory vaccination is no different than a national lottery to determine one person who will be summarily executed in order to save five hundred others.

By now, I had established the pattern of giving my daily announcements at the beginning of the second session, following the fifteen-minute break. I gave my telephone number to everyone once again, to make sure that people could reach me when Griswold Hall is locked. I also went over the examination instructions in detail, to make certain that there would be no confusion. I made clear that the choice of a paper or a standard examination was entirely up to the student. I also made clear that the choice was between doing an essay of their choice or one of two essays of my choice.

Back at my office at 11:30, I read and reread the examination as typed by Joe Guberman. I wanted to make certain that it was absolutely perfect. I asked Joe to use spell check on his computer, but he said that he could not do it on his machine.

A second year student, Kurtis MacFerrin, had called me a week ago to say that Jur Strobos, the Director of the Policy Research Staff in the Office of the FDA Deputy Commissioner for Policy, would give a talk at 12:30 in Room C-4 of the International Law Center today. Jur was a physician and a lawyer. He worked for Wilmer, Cutler & Pickering and then as a law clerk to Judge Ray Clevenger of the United States Court of Appeals for the Federal Circuit. Ray had called me three years ago to ask whether there might be a job for Jur at FDA, and I had put Jur in touch with Michael Taylor, the new Deputy Commissioner for Policy. That was how Jur got his job.

About twenty-five members of the class, and no one else, showed up for the session with Jur. It was very disappointing both to me and to the students. Jur used slides that were clearly created for a different purpose (they related largely to Congress and not to FDA), his talk was a basic political science lecture, he said little about FDA and his work there, and at no time did he involve the students or even recognize that they have been taking an intensive course on food and drug law. Even though he was offering four internships for the summer and had only one application thus far, there was little interest.

During the afternoon, I again saw students about their papers. Just as Beth's cookies were depleted, a new supply arrived by Federal Express from Patty Olender at the Foundation for Biomedical Research. I found two more errors on the examination and had Joe Guberman correct them. When I tried to reach Beth, I discovered that the terrible weather in Washington had kept her home.

At 5:30, I walked to the Crimson Laundry to leave my laundry from this past week. It was now ten degrees, and all the slush had frozen. It was very difficult to walk without slipping and sliding.

At 6:45, I walked to Upstairs at the Pudding, a restaurant at 10 Holyoke Street, for dinner with Mark Butler, Dick Wurtman, Peter Feinstein, and Peter's colleague, Mark. It was an excellent meal and very good conversation. When I returned to the Law School at 10:00, it was bitter cold, with a strong wind and ice everywhere. After reviewing my outline for the next day, I walked back through Harvard Yard at 11:00 in zero degree temperature and a strong wind. Once again, I wrapped my scarf around my face to ward off the bitter cold. I was in bed at 11:45, some fifteen minutes before a large number of Harvard freshmen streaked around the Yard to celebrate the beginning of examinations. I hope they at least had something on their feet.

January 19, 1994 Wednesday

The radio today said that it was minus two degrees, with a wind chill of minus thirty to minus forty degrees. Walking up Dunster Street, I was glad that the wind was at my back. The streets and paths were solid ice. I stopped for coffee at the Greenhouse Cafe, selecting chocolate/raspberry.

The class covered the first half of the materials on human medical devices. We had a major discussion about the structure of the Medical Device Amendments of 1976 in general, and the substantial equivalence provision in Section 510(k) in particular. Steve Stranne argued that tapes and computer programs that do no more than provide advice should not be regulated as medical devices, and I argued against that position. Katharine Bolland contended that the FD&C Act should be amended to delete the "substantial equivalence" exception to the requirement of premarket approval for medical devices, and Jeffrey Buckholtz took the opposite position. Steve Kaiser urged that the FD&C Act be amended to delete Class II for medical devices, and I argued that Class II should be retained. The students made excellent presentations. I gave my personal rationale for drafting the statutory provisions as I did when I was at FDA, and there was spirited debate about them.

After seeing students in my office, I had lunch at 12:30 at Changsho with Jeffrey Buckholtz, Catherine Dargan, Jennifer Johnson, and Christine Solt. The temperature was still hovering about zero degrees, and the wind remained strong. We were glad that we did not have far to walk.

I have been using these sessions with students not only to get to know them better, but also to get their views on all aspects of the course. The basic message that I was receiving was that they were tremendously interested in the subject matter and that they greatly appreciated the teaching style. We debated such other issues as the use of resumes and name cards, the length of each daily session (whether it should be extended to three hours from the present two and a half hours), and other related matters. It was clear to me that the basic format was working. The students uniformly praised the required student presentations, the spontaneous role playing (designation of students to be the FDA Commissioner or General Counsel, a member of Congress, a corporate attorney, a trade association official, a physician, or a farmer, to name only a few), and calling on students randomly to respond to probing questions in true Socratic style. Thus far, I had heard not a single negative comment about any part of this format.

Once I changed my approach at the end of the first week, to emphasize major issues rather than trying to cover everything, the pace of the course was generally regarded by the students as very reasonable. There was disagreement among the students about the syllabus. Some thought it should specifically refer to the statutory sections that would be covered, and other thought that this was unnecessary because it was obvious from the reading materials in the casebook. I was undecided myself as to which was the better approach.

We also talked about the other Faculty. I heard endless complaints about the general Faculty disinterest in the students and even their disinterest in teaching. Some of the behavior described to me, and verified by having it described independently in different sessions with the students, ranged beyond the erratic to the truly bizarre. Teachers during my three years at the Law School may have been distant and at times uninteresting, but the current teachers seem even less involved with the students. I always made it clear, however, that my accessibility could not fairly be compared with the regular Faculty. I was there for only a month, with no other obligations or responsibilities.

During the afternoon, I saw a number of students. Betty Dunkum asked me to provide recommendations for possible clerkships, and I agreed to do so.

At 6:30, I met Lawrence Kinet, President of Oculon, for dinner at Giannino's. I was so frozen by my brief walk from my office to Massachusetts Avenue that I was grateful to find a taxi to take me the rest of the way. Lawrence kindly drove me back to the Law School after dinner.

I spent the rest of the evening going through the materials sent to me by Beth in the customary Federal Express box. Students also called me about their papers. Beth and Peter called from Washington to inform me that, because of snow and ice, a state of emergency had been declared for the next day and the entire city would be shut down.

At 11:30, I decided to brave the elements once again. It was zero degrees as I walked back through Harvard Yard and down Dunster Street to Eliot House, but the wind had died down and it was therefore more bearable. I did have a cup of coffee at the Eliot House dining hall before returning to the Matthiessen Room and going to bed at 12:15.

January 20, 1994 Thursday

The radio woke me up by announcing that it was now minus two degrees. I walked through Harvard Yard, got my usual coffee (this time, the Harvard Blend) at the Greenhouse Cafe, and arrived early at my office.

When I talked to Professor Todd Rakoff last week, I invited him to attend any classes of his choice. He arrived this morning, his face flushed from the cold weather. As chance would have it, the first student presentations of the day related to the FDA decision to prohibit breast implants for cosmetic purposes and to permit breast implants only for reconstructive purposes. The arguments were superb. Tami Lefko, who argued against the prohibition, came prepared with a five page single spaced typewritten summary of her argument, complete with footnotes. Allison Silverman, who argued for prohibiting cosmetic breast implants, gave a strong presentation. She later expressed concern that she had been inconsistent in arguing for consumer choice in the area of patient package inserts and prescription drug advertising to consumers, but against consumer choice with respect to cosmetic breast implants. I was enormously pleased that she and others were beginning to understand the complexity of the policy choices involved in these issues. Anne Curi (the current United States female amateur triatholon champion), who had been sick for her original scheduled presentation and requested another opportunity for an assigned presentation, offered comment on both of these presentations, pointing out their strengths and weaknesses.

At our customary break, Todd Rakoff told me with great animation that the presentations and subsequent discussion had been of very high quality indeed. I responded that this was not unusual, and that we had sustained this level of discussion throughout the course. Unfortunately, he had to leave for another meeting.

During the second half of the class, Daniel Silber argued that the premarket approval requirements for medical devices should be applied by FDA as stringently as the premarket approval requirements are applied for new drugs, but Kimberly Jackson contended that less stringent controls should be applied. Jonady Hom contended that FDA should exert no authority over the emergency use by physicians of an unapproved medical device, and Betty Dunkum said that such authority is essential to public health. Patricia Kaufman took the position that technology assessment should be undertaken by FDA for every new medical device to determine whether the societal benefits outweigh the costs, and Stanford Lin argued that this was unnecessary and inappropriate.

At the conclusion of the class, I suggested that, since FDA has such enormous administrative discretion, the agency should exercise regulatory control over Dr. Kevorkian by determining that the paraphernalia he used to assist suicide were illegal medical devices. This caused an uproar in the class. Steve Rabinowitz argued strenuously that FDA could find no legal authority to do this, but with the help of Christine Solt I turned back every argument he had, summarily dismissed all of his policy positions, and (acting the position to the hilt) declared that this was exactly the type of thing that government officials can and should do. Once again, the enormous discretionary power of FDA was brought home.

I had originally been scheduled to rent a car and drive for a Board of Directors meeting at Parexel in Waltham. Because of the weather, I called Joe von Rickenbach and obtained his agreement that I could participate by telephone. I therefore had lunch with Professor Betsy Bartholet at the Faculty dining room, where we had a delightful discussion about law school teaching and the Legal Action Center.

When I returned to my office, I found an emergency telephone message asking me to come immediately to Parexel for the meeting because others had been detained by the weather. I therefore walked to Harvard Square and took a taxi, arriving at Parexel at 2:00. Following the Board meeting, I returned to my office at 5:00. Once again, it was bitter cold.

At 6:15, I met five students at John Harvard's Brew House at 33 Dunster Street: Joanna Davis, Harold Dichter, Tricia Kauffman, Vernadette Ramirez, and Allison Silverman. We had a thoroughly enjoyable time. The discussion simply reinforced my view that the format of the course was working extremely well. With just a very few changes (mandatory submission of resumes, exchange of resumes among all students, and name cards with both first and last names) it could be improved slightly, but there should be no major changes made.

I decided that I knew them all well enough to have some fun, so I asked Allison Silverman if she were the Allison Silverman who was quoted in the December 3, 1993 Harvard Law Record as stating "I hate Winter Term. I think it's a waste of time. There are no good courses offered." We had a hilarious time as she attempted to explain away her quotation. She said that she would work on some additional defenses and would try them out on me at a later time.

At 9:15, we returned to the Law School. The temperature was zero degrees, but the wind was not as bad as it had been earlier. I worked hard on preparing my scenario for the class on cosmetics. When I was finished with that, I drew up my outline for the fifteenth and final day, on regulation of carcinogens.

It was zero degrees, but only a light wind, when I walked back through Harvard Yard to Eliot House at 11:30. I used only one heater that night.

January 21, 1994 Friday

It was still zero degrees when the radio awoke me at 6:30, but it was again a bright sunny day. I saw Steve Mitchell as I was walking through the quadrangle of Eliot House and stopped to talk for a moment. After my usual detour for coffee at the Greenhouse Cafe, I arrived at my office only to find that it was extremely cold. The heat registers were blowing frigid air. I therefore went immediately to my classroom, which was much warmer, where I put two articles on the thigh cream in front of each seat  – the October 1993 article from the Washington Post and the January 1994 article from Allure.

When the class began, I gave everyone five minutes to read the two articles. Both reported on limited research showing that a cream containing two percent aminophylline (an active ingredient in prescription asthma drugs), when rubbed on the thigh for only five weeks, reduced the circumference of the thigh by an average of one to one and a half inches. I then designated the third of the class sitting to my right as members of my cosmetic company team, the third in the middle as competitive cosmetic companies (with the ones sitting at the back the largest companies and the ones at the front the smallest companies), and the third on my left as various members of the government (FDA, OMB, Congress, and so on). For the next seventy-five minutes we discussed the thigh cream from our designated roles.

My team initially devised a label for the product that we thought would minimize regulatory risk. We called it "Miracle Thigh Cream" that "fights the ugly appearance of cellulite." We labeled the product as a cosmetic, including aminophylline in the statement of ingredients by its chemical name, not the drug name. We used for our advertising a humorous card I found at the Coop which said on the front "The Papa Bear said, 'My what big thighs you have'" and in the inside "Stupid Papa Bear." The largest competitors said that they would not get into this type of product, the smallest said that they would try to beat us into the market, and Katharine Bolland, representing the Body Shop, said that she would make it only with natural ingredients. When Steven Rabinowitz noted that tea naturally contains the same ingredient (theophylline), Katharine named her product "Tea Cream." The FDA Office of Cosmetics (Bryan Liang) wanted to challenge the product, but the FDA Center for Drugs (Peg Bolce) doubted that there was any safety hazard and the FDA Commissioner (Robert Liao) concluded it was a low priority. Congressman Waxman (Roger Shelton), who represented Hollywood, seemed quite disinclined to intervene.

It was a remarkable performance by everyone, and brought out the real life elements and dynamics of this very typical type of situation. When we had concluded the discussion, Fred Server asked me what I would advise a company to do if it wanted to market this type of product. I said that I would do exactly what the company section of the class had done, except that I would at least initially not mention cellulite and would tone down the claims to keep a low regulatory profile. My concern would be that others in the industry would make unmistakable drug claims for the product that would make an easy and irresistible target for FDA. If that occurred, FDA regulatory action would become likely.

At 10:00, I handed out the student evaluation forms and pencils that had been sent to me by the Board of Student Advisors. The students filled out the forms for the next fifteen minutes. I was told that it was customary for the teacher to leave, and I therefore went up to my office.

The previous evening, I had talked to the five students with whom I had dinner about the propriety of a social hour for the class on Sunday afternoon. They agreed that it would be good fun. After dinner was finished, I arranged to set aside a section of John Harvard's Brew House during 4:00 to 6:00 on Sunday afternoon, with food and beer. It would be during the Dallas-San Francisco football game, but there was a large television set available. When I returned to the classroom and all the student evaluation forms were completed, I announced the social hour and distributed invitations to the class. I made a note of those who were not there so that Joe Guberman could put invitations in their mail boxes in Harkness Commons.

The second half of the class was almost as interesting as the first half. Norman Carlin contended that the FD&C Act should be amended in order explicitly to impose more stringent regulatory requirements for cosmetics, but Amy Bahr argued that this was not needed. We discussed whether the various voluntary regulatory programs adopted by FDA and the industry were sufficient. I spent considerable time pointing out the responsibility of a private attorney not just to inform clients about their legal rights and requirements, but to go beyond that and to propose new approaches designed to solve future problems as well.

Following the discussion of voluntary regulation, the class considered appropriate controls for color additives. Ari Wasserman argued in favor of a GRAS exclusion for color additives, and William Aaronson argued against it. The regulation of such natural substances as beet juice under the requirements for color additives seemed excessive to the class. At the end of the class, I felt that the entire session had been an extraordinary success.

Returning to my office, I found that the heat was back on. The problem had been caused by frozen pipes. Fortunately, the Dean's pipes had frozen as well, and the maintenance staff therefore corrected the problem promptly.

After meeting with students, I had lunch at Bertucci's at 21 Brattle Street with Mark Sheft and Roger Sherman. Catherine Dargan, Jennifer Johnson, and Reginald Williams, who were sitting at the next table, had already been to the Body Shop in Harvard Square to review the labeling.

Back at my office, I talked to all of the students who were waiting for me and then went to see Sue Robinson. I talked to her at some length about the approach I was taking in class and the positive response from the students. I reiterated that, if invited, I would be inclined to teach the course every other year, to provide an opportunity for every student to take it. When I asked her about grading, she said that the average is between B and B+. Based upon my experience thus far, my personal impression was that the average for my class should be at the higher end of that scale. I would, however, wait for any final decision until I reviewed the papers and examination answers themselves.

The rest of the afternoon was taken up by chores. I picked up the exams from Mark Slawson, got my photographs from the Coop, went to the Crimson Cleaners for my laundry, and got my new suit from J. Press.

I discussed with Sue and Mark the likely schedule for receiving the answers to the examination. The students were required to hand them in at the Take Home Window between 3:30 and 4:30 on Thursday afternoon. I would be given the original, after it has been photocopied. Although this should be done quickly, it has been known to take as long as a week. I had initially intended to fly to New York for two Nonprescription Drug Manufacturers Association (NDMA) meetings on Thursday morning and then fly back in time to receive the examination answers and begin grading them. In light of this new information, however, I decided to drive to New York on Wednesday evening, attend the NDMA meetings on Thursday morning, and drive back to Washington on Thursday afternoon. Joe Guberman could then obtain the examination answers for me and send them by Federal Express whenever they are available.

For dinner, I met Bryan Liang and his wife, Shannon, and we walked to the Skipjack Restaurant at 5 Bennett Street in ten degree weather. Once again I was thankful for my sheepskin coat. We discussed my participation in a symposium on the Clinton health care legislation that Bryan is organizing for the evening of February 23, following my annual presentation to the Tufts postgraduate course on pharmacology.

Back at my office at 9:30, I spent an hour going through papers that arrived in my usual Federal Express care package. Today, I also received a box of chocolate chip cookies made by a secretary at Covington & Burling, Joanne Bell. They came just in time to tide me over until I returned to Washington. It was still ten degrees as I walked back through Harvard Yard to Eliot House, but the wind had died down and it therefore seemed warmer.

January 22, 1994 Saturday

I did not set the radio alarm and thus woke up at 8:15. I unpacked my laundry and put it away in the Xerox boxes that continue to contain all of my possessions. At 9:00, I walked across the quadrangle to the Eliot House dining hall, where I had coffee and doughnuts with three undergraduates, Kristen, Eli, and Martin. My walk through Harvard Yard was quite pleasant, with a temperature of only eighteen degrees and little wind. I stopped at Au Bon Pain for coffee and arrived at the Law School at 9:45.

After talking to a student about his paper, I called the family to report on the past week, talked to Kevin Van Anglen about my plans for leaving the Matthiessen Room a few days early, and went through all of the remaining papers on my desk. For lunch, I went with Tami Lefko and Michael Pompeo, both members of the Law Review, to the California Pizza Kitchen on Eliot Street. By now, the temperature was up to twenty-five degrees.

Back at my office, I reorganized all of the materials that related to my stay at Harvard, called members of the family, and talked to students about papers. To my surprise, it suddenly turned much colder and began to snow.

For dinner, I went to Chef Chow's House at 50 Church Street with David Gevertz and his fiancee, Allison. David will be spending the summer at Arnall, Golden & Gregory in Atlanta, and I therefore told him about the historic role that firm had in representing Bob Rich in litigation on imitation dairy products throughout the country.

The rest of the evening, I worked on travel plans and dictated a tape of correspondence and memoranda for Beth. At 12:00, I walked back through Harvard Yard to Eliot House in five degree weather.

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