Mr. ROSENBERG. But you have 900 SGE's. Could you give an estimate based on how many days the average SGE works and simply give us some sense of what the figure is? Mr. MEYER. Surely. An SGE in the FDA is paid $128 per day. I would guess they work between 10 and 20 days a year. Let's take the high option. That would be about $2,000 per SGE. Multiply that by a thousand-plus travel. Mr. ROSENBERG. So, we are talking about a substantial amount of money that could, in fact, be used to hire full-time FDA scientists to replace certain SGE's in certain advisory committees; is that correct? Mr. MEYER. Yes. I would guess that we spend in the neighborhood of 1 percent of the budget, between $2 million and $3 million. Mr. ROSENBERG. You said in your statement, Mr. Kennedy, that "virtually every interested group or individual who has reviewed our past decisions on conflict of interest has concluded that our system works." I wonder if you could name the groups that have concluded that. Dr. KENNEDY. Well, among others, the Secretary's Panel on New Drug Evaluation. I think it is fair to say they did not give the EDA an entirely clean bill of health, they did single out the development of these procedures for positive comment. Mr. ROSENBERG. Who is on that particular panel? Dr. KENNEDY. Well, the chairman was Norman Dorsen of the New York University Law School. Other members of the panel included Dr. Norman Weiner, pharmacologist at the University of Colorado; Dr. Marcia Cohen from Hastings Law School in San Francisco. I can obtain the rest of the list for you if you like. Mr. Moss. Without objection, we will hold the record open to receive the list. [The following list was received for the record:] REVIEW PANEL ON NEW DRUG REGULATION Norman Dorsen, Chairman, Professor of Law, School of Law, New York University, New York, N.Y. 10012. Norman Weiner, Vice Chairman, Professor and Chairman, Department of Pharmacology, University of Colorado Medical Center, Denver, Colo. 80220. Allen V. Astin, Director Emeritus, National Bureau of Standards, 5008 Battery Lane, Bethesda, Md. 20014. Marsha N. Cohen, Assistant Professor of Law, Hastings College of the Law, San Francisco, Calif. 94102. Charles E. Cornelius, Dean, College of Veterinary Medicine, University of Florida, Gainesville, Fla. 32610. Robert W. Hamilton, Professor of Law, School of Law, University of Texas, Austin, Tex. 78705. David P. Rall, Director, National Institute of Environmental Health Sciences, Post Office Box 12233, Research Triangle Park, N.C. 27709. Mr. ROSENBERG. That group concluded that there was still some problems with FDA's system, that the new procedures were a step in the right direction, but there were still some problems? Dr. KENNEDY. That is correct. I think that is a fair characterization. Mr. ROSENBERG. What were the other groups that you mention in your statement? You said, "virtually every group or individual," which indicated that there was some number of groups. Dr. KENNEDY. I do not think we are referring here, Mr. Rosenberg, to formal assessments by committees named by some outside agency, but rather to the normal kind of advice-getting procedures that the Agency gets from the scientific community. Mr. ROSENBERG. The scientific community says that you are doing all right as far as conflict of interest is concerned? Dr. KENNEDY. I would not say that every member of the scientific community would say that, Mr. Rosenberg. I think that most of the people in the disciplines on which we draw from for advice feel that it is a fair way to try to answer both of these needs. Mr. ROSENBERG. After a public disclosure is made-a PRDC statement is placed in the record-exactly what uses are made of these statements? Can anyone challenge whether the SGE's should have been appointed in the first place? What practical effect does that statement have? Dr. KENNEDY. Since they are publicly available, such challenges would be possible. I would have to defer to Mr. Meyer in order to find out whether such challenges have actually been issued. Mr. ROSENBERG. Have they, Mr. Meyer? Mr. MEYER. No such challenge has been made. They are placed on public view Mr. ROSENBERG. Is any notification made of the public about what files are on that public review? Mr. MEYER. Yes, sir. That has been published in the Code of Federal Regulations. Mr. ROSENBERG. Is there anything more general than in this publication? Mr. MEYER. Well, we have certainly announced that a number of times at our consumer groups, which include people from Ralph Nader's health research group Mr. ROSENBERG. You have announced that they are generally available. You do not give a listing of the ones that are currently in the file; is that correct? Dr. KENNEDY. My understanding is that we have not. We have not. Mr. ROSENBERG. You are not aware of any challenges that have been made? Mr. MEYER. Not challenges as such. We are aware of interest. From time to time, groups-including the group I believe you are going to hear from next-have gone out and looked. Mr. ROSENBERG. What would be the procedure if someone from the public were to challenge? Suppose they said that there is this memo and they think that there is a conflict which concerns them as a member of the public? What would be the procedure? Dr. KENNEDY. Mr. Rosenberg, I think that would come directly to the Commissioner's attention. I would review it. The question would then arise whether we wanted to handle the matter-it would depend on the nature of the objection. I take it that you are thinking that something that we file as a notice of disclosure that would involve nonparticipation in regulatory decisionmaking affecting that particular interest. Somebody on the outside might say, hey, that's too large a proportion of that committee's work; this person is going to have to disqualify himself or herself too much, and you shouldn't let them on at all. I would certainly review such a complaint. Mr. ROSENBERG. Is there any procedure or standards for that review? Mr. KENNEDY. I think there are standardized procedures for dealing with citizens' petitions, although that is a part of the process that I have not Mr. ROSENBERG. Can you or Mr. Merrill cite the part of the regulations that deals with that kind of challenge? Dr. KENNEDY. Let me ask Mr. Merrill for some help here, if I may, Mr. Chairman. Mr. Moss. Yes. Mr MERRILL. Mr. Rosenberg, I do not think we have a procedure in place specifically to deal with challenges to advisory committees. We do have a procedure in place for any citizen to file a petition with the Agency, asking it to do something it is not doing or to do something different. This procedure has been involved on many issues, but it has not yet been invoked in this situation. Mr. ROSENBERG. On the average, what percentage of total advisory committee work would be classified as generic rather than particular matter? Could you give some estimate about that? Would it be 50 percent? Dr. KENNEDY. I think rather less, Mr. Rosenberg. An estimate that I gave you would really have such wide bounds that I would prefer it, if the chairman would approve, for me to supply that for you for the record. Mr. ROSENBERG. By the way that you have defined particular matter, would not it be impossible to have a conflict of interest with respect to a generic committee?. Dr. KENNEDY. No: I don't think so. I think Mr. ROSENBERG. With respect to a generic committee, it simply would not be possible to have a conflict of interest since the financial interest would be in a particular company. Dr. KENNEDY. Let me ask Mr. Merrill to help me with this. Finding examples of particular situations is difficult Mr. ROSENBERG. I am not asking for specific examples. I am asking, under your definition of particular matter, is it not simply impossible to have any conflict of interest under that definition? Dr. KENNEDY. I do not believe so, Mr. Rosenberg; but I am going to have to have help in convincing you. Mr. MERRILL. You are quite right, Mr. Rosenberg, in suggesting that lots of times, when you are making generic decisions, an involvement with a particular firm would not be disqualifying. But what we have said is, if there is such a close relationship between the generic decision and the fate of the firm or the fate of the firm's production-for example, if the firm is the only manufacturer of the product using that ingredient, or one of two manufacturers— there a disqualification would be in order. What we are trying to do is find out the point at which the impact on the decision is going to be substantial enough to cause genuine concern. One example that we have talked about internally, this is hypothetical because the decision had reached us before we had any occasion to look at it-did not involve, in fact, any disqualification by any members of advisory committees. But we are in court now over an advisory committee's generic recommendation about a particular ingredient which is used by only one company. Mr. ROSENBERG. Even if there are, say, 20 companies manufacturing the ingredient, that generic decision is very important for each of those twenty companies, perhaps; is that not correct? Dr. KENNEDY. Yes; it may be. Mr. ROSENBERG. Thank you, Mr. Chairman. I would want to make one observation. We have addressed ourselves, I think, exclusively today to the agency's application of its own standards. We have not examined the adequacy of alternative standards but have viewed this at all times in context with the application of your own standards and noted the instances where those standards appear to have been breached. The further question exists as to whether or not those are realistic standards. It has been raised by you gentlemen in each instance of the difficulties you had in working with your own standards. So, I think, in reviewing this in your own minds, bear that very clearly in mind. We have yet to give you our suggestions of what our standards would be. We do thank you very much. Dr. KENNEDY. Thank you, Mr. Chairman. [After the hearing, the following correspondence regarding the FDA's testimony took place between the subcommittee and FDA.] Hon. DONALD KENNEDY, HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, Commissioner, Food and Drug Administration, DEAR MR. KENNEDY: On behalf of the Subcommittee, I thank you for your appearance on May 24 to discuss FDA's efforts to avoid conflicts of interest among its special government employees. The hearing was an extremely useful exploration of issues and possible remedies in this complex problem area. To assist us in completing the hearing record, can you please supply the following information: (1) In response to a question from Congressman Andrew Maguire, you indicated you planned to review the transcript of the meeting held November 23, 1976, of the OTC Internal Analgesic Panel, to determine whether the role of the Subcommittee staff's FDA Case Study C shows a conflict. Can you please report on your review. [Transcript of hearing of May 24, 1977, p. 16-17] (2) How much of FDA's advisory committee work is generic in nature? [Transcript p. 60] In the case of advisory committees dealing with products on a generic basis, please indicate the percentage of time devoted to classification as opposed to other activities. Please indicate which activities other than classfication are conducted on a generic basis. (3) In how many instances over the period 1974-1976 have advisory committee recommendations been disregarded in the final action of the agency? What percentage are these of all advisory committee recommendations during the same period? Please indicate, if possible, which recommendations resulted from advisory committee decisions reached on a generic basis. [Transcript p. 46] (4) What dollar amount is spent annually by FDA on special government employees including travel, and per diem? [Transcript p. 54] (5) What is FDA's practice with regard to advisory committee members whoafter their initial appointments-acquire a large financial interest in firm(s) under review by their particular advisory committee? (6) The Subcommittee staff study noted that six applications for appointment or reappointment for advisory committee members were rejected because of conflicting financial interests from January 1, 1976 through February 18, 1977 by the Director of Policy Management. How many applicants were appointed or reappointed during the same period? How many were rejected at stages prior to action by the Director of Policy Management? Please indicate the numbers rejected at each stage and distinguish appointments from reappointments. We would appreciate receiving this information by June 17, 1977. Thank you for your cooperation in this most important study of conflicts of interest in regulatory agencies. Sincerely, JOHN E. Moss, Chairman, Subcommittee on Oversight and Investigations. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. JOHN E. Moss, Chairman, Subcommittee on Oversight and Investigations, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. DEAR MR. CHAIRMAN: As I promised during my appearance before your subcommittee on May 24, 1977, I am enclosing additional information that addresses concerns you expressed during our testimony. I have also included answers to the questions which you raised in your letter of June 8, 1977. Copies of the booklet containing our conflict of interest policies, and the statement which must be completed by our special Government employees prior to appointment, are also enclosed. Although I recognize that this material is late getting in to you, I thought it better to send complete information rather than impose further delay by asking for an extension. I respectfully request that the enclosed be made a part of the official testimony, and I again invite you to contact me should there be a need for additional data. Sincerely yours, Enclosures. DONALD KENNEDY, Commissioner of Food and Drugs. Question 1. In response to a question from Congressman Andrew Maguire, you indicated you planned to review the transcript of the meeting held November 23, 1976 of the OTC Internal Analgesic Panel, to determine whether the role of the Subcommittee staff's FDA Case Study C shows a conflict. Can you please report on your review. [Transcript of hearing of May 24, 1977, p. 16-17] Answer. We believe that any review of Case C would be incomplete if it did not include the background information relating to the manner in which the Panel was established. The Agency was well aware that prospective members would require extensive product experience in order to be qualified to discuss the matters that would come before it. Under these conditions the Agency recognized the potential for appearances of conflict of interest but believed these potential problems could be avoided by limiting panel responsibilities to generic areas. i.e., ingredients rather than specific products, and by identifying those ingredients which were common to a wide variety of brand name products. However, ingredients unique to a single product, i.e., product specific ingredients would be considered the same as a specific product. It was on these concepts that |