Mr. WILLIAMS. I get you. It would have taken us to now to complete the Helsinki Heart Study. As you know, it was completed in the spring, and the manuscript has been submitted and accepted to the New England Journal of Medicine and will be published shortly. Hopefully, within a 30-, 40-day period following the publishing of that, we will submit to the FDA all the necessary documents for the indications. Mr. MORRISON. You are saying your five-to seven-year period would have come from the expiration of your original patent. Mr. WILLIAMS. Correct. Mr. MORRISON. Under prior law, either way, whether you went to market with the first use or not. Mr. WILLIAMS. Correct. Mr. MORRISON. Is that a fair statement? Okay. Now, if you had been a January 1982 rather than a December 1981 application, would you be here today asking for the same relief? Mr. WILLIAMS. I think I would. Congressman Morrison is talking about a quirk in the Waxman-Hatch law which gave a ten-year relief on any product, new chemical entity that was approved after January 1 of 182. This has never been part of our consideration, by the way. Our consideration has always been the uniqueness of what we have done, the long-term study, the costs of it, the need to get our investment back and, I might add, the stick-to-it-iveness and the innovation to really do something for America and for people with coronary heart disease. Mr. MORRISON. I understand how it turns on the change of law in the fact that the generic application process is telescoped into a very short period compared to what it would have been. Why is it only now that this matter is before us if it really did not-other than that which was clearly known at the time? Once that legislation was passed or even at the time of that legislation, it was clear that the new drug application process for the generics was going to have this kind of effect on what you were already engaged in. Let me just say that I understand the statements and there is some testimony from somebody who is going to testify next about your role in the passage of the Waxman legislation, but I guess I do not understand, since regardless of the effect of the date there, you are asking for something different from the date that was set there. You are asking for something that relate to an overall policy concern which seems to me reaches beyond your own company. That is, this unfairness you are talking about is not only an unfairness that would necessarily arise to your company, but the fact that the loss of this market exclusivity for anyone who is really in kind of a Phase IV circumstance like yours might be able to make the same equitable claim that you are making. Mr. WILLIAMS. Mr. Morrison, I say this straightforward. I do not know of any other situation like this. Here again, I would like Mr. Hutt to comment on that because he did a lot of work on that before we began this project. Mr. MORRISON. I am taking too much time. I think I have already exceeded my time by quite a bit. Mr. WILLIAMS. It is a very important point. Mr. KASTENMEIER. Well, I am afraid it is about noon, and we have other witnesses. If Mr. Hutt would want to respond to that in writing, he may. But we are not going to be able to conclude this hearing if we protract it much longer. Mr. WILLIAMS. As you can tell, I have a slight interest in this. Mr. KASTENMEIER. The gentleman from California. Mr. LUNGREN. Thank you, Mr. Chairman. One of the things I want to get clear is this limited use approval that you got in 1981 for Lopid. Exactly what was that for? Mr. WILLIAMS. It was for the patients with pancreatitis with high triglyceride levels. Mr. LUNGREN. And my question is: In terms of the regimen indicated for that, would that have been a daily usage forever as it is for this other purpose? Would the dosage have been different? Mr. WILLIAMS. Mr. Lungren, Dr. Levy is an expert in this area. Dr. LEVY. The dosage probably would not have been any different. It is likely that the usage would have been for a shorter period of time; that is, until one could bring the patient under diet control, get the patient down in weight, and bring other methods along to control the triglycerides. Mr. LUNGREN. So, in essence, in 1981 and up to very recently, most reputable physicians, I would think, would not have used this even for the other purpose, not only because the studies had not been done, but also because the long-term effect of usage of this was not something that was contemplated with respect to the initial limited use. Dr. LEVY. Well, Mr. Lungren, if I can, let me just say I sort of object to the concept of no reputable physician. The issue in cholesterol and heart disease has been a long and controversial one that has been fought out, unfortunately, too often in the press. There are many physicians, based on the data that was on hand long before the coronary primary prevention came out, that concluded that cholesterol lowering was beneficial, and the lower the cholesterol the better. And based on those conclusions, when Lopid came on the market, those physicians on the basis of their judgment were ready to use it. But clearly, as our surveys show, the vast majority of physicians were not ready then and would not use it for an unapproved indication. We are just beginning now the educational effort to make physicians aware of the opportunity and need to approach the cholesterol problem. Mr. LUNGREN. I will withdraw my characterization as reputable. The point I was trying to make is that, in fact, there was an economic loss suffered by the company from the standpoint that even though it was on the market, most physicians would not have used it for the purpose for which it now will be approved following the Helsinki Heart Study. Therefore, an argument that others might make in opposition to your request is, well, it was on the market and other physicians would use it, is only partially true. I do not want to belabor this. Not only am I concerned about this because, as I say, I have a father who is a cardiologist, but my grandfather died of heart disease and my dad has had a quadruple bypass, and he is always complaining about my cholesterol. I think it is extremely important for those of us, as Mr. Hard said, to ensure that the incentive system exists such that this type of research will come forward. One last thing. Mr. Williams, you have indicated that the Helsinki Heart Study may, in fact, be a boost to some of your competitors in terms of the marketing of their drug. How so? Mr. WILLIAMS. As we learn more about long-term studies on effects of cholesterol on the system, there are two foreign drugs that are being developed in this country. One is a French drug and one is a German drug that has a similar therapeutic effect, physiologic effect, I should say, that has the same kind of actions that gemfibrozil does. They will without a doubt ride on the coattails of this very expensive, long-term, innovative research. But that is what our industry is about. We do not have monopolies on therapy. Mr. LUNGREN. But your study will be the most extensive in this area? Mr. WILLIAMS. Yes. It is the most extensive, it is the longest, it is the most expensive private study ever done. Mr. LUNGREN. Thank you. Mr. MORRISON. [Presiding] The gentleman from North Carolina. Mr. COBLE. Thank you, Mr. Chairman. Mr. Williams, my friend from Illinois asked you about the position of the associations that represent the research-based pharmaceutical companies as well as the association representing the generic pharmaceutical manufacturers. I believe your response was that both associations had taken no position? Mr. WILLIAMS. No position. Mr. COBLE. Now, this competitive era in which we live surely has prompted some opponent on the horizon. Has anyone expressed opposition to it? Laboratories or disinterested or interested parties? Mr. WILLIAMS. The only ones that I know of I believe are going to testify following me. Mr. COBLE. Okay. That is the only ones known to you? Mr. COBLE. One more question, Mr. Williams, and you may place this under the heading of curiosity. It may be completely inapplicable about the hearing today. But I am curious as to why you all selected Finland. Would it not have been more cost effective if you had conducted your study in this country and used American patients? Mr. WILLIAMS. We selected Finland, we did the pilot study in Finland that led to the large study. We did it beginning in 1974 on 254 patients as an open label study. In that open label study, we got a 70 percent reduction in the anticipated rate of coronaries. The reason we selected Finland is they have the highest rate of coronaries in the world, so we wanted to test this drug under the best circumstances we could. Cost never entered into it. As a matter of fact, today it would probably cost more in the United States to do the study than it did in Finland. Mr. COBLE. Mr. Williams, I know the others have said this. We appreciate you and your colleagues appearing before us today. Mr. WILLIAMS. Thank you. Mr. COBLE. Thank you, Mr. Chairman. Mr. MORRISON. I just have one last question. Since I have now been given the power of the Chair, I can ask one other question. As that relates to the decision to ask for a five-year period, taking the two alternatives, you have said to us that you have incurred some costs on this of $177 million. That does not include, obviously, the production process, I take it. On that, what kind of economic return are we talking about in the two alternative scenarios? The scenario in which you have to operate under current law such as it may be and such as it may come out, what are you projecting as your gross revenues? And what is the difference there that will be made by this five-year period? In other words, what is this five-year period going to add to your gross return, and how does that reflect your profit on this? Mr. WILLIAMS. Mr. Morrison, I cannot give you the exact gross return, but I can give you a statement that I can live by. If we do not get the five-year extension, our shareholders-and that is whose money it is-we will actually have lost on this major innovative research in this period of time until the patent expires. Extending the patent five years would give us the opportunity to recoup our investment and also will continue to allow us to continue to invest in this kind of research. When Representative Hyde asked me the question, I went on to tell you the commitment we have made over the next five years of $1.5 billion in our research program in the areas of some of the biggest disease problems we have in the United States-AIDS, Alzheimer's, central nervous system drugs, cardiovascular drugs, anti-infective drugs. Mr. MORRISON. Thank you. I would like to thank you and your colleagues for their testimony. Mr. WILLIAMS. Thank you very much. Mr. MORRISON. Our next scheduled witness had been Mr. Edwin Cohen, the President of Barr Laboratories, who unfortunately could not be with us today. Without objection, I will make his statement a part of the record. [The statement of Mr. Cohen follows:] |