ELDBAUM. No short order. Let me take the FDA issue first, efly. iotechnology industry was pleased to work with the Governith the FDA, with the Congress, to enact user fees where companies that wanted-that had products at the FDA ay extra to allow the FDA to hire the experts and the speand the people and the administrative staff, whatever they to give expedited attention to the faster flowing pipeline of 1ology products. estingly, that began to work. The FDA hired 70 new people , and then a hiring freeze was imposed on the whole procich just sent it absolutely backwards. That freeze has been nd we are back again. OEMER. Have we hired any new people since the freeze has ted? ELDBAUM. I only learned that the freeze was lifted last ', and I do not know whether they have hired anyone new. is the short-term problem with the FDA. The longer term -and it is not very long-we are only talking two to three years out there is that while there are 27 biotech drugs market now, there are currently 270 at the FDA and over 1 R&D in the companies spread all around the country. Now e going to hit the FDA in a couple of years like a tsunami. be a wave breaking over them, and in terms of their infrare, they are not set to handle that. There has been a trickle, e of new drugs each year, and now it is going to be a tidal ROEMER. Let me ask you just in relation to that question too, e user fees specifically gone toward the hiring of these peoFDA to process and improve the pipeline for this particular , or have they been hired in other areas as well? FELDBAUM. No. I am informed they have gone for the purquired. I am also told-and this is anecdotal admittedlye effects of new hires have really not been felt yet, really n felt, there has been no substantive impact. ROEMER. Do you have a target as to how many people they hire? ELDBAUM. We do not. We do not, but what we are about to nitiate a longer-term negotiation, conversations, discussion em on what happens. ROEMER. I would appreciate it, Mr. Feldbaum, if you could t to us to address both the short and the long term. FELDBAUM. I am sorry. In terms of the foreign competition, entioned Germany. Interesting-a good friend, Dr. Hahn anover is here listening to this. Germany had-and it apin my statement-instituted price controls on maceuticals some years ago and essentially just wrecked ovation in their own industry. Germany is no competition United States, I am pleased to report, and they did it to lves, and one of my pleas today is that we not do that to es. he other hand, the Japanese, who have recognized this inhave targeted the technology, have seen it as a growth in eventually like to have the manufacturing facilities and the jo And biotechnology products in Japan sell for three times what th do in the United States, and that is a conscious government poli to set the price very high to encourage the industry-just the opp site, an industrial policy that is 180 degrees from what appears current health care reform proposal. Mr. ROEMER. Thank you. Ms. DE PASSE. One of the ideas that we had had in terms speeding up the process of product reviews at FDA would be fund the agency to contract out for product specialists, because many ways it would be monumentally costly for the agency to kee in house the level of expertise that may be necessary for the ver diverse range of products that are developed, and this approach contracting out is one which has been used successfully in Europ and they maintain the in-house people to coordinate the effort and that has worked more efficiently, and the process is a lot fas er. Mr. ROEMER. And did you say that we have allowed that to tak place? Ms. DE PASSE. No, that is not happening in the United States but that is the approach that many European countries are taking Mr. ROEMER. And you are advocating that then as somethin that we might try? Ms. DE PASSE. That is one approach that could be taken to re lieve the bottleneck. Mr. ROEMER. Do you know what the difference might be in con tracting out for cost and how that would address both the long and the short-term problems that Mr. Feldbaum talked about? If you do, let us know. Ms. DE PASSE. I don't have it-I don't have the data here, but I know that some people have developed that, and I could provide it to you. Mr. ROEMER. That would be great to see. Thank you. I thank the panel, unless Dr. Curd Mr. CURD. Have you ever seen a biotechnology plant? Mr. CURD. From the point of view of competitiveness, the technology is incredibly new and a lot of people don't know how to do it, and particularly I think of some of the foreign competitors; what they want from us is the ability to build the plants to apply the technology. You know, after the recombinant technology was discovered in the middle seventies, companies put together manuals now so that high school students and certainly college students can clone and express genes. What was absolutely novel science, it was, you know, looked as the most innovative thing for biotechnology in 1973, 1974, 1975, you can order out of a catalogue, and you have to have about a high school biology background now to do the same kinds of experiments. So everybody can do the science, and as the human genome project is moving forward, everybody will know what genes are there in the category. So then the question will be who is going to select them, make them, study them, and produce them, and that own to clinical development and having the capability, and bility to make these products is miraculous. are very few places outside of the United States where can currently approach this, and, again, without being realatory, when I have visitors from foreign countries, particum ones which make electronics, they are not interested in nce, they have their cameras, and they want to see my They want to see how we make the things, because if they ake them, the science is open to everyone. IH publishes the science, it is in the journal, all you have have the idea and be willing to pursue the technology. Mr. Chairman, when Congressman Klein was speaking, he we would be willing to give him some alternative language e things, and, fortunately for me, I came prepared with the my company, and we have copies of some alternatives for isory Council on Breakthrough Drugs for all the members committee. I have got them right here. ALENTINE. Thank you very much. ne say again to each of you that we have some-I think nderstanding of what it takes to prepare for this exercise, are indebted to you for giving us this much of your time r scholarship. e a question that I want to ask you to chew on finally. It esented to us by our colleague from Minnesota, Mr. Minge. want to say before that that I hope that you don't think of gress and this exercise as if we were here with a big stick it through the cage at John Q. Citizen just to see how loud d squeal and how we could aggravate him. I think I speak st of my colleagues. If this cup would pass from us we -but it isn't, and I, for one, believe that while I am not here sident Clinton or Mrs. Clinton's emissary, I have not enor embraced any of the solutions, I am one who believes e worse thing that the Congress could do is to do nothing. not your fault, and it is not the responsibility of your piece action, but it is a mess, and there are going to be some s, and they are not going to occur all this year, and maybe ill be a settlement that the old country lawyers used to you settle a lawsuit and everybody is dissatisfied, then you t a pretty good settlement. encourage you to send us-give us the benefit of your judgs to what changes be made in any way you deem approeither to me in a telephone call or come to my office or whismy ear on a park bench somewhere and say, "Don't mention ne;" in other words, help us. We want to do what is right. ight surprise a lot of people. I want to say also that you don't-if you are talking about tes, you may be talking about Members of Congress, but you in speak for yourselves with great eloquence. ss there is some objection from a member of the committee, have an understanding that members of the subcommittee bmit questions to you after this hearing, if they are not too some. We would appreciate if you would answer them. questi Minneso California in a case where an HMO refused to approve a bone ma row therapy regimen. The HMO considered the procedure expe mental, and the aggrieved parties sued, and would any of you ca to comment on how we know what ought to be considered-how know or don't know what ought to be considered experimental a when providers and the insurers, HMO's, et cetera, should be r quired to finance or provide treatment and when punitive damag should arise? Dr. Brown? Dr. BROWN. I think that that is a commonly posed questio From my perspective, I would phrase it a little differently in th I think that the emphasis isn't so much on what is experiment and what is not, but what therapies we should be supporting i whatever health care system we have, and by that I mean canc medicine is an intriguing area with regard to this question becaus there are therapies that are commercially approved that, quit frankly, can be used and are considered within the standard care, but the likelihood of their success in any meaningful way very, very, very small. On the other hand, you can have very pron ising, quote, unquote, experimental therapies Mr. VALENTINE. Isn't that like, "The beauty is in the eye of th beholder"? Dr. BROWN. Well, I think the issue is that in areas of cance medicine, since we are talking about cancer, where therapies ar largely ineffectual-for example in advanced colon cancer-ther should be some allowance to ensure access to investigational thera pies for patients, and the same applies to patients with high-ris breast cancer. If there is no standard therapy that is likely to be helpful, the there should be some mechanism, some way, to provide access t appropriate investigational therapies. What is appropriate? In the medical community, that is by and large determined by such things as peer review, that often occur through the NCI mechanism, or through industry where there ma be peer review of a different sort but not necessarily through Federally-supported system. So there are quality assurance mechanisms in place where on could discern what investigational therapies are probably appro priate to give folks access to and which probably are inappropriate because there certainly are some that would fall into the latter cat egory. Mr. VALENTINE. All right. Thanks again. A special thanks to you, Ms. Johnson. I was in service with some people from what they referred to as "Bethlem. Ms. WAGNER-JOHNSON. No. Mr. VALENTINE. It is Bethlehem, Pennsylvania. Ms. WAGNER-JOHNSON. Bethlehem. Mr. VALENTINE. If there is nothing else for us to do, the sub committee stands adjourned. [Whereupon, at 11:55 a.m., the subcommittee was adjourned.] APPENDIX ADVANCED BIOTECHNOLOGY IN THE TREATMENT OF COLORECTAL CANCER. Garth H. Ballantyne, H.D., F.A.C.S., F.A.S.C.R.S. Associate Professor of Surgery Department of Surgery Yale University School of Medicine 333 Cedar Street, P.0. Box 3333, LB13 Telephone: 203-785-2562 FAX: 203-483-5540 |