(Extensions of Remarks - November 19, 1999)

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[Extensions of Remarks]
[Pages E2468-E2474]
From the Congressional Record Online through the Government Publishing Office []

                 OF REPRESENTATIVES ON OCTOBER 26, 1999


                         HON. BRIAN P. BILBRAY

                             of california

                    in the house of representatives

                      Thursday, November 18, 1999

  Mr. BILBRAY. Mr. Speaker, I insert the following for the Record:

       Richard Willis. Good morning, I am Richard Willis, the 
     Regional Manager of ComDis Co. Laboratory and Scientific 
     Services. We are delighted to participate in this first ever 
     BIOCOM Satellite CEO Conference. I think it is a compelling 
     measure of the progress that is being made by so many 
     dedicated people here in this business in San Diego over the 
     past few years. ComDis Co. has a strong presence and a long 
     presence in San Diego. The short commercial is that we offer 
     services ranging from venture finance for early stage 
     entities through to life cycle management services for more 
     advanced companies in this business. We have a local 
     representative here, Gail Obley who is presently working with 
     many of you. Again, we are delighted to participate as a 
     sponsor and wish you well in this activity. Thank you.
       Narrator. Welcome to the Satellite CEO Conference with the 
     Commerce Committee of the U.S. House of Representatives. In 
     San Diego, on today's panel are: President and COO, Alliance 
     Pharmaceutical Company, Ted D. Roth, President and CEO, IDUN 
     Pharmaceuticals, Inc. Steven J. Mento, Ph.D., President and 
     CEO, BIOCOM/San Diego, Joe Panetta, President and CEO, 
     California Healthcare Institute, David L. Gollaher, Ph.D., 
     Chairman, President and CEO, IDEC Pharmaceutical William H. 
     Rastetter, Ph.D, Founder and CEO, INNERCOOL Therapies, Inc., 
     John Dobak, M.D., and your moderator for today, Chairman and 
     CEO, Alliance Pharmaceutical Company, Duane Roth.
       Duane Roth. Let me start and just briefly introduce our 
     panel members: First, Ted Roth who is President of Alliance 
     Pharmaceutical, Bill Rastetter, who is Chairman, President 
     and CEO of IDEC Pharmaceutical, Steven Mento who is President 
     and CEO of IDUN Pharmaceuticals, David Gollaher who is 
     President and CEO of the California Healthcare Institute, 
     John Dobak who is the Founder and CEO of INNERCOOL Therapies, 
     and Joe Panetta who is President and CEO of San Diego's 
     BIOCOM. Let me suggest that we go into the issues, if that's 
     OK with you, that we would like to have a discussion or a 
     dialogue with you on. And for that we've got a moderator for 
     each topic. Congressman, did you want to say anything?
       Congressman Bilbray. I need to inform you, before we get 
     started, that the transcipt of this panel will be entered 
     into the congressional record. So don't say anything that you 
     don't want your grandchildren to read. But, seriously, we 
     want for this dialogue to reflect the fact that these are 
     issues that the biotech industry needs to have addressed and 
     wants to have addressed. So you have been duly warned.
       Duane Roth. We have been warned, and I guess that changes 
     just about everything. However, let me turn to Ted and let 
     him get the first issue on the table.
       Ted Roth. Good morning Congressman, or afternoon I guess 
     out there. Thank you for participating in this program. The 
     issue that I would like to discuss briefly is the access to 
     capital as the issue we are facing right now. As you know, 
     San Diego has about 250 companies that are engaged in the 
     various aspects of bioscience. We employ nearly 25,000 
     people. And spend over a billion dollars a year in research 
     and development. We are the third largest concentration of 
     biotech companies in the nation, or the world for that 
     matter. All of these companies are similar in their issues to 
     the roughly 1,300 other biotech companies in the United 
       Yesterday we had a panel of analysts who talked about the 
     financing environment, both in the public and private 
     markets. As most of us know, they talked about the difficulty 
     in raising money with companies having valuations under 
     approximately between 750 and a billion dollars. I think it 

[[Page E2469]]

     interesting to know that the only company in San Diego that 
     has a market valuation in excess of a billion dollars, in 
     fact, it is greater than two billion, is IDEC 
     Pharmaceuticals. So the vast majority, virtually all of the 
     companies in San Diego are under this level that they talk 
     about being difficult to finance. Most of these companies 
     have less than two years of cash, and many have less than one 
     year. We are currently working on about 75 products that are 
     at a late stage clinical development. And as this development 
     continues, the need for capital to make it through the 
     clinical trials and prepare for commercialization will only 
     make the financing issue more dramatic. Therefore, what we 
     have is a situation where companies have products that are 
     nearing approval that are running low on cash and are facing 
     a dubious financing environment.
       The federal government can take steps to help to create a 
     better environment for us. Most of us remember what it was 
     like in 1993 and 94 with the Clinton Health Care Plan where 
     what was going on in Washington had quite a dramatic effect 
     upon us. While we don't expect that there is anything that 
     can be done now to have that kind of affect on the positive 
     side, we think it is important for the legislators to 
     understand that what you do in Washington really does matter 
     to us.
       What I want to do is put three issues on the table. The 
     first is the R Tax Credit. And I guess that I would ask 
     that you comment on what you think the chances are that it 
     will either be extended or made permanent during this 
       The second issue is Capital Gains and taxation on increases 
     in capital investment. Do you expect, or should we look for 
     any legislative changes to the existing law.
       The final area and the one which is relatively recent. We 
     heard this morning about the New Jersey model whereby the 
     biotech companies are able to transfer a part of their state 
     NOLs to the larger pharmaceutical companies under certain 
     circumstances. This is something that the California 
     Legislature is looking at, they are studying a comparable 
     bill. So I guess, the question I would pose is, what, if 
     anything, can we anticipate at the federal level on an issue 
     such as the NOL transfer?
       Congressman Bilbray. Well I think first of all, let me 
     comment on the fact that you pointed out appropriately the 
     problems that, while we may be talking politics in 
     Washington, things like the comments that were made about the 
     first lady's health care plan--the damage that does. Coming 
     from you, it just shows that this is not a partisan issue, 
     but that all of us in Washington have to be sensitive to the 
     fact that there are more than just political games in 
     Washington at stake here. We are talking about the 
     breakthrough drugs and major investment, so I am glad that 
     you bring that up because it brings credibility to the 
     discussion on both sides.
       The one thing we've got to watch out for, as you've seen in 
     the last couple weeks, there is posturing of ``let's use the 
     availability of drugs and pharmaceuticals to the public as 
     some kind of political ping-pong ball which really hurts you 
     guys right on the front line.'' And let's face it, on the 
     other side of it, you've got to compete against other venture 
     capital opportunities. It seems like recently we've seen that 
     if something has a ``dot-com'' on the end of it, it is 
     basically being perceived as a gold mine. I think hopefully 
     we will see that moderate a bit and that BIOCOM will be on 
     the line there.
       Let me get right to your questions. The R Tax Credit is a 
     very high priority. I think that it is a good possibility 
     that somewhere down the line in the next few weeks that we 
     will see a way to place that into a bill that the President 
     will sign into law.
       The capital gains issue: I think right now, as long as the 
     economy is still strong, no, we won't see that move forward. 
     I think that the Capital Gains, as the Chairman of the 
     Federal Reserve has said, is something that will be used if 
     we see a softening of the economy. It is the adrenaline we'll 
     give the patient, that will stimulate the patient to get the 
     economy moving again. So that will be incremental and will be 
     based on when we need to stimulate the economy. What I think 
     that you are going to find now is that the discussion coming 
     out of DC will effect the latest numbers on inflation. So I 
     see that as being sort of a negative.
       Let me just tell you that this New Jersey model and what we 
     are doing for California. That is totally wide open. I am 
     basically open for suggestion on that. I couldn't tell you 
     one way or the other. You would probably be able to tell me 
     better about that aspect.
       Duane Roth. Would you like to make another comment about 
     Net Operating Loss? No? OK. Then let's move on. If we can we 
     will move on to our second topic, and that is the Food and 
     Drug Administration. You have been very much involved in the 
     past in helping us with some issues with the FDA and the 1997 
     legislation. I'd like to turn to Bill Rastetter and ask him 
     to make some comments regarding user fees and the 
     modernization act. Maybe we can discuss that and then we have 
     a second part that we'd like to talk about. Steve Mento will 
     talk about that, and that deals with appropriations and the 
     mission of the FDA. So, Bill, I'll let you go first.
       Bill Rastetter. Congressman, thanks for being with us here 
     this morning. I would like to talk about PDUFA and FDAMA. For 
     the audience here, that may not use those acronyms every day; 
     PDUFA is of course the Prescription Drug User Fee Act under 
     which those of us developing drugs pay certain fees to the 
     Food and Drug Administration that helps with the hiring of 
     reviewers and the review process. Of course, FDAMA is the FDA 
     Modernization Act of 1997.
       Congressman, I'd like to give you a little feedback from 
     the sector. We think that PDUFA has really been an 
     unqualified success; both for patients and for biotech 
     companies. It has provided for very substantial funding and 
     fast track reviews of products. I know that our own company, 
     IDEC, has certainly benefitted from that with the 9 month 
     approval that we obtained for Rituxan.
       I think the metrics really speak for themselves. With 
     PDIFA, the act was passed originally in 1992 and in that year 
     there were 26 new drugs approved. By 1996, with 600 reviewers 
     hired with user fees there was a record of 53 new drugs 
     approved by the Food and Drug Administration. In fiscal '96, 
     that was the year when those 600 reviewers were on board and 
     I guess still being trained and getting into the swings of 
     things, I to approval, of course I was many years 
     earlier, I to approval for drugs approved in '96 was 
     greater than 90 months. By '98, just two years later, that 
     was down to less than 60 months from application to begin 
     clinical trials to approval, a dramatic change.
       So I think that it is essential that we continue to build 
     on this momentum. It is something that came out of PDUFA and 
     the awareness, that yes we really could do something that we 
     could work with the FDA as a partner, something that came out 
     of that with lots of congressional help and dialogue with the 
     sector was FDAMA, through which Congress provided tools to 
     improve and modernize the review process. I am delighted to 
     tell you today, that I think that from our sector at least, 
     the feedback is generally positive. Certainly we at IDEC view 
     the FDA as a responsive and very active partner in drug 
     development, where we are really jointly making drug 
     development decisions on a real time basis with the FDA, 
     rather than being second guessed after the fact, and this is 
     absolutely critical. Important to being able to achieve this 
     is absolutely critical to have a scientifically trained, well 
     compensated and motivated and retained staff. I know that 
     Steve will speak about that. I think that all the feedback is 
     not positive. Some critics would say that the FDA is still 
     failing to insure that the FDA is failing to ensure that all 
     patients receive our technologies promptly and efficiently. I 
     would refer you to the recent testimony of Pamela Bailey, who 
     is the president of HIMA, or Health Industry Manufacturing 
     Association to the Senate Committee on FDAMA that was as 
     recently as the 21st of this month.
       Of course, HIMA is the device trade association. I think 
     that being in the biotech or the therapeutic side of the 
     industry, I would have to ask if the device sides experience 
     with the regulatory process might not be more positive today 
     if they had put in place a PDUFA type act that would provided 
     through user fees the increase staff at the regulatory 
     agency. I'd welcome your comments on, either now if you wish, 
     or after we wrap up.
       I think though, that by and large, the FDA is more 
     performance oriented these days, and have been really 
     gratified to see the FDA re-engineer itself and be proactive 
     and responsive to the climate, and also pro-active to try to 
     manage the increasingly complex workload with human 
     resources. I think that the metrics at CBR which is the 
     biologic side of the house at the FDA are very telling. In 
     '86 there were 178 I, or IDE's, these are the new 
     applications to take something into the clinic. So '86--178, 
     by '95--452, by '99--587. If you look at the balance of those 
     that were in Biotech, went from 87 out of 178. This year an 
     expected 427 out of 587. So the balance is really shifting in 
     the bureau of biologics over to biotech and the workload 
     certainly up more than threefold in the last 13 years or so.
       Yet, the operating allocation dollars to CBR have gone 
     down. '96 was less than '95, '97 less than '96, '98 less than 
     '97. '99 is slightly up, but it is still in constant dollars 
     down over 10% from '95 in this environment of increased 
     complexity, because of technology, more and more is biotech 
     which takes more scientific review and the number of 
     applications are way way up. So, certainly continued funding 
     growth is essential if we are not going to lose this momentum 
     and indeed we are going to continue to build on this 
     momentum, and Steve will comment on these things.
       Two very very important areas, and I don't want to preempt 
     you. Trained scientific staff at salary at parity with peers 
     in the industry, because if you can not achieve that you will 
     never solve the problem of turnover at the Food and Drug 
       Number 2, information technology. I think this is the 
     single most important factor that can contribute to increased 
     efficiency in the food and drug administration. And we are 
     moving from boxes and boxes, pounds and pounds of 
     applications to single CDs that are hyper linked where the 
     reviewers can go back and forth very quickly, gosh they can 
     take the whole BLA home in their pocket if they want, and 
     work on it over the weekend. An incredible efficiency to be 
     gained if we can get the Food and Drug Administration up to 
     speed in information technology and that will certainly 
     require the hiring of trained motivated retained staff to put 
     all of that in place.
       Another point that I want to make is that it has been very 
     popular in this country to

[[Page E2470]]

     fund the National Institutes of Health. Indeed, our entire 
     sector has come out of the enlightened funding of the NIH 
     that we have had in this country for decades. But, we have to 
     view the NIH and the FDA as bookends with all of our 
     companies being the books in between. All of the books will 
     topple off the shelf if we pull out that FDA bookend. We need 
     to support the industry from both ends from basic science 
     through the regulatory process, we have to be very very sure 
     that we are buttressed from both ends.
       In closing, I think that the agency got a very big boost 
     with the appointment of Dr. Jane Henney. She has an 
     exceptional record of leadership, both in academia and in 
     government, an intimate knowledge of the food and drug 
     administration having served as the deputy commissioner for 
     operations from 1992 through 1994, I think that everybody 
     views that the direction she has said would establish a more 
     efficient, more responsive, more open and better understood 
     agency. I think that from the perspective of our sector, I 
     would like to suggest three very very important objectives 
     for the commissioner to focus on.
       Number one. To ensure that drug, biologics, and device 
     approvals don't get side-tracked by new activities at the FDA 
     such as tobacco and food. And Steve will comment on this. I 
     think that one tool that should be implemented for that is a 
     PDUFA type act for devices to increase reviewers at the FDA 
     for the device sector.
       Objective #2 is a strategic one. To continue to build a 
     modern strategic vision for the FDA. Let me give you three 
     objectives that CBR has identified for itself that I think 
     are just superb and really speak to the scientific quality 
     today within CBR. Three objectives, their own. Establish bio-
     markers and surrogate end points for clinical trials to make 
     clinical trials more efficient and make approvals more 
     streamlined. Number two. To restore protection to large 
     segments of the adult population with biotech vaccines. The 
     old vaccine technology is failing in many regards. Number 
     three. The identification and use of gender specific factors 
     that influence, or might influence drug and biologic safety 
     and efficacy. That is the kind of strategic leadership, 
     objective number two, the agency needs.
       Number Three. A tactical counterpart to that. Building on 
     PDUFA and FDAMA ensuring that through an inside focus on 
     operations, efficiency and performance that the FDA continues 
     to streamline, continues to improve its partnership with our 
     sector. I would suggest, as Congressman, you and I have 
     discussed on occasion, that we move toward a full time Chief 
     Operating Officer. A partner in tactical matters with the 
     Commissioner, to be accountable for performance for day-to-
     day operations for information technology systems, for 
     hiring, training and retention of staff and that person 
     established as a full-time person at the agency would very 
     much complement the Commissioner who should be providing the 
     strategic leadership.
       I appreciate you being with us this morning, and I'm sorry 
     that rambled for so long there.
       Congressman Bilbray. Well, actually there was a benefit to 
     that, and I'll get to it in a moment. But frankly, BIOCOM was 
     really on the cutting edge of this. Actually, I think some of 
     you will remember--even before I was sworn in, you had me in 
     your office and talked about how FDA reform was essential and 
     that the institutional mind set needed to change. I am glad 
     to know that as a result of our efforts, there has been 
     positive movement and an evolution towards being more pro-
     active and cooperative on the part of the FDA. The fact is, 
     there needs to be more. Even Henry Waxman, with whom I have 
     often disagreed with regarding the status quo with the FDA 
     will say that, when it comes to Biotech. The FDA regs at that 
     time were totally inappropriate and they needed to be 
     reformed and attitudes needed to be reformed. And frankly, 
     somebody who has been a real leader in this and really helped 
     us out on the Commerce Committee happens to be Richard Burr, 
     from North Carolina.
       Richard was really involved with the modernization program, 
     he was really there. He serves not only on the Health and 
     Environment Subcommittee, but he also serves with me on the 
     Oversight Subcommittee, which oversees the FDA. You guys 
     really pushed me to get on this committee because of how 
     important this was for San Diego and it has been great 
     working with Richard, who is somebody who has really been on 
     the cutting edge of this, and is somebody that we can depend 
     on to keep pushing. Like it or not, we have to admit that 
     California does not have all the biotech industry in the 
     world, and that North Carolina does other things besides grow 
     something to smoke.
       Let me just sort of throw it over to . . . ladies and 
     gentlemen, I'd really like to introduce my colleague and 
     probably one of the shining stars of not just the Commerce 
     Committee, but of the entire Congress, and that is my 
     classmate, Richard Burr from the great state of North 
     Carolina. Richard.
       Congressman Burr: Thanks Brian, and my apologies for my 
     tardiness. If California is as crazy as Washington is today, 
     you can understand the schedule that we have had as we try to 
     wrap up this appropriations process.
       I think it was appropriate that I wasn't here to make any 
     comments. The advantageous thing for me is to hear the 
     questions that are raised. More importantly, to hear the 
     experiences with post-FDAMA. I think that we continually try 
     to update ourselves on whether the modernization act is in 
     fact executed the same way that we intended. There is no 
     better way than to look at the amount of applications that 
     have been filed. To look at the increase in those that have 
     been approved. But that is not enough. Brian and I realize 
     that, and our colleagues realize that we need to be vigilant 
     in our watching.
       I am not sure of the makeup of our panel, but I also give 
     high marks to the FDA so far on their ability to transition. 
     The Janet Woodcox's of the world, and certainly to the new 
     commissioner. I think that they have made tremendous 
     progress. I think that we still have cultural change yet to 
     determine whether we have started. I am committed to stay 
     involved in it until that the cultural change is evident to 
     all of us. One of the things that we've got to watch out for 
     I think, and when I say ``we,'' I mean members of Congress, 
     as we address health care policy, you will hear more and more 
     the question of pharmaceuticals and biologics come up in the 
     discussion. We've got to make sure that the capital continues 
     to flow to the biotechnology industry. We've got to make sure 
     that our health care policies, as well as our approval 
     agencies, are such that it makes Wall Street comfortable with 
     the industry and with the investment that individuals make. 
     It is because of that investment and the risks that each one 
     of you take that we will experience products in the future 
     that address both chronic and terminal illness that today we 
     have no treatment for. We are here in hopes to listen and 
     also to work hard to make sure that this act is carried out 
     in a way to produce the product that it was intended to.
       Congressman Bilbray: I think you are coming from a position 
     of strength to BIOCOM. With all the partisan bickering you 
     see in Washington, at least on television, for you to come 
     forward and for us to be able to say that there has been a 
     major improvement of the situation. That the FDA has made 
     these great leaps forward gives us more credibility when we 
     start pointing out the shortfalls that still need to be taken 
     care of. I think that is something that we don't do enough of 
     in Washington. In other words, pat them on the back when they 
     have done well, so then when you point out the shortfall, you 
     have more credibility. That it isn't just partisan sniping. I 
     think that is something we have been able to do on the 
     Commerce Committee because we have acknowledged that. It is 
     good that you guys do that. Now let's hear what we should do 
     to improve the system more.
       Believe me, when we talk about this sniping against the 
     industry, it really worries me when I start seeing people 
     looking to use this in the next election. I was just talking 
     to my daughter and making the comment that I'd rather forgo 
     the political advantage and be able to be assured that my 
     daughters don't have to face off with the scourge of breast 
     cancer in the next 20-30 years because we did the right thing 
     now so that we can get these breakthroughs out on the market.
       But let's hear what we can do to get it done from you guys.
       Duane Roth. Thank you very much and thank you Congressman 
     Burr for joining our conference.
       I think what we can summarize the last discussion about is 
     that we have done that right, and that it is moving in the 
     right direction. But there are still issues that remain with 
     the FDA and one of them is that it's really not uniform. 
     There are some divisions that are performing very well, and 
     there are others that are still lagging very far behind, and 
     that has a lot of do with people. I am going to ask Steve to 
     discuss appropriations in a minute, but people, and Bill made 
     a very important point, information technology. There is no 
     reason we should be sending truck loads of books to the FDA 
     for review when we can send it on a CD that they can have in 
     a matter of minutes and it is so much more efficient. I just 
     sent a drug application last week, and the boxes and boxes 
     and boxes of paper that went are really telling about what 
     the FDA is still dealing with.
       Congressman Bilbray. Before we leave this, and Richard you 
     may want to jump in on this, we've actually had an initiative 
     called the Paperwork Reduction Act. We may want to go back 
     and take a look at that as Members of Congress, saying how 
     can we take the intention of that legislation and apply it to 
     this specific issue. Rather than having to reinvent the 
     wheel. Say, ``Look administration, we have this act that is 
     already initiating these programs to avoid paperwork, and 
     here you've got the industry that is ready to work with you 
     to implement that act,'' and maybe we can plug it into this 
       Congressman Burr. I'd also like to tell you that this is 
     part of the cultural change that we hope to see that we 
     haven't seen. Clearly that alarms me that we have an agency 
     that evaluates and approves these methods that are so far 
     technologically advanced that might not accept something on a 
     CD-ROM has to be something cultural.
       Congressman Bilbray. My attitude is just why don't we just 
     package it and call it the Tree Preservation Act and start 
     going to this new high-tech.
       Duane Roth. We could have saved a tree. Steve, why don't we 
     turn it over to you.
       Steve Mento. I also want to add my thanks to the other 
     panel members and thank you Congressmen for taking the time 
     out of your very busy schedule to listen to some of the 
     issues that we want to present here.

[[Page E2471]]

       I want to build my comments on both Ted and Bill's. IDUN 
     Pharmaceuticals is one of those small companies that Ted 
     described. We won't be filing our first I with the FDA 
     until early next year. And again, I want to stress the 
     importance that time is our enemy, so it is critical that FDA 
     appropriations that Bill talked about are adequate, remain 
     adequate, or are even increased, such that the gains that we 
     have made in the last three or four years are even exceeded 
     in the future.
       It is critical to a small company with limited financing 
     that when we submit an application, that application is 
     rapidly reviewed, and it moves forward at an appropriate 
     pace. As Bill said, it is key for the FDA to have sufficient 
     personnel of the highest quality to ensure that the product 
     review process starts and continues to move forward on a 
     timely pace.
       Critical to understand, very simple, in order to regulate a 
     scientific industry, and biotechnology is clearly a 
     scientific industry, we need strong scientific regulators. I 
     will draw from a past experience I had earlier in my career 
     when I was involved in the early days of gene therapy.
       When we first started talking to the FDA about Gene 
     Therapy, it was an industry that didn't exist. I want to 
     commend the FDA response to our early discussions. They 
     basically put a new group together, the Cell and Gene Therapy 
     group, and they staffed that group with very strong 
     scientists. I think that just looking at the safety record in 
     that gene therapy industry over the past five or six years is 
     not in small part due to the fact that there was strong 
     science at both ends, both ends of the table. And even with 
     the recent set-back in gene therapy where there was a death--
     the first death in a clinical trial, I think the appropriate 
     and rapid response on both sides of the table have enabled 
     the trials to move forward. It is very important to have 
     strong science on both ends, and have the funding to make 
     sure that this is possible.
       And as Bill said, we are particularly concerned in our 
     industry about so called mission creep. With funding being 
     what it is, how will the FDA be able to respond to new 
     initiatives that will be placed on them, new requirements 
     with genetically modified foods, or even tobacco, with the 
     increasing number of applications that are coming from our 
     industry, and keep pace with the review process.
       So I guess the one question I would have is, how will 
     Congress ensure that FDA staffing, and resources are adequate 
     to meet the ever-growing regulatory needs of the biotech 
       Congressman Bilbray. Well, I think, and Richard jump in, 
     right now we are just trying to maintain appropriate 
     oversight. Those of us on the Oversight Subcommittee are 
     watching how these resources being allocated to the 
     administration are being spent. We're actually able to have a 
     substantial maintenance of our effort, and improvement of our 
     effort even with the limits of the balanced budget, while not 
     spending social security.
       I don't see any real critical issue, in which we are going 
     to have to reduce what is available. In fact, with you guys 
     taking such a strong pro-active stance on user fees, which is 
     something that Republicans often get real paranoid about, 
     really helps us to keep this constant effort going because 
     the industry has said that we don't mind participating in the 
     cost as long as we get the services that we need to get these 
     things moving along.
       Richard, do you have a comment about what we need to do?
       Congressman Burr. Yeah, good luck with your first 
     application. If any agency came to me and told me that they 
     didn't have enough money, I would be shocked. I have yet to 
     meet one in Washington. I think that is inherent to this 
     town. We have a very difficult job. I think that we try to 
     work as closely as we can with the people who are on the side 
     of the issue that where you are, and that is the applicants. 
     Is the process working better?
       Then we try to compare and look at the changes that have 
     been made at FDA. We are all concerned with jurisdiction 
     creep as to the issues that the FDA is involved` in. That is 
     purely an oversight role on our part and we are going to 
     continue to be vigilant on it. We think that when you look at 
     the number of employees at the FDA, there has to be some 
     change. The reduction probably frees up the slots for the 
     talented people that all of you have expressed that they need 
     in the process. I think that they also need to culturally 
     address some things, such as the removal of secondary 
     indications, where we can take that process out and possibly 
     put that into the teaching hospitals around the country. We 
     did part of that in FDAMA. Clearly I don't think that the FDA 
     has moved far enough in that method. But we want to free 
     people up so that the talented people can work on those 
     applications that are the various breakthroughs that can 
       We are not at a point yet that we feel that they are tied 
     because of budget restraints, when we continue to see fifty 
     investigators who sole job every day is to chase the tobacco 
     industry. So we go through a little bit of a different method 
     as to how we encourage agencies to staff up in the right 
     places, and sometimes it takes a little longer.
       Congressman Bilbray. I think that we shouldn't move beyond 
     this issue of what's called genetically altered food and 
     stuff. Anybody in the BIOCOM group should not consider this 
     to be somebody else's problem. This prejudice and this 
     practical witch hunt against anything genetically altered is 
     just really something that we have to confront, and we have 
     to confront it head on.
       Just because the debate is focused on foods right now, 
     doesn't mean those of us working on medicine can allow the 
     wolves to go after them. We need to stick together, because 
     not only is genetic research not a threat to society, it is 
     probably the greatest shining example of a bright future for 
     a whole cadre of issues, from beating cancer to feeding the 
     hungry in the world. We have to unite all of us who are well 
     informed and understand this issue, and confront those who 
     are the scare mongers, who will try to intimidate people with 
     fear on this issue.
       On the clinical trials issue, let me just point out a side 
     note that the healthcare issues that were brought up last 
     week. Every one of those managed care proposals had a 
     clinical trials provision added to it, because Washington is 
     finally waking up to the fact that we need to be pro-active 
     on this issue.
       Duane Roth. Let me move to a less controversial issue. 
     Medicare prescription drug benefit. I am going to call on 
     David Gollagher.
       David Gollagher. Congressman Burr and Congressman Bilbray, 
     we appreciate your time, you've been with us on so many 
     issues. Both of you certainly heard, or heard right after the 
     president's remarks yesterday about the drug industry, 
     calling on Health and Human services to initiate a 90 day 
     study of comparative drug prices between the United States, 
     Mexico and Canada. The President has also rolled out his plan 
     for providing prescription drugs for people who are uncovered 
     in the medicare program. There are around 39 million people 
     covered in the medicare program and around 13 million don't 
     have any prescription drug coverage. Our industry has been 
     very concerned that the attacks on the pharmaceutical 
     industry will have repercussions for raising capital and for 
     the health of the Biotechnology and the drug discovery 
     industry so the politicalization of this issue is bad for 
     everyone, I guess that our great concern is that looking 
     ahead to a very contentious election in the year 2000, how 
     can we play a constructive role in to find an approach to the 
     prescription drug coverage for the medicare population that 
     is bipartisan and will work? A lot of us in the past have 
     thought that some type of premium support would provide 
     coverage for the elderly poor would be a good way to go but 
     we can look back as well to catastrophic coverage when the 
     great panthers revolted and seniors refused to pay anything 
     for additional coverage. It seems to us that this issue is 
     very easy for the president and others to politicize by 
     talking about new benefits that people should have and that 
     basic support for these benefits should come out of the 
     companies. So I guess we would like to hear some perspective 
     on the best approach our industry can take to take some of 
     the air out of the political balloon and help for a more 
     bipartisan approach to what is basically a partisan issue.
       Congressman Bilbray. Well, that's a really tough one, 
     because we've seen people in Washington use you guys as a 
     punching bag. It's easy to take a cheap shot, you never get 
     thirty minutes to respond to the Administration's attacks, 
     it's a freebie politically. We've seen the damage it can do 
     in the early minutes, frankly, I'm concerned about the damage 
     it's going to do now. I think that we also need to highlight 
     this issue about how long it takes to get the product on the 
     market, about how few percentages are able to go from R to 
     the market. The things that the administration needs to do to 
     make pharmaceuticals more cost effective is basically to stop 
     being obstructionists. But the other issue is the tort 
     limitation. Being on the Mexico boarded they always say ``in 
     Mexico, we can get it for this, this, and this'' well, also 
     you can get dental care and medical care down there, but you 
     also have a totally different type of tort system. I wish I 
     had the answer for how we counter this, because right now I 
     just see it as a freebie for anyone who wants to take a 
     political cheap shot at you and I think that we really have 
     to take a look at how to preempt it but I don't have that 
     answer. Maybe Richard does, he's used to his industry taking 
     all the shots and maybe he's got some good pro-active counter 
     offensives ready to go, Richard.
       Congressman Burr. Should you be worried? Yes. I gave a 
     speech earlier this morning and I said had I known that the 
     modernization act would be so successful that we would move 
     from an average of the low teens of the applications being 
     approved in a year to fifty or sixty or potentially seventy 
     in future years and that the market place would have so many 
     new drugs that were still under the recover of their R that 
     it's contributed greatly to the increased cost of 
     pharmaceuticals when we look at the entire population and 
     especially seniors. The other thing that has come into play 
     is that technology is a two way street and many seniors and 
     many consumers sit at home and research their illness, they 
     are quick to go into their physicians office. They may have 
     been on Zantac and it treated their stomach well, today they 
     want prylosec, and a physician is almost required to fill out 
     that prescription, and then we move from a $10 over the 
     counter solution to a $110 prescription solution. So the 
     problem has ammunition and I've learned that anytime there is 
     a box of ammunition, Henry and our good friends on the other 
     side will continue to use it. I will tell you that most 
     members and most people

[[Page E2472]]

     across the country believe that there ought to be a drug 
     benefit with medicare. The question is are we going to try to 
     incorporate something into the existing model or are we going 
     to do something that is politically tough but policy right 
     and that's to create a private sector plan to compete against 
     medicare? As I shared with people, we never complained about 
     the post office until fed ex was created. When it gave us 
     something to compare it to we began to ask ourselves 
     questions about when it needs to be there, how confident do I 
     need to be that it gets there and how much does it cost? And 
     when you do that, if we were to create a private sector model 
     whether it's premium support in total or another byproduct of 
     those talks I think we get a fair comparison that seniors and 
     the consumers can compare medicare to. What do you do? I hope 
     that we in Congress, especially as republicans will put out 
     some time of blueprint before we leave. Even if it's a very 
     sketchy one on what we'd like to accomplish and how we'd like 
     to do it on medicare restructuring and the incorporation of 
     drug options as we come back next year. If not then the 
     President will frame what we do and the box that we are in 
     the State of the Union address. How can the industry help us 
     and help themselves? It's to put the image of who you are and 
     what you do in front of the American people. It's to take the 
     scientists out of the lab and put them into the lecture room 
     or the town meeting or the television. Talking about the 
     breakthroughs that they worked on and the real lives that the 
     breakthrough affects. The American people are willing to pay 
     as long as they know what they're going to get and I think 
     this is one area where the people would be willing to chip in 
     to continue the level of research and development. If we 
     allow the President to frame the debate and the others to set 
     the rules, I can assure you that the number one thing I look 
     at, which is capital, will find another industry that is more 
     attractive in from the standpoint of their overall return and 
     we will have a tough time in the biotechnology area.
       Congressman Bilbray. I think that you need to really focus 
     this and be ready to do your own campaign based on things 
     like Biotech. It's not about money, it's about lives. If you 
     compare how much the average American family spends on a car 
     as opposed to pharmaceuticals or breakthrough drugs it's not 
     even comparable because you've got it packaged a certain way.
       The republican proposal I'm seeing coming down, and I think 
     that both the Senate and the House is moving, is the issue of 
     having the needy seniors helped with this cost and really 
     focus on them as opposed to the position that all seniors, 
     even if they're millionaires, should be able to be subsidized 
     by the federal government.
       Congressman Burr. And I want to caution the entire group, 
     don't fall prey to anything other than the administrations 
     intent and the Democrats on the Commerce Committee, most of 
     them, that the first step is to institute price control. And 
     those price controls, whether they're instituted at the state 
     level or whether they're instituted by the federal 
     government, then they have the hoops to redesign the system 
     however they want it. and clearly those price controls, being 
     the first, thing have a great impact on where the capital 
     goes in the future.
       Congressman Bilbray. The would initiate these prices 
     controls and you would watch, in an industry that already has 
     investment concerns and problems, then when it starts hurting 
     more, it justifies Washington sticking it's nose in further. 
     So you've got to watch these things because a lot of these 
     crisis situations are created in Washington and not 
     necessarily without the intention that Washington would have 
     to step in and get involved. I know that sounds like some 
     kind of conspiracy issue, but I think that those of you who 
     have worked in the industry and have seen the reaction of 
     what Washington can do would agree that this is not a 
     Democrat or Republican issue; it's just common sense that we 
     ought to be allies not enemies.
       Duane Roth. We certainly will stay engaged in this issue, 
     it's absolutely crucial to our industry and we really hate to 
     see the way things turned yesterday. That was not helpful and 
     puts us in a very defensive position again. We're certainly 
     going to work on this issue and stay in touch with our 
     constituents. Our constituents are patients. When any one 
     tries to drive a wedge between the industry and the patients 
     who need these products, everyone loses. I think that's what 
     we need to be working on
       Congressman Bilbray. I think you have to point out that 
     you've got elected officials who were on the defensive this 
     week about Social Security. And the best defense, in a lot of 
     their attitudes, was to go on the attack. And so, they had a 
     position that wasn't very defensible on Social Security and 
     so they came up with a proposal and used you guys as a 
     punching bag and as some way to justify their agenda. They 
     had to create an enemy and they were using you, and frankly 
     I'm sorry to see it happen too but please understand that you 
     should be complemented that they were on the defensive so 
     they were going after you to take the heat off of them which 
     is a sad fact about this.
       Duane Roth. I'd like to move to a related issue and this is 
     one that is very key for our industry and that's getting 
     reimbursed once we finally get through the better behaving 
     FDA, how do we get paid for our products and this is another 
     major medicare issue. So I'm going to turn to John Dobak 
     who's going to introduce the subject and get your comments.
       John Dobak. Thank you and thank you folks for taking the 
     time. I represent the medical device community. We often get 
     lumped with Biotechnology but there are some differences 
     between our industries as it relates to a certain issue, and 
     I think it's important to realize that there is a difference 
     between medical device and Biotechnology. This particular 
     issue I think pertains to both industries. I'm going to focus 
     on the Medical device side of these issues however. First, 
     I'd like to note that HIMA has a seven point plan that deals 
     with reimbursement reform and it's a very complex issue and I 
     would encourage some review of that plan because it addresses 
     many of the dilemmas faced by medical device companies. I'd 
     also like to recognize that some of these issues and the 
     solutions proposed by HIMA are addressed in a bill proposed 
     by Orin Hatch and Jim Ramstead. The most important piece 
     that's partly covered in this legislation is that it is 
     trying to establish a more efficient and rapid reimbursement 
     process for medical device companies and other life science 
     companies after they obtain FDA approval. FDA approval is 
     really the pinnacle of any life sciences company or medical 
     device company, it really represents the establishment of the 
     clinical benefit and safety of a product and one would think 
     that with that FDA approval we would see a dissemination of 
     the technology the profitability of the company and 
     additional innovation of that particular company. 
     Unfortunately, because of problems with the medicare 
     reimbursement in particular, the technology is not utilized 
     often times many years after the product was initially 
     approved. I think a case in point is cardiac stints. Cardiac 
     stints are these tubular, cage-like structures that are used 
     to prop open the arteries. These were approved in 1994, 
     however reimbursement was not established until 1997. At the 
     time that the product was approved only about 15% of patients 
     had access to this lifesaving technology. Once appropriate 
     reimbursement was established, the use of the procedure 
     exploded to some 85% or 90% now of interventional cardiology 
     incorporate stinting. My concern is that I think a similar 
     situation is going to evolve with stroke. Stroke afflicts 
     about 700,000 patients each year in this country and that it 
     costs the healthcare system in excess of 30 billion dollars. 
     It's a devastating problem, it leaves people paralyzed, 
     unable to speak and comprehend speech and even blind. 
     Currently there's a bevy of medical device companies that are 
     developing therapies to treat strokes. Currently there's a 
     bevy of medical device companies that are developing 
     therapies to treat strokes. Unfortunately the current 
     reimbursement is only $3000-$4000 and the average length of 
     stay in a hospital for a stroke victim is 5 days, that $3000-
     $4000 will not cover that hospital stay let alone new 
     technologies that are going to prevent the devastating 
     consequences that come from a stroke. I think this brings up 
     a very important point about the fundamental structure of 
     medical reimbursement and that's that medicare focuses on 
     short term cost controls in favor of long term cost saving. I 
     think that technology will never prove to itself to be cost 
     efficient when the reimbursement structure focuses on this 
     short term cost control. I would just be interested to know 
     if there's going to be support for this bill presented by 
     Senator Hatch and Congressman Ramstead and hear your comments 
     about your position.
       Congressman Burr. Well, I'll go first. I'm not sure about 
     the specifics in Senator Hatch or Congressman Ramstad's bill, 
     but it gets to the heart of what private insurance companies 
     refer to as experimental. Those drugs or devices that have 
     been approved by the FDA but for, some unknown definition, 
     still have not been approved for reimbursement whether it's 
     medicare or the private sector. I attempted, in the patients 
     bill of rights legislation, and all the substitutes, to make 
     sure that we had a new definition for experimental which 
     stopped when the FDA approved it. It could no longer be 
     experimental. It meant that medicare and companies had to 
     specify anything that was not covered but was not under the 
     umbrella of experimental. I don't think there's any question 
     that the intermediaries dragged their feet sometimes 
     companies are pushed from one entity to another, who are 
     trying to get a new DRG code or whether they're going to be 
     lumped in an unexisting one and in many cases the 
     reimbursement does not represent the technological advances 
     that have been made. I think it's clear that we're on a 
     generation of heart stint that some of the countries of the 
     world would look at and laugh at based on where they have 
     progressed to. That's part of the approval process. When I 
     look at the reimbursements I clearly don't think that it 
     considers the technological changes that have gone into 
     product advancements, especially in devices, and the 
     reimbursements reflect that. I think it cries for overall 
     medicare reform, not just in the drug model but a true 
     competitive model. One last point, it's one that you touched 
     on which I would call disease management. I remember when we 
     sold for the first time the concept of medicare coverage for 
     diabetes screening for seniors. It took 2\1/2\ years to 
     convince some of our colleagues that it was cheaper long term 
     to pay for this monitoring up front because it was cheaper 
     than amputation and blindness. They now believe that and they 
     believe it about mamograms and they believe it about PSAs. We 
     need to start the cultural change and make people understand 

[[Page E2473]]

     there are drugs and devices that also save money long term 
     with a cost up front. That, again, is a cultural problem that 
     we're going to have with this agency.
       Congressman Bilbray. It's a problem, not just with this 
     agency, but with the entire federal system, judging what is a 
     priority and what is a benefit. A decade ago we were bashing 
     the private sector for looking to the next quarter. Remember 
     we were talking about the Asians looking at the long range. 
     The fact is, we've seen a major reform in the private sector. 
     When Richard and I came here to Washington we were looking at 
     this issue that the whole mentality of what we judge as a 
     benefit or a cost is so antiquated; and it still is. You have 
     the OMB scoring, and you have the Congressional Budget Office 
     scoring, that is really sort of like what's here and now. A 
     good example is, the drugs that are being used for trying to 
     reduce the effects of strokes. I just lost a father to a 
     stroke, so I understand. He was two years in a wheel chair--
     could not speak--needed to have constant service. But, the 
     drug that may help to avoid long term damage isn't really 
     considered a major savings because you still spend up 3 to 5 
     days in the hospital. So they just sort of go right over 
     that. I think that we need to try to raise the sophistication 
     of what we project as expenditures or savings. That could go 
     beyond the here and now and the short term. And this town 
     doesn't do that very well. A good example, was the question 
     about capital gains taxes, and reducing them. In this town 
     the projection was that it was going to be a net negative to 
     the treasury. Well everybody knows that since we've done that 
     there's been a huge plus up and it's been one of the biggest 
     reasons why we have a surplus. But the town does not know to 
     change it's institutional structures and it's institutional 
     background to reflect reality. And I guess from a science 
     background we would say the model here in Washington is being 
     used to judge your industry and to judge service and cost 
     benefit ratios. The model is a one dimensional obsolete model 
     that we have to replace with a whole new modeling system. And 
     maybe we can get these guys who are working on global climate 
     change to work out a model that will be able to sell to the 
     congress so they will have something that reflects reality 
     better than what we have now. This thing runs deeper than 
     just HCFA, it's the entire structure that we are trying to 
       Congressman Burr. Brian if I could, I've been asked to come 
     back up to the Hill, and I do want to allow if there is one 
     additional question that may or may not be on the agenda that 
     somebody has of me before I leave, I wanted to give you an 
     opportunity to ask it.
       Duane Roth. Let me quickly, since you're from North 
     Carolina, and there are some farmers there I think. 
     Genetically modified organisms, and Brian touched on it 
     earlier but this is an area that we do understand has a 
     potential to creep over into the health care as well as the 
     agriculture scare that is going on now. And I'm going to call 
     on Joe to sort of introduce us to that mess.
       Joe Panetta. Congressman Bilbray congressman Burr, thank 
     you very much for joining us, and on behalf of all the 
     members of BIOCOM, I would like to thank you as well. 
     Congressman Bilbray, over the years we know that you have 
     been interested and involved in our issues and we've welcomed 
     that participation on your behalf and we really look forward 
     to working with you in the future. We haven't talked much, 
     through BIOCOM, about the issue of genetically food, although 
     you and I have talked about it on occasion. And it's an issue 
     that certainly become much more in the forefront in recent 
     weeks and months with some of the concerns been raised in 
     Europe over the acceptability of genetically engineered 
     foods. And it's an issue that has a direct impact on our 
     farmers across the country here in San Diego certainly 
     congressman Burr in North Carolina and with a lot of the 
     research that's been going on in San Diego and North Carolina 
     through companies that are involved in this area has a direct 
     impact on us as well. But the two issues that I really want 
     to touch on here are in direct relevance to you in the 
     Commerce Committee, and those have to do with the acceptance 
     of exports of our crops and the impact that that could 
     potentially have on our ability to adopt this technology 
     through our farming systems in the U.S. and also for the 
     potential for there to be a backlash here in the United 
     States as a result of some of the controversy that's been 
     raised in Europe. You both know, I'm sure, that farmers have 
     increased difficulty in adopting this technology due to the 
     fact they've had concerns about acceptance of products in 
     Europe and Japan. The regulations that have been implemented 
     particularly in Europe on GM3 imports in the United States 
     have really deterred farmers in large part from adopting this 
     technology due to their concern. It's causing a huge headache 
     for our farmers here in the U.S. it's raising concern with 
     our large agricultural research companies relative to their 
     investments in this technology in the future. And if we look 
     at the loss in trade just last year in this area as a result 
     of some of these negative regulations that have been 
     implemented we're looking at $200,000,000 in crops that had 
     to sold elsewhere as a result of European negativity on this 
     issue. The fear that's been aroused through the activities of 
     the activists groups in Europe could potentially end up 
     flowing onto shore here in the U.S. and we think that what's 
     really exacerbating these issues are the very regulations 
     that are being created in Europe that are presumably there to 
     deal with the issues themselves. In fact, what we are seeing 
     instead is the reverse and the public's concerns are being 
     raised even more. What that's causing us to see in the U.S. 
     is that the technology is being slowed down and in fact, 
     farmers are having to hang on to older technics as a result. 
     I'll be brief, because Congressman Burr I know you have to 
     get back up to the Hill. But, the concern here has more to do 
     with the fact that we need your support in terms of any 
     regulations that might be considered that goes beyond the 
     already very stringent system that we have in the U.S. And 
     the need to implement science based systems outside the U.S. 
     as something that needs to be focused on more than the need 
     to focus on a system that is very adequate. I think Bill 
     Rastetter and Steve Mento both touched on the concern about 
     the resources that we have at FDA and the need to focus these 
     resources on the approval of some of the new pharmaceutical 
     and device products that are in the system. The need is not 
     there to focus those resources on a process at the FDA that 
     is already adequate. As far as labeling goes, that's another 
     issue that's been discussed very much recently with regard to 
     public concern. I think from our standpoint we felt for a 
     long time that the labeling system that the FDA adopted years 
     ago is an adequate system to deal with any food regardless of 
     the technology through which it's produced. And this is 
     simply one more way of producing food, but the processes that 
     are in place there are adequate. So, in summary we'd ask you 
     to continue to support the efforts through FDA, USDA, and EPA 
     to regulate these products and in terms of exports, to show 
     strong support for our opportunity to show better crops to 
     improve yields and to be able to export these products 
     throughout the world to the benefit of our farmers here in 
     the U.S. Thanks very much for your time.
       Congressman Burr. Well, I appreciate the question. Yes we 
     do have farmers in North Carolina, most of them are still 
     under water, unfortunately. But we will bounce back and I'm 
     hopeful that we will at least pay attention to what's 
     happened in Europe. I've been there twice in the last twelve 
     months. This has been one of the topics of discussion every 
     time I've been there. Clearly this is not a trade policy 
     breakdown, it's an attempt to continue subsidies that we 
     tried to negotiate out. And when they finally hit on the food 
     safety it took hold with consumers all across the EU. The 
     concern is, and should be, what happens when that same type 
     of campaign comes across the ocean and starts in this country 
     and we've begun to see this already with the attempt on baby 
     foods, where most companies have pulled many GMO products out 
     of it. I think we've got to be very conscious of the good 
     science that's needed. And I would hope that we would spend 
     our time with the EU now trying to set the standards for good 
     science and backdoor into standards that would allow us to 
     have those markets for export purposes. I'm sure the French 
     would be alarmed to find out today that they currently use 
     genetically modified grapes in the majority if not all of 
     there wine. I'm sure that they would argue that rubbing it on 
     as opposed to injecting it in is two different things, but 
     reality is reality. I think that this is an area of great 
     concern not only to those of us on Commerce. I know that 
     Senator Pat Roberts has spent a tremendous amount of time on 
     it, and is concerned that if we are not vigilant, and if we 
     don't watch this, that we will no longer be able to produce 
     the world's food here in this country because of what can 
     happen. As the member of Congress that has the Novartis 
     agricultural headquarters for this country, it is alarming 
     for me, and I know the impact potentially not only on North 
     Carolina's farmers, but our ability to be the world's 
       Congressman Bilbray. I think that we and everybody, there 
     are those in the medical field that say this is an ag problem 
     just as much as it was those to make sure you didn't go after 
     genetic research. Remember that scare tactic, it may be good 
     politics, but it was bad science. Just like Richard and I 
     worked with a guy name Ganske about this issue of radiating 
     meat, which is the safest thing you can do to stop the 
     disease carrying potential of beef. I think we need to put 
     together a coalition and I want to tell you this, I was on 
     the Floor today talking to my corn growers in the Midwest. I 
     need you to give me that information because we need to get 
     Archer Daniels Midland and the rest of the big corners who 
     are fighting us on other issues, that they ought to be 
     working with us on this issue. I think that there is a flip 
     side here too. The environmental community, rather then being 
     your enemy should be your biggest ally, except that they 
     don't have the facts. We're talking about the ability to use 
     genetic research as a way of reducing the use of herbicide 
     eliminating or reducing the substantial use of insecticide 
     that are polluting the environment. I think that we need to 
     talk about this. And we need to confront Europe and say, 
     ``You want to play this game?'' We can look at the herbicide 
     or the insecticides that you are using and say that we don't 
     want any of your products that you are using those in. If 
     they want to play this tough game, I think we need to get the 
     facts out there. And I think that the pro-active approach--I 
     propose that what we ought to be talking about up in the 
     Northwest right now and what the administration should be 
     pushing for is not what is genetically altered, but an 
     international interpretation of what is organic. If you want 
     to eat

[[Page E2474]]

     food that was grown and processed exactly the way your great 
     great grandfather did, 150 years ago, then I think we can 
     find a common purpose. But the talk about genetically altered 
     is such a ruse because the one thing that we talk about is 
     domesticated plants. If we didn't have, quote unquote, 
     altered plants, our corn would be about three inches long the 
     way the Anasazi a thousand years grew their corn. And I think 
     that we need to get this out. So the environmental community 
     has to be confronted with the fact that rather then attacking 
     and fearing the genetic alterations we should be moving 
     towards it to stop all the spin off pollution that we've seen 
     for decades. I think that we got a big question here, but we 
     all need to pull together. I ask the medical people to take a 
     look at the ag people because we need the ag people to help 
     us with the medical side and with the device side. We are all 
     in this together. We're the people with the facts. We have to 
     stand up for them; even in the short run, politically, it 
     doesn't seem expedient. Outside of that, I really don't have 
     an opinion about this whole issue.
       Duane Roth. We will certainly give you the information and 
     keep working on this issue it's a very important one. Let met 
     give you a chance to sign off here, I know that you have to 
     get back to more important business. But, from our side thank 
     you very much for taking the time, both of you, to spend with 
     us today.
       Congressman Bilbray. Well, thank you very much for how 
     proactive that you guys have always been. And one thing that 
     is great about the BIOCOM people and your entire group is 
     that rather then sit back and then complain that things 
     didn't work out, you've been very pro-active. I think that 
     one of the best things that we've done is to see the kinds of 
     things that you put into it. I couldn't help but think about 
     the device issue and our tort reform device that was named 
     after your nephew. It's something that I think has been one 
     of our great successes. Thanks a lot, and continue the work. 
     One thing that I really like about it is that you can look at 
     this panel and you can see that they go across the political 
     spectrum, but they stick together on one issue. The well 
     being of Americans is something that we all have to cooperate 
     on and find answers for, rather then always pointing fingers 
     and finding problems. So thanks again for taking the time. 
     This was a very, very great way to be able to communicate. 
     And hopefully Richard and I can go back and to carry your 
     message and not just to the Commerce Committee, but to the 
     House of Representatives. Thank you very much for the time.
       Duane Roth. Thank you. And let me just conclude by thanking 
     my panel members for taking time to help with this. Thank you 
     very much.