Jim Greenwood

Mr. GREENWOOD

Mr. GREENWOOD. Mr. Chairman, I thank the gentleman.

Mr. GREENWOOD. I yield to the gentleman from Illinois.

Mr. GREENWOOD. Mr. Chairman, I move to strike the last word. Mr. Chairman, I rise to engage the gentleman from Illinois [Mr. Porter] in a colloquy regarding traumatic brain injury. As the gentleman is aware, I have been working for 3 years for enactment of a comprehensive bill to address the needs of those affected with traumatic brain injury. H.R. 248, of course, the Traumatic Brain Injury Act, passed the House earlier this week and is expected to pass the Senate before the week is out. We believe it will be this evening. The bill authorizes a number of activities that are essential to those with serious brain injuries: Prevention projects, enhanced NIH research, demonstration projects to improve access to health services, and epidemiological data collection. We had hoped this bill would be signed into law by the time the House considered the Labor-HHS appropriation so that we could take the next step to fund these important new activities. I realize that that will not be possible under the rules of the House, but I would ask the chairman if he would consider supporting these activities in later action on the bill once they are authorized.

Mr. GREENWOOD

Mr. GREENWOOD. Mr. Chairman, I yield myself the balance of my time. Mr. Chairman, imagine three children. The first child is the child we would all like to raise. The child abstains from sexual behavior long beyond their minority status. The second child makes a mistake and becomes involved sexually and that child has a great relationship with mom and dad, and the world works again as the gentleman from Oklahoma would like it to. But, Mr. Chairman, there is a third child in the world and that is a lonely child with very poor parents, no communication skills, and the terror of being pregnant or suffering from AIDS. That is the child we need to think of in this vote. Support the Obey amendment. (Mr. ISTOOK asked and was given permission to revise and extend his remarks.)

Mr. GREENWOOD. Mr. Chairman, I yield 1 minute to the gentleman from Ohio [Mr. Hobson].

Mr. GREENWOOD. Mr. Chairman, I yield 1 minute to the gentlewoman from Maryland [Mrs. Morella]. (Mrs. MORELLA asked and was given permission to revise and extend her remarks.)

Mr. GREENWOOD. Mr. Chairman, I yield myself 1\1/2\ minutes. Mr. Chairman, I rise in support of the Obey substitute. My friend, the gentleman from Oklahoma [Mr. Istook], and I share parenthood. I have four children. I understand the impulse to want to make sure that parents are involved. Ideally we want our young people to abstain from sexual behavior. We all want that, we all hope that, and we do our best for that. And if they do become involved, if they make mistakes, ideally they can come and talk to mom and dad. That is the ideal. That is what we spend our whole lives as parents trying to achieve. But we do not all succeed. Some parents cannot talk about sex to their children, and some children cannot talk sex to their parents. That is the real world. So what happens? How do we strike a balance when we have a young lady who is afraid that she is pregnant? Kids do not go to family planning clinics because they are thinking about having sex; they go because they have been having sex; they go because they are afraid that they are pregnant; they go because they fear that they have a sexually transmitted disease. What happens to those kids who cannot get parental consent? They do not get treated for disease. They do not get treated for sexually transmitted diseases. We have more teenage pregnancies. We have more teenage abortions. The Obey amendment strikes the right balance. It requires these agencies to encourage the involvement of their families, and that is what we all should be about. A child untreated for HIV becomes a child, a teenager, with AIDS. When kids cannot get the diagnosis or treatment for that disease, they die. That is how important this is.

Mr. GREENWOOD. Mr. Chairman, I yield 1 minute to the gentleman from Maryland [Mr. Gilchrest].

Mr. GREENWOOD. Mr. Chairman, I yield 1 minute to the gentleman from Illinois [Mr. Porter].

Mr. GREENWOOD. Mr. Chairman, I yield 1 minute to the gentlewoman from Connecticut [Mrs. Johnson].

Mr. GREENWOOD

Mr. GREENWOOD. Mr. Speaker, I reserve the balance of my time.

Mr. GREENWOOD. Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. GREENWOOD. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I am pleased to report that the legislation before us is the result of a strong bipartisan effort in both Chambers over the past 3 years. I especially want to thank chairmen Bliley and Bilirakis, and Congressmen Dingell, Waxman, and Pallone for their willingness to work with me to secure enactment of this important bill. The beneficiaries of this cooperation are the millions of individuals who sustain severe brain trauma each year. Traumatic brain injury has become the No. 1 killer and cause of disability of young people in this country. We now have enhanced abilities to respond rapidly to the scene of vehicle accidents and other mishaps with highly trained personnel to airlift victims to state-of-art trauma centers and provide them with miraculous lifesaving procedures during the critical post injury ``golden hour.'' As a result, thousands of our sons and daughters, and fathers and mothers have survived serious brain injury and now must be cared for humanely. Our challenge now is to develop in-home residential and long-term- care facilities where those recovering from head injury can receive physical therapy, occupational therapy and cognitive rehabilitation so that, whenever possible, they may resume their places at home with their loved ones. In 1989, the Department of Health and Human Services issued an interagency task force report that recommended development of a national strategy to address prevention of traumatic brain injuries, and to provide for acute and long-term care and community reintegration of traumatic brain injury survivors. This legislation does just that. The bill would authorize $3 million for each of the fiscal years 1997 through 1999 for the Centers for Disease Control and Prevention [CDC] to carry out projects to prevent traumatic brain injury; authorize the National Institutes of Health [NIH] to conduct research into the prevention and treatment of traumatic brain injury; and authorize grants to States equal to $5 million for each of the fiscal years 1997 through 1999 for the establishment of demonstration projects to improve access to health and others services regarding traumatic brain injury. States are required to contribute $1 for every $2 of Federal funds. Require the Secretary of Health and Human Services to conduct a study to determine the incidence and prevalence of traumatic brain injury; develop a uniform reporting system concerning the reporting of incidents of such injuries; and identify common therapeutic interventions used for the rehabilitation of injured individuals; and require the Secretary of Health and Human Services to conduct a consensus conference on managing traumatic brain injury and related rehabilitation concerns. An aggregate of $500,000 is authorized for these purposes. Enactment of this legislation is an important step toward preventing, understanding, and effectively beating these devastating brain injuries. I urge my colleagues to support this important legislation.

Mr. GREENWOOD. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 248) to amend the Public Health Service Act to provide for the conduct of expanded studies and the establishment of innovative programs with respect to traumatic brain injury, and for other purposes, as amended.

Mr. GREENWOOD

Mr. GREENWOOD. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on H.R. 248.

Mr. GREENWOOD

Mr. GREENWOOD. Mr. Speaker, I thank the gentlemen who have participated in the special order. I think we are going to make this a textbook example of how the Congress of the United States can put politics aside completely and utterly, work with Democrats and Republicans evenhandedly, put a bill into law that will save thousands of lives, and I look forward to the bill signing ceremony.

Mr. GREENWOOD. Mr. Speaker, then on the Delaney clause, all we are saying, again, is we want the FDA to decide what the standard should be for products that might be remotely tested in animals to have some carcinogenic quality. It is the old story, you hear these stories, well, if you ate 500,000 pounds of grapes every day for the next 500,000 years, you might have a one-in-a-million chance of having cancer. That is sort of an absurd level of micromanagement. What we really want the FDA to do is tell us what is safe for our kids to eat, what is safe for us to eat, what will not increase our chances of cancer. And you tell us, you have got the experts, and we will make it apply nationwide.

Mr. GREENWOOD. Mr. Speaker, I thank the gentleman. I think it is fair to say that, in both of the central issues of the food bill, what we are really trying to do is leave the authority in the FDA in terms of the uniformity. I represent the State of Pennsylvania, and we have Hershey Foods. As you talked, I tried to imagine a Hershey bar that might have to have one label in Minnesota and a different label in Houston, TX, and yet a third label in some community in New York, et cetera. It would be virtually impossible for the company to comply with all of that crazy patchwork quilt of labels. All we are saying is the FDA does a good job at this. Let them be the experts. Let them determine what should be on the label, and leave it there because of the interstate commerce.

Mr. GREENWOOD. That story tells what needs to be told and what we are trying to accomplish here, and that is save lives. He was fortunate. He could afford to go to Italy and have the surgery and pay for it, but most Americans do not have that luxury. Let me share one final point with the gentleman. We have something else in common. My dad is a B-24 liberator pilot as well. Mr. Speaker, I would like to now yield to my colleague, the gentleman from Wisconsin [Mr. Klug], who is the prime sponsor of the second of our three-bill package and that is the bill that would reform FDA with regard to its responsibilities for approving food products.

Mr. GREENWOOD. Finish the story. He did go to Italy.

Mr. GREENWOOD. Before the gentleman leaves, I want to recall the gentleman who came to our first press conference who suffered from a coronary problem where he had an artery that was closing down, and he needed a stint. Is that the right term? A stint that could be implanted in this artery to keep it open and keep the blood flowing. He was told that his time was limited, he did not have long to live. There was a device that had been invented; I have it in my hand. I do not know that the camera can pick it up. It looks like a spring you might take out of a ball point pen. This is implanted in the artery and holds it open.

Mr. GREENWOOD. Mr. Speaker, the Food and Drug Administration was created by this Congress at the turn of the century, about 90 years ago, and the Food and Drug Administration has a very important task. Americans from all walks of life, as parents, as sons and daughters, as spouses, rely on the Food and Drug Administration to make sure that the drugs that are prescribed to us, that the food that we consume, that the medical devices that are utilized in our care and hospitals are safe and are effective. And we are blessed because in this country we have the greatest pharmaceutical industry in the world, we have the greatest medical device industry in the world, and our people enjoy safety and the best health care in the world as a result of the work of the Food and Drug Administration. It does a very good job of making sure that the products that reach us in the marketplace, that our doctors prescribe to us, that we encounter in our hospitals are, in fact, safe and, in fact, are effective; that they do what the makers say they will do for us. That is the good news. But there is another side of the FDA, and the problem with the FDA is the time it has taken to move these products from the research laboratory through the Federal bureaucracy of the FDA, some 10,000 employees, to those Americans who are waiting for miracle cures, for new drugs, for the latest heart transplant devices, mechanical hearts. That time is too long. It is taking 12 years, on average, to move a product, a pharmaceutical product, through the Food and Drug Administration. It costs about $350 million for a company to do it. And I think that probably most Americans watching tonight would be surprised to learn that two-thirds of all of the drugs that are actually developed in the Untied States by our pharmaceutical companies are first available to patients overseas, not in our country at all. So our task has been with this legislation to see if we cannot reengineer the FDA, the Food and Drug Administration; to redesign it, reform it, update it, modernize it, make it better so that as we move into the next century, the FDA can still be the gold standard for safety and efficacy but also will begin to be able to bring these miracle products and miracle cures to our people much more quickly, because patients die in America today waiting for the bureaucracy within the FDA to act. We appreciate the FDA needs to act with caution, but we think that we can reform the FDA so that it will act much more efficiently and much more in the patient's interest. Now, as many Americans have noticed, getting things done in this Congress is not easy. It is a partisan place. It is a place of 535 individual Members of Congress. And in a Presidential election year, an election year for most of the Congress, it is difficult to come to an accord, and particularly on an issue as important and critical as reform of the FDA. So my colleagues who we will hear from tonight, Mr. Barton from Texas, Mr. Klug from Wisconsin, Mr. Burr from North Carolina, and Mr. Fox from my own State of Pennsylvania, have done something that is a little unusual lately in the Congress, and that is we have reached out from the beginning in a bipartisan fashion. We have said to our colleagues on the other side of the aisle, this issue is about life and death. This issue is about saving the lives of our children and our parents and our husbands and our wives, and we need to put partisan politics aside. 2045 We need to get the job done. We need to cooperate. We need to work together. And our success to date has been, I think, miraculous. We have gathered 159 cosponsors onto our bills, Republicans and Democrats across the political spectrum. We have reached out to the patient groups. We have talked to our fellow Americans who suffer from AIDS or who are HIV-positive. We have talked to cancer patients. We have talked to the practitioners treating those patients and talked to patients who suffer from multiple sclerosis and Lou Gehrig's disease, kids who suffer from diabetes, and Americans who suffer from coronary artery diseases and a long, long list of diseases that is extensive. We asked them what they think we need to do to make sure that these miraculous products being developed in our universities and our laboratories are brought to those who are literally dying, to receive them more quickly; and the result has been legislation that we think is exciting, we think is innovative, and we think actually will be signed into law in 1996. We would like to share the details of this information with America this evening. To that end, I would first like to recognize my good friend and colleague from Texas, Mr. BARTON, who is the primary sponsor and the lead on the medical devices bill. He will tell us about medical devices and what we hope to do there.

Mr. GREENWOOD. Mr. Speaker, before we proceed, I would like to ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on this special order.

Mr. GREENWOOD. Mr. Speaker, a number of my colleagues and I this evening have taken it upon ourselves to engage in a 1-hour special order on a very special package of bills we intend to move from the Committee on Commerce, on which we all serve, through the House of Representatives. We expect that the Senate will move its package and that we will put this package on the President's desk and that he will sign it. The issue is reform of the Federal Food and Drug Administration. general leave

Mr. GREENWOOD. Mr. Speaker, I thank the chairman very much. Let me say that the gentleman from Florida [Mr. Bilirakis] has served long and with great distinction on the Health and Environment Subcommittee, and this is his first term as the chairman of that committee. I think that working together in bipartisan fashion, we will be able to accomplish something that we will be able to say that on your watch, we passed legislation, the President signed it, and we talked about life and death issues. This will save lives. Children will survive rare diseases. Cures for horrible plagues, like AIDS and cancer will come to patients, relieve their suffering much more quickly for years and years to come. That will be just a part of your legacy as chairman of this subcommittee, and we are very pleased for your leadership. Mr. Speaker, I would now like to yield time to my colleague, the gentleman from North Carolina [Mr. Burr]. Mr. Burr is the prime sponsor of the pharmaceutical bill, deals with pharmaceutical products and biologic products, all that new science that deals with fighting disease at the molecular level. It is where we are, I think, on the dawn of a new age in medicine where we will have cures for diseases that we cannot even image right now. Mr. Speaker, Mr. Burr is a new Member. He is a freshman, but he has done just an extraordinary job on this project. He has, I would say, far more than anyone else in the House been responsible for the large number of cosponsors on this bill. He has been working with Members from around the country, from both sides of the aisle, preaching the good word of FDA reform and has converted a lot of folks to this cause. With that, I would like to yield such time as he may consume to the gentleman from North Carolina [Mr. Burr]. 2115