Fred Upton

Mr. UPTON

Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume. I stand in strong support of S. 330, known as the HOPE Act. The HOPE Act would eliminate the restriction on acquiring HIV- positive organs in order to permit research on transplants between HIV- positive individuals. The legislation will increase the number of available organs and will help all of those who are awaiting a transplant. In 1984, Congress enacted the National Organ Transplant Act, NOTA. The purpose of NOTA was to guide organ donation and transplantation. In 1988, Congress amended NOTA to ban the transplantation of HIV-infected organs. Today, HIV treatments have extended and have improved the lives of countless HIV patients. This, in turn, has increased the need for organ donations. This bill would allow research to fully evaluate the safety and effectiveness of organ transplantation between individuals with HIV. Specifically, the bill would permit research on transplants involving HIV-positive individuals by eliminating the restriction on acquiring HIV-positive organs. The legislation also would direct the Secretary of HHS to develop and implement standards for research on the transplantation of HIV-infected organs. Finally, the bill would require the Secretary of HHS to revise transplant standards based on that research. H.R. 698 is the House companion to the HOPE Act. Mrs. Capps, on our committee, authored H.R. 698, and the Energy and Commerce Committee passed it by voice vote last July. Earlier this year, the Senate passed the legislation before us today, which was led by Senators Boxer, Coburn, Baldwin, and Paul--a bipartisan group. By passing the HOPE Act now, we will send it directly to the President so that he can sign it into law and avoid a conference. This commonsense proposal has the potential to save lives. With 100,000 patients waiting for life-saving organs, permitting HIV- positive donors to be used for transplants could save as many as 1,000 HIV-infected patients every year. So, tonight, we provide some hope for those in need of new organs. I support this bill, and I urge my colleagues to do the same. I reserve the balance of my time.

Mr. UPTON. Mr. Speaker, I ask unanimous consent that the balance of my time be managed by the gentleman from Pennsylvania (Mr. Pitts).

Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill (S. 330) to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV).

Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and to insert extraneous materials in the Record on the bill.

Mr. UPTON

Mr. UPTON. I yield myself the balance of my time. Mr. Speaker, every one of us has beautiful children like in this our districts. This bill is going to save lives, and it has been bipartisan from the get-go. Again, I want to commend Republicans and Democrats on our committee-- but certainly those on the House floor as well--when we passed this bill a number of months ago. I was a speaker and a participant in an event just last week for FasterCures, a networking group from around the country. Dr. Francis Collins was there, who is the head of the NIH. I spoke to Dr. Collins just in the last hour or so, and he is delighted that this legislation is reaching the House floor tonight. Hopefully, it will pass. I know that we are going to continue to make a real difference in the lives of families, and that is what this is all about, so I would urge all of my colleagues to vote ``yes.'' I yield back the balance of my time.

Mr. UPTON. I yield the gentleman an additional 1 minute.

Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill (S. 252) to reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy, and to reduce infant mortality caused by prematurity, as amended.

Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials in the Record on the bill.

Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from New Jersey (Mr. Lance), another author of this legislation and someone who helped carry it across its bipartisan path.

Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Pitts), chairman of the Health Subcommittee.

Mr. UPTON

Mr. UPTON. Mr. Speaker, I rise tonight in strong support of the Food and Drug Safety Act. As we try to work out our fiscal differences, it is imperative that the Food and Drug Administration does have the resources that it needs to ensure the safety and quality of our Nation's food and drug supplies and medical devices. This bill will help ensure that the FDA can focus on that very important mission. Over the past week, the House has acted to reopen major parts of other government. The legislation before us is yet another piece of that important effort to continue critical programs for the American people. From food inspections to approvals of breakthrough new drugs and devices, Members on both sides of the aisle indeed understand and appreciate the important role of the FDA. This essential work should continue as we wait at the negotiating table for the President to join in a conversation to resolve our differences. I urge my colleagues to support this bill to ensure that the FDA has the resources to get the job done. Let's stand together in support of food safety and drug approvals.

Mr. UPTON

Mr. UPTON. Mr. Speaker, let's face it: the failure of not having a CR is that both sides have failed to negotiate an agreement to keep the government open. Let's hope that the 5:30 meeting this afternoon between Speaker Boehner, Leaders Pelosi, McConnell and Reid, and the President is not a finger-pointing meeting and that it's not a ``my way or the highway'' meeting but, in fact, a constructive way to get an agreement that most of us, Republicans and Democrats, can support. Whether that agreement comes tonight or tomorrow or, God help us, next week or the following week, at some point, the Sun is going to come up. It's going to happen. In the meantime, we shouldn't harm the folks who are in dire need. I strongly support the NIH. I look at Mr. Waxman, my colleague and ranking member on the Energy and Commerce Committee, as the two of us led the effort to double the money for the NIH a number of years ago. We have folks waiting in the queue to participate in lifesaving clinical trials. They have every right to be furious with this body, but we can fix that by passing this bill so that they don't have to wait. Come on. Let's put policy over politics and do this, not for us but for them.

Mr. UPTON

Mr. UPTON. Mr. Speaker, I yield myself the balance of my time. Mr. Speaker, this legislation that we hopefully will pass in the next few minutes is very important. It clearly, I think, would have saved the lives of those folks that were taken, and it reflects the hard work of our committee on a bipartisan basis. From the very start, the Oversight and Investigation Subcommittee went to work. It got to the bottom of a very tragic situation that impacted some 20 States, hundreds and hundreds of people, and we've changed that system now. Because of their work and their investigation, we came back and moved legislation through the proper channels, regular order, through the Health Subcommittee and through our committee. We worked very closely with Republicans and Democrats in the Senate to craft this bill that would have stopped this awful thing that happened a year ago. Congress does work and can work when we work together, and I am proud of this product. I am proud of this legislation. I urge the Senate to take it up in the next day or two so we can, in fact, get it to the President's desk, and I thank every Member who worked so hard. We saw today certainly the personal impact on all of our districts and on the Members themselves. Many of us, in fact, did know folks directly impacted not only through death, but also those who were impacted because of the impact on their own lives as they still try to recuperate and survive. I urge all of my colleagues to vote ``yes.'' I yield back the balance of my time.

Mr. UPTON. I continue to reserve the balance of my time.

Mr. UPTON. Mr. Speaker, at this time I yield 2 minutes to the gentleman from Pennsylvania, Dr. Murphy, the chairman of the Oversight and Investigations Subcommittee.

Mr. UPTON. Mr. Speaker, I have no further requests for time on our side, so I'm ready to close.

Mr. UPTON. Mr. Speaker, we have no further speakers, and I reserve the balance of my time.

Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from Ohio (Mr. Latta), a member of the committee.

Mr. UPTON. I yield the gentleman an additional 30 seconds.

Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from Virginia (Mr. Griffith), who played a very large part on the compounding side of this legislation.

Mr. UPTON. At this time, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Pitts), the chairman of the Health Subcommittee.

Mr. UPTON. I yield the gentleman an additional 1 minute.

Mr. UPTON. Mr. Speaker, I yield myself 3 minutes. I rise today in strong support of H.R. 3204, the Drug Quality and Security Act. I am so proud to say that this piece of legislation is a product of true bipartisan and bicameral work. The Senate and the House, Republicans and Democrats, came together to produce a bill that will protect American patients by ensuring that they receive safe drugs. This legislation will strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs. The bill also eliminates and prevents increases in drug prices; it avoids additional drug shortages; and it eliminates hundreds of millions of dollars worth of duplicative government red tape on American businesses, which is harming job growth. The supply chain provisions of the Drug Quality and Security Act are the product of many years of tireless work. We know from stakeholders like Pfizer and Perrigo in Michigan that this is not just a patient safety issue; it's a jobs issue. This bill will bring certainty to the drug supply chain and ensure that patients will continue to receive the medicine that they need without interruption. This bill also addresses drug compounding. H.R. 3204 is the result of the Energy and Commerce Committee's thorough investigation of the NECC meningitis outbreak, which began its devastating spread almost a year ago today. To date, the CDC has linked 64 deaths and nearly 750 cases in 20 States to contaminated drugs from the NECC. My home State of Michigan has been the hardest hit by the outbreak, with 19 lives needlessly lost--three in my district. The sad truth is that, yes, they could have been prevented. This legislation is an important step in helping to prevent any such tragedy from ever occurring again. By reviewing countless documents, holding four committee hearings, and reviewing various legislative proposals, we better understand what is needed to help prevent a future NECC, and we have built that into this legislation. Mr. Speaker, this bill upholds the current section 503(a) of the law, and provides it with the clarity that FDA needs by eliminating the unconstitutional provisions. The bill also requires FDA to engage in meaningful communication with State boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That's why the bill has the support of the National Community Pharmacists Association, and I would like to thank them for working with us so closely. I also want to thank Chairman Pitts, Chairman Murphy, Vice Chair Blackburn, Mr. Latta, and particularly Mr. Griffith for their outstanding leadership on these issues. I want to commend Mr. Waxman, Mr. Pallone, Mr. Dingell, Ms. DeGette, Mr. Green, and Mr. Matheson for their work as well.

Mr. UPTON. I yield myself an additional 1 minute. I also want to thank Chairman Harkin and Senator Alexander for their leadership, and I've talked with them a number of times over the last number of weeks. I want to thank our staffs on both sides, particularly on our side: Clay Alspach, Paul Edattel, John Stone, and Carly McWilliams. It is because of their collaborative and tireless efforts that we are near the resolution of last year's deadly outbreak, and their work is to be applauded. To all of the families who have lost loved ones and to those who are still suffering today--and I talked to someone just within the last hour whose relative is still suffering--we are near the resolution of last year's deadly outbreak. To those families who have lost loved ones and to those who are still suffering today, with this bill, we say: never again. I urge my colleagues to support the bill, and I reserve the balance of my time.

Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3204) to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.