Fred Upton

Mr. UPTON

Mr. UPTON. Mr. Speaker, I yield 1 minute to the chairman emeritus of the Energy and Commerce Committee, the gentleman from Texas (Mr. Barton). (Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

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

Mr. UPTON. Mr. Speaker, I have no further requests for time. So if the gentleman wants to close, then I will close.

Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New Hampshire (Mr. Bass), a member of the committee.

Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill (S. 3187) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes, 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 material in the Record.

Mr. UPTON. Mr. Speaker, I yield myself 2 minutes. Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator Enzi, and Members on both sides of the aisle in both the House and the Senate who played a role in this process. S. 3187 is a reflection of the hard work put in by both Members and staff, and of everyone's willingness to put partisanship aside to look at the issues together. Because of that outstanding dedication, we have a bill today that will make a real difference in the lives of so many patients and provide much-needed support for innovators across our great country. At the outset of this Congress, I set a goal of enacting this bill by the end of June--and here we are, well before the clock expires for this month--in order to provide certainty for American patients and innovators. I never lost confidence that we could deliver the bipartisan reforms we needed, and I am so proud that we will accomplish that goal. Mr. Speaker, this is a jobs bill, and it's a medical innovation bill. And as we put this package together, our goal was to improve the predictability, consistency, transparency, and efficiency of FDA regulation. These reforms will help get new treatments to patients more quickly. They will help us not only keep jobs in Michigan and all across the country, but also to create new ones. In order to get it right, we turned to patients, innovators, and job creators who provided firsthand experience of how the current system is broken. And we included many of their suggestions in the bill. This bill includes significant accountability and reform measures designed to hold the FDA responsible for its performance. The measure includes independent assessments of FDA's drug and device review process. It also includes requiring quarterly reporting from the device center so we don't have to wait a year to find out FDA's progress. The bill is about patients, and that's why so many patient advocates have spoken out in support of these reforms. Whether it is steps that we took to support treatments for rare diseases or mitigate drug shortages or speed up the approval of devices that will improve a patient's quality of life, these are steps that will make a real and significant difference. They're going to keep the U.S. at the forefront of medical innovation where we belong. This bill is just the first step. This bill provides the resources and the game plans so that FDA can improve its performance.

Mr. UPTON. I yield myself an additional minute. It is now up to the FDA to execute that game plan. And I give my commitment today that our committee will continue to monitor and hold the FDA accountable for its performance. So, together, the Members of the House and the Senate have produced a bill that is a win for American patients, innovation, and job creation. Before I conclude, I would like to recognize Warren Burke and Megan Renfrew from the Legislative Counsel's Office for their tireless work. The role of Legislative Counsel often goes unnoticed. I also want to appreciate our staff, starting with our staff director, Gary Andres, for pushing this legislation over the finish line; Clay Alspach, on the majority staff; Rachel Sher, on the minority staff; and in particular, Ryan Long, the chief counsel for the Health Subcommittee. This bill, when it becomes law, patients will benefit from faster, newer, and better treatments, and American workers will keep us on the cutting edge of medical innovation. I reserve the balance of my time.

Mr. UPTON

Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks on the legislation and to insert extraneous material on H.R. 4480.

Mr. UPTON

Mr. UPTON. Mr. Speaker, last week, the House passed, by 387 5, major legislation that impacts millions of jobs by allowing the faster and safe approval of medical devices and pharmaceutical drugs. Rather than sending those jobs overseas, they're staying here. The administration's impending tax on medical devices is a ticking time bomb for manufacturing jobs and innovation across the country and especially in Michigan, which is why we need to repeal it and pass this legislation. Last month, I visited Stryker, a major device manufacturer that is headquartered in Kalamazoo and Portage, Michigan. They reinforced the harmful impacts that this tax will have on our corner of the State. Stryker employs about 2,500 workers in Kalamazoo County. They tell me that the tax is going to cost their company alone $150 million, and that number does not include the millions of dollars and thousands of man-hours that they're going to have to expend on ensuring that they're in compliance with that tax. These are dollars that could be better spent on wages, research, development, and investments in lifesaving technologies, which would not only help the employment sector but, obviously, patients as well. Stryker also recently announced the elimination of 1,000 jobs worldwide, which is a 5 percent reduction in its global sales force. The cause of that reduction: making up the cost for this impending tax. The President said earlier this year that he would do whatever it takes to create jobs in America. He needs to sign this bill because, without it, it's going to cost jobs--as has been proven in Michigan alone.

Mr. UPTON

Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Pitts), chairman of the Health Subcommittee on the Energy and Commerce Committee.

Mr. UPTON. I yield myself 1\1/2\ minutes for the purpose of a colloquy, and I yield to the gentleman from Florida (Mr. Buchanan).

Mr. UPTON. I appreciate your constant leadership on the national problem of prescription drug abuse. I appreciated your input during your phone call to me last week back in Michigan when the Senate passed this amendment. Our committee has focused on this issue, and you have been an outstanding partner with Congressman Ed Whitfield and Congresswoman Bono Mack on this. When used properly, we know that these medications provide needed therapies for those suffering from pain. However, the abuse of some of those products has devastated communities and destroyed families across the country. So, as we move forward on this bill in our discussions with the Senate, I hope that we can continue the partnership and be able to work this issue out. At this point, Mr. Speaker, I ask unanimous consent that the balance of my time be controlled by the gentleman from Pennsylvania (Mr. Pitts).

Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5651) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes, 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 into the Record.

Mr. UPTON. Mr. Speaker, I yield myself 2 minutes. Mr. Speaker, I want to thank, first of all, Chairman Pitts, Dr. Burgess, Mr. Barton, Mr. Waxman, Mr. Pallone, Mr. Dingell, and other committee members on both sides of the aisle for their bipartisanship through this process. H.R. 5651 is a reflection of their hard work, dedication, and willingness to work together. And because of that outstanding work, we have a bill today that will help American patients and innovators, and it will support millions of jobs, believe it or not, millions of jobs in an important sector of our economy. As I've said since the beginning of this Congress, we need to enact this user fee by the end of June, and I believe that we're on track to accomplish that goal. And as we put this user-fee package together, I wanted to ensure that it fostered American innovation by improving the predictability, consistency, transparency, and efficiency of FDA regulation. Fostering innovation is essential in getting new treatments to patients and creating American jobs. This bill will foster American innovation because it includes significant accountability and reform measures designed to hold the FDA responsible for its performance. The measures include independent assessments of FDA's drug-and-device review process. It also requires quarterly reporting from the device center so that we don't have to wait a year to find out their progress. I commit today that our committee will continue its vigorous oversight of the FDA. For example, we're going to use the independent assessments to determine where the review process can be improved, and we will ensure FDA fixes the problems. Also, we'll use the quarterly data on device reviews and bring the FDA before our committee to explain how it's doing. This bill will give us the information that we need to understand how the FDA is performing. It is up to us to ensure that we use that information to hold the FDA accountable for their performance. Together, the committee members have produced a bill that will help American patients, while supporting innovation and job creators. I thank the committee for their participation. I reserve the balance of my time.

Mr. UPTON

Mr. UPTON. Mr. Speaker, Americans have demanded a more efficient government that eliminates outdated and unnecessary bureaucracy; a government that takes a hard look at the market before deciding to regulate it--in short, a government that works. The FCC Consolidated Reporting Act accomplishes those goals, all at no cost to the taxpayer. Today, the FCC is required to write eight separate reports on discrete components of the communications marketplace. Eight separate reports multiplies the number of hours the FCC spends writing reports, multiplies the number of employees working on such reports, and multiplies the number of times industry has to respond to information requests from the Commission. The FCC Consolidated Reporting Act takes a smarter approach. It consolidates these eight reports into a single, comprehensive report on the state of the communications marketplace, and eliminates twelve other reports from the Communications Act. I want to thank Communications and Technology Subcommittee Chairman Greg Walden and Representative Steve Scalise for working on this important legislation. I support it, and I urge my colleagues to support it as well.

Mr. UPTON

Mr. UPTON. I would like to claim time on the Republican side in support of the motion.

Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, this amendment is really about jobs and the economy. The President, you will remember, in a national address in January, said he would do whatever it takes to create U.S. jobs. That's what this bill does. It creates, by just about everybody's estimate, 20,000 direct jobs and more than 100,000 indirect jobs. And I would note that under Ed Whitfield's leadership, the chairman of the Energy and Power Subcommittee, we went through regular order on this bill last year. We held hearings, we held a subcommittee markup, we had a full committee markup, and last summer we passed it on the House floor by almost a two-to-one margin; obviously, bipartisan. Mr. Speaker, we consume about 18 or 19 million barrels of oil every day. We produce only 8 to 9 million barrels a day. This is a pipeline that will bring us 800,000 barrels a day from our friends, the Canadians. We've waited 3 years. You'll remember that Secretary of State Hillary Clinton said in October of 2010 that she was inclined to support this. And in August of last year she said, We'll have the review done before the end of the year. It's not been done yet. And even though this House passed the bill by a significant margin, the Senate did not act. That's why this bill has been attached to a couple of different bills, and now it's part of the highway bill. I support the gentleman's instruction to the conferees to include this. The route has been rerouted through Nebraska. They now support this new route. We have spent billions of dollars in our refineries across the country trying to get ready for this new source of oil coming from our friends, the Canadians. So what happens if we continue to say no? The Canadians, for sure, are going to still produce this. They're still going to mine the oil sands in Alberta. But it's not going to come here. It's going to go to China. China is prepared to spend with the Canadians literally billions of dollars to send it there, of which none of it will come back to the United States. That is not the right answer. No, it's not. That's why it's not only a national security issue as part of the highway bill, but it's also a way that we will know that we will have a steady source of supply. Now let me just make one more point. Today, we import from Canada 2.6 million barrels of oil every single day. A million barrels of that already is oil sands. In my home State of Michigan, the Marathon refinery outside of Detroit has spent $2.2 billion expanding their refinery, preparing for oil sands--not from Alberta, not from this part of Canada, but other parts--of which the oil sands will then be part of what we consume here in the United States. A million barrels of the 2.6 million that Canada sends us every day is oil sands. What is the problem with expanding that by another 800,000 barrels a day that will produce American jobs and allow us to have less reliance on friends like Venezuela and folks in the Middle East, if we can use our best friend, Canada, to help us provide this oil to the United States? So I support the gentleman's instruction. I hope that it will pass when we have the vote tomorrow. I ask unanimous consent that the balance of my time be reserved and under the direction of Mr. Whitfield, the subcommittee chair of the Energy and Power Subcommittee.

Mr. UPTON

Mr. UPTON. I would just like to remind the House that this amendment is the same bill that the House passed last year with a vote of 267 144. We moved this through regular order through our committee hearings, subcommittee and full committee markup, and I want to say, as I recall, by nearly a 3 1 margin in the full committee did we pass this amendment. This amendment establishes a program that protects human health and environment. It requires groundwater monitoring and requires that States monitor for the same constituents that EPA identified as being important for the regulation of coal ash. The amendment also requires that States require liners for new structures and establishes appropriate controls on fugitive dust. For 2 years, EPA has been considering regulating coal ash. This bill would allow the safe use of coal ash in such products as concrete, wallboard, and roofing shingles. As the gentleman from West Virginia said, it saves 316,000 jobs. This is a highway and infrastructure bill. It is a jobs bill. This saves American jobs, and it is very important that the House continue to support the McKinley amendment, whether it be a freestanding bill, as we did last year, or the amendment to this bill.

Mr. UPTON. Mr. Speaker, we haven't built a new refinery since 1976. EPA will not allow new refineries to be built. We have spent instead billions of dollars to expand the refineries that we have. Under regular order we moved this Keystone pipeline last summer. It passed on the House floor two-to-one. There is no reason why a construction project like this shouldn't be in this bill. I look forward to the passage of this bill later this afternoon with the inclusion of the Keystone XL pipeline.

Mr. UPTON. I thank the chairman for yielding. Mr. Chairman, this is a highway and infrastructure bill. That means it is a jobs bill. Now, I would remind my colleagues and those watching that the President said back in January, as part of his weekly address, that he would do whatever it takes, whatever it takes, to create jobs. There is not a more shovel-ready project than the Keystone XL pipeline, period. Secretary Clinton said in October of 2010, I am inclined to support this project. In August of 2011, she indicated that there was no reason why they couldn't give an approval or a denial by the end of last year. This is 20,000 direct jobs, more than 100,000 indirect jobs, a $7 billion privately funded pipeline that will subscribe to the pipeline safety bill that this committee as well as the Energy and Commerce Committee worked on, that the President signed this last year, raising the standards, raising the fines for those that violate those standards. It is a better pipeline safety route than ever before. I have to say for those detractors, the route has been changed through Nebraska. It will no longer go through that aquifer. We will bring as much as 800,000 barrels of oil from the oil sands in Canada. As these gas prices continue to go up, Americans understand supply and demand; 800,000 barrels a day that we can get from our friends, the Canadians. If we don't do so, where is it going to go? China. China is already preparing to spend billions of dollars to instead build that pipeline to Vancouver, send it to China to be refined and, guess what, we will get none of that refined oil back. Some detractors of this project say why don't we just build a refinery in North Dakota. Well, let's say we did. Are you not going to still then build a pipeline to connect it with the supply routes across the country?

Mr. UPTON. Mr. Chairman, this is a highway and infrastructure bill, which means it is a jobs bill. I commend Mr. Boustany in a bipartisan effort to add this as an amendment to this bill. I represent the Great Lakes. We have a number of commercial as well as recreational harbors, but throughout the season we're bringing sand, gravel, cement, salt for the winter into our commercial ports. And sadly we've had a number of ports close this year in west Michigan, where those lake carriers have not been able to get in because they need to be dredged. This bill allows the Great Lake harbors to be dredged with its passage. The difference is this: on a lake carrier, it's about 600 miles per gallon per ton of cargo that you can ship on a lake carrier rather than spending 4 cents or 5 cents on diesel fuel per mile per truck. The difference for just my district is you can bring this in from the UP and other places into the southern part of Lake Michigan rather than trucking it in for hundreds of miles to the closest border. This is a good bill and a good amendment. I'm glad to support it.

Mr. UPTON

Mr. UPTON. Mr. Speaker, I rise today to congratulate Benton Harbor's Destiny Williams of the Lady Bears of Baylor University on her team's victory in the NCAA women's basketball championship. She is an outstanding young woman who helped lead her team to a perfect season, a rare and timeless accomplishment. Our entire community could not be more proud of Destiny and the remarkable basketball career she has made for herself. This is only the second time her team has won the championship and is a testament to her great success. Winning a national championship is something that will last a lifetime. It is a remarkable achievement that few athletes ever experience, and is a legacy that will live with Destiny and the Lady Bears forever. Destiny knows that hard work, discipline, and teamwork helped her team win this championship. These same qualities brought a big 2008 victory to the Benton Harbor Lady Tigers in the state championship game. Nobody outworked the Lady Bears and nobody could beat them in the tournament or the regular season. Ending their perfect season with an NCAA championship speaks to Destiny's abilities as a leader and team player. Destiny's 12 points and 6 rebounds in the championship game helped her team to victory. She is such an inspiration for young women back home and we are all so eager to see what the future holds in store for our Lady Tiger, now Lady Bear. On behalf of all the residents of southwest Michigan, congratulations again to Destiny Williams. You make all of us here in Michigan very proud.

Mr. UPTON

Mr. UPTON. Mr. Chairman, I yield 2 minutes to the chairman emeritus of the Energy and Commerce Committee, Mr. Barton, the gentleman from Texas. (Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)