Michael Burgess

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I rise today to honor the public service of Mr. Gary Shafferman, Principal of Edward S. Marcus High School in Flower Mound, Texas and congratulate him on his retirement after a successful thirty-five year career in education. Upon retirement, his dedication and leadership will be greatly missed by his Lewisville ISD colleagues, as well as the students and parents he served so well at Marcus High School. Mr. Shafferman received his bachelor's and master's degrees in education from the University of North Texas. He began his career in education as a science teacher and coach in Grand Prairie ISD. Prior to spending ten years as principal at Marcus High School, he served at schools across North Texas as a coach, teacher, counselor, assistant principal, and principal. Throughout his career, Mr. Shafferman has fostered close working relationships amongst community leaders, parents, and staff, and he has encouraged his students to pursue excellence and achieve their greatest potential. Please join me in recognizing Mr. Gary Shafferman, Principal of Marcus High School, for his commitment to the teaching profession, his sincere dedication to the education and well-being of his students, and his many years of exemplary public service. It is a privilege to represent the students, families, teachers, and staff of Lewisville ISD in the U.S. House of Representatives.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I rise today to recognize Heroes Park in Providence Village, Texas. Heroes Park, which will be dedicated on Memorial Day of this year, seeks to honor the selfless acts of men and women in uniform, first responders, and other unsung heroes. Today I would like to thank the Providence Village Hope Foundation for its work to establish this park and support our community's men and women in uniform. Each Memorial Day, we remember the brave members of our Armed Services who put their service to our nation first. While Heroes Park is a physical tribute to them, our gratitude and respect extends far beyond the confines of its land. I am grateful to join Providence Village Mayor Michael Jordan and Providence Village Hope Foundation Founders Eric and Karen Mattson to dedicate this beautiful park, and pay tribute to North Texas service members past and present.

Mr. BURGESS

Mr. BURGESS. Madam Speaker, I yield 1 minute to the gentleman from Tennessee (Mr. Kustoff).

Mr. BURGESS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 905 and ask for its immediate consideration.

Mr. BURGESS. Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Florida (Mr. Hastings), pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only. General Leave

Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks.

Mr. BURGESS. Mr. Speaker, House Resolution 905 provides for the consideration of three important bills aimed at protecting our country, reducing regulatory burdens in the financial sector, and allowing patients who have nowhere else to turn with another option to potentially save their lives. These three bills, taken together, show House Republicans' commitment to putting Americans' interests first. Today's rule provides for a structured rule to begin consideration of H.R. 5515, the National Defense Authorization Act for Fiscal Year 2019. The resolution grants 1 hour of debate equally divided between the chair and ranking member of the House Committee on Armed Services. In addition, as the first of two likely rules on the fiscal year 2019 NDAA, the rule provides for the consideration of 103 amendments to the defense bill. Along with the Defense Authorization Act, the resolution today provides for a rule for House consideration of S. 2155, the Economic Growth, Regulatory Relief, and Consumer Protection Act, the Senate- passed bipartisan bill to reduce the regulatory burdens imposed on community and local banks by the Dodd-Frank financial regulatory legislation. The legislation went through rigorous debate in the House and the Senate, and it mirrors in many ways the House-passed CHOICE Act, passed by the House in the summer of 2017 under the stewardship of Financial Services Chair Jeb Hensarling. Moreover, the resolution before us provides for a rule to allow the House to consider the unanimously passed Senate bill, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. This legislation, highlighted by the President during his last State of the Union address, has been a top priority of the President for the Congress, allowing terminally ill patients a last chance at survival using a carefully crafted FDA process. H.R. 5515, the National Defense Authorization Act for Fiscal Year 2019, would authorize appropriations for military activities of the Department of Defense and for military construction, as well as prescribe military personnel strengths for the next fiscal year. This critical piece of legislation, one of the most important bills that any Congress will consider in any year, provides the resources and the direction necessary for our men and women in uniform to do what they do best: protect and serve our country throughout the world. As will be discussed by many Members of this body over this week, this bill touches on all aspects of military policy, from the Middle East to the Korean Peninsula to the Arctic waters. Among the hundreds of amendments the Rules Committee is likely to make in order on this legislation, I am pleased that, once again, my amendment, offered with Ms. Lee, Mr. Lance, Mr. DeFazio, Mr. Jones, Mr. Welch, Mr. Lewis, and Ms. Schakowsky, will again be made in order. This continues to push the Department of Defense to finally complete a full audit of its finances, as required by law. S. 2155, the Economic Growth, Regulatory Relief, and Consumer Protection Act, corrects some of the more egregious provisions in the Dodd-Frank financial regulatory legislation. The bill focuses on regulatory relief on smaller financial institutions--namely, community banks and credit unions--so they can more readily meet the needs of their local communities without burdensome Federal regulations stifling their economic growth. This places the focus of the financial institutions back on their customers instead of completing paperwork and answering to agencies in Washington, D.C. Finally, Mr. Speaker, our final bill in today's rule, S. 204, will look familiar to many people here today, as we are again considering legislation that would bring hope to terminally ill patients across our country. A similar bill, H.R. 5247, passed this House in March. Minority Leader Chuck Schumer and Senate Democrats have refused to act on H.R. 5247, the revised version of the Right to Try legislation, which passed the House 2 months ago on a strong bipartisan vote. As this body had heard earlier this year, Right to Try was the one piece of legislation that President Trump came and stood in the well of this House and specifically promised to the American people in his State of the Union address. Today, I will say again what I said in March when we first took up Right to Try: I stand with the President and I stand with the thousands of Americans with terminal diseases and their families and their friends in getting this important policy to the President's desk. Mr. Speaker, when we pass this bill today, it doesn't go back to the Senate. It has already been passed by the Senate. It goes immediately down to the White House for a signature and becomes law. Here is an interesting fact. In the last couple of months since the House passed its Right to Try bill, even more States have joined this strong grassroots movement. Now, 40 States, including my home State of Texas, have passed and signed a version of Right to Try into law. In nine other States, a version of Right to Try has already been introduced, including the State of New York, which is the home State of the minority leader of the United States Senate. Last year, the Energy and Commerce Health Subcommittee held a hearing on access to investigational drugs where S. 204 was discussed. At that time, the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, and other advocacy groups expressed concerns on the various Right to Try bills introduced in the Senate and the House. So, when the President asked the Congress to act, the House responded by holding multistakeholder discussions with patient groups, medical research advocates, and the administration in order to improve the original Right to Try bill. I want to commend Chairman Walden for leading these negotiations. I am also proud of the revised Right to Try legislation that the Energy and Commerce Committee produced because the policies were sound, and I believe it was a positive step forward in granting access to new treatments while allowing additional input from the Food and Drug Administration. Unfortunately, the minority party on the other side of the Capitol, Senate Democrats, said ``no, thank you'' to the revised House bill. While I am not surprised by their decision, I think the American people, particularly patients with terminal diseases and their loved ones, would not be satisfied with a ``no, thank you'' nonaction by Congress on such an important issue. Today, the House is ready to act for the American people and will be considering S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. This passed the Senate unanimously last August. This bill will offer terminally ill patients a chance at life. After it passes this House, it will be signed into law. Our Nation has achieved unprecedented innovation and scientific breakthroughs recently and over the course of the last decade. American patients have widespread access to innovative treatments, thanks to researchers and our academic institutions and those working in the pharmaceutical and medical device industries. Despite these achievements, we continue to hear from patients with serious, life-threatening conditions, including my constituents from north Texas, who remain frustrated with what they see as regulatory barriers from trying new therapies when everything else has failed them. As a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for loved ones diagnosed with very difficult diseases. This crossroads where our Nation seems to be--when a potentially lifesaving treatment, while not approved, both exists but remains unavailable--is an important debate that we are having for these Americans. To them, it is not only a matter of life or death but another chance to spend more time with their children, grandchildren, parents, and other family members. Some of the opponents of Right to Try point to the Food and Drug Administration's current expanded access program, which is aimed at helping patients who do not qualify for clinical trials gain access to therapies that the agency has yet to approve. While this program makes a good faith effort to help patients, we can do more by passing Right to Try and creating an alternative pathway for these patients to access eligible investigational drugs. Additionally, we know that many individuals may not qualify for a clinical trial if they do not meet strict patient inclusion criteria, which may include factors such as age, gender, type and stage of their disease, previous treatment history, and other medical conditions. There are also many patients for whom participation in a clinical trial is not feasible, especially those who live in rural areas far from the clinical trial sites. Most, if not all, of the patients with a terminal medical condition fall into one of these categories. This legislation that we are doing today allows these patients to participate in an alternative pathway, opening another door to investigational drugs that does not exist today. While there are a few differences between S. 204 and the House-passed Right to Try legislation, the underlying policies between the two bills are very similar. For example, only certain investigational drugs are considered eligible under both bills. In order to qualify, the drug must have completed a phase one clinical trial; have an active application at the Food and Drug Administration; be under active development or production by a manufacturer; and not have been approved, licensed, or cleared for sale under current law. Also, both bills require reporting of serious adverse events, having written informed consent to the treating physician, and notifying the agency when a sponsor provides an investigational drug. Lastly, Commissioner Gottlieb at the Food and Drug Administration recently expressed support for the Senate-passed Right to Try bill being considered today and said that his agency could ensure an appropriate level of patient safety through guidance and rulemaking. In other words, while the Food and Drug Administration may have some additional work, the key point is the agency can achieve the proper balance of ensuring patient safety and granting access to new investigational drugs. I think the Commissioner would agree that we would have preferred the revised House Right to Try legislation, but doing nothing is currently not an option. Hundreds of thousands of Americans with terminal illnesses and their families are looking for us to act. I support restoring hope for these patients and giving them a fighting chance at life. Mr. Speaker, I urge Members of this esteemed body to support today's rule and all three underlying bills, and I reserve the balance of my time.

Mr. BURGESS. Madam Speaker, I yield 2 minutes to the gentleman from Michigan (Mr. Bergman), a member of the Financial Services Committee.

Mr. BURGESS. Madam Speaker, I yield 1 minute to the gentleman from Indiana (Mr. Messer).

Mr. BURGESS. Madam Speaker, I yield myself 30 seconds for purposes of rebuttal before I yield to the gentleman from North Carolina (Mr. Budd). As a point of situational awareness, as of last week, in this Congress, over 1,000 amendments have been heard on the House floor: 47 percent Democratic, 41 percent Republican, 15 percent bipartisan. For a point of reference, the last term that Nancy Pelosi was Speaker of the House, the 111th Congress, less than 1,000 amendments for the entire Congress. We passed that milestone prior to last week. We will continue to hear amendments on the floor. Madam Speaker, I yield 1 minute to the gentleman from North Carolina (Mr. Budd).

Mr. BURGESS. Madam Speaker, I yield 1 minute to the gentleman from Georgia (Mr. Loudermilk).

Mr. BURGESS. Madam Speaker, I yield 1 minute to the gentleman from Ohio (Mr. Davidson).

Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the gentleman.

Mr. BURGESS. Mr. Speaker, seeing no more speakers on my side, I am prepared to close.

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

Mr. BURGESS. Mr. Speaker, I continue to reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I was unavoidably detained. Had I been present, I would have voted ``yea'' on rollcall No. 210.

Mr. BURGESS. Mr. Speaker, I yield myself 1\1/2\ minutes for the purposes of a response. I would, of course, lead with the observation that those who do not remember their history are doomed to repeat it. I don't remember precisely who said it, but I think it bears repeating today. In the 111th Congress, Speaker Pelosi and the Democrats allowed less than a thousand amendments to be considered on the floor. Of the bills that were considered at that time, the Dodd-Frank bill was one of those bills. The amendments that were blocked by the Democrats in the 111th Congress were precisely the type of amendments that we are now considering today in the bill to alleviate some of the obstructions, some of the gridlock that has occurred with our credit unions and smaller banks--things that people have been asking us for repeatedly for the last 5 to 7 years. Mr. Speaker, the number of amendments that were blocked in the 111th Congress was significant. We have a chance today to undo some of that process, and I believe we ought to take that opportunity. As of 1\1/2\ weeks ago, over a thousand amendments had been made in order in this Congress. The Committee on Rules is run differently today than it was in the 111th Congress. It used to be that you had to submit 45 copies of an amendment and you had a time limit by which you had to submit those amendments. You can submit amendments late now.

Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to myself. Chairman Sessions has been very accommodating in allowing us to bring amendments to the Committee on Rules late. There is no clock in the Committee on Rules, as the gentleman well knows. You can talk as long as you want in the Committee on Rules about your amendments, and you can offer whatever amendments you prefer. The process is not ideal, but it is important that we move forward with these important reforms that people have been asking us for years. And, today, that day is at hand, and those reforms will be delivered. Mr. Speaker, I reserve the balance of my time.

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

Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time. Mr. Speaker, I again want to reiterate, the Rules Committee has spent hours listening and considering Member testimony. We have welcomed over 225 Members to testify during this Congress, and roughly 493 times have made over 1,000 amendments in order, including 474 from Democrats, 383 from Republicans, and over 150 which were bipartisan amendments. The rule today is important, three important pieces of legislation. The National Defense Authorization Act. Our number one priority when we are elected to this body is the defense of our Nation, and we are authorizing that expenditure today. The bill to reform the financial services institutions is one that has been requested by small banks and credit unions for years, and this body is today prepared to deliver. Then finally, the Right to Try Act. The President stood in the State of the Union message and said that it was not correct that people had to go to other countries in order to get the medicines that they needed to prolong their lives. He wanted that to end, and today we are taking the step to end that. Mr. Speaker, I urge my colleagues to support today's rule and the three underlying pieces of legislation

Mr. BURGESS. Mr. Speaker, I yield back the balance of my time, and I move the previous question on the resolution.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, on that I demand the yeas and nays.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, here in the people's House, we reflect the will of the American people. When the Right to Try Act is law in 40 States, it may no longer just be a grassroots movement. It is a call to action from Americans from coast to coast--many of the over 1 million Americans who die from a terminal illness every year--to return choice and control over treatment options to where it is most effective: with the patient, with the doctor. Today, the House is taking up the Right to Try Act for the third time. But the reason we are here again debating this issue is because of the Senate Democrats' refusal to take up the revised right-to-try legislation that passed this House by a bipartisan vote 2 months ago. That revised bill, H.R. 5247, was more narrowly crafted than this version of S. 204. This version, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, is before us today. S. 204 was authored by Senator Ron Johnson of Wisconsin and passed by unanimous consent in the Senate last August. I think it is important, so let me take a moment to lay out the efforts by the Energy and Commerce Committee since that time. First, the Energy and Commerce Health Subcommittee, which I chair, held a hearing last October to consider right-to-try bills, including this bill, S. 204, where Members heard from Dr. Scott Gottlieb, the Commissioner of the Food and Drug Administration, from patients and other groups that either support or oppose the concept of right to try. For several months, our committee engaged in conversations with patients, advocates, the administration, particularly the Food and Drug Administration, and stakeholders on all sides of this complex topic. Our aim was to open the door to innovative, experimental drugs for terminally ill patients without necessarily compromising the vital work and mission of the Food and Drug Administration. The product of that aim was H.R. 5247, the revised House right-to-try bill. Sadly, Senate Democrats said ``thanks, but no thanks'' to the House bill. Frankly, I am perplexed by their decision, because not a single Senate Democrat expressed any reservation when S. 204 passed their Chamber by unanimous consent last August. So House Republicans will show the American people that we hear you. We will act to deliver on a promise made by the President in this House before the joint session of the House and Senate during the State of the Union address. He told us that we would pass the right-to-try legislation. Well, today, we are doing just that. You know, this was kind of a bold statement by the President, to stand up in the State of the Union and say that he wanted to sign this bill into law. So I am proud to boldly stand with him and stand with the American people. Mr. Speaker, we live in the greatest Nation in the world. An unprecedented amount of innovation and scientific breakthrough is the norm. We have innovative treatments at our fingertips because of the valuable contributions of researchers in academia and the private sector. Despite these achievements, I still hear from patients with serious, life-threatening conditions, including constituents from north Texas, who remain frustrated with the current regulatory processes that prevent them from trying or experimenting with new therapies when everything else has failed them. As a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious terminal conditions. To my friends on the other side of the dais in the committee and the aisle here in the House, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future? Mr. Speaker, I am proud to support H.R. 5247, the House right-to-try bill that currently remains in the Senate. However, the right-to-try legislation before the House today is the Senate bill, S. 204, so I am pleased that we are considering this right-to-try bill so that terminally ill patients have a chance, maybe a second chance, at life. These patients are our constituents. They could be someone we know. Let us take this opportunity to improve access to experimental treatments for them and give them renewed hope. S. 204 establishes an alternative pathway for terminally ill patients to access certain investigational drugs that have successfully completed a phase one clinical trial and have an active application at the Food and Drug Administration. They also must be under active development or production by the manufacturer. It is important to note that, for these patients, they have exhausted all FDA-approved treatment options and are unable to participate in a clinical trial involving these investigational drugs. The bill we will be voting out soon is about patients. It is about having more time with their loved ones. In the words of Vice President Mike Pence, ``It's about restoring hope and giving patients with life-threatening diseases a fighting chance.'' With hundreds of thousands of Americans with a terminal illness and their families looking for us to act, I urge Members of this House, the people's House, to support restoring hope and giving them a fighting chance at life. I urge a vote in support of S. 204. Let us send this groundbreaking legislation to the President's desk for his signature, and let it become the law of the land. Mr. Speaker, I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the gentleman from Texas.