Michael Burgess

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I yield myself 1 minute. We do have before us today a unique opportunity. We have an opportunity to lay the groundwork for the future. We have the way to lead in the 21st century in providing 21st century cures. To be sure, we are providing additional funding to the National Institutes of Health and we are providing additional funding to the Food and Drug Administration, but we are also placing requirements upon those institutions. We all know we have to do things faster, better, cheaper, smarter and that we have to do more with less. That is what the 21st Century Cures bill lays before us, and that is why this rule is so crucial and critical today and why I urge its passage. I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield myself 30 seconds for the purpose of the introduction of my next speaker. Mr. Speaker, it is really a great privilege to recognize the next speaker on our side, the chairman emeritus of the Energy and Commerce Committee. In fact, the last reauthorization for the National Institutes of Health occurred under Joe Barton's watch, one of the last things we did at the waning hours of the 109th Congress. Mr. Speaker, he did provide additional funding to the NIH; he provided an increase of 5 percent a year for the lifetime of that reauthorization. Unfortunately, it was never appropriated to that level after the Democrats took charge in the 110th Congress. I yield 3 minutes to the gentleman from Texas (Mr. Barton), the chairman emeritus of the Energy and Commerce Committee, for his observations. (Mr. BARTON asked and was given permission to revise and extend his remarks.)

Mr. BURGESS. Mr. Speaker, may I inquire to the time remaining?

Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from Michigan (Mr. Upton), the chairman of the Energy and Commerce Committee and the author of the Cures legislation.

Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from Kansas (Mr. Yoder).

Mr. BURGESS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 350 and ask for its immediate consideration.

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

Mr. BURGESS. Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Massachusetts (Mr. McGovern), 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, at this time, I yield 1 minute to the gentleman from Florida (Mr. Bilirakis), a valuable member of the Energy and Commerce Committee.

Mr. BURGESS. I yield 1 minute to the gentleman from Texas (Mr. Veasey).

Mr. BURGESS. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from Texas (Mr. McCaul), the chairman of the Homeland Security Committee.

Mr. BURGESS. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from Tennessee (Mr. Roe), the chairman of the House Doctors Caucus.

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

Mr. BURGESS. Mr. Speaker, House Resolution 350 provides for a rule to consider a critical bill that will help millions of Americans and their families who are suffering from diseases for which there is no cure. The rule provides for 1 hour of debate, equally divided between the majority and the minority of the Energy and Commerce Committee, and makes eight amendments from Members of both parties in order so that the House may fully debate the merits of this legislation. As is custom, the minority is offered a final motion to recommit the bill prior to its passage. I am pleased the House is considering this bipartisan legislation. The Energy and Commerce Committee has spent 14 months working to bring our healthcare innovation infrastructure into the 21st century. Today, there are 10,000 known diseases or conditions, and we have got cures for 500. There is a gap between the innovation and how we regulate our therapies. It is not unheard of to have a company take 14 years and spend $2 billion to bring a new device or drug to market. Members held nearly 20 roundtables and events around the country to ensure that we involved patients, advocates, researchers, innovators, and investors that have firsthand experience and help understand the gaps in our current system. H.R. 6 touches each step of the healthcare innovation process: discovery, development and delivery. This bill attempts to close the gap between the fast pace of innovation and our current, often burdensome regulatory process. The bill provides exciting new tools to uncover the next generation of treatments and cures. H.R. 6 is, indeed, transformative-- transformative of the way that doctors and researchers study diseases, develop treatments, and deliver care. It encourages innovation. It fosters the use of data to further research. It modernizes clinical trials and takes steps toward the future of personalized medicine. Not only does this bill take a major step forward in bringing more cures to patients, this bill addresses our Nation's ever-increasing healthcare spending. This bill establishes a temporary innovation fund which is fully offset, including permanently reforming our entitlement programs. Beyond the budget window, these reforms in Medicare and Medicaid are established to yield at least $7 billion in additional savings for taxpayers; but make no mistake. The biggest cost saver--the biggest cost saver--will be finding cures to some of America's most deadly and costly diseases. I am thankful to have worked on many parts of this bill. The legislation contains five bills that I have introduced and other provisions that I helped with the authorship. I would like to take a minute to talk about a few of the sections where I have personally worked on them. While thousands of Americans are affected by multiple sclerosis, Parkinson's, and other neurologic diseases, very little accurate information exists to assist those who research, treat, and provide care to those suffering from these diseases. H.R. 6 actually includes H.R. 292, that I introduced, with Mr. Van Hollen of Maryland, to advance research for neurologic diseases. H.R. 6 will allow for surveillance systems for tracking key neurologic diseases, which may then be used to help us further understand these devastating diseases and deliver their cure. We are improving patient access to needed treatments by supporting expedited approval for breakthrough therapies and actually making it easier to seek approval for new indications of approved therapies. Currently, the Food and Drug Administration approved drugs may be only promoted for the approved indication, even if the sponsor determines that the drug is an effective treatment for another indication. H.R. 6 includes another bill, H.R. 2415, which I introduced with Mr. Engel of New York, and would formally establish a program within the Food and Drug Administration, which would allow companies with approved drugs or biologics to submit clinical data summaries for consideration of a new indication. This would reduce the time to approval and reduce resources required to approve new indications of drugs, drugs that have a well-established knowledge base and well-established safety information. I introduced H.R. 293, with Representative DeFazio of Oregon, to protect continuing medical education, which plays a vital role in our healthcare system. This improves patient outcomes, facilitates medical innovation, and keeps our Nation's medical professionals up-to-date. With the inclusion of this provision in H.R. 6, we will ensure that doctors continue to have access to these vital tools. The provision simply enforces current law, which states that educational materials were explicitly excluded from reporting requirements in the Affordable Care Act. Unfortunately, the Center for Medicare and Medicaid Services has acted in conflict with the law, but we correct that in H.R. 6 and ensure that physicians have access to materials and information to keep us informed and up to date on medical innovation. With its inclusion in H.R. 6, we will ensure that doctors continue to have access to these vital tools. We ensure that Americans have access to their critical health information by identifying barriers to achieving fully interoperable health records. Mr. Speaker, the United States taxpayer has spent well over $30 billion to ensure that healthcare providers obtain an electronic record system. However, the investment has not resulted in access to information in those records and patients across the healthcare spectrum. While we have seen widespread adoption of electronic health records, our Nation continues to maintain a fragmented healthcare system, making it difficult to ensure the continuity for evidence-based care for patients. The 21st Century Cures Act would finally set the United States on a path toward achieving a nationwide interoperable health information system. This will be transformative for research and for medical treatment. Finally, along with Mr. McCaul and Mr. Butterfield, we aid patients by requiring companies to clarify availability of expanded access programs. Further, with the inclusion of H.R. 2414, which I introduced with Mr. Schrader of Oregon, we are requiring the Food and Drug Administration to issue guidance on the dissemination of up-to-date, truthful, scientific medical information about FDA-approved medications. This legislation passed out of Energy and Commerce's Subcommittee on Health on May 19 on a voice vote, and it passed the full committee on May 21, 51-0, the second time in 3 years that the committee has had a 51-0 vote, the previous one being on the repeal of the sustainable growth rate formula. I encourage all of my colleagues to vote ``yes'' on the rule and ``yes'' on the underlying bill. 21st Century Cures would not only deliver hope to the millions of American patients living with untreatable diseases, but it will help modernize and streamline the American healthcare system. I reserve the balance of my time.

Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from Oregon (Mr. Walden), a member of the Energy and Commerce Committee.

Mr. BURGESS

Mr. BURGESS. Mr. Chairman, I have an amendment at the desk.

Mr. BURGESS. Mr. Chairman, I urge support of the amendment. It is clear that this program does need the scrutiny of the authorizing committee. We are prepared to do that if this amendment passes. I yield back the balance of my time.

Mr. BURGESS. Mr. Chairman, I thank the subcommittee chairman for his indulgence at this late hour. Mr. Chairman, this is an issue that has been under investigation by the Subcommittee on Oversight and Investigations on the Energy and Commerce Committee for over the last 6 years. In 2006, without consultation from the Energy and Commerce Committee, there was included a provision in the annual Interior, EPA appropriations bill that allowed the Environmental Protection Agency to begin using a special pay program that was explicitly and exclusively authorized for use by the Public Health Service administration under the Department of Health and Human Services. This special pay mechanism allows a government employee to leave the normal GS pay scale and receive nearly uncapped compensation, upwards of $200,000 to $300,000 per year. This special provision was intended to be used only in unique circumstances where, perhaps, leaders of the healthcare industry would not be able to work for the Federal Government because of pay considerations if they did not have access to these higher salaries. This justification cannot be used for anyone at the Environmental Protection Agency. Indeed, some of the employees that the Environmental Protection Agency pays under title 42, the part of the U.S. Code that allows for this special pay, were previous government workers and were merely moved to this special pay scale because they wanted additional money. The EPA claims that, because the Environmental Protection Agency is a health organization, it may use this statute to pay special hires, and this, in fact, has endured for several years. Originally, the Environmental Protection Agency was granted only a handful of slots to fill with title 42 hires. That number is now over 50. The cost to taxpayers for these 50 employees is in the tens of millions of dollars. This amendment would prevent the Environmental Protection Agency from hiring any new employees under title 42 or from transferring current employees from the GS pay scale to title 42. It would not affect current employees being paid by this provision. It would give the Energy and Commerce Committee, the authorizing committee, the time it needs to address whether the Environmental Protection Agency truly deserves this special pay consideration. The General Accountability Office looked into the abuse of title 42 several years ago and found numerous problems with the implementation of the program. Why we would allow this problematic pay structure to be advanced by the EPA is, in fact, mysterious. In multiple hearings in the Energy and Commerce Committee, both Administrator Lisa Jackson and current Administrator Gina McCarthy refused to give specifics regarding this program. A Freedom of Information Act request sent to my office by the EPA union, the American Federation of Government Employees, showed that title 42 hires at the EPA are actually sowing the seeds of discontent amongst workers, with the union asking the Congress to stop this unfair hiring technique. Both former Energy and Commerce Committee Chairman Barton and I have introduced legislation further clarifying that the Public Health Services Act, written for the Department of Health and Human Services, does not permit the Environmental Protection Agency to use its language to hire employees under a special pay structure. This amendment prevents further abuses of the program, and I urge its adoption. I reserve the balance of my time.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I rise today to recognize National Sunglasses Day and to honor the sunglass manufacturers and suppliers throughout my Dallas Congressional District, the State of Texas and around the country. Texas and the Dallas area are home to a variety of optical industry leaders including 24 optical laboratories that manufacture prescription sun wear, 3 lens manufacturers that supply UV filtering lenses, and 6 sun wear frame suppliers. As a physician, I commend the sunglass industry and their trade association The Vision Council (TVC) for ongoing outreach campaigns to educate consumers regarding the damaging effects of ultraviolet (UV) rays to the eye and healthy vision. In the case of eye protection, what you don't know can hurt you. When it comes to the human eye and the sun's rays, it's what we can't see that matters most. UV radiation that reaches the earth's surface, made up of two types of invisible rays, UVA and UVB, endangers an unprotected eye. The effects of long-term exposure can include cataracts, macular degeneration, abnormal growths on the eye's surface and even cancer of the eye. While everyone should shield their eyes from UV rays, certain risk factors like age and eye color increase an individual's vulnerability to UV related eye disorders. Where you live and travel can also make a big difference in the level of UV exposure. Since UV damage can't be reversed, prevention through protection is key. Later this summer, sunglass manufacturers and distributors from my home district in Texas and The Vision Council (TVC) will be convening a Capitol Hill briefing on the topic of UV danger and protecting your eye health. I encourage my colleagues to attend and applaud the sunglass community and The Vision Council for their leadership in promoting healthy vision.

Mr. BURGESS

Mr. BURGESS. Mr. Speaker, I rise today to posthumously honor Dr. Gilbert Ernest Adami, who passed away on June 24, 2015 at the age of 92, leaving behind a proud legacy. Dr. Adami was born September 2, 1922 in Winters, Texas to Ernest and Emma Adami. Even as a child, he knew his calling in life was to heal others. He graduated from Winters High School at age 16, and attended the University of Texas. At age 19, he was admitted to Tulane University School of Medicine, obtaining his medical degree at age 22. Dr. Adami entered the United States Navy in 1945 and after completing a residency in Los Angeles General Hospital, served at the Long Beach Naval Base in the V12 training program. He left California to complete a surgical residency at the Veterans Administration Hospital in McKinney, Texas. While performing surgery there, he met a surgical nurse, Lillian, who became the love of his life. In 1951, Dr. Adami and Lillian married and moved to Denton, Texas, where he opened his surgical practice. Dr. Adami joined eight other physicians and developed Westgate Medical Center, which later became Denton Regional Medical Center, furthering his goal of expanding emergency services in Denton. In addition to managing his medical practice for over 50 years, Dr. Adami, with his wife's help, developed real estate, operated a ranch, and engaged in other entrepreneurial pursuits. Dr. Adami attended Immaculate Conception Catholic Church and was a Charter Member of the local Chapter of the Knights of Columbus. He was also a great tennis player, pilot, and loved being outdoors, especially with fellow hunters, sons, son-in-laws, and grandsons. In 1998, the Denton County Medical Society awarded Dr. Adami the prestigious Gold-Headed Cane Award, honoring him as an outstanding physician who demonstrated the highest qualities of excellence, service, and selflessness in contributions to his family, the art and science of medicine, and to the community. He will be missed greatly. It was an honor and a privilege to represent Dr. Gilbert Ernest Adami in the U.S. House of Representatives and I extend my condolences to his family, friends, and the patients, nurses, doctors, and medical professionals who loved and respected him.

Mr. BURGESS

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

Mr. BURGESS. Mr. Speaker, I would reiterate my earlier announcement that all time yielded is for the purpose of debate only, and I do not yield time for any other purpose.

Mr. BURGESS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 333 and ask for its immediate consideration.

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

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