Pete Sessions

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, I appreciate the gentleman, my friend from Massachusetts, for his words of wisdom about the direction we ought to be going. That is what we are going to do; we are going to continue moving. I find in my job, as I perform my duties, that I have a chance to really interact with a lot of people in government. Over Christmas, I had a chance to visit our troops around the world and look at them and give them the confidence that what we do in Washington will allow them to keep working for freedom and to represent us. Dr. Francis Collins at the National Institutes of Health, an enormously brilliant man who helped with the genome project, who keeps NIH up and working; and at the National Eye Institute, Dr. Paul Sieving; and so many others who do count on us getting it right, whether it be the United States military, whether it is our border patrol, whether it is our health and human services, but the person who knows these characteristics of what it takes to get agreements is also on the Rules Committee. He is a valuable member of our Rules Committee. He is the gentleman from Oklahoma (Mr. Cole). Mr. Speaker, I yield 10 minutes to the gentleman from Oklahoma (Mr. Cole), vice chairman of the Labor, Health and Human Services, Education, and Related Agencies Subcommittee.

Mr. SESSIONS. Mr. Speaker, also I want to recognize the gentleman from Oklahoma (Mr. Cole) for another birthday today. The gentleman from Oklahoma was very silent last night at the Rules Committee. He didn't let us know, so we didn't say anything. But today is his birthday, and I congratulate him for that. I reserve the balance of my time.

Mr. SESSIONS. Mr. Speaker, last night at the Rules Committee, we had a debate where we focused our attention not only on the legislation, but also on the need to get this done. I appreciate the gentlewoman from Florida (Ms. Castor), the gentleman from Oklahoma (Mr. Cole), and the gentleman from Massachusetts (Mr. McGovern) and their attention to the ideas that they have. They do have ideas, and they do have decisions that would help make this process even better. We are here today for the right reasons. I would advise the gentleman from Massachusetts (Mr. McGovern) that I do not have any further speakers, and I reserve the balance of my time pending his close.

Mr. SESSIONS. Mr. Speaker, I yield myself such time as I may consume. I want to thank the gentleman from Massachusetts. I want to thank the gentlewoman from Florida and the gentlewoman from Texas for their comments about trying to focus us on the activities that perhaps they would want or not want. Mr. Speaker, today we are here because Chairman Frelinghuysen and Ranking Member Lowey came to the Rules Committee yesterday and asked us to please consider the offer that they were laying on the table, and that is to fund the government for 1 more week, with an assurance that they needed 1 more week to complete their work. You heard the gentleman, the Honorable Tom Cole, distinguished gentleman from not only Oklahoma, but a gentleman from the Appropriations Committee, reinforce how important the work is. We have heard from our colleagues on the Democratic side how important the NIH is, Francis Collins, the work that he does there; the United States Military; Secretary of Defense Mattis; the men and women that protect us; those people that are in Homeland Security. That is what we are going to do, so that is what we are going to focus on, and that is just the way it is. So, Mr. Speaker, I would urge all my colleagues to support this rule and the underlying legislation. I yield back the balance of my time, and I move the previous question on the resolution. The previous question was ordered.

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

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, this morning, the Rules Committee issued an announcement outlining the amendment process for H.R. 1180, the Working Families Flexibility Act of 2017, which will likely be before the Rules Committee next week. An amendment deadline has been set for Monday, May 1, at 10 a.m. The text of the bill is available on the Rules Committee website. Feel free to contact me or my staff if you have any questions.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, I move that the House do now adjourn.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, I send to the desk a privileged concurrent resolution and ask for its immediate consideration.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, I ask unanimous consent when the House adjourns today, it shall adjourn to meet at 11 a.m. on Saturday, April 8, 2017, unless it sooner has received a message from the Senate transmitting its concurrence in House Concurrent Resolution 48, in which case the House shall stand adjourned pursuant to that concurrent resolution.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, pursuant to the order of the House of today, I move that the House do now adjourn.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, together with Congressman Eric Swalwell, we rise today to thank Acting Commissioner of the Food and Drug Administration (FDA), Dr. Stephen M. Ostroff, and his team for their efforts to assist Congress and the Administration in improving patient enrollment, retention, minority participation and equitable access in cancer clinical trials, especially among underserved and underrepresented populations. Patient participation is the single most critical ingredient to successful cancer trials being completed on time and on budget as well as bringing life-saving cancer drugs to market. Unfortunately, most cancer clinical trials only provide for the cost of the trial drug and require the patient to cover all other costs affiliated with participation including but not limited to travel, lodging, and ancillary medical costs. The result of this has been abysmally low cancer participation rates. Overall, only 6 percent of eligible cancer patients participate in clinical trials and a mere 5 percent of those participants represent the Black, Hispanic, Asian, Native American and Pacific Islander populations combined. According to Tufts Research, 38 percent of all clinical trials fail to finish on time or within budget due to lack of enrollment, and an astonishing 11 percent of trials fail to ever enroll a single patient, primarily due to the financial burden on patients to participate. Joined by over a dozen of our colleagues from both sides of the aisle, we sent a letter to the FDA regarding possible misperceptions surrounding the regulatory meaning of inducement and coercion and asked for its assistance in providing clarity. The FDA's letter in response we include in the Record today, helps provide this needed clarity, explaining that reimbursement is neither inducement, coercion, nor even a so-called ``benefit'' but rather fair compensation creating parity and equality in cancer trial access. The letter also states the FDA's commitment to further addressing our concerns when it finalizes guidance on this issue. Accordingly, we, along with our colleagues, will continue our dialogue with national stakeholders, patient advocacy organizations, the pharmaceutical industry, and the Administration to continue to improve patient enrollment, retention, minority participation and equitable access in cancer clinical trials, especially among underserved and underrepresented patients. U.S. Food & Drug Administration, Silver Spring, MD, March 22, 2017. Hon. Pete Sessions, House of Representatives, Washington, DC. Dear Mr. Sessions: Thank you for the discussion on September 21, 2016, with Dr. Robert Califf, the former Commissioner of the U.S. Food and Drug Administration (FDA or the Agency) and Dr. Richard Pazdur, regarding the improvement of patient participation, enrollment, retention, and equitable access to oncology clinical trials. In a follow-up letter dated October 6, 2016, you asked the Agency to confirm that it views reimbursement for travel expenses to and from clinical trial sites, including reimbursement for travel costs such as parking and lodging, as permissible and suggested that such reimbursement should not be construed as coercion or inducement. As discussed with you on September 21, 2016, FDA generally would not consider reimbursement for such expenses to be undue influence or coercion intended to induce participation in a clinical trial. FDA has stated in the past that it is not uncommon for subjects to be paid for their participation in research, and has provided guidance on how those payments should be addressed during Institutional Review Board (IRB) review of a proposed clinical tria1. When appropriate, the informed consent would identify any additional costs to the participant that may result from participation in the research and whether such expenses would be reimbursed. In July 2014, FDA issued a draft guidance entitled, ``Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors,'' which provides recommendations on informed consent content and the informed consent process. In this draft guidance, the issue of additional cost and payment to research participants is briefly addressed. For example, we recommend that, beyond the costs directly related to participation in the research, it may be appropriate to identify additional costs that the subject may incur. Additional costs may include the loss of income when the subject takes time off from work to participate in the clinical investigation and transportation costs. The consent form would also make clear whether and, if so, how funds for reimbursement will be made available to subjects, or the form would provide direction to subjects regarding how to obtain further information. The draft guidance also states that FDA considers payment to subjects for participation in clinical investigations to be compensation for expenses and inconveniences, not a benefit of participation in research and that if payments are provided, the consent process should not identify them as benefits. Further guidance on when payments to research participants may be considered coercive or an exercise of undue influence is available on FDA's webpage ``Payment to Research Subjects--Information Sheet.'' As we finalize the draft guidance, we will look for ways to address your concerns about reimbursement of these types of expenses so that the final guidance will be more useful to patients and our stakeholders. We will also take advantage of our educational outreach activities to clarify this issue with the research community. Thank you again for bringing this important issue to our attention. Please let us know if you have any further questions. Sincerely, Stephen M. Ostroff, M.D., Acting Commissioner of Food and Drugs.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, yesterday, the Rules Committee issued announcements outlining the amendment processes for two measures likely to come before the Rules Committee next week. An amendment deadline has been set for Monday, April 3, at 10 a.m., for the following measures: H.R. 1343, Encouraging Employee Ownership Act; and H.R. 1219, Supporting America's Innovators Act. The text of these measures is available on the Rules Committee website. Feel free to contact me or my staff if anyone has any questions.

Mr. SESSIONS

Mr. SESSIONS. Mr. Speaker, I yield 2 minutes to the gentleman from Alabama (Mr. Byrne), a distinguished member of the Rules Committee.

Mr. SESSIONS. Mr. Speaker, I yield 1 minute to the distinguished gentleman from Pasco, Washington (Mr. Newhouse), who is a member of the Rules Committee.

Mr. SESSIONS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 228 and ask for its immediate consideration.

Mr. SESSIONS. Mr. Speaker, I yield 5 minutes to the gentleman from Georgia (Mr. Woodall), who will be describing the third piece of this, and that is the putting together of the piece from the Budget Committee.

Mr. SESSIONS. Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Massachusetts (Mr. McGovern), my friend, 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. SESSIONS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks.

Mr. SESSIONS. Mr. Speaker, I rise in support of this rule and the underlying legislation. This rule is a fair rule that adequately provides both sides of the aisle with ample time to debate the merits of the underlying legislation. In fact, the Rules Committee thought it was so important that ample time be provided to this debate, that we are provided 4 hours of general debate on the underlying bill. Mr. Speaker, in honor of our former President, Ronald Reagan, I wear brown today. The former President, when he was President, believed that wearing brown was good luck to him and good luck for the things which he was undertaking. So, in honor of Ronald Reagan, I, too, wear my brown jacket today. Mr. Speaker, it has become abundantly clear that ObamaCare has failed the American people. Our Nation's healthcare system today is broken and only getting worse under the current law, known as the Affordable Care Act, or ObamaCare. Simply put, ObamaCare is collapsing, and it is collapsing fast. Options and choices are disappearing for consumers, and an anticompetitive marketplace has been created that firmly harms patients. How bad is it? Nearly one-third of all U.S. counties currently have only one insurer offering plans on their State's exchanges. That is a government-created monopoly, Mr. Speaker, and that kills the free market, meaning no choices for the American people and higher costs are what the American consumer and the healthcare market are finding. And it is only continuing to get worse. As more and more insurers leave the marketplace, prices will continue to rise, forcing healthy individuals to make economic decisions not to purchase health care, creating a self-defeating spiral of rising costs and less options. That is why we must act, and act today, which is what we are doing. It is no wonder that in such a government-controlled system that premiums have increased by an average of 25 percent on the ObamaCare exchanges this year alone. And it is no wonder that some 19.2 million taxpayers chose to outright pay the individual mandate penalty or claimed an exemption. What this means is that ObamaCare is not a good option to these 19.2 million people. Mr. Speaker, the American people, I believe, sent us to Washington, D.C., to fix this issue. They are telling us directly: this must be fixed now. And people certainly outside of Washington resent the Federal Government telling them how to purchase health care and what that healthcare marketplace would look like. But we really do not have to tolerate this. We do not have to agree that we will accept the status quo. Mr. Speaker, I believe the American people are smart. I believe the American people want independence, they love freedom, and they want to know that they can make their own choices, because they believe they make better choices than a one-size-fits-all plan out of Washington, D.C. What brings us here today, however, most assuredly, is a broken system. So, Republicans offer today H.R. 1628, the American Health Care Act of 2017, which will eliminate Washington's one-size-fits-all healthcare policy for the American people. It dismantles the disastrous ObamaCare taxes that are strangling the working middle class and diminishing America's economic prowess. We will end this with the opportunity to vote today to change the status quo. It eliminates the onerous employer and individual mandates. It prohibits health insurers from denying coverage and helps young adults access health care by getting back into the marketplace while stabilizing and restoring the free market opportunities for all Americans. Mr. Speaker, the American people are counting on Washington getting it right this time. What does getting it right mean? Getting it right means giving them the opportunity to exit a bad system and to have a better chance at a new system. This rule provides House Republicans with the opportunity to restore exactly that--a better healthcare plan to provide the middle class and low-income families who have been left behind on either side of the aisle, and it gives them an opportunity to have tax advantages in the employer marketplace. Mr. Speaker, today, we will be dissecting this into three separate areas. We will have Members of the Republican majority here to explain that and the bill. Mr. Speaker, I reserve the balance of my time.

Mr. SESSIONS. Mr. Speaker, I yield 10 minutes to the gentleman from Lewisville, Texas (Mr. Burgess), a distinguished member of the Rules Committee, a gentleman who sits on both the Energy and Commerce and the Rules Committee. He is quite literally the most knowledgeable person on health care in the United States Congress.

Mr. SESSIONS. Mr. Speaker, I yield myself such time as I may consume, and I thank the gentleman from Florida very much. In fact, the gentleman is correct. We had an opportunity to quote the Bible, Janis Joplin, and ZZ Top when we were doing our hearings. We had so much time with each other, and I enjoyed the hours and hours that we had to debate these essential items. But the other side of the story is essential health benefits are not being done away with. They are being transferred entirely to States. States have asked for the ability to manage their own money, and manage their own people's benefits of what would be required in the States. So in no way should a person take away, well, we just did away with it. In fact, we transferred the authority and the responsibility of essential health benefits to the States because Governors have been asking for this. Mr. Speaker, I want to take just a moment to explain what I believe is at the heart of the legislation and really, in reality, the key to fixing health care. It is the second part of this. We heard the gentleman from Lewisville, Texas, Dr. Burgess, speak about the Energy and Commerce portions. I now would like to take a minute to talk about the portions that come directly out of the Ways and Means Committee. The gentleman, Mr. Brady, from The Woodlands, Texas, today, spoke about many of these; but at the heart of it, 170 million Americans currently receive their health care through an employee-employer tax advantage or tax benefits, an untaxed benefit whereby people who have an employer who can provide their health care, it is not taxed-- pretaxed to the employee, allowing them to have a good healthcare system. Well, all the while, millions of Americans pay higher premiums out of their pockets in the individual market. Those are people that do not have an employer who is able to help them. So that is not fair. That does not help these people. What we are doing here is putting together an addition of, really, a great Republican idea; and it takes the important step to provide the same tax-free benefits for those employer-sponsored plans that we will give to regular employees, and it is called a tax credit. This tax credit is going to work because it allows every single American that does not receive the tax benefit at work to get it for themselves. Who is this? Well, quite honestly, it is small-business owners; it is low-income workers; it is entrepreneurs. It includes, really, a lot of real estate agents and people that work for a small business, maybe heating and air-conditioning systems like we have all across this country. It will give their families an opportunity. How much money? Well, we will provide them between $2,000 and $14,000 a year for their families to be able to have these opportunities to purchase a nongovernment healthcare plan, meaning that, as they would go to the marketplace, we are going to help these people through a tax credit available January 1, providing them with an opportunity to purchase health care on a benefit basis. Why is this important? It saves money because what it does, it creates two things: a family then has an insurance plan, including a healthcare component that goes to the hospitalization; and secondly, it gives them an opportunity to have their own doctor or healthcare plan that they choose. This is important because many of these people end up in the hospital in the most expensive kind of way we can provide health care: at the emergency room. So this gives these families parity in the marketplace. We believe that that is important and is another part of this Republican healthcare plan. Mr. Speaker, I reserve the balance of my time.

Mr. SESSIONS. Mr. Speaker, I yield 2 minutes to the gentleman from Oklahoma (Mr. Cole), the vice chairman of the Rules Committee.

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

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

Mr. SESSIONS. Mr. Speaker, we are going to keep moving on. We were allocated the same amount of time. I guess the answer would be no.