Floor Statements

Mr. Speaker, I thank the gentleman for yielding, and I thank the gentleman for calling this Special Order hour to honor the life and legacy of his constituent, Barbara Pierce Bush, whom we lost last week. I am certainly proud to stand with my colleague from Texas to honor the life and the legacy of our former First Lady Barbara Bush.

From Rye, New York, to west Texas, to the West Wing, Mrs. Bush served her family and her country with integrity, strength, and grace. She, indeed, was a member of the Greatest Generation and spent her life in service to others.

It is incredible to reflect. She was only the second woman in our Nation's history to be both the wife and the mother of a United States President. Mrs. Bush joined Abigail Adams in an exclusive club of those who have advised our Nation's Chief Executives long before they reached the Oval Office.

In her capacity as First Lady, Mrs. Bush used her influence to enact positive change. Although her name was never on a ballot, the American people chose Mrs. Bush as a leader and as a role model.

Just yesterday, the Energy and Commerce Health Subcommittee marked up more than 50 bills that offer solutions to what is currently a significant crisis in our country dealing with deaths caused by opioids, a devastating epidemic that has touched literally every neighborhood in our Nation. Combating this crisis requires not only legislation, but compassion and understanding.

But years ago, in her work to help the most vulnerable, Mrs. Bush epitomized such compassion. I actually mentioned this at the start of yesterday's markup in committee. A significant part of Mrs. Bush's legacy will always be her simple embrace of a child with HIV/AIDS at a clinic at a time when the illness was not well understood and, I dare say, the illness was feared by most people in the country. This simple act, this simple embrace, to reach out and pick up a child at an HIV/ AIDS clinic, helped to destigmatize HIV/AIDS in American culture. It was a seemingly small, but a powerful, gesture in 1989.

Then Mrs. Bush paved the way for acceptance of patients with HIV/ AIDS, their families, and they were moved out of the shadows and could begin to look at treatment options. The world is vastly different today for the patient with HIV/AIDS because of that simple act of compassion evidenced by Mrs. Bush.

As Congress now considers how best to end the opioid crisis and other human dignity issues before us, I hope we can remember and follow Mrs. Bush's unwavering dedication to always do what is right.

I am certainly proud to join my fellow Texan from Houston honoring his constituent tonight and expressing our condolences to former President George H.W. Bush and the rest of the Bush family and celebrating the wonderful life of former First Lady Barbara Pierce Bush.

Mr. Speaker, I rise today to honor the life and legacy of Mark Chew, a pastor and public servant, who passed away on April 6, 2018. Rev. Dr. Mark Chew, Jr. committed much of his life to serving Denton in a variety of roles.

Though he was born in Mississippi, Reverend Chew grew deep North Texas roots. He attended Fred Moore High School in Denton and graduated from Booker T. Washington High School in Dallas before receiving an associate's degree from North Central Texas College, a bachelor's degree from Southern Bible Institute, and a Doctorate of Divinity from the International Bible School in Houston.

In 1967, Reverend Chew began his pastorate at Pleasant Grove Baptist Church. Throughout his half-century of pastoral ministry there, he oversaw the development of Outreach Ministry and Rays of Hope. Reverend Chew celebrated his 50-year pastoral anniversary in December 2017, a rare achievement.

Spurred by his love for the community, Reverend Chew served the people of Denton far beyond his local church. In 1981, he became the first African American elected to the Denton City Council, serving three full terms in the 1980s and two additional consecutive terms in the 1990s. In addition to serving as President of the Denton County NAACP for 8 years, Reverend Chew was an active member of the Lions Club, the Denton Public Utility Board of Directors, and the Camp Copass Board of Directors. He also was Chaplain at both Peoples Funeral Home and Texas Health Presbyterian Hospital Denton.

Reverend Chew has left a rich legacy of service to faith, family, and community. I extend my condolences to his wife of 38 years, Dr. Rose Marie Chew, their family, the members of Pleasant Grove Baptist Church, and all who knew him.

Mr. Speaker, the opioid epidemic has swept across the country impacting millions of Americans who lost loved ones to this preventable crisis. No community is immune.

Just as the President of the United States has said, this is, in fact, the crisis next door.

This is even more true in neighborhoods in north Texas where we are all too familiar with this fatal epidemic.

Overdose deaths from opioids have increased more than five times in the last 30 years, and it is estimated that more than 115 Americans die each and every day from opiate-related overdoses. There is no question that we must act to stop this crisis.

To that end, I am very grateful to the members of my committee, the Committee on Energy and Commerce. I am grateful to the chairman of the committee for participating in this hour.

Mr. Speaker, I yield to the gentleman from Oregon (Mr. Walden), who is the chairman of the Energy and Commerce Committee.

Mr. Speaker, I thank the chairman of the full committee for his participation in this hour tonight.

The chairman is correct; our committee has a history of working in a bipartisan fashion. This, obviously, is an illness that can strike regardless of political party or political persuasion; and in the interest of that theme, I am happy to yield to the gentleman from Texas (Mr. Gene Green), my counterpart, the ranking member on the Democratic side of the dais in the Energy and Commerce Committee and the Health Subcommittee.

Mr. Speaker, I thank the gentleman for his participation this evening.

Again, the problem is not likely to be solved by one political party or the other. It is going to require a collaborative approach. Opioid abuse can happen by access to dangerous drugs in a family member's medicine cabinet or by obtaining them illegally. The fight against this crisis is indeed a team effort, and we must evaluate it from all angles.

We must consider how opiate medications are produced and distributed, and we must look at how agencies track and respond to distribution discrepancies. We are required to take a hard look at how the medications are prescribed and dispensed, while addressing the disposal of unused medication. We need to look at the treatment for those who suffer from addictions and the future of pain medications.

It is also imperative that we address the access and enforcement of illicit drugs. We must work to stop the unfettered distribution of harmful drugs that flow into this country from outside our borders.

Earlier this year, I joined the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, in visiting the international mail facility at John F. Kennedy Airport in New York. This facility is one of nine in our country and acts as a barrier for these illicit and dangerous drugs being sent to America through the international mail. The Food and Drug Administration and the United States Customs and Border Patrol, together, work to identify and destroy dangerous substances hidden in pieces of mail, but more authority is needed to provide these agencies with tools to swiftly act and act more efficiently.

There are millions of suspicious packages full of illicit drugs and other contraband crossing our borders. Sometimes the FDA is powerless in its ability to destroy these harmful and illicit substances, sometimes they are required to send them back to the sender, and sometimes they will see a package recycled and brought back into this country for yet another try. That, Mr. Speaker, must end.

Now, as chairman of the Subcommittee on Health, I have already held three hearings and considered a total of 67 related opiate bills. Last October, we opened the doors of the subcommittee to any Member, not just of the subcommittee, not just of the full committee, but any Member of Congress who wanted to come and talk to us about problems they have seen in their district related to opiates, solutions that they may be considering or people in their communities might have asked them to consider.

We heard from well over 50 Members of Congress that day, and as a consequence of that Member involvement, we have distilled these 67 pieces of legislation. We have had three legislative hearings. We have heard from key members of the administration. We have heard from stakeholders who are at the forefront of our efforts to stem this epidemic.

We have evaluated this crisis from all fronts, from public health and prevention and intervention, law enforcement, education and recovery, and then finally, lastly, looking at the Medicaid and Medicare programs and the role that they may play. It is evident that this is a multifaceted problem and will require an all-hands-on-deck approach.

As a physician, I also understand and respect the importance of successfully treating and managing patients with chronic pain. One of the reasons that most of us went into the practice of medicine was to be of service. One of the highest callings is to ask to be worthy to serve the suffering. Opiates are an essential tool. We must respect the fatal and addictive properties that opiates possess, while also understanding the vital role that these medications play in the lives of individuals who are suffering from serious or chronic illness, such as cancer.

As we evaluate this complex issue, we must strike the right balance between necessary enforcement and patient safety. Unfortunately, there is no easy answer and there is no single party to blame.

We also know that Congress cannot fight this battle alone. We must all work to strengthen our commitment to overcome this scourge. With an average of more than 100 Americans dying

every day from opiate overdoses, we must be willing to ask hard questions and consider solutions.

At this time, I am pleased to yield to the gentleman from Mississippi (Mr. Harper), who is a member of the Health Subcommittee and also the chairman of the Energy Subcommittee on Oversight and Investigations and has led a number of our efforts in trying to control the opiate crisis.

Mr. Harper, thank you for joining us tonight.

Mr. Speaker, I thank the gentleman from Mississippi for participating in our Special Order tonight. I thank him for his leadership in the Subcommittee on Oversight and Investigations and the work that he has done to help control this crisis.

I now yield to the gentleman from Kentucky (Mr. Guthrie), vice chairman of the Health Subcommittee, for his observations.

Mr. Speaker, I thank the gentleman from Kentucky for his participation this evening.

Mr. Speaker, I yield to the gentleman from West Virginia (Mr. McKinley), the vice chairman of the Environment Subcommittee.

Mr. Speaker, I thank the gentleman from West Virginia for his comments.

Mr. Speaker, now I am pleased to yield to the gentleman from Michigan (Mr. Walberg).

Mr. Speaker, I thank the gentleman for his participation this evening. He brings some valuable insights, and I am always grateful to hear his perspective from the State of Michigan.

I now go way out West to California. Mr. Speaker, I yield to the gentlewoman from California (Mrs. Mimi Walters) for her thoughts on the crisis.

Mr. Speaker, I thank the gentlewoman for her participation in this evening's Special Order hour.

Mr. Speaker, it is now my great privilege to yield to the gentleman from Virginia (Mr. Griffith), the vice chairman of the Subcommittee on Oversight and Investigations in the Energy and Commerce Committee, certainly one of the most thoughtful Members of this body.

Mr. Speaker, I thank the gentleman for his participation.

As the gentleman was talking about, the fact that in his State and the surrounding States it is possible that, if there is not collaboration between State prescription monitoring programs, a doctor or a pharmacist would never know what other prescriptions might have been written for a patient.

Our committee actually has a history of working on this. Charlie Norwood, a Member of Congress from Georgia, 15 years ago came up with the National All Schedules Prescription Electronic Reporting Act, or NASPER. We have authorized NASPER several times. I am happy to say that, this year, in the omnibus bill, there actually was funding, for the first time, provided for the NASPER program. It is just a beginning.

Clearly, the need for this national reporting program is so critical. In a State like Texas, we are huge, where we don't even think about other States in Texas. But the crossing of State lines with this information can be extremely powerful and, in fact, it can be lifesaving.

Mr. Speaker, I thank the gentleman for bringing that up, and I thank him for the work that he is doing on the Oversight and Investigations Subcommittee, and I thank him for the work he is doing on the prevention of pill dumping.

Mr. Speaker, the fact that the opioid crisis is devastating our country and undermining our social structures and eroding our economic productivity is, every day, more and more tragic. But the good news, Mr. Speaker, is the current trends can be reversed. We are building on years of previous bipartisan efforts. We all know that our action is important to the families, to the communities, to our constituents, and to the patients impacted by the opioid epidemic.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, today I rise to recognize the 100th anniversary of the American Association of Oral and Maxillofacial Surgeons. Founded in 1918 by just 29 dentists as the American Society of Exodontists, the organization has now grown to include more than 9,000 members today.

Oral and maxillofacial surgery is the surgical arm of dentistry. According to the American Dental Association, this specialty includes the diagnosis, surgical, and adjunctive treatment of diseases, injuries, and defects involving both the functional and esthetic aspects of the hard and soft tissues of the oral and maxillofacial region.

These surgeons are a vital component of the medical profession. They practice in a variety of settings, including private clinical practice, ambulatory surgical centers, and hospitals. They also provide service in academia, the military, and the research industry. Many of these surgeons reside and provide critical patient care in my home state of Texas.

This year, the American Association of Oral and Maxillofacial Surgeons will host its 100th Annual Meet and Scientific Sessions and Exhibition. As the members gather in Chicago to consider ``Safety and Innovation for the Next Century,'' we also should reflect on the last 100 years of progress, led by this organization.

Today, I recognize the members of the American Association for Oral and Maxillofacial Surgeons for their work, and offer my support for their mission to assure excellence in patient care by advancing, promoting, and preserving the specialty of oral and maxillofacial surgery.

Mr. Speaker, I rise today to recognize the 100th anniversary of the American Association of Oral and Maxillofacial Surgeons. Founded in 1918 by 29 dentists, the organization has grown to include more than 9,000 members today.

Oral and maxillofacial surgery is the surgical arm of dentistry. These doctors are a critical component of the medical profession. They practice in a variety of settings, including private clinical practice, ambulatory surgery centers, and hospitals. They also provide service in academia, the military, and the research industry. Many of these surgeons reside and provide critical patient care in my home State of Texas.

Mr. Speaker, today, I recognize the members of the American Association of Oral and Maxillofacial Surgeons for their work, and I offer my support for their mission to ensure excellence in patient care by advancing, promoting, and preserving the specialty of oral and maxillofacial surgery.

Mr. Speaker, today I rise to honor the life of Mayor Hector F. Garcia. Mayor Garcia served the City of Watauga for more than 29 years. He passed away this year at the age of 78 after a lifetime of service to his community and our nation.

Mayor Garcia and his wife Wendy first moved to Watauga in 1968 to raise their family. In 1979, Mayor Garcia began his service as co-chair of Watauga's first charter commission. He was elected to the city council in 1980 and served until 1986. In 1994, he chaired the Zoning Board of Adjustment. Two years later, he was elected mayor of Watauga and served until 2002. After a brief hiatus, Mr. Garcia was elected for a second time as mayor in 2013 and served until his death.

In 1958, Mayor Garcia joined the U.S. Air Force and served our country for more than ten years. Following his service, he worked for General Dynamics, now Lockheed Martin, for more than 35 years. Initially hired as an aircraft assembler, he rose within the company, retiring from the the engineering and planning department.

A lifelong North Texan, Mayor Garcia selflessly served not only the City of Watauga, but

our entire community. He will be deeply missed. I extend my deepest condolences to his wife Wendy, their family, and all who knew him.

Mr. Speaker, today I rise to honor the life of Edward V. Smith, III, a dedicated North Texan who devoted his life to serving our community. In addition to many professional and charitable interests, Mr. Smith was a passionate alumnus of the University of North Texas, the former North Texas State College.

A fifth generation Texan, Mr. Smith maintained deep roots in the Dallas area. After graduating from North Dallas High School in 1955, he enrolled in then-North Texas State College. During Mr. Smith's time in college, he served as president of his class, attorney general of the student body, vice president of the student body, president of the Kappa Sigma Fraternity, and president of Blue Key. Even following graduation, he never stopped giving back to his beloved alma mater.

Mr. Smith generously volunteered his time and attention to serve as president of the University of North Texas Alumni Association, Chair of the UNT Foundation, Chair of the Professional Development Institute, and as a member of numerous committees. He served as membership chair for the State of Texas and as a Regent of the College. In recognition of this service, he was named a Distinguished Alumnus in 1992.

In addition to his charitable work for the University of North Texas, Mr. Smith exceled professionally as a Dallas attorney. After graduating from law school at Southern Methodist University, he began a long legal career. Mr. Smith served on many committees in the Dallas and Texas Bars, and he was awarded the lifetime achievement award from the probate sections of both the Dallas Bar and the State Bar of Texas. He also received the Professionalism Award from the Dallas Bar and the Texas Center for Legal Ethics.

Mr. Smith selflessly served his community as a member of the board of the United Way, Advisory Board member of both the Dallas Foundation and the Communities Foundation of Texas, and as Chairman of the Board of the Grace Foundation. A lifelong Presbyterian, he also served his church as a deacon, an elder and, for many years, as Clerk of the Session.

Mr. Smith has left a rich legacy of generosity, loyalty, and excellence. I extend condolences to his wife Nikki, their family, the University of North Texas community, and all who knew him.

Mr. Speaker, I rise today alongside my friend, Congressman Rick Crawford, to pay tribute to Johnie Mae Sittonen, a World War II veteran and Des Arc, Arkansas native who passed away in January of this year. Throughout her life, Johnie Mae Sittonen served her country, her Arkansas community, and her family selflessly.

Johnie Mae Sittonen was born in Biscoe, Arkansas in 1924. In 1942, she graduated from Des Arc High School as an exemplary student and enrolled at Arkansas State University. As a young woman, Johnie Mae was one of the great Americans who volunteered to serve our nation. She joined the U.S. Navy in 1944, at the height of World War II. During her service, she met and married Paul Sittonen. After several years in Massachusetts, she and her husband Paul returned to Des Arc in 1959 to raise their five children and run a family farm.

Johnie Mae Sittonen spent many years serving her Arkansas community. For more than 20 years, she worked in the Des Arc Schools as the cafeteria supervisor before retiring in 1986. A committed member of the First United Methodist Church in Des Arc, she taught Sunday School, sang in the choir, and served as an active member of United Methodist Women. She was a lifelong Democrat,

and served as both the Chair of the Prairie County Democratic Women's Group and as an active member of the Retired Teachers Association.

Johnie Mae Sittonen's hard work for those in her community did not go unnoticed. She was honored as the Outstanding Community Citizen in 1972 and the Des Arc High School Citizen of the Year in 1983, and later received Baptist Health's Amazing Sprit Award in 2006.

A member of the ``Greatest Generation,'' Johnie Mae Sittonen is an example of American excellence, servant-hearted kindness, and commitment to service. She will be deeply missed, not only by her family and loved ones, but also by the northeast Arkansas community she served throughout her life.

Mr. Speaker, I rise today to recognize the exemplary work of William ``Tom'' Tackett as he retires as Chief of Police for the Town of Argyle, TX on March 22, 2018. He has over 25 years of service at the Argyle Police Department and previously served his country in the U.S. Army as a Military Police Officer.

After his military service, Chief Tackett graduated from the Tarrant County College Police Academy and joined the Argyle Police Department in April 1992 as a part-time reserve police officer. He transitioned to a full-time police officer in March 1995 and rose through the ranks to become Chief of Police in April 2000. Not only is Chief Tackett the most tenured Chief to lead the Argyle Police Department, he is the longest tenured employee to serve the Town in its 55 year history. He is a licensed Master Peace Officer and holds Texas Commission on Law enforcement certifications for Instructor, Forensic Hypnosis and Special Investigator.

Chief Tackett also serves as the Town's Emergency Management Coordinator and is an amateur radio operator and active in the Denton County Amateur Radio Club. In addition to his professional work, he is a Master Mason, serving as past Master of Roanoke

Lodge 668, and he is a life member of the Moslah Shrine Circus and Legion Corps.

For more than two and a half decades, Chief Tackett has faithfully served and protected the citizens and businesses of Argyle, while holding himself and his staff to high ethical and professional standards as he has capably led the Police Department. I am deeply grateful for his service to the City of Argyle and North Texas and extend best wishes to Chief Tackett and his family upon his retirement.

Mr. Speaker, pursuant to House Resolution 787, I call up the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes, and ask for its immediate consideration in the House.

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 material on H.R. 5247.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, earlier this year, Members of Congress heard the President during his State of the Union Address make a specific promise to the American people that the passage of right-to-try legislation would occur. This afternoon, I am proud to stand with the President and the thousands of Americans with terminal illnesses, their families, and their friends, in passing this important bill in the House.

Since 2014, nearly three out of four States, including my home State of Texas, have passed a version of right-to-try laws. I am pleased that the House is again considering H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, so that terminally ill patients have a chance, or 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.

Over the course of the past decade, our Nation has achieved an unprecedented number of innovations and scientific breakthroughs. Through the contributions of researchers in academia and the private sector, Americans have more innovative treatments at their fingertips.

Despite these achievements, I still hear from patients with serious, life-threatening conditions, including my own constituents in north Texas, who are frustrated with what they see as regulatory barriers from trying new therapies when everything else has failed.

Mr. Speaker, 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, life- threatening conditions.

To my friends on the other side of the aisle, I have a simple question: Why do you not want to allow these patients to exercise their right to fight for their future?

It is worth mentioning that the bill before us today is a revised, more narrowly crafted version of the one that passed the Senate last August. Since that time, the Energy and Commerce Subcommittee on Health held a hearing in early October to consider the Senate bill, where Members heard from

the Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, about the agency's concerns. We also heard testimony from patients and groups that support and oppose right to try.

From then to just recently, our committee engaged in multistakeholder efforts to improve the original right-to-try bill, as passed by the Senate. It entailed numerous conversations with patients, advocates, the Administration, authors of the bill, and stakeholders on all sides of this complex topic.

The Food and Drug Administration was never left out of the discussion. In fact, the agency provided valuable input throughout the process and up until the introduction of H.R. 5247. The aim was to open the door to innovative, experimental drugs for terminally ill patients without necessarily compromising the vital work and the mission of the Food and Drug Administration.

The current compassionate use program at the Food and Drug Administration does make a good faith effort to help patients who do not qualify for clinical trials. But right to try would actually offer patients an alternative pathway to access eligible investigational drugs, so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.

Again, we have worked closely with the Food and Drug Administration to ensure that this new, alternative pathway does not hinder or conflict with the critically important oversight that the agency conducts.

Additionally, this bill protects patients from manufacturers mislabeling or misbranding drugs, requires sponsors and manufacturers to report adverse events to the Food and Drug Administration, and provides certain liability protections for parties participating in the new pathway.

Mr. Speaker, this alternative pathway would also be limited to individuals who are suffering from a disease or a condition where there is a reasonable likelihood of death within a matter of months or significant, reversible morbidity, and who have exhausted all FDA- approved treatment options.

Lastly, it is essential that we do not create additional hurdles in this process so that manufacturers in the drug approval process have the certainty that they need.

The revised right-to-try bill clearly states that the Secretary of the Department of Health and Human Services ``may not use a clinical outcome associated with the use of an eligible investigational drug . . . to delay or adversely affect the review or approval of such drug. . . . `'

After months of work and thoughtful discussions, this legislation is a positive step forward in our shared goal of improving care for America's patients. It strikes the proper balance between ensuring patient safety and granting access to new treatments.

The President outlined in his State of the Union Address that this was an important priority for the administration. In the words of our Vice President and former colleague, Mike Pence: ``It's about restoring hope and giving patients with life-threatening diseases a fighting chance.''

Mr. Speaker, for these reasons, I urge my colleagues in the House to vote in support of H.R. 5247, and I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Fitzpatrick), one of the authors of the bill.

Mr. Speaker, at this time, I am pleased to yield such time as he may consume to the gentleman from Oregon (Mr. Walden), the chairman of the full committee.

Mr. Speaker, I am pleased to yield 3 minutes to the gentleman from Virginia (Mr. Griffith), a valuable member of the Energy and Commerce Committee, the vice chairman of the Oversight and Investigations Subcommittee.

Mr. Speaker, I yield 4 minutes to the gentlewoman from Indiana (Mrs. Brooks), another valuable member of the Committee On Energy and Commerce and the Subcommittee on Health.

Mr. Speaker, I yield 3 minutes to the gentleman from Arizona (Mr. Biggs), one of the primary drivers on this legislation.

Mr. Speaker, I yield 3 minutes to the gentleman from Georgia (Mr. Allen).

Mr. Speaker, I yield 3 minutes to the gentleman from Tennessee (Mr. Roe), the chairman of the Committee on Veterans' Affairs.

Mr. Speaker, I will be closing.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, yesterday, during the rule debate on this bill, I outlined a case where the previous Speaker, Nancy Pelosi, provided the right to try for a patient, a Democratic donor, back in my home State of Texas. So, really, all we are asking today is that we give regular Americans, the forgotten men and women of this country, the same rights that the Speaker of the House provided to a Democratic donor back in October of 2008.

Yesterday I quoted from an article from the Dallas Morning News. I have a different but similar article today talking about the same case, talking about the individual who had a diagnosis of multiple myeloma.

There was a drug that perhaps would provide some hope. The individual was clearly terminal. This monoclonal antibody that was primarily used to treat multiple sclerosis might show some efficacy in treating the advanced form of multiple myeloma that this patient had. The drug had been through phase 1 clinical trials. The patient did not have time for the drug to go through phase 2 and phase 3 clinical trials.

The article says:

Enter Nancy Pelosi. Through means to which we have never

been privy, Ms. Pelosi got the FDA to give the manufacturer

the all-clear to give the drug to the patient. The patient

got the drug, the patient took the drug, but, unfortunately,

the patient died anyway, but his family remains grateful to

the Speaker for interceding on his behalf.

I don't doubt that they are.

Yesterday, I quoted the Dallas Morning News article where the patient's spouse said, somehow, Nancy Pelosi got it done.

Well, do you know what, Mr. Speaker? You shouldn't have to depend on the Speaker of the House to intercede on your behalf to get the FDA to get the manufacturer to make a drug available. If you are really up against a bad situation, wouldn't it be better if we provided everyone that same pathway?

That is what this bill does today. That is why the right-to-try legislation was advocated by the President of the United States. In fact, I think it was the only legislative priority that the President laid out during his State of the Union Address where he wanted to see Congress act.

So today, we are going to do that. Today, we are going to act. It is an important bill. I encourage my colleagues to vote in favor of it.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I claim the time in opposition to the motion to recommit.

Mr. Speaker, while well-intentioned, this motion to recommit falls short of providing vulnerable patients full access to experimental treatments.

Providing clarity on how negative side effects will be accounted for during drug approvals is helpful. Giving manufacturers, sponsors, physicians, hospitals, and clinical investigators certainty on liability protections is meaningful. Taken together, these improvements to the existing expanded access program could lead to enhanced manufacturer and sponsor participation and increased patient access.

But this would not provide an alternative pathway for patients who cannot get into a clinical trial and have been rejected from participation in the existing compassionate use program.

This bill before us today does provide an alternative pathway, one that strengthens patient protections with clearer informed consent and real-time adverse event reporting. This bill--the underlying bill--also makes certain that the FDA is notified when a patient receives an unapproved drug through the new alternative pathway to ensure proper oversight. These are significant patient protections.

With this motion to recommit, we have a choice. The underlying bill is the only choice that gives those patients in the greatest need of help access to investigational drugs, with their consent, even after they were rejected from participating in a clinical trial or expanded access.

Mr. Speaker, the choice is clear. We need to vote to expand patient access. We need to vote down the motion to recommit. We need to vote for the underlying bill.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 787 and ask for its immediate consideration.

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

Mr. Speaker, House Resolution 787 provides for the consideration of two important bills whose focus is to empower the people of this Nation by removing governmental obstacles standing in the way of life and prosperity in this country.

The first bill, H.R. 4566, the Alleviating Stress Test Burdens to Help Investors Act, is a bipartisan effort from the Committee on Financial Services under Chairman Jeb Hensarling, authored by the gentleman from Maine (Mr. Poliquin).

The second piece of legislation in today's rule, H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, authorizes the use of certain drugs to eligible patients who have been diagnosed with a stage of a disease or a condition for which there is a reasonable likelihood that death will occur in a matter of months.

The rule provides for 1 hour of debate for H.R. 4566, the Alleviating Stress Test Burdens to Help Investors Act, equally divided between the Chair and the ranking members of the Committee on Financial Services.

The rule makes one amendment in order, authored by the gentlewoman from California (Ms. Maxine Waters), the ranking member. Further, the rule provides for the consideration of one motion to recommit with or without instructions.

For H.R. 5247, the Right to Try Act of 2018, the rule provides for 1 hour of debate equally divided between the Chair

and the ranking member of the Committee on Energy and Commerce. Although no amendments to the bill were made in order, the rule does provide for one motion to recommit.

Mr. Speaker, before I speak about the substance of the two bills under consideration in the rule before us today, I do want to take a minute to honor our colleague and the Rules Committee's ranking member, Louise Slaughter, who passed away unexpectedly last week.

I have known Ranking Member Slaughter since I first joined Congress in 2003. We spent countless hours debating every issue one can imagine in the Rules Committee upstairs, often long into the night.

When I joined the Rules Committee in 2013, Ranking Member Slaughter was then the ranking member, but it was under her chairmanship where she ushered through the Affordable Care Act, where my largest memories reside. During the debate for the Affordable Care Act, I went up to H- 313, the Rules Committee hearing room, with 18 amendments under my arm, a small selection of the many ways I felt the law needed to be changed.

Certain that I would only be able to get through a small portion of those amendments before I was cut off, I began my testimony. To the chairwoman's credit, she let me go on and on and on, and despite my being convinced that she was going to gavel me down at any second, she allowed me to finish speaking on all 18 amendments.

Mr. Speaker, it wasn't until I actually became a member of the Rules Committee several years later that I discovered there is, in fact, no time limit for Members and witnesses to speak, much to the chagrin of many Members when we debate the National Defense Authorization Act.

Ranking Member Slaughter was always proud of her background as a microbiologist, and it served her well during her tenure in Congress, because, after all, we deal with, sometimes, almost miniscule, microscopic issues, so time as a microbiologist would be good preparation.

One moment where I was glad to be able to work with Ranking Member Slaughter was in 2007. This was right after the Democrats took control of the House. Ms. Slaughter had been pushing for years for legislation that would prohibit the discrimination of employees based on genetic information.

The legislation was forward leaning, long before companies offered DNA testing kits in every pharmacy of the country. And, in fact, it was former Speaker Newt Gingrich himself who brought this bill to my attention, the Genetic Information Nondiscrimination Act, which I was proud to support as it moved through the Energy and Commerce Committee and was eventually signed into law by President Bush.

I would also like to mention Don Sisson, the staff director for the minority on the Rules Committee. Don has been with the committee for years--even at one point working under Chairman Drier--and has been with the ranking member of the Rules Committee through many events in the past years, including the death of her own husband, who, in fact, often sat in the audience of the Rules Committee and joined Ms. Slaughter during our late-night Rules hearings.

Don is, indeed, a loyal staffer, himself hailing from Rochester, New York, and is a great example of how Ms. Slaughter's life and passing is affecting so many people. I do want to thank Don for his written remarks that were read into the record of the Rules Committee last night from the staff perspective on the passing of Ranking Member Slaughter.

Mr. Speaker, at this point, I would like to hold off making further comments on the legislation before us to allow others to speak.

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

Madam Speaker, I yield myself such time as I may consume.

Madam Speaker, it was indeed incredibly disappointing last week when our Democratic colleagues did not join us in supporting what was very carefully crafted right-to-try legislation.

The President came and talked to us at the beginning of February, and right to try was one of the issues that he highlighted there from the podium. So it should be to no one's great surprise that this House would indeed take up and work on that issue that the President himself highlighted. Right to try was the one piece of legislation that President Trump specifically promised to the American people in the State of the Union address.

Today, I want it to be known that I stand with the President. I stand with the thousands of Americans with terminal diseases and their families and their friends in getting this important bill passed.

Since 2014, 37 States, including my home State of Texas, have passed a version of a right-to-try law, and through a strong grassroots movement, they have accomplished that.

Today, the House is considering H.R. 5247, the Right to Try Act of 2018, which would improve access to experimental treatments for terminally ill patients and offer them a chance--a second chance, a third chance--at life.

Over the course of the last decade, our Nation has achieved unprecedented innovation and scientific breakthroughs. Thanks to researchers in our academic institutions and those working in the pharmaceutical and medical device industries, American patients have access to innovative treatments.

Regardless of these achievements, I hear from patients with serious life-threatening conditions, including my constituents from north Texas, who are frustrated with what they see as regulatory barriers from trying and experimenting with new therapies when every other avenue has failed.

It does seem we are at a crossroads when lifesaving treatments, while not yet approved, both exist and remain unavailable to patients.

As a physician, I understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for themselves or loved ones with a serious and life-threatening condition.

It is crucial to mention the multistakeholder efforts that have gone into improving the original right-to-try bill. Chairman Walden of the Energy and Commerce Committee led negotiations with the Commissioner of the United States Food and Drug Administration, Dr. Scott Gottlieb, and with other stakeholders to ensure that this legislation opens the door to innovative experimental drugs for these patients without necessarily compromising the vital work and the mission of the Food and Drug Administration. The product of those negotiations is a bill that strikes the proper balance between ensuring patient safety and granting access to these treatments.

I also want to mention that the Subcommittee on Health did have a hearing in this regard October 3. We heard from the Commissioner of the Food and Drug Administration during that hearing. We heard from a number of patient groups and stakeholders who felt that it was, in fact, in their best interest for us to advance legislation.

Currently, the Food and Drug Administration conducts an expanded access program aimed at helping patients who do not qualify for clinical trials to gain access to therapies that the agency has yet to approve. While this program makes a good faith effort to help those patients, right to try would create an alternative pathway for those individuals, allowing them to access eligible investigational drugs.

The fact is that individuals may not qualify for a clinical trial if they do not meet very specific patient inclusion criteria, which may include factors such as age, gender, type and stage of 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 where those academic clinical trial sites exist.

Most, if not all, of the patients with a terminal medical condition fall into one of these categories. This legislation allows those patients to participate in the alternative pathway so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill.

Again, we worked closely with the Food and Drug Administration to ensure that the new alternative pathway does not hinder or conflict with the critically important oversight that that agency conducts. While some people may have reservations about the safety of a new pathway, this bill protects patients from manufacturers mislabeling or misbranding drugs, requires sponsors and manufacturers to report adverse events to the Food and Drug Administration, and provides certain liability protections for parties participating in the new pathway. This alternative pathway would also be limited to individuals who have exhausted all FDA-approved treatment options.

Additionally, only certain investigational drugs are considered eligible under this legislation. In order to qualify, the drug must have completed a

phase one clinical trial, must have an active application, must be under active development or production by the manufacturer, and must not be the subject of a clinical hold.

Eligible patients include those suffering from a stage of a disease or condition for which there is reasonable likelihood that death will occur in a matter of months or that would result in significant irreversible morbidity that is likely to lead to premature death.

This revised right-to-try bill also provides certainty to manufacturers in the drug approval process. It is essential that we do not create additional hurdles in that process. The legislation clearly states that the Secretary of the Department of Health and Human Services ``may not use a clinical outcome associated with the use of an eligible investigational drug . . . to delay or adversely affect the review or approval of such drug.''

Since the Health Subcommittee first considered the right-to-try legislation, the bill has passed in the Senate, and we have had many conversations with patients, advocates, the administration, and stakeholders on all sides of this complex topic. That collaborative effort was necessary, and I am certainly grateful to all who participated in those discussions.

Madam Speaker, this represents months of hard work and thoughtful discussions and decisions. I believe this legislation is a positive step forward in our shared goal of improving care for American patients. Again, this was the one aspect of the President's State of the Union Address where he asked us specifically to act on this legislation.

For these reasons, I urge my colleagues to support the rule and the underlying bill.

Madam Speaker, I reserve the balance of my time.

Madam Speaker, I yield 3 minutes to the gentleman from Washington (Mr. Newhouse), who is a fellow member of the Rules Committee.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I include in the Record an article from The Dallas Morning News from 2010. The title of the article--and I am not going to read the whole thing--is: ``Pelosi Pulled Strings to Let Dying Dallas Lawyer Try Experimental Cancer Drug.''

[From the Dallas Morning News, 2010]

Pelosi Pulled Strings To Let Dying Dallas Lawyer Baron Try Experimental

Cancer Drug

(By Todd J. Gilman)

Washington.--Dallas' top Democratic donors will cut big

checks to share dinner later this month with House Speaker

Nancy Pelosi. Most will be motivated by a desire to protect

the party's congressional majority.

Lisa Blue will have an extra reason: to say thanks for

Pelosi's efforts when her husband, Fred Baron, was dying of

bone marrow cancer. His only option was an experimental drug

whose manufacturer refused to give permission to use it for

Baron's condition.

``He was a big fan of hers, and now I am as well,'' Blue

said.

Baron, the ``King of Toxic Torts,'' built a fortune suing

on behalf of asbestos victims. He died the week before

Election Day 2008 at age 61.

A prolific Democratic fundraiser, he served as finance

chief that year for his friend John Edwards, who also made

his fortune in court. Baron later acknowledged funneling

large sums to Edwards' mistress--a scandal that gave

ammunition to those who already despised trial lawyers.

But to Blue, first and foremost, Baron was a husband.

The tale she tells of his final weeks is not so different

than any widow might tell, except, of course, that the couple

had friends in especially high places--friends like Pelosi,

who will headline the Aug. 24 dinner to raise cash for the

Democratic Congressional Campaign Committee.

In 2002, Baron was diagnosed with multiple myeloma. By

October 2008, his doctors at the Mayo Clinic were telling him

he had just days to live.

They also offered a glimmer of hope. Over the years, the

couple had donated about $1 million to Mayo. The staff was

especially diligent, Blue said. They tested an arsenal of

drugs and finally discovered that Baron's cancer responded

surprisingly well, in the lab, to a drug called Tysabri.

Mayo had an ample supply, but the drug was--and still is--

approved only for treatment of multiple sclerosis and Crohn's

disease. The manufacturer, Biogen Idec, refused to give

permission, even under special ``compassionate use'' rules

that protect a drug-maker from a black mark in case of an

adverse outcome.

Biogen said it didn't want to jeopardize the drug's

availability to other patients. (The company did not respond

to a request for comment last week.)

``I told Mayo, `I'll sign anything, I'll release anything.

Just give him the drug,' '' Blue said.

Blue, also a top lawyer, began making calls. She started

with Lance Armstrong, the bicyclist and cancer survivor, whom

she had represented.

``I started going through Fred's Rolodex,'' she said. ``I

called every politician, every celebrity that I knew and just

begged them to help. . . . I must have made 200 calls.''

She called clinics in Canada, trying in vain to find

doctors willing to administer the drug without Biogen's OK.

She hired a lawyer and prepared to sue Mayo to force it to

dispense the drug. She even bought some Tysabri online from

Australia, intending to send stepson Andrew Baron to smuggle

it back, she said.

The younger Baron posted an open plea online to Biogen,

noting that Bill Clinton, Sens. John Kerry and Edward Kennedy

of Massachusetts, Sen. Tom Harkin of Iowa and even the head

of the Food and Drug Administration had urged the company to

reconsider.

``You talk about mental anguish,'' Blue recounted. ``Fred,

every day, would wake up and he said, `Am I going to get the

drug?' ''

Others were supportive, she said, but Pelosi ``put her

heart and soul'' into the cause, as did Harkin.

Somehow--Blue still isn't sure how--Pelosi cajoled the FDA

to find a legal justification that let Mayo administer the

drug, even without Biogen's consent.

``Nancy figured out a way,'' she said.

The drug beat back the cancer for a few days, but not

enough.

Blue has no illusion that a typical family could pull such

strings.

``There are so many cases like Fred's,'' she said. ``One

thing he taught me was politics matters. What a personal

experience for me to understand how politics matters.''

And no, she added, ``It's not fair that other people can't

pick up the phone and make the government give them a drug. .

. . It was just such an awakening about how the drug

companies have so much power.''

That's what she'll tell Pelosi over dinner.

Mr. Speaker, this article references events that occurred in 2008.

In 2002, this individual was diagnosed with multiple myeloma. By October of 2008, his doctors were telling him that

he had just days to live. They also offered a glimmer of hope. There was perhaps one chance of therapy. It was an unproven therapy that might, in fact, be helpful to him.

The family made inquiries, made entreaties, but they were not successful until they invoked the then-Speaker of the House, Nancy Pelosi, who actually helped this lawyer get access to this medication. Unfortunately, it was not successful. His disease spread to a point where the therapy was not helpful. But the family observed, ``Nancy figured out a way.''

How about that. The Speaker of the House figured out a way to get this medication to an individual who was dying of a disease, who obviously was very important--a large Democratic donor, and I get that.

But the Speaker of the House intervened because the clinic where he was being treated felt that they did not have the authority to give him the medication. The company that was manufacturing the medication did not feel that it was in anyone's best interest to give him the medication. But Nancy found a way.

Well, Mr. Speaker, today, we are going to find a way. The President asked us, and we are going to find a way for those millions of Americans who are asking for that same chance.

So today's rule provides for consideration of two important consumer- driven pieces of legislation:

H.R. 4566, by Mr. Poliquin, will help alleviate some of the regulations that were put in place under the Dodd-Frank Act.

H.R. 5247, the right-to-try bill which garnered a majority of bipartisan support last week, will give patients who have nowhere else to turn another option to fight the potentially fatal health conditions with which they have been diagnosed.

I do want to thank President Trump and Vice President Pence for their leadership on this issue and helping us understand here in this body how important it is to move forward with this patient-centered legislation.

I urge my colleagues to support today's rule and the two underlying pieces of legislation.

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

Mr. Speaker, I thank the chairman for yielding.

Mr. Speaker, just a little over a month ago, President Trump stood here at this podium behind me and told us: ``People who are terminally ill should not have to go from country to country to seek a cure.''

Along with President Trump, I want to give patients a chance right here at home.

A little over a year ago, this House passed the 21st Century Cures Act, made unprecedented acceleration of discoveries. Thanks to our researchers and our academic institutions, and those working in the pharmaceutical and medical device companies, Americans have access to more and more innovative treatments. However, I continue to hear from patients with serious life-threatening conditions, including my constituents in north Texas, who are frustrated with what they see as regulatory barriers from trying and experimenting with new therapies when everything else has failed.

When potentially lifesaving treatments exist but remain unavailable to patients, we have an opportunity to move past what has long been a dilemma towards delivering a hopeful message.

Since 2014, 38 States, including Texas, have passed a version of right-to-try laws.

I am pleased that the House of Representatives is considering right- to-try legislation that gives patients a chance at life by improving access to experimental treatments.

Mr. Speaker, a lot of people deserve thanks for getting this bill to us today, but, in particular, I want to thank the President of the United States, President Trump, and Vice President Pence for their leadership in this effort.

Mr. Speaker, I urge my fellow Members to support this bill.

Mr. Speaker, I rise today to pay tribute to Rodney Mitchell, associate dean of students at the University of North Texas in Denton, Texas. He tragically passed away February 26, following almost 30 years of affiliation to UNT first as a student and then as a cherished staff member.

Rodney was a UNT alumnus who earned his BA in Applied Arts and Sciences in 1996 and his MPA in 1999. A proud member of the Mean Green family, he was a life member of the UNT Alumni Association, a Mean Green football season ticket holder, and supporter of various student programs with his gifts to the university. The Residence Hall Association created the ``Rodney T. Mitchell Advocate of the Year'' award in honor of his service and leadership as the College Inn Hall Director and Residence Hall Association President.

After working for the City of Denton as the Assistant to the City Manager, he returned to UNT as a member of staff in 2001. He served as assistant director for academic development--Upward Bound program and as director of TRIO Upward Bound and student support services before becoming associate dean of students in 2013.

Throughout his time at UNT, it was clear that Rodney had an enormous heart for students. He assisted students through the SOS (Seeking Options and Solutions) Program, opened and grew the UNT Food Pantry, and oversaw various intervention programs to support student success. He made a significant impact as a part of the University and community he loved, touching thousands of lives as a generous, caring servant.

It was at UNT that Rodney met his wife Melanie. Together they served for many years at the Denton Church of Christ at Welch Street on the UNT campus and at the Singing Oaks Church of Christ.

Rodney was a kind and generous man, and the world is a lesser place with his departure. His servant heart is a shining example as we seek to treat others as we want to be treated. He is survived by Melanie, a current UNT employee, and his 13-year-old son, Hayden.

On behalf of the 26th Congressional District, I wish to extend condolences to Melanie, Hayden, Rodney's mother Joyce Mitchell, his father Marvel Mitchell, his brother Zachary Mackey and many other family members, as well as the entire UNT and Denton communities. Rodney will be remembered and loved forever by his family and a multitude of friends. I am grateful for the legacy he has left for the UNT and our North Texas community.

Mr. Speaker, I have a motion at the desk.

Mr. Speaker, I rise today to pay tribute to Tom McCoy, Ph.D., Vice President of Research and Innovation, as he retires from his position at the University of North Texas.

Dr. McCoy joined UNT from his role as Vice President for Research, Creativity and Technology Transfer at Montana State University in July 2013 where he had previously helped MSU reach Carnegie Tier One research status. In assuming the role at UNT, Dr. McCoy was charged with similar expansion of the university's growth, breadth and impact in research toward the Tier One status here in Texas. Ultimately, UNT was announced as reaching the classification in February 2016.

Additionally, Dr. McCoy ably led UNT's path forward with the development of the 2017-2022 Strategic Plan for Research which was approved by the President and submitted to the Texas Higher Education Coordinating Board. This was accomplished, along with continued efforts on organization and funding related to the four Institutes of Research Excellence; pursuit of partnerships involving the Army Research Lab and also Denton Municipal Electric; recruitment of targeted research faculty; review of grant management processes; and review and allocation of research facilities and related processes.

I have personally appreciated Dr. McCoy's direct involvement and assistance with the Annual Energy Efficiency Summit held each July at UNT's Discovery Park and the educational opportunity it affords the Constituents of the 26th Congressional District and the showcase it provides of UNT's facilities and research efforts. I wish both he and his wife Shari much happiness in their retirement plans. I have been honored to represent them during their time as residents in Texas.