Floor Statements

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

Madam Speaker, I rise today in support of the Fairness in Orphan Drug Exclusivity Act.

The Orphan Drug Act was enacted to incentivize the development of drugs for rare diseases by giving products that receive an orphan drug designation 7 years of market exclusivity, meaning a drug produced by another manufacturer that contains the same active ingredient to treat the same condition is barred from entering the market during this time.

One way a drug can receive an orphan designation and, subsequently, market exclusivity is by the manufacturer's demonstration that there is no reasonable expectation that the cost of developing the drug will be recovered. However, we have seen in recent years that some drug manufacturers, in an effort to block competitors from the market, have tried to take advantage of a loophole in the law. Existing law allows an orphan drug designation and market exclusivity to carry forward to future versions of the same drug without requiring the manufacturer to demonstrate that the drug has not been, and remains unlikely to be, profitable.

This legislation will close that loophole, requiring manufacturers to show there is no reasonable expectation that the cost of research and development will be covered for each successor drug, while still preserving incentives for orphan drug development.

We must preserve incentives to innovate while preventing bad actors from exploiting those incentives to benefit from a national crisis, as we saw during the opioid epidemic.

While no drug currently benefits from market exclusivity awarded through this mechanism, I remain concerned about including language that allows for the retroactive revocation of an incentive through legislation.

Legislation that sets a precedent of revoking a benefit awarded prior to enactment creates a slippery slope and could chill innovation if adopted elsewhere in statute. While this bill itself is narrowly tailored, we do not want uncertainty caused by Congress retroactively legislating to discourage truly innovative drugs from coming to the

market, especially for the rare disease community.

However, I will support this bill as it moves forward today as I believe it is important to prevent the abuse of this program in the future. I look forward to continuing discussions to come to a resolution on this outstanding concern as we work with the Senate to get this bill to the President's desk.

Madam Speaker, I reserve the balance of my time.

Madam Speaker, I yield myself such time as I may consume for the purpose of closing.

Madam Speaker, it is so important that we have the Orphan Drug Act. We have so many people who have rare diseases come to our offices and visit us on Capitol Hill, as they should. Hopefully we will be able to do that again soon. It just touches your heart. Many of these diseases have so few people affected by it; but if it is you or your child or somebody in your family, it is devastating.

We have all seen the power of the private marketplace to come in and produce these pharmaceuticals that make a difference. So we have to have provisions to allow these drugs to come into the marketplace and incentivize that private innovation moving forward.

But when people use that in order to move forward, this loophole has to be closed. I am glad that it is here, and it is these things that we need to work on. It is really not specifically here; it is just maybe a slippery slope in other places as we move forward.

I thank my friend from Pennsylvania for bringing this forward, and the Energy and Commerce Committee for addressing this, because we have to preserve orphan drug status for those afflicted by the rarest and the most devastating diseases. We also need to bring lower drug prices to Americans, and we can do that working together.

Madam Speaker, I appreciate this being brought forward. I urge my colleagues to support this piece of legislation, and I yield back the balance of my time.

Madam Speaker, on that I demand the yeas and nays.

Madam Speaker, I rise today very concerned about the deadly threat of fentanyl and fentanyl analogues.

Last week, the Committee on Energy and Commerce held a hearing on this exact issue.

Here are the facts: More than 88,000 overdose deaths were reported by the CDC in a 12-month period ending in August of 2020. This is a record for the highest number of overdose deaths ever recorded in a year.

In 2018, synthetic opioids, which includes these dangerous fentanyl analogues, were involved in 744 deaths in just Kentucky. I learned from a substance use healthcare provider in my district that almost all their patients have some sort of fentanyl in their system. Many of the patients are not aware of it themselves. Just last month a 2-year-old in Kentucky died from exposure to fentanyl; therefore, I support a permanent solution of scheduling fentanyl analogues.

Last week, some of my colleagues--and we had witnesses--tried to argue that a long-term solution for banning fentanyl is a social justice issue. In fact, one witness shared, ``it is being argued that fentanyl class scheduling is suddenly unnecessary because of the low number of prosecutions to date--eight. However, eight mandatory minimum sentences in 3 years, four of them being members of a cartel, proves that prosecutors are not going after low-level users.

The witness also argued that this scheduling of fentanyl analogues-- the decrease of new fentanyl analogues coming to this country was 90 percent.

If someone is being unjustly prosecuted for fentanyl analogues, then that should be addressed.

However, not scheduling fentanyl analogues, when we had a witness testify it drops 90 percent being imported, would be deadly for Americans since fentanyl and its analogues are responsible for thousands of deaths each year.

Mr. Speaker, sadly, Kerry McDaniel passed away in February at just 65 years of age from COVID-19 complications.

Kerry was described as ``can't be replaced,'' ``top-notch in every regard,'' and ``an exemplary model of generosity and selflessness.''

Kerry loved serving his community and did so in various positions throughout the years. For almost three decades, Kerry worked for the Kentucky Department for Environmental Protection, and most recently, he was the Hart County Emergency Management Director and Solid Waste Coordinator.

As a frontline responder, he worked hard to obtain personal protective equipment and protect Hart County from COVID-19. Throughout the county, Kerry was known for his service and generosity to others.

Kerry is survived by his dear wife, Vicki; his son, Curtis; his daughter-in-law, Tara; his grandson, Briar Allen, and many other family members he loved so dearly.

Mr. Speaker, I am proud to have known Kerry; he was an exemplary citizen. Kerry was a great friend, and he will be missed by all who knew him.

Madam Speaker, I rise today to recognize Brad Richardson for his 10 years of service as the President and CEO of the Hardin County Chamber of Commerce.

Since 2011, he has worked in his leadership role to promote economic development, advance businesses, and grow the local economy in Hardin County. Brad played a fundamental role in establishing the Knox Regional Development Alliance (KRDA), and in 2017, he was given the Ft. Knox Gold Neighbor Award for his work in bringing together Fort Knox and nearby communities. He also invested in the next generation of local talent through the Youth Leadership Hardin County and Leadership Hardin County programs.

I want to thank Brad for his work in the Hardin County community.

Madam Speaker, I rise today due to my strong concerns with the Democrats' COVID-19 bill. With a very small percentage of this massive package specifically directed at combating COVID-19, the $1.9 trillion COVID bill is more of a Democratic wish list.

I have tried to add relief for healthcare providers, with funds specifically for rural and Medicaid providers, but Democrats voted this down.

It is amazing how it is okay to have the Silicon Valley subway, the Seaway bridge in New York, and a bailout of multiemployer pension plans from problems prior to COVID-19, but my amendment to help healthcare providers was not included.

I was proud to support the last five COVID-19 relief packages to help Kentuckians. I think we can all agree that we need to boost vaccine distribution, safely return all students back to in-person learning, and help people return to work. Much of the funds in this partisan bill will not be used until next year or later.

Madam Speaker, I urge my colleagues to oppose this bill.

Madam Speaker, this week, we had a hero lie in honor in the dome of the United States Capitol.

United States Capitol Police Officer Brian Sicknick gave his life to protect the U.S. Capitol, one of our greatest symbols of democracy. I had the opportunity to pay my respects to Officer Sicknick in the Capitol rotunda, which is safe and secure because of his sacrifice and also the bravery of his fellow Capitol Police officers and other law enforcement.

I am devastated by the loss of Officer Sicknick, and I want to provide my deepest condolences to Officer Sicknick's family and fellow officers.

I want each and every Capitol Police officer to know that I am grateful and appreciative of their work here that they do each and every day to protect democracy and all who work here, and they protect all of our constituents who visit.

Mr. Speaker, I thank the gentleman from Oklahoma for yielding.

All of us just still are speechless about what happened last Wednesday. It is just amazing that it happened here, and I condemn it in the utmost words as a violent act against the Capitol Building. We must find those who did it, and we must prosecute them to the fullest extent of the law.

Every time I travel to Washington, the first thing I look for, as I did today, is if I could see it from my airplane window or if I could see it driving across the Potomac, the dome. I always feel pride that the people of the Second District of Kentucky, Mr. Speaker, allow me to serve under the dome.

When I got here today, it is still here. It is still standing. It is still the beacon throughout the world. It is bruised, but it is there. It is something that we all hold dear.

The protection of this building, that dome, this building, the office buildings but, most importantly, the people who work here, not those of us who are just elected to be here but those of us who work here and in service, I have faces I have talked to tonight on the floor that--I was not on the floor when it happened, but I knew the faces of the people who were, not just my colleagues, but those standing at the doors here tonight, Mr. Speaker, who have been through so much.

We can't let this happen again. If we defeat the PQ, the amendment my friend from Oklahoma has is a bipartisan commission to examine the circumstances and the attack, as well as its aftermath.

It will be modeled after 9/11 Commission to reduce duplication and increase communication and info-sharing between relevant government entities and law enforcement. The goal is to investigate, find the facts, and deliver reports so this can never happen again, and so we can better protect the Capitol complex and, most importantly, the employees that work here, serving our great country. We will protect them moving forward.

We all want answers, and this is the most prudent step at this time. We will follow wherever the facts lead us and take appropriate actions in response.

I urge the defeat of the PQ and the adoption of the amendment.

Madam Speaker, I rise today to honor the life and service of Wilson Spencer ``W.S.'' Everett of Glasgow, Kentucky. Mr. Everett was a proud patriot throughout his life, serving in the Kentucky National Guard and the United States Army during the Korean War.

For the last 30 years, Mr. Everett dedicated his time to honor the legacies of his fellow soldiers, whether through his involvement with the Glasgow chapter of the Disabled American Veterans, or his regular participation with the Chapter 20 Color Guard. Mr. Everett also designed two memorials in my district: the Hiseville Veterans Memorial and the Glasgow-Barren County Veterans Wall of Honor. His dedication to this endeavor was so great that even in his final days, Mr. Everett went to the Wall of Honor to install the final veteran's title.

Today, I join with Mr. Everett's family in remembering the legacy that he left behind. He is truly an American patriot that strived to live his life in honor of each fold of the flag and I am grateful for his service not only to the country, but also to his community.

Madam Speaker, I rise today to recognize the service of longtime Kentuckian Mr. John Weeks and to wish him well in his retirement.

For over 40 years, John has provided legal counsel in the commonwealth of Kentucky be it to the Courier Journal daily newspaper, WHAS TV and radio, Standard Gravure, Blue Cross and Blue Shield of Kentucky, and--since 1992--Delta Dental of Kentucky. In 2000, he became Vice President and General Counsel and in that capacity has been responsible for legal affairs and legal compliance including insurance regulation, HIPAA, employment law, federal requirements, and government relations for the company at both the state and federal level.

Prior to his successful legal career, John served this great county in the United States Navy submarine and intelligence branches. And continued to help other veterans--serving on the board of the Kentucky chapter of USA Cares, a veterans support organization.

I was able to work directly with John from time to time and enjoyed getting to know him and his family well. I'm sure he is looking forward to spending more time with his wife, Lynda, and their children and grandchildren. I would like to formally congratulate John on his retirement and wish him luck in this next chapter.

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

Mr. Speaker, I rise today in support of H.R. 3253, the Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019.

This legislation will extend the Money Follows the Person program through 2024. This important program provides resources to State Medicaid programs to help individuals with chronic conditions and disabilities transition from institutions back into local communities if they choose to do so.

Money Follows the Person offers a choice for individuals who often have very limited options. This program allows the person to choose where they would like to receive their care.

This legislation will also extend the Spousal Impoverishment program through 2024.

H.R. 3253 will also extend the Excellence in Mental Health demonstration for 2 years. The Excellence Act is designed to increase Americans' access to community health in substance use treatment services.

In addition, this bill will clarify the authority of State Medicaid fraud and abuse control units. This clarification will give these important units the authority to investigate and prosecute abuse and neglect of Medicaid beneficiaries in noninstitutional settings, as well as broaden the permissible use of Federal Medicaid fraud and abuse control units to screen complaints or reports alleging potential abuse or neglect of Medicaid beneficiaries.

I have enjoyed working with my colleague from Michigan, my friend, Mrs. Dingell, and the hard work that she has put into this program, both this Congress and the previous Congress, to move this forward.

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

Mr. Speaker, I yield 3 minutes to the gentleman from Michigan (Mr. Walberg).

Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr. Walden), the Republican leader of the Energy and Commerce Committee and my good friend.

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

Mr. Speaker, in closing, I thank Chairman Pallone, Republican leader Walden, and the Energy and Commerce Committee staff for their hard work to help this bipartisan package come together.

Mr. Speaker, I also thank my colleague, Congresswoman Debbie Dingell, for working with me on extending Medicaid Follows the Person. I also thank my colleagues, Representative Matsui, Representative Eshoo, Representative Welch, and Representative Walberg, for their hard work on this package.

Mr. Speaker, I urge my colleagues to support this bill, and I yield back the balance of my time.

Madam Speaker, I rise today to recognize World War II veteran Alvin H. Perry, of Wilmore, Kentucky, who will receive the Legion of Honor Medal from France this week on the 75th anniversary of the D-Day Landings. The Legion of Honor Medal is the highest honor presented by France for military service to the French people.

Pfc. Perry served in the 331st Infantry Regiment, 83rd Infantry Division. He fought in the Battle of Normandy from June 18, 1944, to July 19, 1944, when he was wounded and captured by enemy forces. He has been awarded the Prisoner of War Medal, the Purple Heart Medal, the Good Conduct Medal, and the WWII Victory Medal for his valiant service.

Pfc. Perry truly represents the greatest generation, answering the call to defend freedom and to liberate Europe from Nazi control. I am incredibly grateful for his service. I can think of no one more deserving of this prestigious honor.

Mr. Chairman, I rise today in opposition to H.R. 987, the supposed Strengthening Health Care and Lowering Prescription Drug Costs Act.

I wish I wasn't giving this speech. As many of my colleagues know, I have a bipartisan track record here in the House. I have been proud to work with many of my Democrat colleagues on a number of issues that impact Kentuckians and people across the country, such as Alzheimer's, the opioid crisis, and workforce development.

Last Congress, I had 10 bipartisan bills signed into law, and I had two additional bipartisan bills pass the House. I hope my colleagues on both sides of the aisle know that I take bipartisanship and our responsibility to get things done for our constituents very seriously. That is why I am extremely disappointed that I will have to vote against H.R. 987 today.

Wherever I go in my district, I hear from Kentuckians about how drug prices are simply too high. This an issue that affects everyone, and it is one of the few big issues these days that Republicans and Democrats can all agree on. And President Trump has made this a priority.

As ranking member of the Oversight and Investigations Subcommittee, I have launched, with Chair Diana DeGette from Colorado, an investigation on rising insulin prices.

I was proud to support bipartisan legislation in the Health Subcommittee and the full Energy and Commerce Committee. Sadly, Mr. Chairman, Democrats have loaded up what was previously a bipartisan drug pricing legislative bill with political land mines that they know we, as Republicans, will never support.

They made a bipartisan drug pricing bill into an ObamaCare bailout bill. They know that this bill is dead on arrival in the Senate and that President Trump will never sign it.

My colleagues are playing games to score cheap political points in the short term at the expense of Americans across the country who are paying too much at the pharmacy counter.

I urge my colleagues on the Democratic side not to make lowering drug prices another partisan fight. I am willing to work with any of my colleagues to fix this problem, and I urge all my colleagues to do the same.

Madam Speaker, I rise today to recognize Chief Jamie Land of Elizabethtown, Kentucky, for his retirement from the Elizabethtown Police Department. Chief Land

has honorably served in the Elizabethtown police force for over 21 years, and he will be missed when he retires at the end of this month.

Before joining the Elizabethtown Police Department in 1998, Chief Land served as a military policeman in the United States Marine Corps. Land's distinguished career at the department started as a patrol officer, and he has held many roles at the as he has risen through the ranks, including detective, a leader of the police department's special response team, patrol sergeant, and deputy chief of operations. Throughout his tenure with the Elizabethtown Police Department, Chief Land has dedicated himself to his community and proven himself to be a trusted leader.

I thank Chief Lind for his years of service to the Elizabethtown community. I wish Chief Land and his wife Brandi nothing but the best in his retirement.

Mr. Speaker, I rise today in support of H.R. 1503, the Orange Book Transparency Act of 2019.

The Food and Drug Administration's list of approved brand name therapeutic drug products, known as the Orange Book, plays an important role in drug development. H.R. 1503 will ensure the Orange Book continues to be effective and accurate by requiring drug companies to provide up-to-date information on patents that are relevant to each individual drug. It also directs the Government Accountability Office to study the impact of the patents being listed in the Orange Book.

Mr. Speaker, I thank Congresswoman Kelly from Illinois for her commitment to maintaining the value of the Orange Book to drug manufacturers, payers, providers, and patients. I appreciate her willingness to work together in a bipartisan manner, and I urge my colleagues to support H.R. 1503.

Mr. Speaker, pursuant to clause 1, rule I, I demand a vote on agreeing to the Speaker's approval of the Journal.

Mr. Speaker, I object to the vote on the ground that a quorum is not present and make the point of order that a quorum is not present.