The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
“EXECUTIVE CALENDAR--Continued” mentioning the U.S. Dept. of Transportation was published in the Senate section on pages S2950-S2954 on May 16, 2017.
The Department handles nearly all infrastructure crisscrossing the country. Downsizing the Federal Government, a project aimed at lowering taxes and boosting federal efficiency, said the Department should be privatized to save money, reduce congestion and spur innovation.
The publication is reproduced in full below:
EXECUTIVE CALENDAR--Continued
The PRESIDING OFFICER. Under the previous order, the time until 5:15 p.m. will be equally divided in the usual form.
The Senator from Utah.
National Police Week
Mr. HATCH. Mr. President, peace and order are the indispensable pillars of a stable society. They grant us security in our daily lives, trust in our communities, and faith in our democratic institutions. Where peace and order reign, so too does society thrive and prosper, but none of that is possible without our Nation's 700,000 men and women in blue.
Each and every day, these brave sons and daughters--brave souls--
stand up for all of us. Each and every day, they stand guard, ready to do justice or risk harm--all on our behalf. So today I rise on behalf of a grateful Nation to recognize them. Their performance is exceptional, and their sacrifice is immense.
Far too often, we take our police officers for granted. Far too often, we forget how hard it is to win and how easy it is to lose the peace and order that we all enjoy, but our police officers never forget. They are always at the ready. As we honor them this week, we remember that the question is not ``What causes violence or what causes crime?'' but rather, ``What causes peace, and what causes security?''
The answer is our men and women in blue.
In celebration of our National Police Week, I wish to express my profound appreciation for our Nation's law enforcement community--the courageous men and women who each day put the safety of others before their own. Their success is impossible to fully measure. It cannot be counted in crime statistics or etched into medals. It can only be seen in the peace and order that their sacrifice makes possible.
Therefore, allow me for a moment to speak directly to our police officers.
Trust that your selflessness does not go unseen, that your service does not go unfelt, and that your sacrifice does not go unknown. We appreciate you, we support you, and we honor you. Law enforcement is among the noblest of professions. You are the brave guardians among us who fight for peace and protect the vulnerable from harm. On behalf of a grateful nation, I wish to thank you and your families for bearing the burden, shouldering the sacrifice, and making us all proud.
Let it be known that I proudly back the blue.
This is a critical moment to show the police our support. We live in a time when law enforcement officials are not only underappreciated but often maligned and, quite often, openly disparaged. Day in and day out, they suffer criticism and pressure. This week we let them know of our respect and admiration.
Today, I wish to express my gratitude for our men and women in uniform by sharing stories of their heroism. You see, we hear all about police mistakes, and we hear wall-to-wall coverage of the controversies, but we seldom hear about the acts of bravery and professionalism that distinguish our police officers as the finest in the world. In particular, I would like to relate the account of Utahns Bre and Kayli Lasley, two sisters whose lives were saved by an on-duty police officer.
In September 2015, a man armed with a knife climbed through a bedroom window in Bre and Kayli's Salt Lake City apartment. Once inside, he brutally beat both sisters before pulling out a knife and repeatedly stabbing Bre. Just as the attacker raised his knife to Bre's throat, Salt Lake City police officer Ben Hone charged into the room. He told the intruder to drop his knife.
In that critical moment, with lives literally hanging in the balance, Bre remembers:
That's when I saw the officer, and he was our angel . . . I looked at the officer in his eyes, and he was so professional and calm.
When the attacker refused to surrender his weapon, Officer Hone raised his service pistol and fired, killing the armed intruder and saving Bre's life. In that moment, Officer Hone was truly Bre's guardian angel.
She remembers:
When [we] made eye contact, I knew I was safe. It's a miracle that he had so much composure and was able to take that shot.
In recognition of his heroism, Officer Ben Hone was honored by the National Associations of Chiefs of Police and the American Police Hall of Fame as the 2015 Law Enforcement Officer of the Year. I think it was an honor richly deserved.
Officer Hone survived that day. For that, we give thanks, but the sad reality is that many lose their lives in the line of duty. So today I wish to honor those men and women who have made the ultimate sacrifice and paid the highest price that society can ask. Our debt to them will not--indeed, cannot--be repaid.
Among the fallen is Utah Highway Patrol Trooper Eric Ellsworth, who died only a few days after being struck by a car while on duty in Box Elder County. We also mourn the passing of West Valley City police officer Cody Brotherson and Greater Salt Lake Unified Police Department officer Douglas Barney, who were both killed in the line of duty this past year in Utah.
I express my deepest condolences to the families and friends of these brave heroes and the countless others who have experienced similar tragedies.
Although we cannot bring these officers back, we can honor their legacies by committing ourselves to supporting their brothers and sisters in uniform. To that end, I have introduced and cosponsored a number of bills this Congress that are meant to assist law enforcement as they serve our communities. These bills include the Rapid DNA Act, the Probation Officer Protection Act, and the Child Protection Improvements Act. Just yesterday, I joined Senator Coons in introducing the U.S. Marshals Service Hiring Improvement Act, which was named in honor of U.S. Marshals Service deputy Patrick T. Carothers, who was a 26-year veteran of the U.S. Marshals Service who died in the line of duty in Georgia in November 2016.
Last week, I was grateful to see the Senate Judiciary Committee favorably report my bipartisan bill--the Rapid DNA Act of 2017. This critical legislation, which has garnered support from the National Association of Police Organizations, the Fraternal Order of Police, and the National District Attorneys Association, updates the law and leverages advancements in rapid DNA technology to expedite analysis in the FBI's Combined DNA Index System. If enacted, this commonsense proposal will enable law enforcement to analyze DNA in record time, reducing backlogs in rape kits and keeping violent criminals off of our streets. By facilitating the use of rapid DNA technology, this bill will also help to exonerate those wrongly accused of crime.
The Rapid DNA Act has received strong support from U.S. Attorney General Sessions. During his confirmation hearing, Attorney General Sessions said:
Rapid DNA analysis is a hugely important issue for the whole American criminal justice system. It presents tremendous opportunities to solve crimes in an effective way and produce justice because it's the kind of thing that you can't fake or mislead, so I am very strongly in favor of it.''
In remarks before the Senate Judiciary Committee, former FBI Director James Comey said that the Rapid DNA Act ``will help us change the world in a very exciting way,'' and it ``will materially advance the safety of the people of the United States.''
Each time I talk to a police officer, I always hear nearly the same thing. They have no need for fanfare or fame. All they need is the public's support and the tools necessary to do the job. In commemoration of National Police Week, let's make sure to give them both. I encourage my colleagues to join me in passing these bills and in showing our heroes in blue the gratitude and admiration they deserve.
Tribute to Lieutenant General Christopher C. Bogdan
Mr. President, in addition to honoring our men and women who wear the police uniform, I wish to pay tribute to a seasoned leader who wears the military uniform--Lt. Gen. Christopher C. Bogdan. General Bogdan is the program executive officer of the F-35 Lightning II Joint Program Office. He is really a respected airman, a true patriot, and a dear friend.
Nearly singlehandedly, he salvaged the F-35 program from ruin, providing much needed leadership at a critical time in the development of this important weapons system. He will be retiring this June after more than three decades of dedicated and decorated service in the U.S. Air Force. On behalf of a grateful nation, I wish to thank General Bogdan for his leadership, service, and his sacrifice.
General Bogdan is an exceptional leader and a man of unwavering character and integrity. Several years ago, the general was given the daunting task of saving the F-35 program from the clutches of ``scandal and tragedy,'' as Senator McCain once so accurately described. During his tenure, General Bogdan overcame seemingly insurmountable obstacles to right the ship at the F-35 program office. Along the way, he demanded the highest performance from his own staff and industry partners to establish a corrective path forward.
I first met General Bogdan in October 2013, when I made a special visit to the F-35 program office in Arlington, VA. General Bogdan warmly greeted me before introducing me to all eight of the national deputies from the program's partner nations. I was so impressed to see all of them in uniform--these great heroes from all of these other nations that are dependent upon the United States and our F-35 program. The general spoke briefly about how important this weapons system was not only to our own national security but also to the collective defense of the program's partner nations--the United Kingdom, the Netherlands, Italy, Turkey, Canada, Australia, Norway, and Denmark, and, in the case of military sales, Israel and Japan. At that moment, I realized just how vital this cutting-edge platform was to the cause of freedom around the globe.
We then adjourned to General Bogdan's office, where he asked for my help in three areas that would be critical to bringing the F-35 to full operational capability: activating depot workloads, expanding the Utah Test and Training Range, and building infrastructure for the sustainment of F-35 software--one of the most complicated and the most highly scientifically run airplane in the world.
That day, I made a commitment to help General Bogdan. Years later, I am pleased to say that, in working together, we were successful in achieving all three objectives. In last year's National Defense Authorization Act, I offered an amendment to expand the Utah Test and Training Range by 40 percent, which is an increase of more than 1,000 square miles. With a little help from Congress, the depot activations at Hill Air Force Base progressed quickly, enabling the Air Force to station its first operational F-35 squadron at the base last August. In working alongside State leaders, I was also able to generate support for the construction of a software facility that will help sustain the F-35 for years to come.
Without General Bogdan's vision and strategic direction, none of these accomplishments would have been possible. It really is important. Utah is the only place over land where you had a big enough area where you could fly this immensely important F-35 and do the training that needed to be done--with live ordnance by the way.
A year after we met, General Bogdan cleared his schedule so he could accompany me on a visit to the F-35 production line in Fort Worth, TX. There, I witnessed the current production run of over 100 F-35s progressing through the assembly line--truly a sight to behold. As planes moved out of the assembly line, General Bogdan explained critical challenges at each stopping point. I wondered how one man could be so intimately involved in every minute detail of the plane's production, yet still have the capacity to lead at the highest levels. In that moment, I knew General Bogdan was the right man to be in the largest acquisition program the world has ever seen.
When General Bogdan first took the helm of the F-35 Joint Program Office, he walked into a hostile environment, knowing full well he would face constant scrutiny and tremendous political pressure from all sides. He knew he would have to answer for every decision he would make, but General Bogdan was more than up to the task. In his leadership of the F-35 Joint Program Office, General Bogdan embodied three core values of the U.S. Air Force: integrity first, service before self, and excellence in all they do.
Both in the Air Force and in his private life, General Bogdan is a model of commitment and sacrifice. As great as his service to our Nation, the Air Force, and the F-35 program has been, it pales in comparison to the dedication he has shown his lovely wife April and their two children, Amanda and Adam.
Our Nation is safer today thanks to General Bogdan's 34 years of distinguished military service. I would like to congratulate my friend on the Senate floor on a stellar Air Force career. I consider myself lucky to know General Bogdan and even luckier to call him a friend. I wish him and April the very best as they begin the next chapter of their lives.
This is a man for whom I have the utmost respect. I lost my brother in the Second World War. He was a flier on a B-24 in one of the Palestine oil raids. I have to say that General Bogdan reminds me of my brother and a lot of heroes I have met who have served this country so well. He is at the top of the list. I just think the world of him, I think the world of his family, and I wish him the absolute best.
I thank the Chair.
I yield the floor.
The PRESIDING OFFICER. The Senator from North Dakota.
National Police Week
Ms. HEITKAMP. Mr. President, I come to the floor this afternoon to honor the incredible men and women of our Nation's law enforcement agencies. Each year, peace officers from all over the country and from countries all over the world come to Washington, DC, to celebrate and remember the lives of their colleagues whom they have lost in the line of duty.
The men and women who serve as peace officers in our Tribal, Federal, State, and local law enforcement agencies selflessly put their lives before the lives of those whom they have taken an oath to protect and serve. I am here to not only remember those peace officers we have lost but to thank each and every officer who puts on a uniform and a badge every day to protect our citizens and our communities.
As a former attorney general of North Dakota, I have always had a special relationship and appreciation for law enforcement. Serving as the top law enforcement officer in my State will always be one of the most meaningful moments in my professional career. When I began serving as attorney general, law enforcement wasn't one of the goals I had. So I told my head of the Bureau of Criminal Investigation, a brilliant leader by the name of Bill Broer, that he could just deal with the law enforcement portion of the job, and I would take responsibility for the rest of the job.
Bill was going to have none of that, and consistently invited me along as he visited peace officers from all over the State, as we went to intel meetings, and as we talked about the challenges of equipping and staffing our law enforcement agencies. I can tell my colleagues that after 8 years of being North Dakota's attorney general, that portion of the job was the job I miss and love the most because I worked with the finest collection of peace officers in the country, and I could not be more proud to continue that work and work alongside of them as their U.S. Senator.
I am here to thank each and every one of the peace officers who selflessly serve in communities throughout North Dakota and to let you know I don't just appreciate the work you do and the sacrifices you and your family make each and every day, but I also have your back, 24/7, 365 days a year.
I also come to the floor with a heavy heart, as I have had to come to the floor twice already in less than a year, to honor North Dakota peace officers who have lost their lives in the line of duty.
We lost Officer Jason Moszer of the Fargo Police Department on February 11, 2016. Less than a year later, we lost Rolette County Deputy Colt Allery on January 18, 2017. I say ``we'' because the loss of these fine, young peace officers was felt across the entire State of North Dakota, and it still impacts their families, their departments, and our communities to this day.
Both of these young men made the ultimate sacrifice in service to their State and their communities, each succumbing to gunshot wounds inflicted by individuals who were prepared to inflict even more damage and take more lives. The brave actions of these two peace officers prevented that from happening.
Officer Jason Moszer's name was etched into the Peace Officer Memorial here in Washington, DC, this week, and his name was read out loud during a ceremony this past weekend honoring all the officers who died in the line of duty last year and whose names have been added to the wall.
Officer Moszer's name will now serve as an example not just to North Dakotans but to people from all over this country and all around the world who visit the memorial each year. He will serve as an example of the best our State and country has to offer, an example of what it truly means to have lived and died so others may be safe; quite simply, an example for everyone of what it means to be a hero.
We must also remember the families of our peace officers that sacrifice so much, not knowing if their loved ones will return each time they walk out the door. I want to recognize Officer Moszer's family, his wife Rachel, his children Dillan and Jolee, his brother Brian, his sister Michelle, and especially his parents Dave and Karen, who care so much and have sacrificed so much and today suffer that loss with their community, but, more importantly, in private. So I know what Jason meant to you. I know what he means to you. He now belongs to the entire State of North Dakota. We will never forget his name or his sacrifice.
To the men and women of the Fargo Police Department, led by a great guy, Chief David Todd, I commend all of you for your courage and strength, for standing alongside the Moszers every step of the way. Jason's loss was your loss too. I stand in awe and appreciation of the job you do each and every day, and I thank you.
Next year, unfortunately, I will be coming to the floor again to honor Deputy Allery, as his name will be engraved on the memorial wall. My heart breaks about having to do this again, but I also consider it an incredible privilege to honor the very best of what we as a State and country have to offer.
To all of our peace officers, especially those back home in North Dakota, I thank you from the bottom of my heart for your sacrifice to the people of Fargo and the State of North Dakota.
I also want to mention that we walk by peace officers every day--
peace officers who have the responsibility of protecting the most iconic image of American democracy; that is, the U.S. Capitol and the buildings we serve in. They stand ready to take anything that walks through that door. Let me tell you, anyone who thinks that is an easy job--trying to anticipate, trying to pay attention, and trying to know how to treat our citizens with the utmost respect but also recognizing that every one of those people coming through the door at any of these gates, any of these doors, could be intent on doing damage to this institution and causing death among the people we work with every day--
it is an awesome responsibility and I think a responsibility that too often goes unattended and unrecognized and unappreciated.
I want to stand today and give a shout-out not only to the great peace officers of my State but the great peace officers who serve with us every day. Whether they are in border patrol and protection, whether they are in Customs and Border Protection, whether they are police officers at the parks, whether they are police officers serving all across these Federal agencies, whether it be ICE or the FBI, we should be proud of the work that they do. We should be standing with them in the work they do because their job is as important as our job, and that is to protect our country and protect our people.
So I want to say it is not enough to just stand here and recognize the heroes. If we really want to appreciate peace officers and peace officer week, and if we want to really honor peace officers, every day is a day that we say thank you. Every day we pass a uniform of a peace officer who is protecting us, we say thank you. We recognize their service, we recognize their sacrifice, and we recognize that all too often they are the only people who stand between us and chaos, who stand on that line and protect our country and protect our children and protect our citizens.
May God bless all of our peace officers and may God bless the United States of America.
I yield the floor.
The PRESIDING OFFICER. The Senator from Nevada.
Mr. HELLER. Mr. President, I, too, stand in honor of National Police Week. I want to thank my two previous colleagues from Utah and North Dakota for their heartfelt tributes to the men and women in blue and the hard work they do in protecting us every day.
National Police Week was established in Congress in 1962. National Police Week is an opportunity to pay tribute to law enforcement officers who have lost their lives in the line of duty. It is also an opportunity to recognize and thank the members of our law enforcement community in Nevada and throughout the country.
Each day our law enforcement officers put themselves at risk to protect our families and to protect our communities. Their courage, selflessness, and commitment to serve is a reflection of what makes this country so great; that is, their willingness to answer the call--
without being asked--to put the welfare of others over themselves.
This commitment doesn't come without tremendous sacrifice. I was reminded of that earlier this month at the 30th annual James D. Hoff Peace Officer Memorial in Reno.
The James Hoff Peace Officer Memorial is a tribute to Nevada law enforcement officers killed in the line of duty. The memorial also recognizes officers who were placed in danger and survived. Named after Reno Police Officer James Hoff, who was killed in 1979 by the suspects he was investigating, the memorial hosts an annual ceremony attended by State and local officials and members of the law enforcement community. It is always a privilege to attend this annual event honoring the heroism of fellow Nevadans whose names and legacies are enshrined in this memorial.
At this year's ceremony, we honored and celebrated the life of Detective Chad Parque, who served with the North Las Vegas Police Department for 10 years. At just 32 years old, Detective Parque tragically lost his life after his department vehicle was struck head-
on by another vehicle earlier this year. Detective Parque is survived by his wife, children, and siblings, and mourned by all of those who had the privilege to know him.
In describing Detective Parque, a fellow law enforcement officer said:
He was a ten-year officer and you could see the fire in his eyes as if he had just signed on. He loved his community.
He served with passion and dignity. He will never be forgotten for the many contributions to North Las Vegas and to our great State.
His plaque is now alongside other members of Nevada's law enforcement community who were enshrined on this memorial from past years and whose stories continue to inspire all of us.
In 2016, at least 144 law enforcement officers across this country lost their lives in the line of duty, a sharp increase from the previous year.
Let's not forget that behind the names--the many names--of those who have fallen are the people, spouses, children, and parents who may not have had a chance to say good-bye. Most of us will never know their pain, but we are deeply appreciative of their unwavering support for their community. While there is nothing we can do to bring back those who died in the line of duty, I am committed to doing everything I can at the Federal level to try to prevent it from happening to one more officer and one more family.
I am proud to support the Back the Blue Act, legislation that increases penalties for killing law enforcement officials. The bill ensures that anyone who purposely targets law enforcement should, and would, face justice for that crime.
The Nevada law enforcement community has my full support this Police Week--and every week and every day, each year they are on the job.
To all our law enforcement officials, we are all indebted to you and your families for all your sacrifices, and I am personally and sincerely grateful for your dedication to the people of Nevada.
To our protectors, our peacekeepers, and those who are first to answer the call for help and who run toward, not away, from danger, we thank you, and we honor you.
I yield the floor.
Mr. VAN HOLLEN. Mr. President, I oppose Jeffrey Rosen's nomination to be Deputy Secretary of the Department of Transportation. Mr. Rosen has a troubling history of standing with industry over consumers and opposing common sense public health and environmental protections.
In both his time as general counsel at the Department of Transportation in the George W. Bush administration and his private sector work on behalf of industry, Mr. Rosen advocated for limits on the agency's authority to protect health and safety through the regulatory process. In one case when he was at the Department of Transportation, the National Highway Transportation Safety Agency proposed a weak standard for the required strength of vehicle roofs, which could collapse in rollovers. In addition to the weak standard, the rule would make it difficult for consumers who had been in accidents to seek damages from the companies responsible.
Mr. Rosen has also repeatedly questioned the necessity of limiting carbon emissions from vehicles. He opposed efforts to improve fuel economy standards that have spurred innovation, cut pollution, and saved consumers at the pump.
Mr. Rosen's ideological approach to regulation appears bent on minimizing rulemaking at any costs, regardless of the need. He has advocated for one-in, one-out regulatory schemes and ``regulatory budgeting'' that place arbitrary limits that would interfere with the ability of agencies to implement the law.
Agency leadership must focus on their mission and use the best available science and data to guide implementation of the law. Based on Mr. Rosen's history, I am concerned that he may politicize rulemaking, so I must oppose his nomination today.
Mr. HELLER. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant bill clerk proceeded to call the roll.
Mr. ALEXANDER. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
User Fees
Mr. ALEXANDER. Mr. President, last year seems like a long time ago, but just 5 months ago, 94 Members of this body voted for a bill called the 21st Century Cures Act. Senate Majority Leader Mitch McConnell called it the most important legislation of the year. The Presiding Officer, the Senator from Ohio, had a major role in that legislation, especially the part having to do with opioids. This was legislation to spur research and development of cures, devices, and treatments for some of the most deadly and some of the most stubborn illnesses and diseases.
Dr. Frances Collins, head of the National Institutes of Health--which he calls the ``National Institutes of Hope''--last year offered what he called bold predictions about major advances that we could expect over the next decade with a sustained commitment to medical research. One prediction of Dr. Collins is that science will find ways to identify Alzheimer's before symptoms appear, as well as how to slow down or even prevent the disease. Another is that doctors could use the patient's own stem cells to rebuild his or her heart. An artificial pancreas will help diabetes patients by tracking blood glucose levels and by creating precise doses of insulin. He also predicts a Zika vaccine, a universal flu vaccine, and an HIV/AIDS vaccine in the next 10 years. To relieve suffering and deal with the epidemic of opioid addiction, Dr. Collins predicts new, nonaddictive pain treatments to manage pain.
The 21st Centuries Cures Act became a law last year and authorized 4.8 billion new dollars for medical research, on top of the support Congress already provides through the annual appropriations process. Because of bipartisan support, that was an extra $2 billion last year and an extra $2 billion this year. The way we add up money around here, over 10 years, that is $20 billion over 10 years last year and another
$20 billion this year, which includes the $4.8 billion authorized in the 21st Century Cures legislation, all for medical research.
The next step in our efforts to turn Dr. Collins' predictions into a reality and to help America's patients benefit from all the research we are helping support is to fund the Food and Drug Administration. The FDA, as we call it, is the agency responsible for making good on the promise of the 21st Centuries Cures Act to actually reach America's patients.
Before September 30 of this year, four different FDA user fee agreements need to be reauthorized. They need to be acted on by the Senate, by the House, and sent to the President of the United States. These user fees are paid by manufacturers of drugs and medical devices and account for $8 billion to $9 billion over 5 years and over a quarter of all FDA funding.
Last week, 21 of the 23 members of the Senate HELP Committee voted to send to the Senate floor a bill reauthorizing those four user fee agreements based on recommendations from industry and from the FDA after a thorough and lengthy public process.
The FDA Reauthorization Act, sponsored by me and by Senator Murray, the distinguished Senator from Washington who is the ranking Democrat on our Senate HELP Committee, reauthorizes the four user fee agreements that expire at the end of September. The four agreements are, No. 1, the prescription drug user fee, which accounted for 70 percent of the brand drug review budget last year; No. 2, medical device user fee amendments, which accounted for 36 percent of the medical device review budget in fiscal year 2016; the generic drug user fee amendments, which accounted for over 75 percent of the generic drug review budget in fiscal year 2016; and the biosimilar user fee amendments, which accounted for 29 percent of the biosimilar review budget in fiscal year 2016.
So here is my message to colleagues: The U.S. Senate has the opportunity to provide Americans with a prompt, bipartisan reauthorization of the Food and Drug Administration user fee agreements and, in doing so, take the next crucial step in helping Americans see the benefits of the results of our 21st Century Cures Act passed last year. If we do not move quickly to pass these agreements in late July, the FDA will be forced to send layoff notices to more than 5,000 FDA employees to notify them that they may lose their job in 60 days.
As I said, these reauthorizations are based on recommendations both from industry and from the Food and Drug Administration after a thorough public process. The FDA posted meeting minutes after every negotiation and held public meetings before discussions began and to hear feedback on the draft recommendations last fall.
Patients were also involved in developing commitment letters. We have received support from patient groups asking us to authorize the agreements expeditiously.
In Congress, over the last 15 months, the Senate HELP Committee, of which I am chairman and Senator Murray is the ranking Democrat, had 15 bipartisan briefings, some of which were with the Energy and Commerce Committee of the House of Representatives, and heard, as well, from the FDA and industry about the reauthorization.
Our HELP Committee held two bipartisan hearings earlier this year on the Food and Drug Administration medical device and drug user fees and released a discussion draft of our legislation on April 14, which provided 2 weeks for public comment.
I go into all this because I want everyone to see how thoroughly this has been discussed and how important it is.
The committee then worked in a bipartisan way to incorporate comments from the public and from members of the committee.
The manager's amendment--which we approved in the committee last week, as I said, by a vote of 21 to 2--includes many priorities that are broadly bipartisan. Here are a few examples: legislation from Senators Isakson and Bennet to improve the medical device inspection process; a provision from Senator Hassan, Democrat, and Senator Young, Republican, to improve communication about abuse-deterrent opioid products; from Senators Franken, Democrat, and Senator Enzi, Republican, a provision to encourage medical device development for children and make sure FDA has the appropriate expertise to review devices for children; from Senator Baldwin, a provision to make sure the full experience of clinical trial participants is studied; from Senator Burr and Senator Young, additional reporting to make sure that the FDA is meeting their goals and that we can do proper oversight of the new agreements. It includes legislation by Senators Casey, Franken, and Warren on a pilot project on studying medical devices after approval to make sure they work as intended. A provision from Senator Cassidy requiring additional guidance for complex generics, like EpiPens, so manufacturers know what they have to do to make a generic version, was also included. A provision to make new hearing aid technology available came from Senators Warren and Isakson, as well as a provision from Senators Roberts, Donnelly, and Burr to allow more appropriate classification of accessories used with medical devices.
In the committee markup last week, we unanimously adopted these bipartisan amendments, which follow: an amendment from Senator Collins, which reflected legislation from Senators Collins, Franken, McCaskill, and Cotton on improving generic drug development and helping to lower prescription drug costs; an amendment from Senators Hatch, Burr, and Casey to improve patient access to clinical trials.
A delay in reauthorizing these agreements would delay the review of drugs and devices submitted after last April 1--more than a month ago. If we don't pass these reauthorizations into law on time, which means by the end of July, an FDA reviewer who gets started reviewing a cancer drug submitted to the agency in April would be laid off on October 1, before the reviewer is able to finish his or her work. In addition to harming patients and harming families who rely on medical innovation, a delay in the reauthorization would threaten America's global leadership in biomedical innovation.
After reviewing the recommendations from industry and from the FDA, I am convinced these are good agreements for patients. The sooner we pass this legislation, the better, to give certainty to patients, doctors, FDA reviewers, and companies.
Mr. President, I yield the floor.
I suggest the absence of a quorum.
The PRESIDING OFFICER (Mr. Hoeven). The clerk will call the roll.
The assistant bill clerk proceeded to call the roll.
Mr. ALEXANDER. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________
