Floor Statements

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I ask for the yeas and nays.

Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Madam President, here is the scorecard on 557 Presidential nominations during the first 100 days of the Trump administration, through April 29. According to the Partnership for Public Service, in collaboration with the Washington Post, on Cabinet appointments, President Trump did his job, but Senate Democrats did not do their job. The President announced all of his Cabinet nominations before he was inaugurated on January 20, but Democrats delayed confirmation of Cabinet nominations more than those of any other recent President. On sub-Cabinet appointments, President Trump did not do his job. He was slower than any other recent President to send his nominations to the Senate.

So here is what could happen. If Democrats continue their delaying tactics, when President Trump does send sub-Cabinet nominees to the Senate, the President would have every excuse to stop nominating and simply appoint acting officials to about 350 of the remaining key positions.

An administration managed by acting Presidential appointees who have not been confirmed by the Senate would be a first in American history. Delaying the inevitable approval of nominations of a President you oppose might sound to your political base like good politics, but it would be supremely bad governing. Senate Democrats would actually diminish their influence and shoot themselves in both feet. They would be turning over to a President they don't like an excuse to staff the government with about 350 key appointees who are unconfirmed and unaccountable to the Senate. Now, this 350 number does not even include the Ambassadors in embassies all around the world, where there may be acting heads of the embassy.

Now, what difference would it make to have an administration mostly unexamined and unconfirmed by the Senate? Well, it would mean that the Senate would be giving the Executive more power at the expense of the legislative branch.

This undermines the checks and balances created by our Nation's Founders. Democrats complained that Republicans delayed some of President Obama's nominees, and that is true. In fact, that has always been true. My own nomination for U.S. Education Secretary in 1991 was delayed for 2 months by a Democratic Senator who put a hold on my nomination for unexplained reasons.

President Ford's nomination of Warren Rudman to the Interstate Commerce Commission in 1976 was blocked by Democratic New Hampshire Senator John Durkin.

The rest of the story is that Rudman eventually asked President Ford to withdraw the nomination, ran against Durkin, and defeated him in the next election. That is how Warren Rudman got to be a U.S. Senator. There is a better way to resolve differences between Senators and the President.

In December of 2015, President Obama seemed content to allow John King of New York to serve as his Acting Secretary of Education for the last year of President Obama's term. I told the President I thought it was inappropriate for a President to have an acting Cabinet member for so long and that, while I disagreed with Mr. King on many points, I urged him to nominate King and, if he did, I promised that I would hold a prompt hearing and see to it that he was confirmed.

President Obama nominated John King on February 11, 2016. John King was confirmed by the U.S. Senate on March 14, 2016. I disagreed with Secretary King often, but the Secretary was confirmed. He was confirmed by and accountable to the U.S. Senate, as he should have been and as our Constitution envisions.

All of President Trump's Cabinet nominees are now confirmed, but this is how long it took compared with his three immediate predecessors: All of President Trump's nominations were announced before his inauguration, but the Senate confirmed only two of those nominations on day one because Senate Democrats would not agree to any more than that. A third Cabinet nominee was confirmed on January 31st. To compare, by January 31st in prior administrations, President Obama had 10 nominees confirmed, and George W. Bush and Bill Clinton each had 13 confirmed.

Please keep in mind that it is impossible for Democratic Senators by themselves to defeat a Trump nominee. Confirmation requires only a majority voting to be present; that is usually 51 Senators. There are 52 Republican Senators and, in addition, Vice President Pence can vote in the case of a tie. There is no 60-vote filibuster available to block nominees because Democrats, when they were in the majority in 2013, changed Senate rules to eliminate the filibuster on nominations. So by their obstruction, Democrats are only delaying the inevitable, using various tactics to require the Senate to use nearly a week of floor time to approve even noncontroversial nominees.

We don't know how Democrats will treat President Trump's more than 350 remaining key nominees because the President has made so few of those. For example, I am chairman of the Health, Education, Labor, and Pensions Committee. Aside from the Cabinet secretaries who come to our committee, of the 557 key positions identified by the Washington Post, 35 of them within the Cabinet agencies require recommendations to the full Senate by the HELP committee. In the Department of Health and Human Services, we have eight. In the Department of Education, we have 14. In the Department of Labor, we have 13.

At the end of the first 100 days, April 29th, our committee had received just one sub-Cabinet nomination from the Trump administration--that of Dr. Scott Gottlieb for FDA commissioner. He was promptly confirmed on May 9th.

Compared with President Trump's one sub-Cabinet nomination sent to our committee in his first 100 days, President Obama made 13 sub- Cabinet nominations in his first 100 days, President George W. Bush made 10, and President Clinton made 14 to our committee.

There are actually nearly 700 more Presidential nominees requiring Senate confirmation who aren't considered key by the Washington Post analysis, so you can see this adds up to be a pretty big number of Presidential nominees whom we have a responsibility to consider and to confirm if we approve them.

Unfortunately, there are ominous signs about how Democrats will treat non-Cabinet nominees. As the Presiding Officer is especially aware, Democrats required the Senate to take nearly a week of floor time to consider the nomination of Iowa Governor Terry Branstad to serve as Ambassador to China. There was absolutely no excuse for this other than obstructionism.

Governor Branstad is the longest serving Governor in American history. He has a well-documented relationship with the Chinese President. He was one of the first appointees that the President announced. He was approved by a voice vote by the Senate Foreign Relations Committee, and ultimately approved by the full Senate earlier this week 82 to 13.

Yet, as a delaying tactic, Senate Democrats forced us to use nearly a week of our floor time to consider Governor Branstad. If Democrats treat other noncontroversial Ambassadors and sub-Cabinet members the same way they treated Governor Branstad, requiring nearly a week of Senate floor time to consider a nominee, then I think President Trump would almost certainly bypass the Senate and name hundreds of acting heads of sub-Cabinet departments. Under our Constitution, he may do that whenever he chooses. There are flexible limits on the time one may serve in an acting position, but if that time expires, the President can simply appoint someone else.

Hopefully, President Trump will speed up his nomination of sub- Cabinet members, and hopefully Democrats will return to the common practice of routine floor approval of Presidential nominations when the confirmation process has determined that the nominee deserves to be approved.

Our Founders created a system of government based on checks and balances of the three coequal branches of government. There has been much complaining recently about the rise of the executive branch at the expense of the legislative branch. Having an executive branch and embassies mostly staffed by acting personnel not confirmed by or accountable to the U.S. Senate undermines the principle of three coequal branches of government.

The President should want his team in place and should speed up recommending key nominees to the U.S. Senate. And Senators, especially those in the minority, should want to have a say in the vetting and accountability that come with the Senate confirmation process.

Mr. President, as in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of H.R. 375, which was received from the House.

Mr. President, I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table.

Mr. President, I am grateful that the Senate has approved that measure naming the Fred D. Thompson Federal Building and United States Courthouse in Nashville.

I stand at the desk of former Senator Thompson. This was a desk that Senator Howard Baker also had. I have the desk myself because Senator Thompson and I were inspired by Senator Baker to be involved in politics and government in our State and the House of Representatives-- our delegation.

I think Senator Carper and his committee all seem to think that it is very appropriate that the new Nashville courthouse be named for Senator Thompson. It gives me a great deal of pride and personal privilege to be able to ask for that to be done. I thank Congresswoman Blackburn in the House for her leadership and all the Members of the delegation and the Members of the Senate for their cooperation in this.

I thank the Presiding Officer.

I yield the floor.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

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.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, as in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 10, S. 419.

Mr. President, I ask unanimous consent that the Grassley substitute amendment at the desk be considered and agreed to; the bill, as amended, be considered read a third time and passed; and the motion to reconsider be considered made and laid upon the table.

Mr. President, as in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 74, S. 139.

Mr. President, I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table.

Mr. President, as in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 75, S. 583.

Mr. President, I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table.

Mr. President, as in legislative session, I ask unanimous consent that the Committee on the Judiciary be discharged from further consideration of S. 867 and the Senate proceed to its immediate consideration.

Mr. President, I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table.

Mr. President, as in legislative session, I ask unanimous consent that the Committee on the Judiciary be discharged from further consideration of S.J. Res. 22 and the Senate proceed to its immediate consideration.

I further ask unanimous consent that the joint resolution be considered read a third time and passed, the preamble be agreed to, and the motions to reconsider be considered made and laid upon the table with no intervening action or debate.

Mr. President, I suggest the absence of a quorum.

Mr. President, I congratulate the Senator from Ohio not just on his speech and his remarks but on his leadership on the opioid epidemic in our country and its progression into other areas. He speaks passionately about it publicly and privately to his colleagues, just as he did today at our lunch as we discussed healthcare. He was a leader last year when we passed the 21st Century Cures Act to try to move these medical miracles that we know are coming through the regulatory and investment process more rapidly and into medicine cabinets and doctors' offices.

Senator Portman and Senator Whitehouse and others, in a bipartisan way, worked to add at least $1 billion more funding for States to deal with opioids after they had passed the Comprehensive Addiction and Recovery Act earlier that year. So the opioid epidemic and the families who suffer from it have no more effective spokesman and advocate than the Senator from Ohio, and I am glad I had an opportunity to hear his remarks today.

Mr. President, I ask unanimous consent that the time until 4:30 be equally divided in the usual form; further, that all postcloture time on the Gottlieb nomination expire at 4:30 p.m. today; and that, if confirmed, the motion to reconsider be considered made and laid on the table, and the President be immediately notified of the Senate's action.

Mr. President, while the Senator from Ohio is here, one more word on opioids.

Dr. Francis Collins, the head of the National Institutes of Health, has testified before the Senate that in the next decade we could have-- we should have a discovery of a nonaddictive pain medicine.

I cannot think of anything that over the long run could deal more with opioid addiction than to find a substitute for opioids that wasn't addictive. So we have discussed that with the President, with the new head of the FDA--after today, Dr. Gottlieb, I hope--with Dr. Price, Senator Portman, and with others, and, hopefully, in a bipartisan way, we can lean forward into accelerating the discovery of a nonaddictive pain medicine, and we can make that contribution in this effort.

Mr. President, the Senate will vote shortly at 4:30 p.m. on the President's nomination of Scott Gottlieb to serve as Commissioner of the Food and Drug Administration. He is the right person to lead the FDA in this vital mission and move the agency forward so America's patients can benefit from the remarkable discoveries--one of which I was just discussing--that our Nation's researchers are working on.

Dr. Gottlieb has impressive qualifications from every perspective. He was a practicing physician and hospitalist for many years, received his medical degree at Mount Sinai School of Medicine and completed his residency there. He held three positions in the Department of Health and Human Services, including two at the FDA as Deputy Commissioner, from 2005 to 2007, and before that, in 2003 to 2004, as a senior adviser to Commissioner Mark McClellan, and as the FDA's Director of Medical Policy Development.

Dr. Gottlieb has studied health policy as a resident fellow at the American Enterprise Institute. He is a prolific writer and speaker on medical innovations. He has testified in front of Congress 18 times on a variety of issues, including the drug approval process, drug costs, drug shortages, importation, and healthcare reform.

Dr. Gottlieb is also a cancer survivor. He knows firsthand how medical treatments affect patients and their families.

Dr. Gottlieb, like others who were nominated by Presidents, has been through an exhaustive vetting process. The President announced the Gottlieb nomination on March 10. We received the nomination March 27. On April 5, Dr. Gottlieb testified for 2\1/2\ hours in our Senate HELP Committee. I offered Senators an opportunity to ask any questions they wished. Following his hearing, he answered 189 follow-up questions. If you count all the subquestions, it was 372 questions.

On April 27, our committee approved his nomination by a vote of 14 to 9, readying that nomination for consideration by the full Senate today.

On March 28, more than a month ago, the independent Office of Government Ethics concluded that Dr. Gottlieb ``is in compliance with applicable laws and regulations governing conflicts of interest.''

Let me read from the Office of Government Ethics' website about what that agency does. It says: ``OGE provides an independent review of the financial disclosure reports of candidates for Senate-confirmed nominees. OGE makes sure that these individuals have complied with the extensive requirements for financial disclosure under the Ethics in Government Act. OGE ensures compliance with financial disclosure requirements and assists in the resolution of potential conflicts of interest. It carefully evaluates nominees' financial disclosure reports and works with agency ethics officials to prepare individualized ethics agreements.''

The website continues: ``After confirming with the agency that there are no unresolved conflicts of interest, OGE then transmits the financial disclosure report, the ethics agreement, and a cover letter directly to the Senate.''

That all arrived at our committee on March 28. So that should answer any questions about whether Dr. Gottlieb has a conflict of interest because the independent agency Congress set up to resolve that question says he has none--or if he has any, he will resolve them according to an agreement with that office.

I believe Dr. Gottlieb will help to move the FDA forward so patients can benefit from the remarkable medical discoveries that researchers are working on. The FDA affects nearly every

single American and regulates about a quarter of all consumer spending in our country, over $4 trillion annually.

It is responsible for areas as diverse as prescription drugs for humans and animals, medical devices, biologics, dietary supplements, cosmetics, over-the-counter medications, food, and tobacco products. In addition to drugs and medical devices, the FDA is responsible for protecting our Nation's food supply and working to reduce the number of people who get sick from foodborne illnesses.

Some of my Democratic colleagues have expressed concern about Dr. Gottlieb's prior work with companies that are regulated by the Food and Drug Administration, but the fact is, it is not so unusual to have an FDA Commissioner who has consulted with the food and drug industry. Dr. Califf, the distinguished former FDA Commissioner under President Obama, consulted for many companies prior to his confirmation from the Senate. That didn't disqualify Dr. Califf. I supported him. So did 89 other Senators. He was confirmed 89 to 4.

I think we should recognize the obvious fact that it is a good idea to have people serving in government with some experience in the types of industries they are in charge of. The other day we confirmed a Secretary of Agriculture. I think it helps that he is a farmer and a veterinarian. We confirmed the Secretary of Commerce. I think it helps that he has some background in business. Some of the same people who are criticizing Dr. Gottlieb for having a background in working with companies that manufacture drugs criticized President Trump's Secretary of Education because she had never been on the payroll of the people she was about to be in charge of. So you can't have it both ways.

I believe Dr. Gottlieb's background in understanding how drugs are manufactured, how they can be manufactured safely, how they can be moved through the regulatory and investment process more rapidly is vitally important to the opportunity we have in America--more than we have ever had before--of finding these new medical miracles and putting them in our medicine cabinets and our doctors' offices.

Dr. Gottlieb has broad support from an array of patient, industry, and research organizations. The supporters include three former FDA Commissioners and President Obama's Administrator of the Centers for Medicare & Medicaid Services.

On Friday, I received a letter of support for Dr. Gottlieb from 10 State attorneys general who particularly praised the nominee as ``a leader in the fight against opioid abuse,'' the subject Senator Portman spoke on a moment ago.

Mr. President, I ask unanimous consent to have printed in the Record a list of 93 groups that support Dr. Gottlieb's nomination at the conclusion of my remarks.

Mr. President, here are a few examples of what some of these groups had to say.

Dr. Jeff Allen, the President and CEO of Friends of Cancer Research, said: ``Through his knowledge and experience, we have no doubt that Dr. Gottlieb will be the right person to ensure FDA keeps pace with science and innovation without sacrificing the safety and efficacy gold standard established by FDA.''

The Healthcare Leadership Council said: ``Dr. Gottlieb's qualifications to lead the FDA are extensive and indisputable. . . . Dr. Gottlieb has consistently demonstrated his vision for accelerated medical innovation in this country and greater patient access to the drugs and devices that improve lives.''

Dr. Mark McClellan, FDA Commissioner from 2002 to 2004, said: ``He's a very good nomination,'' adding ``he is very dedicated to finding better ways to protect and improve the health of the public, all of which are great prerequisites for FDA Commissioner.''

Andy Slavitt, who just stepped down as the Administrator of the Centers for Medicare & Medicaid Services under President Obama, said that Dr. Gottlieb is ``a very good choice.''

The FDA has always been important, but there never has been a more important time for this agency. It is responsible for making sure patients benefit from the promising research driven by significant funding Congress has given to medical research in last year's 21st Century Cures Act, which the majority leader called ``the most important legislation of the year.''

I don't want it to go unnoticed that last year Congress increased funding for the National Institutes of Health by $2 billion. Last week, Congress increased funding for the National Institutes of Health by another $2 billion. The 21st Century Cures Act, which Congress also passed last year, authorized a $4.8 billion increase in funding for the National Institutes of Health for President Obama's Precision Medicine Initiative and for the Cancer Moonshot the Vice President worked on. Speaker Ryan and Majority Leader McConnell, President Obama, Vice President Biden, all of us want to see these medical miracles move forward, and having competent leadership in the FDA is absolutely essential to that effort.

I am very excited about the prospect of having Dr. Gottlieb and Dr. Francis Collins, who is the head of the National Institutes of Health, at the head of these two lifesaving agencies, which are important to every single American family.

The reason 21st Century Cures is such an important bill is that it will drive forward this extraordinary research, and Dr. Collins talked about some of the discoveries that will be possible in the next decade. I mentioned the possibility of nonaddictive pain medicine. Dr. Collins said that we will also have hearts that will be rebuilt from our own stem cells. We will have a universal flu vaccine. Did you know that the flu kills between 12,000 and 56,000 Americans a year? There will be a universal flu vaccine. There will be an HIV/AIDS vaccine and an artificial pancreas for patients with diabetes who have spent decades injecting themselves with insulin. These are the discoveries that are just over the horizon, not to mention medicine that will identify Alzheimer's before there are symptoms and then slow the progression of the disease. Think of the grief it would save families and the billions it would save the country. We have invested in that.

We have competent leadership to be approved by the Senate today, in working with Dr. Collins and Dr. Price, who can make sure those dreams become a reality perhaps even more rapidly.

The FDA plays a key role in this. At the committee hearing, I asked Dr. Gottlieb about the subject Senator Portman and I just talked about. I asked him how the FDA can be forward-leaning in accelerating the finding of new nonaddictive pain medicines--the ultimate cure for the opioid epidemic. It is a heartbreaking issue that almost every Senator knows about. Dr. Gottlieb said that the opioid epidemic is ``having staggering human consequences.''

He also said:

I think it's the biggest crisis facing the agency. It's

going to require dramatic action by whoever steps into the

agency. I think it's going to require an all-of-the-above

approach that does include reevaluating the framework for how

we can develop alternatives to opioid drugs. I think it also

includes looking at device alternatives to opioid drugs and

looking at devices in the context of drugs.

Dr. Gottlieb's first order of business will be to work with us on the reauthorization of the FDA user fee agreements, which experts at the FDA told members of our HELP Committee at one of the two bipartisan hearings on the agreements, are integral to helping patients and continuing the implementation of the 21st Century Cures Act.

Before September 30, four different agreements need to be reauthorized. They fund $8 billion to $9 billion over the next 5 years, which is about a quarter of the Food and Drug Administration's budget. If we do not move quickly to pass these agreements in late July, the FDA will be forced, by law, to send layoff notices to more than 5,000 FDA employees and notify them that they may lose their jobs in 60 days.

A delay in reauthorizing these agreements would delay the reviews of drugs and devices that were submitted after April 1--1 month ago. For example, if we do not pass these user fee reauthorizations on time, an FDA reviewer who gets started in reviewing, say, a cancer drug that was submitted to the agency in April would be laid off on October 1, which would be before the reviewer is able to finish his or her work.

In addition to harming patients and families who rely on medical innovation, a delay in reauthorization would

threaten America's global leadership in biomedical innovation.

After reviewing the recommendations from industry and the FDA, I believe these are good agreements for patients. The sooner we pass the legislation, the better so as to give patients, doctors, FDA reviewers, and companies' certainty.

At this moment, Washington, DC, is not a very bipartisan town on many issues, but on this issue--the issue of user fees to support the Food and Drug Administration--it has been.

I compliment Senator Patty Murray and her staff. Senator Murray is the ranking Democrat on the HELP Committee. Our staffs have been working together for 15 months in a bipartisan way and working with the House of Representatives to try to make sure we can present to the full Senate our FDA user fee agreements. We have had two bipartisan hearings. Tomorrow, we have a markup at which we hope those agreements will be reported to the Senate floor.

The FDA has a vital and important mission, and I am confident Dr. Gottlieb is the right person to be leading the agency. We are fortunate that he is willing to serve. I look forward to the Senate's approving Dr. Gottlieb's confirmation this afternoon.

Mr. President, I yield the floor.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, the House of Representatives has just passed a bill that would make major changes in the Affordable Care Act by a vote of 217 to 213. I congratulate the House. The Senate will carefully review the House bill, and we will go to work on a Senate bill.

Here are my goals for a Senate bill. I don't pretend to speak for every Member of the Senate or even every Republican, but these are my goals for a bill we will fashion here.

No. 1, rescue the thousands of Tennesseans and millions of Americans who, under the Affordable Care Act, will be trapped in ObamaCare exchanges with few or zero options for health insurance in the year 2018 unless Congress acts.

My second goal is to lower premium costs. Premium costs have increased and, in some States, are going through the roof under the Affordable Care Act.

No. 3, gradually transfer to the states more flexibility in administering the Medicaid program and do that in such a way as to not pull the rug out from under those who rely on the Medicaid program.

No. 4, make sure those who have preexisting health conditions have access to health insurance. This is one thing in the Affordable Care Act that has strong support from just about everybody, including the President, that if you have a preexisting condition, you must have access to healthcare. We need to make sure that is still true in any bill we create in the Senate.

There is some urgency here because of what is happening in the individual market. When we say ``individual market,'' here is what we are talking about. Most Americans get their insurance either from the government or on the job. About 18 percent of Americans get their insurance through Medicare. We are not talking about Medicare today. The bill in the House or the bill we will create in the Senate does not affect Medicare.

About 60 percent of Americans get their insurance on the job and about 20 percent or so through Medicaid, and that leaves about 6 percent who go into an Obamacare market to buy it. Many of these Americans buy their insurance on marketplaces or exchanges created by the Affordable Care Act. We call those the ObamaCare exchanges. About 85 percent of those who buy their insurance on the exchanges have a government subsidy to help them buy the insurance.

As every day goes by, we hear and we are going to continue to hear about insurance companies pulling out of counties and States. Yesterday we heard that the only insurer left in Iowa is now likely to leave. That means more than 70,000 people on the exchanges will have no insurance to buy. Most of them will have subsidies from the government. So it is like thousands of people in Iowa have bus tickets in a town where no buses run.

That is what is happening right now because of the 2010 law that we call the Affordable Care Act. I know this all too well because 34,000 people in Knoxville, TN, my home area, are going to have subsidies in 2018 but no insurance to buy with their subsidies unless Congress acts. That is because of the 2010 law that we seek to change. In 2016, last year, 7 percent of counties in the United States had just one insurer offering plans on their Affordable Care Act exchanges. This year, 2017, that number jumped to 32 percent. In one in three counties in the United States, if you have a subsidy to buy insurance on the ObamaCare exchange, you had only one insurance company offering you insurance. Five entire States have only one insurer offering ACA plans in their entire State this year: Alabama, Alaska, Oklahoma, South Carolina, and Wyoming. That is because of the Affordable Care Act passed in 2010.

Unfortunately, every day we are going to be hearing not just about insurers leaving counties and States, but about the ones that remain because they are going to be charging sky-high premiums.

Premiums went up by as much as 62 percent this year in Tennessee and by 116 percent in Arizona. As the new rate increases are proposed to the States over the next few weeks and months, our constituents are going to be saying: What are you going to do about that? So there is an urgency, but we want to get it right.

So, again, here are my goals for the Senate bill we will write in the next few weeks:

No. 1, rescue--and ``rescue'' is not too strong a word--the millions of Americans across this country who are going to have few or zero insurance options in the year 2018 because of collapsing ObamaCare exchanges, unless Congress acts.

No. 2, lower premium rates because, in many States, premiums are going through the roof under the Affordable Care Act.

No. 3, gradually transfer to States more flexibility in managing their Medicaid programs. About 18 percent of Americans get their insurance on Medicaid. We will do so in a way that does not pull the rug out from under those who are currently served by Medicaid.

Finally, preexisting conditions--make sure Americans who have insurance for preexisting conditions continue to have access to it. If you are on Medicaid or if you are on Medicare or, in almost every case, if you get insurance on the job, you have insurance for preexisting conditions. Under the Affordable Care Act in 2010, there had to be insurance for people with preexisting conditions. We want to make sure that those Americans continue to have access if they have a preexisting condition.

We will move ahead with deliberate speed. We are doing that because the exchanges are collapsing, people could be without insurance, and premiums will go up if we don't act, but we want to get it right. There will be no artificial deadlines. We will carefully consider the legislation passed by the House. We will work together carefully to write our own bill. We will make sure we know what our bill costs when we vote on it. In fact, by law, we have to do that. We will get it right, and then we will vote. And hopefully, Mr. President, the end result will be significant improvements for most Americans, giving them more choices of health insurance at a lower cost, and do that by gradually transferring more decisions from Washington, DC, to the states and to individuals.

I yield the floor.

Mr. President, I suggest the absence of a quorum.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I ask for the yeas and nays.