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Congressional Record2017/08/03Senate | House | Extensions

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[Pages S4789-S4792]
From the Congressional Record Online through GPO




                           EXECUTIVE SESSION

                                 ______
                                 

                           EXECUTIVE CALENDAR

The PRESIDING OFFICER. Under the previous order, the Senate will proceed to executive session to consider the following nomination, which the clerk will report.

The legislative clerk read the nomination of Dan R. Brouillette, of Texas, to be Deputy Secretary of Energy.

The PRESIDING OFFICER. There will now be 15 minutes of debate equally divided in the usual form.

The Senator from Washington. FDA Reauthorization Bill

Mrs. MURRAY. Mr. President, I want to say I am really pleased we are moving forward on the FDA Reauthorization Act today. This is really a great example about how Congress can actually work together on health issues and compromise and solve challenges by putting patients and families first.

As my colleagues well know, these so-called user fee agreements are essential to supporting FDA's operation and mission. They allow FDA to meet the complex challenges of the 21st century technology and the movement toward precision medicine, and they help ensure that FDA upholds the gold standard of approval while evaluating new drugs and devices efficiently. Put simply, passing the FDA Reauthorization Act is absolutely necessary if Congress wants to advance safe, effective [[Page S4790]] and innovative medical products for patients and families across the country.

I would add, when we pass this reauthorization today, more than 5,000 employees at FDA will be able to continue their critical work without worry of interruption, employees that worked every day to protect the health and families and advance medical innovations to patients.

So I am really pleased to have worked alongside the chairman of our HELP Committee, the Senior Senator from Tennessee, and all of our colleagues on and off the committee to bring to the floor these finalized agreements.

They truly reflect years of negotiations between FDA and the industry, incorporate input from patient and consumer groups, and support some of our most urgent priorities: restructuring the generic drug user fees, building up the Biosimilars Program, making sure patients' perspectives are considered in drug and device development, and advancing many of the policies we passed as part of the 21st Century Cures Act.

In addition to those agreements, the FDA Reauthorization Act includes priorities and provisions from Members across the political spectrum, so I again want to thank Chairman Alexander and all my colleagues, in particular, Senators Casey, Franken, and Warren, on their work to improve medical device safety; Senators Hassan and Young on their provision to get better information to providers about opioids; Senators McCaskill, Franken, and Collins for their commitment to improving the generic drug market; and Senators Bennet, Van Hollen, and Rubio for their drive to get new medicine for kids with cancer.

I really want to thank my staff and Chairman Alexander's staff who worked so well together over months of hard work to get this done.

Mr. President, this bill advances several significant bipartisan priorities I am proud to support. As many know, the HELP Committee has a strong tradition of bipartisan success in these user fee agreements, and I am very proud to say we have kept it this way. I think this bill not only improves FDA, but it also shows that when we work together with a common goal, we can get things done and make progress.

I thank the chair and my partner, Senator Alexander.

I yield the floor.

The PRESIDING OFFICER. The Senator from Tennessee.

Mr. ALEXANDER. Mr. President, I see Senators Isakson and Tester are here. I think they want to make remarks before the vote.

Let me say a few words following up on Senator Murray, and then I will place the rest of my comments in the Record.

This is very important legislation. Last year, we passed the 21st Century Cures Act to move these modern medical miracles into medicine cabinets and doctors' offices more rapidly. This is funding that pays for one-quarter of the Food and Drug Administration, which has a critical role in approving the safety and effectiveness of drugs, treatments, and devices. As with most things in the Senate that actually are important and work well and get a result, a lot of hard work has gone into this.

It started 2 years ago with Republicans and Democrats; Senator Murray and I and our staffs working together with the House of Representatives at the same time, working with manufacturers, the FDA, many others, working out many differences of opinion. So now we are going to get to a result within a few minutes. We are probably going to adopt this by voice vote almost unanimously. Everyone will say that must have been easy. It wasn't that easy, but it is how work gets done in the U.S. Senate when we do it well.

I want to comment on our colleagues and the staff and the House of Representatives on what they have done. We will continue to focus our attention on the 21st Century Cures Act. A piece of legislation is not worth the paper it is printed on unless it is implemented properly, but this funding today, done in a timely way, says to the men and women who work at the Food and Drug Administration and to their leader, Dr. Gottlieb: We value what you do.

In the 21st Century Cures Act, we gave the Commissioner more authority to hire and pay talented people to work at FDA and approve these medical miracles that are coming. We are reauthorizing the user fees in a timely way so the FDA's work will not be interrupted.

I thank Senator Murray for the way she worked on this. This is typical of our committee when we work well, which we most always do.

I will make remarks in the Record concerning the staff. They are almost too numerous to mention. Senator Murray's staff, my staff, Chairman Walden's staff, Ranking Member Pallone's staff, Food and Drug Administration staff, Congressional Budget Office legislative counsel, and Senator McConnell's staff--they have all been critical to the success we are about to have today.

I would like to thank the staff who have been devoted to reauthorizing these important programs. Some of them have been working on this bill for over 2 years. I am deeply grateful to them. I have deep appreciation for their hard work, their ingenuity, and their skill in helping us come to this result. Without their hard work and tireless effort, we wouldn't have been able to pass this before the deadline, ensuring the FDA can continue its important mission.

On Senator Murray's exceptional staff, I would like to thank Evan Schatz, John Righter, Nick Bath, Andi Fristedt, and Remy Brim.

On my hard-working and dedicated staff, I would like to thank David Cleary, Lindsey Seidman, Allison Martin, Mary-Sumpter Lapinski, Grace Stuntz, Margaret Coulter, Curtis Vann, Lowell Schiller, Bobby McMillin, Liz Wolgemuth, Margaret Atkinson, Taylor Haulsee, Elizabeth Gibson, and Anthony Birch.

On Chairman Walden's staff, I would like to thank Ray Baum, Paul Edattel, and John Stone.

On Ranking Member Pallone's staff, I would like to thank Jeff Carroll, Tiffany Guarascio, and Kimberlee Trzeciak. I would also like to thank much of the hard-working staff from the Food and Drug Administration who provided great help in getting this bill completed and working out the user fee agreements in a timely manner. From legislative counsel from the House and Senate, I would like to thank Warren Burke, Michelle Vanek, Kim Tamber, and Katie Bonander.

From the Congressional Budget Office, I would like to thank Darren Young, Andrea Noda, Chad Chirico, Holly Harvey, Ellen Werble, and Rebecca Yip.

On Senator McConnell's staff, I would like to thank Scott Raab.

On Speaker Ryan's staff, I would like to thank Matt Hoffman.

Finally, I would like to thank all the patients, doctors, researchers, innovators, thought leaders, and experts who dedicated time and expertise to helping improve the legislation and supporting its approval.

To reiterate, today the Senate will take up and I expect it will pass the Food and Drug Administration Reauthorization Act of 2017 to speed cures and treatments into patients' medicine cabinets.

Last year, 94 Senators voted to pass 21st Century Cures and send $4.8-billion to spur medical research at the National Institutes of Health.

Leader McConnell called it the “most important piece of legislation” that year.

Today's passage of the FDA user fees will help ensure advancements in research supported by 21st Century Cures actually make it to patients who are waiting.

The Food and Drug Administration is the agency responsible for making sure promising research supported by 21st Century Cures can turn into lifesaving treatments and cures.

This legislation we will vote on today includes four FDA user fee agreements--which are set to expire on September 30--and will speed the agency's ability to review new prescription drugs, generic drugs, biosimilar drugs, and medical devices and bring those treatments and cures to patients more quickly.

This legislation will reauthorize the authority for the FDA to accept user fees--paid by manufacturers of drugs and medical devices--that account for $8 to $9 billion over 5 years and is over a quarter of all FDA funding.

The reauthorizations are based on recommendations from industry and FDA after a thorough public process. [[Page S4791]]

FDA posted meeting minutes after every negotiation and held public meetings before discussion began and to hear feedback on the draft recommendations last fall.

We began almost 2 years ago working in a bipartisan way to reauthorize and update the user fee agreements. We held 15 bipartisan Senate health committee briefings, including several with the House Energy and Commerce Committee.

In the Senate HELP Committee, we held two bipartisan hearings on these agreements--one in March and one in April of this year.

We heard from the FDA, witnesses representing the manufacturers of drugs and medical devices, and witnesses representing the patients who rely on the products they make.

Throughout this process, we have worked closely with the House. In April, the leaders of the Senate and House health committees released a discussion draft of bipartisan legislation to reauthorize and update the user-fee agreements and which reflected the recommendations sent to Congress by the FDA in January.

In May, the Senate HELP Committee overwhelmingly approved this legislation reauthorizing the user fees by a vote of 21 to 2. This also included over 20 provisions that were adopted in committee and were priorities for HELP members.

The bill includes provisions from Senators Isakson and Bennet to improve the medical device inspection process; Senators Hassan and Young to improve communication about abuse-deterrent opioid products; Senators Enzi and Franken to encourage medical device development for children and make sure FDA has appropriate expertise to review devices for children; Senators Roberts, Donnelly, and Burr to allow more appropriate classification of accessories used with medical devices; Senators Collins, Franken, McCaskill, and Cotton to improve generic drug development and help lower prescription drug costs; Senators Hatch, Bennet, Burr, and Casey to improve access to clinical trials for all patients; and Senators Bennet, Rubio, Van Hollen, and Gardner to increase the development of new drugs to treat pediatric cancers and other diseases.

The House passed this user fee legislation on July 12 by voice vote.

Now it is our turn to pass this bipartisan legislation that is integral to helping patients and families who rely on the lifesaving medical innovation that FDA is responsible for reviewing.

The goal of getting this to the President's desk is an important one. If we do not pass this legislation before the end of September, FDA will begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days.

If we do not pass this bill, a FDA reviewer who gets started reviewing a cancer drug submitted to the agency in April could be laid off before the reviewer is able to finish his or her work.

A delay in reauthorizing the user fees would not only harm patients and families who rely on medical innovation, but it would threaten biomedical industry jobs and jeopardize America's global leadership in biomedical innovation.

I am glad the Senate is taking the step of voting on this legislation today. I look forward to supporting this important bipartisan bill and sending it to the President's desk. I urge my colleagues to support it as well.

The PRESIDING OFFICER. The Senator from Georgia. Veterans Legislation

Mr. ISAKSON. Mr. President, I rise for a moment to reflect on what was a great night for the U.S. Senate, the U.S. Government, for the population of our country but most importantly for those who served as veterans in the military.

Last night, the Senate agreed to significant legislation on three fronts to make the VA better and more responsive to our veterans.

Ranking Member Tester and I have spent the entire year working toward making sure we dealt with the needs the VA has so all these stories we see on the front page of papers, stories about there being unsafe conditions, stories about people being mistreated, stories of people having to wait so long for their appointments--we want to put an end to all this, and we have given the Secretary the tools to do exactly that.

I was telling the ranking member this is called “no excuses day.” Secretary Shulkin will have no excuses for any mistakes to be made. Every tool he needs in his toolbox to see that the Veterans' Administration is responsible to the veterans of the United States of America passed in this Senate, passed in the House. There were six major bills the first 7 months of this year, a remarkable achievement, a testimony to teamwork, to staff, and to the leadership of the Republican and the Democratic Parties. The majority and minority leaders of this Senate made it possible for that to happen last night. I am eternally grateful to both of them for their support and help.

I am not going to read all the names of the staff now because we are in limited time.

I ask unanimous consent that the names of every staff member who worked with the VA Committee to make it the best year ever be printed in the Record.

Credit is given to captains, Presidents, and people with titles. Senator Tester and I have the titles, when it comes to the VA Committee, but the reason the VA Committee was successful in accomplishing every single goal, was because of every ranking file member, Republican or Democratic. We took our labels off, we put our armor on, and we plowed ahead. We didn't say no to problems that looked like they were too hard. We said yes to solutions that looked like they made sense.

Veterans of the United States of America have better healthcare, better educational benefits, and a modern VA to deal with in the years ahead. I am proud to have been a part of it. I want to commend Senator Tester for his contribution.

There being no objection, the material was ordered to be printed in the Record, as follows: Staff on the Senate Committee on Veterans' Affairs: Tom Bowman, staff director, soon-to-be Deputy Secretary of VA; Amanda Meredith, deputy staff director, soon-to-be judge on the U.S. Court of Appeals for Veterans Claims; Leslie Campbell; Gretchan Blum; Maureen O'Neill; Adam Reece; David Shearman; Jillian Workman; Kristen Hines; Thomas Coleman; John Ashley; Mitchell Sylvest; Joan Kirchner; Trey Kilpatrick; Jay Sulzmann; Ryan Evans; Salvador Ortega; and Amanda Maddox.

Mr. ISAKSON. I yield to Senator Tester.

The PRESIDING OFFICER. The Senator from Montana.

Mr. TESTER. Thank you, Mr. President.

I want to thank Chairman Isakson for his work on the VA Committee. We have gotten a lot of work done the first part of this Congress because we communicated. We haven't put up artificial barriers. We sat down and all realized taking care of our veterans is the cost of war. We need to do it and live up to the promises of these folks when they signed up. We have done pretty good work.

It is not only Johnny. It is not only myself. It is also the people who have served on that committee, many in the Chamber right now. I want to thank them for their commitment to making sure we live up to the promises we made our veterans, but it is about working together. It is about talking to folks. It is about compromise. It is about not digging in but moving together. This is a great country, and it was built by people working together.

The VA Committee is a prime example of people working together. We set aside our differences. We listened to the veterans service organizations. We let them drive the bus, to an extent. We worked with Secretary Shulkin and other leaders within the VA. We have been transparent. We have been honest when we disagreed. We haven't embarrassed one another. Quite frankly, this is the way it can work in this body when we start from a point of agreement rather than disagreement.

We have two bills already signed into law: an accountability bill, which holds VA employees accountable to the veterans, fires bad employees, protects whistleblowers; and the Veterans Choice Improvement Act, which makes VA the prime payer and reduces out-of-pocket expenses for veterans. Then, the bills passed last night to take care of the disability appeals, some 470,000--we are going to expedite that process and bring it down from 3 years to 1 year. [[Page S4792]] The VA will do that. We will give them the tools to do that. It will simplify it and cut the redtape.

Veterans Choice funding is a fix to allow the private sector to fill in the gaps where the VA can't provide healthcare. It will help recruit and retain more doctors and nurses, critically important, and it expands the capacity in the VA, which is critically important.

Then there is the “Forever” GI bill which eliminates the 15-year limit. It breaks down educational barriers and helps veterans transition into civilian life.

We have done some good work. We have done some good work for this body. We have done some good work, more importantly, for the veterans, and we need to continue on that line as we continue to address healthcare and we continue to address important issues like tax reform. It is about working together. It is about finding common ground. It is about taking everybody's opinion into context and then drafting up bills.

Chairman Isakson and I have done that, and we are going to continue to do that. We have some more tough issues to deal with over the next year and a half, but we are going to work together to make sure we do it and we do it right. With help from the committee and help from the Senate, we could have more successes.

I thank the chairman of the committee and thank you, Mr. President.

I yield the floor.

The PRESIDING OFFICER. The Senator from Alaska.

Ms. MURKOWSKI. Mr. President, we are considering the nomination of Dan Brouillette to be the Deputy Secretary for the Department of Energy. Mr. Brouillette has a long history of distinguished service to our Nation. He is a veteran. He has served in the Department of Energy. He has been the staff director for the House Energy and Commerce Committee. More recently, he has held high-level posts in the private sector--first, as vice president at Ford, currently as senior vice president at USAA.

He has strong experience and thorough knowledge of the Department he has chosen to return to. He understands the work that its thousands of scientists undertake and the importance of maximizing their research efforts, especially in a time of constrained Federal budgets.

He recognizes the importance of our 17 National Labs and the Department's responsibility for environmental management, including the cleanup of Cold War-era legacy sites. As second in command to Secretary Perry, Mr. Brouillette will oversee programs critical to our Nation's cyber security, energy innovation, and scientific discovery.

Based on his hearings before the Energy and Natural Resources Committee, I am confident he is up for the challenge and ready for this role. I would urge all of my colleagues to support the nomination of Dan Brouillette to be the Deputy Secretary of the Department of Energy.

Mr. President, I yield all time.

The PRESIDING OFFICER. All time is yielded back.

The question is, Will the Senate advise and consent to the Brouillette nomination?

Mr. RUBIO. I ask for the yeas and nays.

The PRESIDING OFFICER. Is there a sufficient second?

There appears to be a sufficient second.

The clerk will call the roll.

The bill clerk called the roll.

Mr. CORNYN. The following Senators are necessarily absent: the Senator from North Carolina (Mr. Burr), the Senator from North Dakota (Mr. Hoeven), the Senator from Oklahoma (Mr. Inhofe), and the Senator from Arizona (Mr. McCain).

The PRESIDING OFFICER (Mrs. Fischer). Are there any other Senators in the Chamber desiring to vote?

The result was announced--yeas 79, nays 17, as follows: [Rollcall Vote No. 186 Ex.] YEAS--79 Alexander Baldwin Barrasso Bennet Blumenthal Blunt Boozman Brown Cantwell Capito Cardin Carper Casey Cassidy Cochran Collins Coons Corker Cornyn Cotton Crapo Cruz Daines Donnelly Durbin Enzi Ernst Feinstein Fischer Flake Gardner Graham Grassley Hassan Hatch Heinrich Heitkamp Isakson Johnson Kaine Kennedy King Klobuchar Lankford Leahy Lee Manchin McCaskill McConnell Moran Murkowski Murphy Murray Nelson Paul Perdue Peters Portman Risch Roberts Rounds Rubio Sasse Schumer Scott Shaheen Shelby Stabenow Strange Sullivan Tester Thune Tillis Toomey Udall Warner Wicker Wyden Young NAYS--17 Booker Cortez Masto Duckworth Franken Gillibrand Harris Heller Hirono Markey Menendez Merkley Reed Sanders Schatz Van Hollen Warren Whitehouse NOT VOTING--4 Burr Hoeven Inhofe McCain

The nomination was confirmed.

The PRESIDING OFFICER. Under the previous order, the motion to reconsider is considered made and laid upon the table and the President will be immediately notified of the Senate's action. ____________________



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