From the Congressional Record Online through GPO
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
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
and innovative medical products for patients and families across the
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
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
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
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
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
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
The reauthorizations are based on recommendations from industry and
FDA after a thorough public process.
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
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
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
The PRESIDING OFFICER. The Senator from Georgia.
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
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
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
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.
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
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
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.]
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.