[Congressional Record Volume 162, Number 171 (Wednesday, November 30, 2016)]
[House]
[Pages H6887-H6893]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
[[Page H6887]]
House of Representatives
PROVIDING FOR CONSIDERATION OF SENATE AMENDMENT TO H.R. 34, TSUNAMI
WARNING, EDUCATION, AND RESEARCH ACT OF 2015, AND PROVIDING FOR
CONSIDERATION OF H.R. 6392, SYSTEMIC RISK DESIGNATION IMPROVEMENT ACT
OF 2016
Mr. BURGESS. Mr. Speaker, by the direction of the Committee on Rules,
I call up House Resolution 934 and ask for its immediate consideration.
The Clerk read the resolution, as follows:
H. Res. 934
Resolved, That upon adoption of this resolution it shall be
in order to take from the Speaker's table the bill (H.R. 34)
to authorize and strengthen the tsunami detection, forecast,
warning, research, and mitigation program of the National
Oceanic and Atmospheric Administration, and for other
purposes, with the Senate amendment thereto, and to consider
in the House, without intervention of any point of order, a
motion offered by the chair of the Committee on Energy and
Commerce or his designee that the House concur in the Senate
amendment with an amendment consisting of the text of Rules
Committee Print 114-67 modified by the amendment printed in
part A of the report of the Committee on Rules accompanying
this resolution. The Senate amendment and the motion shall be
considered as read. The motion shall be debatable for 80
minutes, with 60 minutes equally divided and controlled by
the chair and ranking minority member of the Committee on
Energy and Commerce and 20 minutes equally divided and
controlled by the chair and ranking minority member of the
Committee on Ways and Means. The previous question shall be
considered as ordered on the motion to its adoption without
intervening motion.
Sec. 2. Upon adoption of this resolution it shall be in
order to consider in the House the bill (H.R. 6392) to amend
the Dodd-Frank Wall Street Reform and Consumer Protection Act
to specify when bank holding companies may be subject to
certain enhanced supervision, and for other purposes. All
points of order against consideration of the bill are waived.
The bill shall be considered as read. All points of order
against provisions in the bill are waived. The previous
question shall be considered as ordered on the bill and on
any amendment thereto to final passage without intervening
motion except: (1) one hour of debate equally divided and
controlled by the chair and ranking minority member of the
Committee on Financial Services; (2) the amendment printed in
part B of the report of the Committee on Rules accompanying
this resolution, if offered by the Member designated in the
report, which shall be in order without intervention of any
point of order, shall be considered as read, shall be
separately debatable for the time specified in the report
equally divided and controlled by the proponent and an
opponent, and shall not be subject to a demand for a division
of the question; and (3) one motion to recommit with or
without instructions.
The SPEAKER pro tempore. The gentleman from Texas (Mr. Burgess) is
recognized for 1 hour.
Mr. BURGESS. Mr. Speaker, for the purpose of debate only, I yield the
customary 30 minutes to the gentleman from Colorado (Mr. Polis),
pending which I yield myself such time as I may consume. During
consideration of this resolution, all time yielded is for the purpose
of debate only.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days to revise and extend their remarks.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BURGESS. Mr. Speaker, House Resolution 934 provides for a rule to
consider a critical bill that will help millions of Americans and their
families who are suffering from diseases. The rule provides 80 minutes
of debate, with 1 hour being provided to the Energy and Commerce
Committee, and 20 minutes given to the Committee on Ways and Means. The
rule provides for a motion to concur with the Senate amendment to H.R.
34, placing the base text of the 21st Century Cures into the bill. The
rule further incorporates the manager's amendment into the base text of
the Cures bill, reflecting the bipartisan and bicameral negotiations
which took place to get us to where we are today with the legislation.
Second, the resolution before us today provides for a rule to
consider H.R. 6392, the Systemic Risk Designation Improvement Act of
2016, an important bill to remove onerous Federal regulations imposed
on small and community banks by the ill-conceived Dodd-Frank Act by
replacing current and arbitrary SIFI designation standards with a more
effective activity-based standard. The rule provides for 1 hour of
debate, equally divided between the majority and minority of the
Committee on Financial Services. Further, the rule makes one amendment
in order and provides the minority with the standard motion to
recommit.
I am pleased that the House is considering both of these pieces of
legislation today.
The Energy and Commerce Committee has spent 4 years working to bring
our healthcare innovation infrastructure into the 21st century.
Today, there are 10,000 known diseases or conditions, but the bad
news is we have cures and treatments for only 500.
There is a gap between innovation and therapy. There are problems
with how we regulate our therapies. It is not unheard of to have a
company take over 14 years and $2 billion to bring a new drug to
market.
{time} 1230
Members held 20 roundtables, discussions, hearings, field hearings,
and events around the country to ensure that we involved our patients,
their advocates, researchers, innovators, financiers--all who have
firsthand experience and who understand the gaps in our current system.
The House amendment to H.R. 34 includes two bipartisan bills that
have
[[Page H6888]]
been developed over the course of several years by the Committee on
Energy and Commerce and its members to meet some of our country's most
pressing healthcare needs. The mental health reforms that are based on
the Helping Families in Mental Health Crisis Act, authored by
Representative Tim Murphy, passed the House in July by a vote of 422-2.
This legislative effort represents the most significant reforms in the
mental health system in over a decade.
The 21st Century Cures Act title in the bill is the result of a
unified Energy and Commerce Committee effort, championed by Chairman
Fred Upton of Michigan and Representative Diana DeGette of Colorado
over the course of multiple Congresses, to bring our laws into a modern
era of medicine. The House passed the 21st Century Cures Act in July of
2015 by a vote of 344-77. Our commitment to this transformational bill
has not and must not waver until it is across the finish line and
signed into law. We owe it to the patients, their families, medical
providers, advocates, scientists, and researchers to see this through.
Our country is a global leader in medical innovation, but even in
recognizing that, there is progress that we can make. With 10,000 known
diseases and with 10,000 known conditions, and with cures and
treatments for only 500, we must do more to alleviate that gap which is
causing so much human suffering. Advances in science and technology
over the past decade have the potential to revolutionize medical
innovation; yet the way drugs and devices are approved is back in the
horse-and-buggy days. It is largely unchanged.
In recognizing the growing divide between innovation and regulation,
the House Committee on Energy and Commerce launched the 21st Century
Cures Initiative in the 113th Congress--that was a Congress ago--to
examine the state of discovery, development, and delivery of medical
therapies in America. The ensuing process by which the Cures
legislation was developed should serve as a model for policy
development long into the future.
Members of the committee convened hearings, forums, and roundtables
in Washington, DC, and in centers and locations around the Nation.
These forums brought together the leading scientists, the medical
experts, patient and disease group advocates, and researchers and
innovators across multiple sectors. The objective of these events was
to uncover opportunities and to strengthen and streamline the process
by which cures are discovered and made available to patients.
Based on what we have learned, Representatives worked across the
aisle--across the dais--on comprehensive legislation that would make
the government an ally rather than an obstacle in the cycle of medical
innovation. The 21st Century Cures Act touches each step of the process
through which new treatments and cures come to market: the discovery,
the development, the delivery.
To accelerate discovery, the House amendment to H.R. 34 includes
provisions that facilitate collaboration and increase access to health
data. It invests billions of dollars in research through the National
Institutes of Health, and it incentivizes the exploration of the most
rare and challenging conditions. To modernize the development, among
other things, the 21st Century Cures Act establishes a review pathway
at the Food and Drug Administration for biomarkers and other drug
development tools that can be used to help shorten drug development
time while, at the same time, maintaining the safety standard that the
public demands and that we have all come to expect from the agency.
The very confused regulation of combination products by the very
different centers at the Food and Drug Administration will be improved
to cut down on inefficiencies and to reduce the cost of development.
The Food and Drug Administration will be required to work with
stakeholders and the National Institute of Standards and Technology to
establish a regulatory framework for the development, evaluation, and
review of drugs that are classified as regenerative medicine and
advanced therapies.
A number of provisions seek to empower patients to engage in their
health care and to engage in their treatment decisions with their
doctors, to contribute health information to scientific research, and
to participate in the drug and device approval process. The Food and
Drug Administration is required to engage in a range of activities that
will establish a framework for the consideration of patient experience
data when weighing the benefits of a new treatment. Individuals will
have the opportunity to share health data with the global research
community through platforms, such as the Precision Medicine Initiative
and a new National Neurological Diseases Surveillance System. Multiple
measures ensure patients will have better access to secure, up-to-date
information through their electronic health records, and they ensure
that this health information technology will continue to be developed
with patient needs and patient safety and privacy as a priority.
I am grateful to have had the opportunity to work directly on several
provisions in the bill. This includes the creation of a national
surveillance system for neurologic diseases and conditions which may
then be used to help us further understand these devastating diseases.
Thousands of Americans are affected--multiple sclerosis, Parkinson's,
Alzheimer's, other neurologic diseases--but there is very little
accurate information that exists today to assist those who research,
treat, and provide care for individuals who suffer from these diseases.
I have also worked on a provision that will improve patient access to
pharmaceutical companies' compassionate use policies for drugs that
treat serious or life-threatening conditions. To increase the
efficiency and foster robust data collection analysis, the Food and
Drug Administration will be required to evaluate the use of real-world
evidence and summary-level review where an application is submitted for
a new indication for an already approved drug. To help insurers and
formulary committees make informed coverage decisions, a provision in
the 21st Century Cures Act clarifies how medical product manufacturers
can communicate economic information about therapies and technologies.
I am particularly happy that the House amendment to H.R. 34 includes
multiple provisions that will make meaningful progress toward achieving
an interoperable health system. Increasingly, electronic health system
interoperability is critical to achieving the promises of the 21st
Century Cures and to scaling up the benefits of health reform more
broadly. While we have seen the widespread adoption of electronic
health records, our Nation continues to maintain a fragmented system,
which makes it difficult to ensure the continuity of evidence-based
care for patients.
The 21st Century Cures Act would finally set us on a path towards
achieving a nationwide interoperable health system that puts the needs
of patients and that puts the needs of providers first. Federal
advisory committees are streamlined and directed to prioritize
interoperability. Preference is directed to utilizing the existing
standards of implementation rather than of recreating them.
In addition to increasing the transparency and accountability for
providers and patients, enforcement mechanisms will arm the Office of
Inspector General with the authority necessary to punish bad actors for
improperly impeding the flow of information. Data blocking will stop.
The provisions in this bill will expedite the interoperability of
electronic health record systems to make good on the $30 billion
taxpayer investment in order to benefit patients, doctors, and
researchers.
As I have referenced, developing the 21st Century Cures Act was a
process that brought everyone to the table. No one is getting
everything that he wanted. I would note my disappointment that this
bill does not include an important clarification to the Physician
Payments Sunshine Act that was part of the House-passed version of this
bill and was supported by over 200 supporting organizations.
Certified continuing medical education, peer-reviewed medical
textbooks, and journal reprints play a vital role in improving patient
outcomes. They play a role in facilitating medical innovation, keeping
our Nation's medical professionals up to date with the rapid pace of
scientific discoveries.
[[Page H6889]]
These materials and activities should not be confused with improper
payments from pharmaceutical manufacturers to physicians. These
materials were always intended to be excluded from the reporting
requirements in the physician sunshine law, but, unfortunately, the
Centers for Medicare & Medicaid Services' interpretation of the
exemption has been inconsistent and unreliable. The narrowly
constructed language in the 21st Century Cures Act was carefully
drafted to maintain the transparency originally intended in the
sunshine law while it ensured robust access to medical education.
Mr. Speaker, I think it goes without saying that we all want our
doctors to be smart, that we want them to be informed, and that we want
them to be up to date. Certainly, that is a priority that I will
continue to pursue going forward.
Groundbreaking discoveries rely on a robust and reliable investment
in basic research. The House amendment to H.R. 34 provides the National
Institutes of Health with almost $5 billion in funding, including
almost $2 billion for the Cancer Moonshot and $1.5 billion for the
BRAIN Initiative. It also includes $500 million for the Food and Drug
Administration and $1 billion in grants to four States in order to
address the growing and burgeoning opioid crisis that continues to
claim so many lives across our country. This approach provides
dedicated funding through 2026 while it ensures spending is subject to
review and oversight in the annual appropriations process. In addition
to fully offsetting all of the authorized funds, H.R. 34 will actually
reduce the deficit by almost $6 billion over the next 10 years.
Federal regulation, Federal policy, and Federal investment have been
outpaced by science, medicine, and technology. The bipartisan 21st
Century Cures Act will make needed changes to bring our laws into a
modern era of medicine and to keep the Nation at the forefront of
healthcare innovation. The 21st Century Cures Act not only delivers
hope to millions of patients who are living with untreatable diseases,
but it also helps modernize and helps streamline the regulation in
America's healthcare system.
I encourage all of my colleagues to vote ``yes'' on the rule and
``yes'' on the two underlying bills. The 21st Century Cures Act will
not only deliver hope to millions of people who are living with
untreatable disease, but it will also help modernize and streamline
America's healthcare system.
Mr. Speaker, I reserve the balance of my time.
Mr. POLIS. Mr. Speaker, I yield myself such time as I may consume.
I thank the gentleman for yielding me the customary time, but I have
to say that I think that this somewhat breaks with the custom of this
body not to delay floor proceedings during the reorganization of the
Democratic Caucus. I know that, when the Democrats were in the
majority, we routinely gave deference to the Republican Conference's
plan for retreats and for caucus reorganizations. We have before us
several contested races. Of course, the Nation's business comes first,
which is why we are here making the case on these bills.
I would like to add that I hope that this is not the tone we are
going to be setting for the next Congress. I think it is very important
that, despite our differences on policies, both conferences are
respectful of the responsibilities that Members have not only within
the institution of Congress but within their respective conferences and
caucuses. On our side, we will be brief because we do have additional
responsibilities, as I mentioned.
Mr. Speaker, I yield 2\1/2\ minutes to the gentlewoman from Oregon
(Ms. Bonamici).
Ms. BONAMICI. I thank the gentleman for yielding.
Mr. Speaker, I rise in opposition to the rule on H.R. 34, which is
now the vehicle for the 21st Century Cures Act.
Although I understand the detailed rules of our Chamber, I am deeply
disappointed that the underlying bill, the Tsunami Warning, Education,
and Research Act, was completely stripped out and replaced with
unrelated language. The Tsunami Warning, Education, and Research Act is
bipartisan. It was passed by a voice vote on January 7 of 2015, and a
similar version has passed the Senate. We have worked out our
differences, and this legislation is ready to be signed into law, and
it is vital for our West Coast communities.
My constituents on the Oregon coast know that it is a matter of when,
not if, our community will face a Cascadia subduction zone earthquake
and tsunami. Most of the city of Seaside, including all of its public
schools, is located in the tsunami inundation zone. It is some of my
youngest constituents--the students of Seaside--who have been the most
vocal about keeping their communities safe. Recently, I met with the
students there at the high school. They have spoken all over the State
about the dangers they face from tsunami. Their presentation was very
strong. They made a case for moving their schools out of the tsunami
zone.
{time} 1245
It helped the community pass a bond measure earlier this month to
move the schools. That is a positive step for Seaside, but there is so
much more to be done.
I have an app on my phone. Almost every day, there is an earthquake
off the coast of Alaska or Hawaii. Two days ago there were two
earthquakes off the coast of Oregon. When there is a near-shore
tsunami, the warning time is about 15 minutes. That is all.
The Tsunami Warning, Education, and Research Act would help
communities up and down the entire coast by strengthening the warning
system, providing more assistance to local communities like Seaside to
prepare for that disaster, coordinating government agencies to make
sure they're sharing information and working together, and supporting
community outreach and education programs.
This is not just about Oregonians. Millions of people in Alaska,
Hawaii, Washington State, California also face significant risk. We are
overdue for the really big one.
Now, I understand that the Cures Act may save lives, but I am very
disappointed that the provisions of the tsunami bill, which is also
lifesaving policy, was not retained in the underlying bill.
Mr. Speaker, again, I urge my colleagues to oppose this rule so we
can immediately consider swift passage of the Tsunami Warning,
Education, and Research Act. Our West Coast communities are counting on
us to keep them safe.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Pennsylvania (Mr. Murphy), the author of the mental health portion of
this bill.
Mr. MURPHY of Pennsylvania. Mr. Speaker, this bill includes in it
elements of H.R. 2646, the Helping Families in Mental Health Crisis
Act, which is the most revolutionary change to mental health since the
Community Mental Health Act of 1963.
It includes fundamental changes in how we think about, talk about,
and treat serious mental illness. It establishes an assistant secretary
for mental health and substance use to disseminate evidence-based
practices, ensure grants meet objective outcome measures, conduct
ongoing oversight of grantees, and collaborates with other Federal
departments on mental health.
It creates an interagency coordinating committee to evaluate Federal
programs related to mental illness and provide recommendations to
better coordinate those programs. It authorizes a national mental
health and substance use policy laboratory to promote evidence-based
models of care and further develop, expand, replicate, or scale those
programs. It provides funding for treatment and recovery for homeless
individuals with mental health and substance use disorder services.
It authorizes for the first time in law the National Suicide
Prevention Lifeline program and the Minority Fellowship Program. It
awards grants to develop, maintain, and enhance online psychiatric bed
registries.
It funds programs for telehealth so that people in rural communities
and primary care physicians can have ready access to mental health
services so sorely needed for their patients. It reauthorizes the
Garrett Lee Smith Suicide Prevention program, increases funding for
assisted outpatient treatment and, for the first time, provides Federal
grants for assertive community treatment.
[[Page H6890]]
It increases access to medical residencies and fellowships in
psychiatry and addiction medicine in underserved, community-based
settings for nurse practitioners, physician assistants, health service
psychologists, and social workers. It removes barriers for providing
volunteering at community health centers.
It updates the National Child Traumatic Stress Initiative, which
supports a national network of child trauma centers, including
university, hospital, and community-based centers.
It requires the Secretary of HHS to clarify how healthcare providers
can communicate with the caregiver of an adult with a mental health or
substance use disorder. It clarifies the coverage of eating disorder
benefits, including residential treatment under existing mental parity
requirements.
It allows Federal grants to local law enforcement to be used for
crisis intervention teams to roll back the tragedies of violence that
occur when a mentally ill person encounters a policeman. It provides
funding to develop school-based mental health crisis intervention
teams. And this list goes on.
I am pleased that this has all been merged into one bill here so that
we can move forward on this. This truly will provide many lifesaving
measures and bring mental health treatment out of the shadows.
I encourage my colleagues to support this bill as we move forward and
provide help because where there is help, there is hope.
Mr. POLIS. Mr. Speaker, I just want to note that this rule contains
two completely different bills. The first is the 21st Century Cures
Act, which would help address many of the health crises that we face.
The other bill is H.R. 6392, the Systemic Risk Designation Improvement
Act, that would weaken many of the protections that were put in place
in the Dodd-Frank Wall Street reform bill. So there are two very
different bills here under one rule, a very closed process which the
Democrats will be opposing.
Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr.
Blumenauer).
Mr. BLUMENAUER. Mr. Speaker, it is a pleasure to follow my friend
from Pennsylvania, acknowledging his hard work in the mental health
sphere. I do think that this is setting the platform for the most
significant initiative in the next half century. There are some good
things in this bill, but I hope it is just the beginning. I know the
gentleman has a number of other initiatives that he is working on in a
bipartisan way, and I am hopeful that this Bill serves as a
springboard.
On a personal note, the Garrett Smith Suicide Prevention Act, was
created by our former colleague, Senator Gordon Smith from Oregon, who
took a personal tragedy in his family and moved forward with important
legislation that other families may be spared by that effort.
There are a number of things here that matter in another context. In
terms of what happens dealing with the opioid crisis that we have now,
America has been too slow to respond. I am hopeful that these resources
will help us move in the right direction. Again, I must, I suppose,
note with a certain amount of irony that there are other alternatives
available to deal with the epidemic of opioid overdose deaths.
I would note that it is interesting that States that actually utilize
medical marijuana prescribe fewer pills. There is an opportunity here
for us to do something that is less expensive, less addictive, and not
deadly. But the provisions in this bill, I think, are a step in the
right direction.
It also is important to note the investments in neuroscience. We have
created a Neuroscience Caucus in Congress because this is an area that
has stubbornly resisted being able to have the progress that we have
seen in other areas, like cancer and cardiac health, and building on an
initiative that the administration has, developed the BRAIN Initiative,
which is modest but potentially very significant to accelerate the
understanding of the human brain, leading to new ways to treat and cure
neurological disorders.
Everybody in this Chamber knows a variety of people who suffer--
everything from Alzheimer's, multiple sclerosis, addiction problem--and
being able to double down those investments in a more systematic way
will pay dividends that are incalculable.
Already, mental and behavioral disorders are among the leading causes
of disability around the world. The impact is greater than heart
disease and cancer combined. As I mentioned, where we have actually
made some progress.
Last but not least, there is a technical fix that matters in my
community and others around the country, which is bringing fairness to
hospitals. When Congress changed the hospital payment rules last
November, there were hospitals like Oregon Health & Science University
that were caught unfairly in the middle of payment changes. We did not
provide any exceptions for hospital outpatient departments that were
under development at that time.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. POLIS. Mr. Speaker, I yield an additional 1 minute to the
gentleman from Oregon.
Mr. BLUMENAUER. Mr. Speaker, this means that hospitals like Oregon
Health & Science University, who made significant investments in
building off-site departments under one set of Medicare rules, suddenly
faced a new set of rules that were changed by Congress midstream. I am
pleased that this will prevent pulling the rug out from underneath
them.
So, in sum, Mr. Speaker, this technical fix, which is important,
support for the BRAIN Initiative, the important work in mental health,
and dealing with the opioid crisis are reasons that I think this bill
is worthy of support, although I share the concerns of the gentlewoman
from Oregon (Ms. Bonamici), whose underlying, bipartisan, very
important bill somehow is a casualty of this legislation. That is
unfortunate.
I hope the rule is defeated so we can fix that and get on with
business.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Oklahoma (Mr. Cole).
Mr. COLE. Mr. Speaker, I rise for the purpose of supporting the rule
and the underlying legislation.
I want to begin by congratulating Chairman Upton and the members of
the Energy and Commerce Committee on both sides of the aisle for
crafting what is genuinely a bipartisan piece of legislation in a very
divisive era and working it for years and bringing it to a successful
conclusion. They have given all of us an opportunity to vote for
something really, really important to every single American.
Now, a lot of focus will be put on the money aspect of this bill.
Certainly, $6-plus billion is a nice chunk of change and will be very,
very gratefully received. But in that same multiple-year period, in 5
years, if we didn't increase appropriations by a dime, we would spend
$160 billion dollars at NIH. And over a 10-year period, if we didn't
increase annual appropriations by a dime, we would spend $320 billion.
So the real genius of the bill is not the money. It is actually the
three things that have been mentioned by multiple speakers before me.
First is the regulatory reform that, at the FDA and at the NIH, will
literally save billions of dollars and thousands of lives over the next
decade.
Second is the opioid initiative. We all know the crisis. It touches
all of our districts. To direct money there and then to build on that
through the appropriations process is extraordinarily important, and I
congratulate the Energy and Commerce Committee for taking a lead here.
Finally, the mental health legislation that is wound up in this that
the gentleman from Pennsylvania (Mr. Murphy) provided is just
absolutely spectacular in terms of its long-term importance.
We can all disagree about this or that or some technicality in the
rule. The reality is this is important legislation. If it doesn't pass
now, it won't pass and we will be missing an opportunity.
So I want to urge my friends on both sides of the aisle--I don't
expect my friends to vote for the rule. They shouldn't. They never do.
I wouldn't if I were in the minority. But I hope they will vote for the
underlying legislation because that legislation is worthy of passage.
It is a bipartisan compromise, and it will improve the life of every
single American.
Mr. POLIS. Mr. Speaker, there is a lot of bipartisan support for the
21st
[[Page H6891]]
Century Cures Act. I commend Chairman Upton, Ranking Member Pallone,
Ranking Member DeGette, Ranking Member Gene Green, and so many others
who worked hard on this legislation that will save lives by improving
the access that Americans have to potentially lifesaving drugs and
devices, helping to keep people healthy and independent and out of the
hospital.
I plan to support this legislation. I think we also all know that it
is a starting point. We have additional work to do to make prescription
drugs more affordable, to make the approval process more streamlined
for both prescription drugs and medical devices, regenerative medicines
safe, and, of course, funding levels for research.
Mr. Speaker, I would like to inquire if there are any speakers
remaining on the other side?
Mr. BURGESS. Mr. Speaker, I have two additional speakers and myself
to close.
Mr. POLIS. Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Pennsylvania (Mr. Pitts), the chairman of the Subcommittee on Health
that played a vital role in getting the 21st Century Cures bill across
the finish line.
Mr. PITTS. Mr. Speaker, I rise in strong support of the rule for the
21st Century Cures Act, a momentous innovation package which will help
advance the discovery, development, and delivery of new treatments and
cures for patients and will foster private-sector innovation here in
the United States.
Additionally, the package includes provisions of H.R. 2646, the
Helping Families in Mental Health Crisis Act, as well as provisions to
increase choice, access, and quality health care for Americans.
Arriving here today has been a long journey full of lots of steps and
twists and turns along the way. I especially want to thank legislative
counsel for their tireless efforts in helping translate our legislative
aims into legislative language. Together with our health team staff,
they worked nights and weekends and were consummate professionals
throughout the process.
Additionally, I want to thank the healthcare staff of the
Congressional Budget Office for all of their help in recent months. In
addition to their role in estimating the budgetary effects of numerous
policies in the bill, they were instrumental in helping us shape a
number of proposals the committee considered.
I would be remiss if I did not thank again the outstanding team on
Energy and Commerce and most especially the health team led by Chief
Health Counsel Paul Edattel, supported by Josh Trent, John Stone, Carly
McWilliams, J.P. Paluskiewicz, Adrianna Simonelli, Adam Buckalew,
Sophie Trainor, and Jay Gulshen; and Heidi Stirrup and Monica Valenti
on my staff, without whose expertise, wisdom, and counsel this
legislative work would not be possible.
{time} 1300
This landmark medical innovation package includes provisions designed
to help almost every American family, whether it is leading to the
discovery, development, and delivery of new treatments and cures, or
advancing the President's Precision Medicine Initiative or the Vice
President's Cancer Moonshot, or the BRAIN Initiative to advance
Alzheimer's research. This package is an innovation game changer and
will truly bring our health innovation into the 21st century. I urge
support for this bipartisan effort.
Mr. POLIS. Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Michigan (Mr. Walberg).
Mr. WALBERG. Mr. Speaker, I stand in support of the rule and the
underlying bill. Why? Well, the 21st Century Cures Act is a
transformational piece of legislation that will allow us to discover
and develop new lifesaving cures and treatments for some of the worst
diseases.
This act will offer hope to millions of patients and families,
including Gale, a constituent of mine from Newport, who has been
affected and afflicted with pancreatic cancer. Or Brandon, a boy from
Rives Junction, who has been on a clinical trial for 8 years as he
battles Duchenne muscular dystrophy.
In addition to streamlining the FDA approval process and boosting NIH
funding, the Cures Act includes significant provisions to update our
mental health system and help States fight opioid addiction.
I congratulate my good friend and colleague Chairman Fred Upton for
his vision in tackling this challenge and for his tireless efforts to
get this bill to the floor. The Cures Act is innovative; it is
bipartisan; it is fully paid for and life changing for my constituents
in Michigan and many others around this great country.
I ask my colleagues to vote in support of the rule and the underlying
bill.
Mr. POLIS. Is the gentleman prepared to close?
Mr. BURGESS. I am prepared to close.
Mr. POLIS. Mr. Speaker, I yield myself such time as I may consume.
Again, I do want to point out, in breaking with custom, there were
many other Democrats who wanted to discuss this bill; but, as we speak,
the Democratic Caucus is having elections for the vice chair position.
While we were on the floor, we had elections for the whip position and
the assistant leader position, both of which I was unable to
participate in because, of course, I had to conduct the business of the
Nation.
But, again, I would hope that both parties are respectful of the
scheduling requirements that are incumbent upon being a member of one
of the two major parties of this body. In the past, we have always been
able to work in when Republican Conference has a retreat or a
reorganization meeting. I think that is important to this body because,
while, of course, as Americans and Representatives we have
responsibilities to the institution of Congress, as elected officials
of the Democratic or Republican Party, we do have a responsibility to
select our leaders and establish our rules.
I don't think that the amount of time that either party spends doing
that is unreasonable, but I think that it is very important that both
parties and leadership of this body, the Speaker and the majority
leader, are respectful of that while, of course, understanding we have
important people's business to conduct. There were, of course, many
other options. This House could have come to order and gotten this work
done at 8 in the morning or they could do it later in the afternoon.
There are a number of different ways we could have worked around the
previously scheduled reorganization of the Democratic Caucus.
Frankly, I am disappointed not just for myself having been unable to
participate in those party functions, but also on behalf of other
members of the Democratic Caucus who were unable to come and speak on
these very important issues because of playing active roles in running
for or supporting or speaking on behalf of various candidates for party
positions, which is occurring as I speak.
This bill has two completely unrelated bills that are in it. Again,
the 21st Century Cures Act has strong bipartisan support. I add my
voice to those who have praised this legislation, and hopefully it will
challenge the next Congress to continue to move forward with
facilitating the approval process.
I have often heard the approval process, for instance, for a new drug
for inception to market can often be in excess of $1 billion or $2
billion. We hear a number of different figures tossed around. I think
sometimes it is in the high hundreds of millions. Sometimes it is as
high as 1.5 or 2 billion. Regardless, that is one of the reasons that
there is an upward pressure on prices for proprietary prescription
drugs. It is also one of the reasons that lifesaving prescription drugs
are often unavailable here even while they are on the market in Europe
and other areas. Of course, without compromising safety--and Democrats
and Republicans agree on that--there needs to be a way that we can
facilitate, particularly in the realm of personalized medicine,
bringing new lifesaving products to market in an affordable way.
An excellent model for that that has saved hundreds of thousands of
lives was put in place during the first administration of the first
George Bush, which provided an expedited route for HIV drugs. Thanks to
that route that
[[Page H6892]]
was used for many of the HIV drugs, some of which are still in use
today, hundreds of thousands of people affected by HIV, including many
LGBT Americans, are still alive today because of that effort. I am also
confident, because of today's effort with the 21st Century Cures Act,
it will save the lives of many more Americans. Again, it is a starting
point. We have room to go.
The other bill would, for some reason--it is not something I hear
from constituents, but apparently it is something Republicans want to
do--exempt some of the very biggest banks from some of the requirements
under Dodd-Frank regarding ensuring their stability and preventing them
from failing. It is my understanding it only affects a few dozen banks,
the very largest banks, banks that are worth tens or hundreds of
billions of dollars. I am sure they like it. It probably reduces their
ability to have to comply.
But there is a reason those requirements were put in place for those
very big banks. We are worried that the failure of any one or certainly
multiple banks could create a systemic risk and lead to future
bailouts. So I strongly believe that this bill before us today on the
banking regulations, if it were to become the law, it would increase
the likelihood of future bailouts, which surprises me because many of
us have been traditionally opposed to those very kinds of bailouts.
It is my understanding there is one remaining speaker on the other
side, so I reserve the balance of my time to allow that speaker to
speak.
Mr. BURGESS. Mr. Speaker, I thank the gentleman for the
accommodation. I am pleased to yield 2 minutes to the gentleman from
Oregon (Mr. Walden).
Mr. WALDEN. Mr. Speaker, I want to thank my colleagues on both sides
of the aisle and especially for the courtesy to spend a minute or two
talking about not only this rule, but also the legislation that will be
coming to the floor soon. I want to thank especially Chairman Fred
Upton, who has put his whole heart and soul into the 21st Century Cures
Act, joined by Diana DeGette, certainly Dr. Burgess, Congressman
Murphy, and others who have really played a key role in trying to find
cures to diseases that don't exist today, find treatments for those in
order to bring better health to all Americans, both physical health
and, certainly in the case of Dr. Murphy, mental health as well.
This really means a lot. This will make a difference in real people's
lives back home in our communities. I have heard from those people,
like Carol Fulkerson in Bend, who has MS. She is ecstatic about this.
She said it is a great step toward making it possible to find a cure to
MS. Can you imagine what that means in a person's life?
There are critical reforms and improvements on mental health and
substance abuse programs, as we have heard. These changes will help
people all across America, and certainly in Oregon. A Medford resident,
Justin, overcame his own battle with addiction through a dual diagnosis
treatment program that dealt with the underlying issues fueling
addiction instead of just sort of a Band-Aid approach to his symptoms.
These are the kinds of ideas coming from our folks back home that are
now incorporated in legislation.
I heard from a clinical lab owner in rural Oregon, Judy Kennedy, who
voiced her support for the provisions in Cures that provide precise
diagnostic testing services to rural and other underserved communities
across the country. We are going to do so much to improve the health,
both mental and physical, in the lives of people we represent when this
legislation becomes law.
Mr. Speaker, I am just delighted to support this bill. I think it is
an enormous step forward in so many ways, and I commend Chairman Upton
and all those who have been involved in this in its writing. I urge
passage of the rule so we can get on to this legislation.
Mr. POLIS. Is the gentleman prepared to close?
Mr. BURGESS. Once again.
Mr. POLIS. Mr. Speaker, I yield myself the balance of my time.
So, again, I think there is some good and some bad in this. The 21st
Century Cures Act is very important, and I hope that this body sees it
as a starting point, not an ending point. There are some important
reforms in there that will save lives and also help remove some of the
upward pressure on prescription drug prices, something we hear about
very often from constituents.
There is another bill in there which most Democrats will be voting
against with regard to making it potentially more likely that larger
banks can fail us or need bailouts, and that is not something that most
of us have an appetite for. Of course, the closed nature of the bill is
not consistent with the expressed desire of the Speaker to have an open
process. The Committee on Rules yesterday shut down a number of
excellent ideas and amendments that were offered, and they are not
allowed to be debated here on the floor.
Of course the timing of this bill, particularly for a bipartisan
bill, to bring it up in a way, in a manner and a time that conflicts
with the previously noticed meeting that happens to include all of the
members of one of the two political parties is not the best way to
foster the type of bipartisan cooperation that is important to get
things done around here.
So Democrats will not be supporting the rule. Many of us will, thanks
to the work of Chairman Upton, Ranking Member Pallone, Ranking Member
DeGette, Ranking Member Gene Green, and others, be proud to hopefully
send to the President's desk the 21st Century Cures Act as an excellent
starting point in helping to save lives.
I urge a ``no'' vote on the rule.
Mr. Speaker, I yield back the balance of my time.
Mr. BURGESS. I yield myself the balance of my time.
Mr. Speaker, today's rule provides for the consideration of two
important bills: a bill that will transform and advance the discovery,
the development, the delivery of treatments and cures; and a bill that
will help our small and community banks, institutions that, in turn,
can further assist small and local businesses and help our communities
grow.
I want to thank all of the Members who did put a lot of effort into
the final package on the Cures bill, as well as the staff on both sides
of the aisle, all members of the Committee on Energy and Commerce, and
the House as a whole, who were asked to bring their ideas to the table,
and we worked to include as many of those as we could.
I would also like to express my thanks to the great attorneys at the
Legislative Counsel who sometimes worked around the clock to get this
bill ready for both the committee and floor activity. I want to thank
Chairman Upton, Representative DeGette, as well as Chairman Pitts and
Ranking Member Pallone and Ranking Member Gene Green for their
leadership throughout.
It has already been mentioned, but I also want to thank the staff,
both in our personal offices and at the committee staff, who have
worked so hard on this over the past 4 years. This was truly all hands
on deck. There is not one staffer on the Subcommittee on Health of the
Committee on Energy and Commerce who does not have their fingerprints
all over this bill.
Mr. Speaker, I yield back the balance of my time, and I move the
previous question on the resolution.
The previous question was ordered.
The SPEAKER pro tempore. The question is on the resolution.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. POLIS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, this 15-
minute vote on adopting House Resolution 934 will be followed by a 5-
minute vote on suspending the rules and passing H.R. 5047.
The vote was taken by electronic device, and there were--yeas 230,
nays 180, not voting 24, as follows:
[Roll No. 590]
YEAS--230
Abraham
Aderholt
Allen
Amash
Amodei
Babin
Barr
Barton
Benishek
Bilirakis
Bishop (MI)
Bishop (UT)
Black
Blackburn
Blum
Bost
Boustany
Brady (TX)
Brat
Bridenstine
Brooks (AL)
Brooks (IN)
Buchanan
Buck
Bucshon
Burgess
Byrne
Calvert
Carter (GA)
Carter (TX)
Chabot
Chaffetz
Coffman
[[Page H6893]]
Cole
Collins (GA)
Collins (NY)
Comer
Comstock
Conaway
Cook
Costello (PA)
Cramer
Crawford
Culberson
Curbelo (FL)
Davidson
Davis, Rodney
Denham
Dent
DeSantis
DesJarlais
Diaz-Balart
Dold
Donovan
Duffy
Duncan (SC)
Duncan (TN)
Emmer (MN)
Farenthold
Fitzpatrick
Fleischmann
Fleming
Flores
Forbes
Fortenberry
Foxx
Franks (AZ)
Frelinghuysen
Garrett
Gibbs
Gibson
Gohmert
Goodlatte
Gosar
Gowdy
Granger
Graves (GA)
Graves (LA)
Graves (MO)
Griffith
Grothman
Guinta
Guthrie
Hanna
Hardy
Harper
Harris
Hartzler
Heck (NV)
Herrera Beutler
Hice, Jody B.
Hill
Holding
Hudson
Huelskamp
Huizenga (MI)
Hultgren
Hunter
Hurd (TX)
Issa
Jenkins (KS)
Jenkins (WV)
Johnson (OH)
Johnson, Sam
Jordan
Joyce
Katko
Kelly (MS)
Kelly (PA)
King (IA)
King (NY)
Kinzinger (IL)
Kline
Knight
Labrador
LaHood
LaMalfa
Lamborn
Lance
Latta
LoBiondo
Long
Loudermilk
Lucas
Luetkemeyer
Lummis
MacArthur
Marchant
Marino
Massie
McCarthy
McClintock
McHenry
McKinley
McMorris Rodgers
McSally
Meadows
Meehan
Messer
Mica
Miller (FL)
Miller (MI)
Moolenaar
Mooney (WV)
Mullin
Mulvaney
Murphy (PA)
Neugebauer
Newhouse
Noem
Nunes
Olson
Palazzo
Palmer
Paulsen
Pearce
Perry
Pittenger
Pitts
Poliquin
Pompeo
Posey
Price, Tom
Ratcliffe
Reed
Reichert
Ribble
Rice (SC)
Rigell
Roby
Roe (TN)
Rogers (AL)
Rogers (KY)
Rohrabacher
Rokita
Rooney (FL)
Ros-Lehtinen
Roskam
Ross
Rothfus
Rouzer
Royce
Russell
Salmon
Sanford
Scalise
Schweikert
Scott, Austin
Sensenbrenner
Sessions
Shimkus
Simpson
Sinema
Smith (MO)
Smith (NE)
Smith (NJ)
Smith (TX)
Stefanik
Stewart
Stivers
Stutzman
Thompson (PA)
Thornberry
Tiberi
Tipton
Trott
Turner
Upton
Valadao
Wagner
Walberg
Walden
Walker
Walorski
Walters, Mimi
Weber (TX)
Webster (FL)
Wenstrup
Westerman
Wilson (SC)
Wittman
Womack
Woodall
Yoder
Yoho
Young (AK)
Young (IA)
Young (IN)
Zeldin
Zinke
NAYS--180
Adams
Aguilar
Ashford
Bass
Beatty
Becerra
Bera
Beyer
Bishop (GA)
Blumenauer
Bonamici
Boyle, Brendan F.
Brady (PA)
Brownley (CA)
Bustos
Butterfield
Capps
Capuano
Cardenas
Carney
Carson (IN)
Cartwright
Castor (FL)
Castro (TX)
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clay
Cleaver
Clyburn
Cohen
Connolly
Conyers
Cooper
Costa
Courtney
Crowley
Cuellar
Cummings
Davis (CA)
Davis, Danny
DeFazio
DeGette
Delaney
DeLauro
DelBene
DeSaulnier
Deutch
Dingell
Doggett
Doyle, Michael F.
Duckworth
Edwards
Ellison
Engel
Eshoo
Esty
Evans
Foster
Frankel (FL)
Fudge
Gabbard
Gallego
Garamendi
Graham
Grayson
Green, Al
Green, Gene
Grijalva
Gutierrez
Hanabusa
Hastings
Heck (WA)
Higgins
Himes
Hinojosa
Honda
Hoyer
Huffman
Israel
Jackson Lee
Jeffries
Johnson (GA)
Johnson, E. B.
Kaptur
Keating
Kelly (IL)
Kennedy
Kildee
Kilmer
Kind
Kuster
Langevin
Larsen (WA)
Larson (CT)
Lawrence
Lee
Levin
Lewis
Lieu, Ted
Lipinski
Loebsack
Lofgren
Lowenthal
Lowey
Lujan Grisham (NM)
Lujan, Ben Ray (NM)
Lynch
Maloney, Carolyn
Maloney, Sean
Matsui
McCollum
McGovern
McNerney
Meeks
Meng
Moulton
Nadler
Napolitano
Neal
Nolan
Norcross
O'Rourke
Pallone
Pascrell
Payne
Pelosi
Perlmutter
Peters
Peterson
Pingree
Pocan
Polis
Price (NC)
Quigley
Rangel
Rice (NY)
Richmond
Roybal-Allard
Ruiz
Ruppersberger
Rush
Ryan (OH)
Sanchez, Linda T.
Sanchez, Loretta
Sarbanes
Schakowsky
Schiff
Schrader
Scott (VA)
Scott, David
Serrano
Sewell (AL)
Sherman
Sires
Slaughter
Smith (WA)
Speier
Swalwell (CA)
Takano
Thompson (CA)
Thompson (MS)
Titus
Tonko
Torres
Tsongas
Van Hollen
Vargas
Veasey
Vela
Velazquez
Visclosky
Walz
Wasserman Schultz
Waters, Maxine
Watson Coleman
Welch
Wilson (FL)
Yarmuth
NOT VOTING--24
Barletta
Brown (FL)
Clawson (FL)
Crenshaw
Ellmers (NC)
Farr
Fincher
Hahn
Hensarling
Hurt (VA)
Jolly
Jones
Kirkpatrick
Love
McCaul
McDermott
Moore
Murphy (FL)
Nugent
Poe (TX)
Renacci
Shuster
Westmoreland
Williams
{time} 1333
Mr. HONDA changed his vote from ``yea'' to ``nay.''
So the resolution was agreed to.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
____________________