[Congressional Record Volume 161, Number 106 (Thursday, July 9, 2015)]
[House]
[Pages H5008-H5016]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         21ST CENTURY CURES ACT


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members have 
5 legislative days to revise and extend their remarks and include 
extraneous material on H.R. 6.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  The SPEAKER pro tempore. Pursuant to House Resolution 350 and rule 
XVIII, the Chair declares the House in the Committee of the Whole House 
on the state of the Union for the consideration of the bill, H.R. 6.
  The Chair appoints the gentleman from Nevada (Mr. Hardy) to preside 
over the Committee of the Whole.

                              {time}  1803


                     In the Committee of the Whole

  Accordingly, the House resolved itself into the Committee of the 
Whole House on the state of the Union for the consideration of the bill 
(H.R. 6) to accelerate the discovery, development, and delivery of 21st 
century cures, and

[[Page H5009]]

for other purposes, with Mr. Hardy of Nevada in the chair.
  The Clerk read the title of the bill.
  The CHAIR. Pursuant to the rule, the bill is considered read the 
first time.
  The gentleman from Michigan (Mr. Upton) and the gentleman from New 
Jersey (Mr. Pallone) each will control 30 minutes.
  The Chair recognizes the gentleman from Michigan.
  Mr. UPTON. Mr. Chairman, I include the Committee on Energy and 
Commerce exchange of letters with the Committee on Ways and Means and 
the Committee on Science, Space, and Technology.
         House of Representatives, Committee on Science, Space, 
           and Technology,
                                     Washington, DC, July 9, 2015.
     Hon. Fred Upton,
     Chairman, Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
       Dear Mr. Chairman: I am writing concerning H.R. 6, the 
     ``21st Century Cures Act,'' which your Committee ordered 
     reported on May 21, 2015.
       H.R. 6 contains provisions within the Committee on Science, 
     Space, and Technology's Rule X jurisdiction. As a result of 
     your having consulted with the Committee and in order to 
     expedite this bill for floor consideration, the Committee on 
     Science, Space, and Technology will not seek a sequential 
     referral. This is being done on the basis of our mutual 
     understanding that doing so will in no way diminish or alter 
     the jurisdiction of the Committee on Science, Space, and 
     Technology with respect to the appointment of conferees, or 
     to any future jurisdictional claim over the subject matters 
     contained in the bill or similar legislation.
       I would appreciate your response to this letter confirming 
     this understanding, and would request that you include a copy 
     of this letter and your response in the Congressional Record 
     during the floor consideration of this bill. Thank you in 
     advance for your cooperation.
           Sincerely,
                                                      Lamar Smith,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                     Washington, DC, July 9, 2015.
     Hon. Lamar Smith,
     Chairman, Committee on Science, Space, and Technology, 
         Washington, DC.
       Dear Chairman Smith: Thank you for your letter concerning 
     H.R. 6, the ``21st Century Cures Act.''
       I appreciate your willingness to forgo seeking a sequential 
     referral on H.R. 6 in order to expedite this bill for floor 
     consideration. I agree that doing so will in no way diminish 
     or alter the jurisdiction of the Committee on Science, Space, 
     and Technology with respect to the appointment of conferees, 
     or to any future jurisdictional claim over the subject 
     matters contained in the bill or similar legislation.
       I will include a copy of your letter and this response in 
     the Congressional Record during the floor consideration of 
     this bill.
           Sincerely,
                                                       Fred Upton,
     Chairman.
                                  ____

                                         House of Representatives,


                                  Committee on Ways and Means,

                                     Washington, DC, July 7, 2015.
     Hon. Fred Upton,
     Chairman, Committee on Energy and Commerce, Washington, DC.
       Dear Chairman Upton: I am writing with respect to H.R. 6, 
     the ``21st Century Cures Act.'' As a result of your having 
     consulted with us on provisions in H.R. 6 that fall within 
     the Rule X jurisdiction of the Committee on Ways and Means, I 
     agree to waive consideration of this bill so that it may 
     proceed expeditiously to the House floor.
       The Committee on Ways and Means takes this action with the 
     mutual understanding that by forgoing consideration of H.R. 6 
     at this time, we do not waive any jurisdiction over the 
     subject matter contained in this or similar legislation, and 
     the Committee will be appropriately consulted and involved as 
     the bill or similar legislation moves forward so that we may 
     address any remaining issues that fall within our Rule X 
     jurisdiction. The Committee also reserves the right to seek 
     appointment of an appropriate number of conferees to any 
     House-Senate conference involving this or similar 
     legislation, and requests your support for such request.
       Finally, I would appreciate your response to this letter 
     confirming this understanding, and would ask that a copy of 
     our exchange of letters on this matter be included in the 
     Congressional Record during floor consideration thereof.
           Sincerely,
                                                        Paul Ryan,
     Chairman.
                                  ____

                                         House of Representatives,


                              Committe on Energy and Commerce,

                                     Washington, DC, July 9, 2015.
     Hon. Paul Ryan,
     Chairman, Committee on Ways and Means, Washington, DC
       Dear Chairman Ryan: Thank you for your letter with respect 
     to H.R. 6, the ``21st Century Cures Act.'' I appreciate your 
     willingness to waive consideration of H.R. 6 so that it may 
     proceed expeditiously to the House floor.
       I agree that by forgoing consideration of H.R. 6 at this 
     time, the Committee on Ways and Means does not waive any 
     jurisdiction over the subject matter contained in this or 
     similar legislation, and the Committee will be appropriately 
     consulted and involved as the bill or similar legislation 
     moves forward so that the Committee may address any remaining 
     issues that fall within its Rule X jurisdiction. Further, I 
     understand that the Committee reserves the right to seek 
     appointment of an appropriate number of conferees to any 
     House-Senate conference involving this or similar 
     legislation, and I will support such a request.
       I will include a copy of your letter and this response in 
     the Congressional Record during the floor consideration of 
     this bill.
           Sincerely,
                                                       Fred Upton,
                                                         Chairman.

  Mr. UPTON. Mr. Chairman, I yield 2 minutes to the gentleman from 
Pennsylvania (Mr. Pitts), the distinguished chairman of the Health 
Subcommittee.
  Mr. PITTS. Mr. Chairman, I want to first commend Chairman Upton, 
Ranking Member Pallone, Congresswoman DeGette, and Ranking Member Gene 
Green of Texas for their outstanding support and leadership on this.
  Mr. Chairman, I rise in strong support of H.R. 6, the 21st Century 
Cures Act, 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.
  I have a whole list of people I would like to thank. I will provide 
that for the Record. I especially want to thank legislative counsel for 
their tireless efforts, the healthcare staff of the Congressional 
Budget Office, and the outstanding team on Energy and Commerce. They 
have been fantastic, working 24/7.
  Mr. Chairman, H.R. 6 was reported from Energy and Commerce Committee 
by a vote of 51-0 and advances conservative and fiscal and regulatory 
reforms. Every dollar of advanced appropriations in the bill, which 
will sunset at the end of FY 2020, is offset by other permanent 
reforms, including billions of dollars in mandatory entitlement savings 
in Medicare and Medicaid.
  This is no ordinary spending, like the kind we usually see in 
entitlement spending such as Social Security, Medicare, Medicaid, and 
ObamaCare. This mandatory spending is for 5 years only, and then it 
sunsets. This mandatory spending is fully paid for with mandatory 
spending cuts elsewhere that will not stop in 5 years, but are 
permanent reforms resulting in real savings. By comparison, the Ryan-
Murray budget deal for healthcare savings yielded much less.
  This innovative hybrid approach allows us to cut mandatory spending 
and use the savings to fund what would otherwise be a discretionary 
project, but in this case, it is a 5-year dedicated spending on medical 
research.
  The Congressional Budget Office determined that H.R. 6 will reduce 
the deficit by $500 million over the first 10 years and at least $7 
billion over the second decade. The funds provided to the NIH and FDA 
will be subject to explicit review and reprogramming through the annual 
appropriations process. Congress can review the dedicated funding and 
allocate it for specific initiatives.
  Mr. Chairman, by modernizing clinical trials, eliminating duplicative 
administrative requirements, and perhaps, most importantly, making FDA 
less bureaucratic by advancing the voice and needs of patients in the 
drug and device approval process, H.R. 6 will make lasting, positive 
changes to the entire ecosystem of Cures. Over 250 patient groups have 
enthusiastically said ``yes'' and endorsed this legislation.
  Mr. Chairman, I urge all of my colleagues to think of the patients 
and vote ``aye'' in support of H.R. 6.
  Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume.
  Mr. Chairman, today the House is considering H.R. 6, the 21st Century 
Cures Act, legislation that will further encourage biomedical 
innovation and the development of new treatments and cures that will 
benefit millions.
  More importantly, this legislation will ensure that our country 
remains on the forefront of medical innovation while maintaining the 
gold standard for approvals of medical products.
  Mr. Chairman, this legislation is the product of numerous forums that 
occurred in Washington and around the Nation that heard directly from 
patients and advocacy groups about what innovations could make a 
difference in curing diseases.

[[Page H5010]]

  It is a truly bipartisan initiative of the Energy and Commerce 
Committee, and I want to thank Chairman Upton; Health Subcommittee 
chairman Mr. Pitts; Ranking Member Green; and our sponsor on the 
Democratic side, Representative Diana DeGette, for working together on 
this bill.
  The legislation includes a number of policy proposals that are meant 
to advance the work that NIH and FDA are already doing to encourage 
innovation in medicine, and I want to highlight some of those.
  First, it promotes and supports the best biomedical workforce in the 
world while also increasing the diversity of that workforce by 
requiring the NIH to ensure participation of scientists from 
underrepresented communities.
  Second, it encourages the development of precision medicine and next 
generation treatments.
  Third, it provides FDA with additional tools to make the drug 
approval process more efficient, such as streamlined data review and 
the use of biomarkers in clinical experience to ensure that new 
treatments can reach patients in a timely manner.
  Fourth, it modernizes clinical trials and supports the inclusion of 
diverse populations in clinical research through the National Institute 
on Minority Health and Health Disparities.
  Fifth, it facilitates the development of important antimicrobials and 
treatment for rare diseases and clarifies the regulatory pathway for 
software for medical applications at FDA.
  Finally--although not finally--there are many, many more positive 
developments in this bill, but I do want to mention last, ensuring 
interoperability of our health system which will lead to better access 
to health information, coordinated care, and improved outcomes.
  Most importantly, Mr. Chairman, 21st Century Cures also provides 
mandatory funding to both NIH and FDA to carry out the activities in 
this legislation, funding that is critically needed if Congress wants 
NIH and FDA to fund innovative ways to cure diseases.
  However, I am concerned that the very goal this legislation set out 
to achieve to encourage biomedical innovation and the development of 
new treatments and cures is undermined somewhat by a reduction in 
funding for NIH from $10 billion to $8.75 billion.
  This funding level, the larger one, the $10 billion over 5 years in 
the original bill, enjoyed the unanimous support from the members of 
the Energy and Commerce Committee and the 230 Members of the House who 
were cosponsors of H.R. 6.
  If Congress is truly committed to advancing and encouraging 
biomedical innovation, we must ensure that the Federal Government 
agencies we entrust with facilitating that goal have the resources to 
do so, and I hope that, at some point, as we move further, we can go 
back to the $10 billion.
  I would also urge my colleagues to reject any attempts to make the 
critical funding included in the legislation for NIH and FDA 
discretionary. The NIH ensures the innovation fund was created to be a 
resource to both NIH, FDA, universities, and researchers, including 
those just beginning their careers.
  Any efforts to make this funding discretionary threatens the 
commitment made in 21st Century Cures to encourage innovation.
  I also want to express, Mr. Chairman, my disappointment over the 
inclusion of controversial policy riders on what was otherwise a strong 
bipartisan bill. This inclusion, added to the bill after unanimous 
passage out of the Energy and Commerce Committee, is a political 
distraction from the discussion we should be having on the underlying 
policy.
  I hope that, tomorrow, my colleagues will join me in supporting 
Congresswoman Lee's amendment which will strike those troubling riders 
from the legislation.

  Despite these concerns, I remain totally supportive of the 21st 
Century Cures Act, as I believe it does take significant steps towards 
enhancing how we discover and develop innovative new medical treatments 
in the United States.
  Once again, I take great pride in the fact that we were able to do 
this on a bipartisan basis in our committee and report the bill out 
unanimously.
  Mr. Chairman, I would urge a ``yes'' vote, and I reserve the balance 
of my time.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the vice chair of the 
full committee, the gentlewoman from Tennessee (Mrs. Blackburn).
  Mrs. BLACKBURN. Mr. Chairman, America really is at its best when we 
are facing challenges, and so many of the challenges that we face today 
are in the area of health care and healthcare delivery.
  Right now, we know we have over 10,000 identified diseases. We only 
have cures for 500 of those. This is why we need to work to focus the 
NIH and the FDA on a cures strategy and do this through the legislation 
that is before us today. Indeed, it is bipartisan, and it carries 
different components of bipartisan legislation.
  One is the SOFTWARE Act that Representative Green and I have worked 
on. Mr. Chairman, getting bureaucracy out of the way and allowing 
innovation is the goal of the SOFTWARE Act. It would codify the manner 
in which the FDA approaches health IT, including the wonderful apps 
that we use to help make us healthy.
  The FDA is the agency charged with ensuring the safety and efficacy 
of drugs and medical devices, but data is not a drug or a device, and 
it makes no sense to regulate it as such. That is why we bring forward 
the SOFTWARE Act. We support the bill and encourage others to support 
it.
  Mr. PALLONE. Mr. Chairman, I yield 3 minutes to the gentleman from 
Texas (Mr. Gene Green), who is the ranking member of our Health 
Subcommittee.

                              {time}  1815

  Mr. GENE GREEN of Texas. Mr. Chairman, I rise in strong support of 
the bipartisan landmark legislation, H.R. 6, the 21st Century Cures 
Act.
  Dozens of roundtables and hearings, thousands of responses from 
stakeholders, and countless hours went into crafting this bill. This 
legislation is the product of months of bipartisan collaboration with 
the administration and stakeholders. As a result, H.R. 6 is supported 
by more than 370 patient groups, physician groups, and research 
institutions across the country.
  The investments and provisions in this bill will accelerate the 
development of new tools and treatments for the fight against diseases, 
which have a great cost to our economy and an even greater toll on the 
patients and families that suffer from them.
  After more than a decade of cuts and stagnant budgets, the National 
Institutes of Health will receive $8.75 billion, and it will not 
increase the deficit. This influx of investment will be put toward 
solving today's complex scientific problems and discovering the next 
generation of medical breakthroughs.
  In addition to this much-needed funding for medical research, there 
are so many provisions in this package worthy of support. The 21st 
Century Cures Act will deliver hope and new treatments to Americans.
  While some of the provisions are technical in nature, their real-
world impact is not abstract. Patients and families deserve to have 
their elected officials respond to their needs, and that is what this 
bill does.
  I want to thank Chairman Upton, Congresswoman DeGette, Ranking Member 
Pallone, and Chairman Pitts for their leadership, vision, and 
determination to speed the medical progress. This is an example of what 
our constituents want us to do: legislate and solve problems.
  It was a privilege to be involved in this landmark effort, and I want 
to thank the staffs, legislative counsel, and the countless 
stakeholders who worked tirelessly to craft a bill that lives up to the 
promises of the 21st Century Cures initiative.
  I strongly support H.R. 6 and urge my colleagues to do the same.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from 
Mississippi (Mr. Harper).
  Mr. HARPER. Mr. Chairman, I rise today to speak about the importance 
of tomorrow's vote on the 21st Century Cures initiative. This takes the 
necessary steps forward so that we can deliver safe, effective 
treatments much more efficiently and creatively across America. This 
legislation would give NIH, along with the FDA, much-needed additional 
research dollars.
  Specifically, imagine how a significant increase in funding could 
speed up

[[Page H5011]]

treatments and cures for such debilitating diseases such as Alzheimer's 
and ALS. This legislation gives researchers a fighting chance in the 
hope of finding a cure for so many diseases and disorders. Investing in 
research today will pay dividends long into the future and will 
significantly reduce costs of treatment.
  Give families hope. Vote ``yes'' on 21st Century Cures.
  Mr. PALLONE. Mr. Chairman, I would ask my chairman to proceed with 
another Republican because the gentleman seems to have more people.
  Mr. UPTON. I yield 1 minute to the gentleman from Illinois (Mr. 
Shimkus).
  Mr. SHIMKUS. Mr. Chairman, I am here on the Democrat side, 
congratulating them for great work on 21st Century Cures.
  I was involved in a couple pieces of the legislation that were added, 
one on antibiotic resistance and a lot on medical devices, because we 
need to reform the process. The bureaucracy is tough.
  So, in streamlining these procedures, we are not questioning or 
addressing or harming individual safety, but what we are doing is 
making sure these devices get to where they need it in the quickest 
possible time.
  This is just a small part of the great work of my friends on this 
side--I hope you don't mind me being over here--and the majority side 
in that it is a tribute to what we can do when we work together. I am 
proud to be part of this team.
  Mr. PALLONE. I yield 5 minutes to the gentlewoman from Colorado (Ms. 
DeGette), the Democratic sponsor of the bill who has worked so hard to 
bring us to this day with this bill on the floor.
  Ms. DeGETTE. Mr. Chairman, my father-in-law, Lino Lipinsky de Orlov 
Senior, was a true renaissance man. During World War II, he was a 
member of the Italian resistance, whose family sheltered Jews and 
Allied solders in their apartment. An artist by training, he made his 
way to this country with letters of introduction and became a world-
renowned etcher and museum curator.
  Most importantly, Lino Senior was a wonderful person. Kind to all and 
beloved by his family and friends, he reveled in life's small 
pleasures, creating whimsical drawings for his loved one's birthday 
cards and recounting tales of Italian youth, from idyllic summers on 
Capri to his escapades in the Resistance.
  So, Mr. Chairman, it was more than a tragedy when in 1988, we lost 
Lino Senior to ALS, or Lou Gehrig's disease. ALS is a debilitating 
disease that weakens and atrophies muscles, leaving those with the 
disease the inability to perform even the most mundane tasks, much less 
the ability to create great art.
  Last week, at Craig Rehabilitation Hospital in Denver, I met a young 
man stricken with ALS who was already confined to a wheelchair. He was 
there to support our bill, the 21st Century Cures. But what struck me 
was, in the 25-plus years since we lost Lino Senior, there has been no 
cure. There has been no real treatment for patients who receive this 
diagnosis.
  ALS has been well known and thoroughly evaluated for a long time--
after all, it gets its nickname from one of the most popular athletes 
of the 1920s--but we have made virtually no progress in finding a cure. 
This is not for lack of trying.
  The ALS community is incredibly active. Plenty of us in this Chamber 
and people all around the country took part in the ice bucket challenge 
last year. I thank Fred Upton for a lot of things, but maybe the thing 
I should thank Fred for the most was giving me the opportunity to take 
the ice bucket challenge last year.
  Thanks so much, Fred.
  There is real hope, however, though, for ALS and for thousands of 
diseases for which we lack treatments and cures. Thanks to the mapping 
of the human genome and technological advances like electronic health 
records, researchers are poised to discover new breakthroughs that 
promise dramatic improvements for patients.
  The bill before us today, 21st Century Cures, will ensure that the 
great promise of these developments is harnessed by our Nation's 
premiere research facilities, the National Institutes of Health, and 
the Food and Drug Administration.
  21st Century Cures is a comprehensive bill which will encourage the 
development of new treatments and cures. It starts by making a major 
investment in research with the creation of a 5-year, $8.75 billion 
innovation fund at the NIH. We create this fund to give the leaders the 
chance to plan strategically and to give longer term support to 
promising research projects. Ultimately, these investments will help 
produce new discoveries in the lab.

  Cures then helps to take those discoveries and turn them into 
treatments for patients. We begin by modernizing clinical trials, 
including new efforts to ensure diverse populations participate in 
these research projects.
  We allow centralized approval for clinical trials and adaptive trial 
designs to eliminate wasteful duplication of effort.
  We include the patient perspective into every facet of discovering, 
developing, and delivering treatments, so that a conceptual 
breakthrough can be applied in practical ways.
  We encourage new disease registries to pool information and help 
researchers drill into the data to find the unique and sometimes subtle 
needs of patient populations.
  We help new scientists begin their careers in research so that great 
minds can tackle our biomedical challenges, and we will unlock the 
potential of modern technologies by facilitating safe data sharing and 
using digital medicine. We include many of the proposals in President 
Obama's precision medicine initiative as part of this.
  With this bill, Mr. Chairman, we are going to make sure that in the 
21st century, the pace of breakthroughs, treatments, and cures 
accelerates to meet the challenges of our time. A healthier world is 
coming, and I look forward to getting there as fast as we all can.
  You know, we couldn't have done this without this team, and I want to 
take my minute to thank so many people who have helped with this. 
Ranking Member Pallone's staff: Jeff, Tiffany, Kim, Arielle, Rachel, 
Eric, Waverly; Ranking Member Green's staff: Kristen; Chairman Upton's 
staff: Gary, Clay, John, Paul, Carly, Katie, Adrianna, Robert, Josh, 
Joan, Bits, Mark, Sean, Noelle, Tom, Leighton--they are the majority; 
they have a lot more staff than we do--Chairman Pitts' staff: Heidi; 
Representative Burgess' staff: JP and Daniel; my unbelievable and 
intrepid staff: Rachel, Elizabeth, Matt, Eleanor, Diana Gambrel, Cole; 
my wonderful chief of staff who has been with me for 19 years; leg 
counsel.
  Most of all, I want to thank my partner and compatriot, Fred Upton. 
You have been fabulous, and I look forward to taking this over the 
finish line with you.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from 
Maryland (Mr. Harris), a member of the Appropriations Committee and a 
very valuable member as we put this package together.
  Mr. HARRIS. Mr. Chairman, curing disease and suffering is something 
that even this Congress can agree on on both sides of the aisle. This 
is obvious from tonight's debate.
  Preventative measures are important, but there are still diseases 
that we don't understand how to prevent, much less treat. And the 
purpose of the cure and innovation fund is, in fact, to accelerate the 
discovery.
  Before I came here, I did research on diseases. Is there anyone in 
the country who doesn't believe that we will cure diseases like 
Alzheimer's or ALS? It is only a matter of time and the investments 
that we place in it. As the gentlewoman from Colorado stated, we have a 
lot of the pieces in place in order to create these tremendous new 
discoveries, and this bill gets us on the path.
  There is going to be a lot of talk about cost on the floor, but the 
cost of these diseases is not just measured in dollars. The cost is 
measured in families in ways that you can't measure in dollars.
  Any family who treated a member with Alzheimer's disease, for 
instance, understands exactly what I mean by that.
  Now, a lot of those costs are huge. Alzheimer's alone, for instance, 
is hundreds of billions of dollars in Medicare and Medicaid expenses 
over the next 10 years. If we can cure it, we can save those.

[[Page H5012]]

  Mr. Chairman, it is time to invest in those cures. We simply can't 
afford not to.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from South 
Carolina (Mr. Duncan).
  Mr. DUNCAN of South Carolina. Mr. Chairman, I lost my father April 14 
of this year to Alzheimer's. It is a terrible disease. I watched how it 
affected him. I know that there are millions of Americans and American 
families that are dealing with Alzheimer's.
  The 21st Century Cures Act will focus some resources so we can find a 
cure for Alzheimer's and we can find a cure for these diseases that are 
costing American taxpayers so much money.
  I want to applaud the chairman, and I want to urge everyone to get 
behind the 21st Century Cures Act so we can find a cure for diseases 
like Alzheimer's in memory of my father, John Duncan.
  Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from 
Illinois (Mr. Rush), who is the ranking member of our Energy 
Subcommittee.
  Mr. RUSH. Mr. Chairman, I rise in support of H.R. 6, the 21st Century 
Cures Act, and I want to thank Chairman Upton, Ranking Member Pallone, 
Ranking Member Green, and Ranking Member DeGette for their tireless 
work and commitment to this issue.
  Mr. Chairman, this landmark piece of legislation will help modernize 
and personalize health care, encourage greater innovation, support 
research, and streamline the healthcare system to deliver better, 
faster cures to more and more patients.
  Mr. Chairman, we might live in different regions, we might live in 
different times, we might be of different nationalities, we might even 
be of different faiths, but when it comes to the overall health of our 
Nation, we can surely put aside our differences and do the right thing 
for the American people.
  I want to highlight two provisions of my bill, H.R. 2468, the 
Minority Inclusion in Clinical Trials Act of 2015, that were included 
in the 21st Century Cures Act.
  The first provision will require the National Institute on Minority 
Health and Health Disparities to include, within its strategic plan for 
biomedical research, ways to increase representation of 
underrepresented communities in clinical trials.

                              {time}  1830

  The second will ensure that it remains a priority at NIH to increase 
the inclusion rates of traditionally underrepresented communities 
within the future biomedical workforce.
  The CHAIR. The time of the gentleman has expired.
  Mr. PALLONE. Mr. Chairman, I yield the gentleman such time as he may 
consume.
  Mr. RUSH. Simply put, Mr. Chairman, these provisions addressed 
persistent systemic and widespread disparities in health outcomes for 
minority communities.
  As you know, many diseases, including cancer, heart disease, stroke, 
HIV/AIDS, diabetes, lupus, osteoporosis, asthma, sickle cell, and 
kidney diseases have been studied at length and still afflict minority 
populations in disturbing numbers and at disturbing rates.
  Minorities are disproportionately underrepresented in clinical 
trials. There are many reasons attributed to this disproportionality, 
such as a lack of funding.
  The chief culprit is that research professionals tend to work toward 
solutions for the cure of diseases to which they have personal 
connections and have personal experiences.
  Mr. Chairman, I am so glad that the 21st Century Cures Act does 
address some of these critical issues. I rise in support of the 21st 
Century Cures Act, and I urge my colleagues on both sides of the aisle 
to vote in favor of H.R. 6.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from 
Florida (Mr. Bilirakis), a member of the Health Subcommittee.
  Mr. BILIRAKIS. Mr. Chairman, I rise in support of the 21st Century 
Cures Act.
  This bill represents meaningful reform for patients with rare or 
chronic conditions. I would like to highlight one provision I am so 
proud of, the OPEN Act.
  There are 1 in 10 Americans who suffer from a rare disease. That is 
10 percent of the country. Over 95 percent of these diseases have no 
treatments.
  Patients like Candace and Laura from the Tampa Bay Area need FDA-
approved safe and effective treatments. Laura has no treatment options, 
and Candace did her own research and took a medication off label and is 
now in remission.
  The OPEN Act will incentivize major market drugs and combination drug 
products to be repurposed to treat rare diseases and put them on label.
  The 30 million Americans with rare diseases need your ``yes'' vote. 
Vote for this bill. Vote for patients.
  Mr. PALLONE. Mr. Chairman, I reserve the balance of my time.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from New 
Jersey (Mr. Lance), a member of the Health Subcommittee.
  Mr. LANCE. Mr. Chairman, this is the way Congress should work, in a 
bipartisan capacity. In my 5 years on the committee, this is the most 
significant piece of legislation to be voted out of the committee 
unanimously.
  To those of us who are listening on C-SPAN this evening, this is what 
the American people demand of Congress, bipartisan cooperation.
  This bill will save countless lives not only in this country, but 
across the globe. I am so pleased it includes language coauthored by 
Congresswoman Anna Eshoo of California and me exempting future Food and 
Drug Administration user fees from sequestration.
  I urge an extremely positive vote tomorrow. I hope that all of our 
colleagues will support this to indicate to the Senate of the United 
States that it should move forward as well so that the legislation can 
reach the desk of the President of the United States.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from 
Indiana (Mr. Bucshon), a member of the Health Subcommittee.
  Mr. BUCSHON. Mr. Chairman, I rise today in support of 21st Century 
Cures, an initiative that gives hope to patients and families who have 
battled or who will battle one of the 10,000 diseases with no known 
cures, like my good friend and mayor of Jasper, Indiana, Terry Seitz, 
who lost his wife and the mother of their two daughters, Ann Seitz, to 
ALS 5 years ago on Thanksgiving Day, the family's favorite holiday.
  As Mayor Seitz put it, 21st Century Cures gives patients and their 
families the opportunity for hope and the ability to cope. These two 
things mean the world to those fighting a rare disease who face so much 
uncertainty about what the future may hold. 21st Century Cures turns 
hopelessness into hope.
  Mr. Chairman, we have a real opportunity today to improve the lives 
of these patients across the country, and we need to seize it.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentlewoman from 
North Carolina (Mrs. Ellmers), a member of the Health Subcommittee.
  Mrs. ELLMERS of North Carolina. Mr. Chairman, I rise today to shed 
light on why the nonpartisan 21st Century Cures Act is important for 
patients everywhere.
  As a nurse and as part of our team working on this effort over the 
last year, I can relay that the 21st Century Cures Act is important 
because of people like my constituent back home, Ellie Helton.
  Ellie was a beautiful, courageous constituent of mine. She loved 
peanut butter cups, the color pink, and most of all her family and her 
friends. At about this time last year Ellie suffered from a ruptured 
brain aneurysm that took her life at the tender age of 14.
  The 21st Century Cures Act legislation creates an accelerated process 
by which we discover and develop cures and treatments for patients like 
Ellie. This legislation is fully offset and will reduce the deficit by 
more than $500 million over the first decade.
  Mr. Chairman, I am so proud to be a Member of Congress who is working 
on this legislation with all of my colleagues, and I am so proud of our 
chairman, Fred Upton, for the work that he has done. This is an 
incredible effort, and I am so proud to be a part of it.
  Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentlewoman from 
California (Mrs. Capps), who is also a healthcare professional.
  Mrs. CAPPS. I thank my colleague for yielding.

[[Page H5013]]

  Mr. Chairman, I rise today to speak on behalf of H.R. 6, the 21st 
Century Cures Act, and I salute the bipartisan authors of this bill.
  I am a cosponsor of this legislation. I am proud of the many hours of 
work that members of the Energy and Commerce Committee have put in to 
find common ground. This is a real achievement. 21st Century Cures is a 
good bill. It has come a long way, but I lend my support with some 
reservations.
  Despite bipartisan agreement in committee to provide robust funding 
for the research initiatives and policies in this bill, the bill before 
us shorts the NIH by over $1 billion, and these funds are the very ones 
that are critical for cures.
  It is important that we provide the necessary support that the NIH 
requires to continue to be the gold standard in research and 
development.
  While we all agree that it is important to speed up research and 
clinical trials to get treatments to those in need, I want to reiterate 
my concerns that this focus on speed should not undercut the work that 
so many have done for years, including many of us here in Congress, to 
improve diversity in research and clinical trials.
  While this bill does include my provision to encourage the inclusion 
of children and the elderly in clinical trials, more needs to be done 
to ensure that women and minorities are included as well. This is an 
effort I led during the FDA reauthorization, and it is one that must 
not be undercut by the Cures effort.

  Finally, I must express my disappointment that once again the House 
majority has decided to add language to the bill that politicizes the 
bipartisan effort and attacks women's personal decisionmaking.
  It is a distraction from the important work that we are trying to do 
here, and I strongly urge my colleagues on both sides of the aisle to 
support the amendment to strip it.
  The 21st Century Cures initiative is such an important bipartisan 
effort to strengthen our medical research and treatment development. It 
could be stronger, and I stand willing to work with my colleagues to do 
just that.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from 
Missouri (Mr. Long).
  Mr. LONG. Mr. Chairman, what an accomplishment it is to have this 
historic legislation on the House floor.
  I want to congratulate the chairman and my Energy and Commerce 
Committee colleagues for their hard work. We are much closer to moving 
American medical innovation into the 21st century. Part of that is to 
keep up with the ability to communicate in a modern way with patients.
  As the chairman knows, I have worked very closely with him and his 
staff during this past year to draft language to update the Food and 
Drug Administration's oversight of healthcare information on the 
Internet, especially on social media.
  Millions of people use the Internet to find critical health 
information on treatments and other health topics. Unfortunately, 
current FDA regulations do not help communicate accurate, meaningful 
information online about healthcare solutions, such as prescription 
drugs and medical devices.
  There is enormous potential to improve American lives if we can get 
the FDA to write workable rules and guidance to communicate information 
where people's attention is focused.
  After all, the FDA itself regularly turns to the Internet to announce 
its activities and inform the public, presumably in a safe and 
informative way.
  I have legislation to do this, and I hope to continue working with 
the chairman to modernize healthcare communications and, thus, help 
improve the lives of all Americans.
  I look forward to continuing to work with the chairman on the 21st 
Century Cures to make sure this monumental bill ultimately meets the 
President's pen and is signed into law.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentleman from West 
Virginia (Mr. McKinley).
  Mr. McKINLEY. Mr. Chairman, I rise today in favor of H.R. 6.
  By encouraging innovation and providing more resources for 
groundbreaking research, we can provide a better future for our 
children and our grandchildren.
  America has a rich history of scientific discovery, from putting a 
man on the Moon to finding a cure for polio. With the right focus, we 
can do the same in finding cures for devastating diseases, like cancer 
and Alzheimer's.
  I want to thank Chairman Upton for his commitment to making 
Alzheimer's one of the neurological diseases on which the CDC will 
collect data. 21st Century Cures will improve the lives of all 
Americans by bringing research from the lab to our families.
  I thank the chairman, the committee, and the staff for all of their 
dedicated work on this.
  Mr. UPTON. Mr. Chairman, I yield 1 minute to the gentlewoman from 
Indiana (Mrs. Brooks), a member of the Health Subcommittee.
  Mrs. BROOKS of Indiana. Mr. Chairman, I rise today to express my 
wholehearted support for the 21st Century Cures initiative. This 
legislation will change lives, and it will save lives.
  When Chairman Upton and Congresswoman DeGette introduced this 
bipartisan initiative, they promised it would be different. They used 
words like ``bold,'' ``transformative,'' ``profound,'' and ``hope.'' 
They promised hope, and they promised to change lives. Thankfully, they 
have delivered on these promises and then some.
  21st Century Cures will profoundly transform our Nation's ability to 
discover, develop, and deliver the cures of tomorrow. It will change 
and even save lives, lives like that of Fifth District constituent 
Teresa Altemeyer, who has a form of chronic leukemia.
  21st Century Cures can make all of the difference. She recently told 
me, as one of the many hundreds of thousands of patients living with 
chronic lingering cancer, ``I am always looking forward to the future 
for the next therapy that can either hold off my cancer or potentially 
cure it, and in the past the wait for these medications has been 
excruciatingly slow.''
  Tomorrow I will be missing the funeral of a dear friend, Judy Warren, 
who died on Sunday from pancreatic cancer. She would have wanted me to 
be here tomorrow, voting on this bill. It couldn't save her, but it can 
save Teresa and many others.
  Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from 
Iowa (Mr. Loebsack).
  Mr. LOEBSACK. I thank the ranking member for yielding.
  Mr. Chairman, this legislation, I believe, as Mr. Lance stated, is 
proof that we can accomplish great things when we put aside 
partisanship and unite around a common goal.
  To that end, I want to thank all of my wonderful colleagues here 
today who have worked on this thing for so long. I am new to the 
committee, and coming into this and being able to be a part of this is 
really a great honor for me.

                              {time}  1845

  I want to thank the chair and the ranking member also for my 
provision to extend and expand the prior authorization program for 
prior mobility devices in this bill, providing certainty to Medicare 
beneficiaries that these critical devices will, in fact, be covered.
  I am also excited about the NIH innovation fund, which entails 
mandatory funding, as was mentioned earlier, and will support 
scientists like those working at the University of Iowa.
  As a result, we will have more groundbreaking advances like the 
University of Iowa researchers' discovery of a biomarker that could 
lead to early detection for the risk of preeclampsia in pregnant women, 
a discovery that could save countless lives.
  While I am disappointed that the NIH funding was cut from $10 billion 
to $8.75 billion, I am hopeful that we can restore this amount as the 
process moves forward.
  Finally, I am really happy that we finally have gotten to a point in 
this body, at least on this legislation, where we can think longer term 
and not just short term, not just about the costs for this program this 
year or even for the next 5 years, but think about all the savings that 
this will entail down the road as well, something that really happens 
far too often, I think, in this body and over in the Senate as well.
  I thank my colleagues for their work on this issue. I am really very 
pleased to be a part of the process. Thank you for having me as a 
member of that committee and to be a part of the process.
  Mr. UPTON. Mr. Chair, I yield 1 minute to the gentleman from New

[[Page H5014]]

York (Mr. Collins), a member of the committee.
  Mr. COLLINS of New York. Mr. Chair, I rise today in support of H.R. 
6, the 21st Century Cures Act. This legislation will modernize and 
advance our healthcare system to help the millions of Americans 
battling rare diseases. It increases funding for NIH grants used by 
scientists at world class universities like those in my district in 
Buffalo and Rochester, New York.
  H.R. 6 streamlines the drug approval process at the FDA, helping get 
new drugs to market faster. Patients are demanding a fresh approach to 
drug approval and biomedical research. This legislation provides 
America's medical innovators the guidance they need to lead a new age 
of medical innovations.
  I want to thank Chairman Upton and my colleagues on the Committee on 
Energy and Commerce for their dedication to this cause. I am proud of 
the work we have accomplished, and I am confident that this legislation 
accomplishes our goal of incentivizing innovation and defeating 
disease.
  Mr. UPTON. Mr. Chair, I yield 1 minute to another gentleman from New 
York (Mr. Gibson), who again had a very positive impact on the 
legislation that was bipartisan as a part of this bill.
  Mr. GIBSON. Mr. Chairman, I rise in support of H.R. 6 on behalf of 
the many Americans who have been impacted by Lyme disease and other 
tickborne diseases. Lyme disease is rapidly becoming a public health 
scourge in the U.S. We simply need to do better at prevention, 
diagnosis, and treatment.
  H.R. 6 includes the text of the Tick-Borne Disease Research 
Accountability and Transparency Act, which is a truly constituent-
driven effort and represents a significant step forward in bringing 
solutions for our chronic Lyme sufferers.
  I would like to thank the physicians, the patient advocates, and 
researchers that helped in this process, including Dr. Richard 
Horowitz, Pat Smith, David Roth, Jill and Ira Auerbach, Holly Ahern, 
Chris Fisk, and other Lyme advocates across the nation, including 
Representative Chris Smith of New Jersey and my coauthor and friend, 
Representative Joe Courtney of Connecticut.
  Finally, I would like to thank Chairman Upton, Ranking Members 
Pallone and DeGette, and their dedicated committee staff for working 
tirelessly to include members' input and manage an open, bipartisan 
process for this important legislation.
  I urge my colleagues to support this bill.
  Mr. PALLONE. Mr. Chairman, how much time remains on each side?
  The CHAIR. The gentleman from New Jersey has 11 minutes remaining. 
The gentleman from Michigan has 14\1/2\ minutes remaining.
  Mr. UPTON. Mr. Chair, I yield 1 minute to the gentleman from Georgia 
(Mr. Allen).
  Mr. ALLEN. Mr. Chair, I rise today to support the 21st Century Cures 
Act and thank the chairman and the Committee on Energy and Commerce to 
keep America at the forefront of medical innovation by removing 
barriers that prevent development and delivery of life-improving 
therapies.
  However, this is not only an issue of keeping America competitive; it 
is a moral issue. The greatest physician in history said in Matthew: 
``Whatever you did for one of the least of these brothers and sisters 
of mine, you did for me.''
  I want to share the story of Brennan Simkins, who was diagnosed with 
childhood cancer. Brennan has had over four stem cell transplants. He 
is still living today, and he is the student of my wife, who is 
teaching him piano.
  He is truly a miracle and a blessing to us, but he still requires 
medications. There are medications out there which are caught up in 
bureaucratic red tape. By passing this bill, we can help patients and 
families across the country, like Brennan Simkins, get access to the 
medicines of tomorrow.
  The CHAIR. The time of the gentleman has expired.
  Mr. UPTON. I yield the gentleman an additional 30 seconds.
  Mr. ALLEN. I urge my colleagues to support H.R. 6.
  Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from 
California (Mr. Aguilar).
  Mr. AGUILAR. Mr. Chair, I appreciate the gentleman from New Jersey 
yielding some time.
  Tomorrow, the House will vote on the 21st Century Cures Act, 
legislation that will advance medical research at the FDA and the NIH 
to lead new treatment for cures for countless people. This is 
necessary.
  However, what is not necessary is the dangerous language that 
Republican leadership quietly tucked in the bill that blocks access to 
reproductive care. This is unacceptable.
  As a member of the Pro-Choice Caucus, I oppose this and other 
attempts to expand restrictions on reproductive care. We cannot allow 
this type of antichoice language to keep appearing in what is otherwise 
important legislation.
  Today, it is in legislation to further medical research. Before, it 
was in legislation to fund community health centers and to protect 
victims of trafficking. Allowing this policy to move forward will move 
women's health care backward. We cannot allow these attacks to 
continue.
  Representatives Lee, Clarke, and Schakowsky have offered an amendment 
to strike this destructive antichoice language. Today, I offer them my 
strong support.
  I urge my colleagues to vote in favor of their amendment and to also 
insist that we need to stop injecting the Hyde language into parts of 
law it doesn't belong.
  Mr. UPTON. Mr. Chair, I yield 1 minute to the gentlewoman from 
California (Mrs. Mimi Walters).
  Mrs. MIMI WALTERS of California. Mr. Chair, I rise today in support 
of the 21st Century Cures Act. This bill is a bold proposal that would 
accelerate our scientists' ability to develop lifesaving cures. Our 
need for action is now. Currently, more than 10,000 known diseases 
exist in the world; however, we only have treatments for approximately 
500.
  In my district of southern California, 4-year-old Callan Mullins was 
born with a severe congenital heart defect. He has undergone four open 
heart surgeries, suffered numerous strokes, been diagnosed with 
cerebral palsy; and at the age of 3, doctors delivered the 
heartbreaking news that he had a brain tumor.
  Callan is a fighter and a survivor, but his parents are still seeking 
answers and medical breakthroughs to ensure that he can live life to 
its fullest. The Cures Act would offer hope to the millions of 
Americans like Callan battling devastating illnesses.
  I thank Chairman Fred Upton for his tireless work on this bill. I 
urge my colleagues to stand with me as we pave the way for lifesaving 
treatments and cures.
  Mr. PALLONE. Mr. Chairman, I yield myself the balance of my time to 
close.
  Before conclusion of debate, Mr. Chairman, let me just take a minute 
to recognize Chairman Upton and Representative DeGette for their 
steadfast dedication to this bill.
  This bill would not have been possible without their work for so many 
years, beginning when they had these forums where they heard from 
patients and the advocacy groups around the country.
  The process that they used to actually obtain information that became 
the basis for this bill was really unusual and was very, I would say, 
populist and grassroots in a way that I think I would like to see 
emulated in the future because it was so successful.
  It is further proof, I think, also that when we want to work together 
to achieve great things, we are capable. I know it hasn't always been 
easy, and the staff has had to work around the clock and on weekends 
and during holidays since January, but this is a good bill that I am 
proud to support.
  I just want to thank not only the members, but also the staff of 
Chairman Upton and Chairman Pitts. That is Gary Andres, Clay Alspach, 
John Stone, Carly McWilliams, Paul Eddatel, Robert Horne, Joan 
Hillebrands, Katie Novaria, Adrianna Simonelli, and Heidi Stirrup.
  Let me also thank Representative DeGette for her work, her staff as 
well: Lisa Cohen, Rachel Stauffer, and Elizabeth Farrar; Mr. Green's 
staff: Kristen O'Neill; and, of course, my staff: Jeff Carroll, Tiffany 
Guarascio, Kim Trzeciak, Eric Flamm, Rachel Pryor, Waverly Gordon, and 
Arielle Woronoff.
  Let me just say this: Obviously, I urge support for this legislation. 
I hope

[[Page H5015]]

that we get a huge vote, but I think the biggest satisfaction that I am 
going to get when this passes and we work to get it passed in the 
Senate and to the President's desk is that every Member of Congress 
knows that, when we go home, there are always events with various 
advocacy groups.
  I think, of course, of the pancreatic cancer group because my mom 
died of pancreatic cancer about 5 years ago, 7 months after she was 
diagnosed, which is actually a long time. Many people die within 6 
weeks or 2 months after diagnosis because the diagnosis takes so long 
and occurs too late, effectively.
  You go to these various events that the groups have. Sometimes, it is 
a run; or it is a walk. Diana DeGette mentioned ALS. I went to an ALS 
walk, I think, about 3 or 4 weeks ago.
  The typical response--and I am thinking of this last ALS walk--is 
that someone will come up to you and say: Why aren't you doing enough 
to find a cure? Why aren't you spending more money? Why aren't you 
prioritizing this disease? Why is it so difficult to have a clinical 
trial or to get involved in a clinical trial?
  For 20 years, most of the time, when somebody has brought that up, I 
haven't really had an easy response because, for many of the diseases, 
there hasn't been really much progress at all.
  Now, the biggest satisfaction I am going to have--and I have already 
had it over the last few weeks--is when I go back and I go to one of 
these events and one of the patients or advocate representatives says 
to me: Well, what are you doing about this?
  I will be able to say: Well, we have a bill called 21st Century 
Cures, and it does a lot of things that could make a difference in 
terms of what your concerns are.
  That, to me, is the greatest satisfaction, really, of our being able 
to pass this bill tomorrow.
  I would urge support on a bipartisan basis.
  I yield back the balance of my time.
  Mr. UPTON. Mr. Chair, if I might ask, how much time do I have 
remaining?
  The CHAIR. The gentleman from Michigan has 12\1/2\ minutes remaining.
  Mr. UPTON. I yield myself the balance of the time to close. I won't 
use 12\1/2\ minutes, I don't think.
  Mr. Chair, I appreciate you being here tonight and the Members, 
knowing that we are going to debate a number of amendments and vote on 
final passage tomorrow morning.
  We have all thanked a lot of people here, a lot of great staff, 
terrific staff, a lot of good Members. I am not sure anyone has 
actually thanked the leadership on both sides.
  I want to thank John Boehner, the Speaker, not only for giving us 
H.R. 6, but his strong support all the way; Kevin McCarthy, our 
majority leader; Steve Scalise, our whip; Cathy McMorris Rodgers, our 
conference chair; and on the Democratic side, too, Nancy Pelosi, former 
Speaker, has been terrific; Steny Hoyer has been in the trenches every 
day on this issue, came and participated in our very first roundtable 
more than a year ago to see this bill move forward. It is, indeed, a 
bipartisan bill.
  Every one of us here, as we think about the 434 of us here in the 
House, every one of us has taken a different path to get here. We each 
represent diverse districts, and despite our differences geographically 
and politically, whether we have an R or a D next to our name, I 
daresay that there is one thread that indeed binds us all.
  We are all here to improve the lives of our friends, our neighbors, 
and our family members at home.

                              {time}  1900

  This is Brooke and Brielle. I am in the middle. So look at just 
Brooke and Brielle. They and so many of our friends, neighbors, and 
family members are why we are here today. These two little girls from 
my district in Michigan are bravely battling SMA. They are two of the 
brightest stars that I know.
  Our 21st Century Cures effort seeks to capture just a sliver of the 
hope and optimism that countless patients like Brooke and Brielle 
exude, despite insurmountable odds.
  A year and a half ago, we had an idea. We sat down, Republicans and 
Democrats, and it was time for Congress to do something positive to 
boost research and innovation and deliver real hope for more cures by 
expediting the approval of drugs and devices. That is what this bill 
does.
  We traveled the country. We had probably 40 or 50 different 
roundtable and subcommittee hearings all over the place, and we 
appreciated Republican and Democratic participation. We visited with 
patients, researchers, innovators, and health experts from across the 
health spectrum. We listened, and we put pen to paper, and then we 
listened some more. And that is why we are here today.
  There is not a single person in this Chamber or watching at home 
tonight who has not been touched by disease in some way, and it is 
about time that we actually do something about it.
  So as we begin debate on this landmark bill, I can't help but think 
of the patients who are sitting across from their doctors right now 
about to get news that certainly is going to change their world.
  It is not just the disease that makes them feel powerless and 
vulnerable. The very system designed to help them has not kept pace 
with scientific advances. They need the next generation of treatment 
and cures, but they don't have until the next generation to wait.
  They aren't interested in debating why the timelines, the failure 
rates, the size and the costs of conducting clinical trials are at all-
time highs. They know that, despite the promise of scientific 
breakthroughs, they can't get the therapy that might save them. That is 
why we need this bill.
  We have all said too many early good-byes--too many--and we have seen 
families robbed of a parent that is never going to get to see their 
child's milestones, like not see them walk down the aisle, maybe not 
see a graduation, maybe not see a career, maybe not see them raise a 
family of their own, and we have seen children that are born without 
the gift of a future. Life is not always fair. We know that, but we 
have got to try and do better.
  The last century and the century before it brought just remarkable 
medical breakthroughs. From x rays and anesthesia to pacemakers and 
transplants, the tools to diagnose and treat patients have been 
transformed over and over and over again; yet for every single disease 
that we defeat, every condition we cure, there are thousands more still 
plaguing our people. Of the 10,000 known diseases, 7,000 of which are 
rare, there are treatments for only 500.
  The history of health innovation is indeed remarkable, but now we 
have got our sights set on this bill, 21st Century Cures. The bill is 
about making sure that our laws, regulations, and resources keep pace 
with scientific advances.
  So what does it take to vanquish a disease? Yes, often billions of 
dollars, millions of hours--that is for sure--thousands of researchers, 
and hundreds--maybe thousands--of failed attempts can go into the 
development of yet just one single treatment or cure. It is daunting, 
it seems impossible, but still, patients like Brooke and Brielle hold 
out hope.
  They battle through pain, transcend physical limitations, and live 
lives filled with joy and optimism. Our brothers and sisters, moms and 
dads, grandparents and friends, they all keep faith in the future, in 
spite of suffering. This bill, the 21st Century Cures initiative, is 
for them. It is for those that we lost, those who grapple with sickness 
today, and those who will be diagnosed tomorrow.
  In this, the greatest century in the world on the greatest country on 
the planet, Americans deserve a system that is second to none. We can 
and must do better. It is about hope--hope that the burden for patients 
and caregivers is less tomorrow than it was yesterday--and it is about 
time.
  So as Brooke and Brielle always say with a smile and a sparkle in 
their eyes, ``We can, and we will.'' The time for 21st Century Cures is 
now.
  Please join us, Republicans and Democrats, leaders on both sides of 
the aisle, for the patients that we want to solve these diseases for, 
by supporting this bill, by working with our colleagues in the Senate, 
but really listening to the voices that call for us to do something 
well. This is it, H.R. 6. Please vote for it tomorrow.
  I yield back the balance of my time.
  Mrs. McMORRIS RODGERS. Mr. Chair, I rise today in support of the 21st 
Century Cures

[[Page H5016]]

Act. I thank Chairman Upton and my colleagues on the Energy and 
Commerce Committee for all the work they've done advancing this 
important initiative.
  For the past year and a half, we have been listening to experts and 
patients across the country detail how we can proactively address 
America's growing health care needs and areas where cures and therapies 
are lacking.
  The single best thing we can do? Make sure that our ultimate goal 
should not be to provide lifelong treatment, but to find life-saving 
cures.
  It shouldn't take 15 years and billions of dollars to maybe get a new 
medical innovation approved. We need to remove the unnecessary barriers 
between Americans and life-changing innovation.
  This means prioritizing resources, cutting through red tape, and 
empowering scientists and researchers so they can discover, develop and 
deliver medical breakthroughs. 21st Century Cures does this.
  I'm proud to have authored six major provisions in the Cures package. 
These are bills that modernize HIPAA laws, accelerate the discovery of 
new cures, create research consortia to treat pediatric disorders, and 
bring our regulatory framework into the 21st century by embracing 
technologies that focus on patient-specific therapies and the potential 
for powerful indicators, like Biomarkers.
  Mr. Chair, we have a unique opportunity here today. Today we are 
offering hope for the millions of Americans suffering from currently 
incurable and untreatable diseases.
  Hope for the Eastern Washington dad with ALS who just wants to see 
his kids grow up.
  Hope for the high school student with cancer waiting for the FDA to 
approve a clinical trial.
  This is our chance to help foster an environment where innovation is 
accelerated, not stifled. Where discovery and high paying jobs are here 
in the United States, not abroad.
  This is our chance to offer the promise of real solutions to the 
American people.
  Mr. Chair, I ask my colleagues join me in taking advantage of this 
tremendous opportunity, and passing 21st Century Cures.
  Mr. WHITFIELD. Mr. Chair, I rise today in support of H.R. 6, the 21st 
Century Cures Act, which will help uncover the next generation of 
ground-breaking cures and treatments for the thousands of diseases that 
currently have none. H.R. 6 will streamline the delivery process, 
enhance research and development, and modernize the regulatory system 
for approving drugs and medical devices. For patients, families, and 
loved ones affected by serious illnesses, this legislation offers real 
hope.
  Last summer, I was fortunate to meet a young man named Scott Andrew 
Mosley who lives in my district in Henderson, Kentucky. Scott is 13 
years old and was diagnosed with Duchenne's Muscular Dystrophy (DMD) at 
the age of 6. DMD is a recessive X-linked form of muscular dystrophy, 
affecting around 1 in 3,600 boys, which results in muscle degeneration 
and premature death.
  DMD begins in the legs and over time attacks all the muscles in the 
body. Young Scott became unable to walk at the age of 9 because of DMD, 
but has never complained about the hand he has been dealt. He offers 
encouraging smiles to everyone he meets, despite knowing he faces a 
disease without a cure. Last year, a group of gentlemen in the 
Henderson community rallied together and volunteered to remodel and 
refit Scott's bedroom with his own shower and equipment necessary to 
transfer him from bed to bath. These gentlemen volunteered their time, 
talent, and money to help Scott and his family because it was the right 
thing to do.
  Mr. Chair, as a Member of this esteemed body, I believe it is our 
duty and obligation to pass the 21st Century Cures Act so that people 
like Scott Mosley can have hope for a cure for DMD and so many other 
diseases. Many other Kentuckians and Americans across this country are 
also in need, and passing the 21st Century Cures Act will bring them 
hope, and it also is the right thing to do. My thoughts and prayers 
remain with Scott and the Mosley family, and I thank them for the 
opportunity to speak on their behalf.
  Ms. EDDIE BERNICE JOHNSON of Texas. Mr. Chair, I rise in support of 
H.R. 6, the 21st Century Cures Act. Unanimously passed out of the House 
Energy and Commerce Committee with a 51-0 vote, the 21st Century Cures 
initiative will encourage innovation in biomedical research and 
development of new treatments.
  With $8.75 billion in mandatory funding over the next five years 
delivered to the newly created National Institutes of Health and Cures 
Innovation Fund and $550 million for the Food and Drug Administration 
over the next five years, it is clear that Congress is committed to 
investing in health research. Developing a better system of funding 
towards high-risk high reward research and research by early stage 
investigators is crucial to finding better health outcomes. With a 
better focus on infectious disease, precision medicine, and biomarkers, 
I strongly believe that we will finally address these areas of unmet 
medical needs, which are often the most pervasive issues in our health 
system.
  The modernization of clinical trials by supporting a more centralized 
system, moving to more adaptive clinical trial designs, and creating a 
national neurological disease surveillance system will help to develop 
better data and provide more patient success stories. The legislation 
also allows for better sharing of clinical trial information for 
researchers and scientists for more efficiency across the board. Also, 
the bill ensures that strategies will be developed to cast a wider net 
for clinical trials in order to increase minority representation.
  Last October, I wrote a letter urging the White House to take into 
consideration UT-Southwesten's existing particle therapy research 
infrastructure and expertise in leading cancer treatment research in 
the U.S. when selecting the planning grant award recipients. The 
planned center would serve as a research adjunct to an independently 
created and funded, sustainable clinical facility for particle beam 
radiation therapy. Currently, the planning grant includes pilot 
projects that will enable a research agenda in particle beam delivery 
systems, dosimetry, radiation biology, and/or translational pre-
clinical studies.
  Mr. Chair, the advanced planning grant the UT Southwestern Medical 
Center received in February 2015, is exactly the type of medical and 
technological advancement the DFW Metroplex and country needs and is 
the type of federal investment we need to continue to lead the world in 
state-of-the-art medical research. Not only is this grant a major 
advancement for STEM, it is a crucial step in the right direction for 
cancer research and those affected by cancer here in the United States.
  This legislation provides new funding opportunities for innovative 
cancer treatment approaches such as the development of America's first 
Heavy Ion Center for cancer therapy and would pave the way to keep 
America at the forefront of medical research and state-of-the-art 
cancer treatment.
  While H.R. 6 contains many provisions regarding the biomedical 
research workforce, clinical trials, FDA improvements, I am most proud 
of the initiative's provisions regarding mandatory funding for the NIH 
and FDA. I strongly believe that the Congress has not placed enough 
importance on scientific research and this is a way to get us back on 
track. Investing in innovation will yield high rewards for the medical 
community, especially patients. I am proud to support H.R. 6, the 21st 
Century Cures Act.
  The CHAIR. All time for general debate has expired.
  Mr. UPTON. Mr. Chairman, I move that the Committee do now rise.
  The motion was agreed to.
  Accordingly, the Committee rose; and the Speaker pro tempore (Mr. 
Thompson of Pennsylvania) having assumed the chair, Mr. Hardy, Chair of 
the Committee of the Whole House on the state of the Union, reported 
that that Committee, having had under consideration the bill (H.R. 6) 
to accelerate the discovery, development, and delivery of 21st century 
cures, and for other purposes, had come to no resolution thereon.

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