[Congressional Record (Bound Edition), Volume 161 (2015), Part 8]
[House]
[Pages 11150-11164]
[From the U.S. 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 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.

[[Page 11151]]

         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,


                             Committee 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.
  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

[[Page 11152]]

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

[[Page 11153]]

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 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

[[Page 11154]]

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.
  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

[[Page 11155]]

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.
  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

[[Page 11156]]

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 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 bone marrow 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.

[[Page 11157]]

  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 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

[[Page 11158]]

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 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

[[Page 11159]]

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.
  Mr. BOUSTANY. Mr. Chair, I rise today to express opposition to H.R. 
6, the 21st Century Cures Act.
  As a doctor, I strongly support medical innovation and research. Over 
the course of my 30 years practicing medicine, I saw tremendous leaps 
and bounds in treatment that saved lives. I appreciate the hard work 
put into creatively attempting to modernize the health-care innovation 
infrastructure, specifically efforts to incorporate a patient 
perspective into the drug and device approval process, support advances 
in personalized medicine, and streamline clinical trials. However, I 
cannot support the sale of 64 million barrels of crude oil from the 
Strategic Petroleum Reserve being used to pay for these changes.
  Over the past year, the price of oil has dropped from above $100 per 
barrel to below $50. Although the price of oil is currently at $54 a 
barrel on the global markets, this is far from stable. I do not 
understand why Congress would agree to sell 64 million barrels from the 
Strategic Petroleum Reserve when the price is low, flooding the global 
oil marketplace, and likely causing the price to drop even further. 
This has the potential to cause havoc for our own domestic oil and gas 
industry.
  The decline in oil prices is hurting the states that had benefited 
from the domestic oil-production boom in recent years. My home state of 
Louisiana ranked second in the U.S. in oil production and second in 
natural gas production in 2013, with more than 64,000 Louisianans 
employed in extraction, pipeline and refining industries. This industry 
matters to everyone in Louisiana.
  According to the American Petroleum Institute the U.S. oil and 
natural gas industry supports more than 9 million jobs nationwide, 
supports over 7% of GDP, and contributes more than $86 million to the 
Federal Treasury every day. Since oil prices began to drop, it has been 
widely reported that the oil and gas industry have been struggling to 
keep their employees on payroll. In April, the U.S. Bureau of Labor 
Statistics announced that Louisiana suffered a 3,300 job loss in the 
mining and logging sector. In June we saw two consecutive week losses 
in mining employment--that's the category that includes many oil and 
gas exploration and extraction jobs--have slipped below 100 in 
Louisiana.
  I will not accept the false choice between supporting medical 
innovation and Louisiana oil and gas jobs. I believe it's irresponsible 
to flood the global market for petroleum with more product while 
Louisiana families are experiencing layoffs because of low global 
prices.
  Many of my colleagues have stated that given the remarkable expansion 
of North American oil production, a reduction in the size of the 
reserve could be seen as responsible cost-effective public policy. I 
would disagree. Research shows that price spikes in transportation 
fuels is highly regressive, with most of the cost disproportionately 
hitting middle class and low-income groups. This vulnerability remains 
even though our work shows that the U.S. and much of the Western 
hemisphere will largely separate from physical trade flows with Middle 
East producers in the next few years.
  According to the U.S. Energy Information Agency (EIA), the U.S. 
economy will continue to rely upon petroleum for many years, and work 
by EPRINC and many other research groups demonstrates that we will 
remain vulnerable to severe economic damage from disruptions in 
petroleum supplies in the world oil market. The SPR remains an 
important strategic asset for protecting the U.S. economy and security 
interests from this vulnerability.
  Selling barrels from the Strategic Petroleum Reserve should be done 
in a thoughtful and strategic manner when global prices are high, not 
as another coffer for Congress to raid at its convenience and at the 
expense of Louisiana's oil & gas industry.
  Mr. UPTON. Mr. Chair, the following is my statement in its entirety:
  We launched this effort a year-and-a-half ago. And with tomorrow's 
House vote, we mark an important milestone in our quest for 21st 
Century Cures--one step closer to the finish line.
  There are so many individuals throughout our 18 month journey that 
helped get us to where we are today. Patients across the country. 
Advocates. Researchers. Innovators. Experts. Academics. Regulators. 
Some of the nation's brightest minds. To all we say thank you.
  Thank you to the staff--on both sides of the aisle--who took the 
meetings, did the research, drafted the language, and sat at the 
negotiating table for countless hours to help us develop this 
incredible product. Gary Andres, Joan Hillebrands, Alexa Marrero, Clay 
Alspach, Paul Edattel, Josh Trent, Robert Horne, John Stone, Carly 
McWilliams, Katie Novaria, Adrianna Simonelli, Graham Pittman, Michelle 
Rosenberg, Traci Vitek, Sean Bonyun, Noelle Clemente, Macey Sevcik, 
Mark Ratner, Tom Wilbur, Bits Thomas, Marty Dannenfelser, Tim Pataki, 
Karen Christian, Peter Kielty, Jeff Carroll, Tiffany Guarascio, Lisa 
Cohen, Rachel Stauffer, Elizabeth Farrar, Matt Inzeo, Cole Leiter and 
all the Democratic staff, the staff of our members . . . thank you all. 
Thank you to House legislative counsel and the Congressional Budget 
Office for your efforts and dedication. Thank you to the members of 
both parties who brought their best ideas, partnered with one another 
to make their case, and delivered so many of the policies we welcome 
today.
  I'd also like to thank Hal Rogers and his staff. The Appropriations 
Committee has been a critical partner in this effort, working with us 
and developing the right approach to achieve our shared goal of helping 
patients in a fiscally responsible way.
  I especially want to highlight my partner in this effort from day 
one, Ms. DeGette. She has been to Michigan, and I have travelled to 
Colorado--we have been on a number of road trips for Cures and I look 
forward to the next journey. I also want to thank Mr. Pitts, Mr. 
Pallone, and Mr. Green for their partnership. We have made great 
strides but our work continues--and we won't stop until the ink is dry 
on the 21st Century Cures Act in the Oval Office.
  I also want to give a hearty thank you to Max--a 6-year old 
ambassador for Cures. Although he is faced with the challenge of Noonan 
syndrome, he has been a little warrior in this effort. He joined us 
when we had our 51 to zero vote in the committee. And I am delighted 
Max will be by my side tomorrow on the floor for final passage.
  Helping Max is why we're here. Helping my friends Brooke and Brielle 
is why we are here.
  With a resounding vote, we will send a signal to the Senate--loud and 
clear--that the time is now for Cures 2015. I look forward to working 
with my Senate counterparts to continue the momentum and get 21st 
Century Cures to the president's desk.
  We have a chance to do something big, and this is our time.
  Vote yes.
  Mr. BILIRAKIS. Mr. Chair, on a personal level, I have family members 
who have suffered with Parkinson's--I witness this debilitating disease 
through them. It is hard to see. Few things in America are truly 
ubiquitous--diseases, sadly, are one of those things.
  In addition to the struggle chronic and rare disease patients face, 
physicians, researchers, clinicians, and medical device companies 
(among others) deal with an outdated and overly burdensome regulatory 
structure. These regulations stifle the development of new cures and 
treatments, whether they are drugs, biologics, or devices.
  Given the reality, we have to ask: how can we get cures and 
treatments to the people who desperately need them?
  That is the question the 21st Century Cures Initiative was created to 
answer. The 21st Century Cures Initiative is a bipartisan undertaking 
by members of the Energy and Commerce Committee to help our healthcare 
innovation infrastructure thrive and deliver more hope for all 
patients. This is a tremendous undertaking, and is much easier said 
than done.
  It is about finding new ways to drive innovation. In addition to 
adequate funding and resources, we need to think critically about 
structural changes to streamline and modernize our health care system. 
We need to rethink what we have been doing and how we are doing it for 
the 21st Century.
  This is what 21st Century Cures Initiative is giving us: an 
opportunity to address some of the structural barriers to new cures and 
promote new ways to incentivize developments. The 21st Century Cures 
Initiative has examined and seeks to accelerate the complete cycle of 
cures--from discovery to development to delivery and back again to 
discovery. This has resulted in the 21st Century Cures Act--a 
culmination of over a year's worth of engaging with patients, 
researchers, physicians, government, and private entities.
  This year included numerous hearings and roundtables in Washington 
D.C. As legislators, we worked tirelessly to engage all stakeholders 
from across the spectrum. The only way we can answer the question--how 
do we get better cures and treatments?--is to work with everyone 
involved in the American health care system.
  I am proud that I was able to have several provisions that were 
included in the final version of the Cures Act. These provisions will 
help to change the lives of patients in small to

[[Page 11160]]

larger ways. I want to take a moment and highlight some of the 
provisions and some of the people that helped shape the policy.
  Rare diseases are not a rare problem. Nearly 30 million Americans--1 
in every 10 people--are living with a rare disease.
  That is why I introduced the OPEN Act--the Orphan Product Extensions 
Now Act. It was included as a provision of the 21st Century Cures Act.
  My bipartisan bill has the potential to help millions of people by 
incentivizing the testing of mainstream drugs--or repurposing them--to 
treat rare diseases and pediatric cancers, and it was included as a 
major provision in the 21st Century Cures Act.
  The OPEN Act would unlock a new world of potential treatments--it 
would put FDA-approved, safe, and effective treatments ``on-label.''
  Through the 21st Century Cures Act, Congress has a chance to come 
together to make a real difference in the lives of the 160 million 
Americans who suffer from a rare or chronic condition, as well as the 
family members and friends of all those afflicted.
  The OPEN Act is one provision in the 21st Century Cures Act, but it 
is one I am proud to have authored, and one I believe will make a 
substantial difference in the lives of a lot of people.
  I want to take this opportunity to thank all the people who helped 
make the OPEN Act a reality, and who fought for this legislation to be 
in the 21st Century Cures Act.
  Julia Jenkins, Max Bronstein, Andy Russell, Harry Sporidis, Tim 
Perrin, everyone at the EveryLife Foundation for Rare Diseases, and the 
other 155 rare disease groups that supported the OPEN Act:

       National MPS Society, With Purpose, National PKU Alliance, 
     Taylor's Tale, RASopathies Network USA, Kids v Cancer, Let 
     Them Be Little X2 Inc., Info and Resources for Idiopathic 
     Pulmonary Hemosiderosis (IPH-NET), Noah's Hope, Mary Payton's 
     Miracle Foundation, Hope4Bridget Foundation, Batten Disease 
     Support & Research Association, Cure Sanfilippo Foundation, 
     Beyond Batten Disease Foundation, Drew's Hope Scientific 
     Research Foundation, International Pemphigus and Pemphigoid 
     Foundation (IPPF), Cure AHC, Autoinflammatory Alliance, MLD 
     Foundation, Fabry Support & Information Group, Children's PKU 
     Network, FMD Chat;
       National Tay-Sachs & Allied Diseases Association (NTSAD), 
     Little Miss Hannah Foundation, Rare Disease United 
     Foundation, Global Genes Project, Fibromuscular Dysplasia 
     Society of America (FMDSA), Lymphatic Malformation Institute, 
     Mastocytosis Society, EB Research Partnership, BRBN Alliance, 
     Jonah's Just Begun, Abigail Alliance for Better Access to 
     Developmental Drugs, Hannah's Hope Fund, GNE Myopathy 
     International, The Ryan Foundation, Organic Acidemia 
     Association, Cardio-Facio-Cutaneous International, NGLY1.org, 
     Gwendolyn Strong Foundation, POMC Island One boy an Ocean of 
     friends, Gene Giraffe Project, International FOP Association, 
     Aware of Angels;
       CureCADASIL, GT23 FOUNDATION, Desmoid Tumor Research 
     Foundation (DTRF), The Association for Glycogen Storage 
     Disease, Gene Spotlight Inc., Amyloidosis Foundation, 
     Heriditary Neuropathy Foundation, Relapsing Polychondritis, 
     Klippel-Feil Syndrome Freedom, CureDuchenne, Prader-Willi 
     Syndrome Association, Bert's Big Adventure, Parent Project 
     Muscular Dystrophy, Sarcoma Foundation of America, The 
     Nicholas Conor Institute, Luck2Tuck Foundation, Team 
     Sanfilippo Foundation, The Rally Foundation for Childhood 
     Cancer Research, CARES Foundation, Inc., Help Extinguish 
     Hunter Syndrome, Sephardic Health Organization for Referral & 
     Education, Hunter Syndrome Research Coalition;
       The Kortney Rose Foundation, Saving Case & Friends, Phelan-
     McDermid Syndrome Foundation, The Children's Medical Research 
     Foundation, Inc., Cure SMA, Narcolepsy Network, Celiac 
     Support Association, Caleb's Crusade Against Childhood 
     Cancer, International Waldenstrom's Macroglobulinemia 
     Foundation (IWMF), PKD Foundation, EDSers United Foundation, 
     Choroideremia Research Foundation, Inc., Genetic Alliance, 
     The Life Raft Group, The Will Luthcke Foundation, Angioma 
     Alliance, Smashing Walnuts Foundation, Castleman Disease 
     Collaborative Network/Castleman's Awareness & Research 
     Effort, The GIST Cancer Awareness Foundation, The Truth 365, 
     The Arms Wide Open Childhood Cancer Foundation, Sophia's 
     Fund;
       Journey4ACure, Princesses on a Mission, Inc., Noah's Light 
     Foundation, Pediatric Cancer Foundation, West Virginia Kids 
     Cancer Crusaders, Inc., Bear Necessities Cancer Foundation, A 
     Kids' Brain Tumor Cure, RARE Science, Inc., ISMRD (the 
     International Advocate for Glycoprotein Storage Diseases), 
     Hermansky-Pudlak Syndrome Network Inc., Run4Rare, A-T 
     Children's Project, The Global Foundation for Peroxisomal 
     Disorders, The Adult Polyglucosan Body Disease Research 
     Foundation (APBDRF), Alexa Nawrocki Pediatric Cancer 
     Foundation, Beckwith-Wiedemann Children's Foundation 
     International, The Brooke Healey Foundation, Talia's Legacy 
     Children's Cancer Foundation, The Rare Childhood Cancer 
     Advocacy Group, Alex's Army Childhood Cancer Foundation, The 
     Catherine Elizabeth Blair Memorial Foundation, Stillbrave 
     Childhood Cancer Foundation;
       Cures Within Reach, ALL4Trey, Team Sabrina, Sofia's Hope, 
     Inc., ALL4Trey, Delainee's Battle, Joey's Wings Foundation, 
     The Bozeman 3, Team Ashley Bragg, Cole vs Cancer, Dominick 
     One in a Million, Samuel Szabo Foundation, Wilms Tumor 
     Survivor Group, Aiden's Army, Sofia's Hope, Inc., Mikey's Way 
     Foundation, Team Serena, Supporting Our Cancer Kids, The 
     Champ's Corner, Habitat for Hope, Ali's Angels Foundation, 
     Gold Rush Cure Foundation;
       Sickle Cell Warriors, Inc., The Rare Cancer Research 
     Foundation, Carson Leslie Foundation, Amyloidosis Research 
     Consortium, Pulmonary Fibrosis Advocates, The Coalition for 
     Pulmonary Fibrosis, Mytonic Dystrophy Foundation, LMSarcoma 
     Direct Research Foundation, BioPontis Alliance for Rare 
     Diseases, Foundation for Ichthyosis & Related Skin Types, 
     Inc., 5p-Society, The Santonio Holmes III & Long Foundation, 
     National Fragile X Foundation, National Organization for Rare 
     Disorders (NORD), OsteoPETrosis Society, Curing Retinal 
     Blindness Foundation, The MAGIC Foundation, Cure HHT, DEFY 
     Foundation, Chase After a Cure, DC Outreach Inc., Children's 
     Cardiomyopathy Foundation, and the Bridget the Gap--SYNGAP 
     Education and Research Foundation.

  These groups' grassroots efforts were instrumental in the effort to 
get the OPEN Act in the 21st Century Cures Act.
  I would like to thank all the participants of the two 21st Century 
Roundtables I held in my District in August of 2014. Your input was 
vital in the early stages of drafting the 21st Century Cures Act, and I 
will be forever appreciative:
  Dr. Wayne Taylor, on behalf of the Leukemia and Lymphoma Society;
  Mrs. Colleen Labbadia, on behalf of the Parent Project for Muscular 
Dystrophy (PPMD);
  Ms. Patricia Stanco, MHS, on behalf of the ALS Association Florida 
Chapter;
  Ms. Ashleigh Pike and Ms. Beth Pike--dysautonomia patient advocates;
  Dr. Samantha Lindsay, on behalf of the Alpha-1 Foundation;
  Ms. Janice Starling, on behalf of the American Association of Kidney 
Patients;
  Mr. and Mrs. Michael and Gretchen Church, on behalf of the 
Parkinson's Action Network;
  Dr. Clifton Gooch, FAAN, Professor and Chair, Department of 
Neurology, University of South Florida;
  Dr. Dave Morgan, CEO and Director of USF's Byrd Alzheimer's 
Institute;
  Dr. Richard Finkel, Chief Neurologist at Nemour's Children's 
Hospital;
  Mr. Geary A. Havran, President of NDH Medical, Inc., and Chairman, 
Florida Medical Manufacturers Consortium (FMMC);
  Ms. Lisa Novorska, CFO, Rochester Electro-Medical, Inc.;
  Dr. Thomas Sellers, MPH., Center Director and Executive Vice 
President for Moffit Cancer Center;
  Dr. Glen Hortin, Clinical Pathology Medical Director for the 
Southeast Region, for Quest Diagnostics.
  Additionally, I want to thank Nick Manetto from PPMD and USAgainst 
Alzheimer's, Miriam O'Day from the Alpha-1 Foundation, John DeMuro from 
Moffitt, Monica Richter from USF, Jennifer Sheridan from PAN, Gary 
Dessatti, John Ray from FMMC, and Erin O'Malley and Virginia Biggar 
from USAgainstAlzheimer's.
  I would also like to thank Candace Lerman, Laura Milford, and Max 
Schill. They are all rare disease patients and advocates who I have had 
the pleasure of meeting. Their in-person advocacy and their dedication 
to improve the lives of everyone with a rare disease is admirable. I am 
truly grateful to their contribution and support of this legislation.
  I also want to recognize Noah Coughlan and Jonny Lee Miller. Noah is 
a young man who ran across the country--over 3,000 miles--three times 
to raise awareness for rare diseases. This is a feat achieved by very 
few, and is a tremendous physical feat demonstrating his dedication to 
this cause. Jonny Lee Miller is an actor and advocate who runs ultra-
marathons to raise money and awareness for rare diseases.
  To everyone else who was involved, supported the OPEN Act, tweeted 
about it, posted about it on Facebook, or advocated on behalf of the 30 
million Americans with rare diseases, I sincerely thank you from the 
bottom of my heart.
  Additionally, the 21st Century Cures Act includes another one of my 
bills, H.R. 2298, the Patient Safety and Prescription Drug Abuse 
Prevention Act. I began work on this bill three years ago, after a 
prescription drug abuse hearing. The problem was apparent, and a fix 
was desperately needed.

[[Page 11161]]

  This provision will create a drug management program within Medicare 
to use the same tools used in Medicaid, TRICARE, and private insurance 
to deal with the growth in prescription drug abuse.
  The Substance Abuse and Mental Health Administration (SAMHSA) 
estimates that there are 15.3 million Americans over the age of 12 that 
``used prescription drugs non-medically in the last year.'' USA Today 
reported that in 2012, the average number of seniors misusing or 
dependent on prescription pain relievers in the past year grew to an 
estimated 336,000, up from 132,000 a decade earlier, based on data from 
SAMHSA. Addiction does not recognize age, race, ethnicity, or income. 
Anyone could be susceptible including seniors.
  The U.S. Department of Health and Human Services' Office of the 
Inspector General has recommended that Medicare have this type of a 
program. In a hearing, the Center for Medicare and Medicaid Services' 
Principal Deputy Administrator stated that they supported this policy, 
but needed a statutory change in the law to create such a program.
  A change to the Medicare program is a herculean task. I want to thank 
some of the people that supported this provision and helped get this 
legislation over the finish line. Lindsay Berman from the Pew 
Charitable Trusts, Jerry Steffl, Jonathan Heafitz, Gary Kline, Sergio 
Santiviago, Richard Hoar, Heather Cutler, Nelson Bunn from the Major 
County Sheriffs Association, and Chuck DeWitt from the Major Cities 
Chiefs Association.
  Mr. DeFAZIO. Mr. Chair, federal funding for biomedical research has 
been stagnant over the past several years, another victim of unwise and 
shortsighted sequestration and budget cuts that put deficit reduction 
before investments that can save lives.
  With no increase to counter the effects of inflation and increased 
cost of research, NIH has lost 22 percent of its purchasing power over 
the last decade. NIH has been forced to cut or deny funding for 
thousands of promising studies that could hold the key to incredible 
breakthroughs.
  We should do everything we can to bring cures to patients as quickly 
as possible. Far too many people suffer from rare, serious and deadly 
diseases, and its outrageous cures could be found except for the lack 
of funding. It's also important we make sure drugs are safe and 
actually do what they are intended to do. I have concerns with some of 
the proposed changes to FDA's approval process designed to speed drugs 
and devices to market. We need to be certain that the proposed changes 
will not subject patients to a high level of risk. I expect the Senate 
will review and fix those provisions when they take up the bill.
  HR. 6 does what Congress has been unable to do because the Republican 
majority refuses to understand a simple fact: Funding biomedical 
research, just like investing in our roads and bridges, is an 
investment, not wasteful spending.
  Ms. JACKSON LEE. Mr. Chair, I rise in support of H.R. 6, the 21st 
Century Cures Act, a bipartisan piece of legislation that is vital to 
the future and health of our Nation's citizens and ecosystem.
  This thoughtful legislation is the culmination of the hard work of my 
dedicated colleagues who have sought out and engaged in public 
conversations with patients, innovators, providers, regulators and 
researchers about how to move advances in science and medicine into new 
therapies.
  This outreach has garnered the critical input and support of more 
than 370 patient and physician groups, state and local organizations, 
cancer centers, and research and life sciences.
  I'm proud to be one of the cosponsors of H.R. 6, which represents a 
new national effort to find treatment and cures for thousands of 
unknown and rare diseases.
  Looking to the various policies this legislation aims to address, it 
is important to highlight the commendable objectives and that will not 
only accelerate the discovery, development and delivery of new 
treatments and cures for thousands of serious and rare diseases, but it 
will also open the doors of innovation and the growth of health care 
system by enhancing and enriching the medical field for all Americans.
  The most ambitious action calls for $10 billion in mandatory funding 
to be delivered over the next five years to the National Institutes of 
Health (NIH).
  NIH is part of our nation's top ranked educational research 
institutions in the world.
  In order to maintain our global competitiveness in the biomedical 
field, we must invest in the industries that guarantee economic 
prosperity for our current and future economies.
  It has been estimated that every $1 of NIH funding generates about 
$2.21 in local economic growth, and, in 2012, NIH funded research 
supported an estimated 402,000 jobs all across the U.S.
  The bill's funding for NIH would provide for an annual 3% increases 
in the NIH budget, which has been stagnant for the past few years and 
which desperately needs more funding to capitalize on emerging 
scientific insights.
  This increased funding not only aims to continue the sustainability 
of our economy but it also supports our President's initiative to 
provide more resources to the biomedical field.
  The 21st Century Cure Act supports the President's Precision Medicine 
Initiative, which would advance a new model of participant-centered 
research to accelerate biomedical discoveries and provide clinicians 
with new tools and therapies tailored to individual patients' needs.
  The Obama Administration believes they can build on their progress in 
improving the drug development and approval process by: incorporating 
patients' voices into the Food and Drug Administration (FDA) decision-
making; encouraging the development and qualification of reliable 
biomarkers to accelerate work on important new therapies; and reducing 
barriers to initiating medical device trials.
  In furtherance of this initiative, H.R. 6 allows for the creation of 
an ``Innovation Fund'' through the National Institute of Health.
  This ``Innovation Fund'' is a welcome effort because it promotes the 
maintenance of the best biomedical workforce in the world and help to 
increase the diversity of the biomedical workforce.
  In particular, the $2 billion provided for the Innovation Fund, will 
not only increase the number of the research projects it supports but 
it also increases the cap for NIH's loan repayment programs.
  This would include a repayment program for clinical scientists who do 
research in health disparities and for clinical scientist from 
disadvantaged backgrounds, from $35,000 per year to $50,000 per year 
plus a yearly inflation for adjustment.
  With the support of H.R. 6, underrepresented communities and those 
with disadvantaged backgrounds from across the country can undoubtedly 
provide the future researchers and workers of the biomedical workforce.
  The Journal on STEM Education reported in 2011 that only 8.34% of the 
STEM doctorates awarded in 2006 were given to underrepresented 
minorities, despite making up approximately 28% of the U.S. population.
  Furthermore, GAO noted that while the percentage of underrepresented 
minorities nationwide increased from 13% to 19% from 1994 to 2003, the 
total number of STEM doctorates awarded to the same group dropped 
during this period from 8,335 to 7,310.
  In response, the National Institute of General Medical Sciences 
(NIGMS) created the Minority Opportunities in Research (MORE) Division 
and similar academic intervention programs.
  The MORE programs are comprised of four primary components: research 
experience, mentoring and advisement, supplemental instruction and 
workshops, and financial support.
  In 2007, NIGMS' annual budget was $1.9 billion, of which nearly $126 
million was spent on its MORE programs.
  This amount includes the Minority Biomedical Research Support-
Research Initiative for Scientific Enhancement (MBRS-RISE) program, the 
Minority Access to Research Careers (MARC), Post-baccalaureate Research 
Education Program (PREP), and the Bridges to the Baccalaureate and 
Bridges to the PhD programs.
  The amount of funds dedicated to these programs reflects the 
commitment by the science and research community to the goals of the 
MORE Division in addressing this problem.
  Increased funding set forth in H.R. 6 will only strengthen NIH's 
focus on diversifying the biomedical workforce by requiring NIH to 
focus on ensuring participation from scientists from underrepresented 
communities.
  In addition to addressing the needs of underrepresented communities, 
H.R. 6 also calls for specific action to increase representation of 
racial minorities.
  The 21st Century Cures Act acknowledges that there are disturbing 
statistics on the low numbers of African Americans, Hispanics and 
Native Americans pursuing academic qualification and participating in 
scientific research.
  Under H.R. 6, the National Institute on Minority Health and Health 
Disparities will necessarily include strategies for increasing 
representation of minority communities in its strategic plan.
  I am proud to say that H.R. 6 includes the Jackson Lee Amendment, 
which makes a good bill even better by ensuring that the national goals 
of finding and bringing more cures

[[Page 11162]]

and treatments to patients and strengthening the biomedical innovation 
ecosystem in the United States is aided by an expanding pool of diverse 
and talented medical researchers.
  Specifically, the Jackson Lee Amendment provides: The Secretary of 
Health and Human Services shall conduct outreach to historically Black 
colleges and universities, Hispanic-serving institutions, Native 
American colleges, and rural colleges to ensure that health 
professionals from underrepresented populations are aware of research 
opportunities under this Act.
  Many racial health disparities stem from lack of access to effective 
test, treatments and cures for illnesses that have devastating 
consequences for African American, Hispanic and Native American 
populations.
  For example:
  1. African-Americans represent 12% of the U.S. population but only 5% 
of clinical trial participants.
  2. Hispanics make up 16% of the population but only 1% of clinical 
trial participants.
  3. Women are under-represented in cardiovascular device trials, which 
have 67% male participation.
  The most significant barriers limiting clinical participation are 
race, age, and sex of participants:
  1. Women and minority patients are more difficult to recruit.
  2. Women and minority physicians have less experience and are 
relatively more costly to engage.
  3. Minority patients with limited English proficiency can require 
costly translation services.
  Physicians are the gateway to the patient.
  Increasing diversity of those conducting research will have 
implications on the types of conditions that are researched and the 
participants in clinical trials that are seeking answers to illnesses 
like lupus, triple negative breast cancer, and sickle cell disease that 
can be difficult to detect, treat and cure.
  Certain medical illnesses have been known to have higher prevalence 
in certain demographic groups, including type II diabetes, lupus, 
sickle cell anemia, and Triple Negative Breast Cancer for which African 
Americans are more than twice as likely to be diagnosed on average.
  Lupus, triple negative breast cancer and sickle cell disease are of 
particular concern because they are often difficult to diagnose and 
disproportionately impact persons of color and especially women.
  In particular, Lupus is a chronic, complex and prevalent autoimmune 
disease that affects more than 1.5 million Americans. Yet, Lupus is one 
of America's least recognized major diseases.
  More than 90% of lupus sufferers are women, mostly young women 
between the ages of 15 to 44, and women of color are two to three times 
more at risk for lupus than Caucasians.
  Triple negative breast cancer also disproportionately impacts younger 
women, African American women, Hispanic/Latina women, and women with a 
``BRCA1 genetic mutation, which is prevalent in Jewish 
women.
  More than 30% of all breast cancer diagnoses in African American are 
of the triple negative variety, and African American women are far more 
susceptible to this dangerous subtype than white or Hispanic women.
  Additionally, there are about 2 million people that carry the sickle 
cell trait and with about 100,000 having the disease.
  According to the Centers for Disease Control and Prevention, sickle 
cell trait is common among African Americans and occurs in about 1 in 
12, and sickle cell disease occurs in about 1 out of every 500 African-
American births, compared to about 1 out of every 36,000 Hispanic-
American births.
  Treatments for Lupus, triple negative breast cancer and sickle cell 
disease are not progressing as quickly as desired by patients, 
researchers, and policy makers.
  We must support the advancement of legislation that will allow for 
the remediation and end of health care disparities and the promotion of 
research parity for diseases such as lupus, triple negative breast 
cancer, sickle cell disease, and countless other rare and serious 
diseases.
  Race and ethnicity have also been shown to affect the effectiveness 
of and response to certain drugs, such as anti-hypertensive therapies 
in the treatment of hypertension in African Americans and anti-
depressants in Hispanics.
  Increased diversity in research trials could help researchers find 
better, more precise ways to fight diseases that disproportionately 
impact certain populations, and may be important for the safe and 
effective use of new therapies.
  As one of the most diverse cities in the country, Houston is the 4th 
largest city in the United States and the 5th most populated 
metropolitan area in the nation.
  Houston is home to the largest medical complex in the world--the 
Texas Medical Center, which provides clinical health care, research and 
education at its 54 institutions.
  The University of Houston, ranked number three out of all other 
colleges and universities in Texas, is an example of a premier 
institution that can produce students with advanced STEM degrees who 
would be able to join a progressing biomedical field.
  Another important requirement of H.R. 6 is that it would require the 
National Institutes of Health to publically report the number of 
children by race and gender who participate in NIH funded clinical 
trials.
  This legislation would help ensure that children of all races are 
adequately represented in clinical trials and that we can determine the 
safety and effectiveness of drugs on children of all demographic 
backgrounds.
  With 10,000 known diseases, 7,000 of which are rare, and treatments 
for only 500 of them--clear there is much work to do.
  Medical research saves lives and improves the quality of life for 
millions of Americans because the government provides a steady and 
reliable commitment to basic research into cures for debilitating and 
deadly diseases.
  Given the array of commendable initiatives, H.R. 6 is a necessary 
piece of legislation that will accelerate the discovery, development, 
and delivery of promising new treatments and cures for all patients 
while investing in our nation's ability to maintain the best and most 
diverse biomedical workforce in the world.
  Mr. Chair, I call for the support of all of my colleagues in ensuring 
the passage of the important legislation.
  Ms. SEWELL of Alabama. Mr. Chair, today, I stand in strong support of 
the 21st Century Cures Act. This bipartisan bill gives our nation's 
best and brightest the tools they need to understand--and eventually 
defeat disease--and reauthorizes both the National Institutes of Health 
(NIH) and the Food and Drug Administration (FDA).
  The 21st Century Cures Act has the potential to accelerate the 
discovery of drugs for life-threatening illnesses; repurpose drugs 
found ineffective for one condition and test them on another; promote 
an interoperable health system; enhance telehealth practices; and 
advance the development of more targeted, personalized treatments.
  My district, the 7th Congressional District of Alabama, is home to 
the University of Alabama at Birmingham, the Southern Research 
Institute, and the University of Alabama. NIH funding is critical to 
the continuing vitality of these three leading institutions, as well as 
to the region.
  The prospect of this act alone provides hope. Hope that cures can be 
discovered, hope that one day no diagnoses indicate inevitable ailment 
or death, and hope that one day treatments will yield more reward than 
risk.
  Despite the potential of this bill, there are two amendments that 
threaten that hope and essentially aim to inhibit the health of several 
Americans. First, the Hyde Amendment has reared its ugly head yet 
again. It is a harmful and discriminatory bill that prevents women from 
making their own healthcare decisions. Further, it serves as a stark 
contradiction to efforts geared toward providing health positive 
resources for all.
  Second, the Brat amendment aims to convert the federal funding of the 
NIH and the FDA from mandatory to discretionary. Such a transaction 
would stifle the progress both federal agencies have already made and 
will continue to make. It will singlehandedly reverse the trajectory of 
medical progress and halt further research efforts.
  I am particularly supportive of the 21st Century Cures Act because of 
its inclusion of provisions for the pediatric and rare disease 
community. This bill will allow Children's of Alabama, ranked among the 
nation's best children's hospitals for six years in a row, to finally 
be able to participate in a national pediatric research network and 
therefore, save more lives.
  With only 5 percent of rare diseases having an FDA-approved 
treatment, it would be a gross understatement to say our medical 
systems have failed to keep pace. Gabe Griffin from Birmingham and 
Houston Sides from Montgomery are two young Alabama boys who asked me 
to support the 21st Century Cures Act because it modernizes the FDA and 
spurs development of pediatric and rare disease treatments. Gabe and 
Houston have a rare and deadly muscle-wasting disorder called Duchenne 
Muscular Dystrophy. This disease takes the lives of children as young 
as 9 or 10. Very few children with this disease will ever reach the age 
of 25. But the 21st Century Cures Act provides hope for these families. 
It promotes `precision medicine,' modernizes the clinical trial system, 
and expands access to investigational drugs.
  Viruses and diseases will not wait for us to catch up; they will 
mutate, grow ever more virulent, and continue to impact our public

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health. We need to leverage our investments to make potentially game-
changing strides in treatment. We need 21st century solutions for 21st 
century threats.
  An investment in health affects more than our physical well-being, 
and the 21st Century Cares Act reflects this. H.R. 6 is not only a 
health bill; it is a jobs bill. Our country has been the leader in both 
the medical device and biopharmaceutical industry for decades, helping 
us become the core of global medical innovation. This puts a target on 
our backs, as China and other countries have attempted to attempt to 
claim this role and thus, our jobs. U.S. medical device-related 
employment totals over 2 million jobs, and the U.S. biopharmaceutical 
industry is responsible for over 4 million U.S. jobs. NIH funding 
currently supports over 400,000 jobs at research institutions across 
the country, including jobs for young and upcoming scientists. Without 
this funding, our jobs are out there for the taking. Without this 
funding, the thousands of jobs in my district provided by the 
University of Alabama at Birmingham, the Southern Research Institute, 
and the University of Alabama are not safe. The policies in this 
legislation will help us fight off foreign competitors and allow us to 
continue innovating, so we can all protect medical jobs in our 
districts and add more.
  We must get serious about addressing the unmet medical needs of the 
American people. I urge my colleagues not to deprive the American 
people of the cures they deserve. Vote against these poison pill 
amendments because when it comes to the health of our constituents, 
there is no place or time for partisan politics. I urge my colleagues 
to oppose the Brat amendment, support the Lee amendment and I urge them 
to support H.R. 6.
  Mr. PITTS. Mr. Chair, I rise in strong support for 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 U.S.
  Arriving here today has been a long journey--full of lots of steps 
and some 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. They worked nights and 
weekends and were consummate professionals throughout the process. 
Specifically, I want to thank the following: Warren Burke, Ed Grossman, 
Jessica Shapiro, Michelle Vanek, and Jesse Cross.
  I also want to thank the health care staff of the Congressional 
Budget Office for all 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 specifically want to thank Holly Harvey, 
Tom Bradley, Chad Chirico, and all their colleagues for their diligence 
and assistance through the process.
  And I would be remiss if I did not again thank the outstanding team 
on Energy and Commerce, and most especially the Health team, led by 
Chief Health Counsel, Clay Alspach, supported by Josh Trent, Paul 
Edattel, John Stone, Robert Horne, Carly McWilliams, Michelle 
Rosenberg, Katie Novaria, Adrianna Simonelli, Traci Vitek and Graham 
Pittman--without whose expertise, wisdom and counsel, this legislative 
work would not be possible.
  H.R. 6 was reported from Energy and Commerce Committee by a vote of 
51-0 and advances conservative fiscal and regulatory reforms. Every 
dollar of advanced appropriations in the bill (which will sunset at the 
end of FY 2020) is offset with other permanent reforms--including 
billions of dollars in mandatory entitlement savings in Medicare and 
Medicaid.
  But this is no ordinary mandatory spending--like the kind we usually 
see in entitlement spending such as Social Security, Medicare, Medicaid 
and Obamacare. This mandatory spending is for five years only and then 
stops or sunsets. This mandatory spending is fully paid for with 
mandatory spending cuts elsewhere that will not stop in five years, but 
are permanent reforms resulting in real savings. By comparison, the 
Ryan-Murray budget deal for health care savings yielded much less.
  This innovative hybrid approach allows us to cut mandatory spending 
(entitlement spending) and use the savings to fund what would otherwise 
be a discretionary project--but in this case is 5-year dedicated 
spending on medical research.
  Congressional Budget Office determined that H.R. 6 will reduce the 
deficit by $500 million over the first ten years, and at least another 
$7 billion over the second decade.
  The funds provided to the National Institutes for Health (NIH) and 
Food and Drug Administration (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.
  Additionally, all the important policy riders that accompany federal 
funding through appropriations will be included--such as the Hyde 
Amendment and the Dickey-Wicker Amendment.
  This bill also includes a policy that excludes authorized generics 
from Average Manufacturers' Price. This is a common sense policy from 
the President's budget proposal, intended to ensure the appropriate 
calculation of Medicaid brand name rebates paid by manufacturers. The 
policy is not intended to effect Medicaid programs' pharmacy 
reimbursements. Instead, the provision, which many states support, will 
result in an increase in manufacturer rebates under Medicaid and thus 
save money for states and the federal government.
  H.R. 6 will help America to innovate its way out of our entitlement 
crisis. The regulatory reforms included in H.R. 6 will accelerate the 
pace of discovery, development and delivery of new treatments and 
cures, thereby providing significant health care savings to the federal 
budget that will only grow over time.
  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 Cures.
  I urge all of my colleagues to think of the patients and vote ``AYE'' 
in support of H.R. 6.
  Mrs. BLACKBURN. Mr. Chair, America has been at her best when facing 
great challenges.
  Some of our greatest challenges today are in the area of healthcare.
  With over 10,000 known diseases, only 500 have cures.
  We need to embrace a national vision of improving lives, and of 
course, saving money, through a Cures Strategy.
  Sepsis is one condition that will benefit from this legislation.
  Sepsis is the body's response to an overwhelming infection.
  Approximately 250,000 people die from sepsis every year in the U.S. 
and yet most people have never heard of it.
  Sepsis is the #1 most expensive condition treated in U.S. hospitals 
and in FY11 the aggregate hospital cost for sepsis was more than $20 
billion.
  This legislation comes too late for Katie McQuestion and Rory 
Staunton, both who succumbed to sepsis as vibrant, health young people.
  But through the work that the CURES legislation will support, we can 
find ways to identify sepsis earlier and even find ways to prevent 
sepsis.
  The 21st Century Cures legislation includes language that I have 
authored with my friend from Texas, Rep. Gene Green--the SOFTWARE act.
  Getting bureaucracy out of the way and allowing innovation is the 
goal of SOFTWARE.
  SOFTWARE will codify the manner in which FDA approaches health IT--
including the wonderful apps that we all use to keep us healthy.
  FDA is the agency charged with assuring the safety and efficacy of 
drugs and medical devices.
  But data is not a drug or device and it makes no sense to regulate it 
as such.
  However obvious that is, it hasn't stopped FDA from trying to make 
medical device law fit health IT.
  We need to modernize the FDA authorities to reflect the new 
technology that is health IT.
  SOFTWARE, as included in 21st Century Cures is an important first 
step in our efforts to modernize the FDA.
  It is common sense legislation to provide opportunity for health IT 
to deliver on the promise of better health for all Americans.
  I look forward to working with my colleagues in the Senate to bolster 
these efforts as SOFTWARE moves through the Senate.
  For all the reasons I've outlined, the 21st Century Cures legislation 
is an important bill. But we must ensure that the new treatments, 
devices and drugs that will be created as a result of this legislation 
get to the people that need it the most. And some of the most needy are 
our nations seniors who get health care through Medicare.
  Today, Medicare struggles with the adaption of new technology. Many 
seniors go years without access to the latest treatment options. We 
must change that. Congress receives great support from the Medicare 
Payment Advisory Commission (MedPAC) who offers recommendations and 
policy support to Congress to improve Medicare.
  But as we are on the cusp of changing how health care is delivered, 
MedPAC could use

[[Page 11164]]

additional policy support including Commissioners that have real-world 
expertise in this area, and who understand the changes that need to be 
made in both Medicare payment and regulatory policies to make that 
happen. I've been pleased to support such candidates in the past, and 
will continue to do so in the future.
  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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