[Congressional Record Volume 158, Number 127 (Wednesday, September 19, 2012)]
[House]
[Pages H6138-H6140]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            NATIONAL PEDIATRIC RESEARCH NETWORK ACT OF 2012

  Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 6163) to amend title IV of the Public Health Service Act to 
provide for a National Pediatric Research Network, including with 
respect to pediatric rare diseases or conditions, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 6163

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``National Pediatric Research 
     Network Act of 2012''.

     SEC. 2. NATIONAL PEDIATRIC RESEARCH NETWORK.

       Section 409D of the Public Health Service Act (42 U.S.C. 
     284h; relating to the Pediatric Research Initiative) is 
     amended--
       (1) by redesignating subsection (d) as subsection (f); and
       (2) by inserting after subsection (c) the following:
       ``(d) National Pediatric Research Network.--
       ``(1) Network.--In carrying out the Initiative, the 
     Director of NIH, acting through the Director of the Eunice 
     Kennedy Shriver National Institute of Child Health and Human 
     Development and in collaboration with other appropriate 
     national research institutes and national centers that carry 
     out activities involving pediatric research, may provide for 
     the establishment of a National Pediatric Research Network 
     consisting of the pediatric research consortia receiving 
     awards under paragraph (2).
       ``(2) Pediatric research consortia.--
       ``(A) In general.--The Director of the Institute may award 
     funding, including through grants and contracts, to public or 
     private nonprofit entities--
       ``(i) for planning, establishing, or strengthening 
     pediatric research consortia; and
       ``(ii) for providing basic operating support for such 
     consortia, including with respect to--

       ``(I) basic, clinical, behavioral, or translational 
     research to meet unmet needs for pediatric research; and
       ``(II) training researchers in pediatric research 
     techniques.

       ``(B) Research.--The Director of NIH shall ensure that--
       ``(i) each consortium receiving an award under subparagraph 
     (A) conducts or supports at least one category of research 
     described in subparagraph (A)(ii)(I) and collectively such 
     consortia conduct or support all such categories of research; 
     and
       ``(ii) one or more such consortia provide training 
     described in subparagraph (A)(ii)(II).
       ``(C) Number of consortia.--The Director of NIH may make 
     awards under this paragraph for not more than 20 pediatric 
     research consortia.
       ``(D) Organization of consortium.--Each consortium 
     receiving an award under subparagraph (A) shall--
       ``(i) be formed from a collaboration of cooperating 
     institutions;
       ``(ii) be coordinated by a lead institution; and
       ``(iii) meet such requirements as may be prescribed by the 
     Director of NIH.
       ``(E) Supplement, not supplant.--Any support received by a 
     consortium under subparagraph (A) shall be used to 
     supplement, and not supplant, other public or private support 
     for activities authorized to be supported under this 
     paragraph.
       ``(F) Duration of support.--Support of a consortium under 
     subparagraph (A) may be for a period of not to exceed 5 
     years. Such period may be extended by the Director of NIH for 
     additional periods of not more than 5 years.
       ``(3) Coordination of consortia activities.--The Director 
     of NIH shall--
       ``(A) as appropriate, provide for the coordination of 
     activities (including the exchange of information and regular 
     communication) among the consortia established pursuant to 
     paragraph (2); and
       ``(B) require the periodic preparation and submission to 
     the Director of reports on the activities of each such 
     consortium.
       ``(e) Research on Pediatric Rare Diseases or Conditions.--
       ``(1) In general.--In making awards under subsection (d)(2) 
     for pediatric research consortia, the Director of NIH shall 
     ensure that an appropriate number of such awards are awarded 
     to such consortia that agree to--
       ``(A) focus primarily on pediatric rare diseases or 
     conditions (including any such diseases or conditions that 
     are genetic disorders (such as spinal muscular atrophy and 
     Duchenne muscular dystrophy) or are related to birth defects 
     (such as Down syndrome and fragile X));
       ``(B) conduct or coordinate one or more multisite clinical 
     trials of therapies for, or approaches to, the prevention, 
     diagnosis, or treatment of one or more pediatric rare 
     diseases or conditions; and
       ``(C) rapidly and efficiently disseminate scientific 
     findings resulting from such trials.
       ``(2) Data coordinating center.--
       ``(A) Establishment.--In connection with support of 
     consortia described in paragraph (1), the Director of NIH 
     shall establish a data coordinating center for the following 
     purposes:
       ``(i) To distribute the scientific findings referred to in 
     paragraph (1)(C).
       ``(ii) To provide assistance in the design and conduct of 
     collaborative research projects and the management, analysis, 
     and storage of data associated with such projects.
       ``(iii) To organize and conduct multisite monitoring 
     activities.
       ``(iv) To provide assistance to the Centers for Disease 
     Control and Prevention in the establishment or expansion of 
     patient registries and other surveillance systems.
       ``(B) Reporting.--The Director of NIH shall--
       ``(i) require the data coordinating center established 
     under subparagraph (A) to provide regular reports to the 
     Director of NIH and the Commissioner of Food and Drugs on 
     research conducted by consortia described in paragraph (1), 
     including information on enrollment in clinical trials and 
     the allocation of resources with respect to such research; 
     and
       ``(ii) as appropriate, incorporate information reported 
     under clause (i) into the Director's biennial reports under 
     section 403.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Upton) and the gentlewoman from California (Mrs. Capps) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.
  Mr. UPTON. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, this legislation brings us a step closer to providing 
more help to children with unmet health needs, especially those with 
rare pediatric and genetic diseases.
  According to the National Institutes of Health, the NIH, there are 
6,800 rare diseases, and most of these conditions have no treatment or 
cure, and they primarily affect children. I would guess that everyone 
in this Chamber is personally aware of the devastating impact of these 
diseases with some family that they know. I, myself, have spent some 
time with a family from my district whose children have spinal muscular 
atrophy, SMA. It is a very rare pediatric disease that is the leading 
genetic cause of death in infants and toddlers.
  These are great kids. I've got a picture of one of them here. When 
they came to see me, they told me that their names were Cinderella and 
Sleeping Beauty. They really are. These are just really marvelous 
children. They're great kids, and it's a source of real sadness that 
their disease is the kind that is often incurable and often 
untreatable.
  The barriers to research on rare and genetic diseases are those that 
are common to most research. It's already difficult to initiate the 
experimental and lengthy research needed to find treatments and cures; 
however, when the population of patients is so small, maybe only a 
couple dozen in a State, these problems are even more difficult to 
solve.
  This legislation is going to help us establish pediatric research 
networks and a consortia that are a proven way to overcome those gaps 
in research. Networks and consortia will be comprised of leading 
institutions that act

[[Page H6139]]

as partners to consolidate and coordinate research efforts. It promotes 
efficiency and collaboration, especially when a disease affects just a 
small number of children.
  Mr. Speaker, I would urge all my colleagues to support this 
bipartisan legislation. I look forward to a strong vote tonight and 
working with our colleagues in the Senate to make sure that this bill 
really does get to the President's desk and makes a difference for 
families that are in search of something that will help them with their 
kids.
  With that, I reserve the balance of my time.
  Mrs. CAPPS. Mr. Speaker, I yield myself 5 minutes.
  Mr. Speaker, in the health care profession, we know that children 
aren't just little adults. They have unique health experiences, 
treatment needs, and research challenges.
  While public and private research has come a long way on pediatric 
diseases over the years, we also know that we are still far behind on 
important diagnostics, cures, and treatments for far too many ailing 
children. That's why I am so pleased to have coauthored the National 
Pediatric Research Network Act with my colleague and friend, 
Representative Cathy McMorris Rodgers.
  This bipartisan bill would improve research and clinical trials on 
pediatric diseases. It would train future pediatric researchers and 
disseminate research findings so quickly so that all children may 
benefit. It does not replace our current pediatric research 
investments. Instead, it builds upon the work already being done at the 
NIH and at research centers across the country by creating, as Chairman 
Upton said, research consortia to form a nationwide network of 
pediatric researchers. This is important so that we can make sure that 
we're always working with the most current science and that information 
is shared and also verified.
  It will expand the geographic scope of research, giving sick kids 
easier access to research programs and clinical trials. Moreover, this 
bill will help a wider variety of institutions participating in this 
critical research while providing training grounds for our next 
generation of pediatric researchers.
  Another key feature to this bill is that it will place an added 
emphasis on researching children's rare diseases, such as the one 
already described, spinal muscular atrophy, and to develop new 
treatments to fight them.
  The low prevalence of these diseases makes them particularly hard to 
research, yet these diseases have such a marked impact on the lives of 
far too many families and communities. The National Pediatric Research 
Network Act will be an important step forward to help these families 
and those who may develop these diseases long into the future.
  I want to thank again the leadership of the Energy and Commerce 
Committee, Chairman Upton, Ranking Member Waxman, Chairman Pitts, and 
Ranking Member Pallone, for their dedication to this bill; and to the 
staff, my staff, and especially Ruth Katz, a committee staffer, working 
to improve the language and to bring this to the floor. I also include 
my colleague, Congresswoman DeGette, for her leadership on this issue 
over the years.
  And just like Chairman Upton, I would especially like to thank my 
constituents, dear friends, and a very remarkable family, Bill and 
Victoria Strong, who are the parents, for their tireless work on behalf 
of their own daughter, Gwendolyn, who has spinal muscular atrophy as 
well and just a few weeks ago celebrated an amazing achievement by 
entering public kindergarten at the age of 5. She's the favorite of all 
her classmates, and the parents are beside themselves with joy that 
this remarkable milestone has been achieved. They work day in and day 
out to make their daughter's world better, and in doing so they have 
created a very strong community within our larger community of people 
who care about Gwendolyn, but also care about other children with 
similar kinds of conditions and what we should be doing as a Nation to 
stand with them. They have shown how entire communities can come 
together to fight diseases like SMA.
  I urge my colleagues to follow their example. We need to come 
together now to support this bill, and in doing so we support families 
like those in Michigan and in Santa Barbara, California, and other 
places, as well, to do all we can do to make this a law and give them 
hope and courage for the future.
  Mr. Speaker, I reserve the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield myself 30 seconds.
  I just want to again thank Mrs. Capps. As we met these families, we 
really did not know about these diseases until we saw their courage and 
what they do as they confront this every day. It's marvelous for me, as 
I now have visited my family that has this disease 2 years in a row. 
It's great to see them grow and remember where they were and to really 
think that there's going to be hope with the legislation that we can 
see that is done.
  With that, I yield 5 minutes to the gentlelady from Washington State, 
Cathy McMorris Rodgers, who has also been, as we look at a bipartisan 
leadership, a real trooper to move this legislation not only through 
our committee, but now on the House floor.
  Mrs. McMORRIS RODGERS. Mr. Speaker, I thank the chairman. I thank my 
colleague and friend, Representative Lois Capps, and rise today in 
strong support of this legislation, H.R. 6163, the National Pediatric 
Research Network Act, which is going to build on America's commitment 
to pediatric medical research.
  That commitment has already led to the prevention and treatment of 
terrible conditions such as polio, meningitis, childhood leukemia, 
congenital heart disease. With budgets being squeezed like no time in 
recent memory, it has never been more important to support projects 
which leverage every single dollar.
  Research networks have a proven track record in their ability to 
ensure collaboration and the sharing of resources which, in turn, have 
led to medical discoveries that have improved lives.

                              {time}  2100

  For example, the National Cancer Institute-funded Children's Oncology 
Group has advanced our understanding and treatment of childhood 
cancers, and this group has resulted in a cure for some types of 
childhood leukemia. The Pediatric Heart Network has improved the 
outcome for children born with congenital heart disease.
  I am proud to have introduced this legislation with my colleague, 
Representative Capps. This legislation is going to authorize NIH to 
establish up to 20 pediatric research networks across this country, and 
each network will be selected by NIH through a competitive review 
process. These networks will allow multiple institutions to work 
together in a ``hub and spoke'' fashion to encourage collaboration.
  Some of those networks will focus on rare diseases such as spinal 
muscular atrophy. Other networks will focus on the genetic diseases 
that have their onset in childhood, including Fragile X and Down 
Syndrome.
  It's important to develop a framework for these rare and genetic 
diseases for a number of reasons. First of all, researchers in these 
areas are often working in isolation, and this legislation is going to 
help overcome that barrier. Secondly, there are not many children with 
these disorders in one place, so it makes it difficult to connect the 
researchers to those that want to participate in the studies.
  Finally, the study of these rare and genetic diseases may lead to 
treatments that will help many people. For example, we've learned that 
there is a specific biological link between Down Syndrome and 
Alzheimer's disease. It's conceivable that the research that can result 
in the improvement in cognition in Down Syndrome could also prevent the 
loss of cognition that is seen in Alzheimer's.
  These pediatric networks will improve health outcomes for children 
and adults by encouraging teamwork among the researchers, the patients, 
and NIH. This is important and positive legislation. I'm proud to 
support it, and I urge my colleagues to support it.
  Mrs. CAPPS. In closing, Mr. Speaker, the National Pediatric Research 
Network Act is a very important bill, not just for current and future 
researchers, but for sick children and their families, today and in the 
future. It's a bipartisan measure that will really leverage

[[Page H6140]]

all the good work that is currently being done on pediatric diseases 
but that will also fill gaps that make it so hard for progress to be 
made.
  I urge full support for this bill, and I yield back the balance of my 
time.
  Mr. UPTON. Mr. Speaker, I yield 2 minutes to the chairman of the 
Health Subcommittee, the gentleman from Pennsylvania, Joe Pitts, in 
support of the legislation.
  Mr. PITTS. Mr. Speaker, H.R. 6163, the National Pediatric Research 
Network Act, seeks to address important unmet needs in pediatric 
health.
  Pediatric research is so important to the health of our children, and 
it is essential to finding answers for unmet health needs. According to 
the National Institutes for Health, there are between 6,000 and 7,000 
diseases considered rare that affect 25 to 30 million people. Most of 
the approximately 7,000 rare diseases are pediatric diseases and often 
genetic. Unfortunately, the doctors do not have sufficient therapies to 
treat them.
  This bill seeks to alleviate that problem by establishing pediatric 
research networks and consortia. They will help by coordinating 
research efforts among participating institutions, concentrating that 
effort on the most pressing needs and enlisting the help of well-
trained researchers.
  Through my association with Children's Hospital of Philadelphia, I'm 
aware that there are too many diseases that children and their families 
face that do not have easy answers, and few adequate treatments. This 
bill will strengthen basic and clinical research and bring us closer to 
finding new treatments and cures.
  Mr. Speaker, this bill has strong bipartisan support. I urge my 
colleagues to support the bill.
  Mr. UPTON. Mr. Speaker, in closing, I know the hour is late. I would 
just urge my colleagues to support this bipartisan legislation. I, too, 
commend every Member that's had a role here and truly appreciate the 
staff to get this bill prepared and ready for us to vote on tonight.
  I yield back the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I am pleased to rise in support of H.R. 
6163, the National Pediatric Research Network Act of 2012.
  H.R. 6163 represents a bi-partisan effort to allow the National 
Institutes of Health, NIH, to establish a national pediatric research 
network dedicated to finding treatments and cures for pediatric 
diseases and conditions--especially those that are rare. The network 
would be comprised of up to 20 research consortia or groups of 
collaborating research institutions such as universities and hospitals. 
These consortia would be investigator-initiated and would conduct 
basic, clinical, behavioral, and translational research on pediatric 
diseases and conditions. NIH funding would be used to create the 
infrastructure necessary to carry out this research.
  Within the network, the NIH Director is instructed to ensure that an 
appropriate number of awards go to those consortia that focus primarily 
on pediatric rare diseases such as spinal muscular atrophy--or SMA--or 
pediatric birth defects such as Down syndrome. These kinds of diseases 
and conditions are rare and some of the children who suffer from them 
are very fragile, making it difficult for them to travel great 
distances to participate in clinical trials or other research. This is 
often the case when--not infrequently--only one institution is 
conducting such research. The availability of consortia--by definition, 
multiple cooperating institutions--should make clinical research 
opportunities far more accessible to these kids and their families. In 
turn, we would hope they would help speed up the time and effort in 
finding treatments and cures for these devastating diseases and 
conditions.
  In addition to the research itself, the consortia are expected to 
serve as training grounds for future pediatric researchers. 
Traditionally, pediatric research has been underfunded. This has 
sometimes resulted in real challenges in recruiting the talent 
necessary to tackle diseases and conditions that affect kids--again, 
especially those that are rare. Thus, H.R. 6163 places a special 
emphasis on pediatric research techniques with the goal of helping to 
``prime the pump'' for a greater number of leading edge pediatric 
researchers.
  Taken together, the components of H.R. 6163 make for a package that 
would allow NIH to build on the strong body of pediatric research that 
it currently conducts and supports. I would encourage NIH to take full 
advantage of this opportunity.
  As we move forward with this legislation--here, and hopefully, in the 
Senate--I want to commend all those members of the Energy and Commerce 
Committee who have come together to make it happen. I especially want 
to the note the effort of Congresswoman Capps. She is the lead 
Democratic sponsor of the bill and has worked tirelessly to bring it 
before us today.
  I urge my colleagues to vote ``yes'' on H.R. 6163.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Upton) that the House suspend the rules 
and pass the bill, H.R. 6163, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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