[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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