[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
      LEGISLATION TO REAUTHORIZE THE NATIONAL INSTITUTES OF HEALTH

=======================================================================

                                HEARING

                               before the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 19, 2005

                               __________

                           Serial No. 109-40

                               __________

      Printed for the use of the Committee on Energy and Commerce


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                    COMMITTEE ON ENERGY AND COMMERCE

                      JOE BARTON, Texas, Chairman

RALPH M. HALL, Texas                 JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida             Ranking Member
  Vice Chairman                      HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                 FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia             BART GORDON, Tennessee
BARBARA CUBIN, Wyoming               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
HEATHER WILSON, New Mexico           BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona             ELIOT L. ENGEL, New York
CHARLES W. ``CHIP'' PICKERING,       ALBERT R. WYNN, Maryland
Mississippi, Vice Chairman           GENE GREEN, Texas
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania        JIM DAVIS, Florida
MARY BONO, California                JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon                  HILDA L. SOLIS, California
LEE TERRY, Nebraska                  CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey            JAY INSLEE, Washington
MIKE ROGERS, Michigan                TAMMY BALDWIN, Wisconsin
C.L. ``BUTCH'' OTTER, Idaho          MIKE ROSS, Arkansas
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee

                      Bud Albright, Staff Director

        David Cavicke, Deputy Staff Director and General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                  (ii)






                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Zerhouni, Elias A., Director, National Institutes of Health..    10
Additional material submitted for the record:
    Zerhouni, Elias A., Director, National Institutes of Health, 
      response for the record....................................    65

                                 (iii)




      LEGISLATION TO REAUTHORIZE THE NATIONAL INSTITUTES OF HEALTH

                              ----------                              


                         TUESDAY, JULY 19, 2005

                          House of Representatives,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2 p.m., in room 
2318 of the Rayburn House Office Building, Hon. Nathan Deal 
(acting chairman) presiding.
    Members present: Representatives Barton, Bilirakis, Deal, 
Wilson, Buyer, Pitts, Walden, Ferguson, Rogers, Myrick, Murphy, 
Burgess, Blackburn, Waxman, Markey, Towns, Brown, Rush, Eshoo, 
Stupak, Engel, Wynn, Green, DeGette, Capps, Allen, Solis, 
Inslee, and Baldwin.
    Staff present: Chuck Clapton, chief health counsel; Cheryl 
Jaeger, majority professional staff; Eugenia Edwards, 
legislative clerk; Brandon Clark, health policy coordinator; 
John Ford, minority counsel; and Voncille Hines, minority 
research assistant.
    Mr. Deal. I call this hearing to order. I need to explain 
to our witness, and to the rest of the committee that our 
chairman and some of our members of this committee are engaged 
in the Energy Conference, and therefore, they may come in, and 
they may have to leave. So--and the fact that they are meeting 
right now--we decided to proceed on with this hearing today, 
and I believe we have enough to proceed.
    I recognize myself for a very brief opening statement. 
First of all, I want to welcome Dr. Zerhouni to this hearing, 
and it is a hearing in our continuing effort to reauthorize the 
National Institutes of Health, and we appreciate you for 
joining us again, as you have in the past. This is an area of 
jurisdiction that is important to this committee, and many of 
you are aware that this is actually the eleventh hearing we 
have had on NIH in the last 2\1/2\ years, and all of us are 
hopeful that the result of those hearings and the work of our 
staffs will allow us to achieve the very important function of 
reauthorizing NIH.
    We have been working on the issue of reauthorization of NIH 
for longer than many people on this committee have actually 
been in--serving in Congress, and some of us are of the opinion 
that now is the time to finalize that issue, and we are hopeful 
of doing that in the very near future. One of the issues that 
is important, I think, to all of us on this committee, 
regardless of our party affiliation, is the fact that in the 
absence of reauthorizing NIH, this committee basically cedes 
its jurisdiction to another committee, namely, the 
Appropriations Committee, and we believe that it is appropriate 
for us to reclaim that issue of jurisdiction, and this effort 
to reauthorize will do that.
    Times have changed, and certainly, as times change, the 
necessity of looking at organizations such as NIH, and whether 
or not it, too, should change is indeed appropriate. Dr. 
Zerhouni, again, we welcome your attendance today, and look 
forward to hearing your testimony and working with you as we 
proceed with NIH reauthorization.
    I am now pleased to recognize my ranking member of our 
subcommittee, but I presume standing in also for the full 
committee, Mr. Brown of Ohio.
    [The prepared statement of Hon. Nathan Deal follows:]
   Prepared Statement of Hon. Nathan Deal, Chairman, Subcommittee on 
                                 Health
    Thank you, Mr. Chairman.
    I want to start off by welcoming Dr. Zerhouni to this hearing on 
our efforts to reauthorize the National Institutes of Health. We 
appreciate your joining us again this afternoon to talk about one of 
the most important priorities under the jurisdiction of this Committee.
    As you are well aware, this will be the Energy and Commerce 
Committee's eleventh hearing on the NIH in last two and a half years, 
and we are hopeful we can all continue to work together to achieve some 
much-needed improvements to this vital component of our federal 
government.
    As many of you know, we have been working on reauthorizing the NIH 
longer than most of the Members of this Committee have been serving in 
Congress, and it is well past time for this Committee to get something 
done.
    Indeed, Mr. Chairman, it is time for Authorizers to be Authorizers 
again, and I applaud you for your leadership on this very important 
issue.
    Times change and organizations must adapt to this change. We must 
modernize the organizational structure of the NIH so that we can 
advance scientific discovery for the benefit of all mankind.
    Again, Dr. Zerhouni we appreciate your attendance and expertise, 
and we look forward to working with you as we strive to improve one of 
the most important agencies in our government.

    Mr. Brown. Thank you, Mr. Chairman, and thank you, Dr. 
Zerhouni, as always, for joining us with your wisdom and your 
knowledge. It is our responsibility to ensure that agencies 
under our jurisdiction have the resources and statutory 
authority they need to advance the public good. NIH represents 
half the discretionary budget at HHS, and the chairman has 
rightly assigned a high priority to its reauthorization.
    As we know, NIH is a complex agency. Its work affects the 
lives of millions of Americans. I want to make it clear that 
passing a consensus, a consensus bill, requires that all 
parties have the necessary time to contribute their ideas, 
perspective, and insight into the final product, and I would 
reiterate, have the necessary time to contribute these ideas 
and perspective.
    Well, this committee has had numerous hearings on NIH. The 
devil, of course, is in the details. Members of Congress and 
stakeholder groups have had less than a week to review 
legislation that translates general concepts into concrete 
operational changes in a very complicated structure, as I have 
seen from both committee hearings and individual personal 
conversations with Dr. Zerhouni. We need time to make sure the 
bill does what we think it does, and that those changes are 
beneficial. However, given the right timeframe, and with the 
right input from inside Congress and outside Congress, I am 
confident we can pass a bill that represents true progress for 
NIH and for all of the American public.
    Thank you.
    Mr. Deal. Thank the gentleman. Does anyone else wish to 
make an opening statement?
    Mr. Bilirakis. Just a very brief one.
    Mr. Deal. Mr. Bilirakis.
    Mr. Bilirakis. Just a very brief one, Mr. Chairman.
    I am one of those people who will probably have to be 
called upon at a moment's notice to go downstairs for a vote on 
the conference, but I did want to join you and the others in 
welcoming Dr. Zerhouni here, and to thank you for your part in 
the preparation of this legislation.
    We must reauthorize NIH. I think we all agree to that, to 
increase transparency and accountability at the agency, and to 
ensure that it is operating as effectively and efficiently as 
possible. And I would also like to say, and really emphasize, 
Mr. Chairman, that we must make certain that any changes that 
we make to NIH will not harm its various institutes. I am 
always concerned about the unintended consequences of our acts. 
Haste sometimes makes waste. We are all--have our minds made up 
that we are going to reauthorize this time around. We are 
working with the minority, which is just great in that regard, 
but let us make sure that we are concerned that our--whatever 
we do do, and whatever changes we do make will not cause more 
harm than good.
    So having said that, Mr. Chairman, I would yield back, and 
thank you.
    Mr. Deal. Thank the gentleman. Anyone else. Mr. Rush?
    Mr. Rush. Thank you, Mr. Chairman. Mr. Chairman, I also 
want to thank you for holding this hearing, and I will be 
brief, since my time in short, and we want to really get to 
hear Dr. Zerhouni.
    Mr. Chairman, I truly appreciate your leadership in this 
committee reasserting its jurisdiction over the National 
Institutes of Health. For too long, the appropriators have had 
way too much authority over NIH, and it is time that this 
committee put an end to that reign. With all due respect to 
that other committee, we are the committee of expertise, and it 
serves this Congress, the NIH, and the American people well 
when we utilize that expertise.
    Having that said, I have two key issues that I would like 
to--the draft legislation before us to address. First, I remain 
concerned that the issue of racial disparities, an old, 
shameful problem that has not gone away, and Dr. Zerhouni, in 
his statement, agrees with this point, that the issue of racial 
disparities is not adequately addressed by this bill. We need 
stronger mandates for our premier medical research institute to 
aggressively address an inexcusable and unconstitutional 
problem in our country here. Specifically, I want to hear what 
NIH can do to include more people of color and women in 
clinical trials, both as researchers themselves, and as 
subjects in the private sector.
    Second, I am concerned that medical research in this 
country is not adequately incorporating children in their 
research and medical deliberations. I believe that NIH needs to 
consider the pros and cons of including children in clinical 
trials, and use its leverage and Federal dollars accordingly.
    As always, I welcome the Director to this hearing, and I 
look forward to his testimony. And Mr. Chairman, I look forward 
to working with you and the rest of the members of this 
committee, so that we can come up with a truly bipartisan, 
cooperative, and deliberative piece of legislation that 
reauthorizes the National Institutes of Health.
    I yield back the balance of my time.
    Mr. Deal. Thank the gentleman. I recognize Ms. Wilson for 
an opening statement.
    Ms. Wilson. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    I think there are some concepts in this draft legislation 
that are worth supporting, certainly in prioritizing the 
research in the most promising areas, and allowing greater 
flexibility to manage research roadmaps across the various 
institutes of the National Institutes of Health, and second, to 
give the Director authority over a certain percentage of 
funding to direct particular research--and there is a precedent 
in this area, with the Department of Energy Laboratories, where 
a certain percentage is set aside for lab-directed research and 
development, to put money toward the most promising research.
    There are a couple of areas I think we need to be attentive 
to. One is that this legislation tries to move forward on 
establishing an electronic data base of research projects, 
which is very helpful to those who are looking for clinical 
trials, and information about research ongoing. I think we need 
to make sure that that data base is publicly available, not 
just to people who are researchers or medical doctors, but 
accessible to the public, who are paying for this research, 
that it is searchable, and it really does enhance access to 
clinical trials.
    The second area where I have some concerns has to do with 
public/private coordination or collaboration. The legislation 
does anticipate some partnership in high risk and high reward 
areas of research, but I wonder whether we should limit those 
collaborative mechanisms to just the high risk research, and 
whether we should expand those mechanisms and encouragement to 
include basic research, because there is a lot more research 
that is done outside of the NIH than is done inside of the NIH, 
and collaboration and coordination could, I think, help both.
    And with those two caveats, I look forward to the testimony 
today. Thank you, Mr. Chairman.
    Mr. Deal. Thank the gentlelady. Mr. Waxman, do you have an 
opening statement?
    Mr. Waxman. Yes, Mr. Chairman.
    The National Institutes of Health is, without doubt, one of 
the premiere agencies in the Federal Government. It is widely 
respected throughout the world. It is an agency with a mission 
critical to the Nation's health; and it is an agency that few 
would dispute is working well.
    Can it do better? Of course. Where it can be strengthened, 
we want to do that. All of us want to provide the necessary 
tools to enhance its ability to perform its mission. But this 
is not an agency which is broken. The changes we make to 
improve it must be thoughtful and measured, and we must be 
certain that we are not unintentionally taking actions which 
reduce the very features that have made it strong.
    Our goal, as authorizers of this institution, should not be 
to restrict the resources the agency receives, but to provide 
fully for its support and growth now and into the future. Our 
goal should be to maintain and defend the peer review process 
which is at the heart of its strength, and to give the 
Institutes the tools to stay at the forefront of medical 
research.
    I look forward to hearing from Dr. Zerhouni today, and from 
any other persons and institutions who support and benefit from 
the work of this agency. And I hope and trust this committee 
will move forward with caution and care and deliberation.
    Thank you.
    Mr. Deal. Thank the gentleman. Anyone on this side have--
Dr. Burgess, recognized for an opening statement.
    Mr. Burgess. Thank you, Mr. Chairman, and I, too, 
appreciate your holding this hearing today, and I know that 
this reauthorization is one of your highest priorities, and I 
think we can see the fruits of your labor before us today, and 
of course, welcome again the Director of the NIH, Dr. Zerhouni, 
and I am looking forward to his comments on the draft bill.
    On my review, I think the draft does strike a balance of 
achievable reforms. Granting the Director greater budgetary 
authority will go a long way in redirecting research priorities 
at the NIH. With additional oversight and authority, the NIH 
director can plan, in a more strategic manner, and respond to 
emergencies as they occur.
    I have visited the NIH. I have visited with the Director, 
and you really get a sense of how precious that organization is 
to this country. In fact, it is my visit to the NIH that is one 
of the few things of the last 2\1/2\ years that have really 
made me optimistic about the future of this country that we are 
leaving to our children and grandchildren.
    The research conducted by the NIH is truly groundbreaking, 
whether it is additional treatment for cancer or a greater 
understanding of the human genome, the NIH has a proven record 
of innovation. Improvements can be made in its managerial 
structure, and that is, in fact, how we will improve the 
quality of research conducted at NIH and the health of all 
Americans.
    Thank you, Mr. Chairman. I will yield back.
    Mr. Deal. Thank the gentleman. Anyone else? Mr. Engel.
    Mr. Engel. Thank you, Mr. Chairman. At the outset, I would 
like to say that I like sitting on this side of the committee. 
I want to thank you for----
    Mr. Deal. You have to act accordingly.
    Mr. Engel. I want to thank you for convening this hearing 
today. I am very pleased to welcome Dr. Zerhouni back for his 
seventh appearance before our committee.
    It is always good to see you, Doctor. It is disappointing, 
though, that none of the stakeholders that will be affected by 
the proposed restructuring of the NIH were invited to give 
their reaction to these proposals. I certainly support 
initiatives to improve coordination and increase transparency 
among the NIH institutes and centers. The proposed 
concentration of budget, management, and grant making authority 
in the office of the NIH, though, may go further than necessary 
to achieve these goals.
    I am concerned that the discussion draft establishes four 
specific authorizations of appropriations line items, which may 
dramatically impact the ability of the constituencies of the 27 
research institutes and centers from having a place at the 
table in the appropriations process. I am not certain that 
authorizing the virtual elimination of these important 
relationships is the best policy proposal.
    I appreciate the commitment of the chairman to open and 
amend the proposed legislation based on feedback from members 
of this committee and the many stakeholders who work with and 
benefit from NIH research. As we move forward, it is my sincere 
hope that we can pass legislation that strengthens the 
management of the NIH without sacrificing the voices of these 
important groups.
    I thank you, and I yield back.
    Mr. Deal. Thank the gentleman. Mr. Ferguson.
    Mr. Ferguson. Does that mean we have to act accordingly on 
this side, Mr. Chairman?
    Mr. Deal. You are excused.
    Mr. Ferguson. Thank you, Mr. Chairman. I certainly thank 
Dr. Zerhouni for being here again with us today, and certainly 
looking forward to the reauthorization process.
    The NIH is a place where groundbreaking research occurs 
daily, research that might lead to a cure for many of the 
diseases that affect people throughout our world. Recently, 
Congress has set out on an ambitious path to increase funding 
for NIH, and we have seen the budget double in the last number 
of years. We have not seen NIH reauthorized in 12 years, since 
1993, and recent hearings have pointed to a need for 
interagency cooperation and coordination to help maximize the 
resources of the Institutes.
    We must give the Director the ability to manage the NIH 
portfolio to focus on research that yields results, cures to 
diseases that are within reach. In the January 2004 edition of 
Health Affairs, Dr. Zerhouni said: ``We need to be able to plan 
across NIH. We need some funds in common. If you have 27 
fingers out there with no palm, you don't have a hand.''
    I look forward to this hearing, to hear Dr. Zerhouni's 
impressions of the hand that you have been dealt, and what we 
can do to give you the upper hand as we go through the 
reauthorization process, and as we try to enable NIH to find 
the cures to diseases which affect so many people throughout 
the world.
    Thank you, Mr. Chairman. I yield back.
    Mr. Deal. Oh, well, at least we don't have a paradox today. 
Recognize Ms. DeGette.
    Ms. DeGette. Thank you, Mr. Chairman, and I would like to 
add my welcome to Dr. Zerhouni.
    The last time we authorized the NIH was 12 years ago in the 
House, and when you think about the status of medical research 
12 years ago, you really realize why reauthorization of this 
important agency is well overdue. The nature of medical 
research and, frankly, the integration of research that we are 
seeing among the 27 Institutes has grown dramatically in the 
last 12 years.
    I agree with Mr. Waxman. The system is not broken, and that 
is why it is such a pleasure to be reauthorizing the agency at 
this juncture. But I think it is important that we discuss what 
the balance is between the 27 fingers and the palm of the 
agency, and we really try to figure out how we can keep the 
autonomy and the important research that is happening among 
those 27 agencies, but at the same time, use the Director's 
Office to ensure that cross-fertilization happens in the 
important way that it can, because that is the only way that we 
will really see medical research advance in the 21st Century.
    Thank you, Mr. Chairman.
    Mr. Deal. Thank the gentlelady. Anyone else on this side 
have an opening statement? If not, anyone on the top row here? 
Yes. Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman. Dr. Zerhouni, thanks 
for coming here today. I look forward to your comments.
    Since I have 1 minute, I am going to focus on one area of 
this draft legislation that I find troubling. The draft strikes 
a section of the Public Health Service Act that authorizes 
pediatric drug studies at NIH. This Section, 409(i)(d), was 
added in 201 as part of the Best Pharmaceuticals for Children 
Act. The BPCA reauthorized a law that gave drug companies 
patent extensions in exchange for testing the drugs on 
children. The incentive doesn't work if the drug has no patent 
protection left, therefore Congress created a research fund 
within NIH to study drugs that are off patent.
    It is one of only a few provisions in law that actually 
mandates FDA and NIH to work together on drug safety. This 
draft would strike that provision. The sad fact is that 
Congress has never funded this provision, but it does not mean 
it is not important. It is more important than ever. Off-label 
use by children of drugs approved and labeled only for adults 
is rampant. The FDA has no power to restrict off-label use, and 
the list of drugs that need to be studied continues to grow. If 
the FDA cannot or will not enforce drug companies to do these 
studies, then at the very least, we should not eliminate a 
safeguard that gives parents some assurance that their 
children's drugs will be tested for safety and efficacy.
    I look forward to working with this committee on this 
issue, and will be submitting additional questions to the 
record. Thank you, Mr. Chairman.
    Mr. Deal. I thank the gentleman. I might tell him that due 
note has been made of your concerns, and will be addressed in 
the next draft.
    Mr. Allen.
    Mr. Allen. Thank you, Mr. Chairman. Welcome, Dr. Zerhouni. 
I hope you enjoyed your brief visit to Maine, and I want to 
thank you for your leadership at NIH.
    I just wanted to mention several concerns about this draft. 
First, the committee needs adequate time to consider this 
legislation, and to obtain input from stakeholders. Second, a 
question. To what degree should the Director have the authority 
to add, remove, and transfer Institute responsibilities without 
ensuring a transparent public process? I do worry that the 
concentration of so much power in the office of the Director 
could result, could, in ideological and political 
considerations trumping good science.
    Third, this draft legislation appears to create an 
arbitrary ceiling of Federal investment in biomedical research. 
Establishing a ceiling would seem to directly contradict 
Congressional success in doubling the NIH research budget, and 
imposing a ceiling could also hamper the agency's ability to 
deal with new public health threats. We just passed an 
appropriations bill with the smallest increase for NIH in 36 
years, so at least now, the budget is growing slower than the 
costs of inflation and new research.
    Finally, I believe that legislation to reauthorize the NIH 
should address the violations of NIH scientists engaging in 
outside consulting agreements with pharmaceutical companies, 
and I want to commend Chairman Barton and Ranking Member 
Dingell for their leadership on this particular issue.
    I look forward to hearing from you, and with that, Mr. 
Chairman, I yield back.
    Mr. Deal. I thank the gentleman. Ms. Solis.
    Ms. Solis. Thank you, Mr. Chairman, and welcome, Dr. Elias 
Zerhouni. I am very interested in hearing what your testimony 
will reveal to us today.
    But one of the concerns I have is, I happen to represent a 
very diverse district in Southern California, where we are 
finding that access to health care, as you know, is a crisis--
it is in a crisis stage for many of the constituents I 
represent. But more importantly, the diverse communities, not 
only in Southern California, but across the country, we 
increasingly see that there is a lack of research being done in 
these different racial and ethnic minority communities. We are 
trying to combat chronic illnesses, asthma, diabetes, obesity, 
and other related illnesses that affect, at a higher degree, 
more minority populations. We would like to see, I believe, 
more research done, not in a vacuum, not in just one office, 
but spread out throughout NIH, so that there are different 
calibers of individuals and researchers that can provide new, 
innovative information, so we can combat these illnesses, and 
hopefully, look at ways of prevention, and making that service 
available in languages and culturally competent, meaningful 
ways that will actually make a difference for our populations.
    There are no party lines when you talk about healthcare 
access in communities of color that many of us represent in the 
House, so I would hope that you would keep an open mind, and 
work with us, the Members of the Congress, to see that we 
really achieve parity, in terms of eliminating disparities 
amongst our communities that currently are faced with some 
severe challenges and a crisis in healthcare.
    So thank you very much.
    Mr. Deal. I thank the gentlelady. Anyone with opening 
statements? Yes, Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman, and thank you, Dr. 
Zerhouni, for joining us again. I enjoyed our discussion when 
you appeared before this committee's Health Subcommittee back 
in March, and look forward to it continuing today.
    Biomedical and behavioral research that is conducted at or 
coordinated by the NIH is of utmost importance to all of 
America, and particularly, in my district, which includes one 
of the Nation's leading research institutions. I applaud the 
chairman's focus on this important part of our government, and 
I hope that, given the size and the importance of NIH, that we 
do take a thorough, thoughtful, and measured approach to NIH 
reauthorization.
    Now, I have some concerns surrounding NIH reauthorization, 
and some of those concerns have been amplified with the 
circulation of the discussion draft last week. As I expressed 
at the subcommittee's hearing in March, I have observed ongoing 
and recently heightened efforts to politicize science and the 
conduct of research, and I believe that we have to insist upon 
safeguards to prevent this, and certainly, the time tested peer 
review process must be protected at all costs.
    I just want to end by noting that, while it is a delight to 
have you return to the committee, I do hope that we will have 
further hearings on this important topic with some of the other 
stakeholders that are involved in NIH reauthorization, 
especially researchers, research institutions, and patient 
groups.
    Thank you, and I yield back, Mr. Chairman.
    Mr. Deal. Thank the gentlelady. Any other opening 
statements?
    [Additional statements submitted for the record follow:]
    Prepared Statement of Hon. Paul E. Gillmor, a Representative in 
                    Congress from the State of Ohio
    Thank you Mr. Chairman for holding this hearing and bringing before 
us a discussion draft aimed at reauthorizing the National Institutes of 
Health (NIH).
    Very briefly, our last NIH revamp bill was enacted 12 years ago, 
and we must continue to focus carefully on the current organizational, 
funding, and management structure of the NIH in order to make 
significant headway in reauthorizing and improving its 27 medical 
research institutes and centers. We must ensure that the NIH continues 
to meet our public health needs as well as embrace cutting-edge 
scientific opportunities.
    I welcome Director Zerhouni, and again applaud Chairman Barton's 
initiative. I yield back the remainder of my time.
                                 ______
                                 
 Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy 
                              and Commerce
    Thank you, Dr. Zerhouni, for testifying once again before the 
Committee. And I thank all of the organizations and Members who have 
expeditiously responded with constructive feedback to improve the first 
discussion draft we distributed last week.
    It's time for us to do our job and have the Energy & Commerce 
Committee reauthorize the National Institutes of Health. This job is 
critically important and long overdue. With great fanfare, we doubled 
the budget of NIH. Unfortunately, NIH did not have the mechanisms in 
place to either account for the increases or strategically apply them. 
It still doesn't, and that must change.
    To date, NIH continues to lack the capability to track dollars 
across institutes and centers for particular types of research or by 
disease categories. Only authorizing legislation can put in place the 
long overdue management tools that NIH needs to provide rational 
accountability to an agency that needs efficiency as much as it needs 
money.
    I strongly believe that the NIH could be better organized to 
achieve its mission. This sentiment is shared by many. Nearly two 
decades ago, the Institute of Medicine reported, when NIH was 10 units 
smaller and had a budget of $4.5 billion--less than 15 percent of the 
size of the President's FY06 budget request for NIH--that there should 
be a presumption against the creation of new research institutes. The 
alarm bells sounded and Congress ignored them. NIH has grown like 
topsy-turvy and now there are 27 Institutes and Centers.
    Let me be clear. I don't have a problem with the research programs 
at the institutes and centers. I'm not looking to cut the budget of 
NIH, nor weaken the fundamental role that the individual institute and 
center directors play in fulfilling their research agendas. But someone 
needs to be in charge of strategic planning for the agency. No one in 
his right mind would ever design a $28.5 billion agency that is 
fragmented 27 ways with a director with only limited control.
    Dr. Zerhouni is certainly to be commended for the job he is doing 
with the power he can currently exercise. In three years time, he has 
put in place new management mechanisms to advance cross-cutting, 
interdisciplinary science. Congress can help Dr. Zerhouni to move 
forward with these initiatives by moving forward a reauthorization 
bill.
    It's time for this Committee to recognize that it has serious 
responsibilities with respect to this agency. We can't simply require 
NIH to conduct more research by spending more money; we must demand 
that NIH achieves more with taxpayer funds. The status quo is simply 
unacceptable. On that note, I would like to personally thank Mr. 
Dingell and Mr. Brown for their help in moving forward this 
legislation. As I said months ago, the NIH enjoys bipartisan support, 
and the bill to reauthorize it should be bipartisan as well.
    The bill that is the subject of this hearing today was drafted with 
two key policy principles in mind: no institute or center at NIH would 
be favored, nor would the bill pick and choose disease winners and 
losers. I ask my colleagues to keep these important principles in mind 
as we move forward to improve the bill.
    Instead, the bill provides a framework for NIH scientists, not 
politicians, to identify areas of emerging scientific opportunity and 
take action to improve public health outcomes. The discussion draft 
creates a new, comprehensive electronic reporting system that will, for 
the first time, catalogue all research activities of the NIH in a 
standardized format. Instead of thousands of pages of reports from each 
of the research institutes and centers, the NIH Director will compile 
biennially a report that comprehensively lays out the strategic plans 
and research activities of the agency.
    The bill will let the NIH Director direct by establishing a formal 
strategic planning process for the entire research portfolio of the 
agency that transcends the research planning activities of individual 
Institutes and Centers.
    And finally, the legislation streamlines how we fund research 
activities at the NIH. Science has changed, and so too must the agency 
that funds it.
    By reauthorizing the NIH, we are once again recognizing the 
critical importance of the biomedical research enterprise that will 
lead to the next generation of medical breakthroughs and therapies. I 
look forward to working with Members of this Committee to see that this 
long overdue bill moves not only through the Committee, but is enacted 
into law.

    Mr. Deal. If not, we will then proceed with Dr. Zerhouni. 
We are, once again, pleased to have you here, and look forward 
to your testimony.

 STATEMENT OF ELIAS A. ZERHOUNI, DIRECTOR, NATIONAL INSTITUTES 
                           OF HEALTH

    Mr. Zerhouni. I am very honored to be here, Mr. Chairman, 
and members of the committee. I think this is probably a 
defining moment for NIH. There are transitions that are 
occurring in science as we speak. There are transitions in the 
way science is conducted, and this topic requires the attention 
that you have exerted over the past 2 years with 11 hearings. 
This is my seventh appearance. I have submitted a written 
statement, and to leave ample time for both comments and 
questions, what I would like to do is summarize my comments 
through a slide presentation, if I may.
    Clearly, what we are trying to do here, all of us, is to 
find a better way for NIH, a way that in no way implies that 
NIH has not been a highly performing organization. In every 
measure, whether it be GPRA plans or progress in science, or 
breakthroughs, or impact on public, I think we can say that NIH 
has been a remarkably successful organization over many, many, 
many years.
    It is important to also remember that our basic authority 
comes from the PHS Act, Section 301, which states that the 
Secretary shall conduct in the service and ``encourage, 
cooperate with, and render assistance to other appropriate 
public authorities, scientific institutions, and scientists in 
the conduct of, and promote the coordination of, research, 
investigations, experiments, demonstrations, and studies 
relating to the causes, diagnosis, treatment, control, and 
prevention of physical and mental diseases and impairment of 
man.''
    And I think what the committee is doing is to reinforce 
this fundamental authority. We are the primary Federal agency 
authorized by this committee to conduct and support medical 
research, and I think the efforts that we are seeing have also 
been, in many ways, summarized in this list, where, in fact, 
the basic authorities do allow us to prioritize research at NIH 
through fundamentally an organizational structure, Institutes, 
Centers, that are created for special purposes related to 
perceived scientific opportunities or public health priorities.
    It mandates biomedical research, it provides grant-making 
authority. It mandates a system of peer review which is the 
envy of the world. It is a world-renowned system that ensures 
that quality science is funded on a competitive basis. It 
mandates training for the workforce that we need to address the 
problems we are dealing with. It also mandates dissemination of 
information, that the information we generate be made public, 
and be made available to the public who funds that research, 
even subject to protections as well, as a wide solicitation of 
the public advice.
    And I think the draft that is being circulated reinforces 
these authorities, and maintains them, and I want to comment 
and say that, to me, this is the most important set of 
reaffirmation of the success of the agency by reaffirming its 
fundamental authorities. It is clear, however, as the Institute 
of Medicine study, entitled ``Enhancing the Vitality of the 
National Institutes of Health: Organizational Change to Meet 
New Challenges,'' said that ``while the NIH is to be 
celebrated, success alone does not answer fully the question of 
whether there is a better way to proceed.''
    Particularly, as one faces a future where the world of 
biomedical science is being rapidly transformed in virtually 
all its dimensions. I would like to take a second. There is a 
quote on the wall there that says: ``Where there is no vision, 
the people perish.'' Proverbs 29:18. And I think this is what 
the IOM and your committee, and our own community, have been 
indicating. If, indeed, there is a transformation, and there 
are different priorities, how do we set those priorities? What 
is the organizational challenge we need to tackle as we go into 
an era of biomedical and behavioral and social science research 
that is characterized by much more complex problems, problems 
that affect an entire population at times, problems that affect 
an aging population, conditions that have become more chronic, 
more long-term, than the conditions we dealt with 30, 40 years 
ago. You can survive cancer today. You can live with cancer as 
a chronic disease. You can live with AIDS as a chronic disease. 
You can live and survive heart disease for many, many years. 
The landscape has changed, and I think we need to adapt as 
well.
    Now, at the March 17 hearing, this chart was highlighted by 
Chairman Barton as illustrating both the opportunity and the 
challenge that we have. Clearly, as any successful 
organization, we have grown in size, we have grown in 
complexity. To the same extent, the complexity and scale and 
scope of the public health problems we have to deal with have 
also grown. And as I said, the organization of NIH is primarily 
an organization driven by structure. So how did we evolve the 
structure; 27 Institutes and Centers represent the operating 
arms of NIH, what I refer to as the fingers, if you will. The 
palm, on the other hand, is represented by some of the 
coordinated offices, which you see at the top left hand corner, 
the offices that have been created for the purpose of better 
coordination, the Office of Research on Women's Health, the 
Office of AIDS Research, the Office of Behavioral Social 
Sciences Research. So as you can see, as time has gone by, more 
structures have been created. But at the same time, we have 
attempted to create what Representative Ferguson mentioned as 
the palm. And I think the balance between the palm and the 
fingers is really our challenge. A strong palm with no good 
fingers is not a good hand. Strong fingers without a palm is 
not a good hand either.
    So I think going forward and analyzing the proposed 
circulation draft, these are some of the observations that we 
can make. I think if you really look not in the structural way 
at NIH, but in the functional way, what you find is you have 
Institutes that are specifically directed to research and 
science that addresses either a disease or a disease process, 
or an organ, the Heart and Lung Institute, or a particular 
disease, like diabetes, or a life stage, childhood, or the 
aging population. These are what I call vertically oriented 
institutes that integrate all of the components of research 
needed to address a particular problem, as identified through 
our public health priority stance.
    These are the 15 Institutes that support research specific 
to either a disease, an organ, or a life stage. Now, any 
complex organization cannot work when there is only a vertical 
orientation of each structure. In fact, other Institutes have, 
for function, research, and science that is just as valuable as 
the what we call mission specific Institutes, but it supports 
what applies to all diseases, all organs, all life stages. For 
example, every discovery at the National Human Genome Research 
Institute applies to the entire aspect, the entire spectrum of 
challenges NIH has. We were talking about cross-cutting issues. 
These Institutes really perform the function of cross-cutting 
science, and cross-cutting issues like minority health, for 
example. Basic science, the National Institute of General 
Medical Sciences, performs science that applies to the entire 
set of diseases, ages, conditions, organs of the human body.
    At the same time, as I mentioned, in the top left corner, 
there are five program coordination offices that are specific 
to particular areas of the portfolio. When you think about 
organizations like this, you also have to realize that as the 
landscape has changed, what also happened is that with chronic 
diseases, patients are not affected by one disease at a time, 
or one organ at a time. They are often affected by multiple 
failures involving multiple organs. Diabetic patients may have 
a vascular problem, a neurological problem, as well as a 
problem of metabolism. So, it is important to realize that 
barriers and silos become, in themselves, both instruments of 
effectiveness, but also, instruments by which you lose 
effectiveness, if you are not able to create that glue.
    So I think the concept, the committee's conceptual 
framework, is a good one. It is truly going from structure, and 
enhancing that by a functional analysis of what NIH does. 
However, the one piece that I believe is important is to create 
the ability for the NIH, on a prospective basis, to analyze its 
portfolio, to have a real radar as to what is it that is being 
done within the agency, what is it that needs to be done, that 
no single institute can do, and what kind of coordination can 
you accomplish, and how do you accomplish it? And how does it 
impact budgets? Do you want to direct all research from such an 
office? No. Centralization is counterproductive in science, 
excessive centralization, too much top down research. Do you 
want to have no coordination? Well, the answer is no. Somehow, 
somewhere, I think the committee is proposing a structure that 
will accomplish this goal, which is very parallel to what the 
IOM recommendations have been, and very parallel to what my own 
actions have been on the ground, when we try to develop trans-
NIH programs, such as the Roadmap for Medical Research, or the 
Blueprint for Neuroscience, or the Trans-NIH Obesity Plan. This 
OD division would be essentially supporting the glue 
mechanisms, the coordination--not dictate, but enhance and 
synergize research. It will include the five specific program 
coordination offices, which will continue their roles, because 
they were created to fulfill a gap, which was coordination, and 
I think they need to continue to do that job.
    So in summary, I think you can see that going from a 
structural organization to a more functional organization does 
make the case that an authorization structure that would 
encourage, rather than discourage, integration, that it would 
encourage synergy, while not losing the autonomy and the 
ability for the most significant part of the activities of the 
Institutes and Centers, to be focused on their mission. I think 
we do see, in my personal view, a great wisdom in what the 
committee is proposing.
    I would like to mention, fundamentally, that NIH and its 
directors have tried to facilitate cross-cutting collaborations 
over time. I think it is true that science has changed over the 
past 12 years, and we have tried to adapt to it. We have 
adapted to it by an ad hoc process, which I don't think is 
codified or formalized, and we have shown that it can work, so 
when we say let us go forward, and make a change, I think I 
resonate with those who say make sure you don't break the 
agency. Make sure that what you are proposing works. And I 
think we have shown that it can work. The Roadmap for Medical 
Research is one example where all the Institutes have come 
together, and pooled funds, admittedly, at a time of generous 
budgets, and have put those funds together to work over a 5-
year period, and continue to see this as a valuable initiative. 
The Strategic Plan for Obesity, or the NIH Neuroscience 
Blueprint, I think this will accelerate the progress, and make 
sure that there is, at least, an exploration of a better way.
    When you look at the role of this division, I think it will 
provide consistent analysis across Institutes. It will provide 
streamlined reporting to Congress. It will provide prospective 
analysis of emerging areas, either scientific opportunities, 
like nanotechnology, or proteomics, rising public health 
challenges, like obesity or any other knowledge gaps can be 
addressed objectively, on the basis of a transparent and 
publicly available analysis. I think in conjunction, it should 
not be done separately from the ICs, in conjunction with the 
ICs, we should identify the areas that require strategic 
coordination, where no single Institute can really accomplish 
the goal that we would like to achieve. And it should launch 
initiatives that are beyond the purview or resources of any one 
Institute or Center. High risk, high reward research is 
difficult to launch when you don't have a common pool of funds 
that allow you to share the risk. This is, I think, what will 
serve NIH as a whole.
    So we need to make sure that whatever we do does not 
supplant what has worked, or dictate IC-specific plans. I don't 
think it is the role of this division to go to the Institute 
for Cancer and say, ``You shall do so.'' I think it is more 
important that we stimulate explorations for a part of the 
portfolio of NIH, to make sure that no stone goes unturned, 
that if there are opportunities to treat, to make progress, 
that those are prospectively, in a formalized process, 
evaluated.
    This institutionalized mechanism for allocating a 
percentage of the total NIH budget for greater synergy is, I 
think, the core, to me, of the reauthorization concept that I 
see, which I think would be very valuable. Essentially, it will 
be a common fund for common needs, with a process that would 
be, obviously, transparent, that will call for consultation, 
that will have the right checks and balances for oversight, but 
at the end of the day, in an era where science has become 
interdisciplinary, collaborative, and converging in many cases. 
Most of the research we do at one Institute applies to another. 
The first treatments for HIV/AIDS actually came from research 
that was done at the National Cancer Institute. There is no 
firm separation of good science. There is only good science and 
good public health.
    So in summary, I think that it is clear that the bill, as 
drafted, does provide, in my view, a higher level of 
coordination. And I, again, should say that it should not bleed 
into centralization. I think it should provide input from NIH 
Institutes and Centers, outside scientists, and the public. It 
should assess, like I said, a radar of the public health 
landscape, look at the scientific landscape on a regular and 
organized and disciplined basis, and manage the NIH portfolio 
for maximum return on the investment, if you will.
    But it will also, in my view, allow something that is 
always difficult to accomplish in a complex organization, 
nimbleness, the ability to be dynamic and responsive to quickly 
emerging opportunities, not wait for the 3 year or 4 year 
cycle, to be able to address a question, but to be there, on 
time, with the right amount of money, the right amount of 
resources, when we need it.
    So in summary, I think I am indicating to you a willingness 
to work with the committee. I think I hear the need for us from 
the standpoint of policy and national interest, to look 
carefully at the reauthorization of NIH. We will work with the 
committee and the staff, in any capacity, to provide the 
technical assistance that you may wish to have, but, in my 
view, I think the committee, after 2 years of work, is 
proposing something that has a functional component to it that 
does make sense.
    [The prepared statement of Elias A. Zerhouni follows:]
Prepared Statement of Elias A. Zerhouni, Director, National Institutes 
        of Health, U.S. Department of Health and Human Services
    Mr. Chairman and Members of the Committee, today is my seventh 
appearance before the Energy and Commerce Committee or one of its 
Subcommittees. I have testified about a variety of topics, including 
research priorities, the organization of Institutes and Centers, 
scientific peer review, the shift of the Nation's health care burden 
from acute to chronic diseases, and the need to revolutionize the 
methods and systems we use to conduct and manage biomedical research.
    Each time I testified, I noted the remarkable achievements made in 
the course of biomedical research, ranging from mapping the human 
genome to reducing mortality from cancer, AIDS, and heart disease to 
the rapid progress in the development of vaccines. But I tempered the 
stories of success by describing the daunting journey that lies ahead 
of the scientific community as we grapple with the remaining obstacles 
impeding progress towards the prevention, diagnosis, or treatment of 
the many causes of human suffering. Much more needs to be learned about 
human biology and behavior. Emerging and reemerging infectious diseases 
continue to threaten the world. Chronic diseases are growing in terms 
of their impact on quality of life and the economic future of America 
and other countries. The threat of bioterrorism continues to loom. 
Health disparities remain a widespread problem.
    As the Institute of Medicine (IOM) has observed, ``While NIH's 
success is to be celebrated, success alone does not answer fully the 
question of whether there is a better way to proceed, particularly as 
one faces a future where the world of biomedical science is being 
rapidly transformed in virtually all its dimensions.''
    This quest for the ``better way,'' as the IOM describes it, is also 
at the core of insuring continued scientific progress in an era when 
the scale and complexity of the problems we are facing require constant 
innovation, increased interdisciplinary efforts, and a balanced 
portfolio of basic, translational, and clinical research investments 
across all NIH Institutes and Centers. Based on my own interactions 
with the Members of this Committee, I know you too strive to find the 
``better way.''
    The IOM had several key recommendations worth recalling in the 
context of today's hearing. It recommended that the ``Director of NIH 
should be formally charged by Congress to lead a trans-NIH planning 
process to identify major crosscutting issues and their associated 
research and training opportunities and to generate a small number of 
multi-year, but time limited, research programs.'' The IOM proposed 
that NIH present the justification for trans-NIH budgeting to Congress 
and that the funding for such research should be held in an escrow 
account. It recommended that such research be included in the 
President's budget request to Congress for NIH.
    The IOM suggested that NIH have a formal process for reorganizing 
offices and programs.
    The IOM also recommended standardizing data and information systems 
at NIH to enhance management, accountability, and transparency.
    The IOM report was followed by three years of analysis by the 
Committee and its staff. I think it is noteworthy that the IOM and the 
Committee reached similar conclusions about NIH. Many of these 
conclusions are manifested in the reauthorization concepts offered by 
the Chairman and Ranking Member.
    In thinking about NIH reauthorization, I want to begin with the 
core research authorities embodied in Title III of the Public Health 
Service Act, which authorize the Public Health Service to ``encourage, 
cooperate with, and render assistance to other appropriate public 
authorities, scientific institutions, and scientists in the conduct of, 
and promote the coordination of, research, investigations, experiments, 
demonstrations, and studies relating to the causes, diagnosis, 
treatment, control, and prevention of physical and mental diseases and 
impairments . . .''
    I believe this core authority is the fundamental reason why NIH has 
been so successful in its mission. I applaud the Chairman and Members 
of the Committee for maintaining these and other vital authorities, 
such as peer review, the pursuit of scientific opportunity through 
investigator-initiated grants, human subjects protections, and the 
requirement to disseminate research findings to the public. In its own 
search for the better way, I think the Committee is correctly focused 
on organizational efficiency and effectiveness, which is the principal 
challenge for an increasingly large and complex organization.
    I agree with the Chairman that we should first and foremost 
carefully reconsider how the organizations of NIH can collectively and 
effectively support the core missions of the agencies. The challenge is 
to accomplish this goal through enhanced coordination and partnerships 
across the NIH Institutes and Centers while avoiding the pitfalls of 
centralization or top-down research. Achieving the right balance 
between the necessary autonomy and diversity of approaches represented 
by the various Institutes and Centers while avoiding the silo effects 
that can reduce the effectiveness of the whole Agency is the central 
question. How can the whole be greater than the sum of the parts? As I 
said in the past, twenty-seven fingers without a palm is not a strong 
hand. Likewise a strong palm without strong fingers is also 
ineffective.
    I agree with the Chairman that NIH needs an organization, such as 
the proposed division of program coordination, planning and strategic 
initiatives, that will serve as a coordinating office for evaluating on 
a regular basis the progress of science in the context of public health 
priorities. It will be responsible for analyzing and reporting with 
consistent methods the portfolios of NIH research that cross the 
boundaries of multiple Institutes and for identifying trans-NIH 
research needs that no single Institute can address but that all of NIH 
needs to support. This structure should be able to conduct appropriate 
strategic planning for emerging areas of scientific opportunities or 
challenges and to develop important data and intelligence to support a 
more comprehensive and informed priority setting process. As you know, 
the Administration has proposed such an office. I support the concept 
that this office be able, through a codified process that includes 
participation from all of the Institutes and the scientific community 
at large, to allocate resources to initiatives that serve the common 
good, subject to review by an advisory committee. However, I do not 
think this office should actually conduct the research resulting from 
any initiatives it identifies. I believe that this research is more 
appropriately conducted by the existing Institutes and Centers.
    The Chairman also proposes to clearly define the roles of NIH 
Institutes and Centers. I agree that each Institute and Center should 
have a defined purpose in support of the overall mission of NIH. The 
Chairman has proposed categorizing Institutes and Centers into either 
mission-specific or science-enabling responsibilities. This has 
resulted in the perception that one category is more significant than 
another. I understand that this is not the intent. All of the 
Institutes and Centers support vital research. Some engage in broader 
areas of science that are useful to all of NIH's organizations while 
others are involved in more specific areas of research, focusing, for 
example, on cancer, heart disease, or infectious diseases. Their 
research is of equal value to the scientific community.
    I will work with the Committee to clarify the roles of each of 
NIH's Institutes and Centers. I agree with his goal of clearly defining 
how each of these organizations serves the overall mission of NIH and 
ensuring that the Agency does not consist of 27 silos that do not work 
in coordination.
    In further pursuit of the ``better way,'' the Chairman has proposed 
consistent coding and reporting of research and a more transparent, 
efficient mechanism for reporting the results of NIH research to 
Congress and the general public. I agree that these steps are 
necessary, and I will work with the Committee to accomplish these goals 
in a way that will enhance the public's understanding of how NIH works, 
while not unduly inhibiting the Agency's ability to conduct and 
translate research quickly.
    In conclusion, I pledge my cooperation to work with the Committee 
as it considers reauthorizing the NIH provisions of the public health 
Act. I look forward to answering any questions that you might have.

    Mr. Deal. Thank you. I will begin with the questions.
    As you know, we are considering in this proposal to divide 
the various Institutes and Centers into two big categories, one 
that is mission specific Institutes, and two, the science 
enabling Institutes and Centers. What do you think about this 
approach to that two major divisions?
    Mr. Zerhouni. I think functionally, you can see that the 
mission is actually different for the two groups. It is really 
important to have the ability to coordinate planning between 
these. As I said, for example, you may have conditions and 
diseases that affect multiple organs. Diabetes affects the 
cardiovascular system, affects the brain. So you want more 
coordination around diseases, for example, that go across 
multiple Institutes that are focused on diseases.
    At the same time, in the cross cutting Institutes, that are 
just as important, you may see an emerging discipline. You may 
see something that--a methodology, or you may actually want to, 
for example, develop computational biologists. Well, that 
cannot be done by any one of them in isolation. So there is, I 
think, merit to--from the planning standpoint, to have these 
Institutes make sure that they get coordinated in a way that is 
strategically directed.
    Mr. Deal. I am sure most of us have heard from groups that 
feel like they are not adequately represented within the silos 
that currently exist, and one of the complaints is that they 
get shuffled from one to the other, that this is not that 
institute's responsibility, it is somebody else's.
    One of the ways that we have anticipated trying to deal 
with that is through the reporting system that is in the draft 
legislation. Do you believe that this reporting system is a 
good way to let the public know what is or is not being done 
and by whom, and is this an important ingredient in setting 
priorities for you within the NIH itself?
    Mr. Zerhouni. First of all, I would like to commend the 
committee, for looking at this issue of reporting. It is a 
consuming activity that consumes a lot of resources and staff 
time, for a benefit that is not necessarily there. So I think 
streamlining reporting would be of great value to us, and 
strategically reporting, in an appropriate way, would be 
important. But think about it. If you had a division like this, 
that had consistent ways of recording data and information, 
that across all activities, the NIH had a way, a consistent 
way, of reporting it dynamically, if you had an issue, you 
wouldn't have to create a report, or a need for a report. What 
you would do, you would say this division should be charged to 
look at, for example, in the case of autism, we developed an 
autism plan, called an autism matrix, and the case of 
Parkinson's disease. And the question should be what is in the 
portfolio, and what is science telling us, or public health 
telling us, that we are not doing. That sort of dynamic 
reporting is, I think, the future, but you can't do it unless 
you have the tool to do it. And I think, with the tools, we 
could streamline it.
    However, I think mandated reports of a very large size, 
basically, in my view, would be counterproductive. We need to 
be more nimble. We need to be more accessible. I think someone 
said accessible public information. That, I think, will solve 
the problem eventually. So I am in favor of streamlining 
reporting.
    Mr. Deal. Thank you. Mr. Brown.
    Mr. Brown. Thank you, Mr. Chairman. Dr. Zerhouni, I just 
have a series of short questions, and I hope that, if possible, 
you can give pretty quick answers to them.
    One of the questions before the committee is whether we 
include specific authorization levels in a bill reauthorizing 
NIH. Do you support the committee legislating a hard ceiling, 
or--a hard ceiling on NIH funding?
    Mr. Zerhouni. Well, you are creating a real conflict in my 
mind here. As the Director of an Agency, there is no ceiling 
that is good enough, but I do understand the necessity for the 
authorizing committees to look at that issue, and clearly, I 
think it--like we said, it really depends on the total 
structure of the authorization bill, and the specific amounts, 
and so on, over what time. I think the details need to be 
worked out, and would be happy to talk about the consequences. 
It needs to be done carefully, if it is to be done.
    Mr. Brown. Well, if we have ceilings or caps, let me push 
it a little further. If we have ceilings or caps, what is an 
appropriate percentage increase? What is an appropriate number, 
if there are those caps or ceilings?
    Mr. Zerhouni. I think you need to really look at the 
planning process, and you need to look at the opportunity well. 
I mean, you can't tell what emergencies will occur, what 
opportunity will come. So it is very, very important to leave 
yourself a significant amount of flexibility.
    Mr. Brown. I am not going to get a specific--answers that I 
want here, am I?
    Mr. Zerhouni. I am willing to work with the staff and the 
committee. I think it is something that needs to be looked at 
in greater detail.
    Mr. Brown. The draft contains several different authorities 
for the Director to transfer funds within the National 
Institutes of Health. One of these follows the Institute of 
Medicine's recommendation that each Institute and Center set 
aside a percentage of its budget into an escrow type account to 
be applied toward trans-NIH initiatives, as we discussed, a 
sort of common fund. What is an appropriate percentage that we 
should set aside, if we do it in the authorizing language for 
trans-NIH authority?
    Mr. Zerhouni. Well, clearly, I think, it wouldn't be 
meaningful if it is not a meaningful percentage. I think--and I 
think the IOM recommended beginning with 5 percent of the 
overall NIH budget, and I think that this is a good way of 
making sure that the NIH Institutes come together on a regular 
basis, because this is not transferred away from the 
Institutes. I think it should stay within the Institutes, but 
allocated dynamically over a period of time, and the 
initiatives to which it is allocated should not be permanent 
initiatives. They should be time limited. If you do that, I 
think, obviously, you need to have a significant portion, 5 
percent is, in my view, a good recommendation as a minimum.
    Mr. Brown. As a minimum.
    Mr. Zerhouni. For a common fund.
    Mr. Brown. Yes.
    Mr. Zerhouni. Now, there is a difference between----
    Mr. Brown. You are saying a minimum----
    Mr. Zerhouni. [continuing] a minimum----
    Mr. Brown. [continuing] or the optimal number, 5 percent.
    Mr. Zerhouni. I am reading you the----
    Mr. Brown. What do you think?
    Mr. Zerhouni. I think 5 percent should be a minimum.
    Mr. Brown. Okay, a minimum. Okay. And you want to set it up 
so that it is not an entitlement, so that it doesn't ultimately 
lead to another Institute, in effect.
    Mr. Zerhouni. That is right. I think the idea of creating 
another structure that has funds, and allocates that to--over 
an infinite period of time is not the concept. The concept here 
is to create an organization that will identify what areas to 
incubate better, what emerging areas need to be supported, what 
emerging areas need to be funded. But it shouldn't be forever. 
It should be time limited, and we can discuss how to do that, 
technically, but I don't believe that those initiatives should 
live there forever.
    Mr. Brown. And what other kind of transfer authority that 
the Director, that allows the Director to transfer funds from 
one Institute or Center to another Institute or Center. My 
understanding of current law is that you have the authority to 
transfer 1 percent of any of the Institutes' or Centers' budget 
in this way. In that 1 percent, that--my understanding, that is 
what the appropriators have done, have allowed. I am not sure 
that we have addressed that. Have you made use of that 1 
percent transfer as Director?
    Mr. Zerhouni. Okay, historically, if you look at the use of 
the transfer authority, because it is an authority that comes 
post facto, it is not planned ahead of time, and if you know 
the reality of the budget process, you have to plan at least 2 
years ahead of time. We are currently dealing with the 2007 
budget, while the 12006 is not done. So what you really need, 
transfer authority is only used in cases where your planning 
missed something. Something happened where you need to quickly 
react to a--something on the ground that is happening in real 
time, so you transfer small amounts. So historically, the 
transfer authority has never been used for a prospective, 
strategic purpose. It is usually reactive and post facto. So 
the transfer authority doesn't have to be a large authority. 
The common fund concept, however, needs to be real and 
significant.
    Mr. Brown. Last question, real quick, Mr. Chairman. On the 
transfer authority, not the common fund, but the transfer from 
one Institute to the other. Is the--should the 1 percent number 
be in the authorizing language? Should it be 2, should it be a 
half? I understand that you haven't used it--you have used it 
very infrequently, if at all. What should we do there? Give us 
a specific number.
    Mr. Zerhouni. There is no doubt in my mind that it should 
be in the authorizing language, because not being in the 
authorizing language makes it unsure.
    Mr. Brown. What should be in the authorizing language, 1 
percent, 2 percent, .5 percent, what?
    Mr. Zerhouni. Again, I will have to think through what the 
topics are, but 1 to 3 is usually what people recommend, the 
AAMC says up to 3, the IOM says up to 3. One to me--it depends 
on what else you have. If you have a common fund that is in 
law, in authorization, where everybody knows that they have to 
come to the table, and plan jointly, then the transfer 
authority can be smaller. If you don't, then you have to rely 
on the transfer authority, like we did for the Roadmap, for 
example. The first year of the Roadmap, I used the transfer 
authority.
    Mr. Deal. Mr. Bilirakis.
    Mr. Bilirakis. Thank you, Mr. Chairman. Doctor, you have 
spoken, and I would say pretty fondly, of the committee draft. 
Obviously, in your remarks, you didn't go into the dollars of 
it. Mr. Brown did, and I would sort of like to maybe hitchhike 
on his questioning.
    In my opening statement, I was concerned that we not cause 
any harm, basically, the old doctor's education adage, ``Do no 
harm.'' In that connection, thinking in terms of multi-year 
commitments in research portfolios, thinking in terms of longer 
range planning, which is, I guess, basically the same thing. 
Thinking in terms of--or politics. Politics sometimes in NIH 
would be maybe even heavier than politics in Capitol Hill. 
Ultimately, it is the real world is, I guess, is what I am 
talking about, the ability to shift funds. Talk about that, in 
general.
    Do you feel that the areas that you have not mentioned, 
such as the four specific authorizations or appropriations, the 
competition which is envisioned there, the transfer authority, 
the increased transfer authority that would be given to your 
office. I think, even though the legislation is blank, it 
leaves it open in terms of what that percentage would be. It 
certainly envisions considerably higher than what your office 
now holds.
    So in terms, again, of the things that concern the--tell us 
a little--take the rest of my time, and tell us a little about 
that.
    Mr. Zerhouni. I think it is a very good area to focus on. 
From my standpoint, what is really important here is to 
establish the proper checks and balances, just like our system 
of government works on checks and balances. There is always the 
possibility of misdirecting decisions at the executive level, 
if you don't have the proper checks and balances. And I think 
the same is true, that you could also have such an 
entanglement, and such a limitation on what the executive can 
do that you are not getting an efficient organization. So the 
answer to that, I think, is what I believe in very strongly. 
No. 1, complete preservation of the peer review process. No. 2, 
relying on the input from the Institutes and Centers who are 
closest to the action, understand the research, and have a 
process that is formalized, where in fact, that consultation 
occurs. And third, an outside oversight mechanism such as the 
Advisory Council of the Director, which is, in law, the 
mechanism by which all Institutes, really, are overseen, with 
public members and scientific members.
    I don't think it is as big a problem as I think some people 
are afraid of, but I think it will depend on the details of how 
you establish the proper checks and balances, so that there 
isn't excessive authority being exercised on a discretionary 
basis without reporting back to Congress, and to the 
appropriate members.
    Mr. Bilirakis. Well, but excessive authority, sir, and 
checks and balances and whatnot, I mean, that is pretty darn 
subjective. It is in the eyes of the beholder, I guess.
    Mr. Zerhouni. Right.
    Mr. Bilirakis. And so here, we put ourselves in the shoes 
of these research facilities out there, and from the 
standpoint, again, of the multiyear planning, and whatnot. 
There still would be, in the hands of--basically, right now, of 
course, they are in the hands of the Appropriations Committee's 
up here.
    Mr. Zerhouni. Right.
    Mr. Bilirakis. They would be in the hands of the Director 
to a very large degree.
    Mr. Zerhouni. I think they would be balanced, because no 
project that the Director can come up with will not--will be 
accepted without peer review. So all of those will go through 
that two level of peer review process. Second, if you predicate 
the ability of having an allocation done for a particular 
purpose, on the need for a consultation with the Institutes, so 
that the scan that I am talking about is done, and remember 
that we are only talking about trans-NIH areas of concerns, 
where the palm has to be stronger than it is today. I think it 
is doable. I don't think--it is an achievable goal. Complex 
organizations do that all of the time. As long as you have a 
proper oversight structure and the corporate board structures 
to have enough input.
    Mr. Bilirakis. You know, over the years, when I chaired the 
subcommittee, I guess the most terrible times that I had was 
when I had people coming in to me in wheelchairs or whatnot, 
and they wanted increases in research funding for that 
particular, specific disease, and having to tell them that we 
have a policy here of not basically telling NIH how they should 
spend that money. So I guess you are making this--if this were 
to go forward, it probably makes it easier on us, in the sense 
we would pass the buck on to, I guess, to you, if you--is that 
correct?
    Mr. Zerhouni. Well, I hope it is not the intent here, 
because I would definitely see that as not a good evolution. I 
think, in fact, the reason our American science is as good as 
it is, and NIH science is as good as it is, is because of the 
wisdom of Congress in avoiding specific earmarks independent of 
the peer review process, independent of that check and balance 
system that is really the envy of the world. So I would prefer 
to preserve that, rather than have more coordination, to be 
honest with you.
    Mr. Bilirakis. Well, thank you, sir. Thank you, Mr. 
Chairman.
    Mr. Deal. Thank you. I know that you cannot see the timer. 
The only thing you can see is probably when the red light goes 
off at Dr. Zerhouni's table there. And we have a timer up here. 
The Science Committee is just not as advanced as we are in our 
committee, but if you would try to watch that timer there, so 
we can get everybody with questions. Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman, Dr. Zerhouni, I want 
to ask you about advisory committees at NIH. The National 
Research Council of the National Academy of Sciences recently 
recommended that appointments be made on the basis of 
scientific and technical knowledge and credentials, and 
professional and personal integrity. Do you agree with that 
statement?
    Mr. Zerhouni. Yes.
    Mr. Waxman. The National Research Council also stated that 
it is inappropriate to ask potential candidates for advisory 
committees about non-relevant information, such as voting 
record, political party affiliation, or position on particular 
policies. Do you agree with that view as well?
    Mr. Zerhouni. Yes, I agree.
    Mr. Waxman. In recent years, there have been serious 
allegations made that advisory committee appointments were 
dictated by politics, and not science. In one well publicized 
case, an advisor to a panel on drug abuse was asked whether he 
had voted for President Bush, and whether he supported abortion 
rights. In another case involving the Fogarty Center on 
International Health, numerous proposed experts were rejected 
by the Department for apparently political reasons, and those 
rejected included a Nobel Prize winner. Would you support clear 
language adopting the National Research Council's standards as 
guiding advisory committee appointments at NIH, and essentially 
saying the NIH Director would make appointments without 
political interference by the Department, these appointments 
should be based on scientific merit, not political litmus 
tests, and Congress should remove any temptation to meddle with 
this process?
    Mr. Zerhouni. Well, when I became Director I looked into 
them. The NIDA case, for example, that was not a department 
selection with NIH. You are talking about a Nobel Prize 
Committee member. I understand that same person is now an 
advisor to the Office of Science and Technology Policy. I have 
heard a report from one member, who had been asked questions 
like this. So----
    Mr. Waxman. Whatever happened in the past--in the future, 
do you think it would be a good idea to write that into the 
language?
    Mr. Zerhouni. Let me just say this, Congressman, that to my 
knowledge, since I was aware of that one case, and I intervened 
no one on any NIH council, peer review or advisory, is 
unqualified to be on that council. So I want to make sure you 
know, my commitment is to, in fact, achieve that. And during my 
tenure, there has not been----
    Mr. Waxman. Dr. Zerhouni, I am not really being critical of 
you. I am just asking for questions on this legislation. Do you 
think we ought to write that in?
    Mr. Zerhouni. By and large I think NIH is--should be 
apolitical. I think it is apolitical, I think disease knows no 
politics. I think we should really advise and inform, and do 
the research that serves the entire country, and do it in the 
most objective way possible.
    Mr. Waxman. You have been a strong advocate for NIH's 
system of peer review of grants, and its independence from 
political pressures. Do you believe the NIH Director should be 
able to defund a grant that has passed peer review by an 
Institute?
    Mr. Zerhouni. I think there would have to be really, a 
very, very scientifically justified reason to defund it. We do 
have cases where there are issues of integrity of the science, 
misconduct, where we have to defund. So the NIH Director needs 
the authority to defund, but not on the basis of a political 
decision.
    Mr. Waxman. Well, the reason I ask is that the idea has 
been floated to make the NIH Director responsible for 
eliminating unnecessary, duplicative research, and for ensuring 
balance in research. I understand the need to constantly----
    Mr. Zerhouni. Well----
    Mr. Waxman. [continuing] review NIH's research portfolio, 
to make sure it is responding to the challenges facing the 
American people, but I am concerned about giving any Director, 
a political appointee, you know, broad authority to second 
guess the scientific experts to rate the grants in their 
fields. What should be the NIH Director's role in assessing the 
portfolio----
    Mr. Zerhouni. I think priorities, in my view, should be 
allocated and priorities means resource allocation, at the end. 
I think----
    Mr. Waxman. But not micromanaging.
    Mr. Zerhouni. Not micromanagement. You should really do it 
on a prospective basis. For example, we allocated resources, 
greater resources, to the obesity issue, that you know well, 
prospectively. Once it goes to that level, I think the Director 
should trust the peer review process, and not second guess a 
two level process. The peer review process, two levels of 
independent review is the cornerstone of NIH, and why it has 
been successful. So prospectively, doing priority setting, 
absolutely. Changing the relative weights, because science 
changes, and public health priorities, absolutely. 
Retrospectively, I don't think it is a good idea.
    Mr. Waxman. Thank you. Thank you, Mr. Chairman.
    Mr. Deal. Chairman Barton, do you have questions?
    Chairman Barton. Mr. Chairman, I am going to defer at this 
point in time, to kind of get a feel for the hearing, but--the 
Energy Conference is in recess for 30 minutes, so before I go 
back downstairs, I would like to be called on. But I want to 
study up a little bit right now.
    I am glad to know where all my energy conferees are, 
though. They are all up here at the NIH hearing. But I am going 
to defer at this point in time.
    Mr. Deal. All right. Ms. Wilson.
    Ms. Wilson. Thank you, Mr. Chairman, and thank you, Doctor, 
for being here to testify.
    I had a couple of questions. I had a particular interest in 
this issue of managing research portfolios, which I think is 
very different than a lot of the other things that we manage in 
government. And I am interested not in what are the best 
opportunities for research and science, but how do you 
determine what are the best opportunities? What tools do you 
have as a Director, or within and across your Institutes, for 
determining what the best opportunities are?
    Mr. Zerhouni. Of how it is done. So fundamentally, about 
60, 65 percent of the budget is allocated to what we call 
scientifically-initiated proposals, so it is investigator-
initiated proposals, a scientist out there has a great idea. 
They submit the idea to the peer review process, which is the 
first step at the top, is the NIH grant proposal. It then goes 
to a scientific review panel. And only 25 percent of these get 
ranked to be funded, and it goes through the program officer. 
Now, the program officer in each Institute follows a particular 
strategic plan, that has been usually developed over a period 
of years by the Institute, to look at program importance and 
program relevance. And that officer will determine whether or 
not the grant fits with the program relevance of that 
Institute. And then, it goes to the second level of review, 
which is the Institute National Advisory Council, and that 
Institute has, in law, in statute, the authority to fund this 
research or not fund it, and sometimes, they will change the 
priorities at that level. And this goes to the Institute 
Director, reported back to Congress, obviously. This is the 
issue of reporting that we cover.
    So this is done at the level of the Institutes, and the 
ability of the NIH in total to combine all these portfolios is 
limited. This is why, I think, this reauthorization strategy 
will provide the ability to look across Institutes and across 
portfolios. And Institutes have done that on their own, and 
many Institutes have come together to look at areas that are 
common. Usually, with a lead Institute serving as the disease-
specific need. So the process seems complex, but there is no 
doubt that within each Institute, planning is done, has always 
been done, in a very effective way, and the Program Directors, 
in conjunction with the Advisory Councils, will then determine 
what the portfolio will be for that Institute.
    What you don't have, as effectively as we--what I believe 
we should have, is a look across all portfolios, with 
analytical tools that tell you how much are you spending in 
this area of research versus that one. And duplication is not 
necessarily bad in research. You need to confirm findings. You 
want to have that. But it is the balance, is the issue of what 
is the right balance.

[GRAPHIC] [TIFF OMITTED] 22987.001

    Ms. Wilson. I find that interesting, that it seems to be driven 
from the bottom up, from the researchers. There may be some value to 
that. At the same time, you as a Director need to be----
    Mr. Zerhouni. Right.
    Ms. Wilson. [continuing] looking at what are the biggest problems.
    Mr. Zerhouni. Right.
    Ms. Wilson. [continuing] that we need to identify research 
roadmaps, and gaps in research in order to fill. And that is--is there 
anything that you currently have that does that kind of an assessment 
of here are the biggest health problems, whether it is the cure for 
diabetes, which is driving health costs, or aging problems? Do you have 
any mechanisms to do that?
    Mr. Zerhouni. Actually, my answer was incomplete. Sixty-five 
percent of the budget is allocated to investigator initiated proposals, 
and about 30 percent is allocated to what we call requests for 
applications, or requests for proposals, or contracts, where we 
identify, ourselves, an area where further investments are needed, or 
an action is needed, or new Centers are created. We put those 
announcements for competition to the field, and that is how we balance 
the portfolio between what comes from the bottom up, and what we want 
to get accomplished. I am sorry, I missed that.
    Ms. Wilson. I will be interested in pursuing that, as we move along 
here on reauthorization. And finally, I just ask for your thoughts on 
how to structure a system to give access to research, and whether you 
think it should be public, or only to medical practitioners. Should it 
include the successes as well as the failures? What are your thoughts 
on how you would pursue this?
    Mr. Zerhouni. This is a topic that we discussed entirely with NIH 
Directors as well as scientists, and it is a very major component of 
the Roadmap for Medical Research, where in fact, we think that we 
should make investments in information technology that would be 
accessible at the community level. We think that we need to train 
community practitioners in research methods, and have a core of 50,000 
community practitioners that would have access to our data base, called 
clinicaltrials.gov, where we are listing about 14,000 clinical trials. 
I think we need to enhance the ability for us to link those trials to 
the results of those trials.
    So my view is more openness, more transparency, more access, to 
community physicians in particular, because chronic diseases are seen 
in the community much more so than they are in academic health centers. 
And we have an initiative, which will start this year, called Clinical 
and Translational Science Awards, which we are going to announce at the 
end of August, September.
    Mr. Deal. Ms. Eshoo, you are recognized for questions.
    Ms. Eshoo. Thank you, Mr. Chairman, for holding this very important 
hearing, and welcome, Dr. Zerhouni.
    This is a very large undertaking. I have been in the Congress, this 
is my thirteenth year, and I am always thrilled when we get to 
reauthorize NIH, which I always like to refer to as the National 
Institutes of Hope, and I think that is the way the American people 
view the NIH, and it is in that spirit that I ask the following 
questions.
    First, on transfer authority. This transfer authority is thought to 
allow you, the Director, and succeeding Directors, more flexibility to 
run projects and to streamline the budget decisions, but of course, we 
don't want flexibility to undermine any accountability. And I raise 
this because last year, broad transfer authority was given to the NASA 
Administrator, and I think with devastating consequences. I have a 
major NASA Ames, maybe it is good that we are the science hearing 
room--someone may come off the walls on this. I have a NASA facility in 
my district, NASA Ames, right in the heart of Silicon Valley, and we 
saw that budgets were being realigned not to spur progress and 
development, but to cover funding shortfalls in other areas.
    So it was--that transfer authority was being completely, I think, 
misused, and I know that there isn't anyone here that wants to see 
transfer authority misused. What would you suggest that could be built 
into the reauthorization, with these proposed changes, that would not 
allow the NASA, you know, the--what I just described happening at NASA, 
to happen within the NIH?
    I want to ask my questions, then you can answer. I mean, I agree 
that NIH scientists are, by and large, more equipped than Congress on 
where--maybe so, you know, as a partner, on how best to spend the 
money, where it should be directed. But I am concerned that scientists 
would not have any kind of role in the transfer authority. I think when 
the--let me just summarize it by making this observation. I think NIH 
works best when it is collaborative. I don't think it was ever meant to 
be an institution that has such a powerful Director that there is only 
one conductor of the orchestra. You have to have someone that leads, 
but I do think that the collaboration needs to be built, and so that it 
is enjoyed across the board. As you explained, I mean, we have entered 
a new era. So this transfer authority business is a bit troubling to 
me, if it is not handled right.
    And I have concerns that dividing the NIH Institutes and the 
Centers into two categories will not necessarily make NIH function more 
effectively, or improve Congressional oversight of appropriations. And 
on that key word of, in terms of appropriations, I know it is a tough 
call for you to make, but you know what the needs of the agency are. I 
am highly skeptical of doing reforms anywhere, when they are meant, 
they are really--it is really dressing the issue up to cut or to not 
fund properly. And you know, one doesn't take the place of the other. 
In fact, reforms, many reforms can't be carried out unless you have the 
necessary resources. I see where the FDA is having a very tough time. 
FDA has not been funded properly by the Congress, and yet, we have so 
much that we expect from the agency. So if we are going to live up to 
National Institutes of Hope, and the changes that are afoot, what would 
you instruct us about transfer authority, so that it is what it should 
be, and not what I described happening in another agency.
    And also, on the organization of Institutes, you know, there was 
one that I helped to found. I don't know if it is--with this plan, it 
is going to be wiped. I mean, I have had people come to me and say it 
is working very, very well, the Biomedical Imaging and Bioengineering 
Institute. So if you would comment on my observations also my 
questions, I would like to see a good, healthy appropriation for NIH. 
It is only to help to make the changes, but we have to--this century is 
going to be the--is going to be known, I believe, as the century of the 
biomedical changes. And if NIH is not embraced by the Congress, in 
terms of an appropriate appropriation, then it is going to be--we are 
going to be talking about out of both corners of our mouth.
    So take it away.
    Mr. Zerhouni. Well, very important points. I think the----
    Mr. Deal. You have 30 seconds to respond.
    Mr. Zerhouni. Okay. That is----
    Ms. Wilson. He can respond--for the committee as well.
    Mr. Zerhouni. Yes, I can certainly respond, but I don't think----
    Ms. Wilson. They are serious questions.
    Mr. Deal. Just looking for the question mark.
    Mr. Zerhouni. As a Director I think it is important to remember 
what I said before, and that is, it is the balance that is key. A 
dictatorial counselor authority wouldn't work, and I would like to just 
read, I think, one of the recommendations of the IOM report, which 
captures what I think is trying to be accomplished here.
    ``The Director of NIH should be formally charged by Congress to 
lead a trans-NIH planning process''--everybody is at the table--``to 
identify major cross cutting issues in their associated research.'' 
That is collaboration, because think, not having any such authority 
removes the accountability of the Director to be able to direct the 
agency to what it needs to do. So there is a balance between the two. 
The question is where you find that balance. And it does instruct the 
Director to present the scientific rationale for trans-NIH budgeting to 
the relevant committees of Congress, including a proposed target for 
investments in trans-NIH initiatives. So it is not a transfer. It is a 
common fund for common good, for common needs. That is the concept. And 
I don't think it should be deviated from that, provided we put the 
right checks and balances and transparency in it. That, I believe, is 
needed by the NIH.
    Mr. Deal. Dr. Burgess.
    Mr. Burgess. Thanks, Mr. Chairman. I will be glad to yield to the 
full committee chairman, if he----
    Chairman Barton. If the gentleman doesn't mind, I appreciate that.
    First, Dr. Zerhouni, thank you for testifying today, and thank you 
for you and your staff's efforts working with us the last year, as we 
have worked with the stakeholders to come up with the legislation, the 
draft legislation, that we are looking at today. I want to let the 
committee know that this is a very high priority for me as chairman. If 
we wish to reestablish the authorizing committees in a meaningful way, 
when overseeing the agencies that we theoretically have jurisdiction. 
Under the current environment, we haven't reauthorized NIH in 12 years, 
and in all--to be totally true about it, most of the oversight that is 
being done is being done by the appropriators. So this effort, while 
you can argue with the specifics of the draft, is an attempt to 
reassert the jurisdiction of the authorizing committees in general, and 
the Energy and Commerce Committee specifically over one of the more, if 
not the most, one of the more important agencies in the Federal 
Government.
    We have--as well as we all know, we have doubled the budget of NIH, 
but we have not done anything to try to help their management 
structure, or help them come up with a mechanism for allocating all 
these new grants and funds that we have provided them. Nothing in the 
current draft legislation in any way denigrates the peer review 
process, the two step solicitation, the grant process at NIH. Nothing. 
We keep our hands off of that. We are not trying to micromanage. What 
the draft does do is collapse the 26 line items to four, No. 1, give 
the Director, in this case, Dr. Zerhouni, more direct authority, by 
empowering him, and enlarging the--his direct discretion, and then two, 
creating this trans-NIH fund, that is multi-agency with NIH, and give 
it real budgetary authority, and real dollars, so that as we have these 
cutting edge ideas come forward, they are looked at across the NIH, 
concurrently, as opposed to individually within each of the 27 
Institutes.
    I think that is a very good idea. So my first question to you, Dr. 
Zerhouni, the general concept of going from multiple line items, in 
this case 26, down to a more, a smaller number, in this case, four, at 
least in approach, do you support that? If you don't maybe support the 
exact numbers, do you support the principle?
    Mr. Zerhouni. Again, I think, as I testified while you were busy 
with the other committee, Mr. Chairman, I believe that the approach, 
the conceptual approach you have taken in bringing functional 
integration, through the mechanism of identifying what is the function, 
relative to the structure is, in my view a good approach. The details, 
obviously, of how you implement that on the ground, and how do you play 
that, it is obviously something we need to work on. But I think the 
fundamental concept, that the agencies become more complex and larger, 
and needs to be more efficiently managed through a transparent process 
that makes people have a common good, a common fund for a common good, 
overall, this is, in my view, a good contribution to the agency.
    Chairman Barton. What about the line item that we would create, 
that is trans-agency, that we give direct authority, with a discrete 
amount of money, that it would allocate funds across the different 
Institutes.
    Mr. Zerhouni. My comments to that are, Mr. Chairman. I think you 
need what I call an opportunity fund. When something comes up that is 
actually critical, you need the ability to house it somewhere, so that 
you can implement it quickly at the time of the budget request, and 
that it be authorized. So that is what I call the opportunity fund.
    Then, I would say that it is important to have a trans-NIH fund of 
some sort, called, what I call the common fund, where everybody is 
incentivized to come around the table and discuss, without being afraid 
of, essentially removing from their own specific mission resources, 
because they are mandated by the authorization language to say you 
need--you shall come together, and you shall identify what is cross 
cutting, and what needs to happen. So the authority for having an 
opportunity fund is important, because you never know what comes up. 
For example, biodefense came up, and we need to react to that.
    A trans-NIH fund is certainly a necessity, and some transfer 
authority. It doesn't--if you have those two, you don't need large 
transfer authorities, because they are different in nature. Transfer 
authority is post facto. A trans-NIH fund is prospective. So I think 
the combination of these three is really what would make the agency 
work well.
    Chairman Barton. My--I see my clock has expired. I want to ask one 
more question. As we put the draft out for review, there appears to be 
a lot of concern about where we would set the baseline, the first--if 
we--if this bill were to become law, where we would set the baseline. 
Now, my preference would be that the first year, if this bill were to 
become law as-is, the baseline for each Institute would be whatever the 
funds that it received in the prior year. So we would guarantee every 
Institute, you know, that--100 percent as the baseline, and then, we 
would start from there, and you could go up, and--or they could go 
down, but the very first year, every Institute would be held whole, and 
then we would begin this internal review and internal competition, and 
with your discretionary fund, and the trans-NIH fund, in terms of the 
first year's baseline, is that your view, too, that each Institute 
would start at 100 percent of last year's funding?
    Mr. Zerhouni. Well, clearly, as you know, the process of science is 
not something you can do over 3 months, stop, and start again. So it 
would be very important to make sure that you don't disequilibrate the 
system, I mean, the agency does work relatively well. To the extent 
that you--and I would certainly echo what you just said. I mean, it 
would be very important to preserve the, you know, the momentum that 
many of these Institutes and Centers have undertaken. What I think is 
important, also, is to realize that the--depending on how we--you 
technically settle on what is common fund, what is opportunity fund, 
what is--then, the answer will affect, obviously, what you wish to 
accomplish through that mechanism of putting, I think, a floor.
    I think it depends on that planning process.
    Chairman Barton. Okay. And I want to thank you, Dr. Zerhouni. I 
also want to thank the chairman of the Science Committee, Mr. Boehlert, 
for allowing us to use his hearing room, the Science Committee hearing 
room, so that we could continue our markup at the Energy Conference 
downstairs. And if we have energy conferees here, not to name names, 
but Mr. Stupak and Mr. Bilirakis, to name a few, we are--and Mr. Wynn, 
we are reconvening in 10 minutes downstairs.
    Thank you, Mr. Chairman.
    Mr. Deal. Mr. Wynn came in late. We are still confused as to why he 
is sitting over here, Mr. Chairman.
    Ms. DeGette, I believe you are next.
    Ms. DeGette. Thank you very much, Mr. Chairman.
    Dr. Zerhouni, we have been told by the leadership of this committee 
that what they are really trying to do with this NIH reauthorization 
bill is to look at the organizational structure, and see if there are 
ways--in a bipartisan manner, that we can reauthorize the bill by 
looking at the structure, and looking at some of what I think are your 
very wise suggestions. I agree with that approach for the most part. I 
think--I mean, I have many fabulous pieces of legislation which are 
bipartisan, that I would like to see included in this bill, but I am 
going to try to work with the leadership. But there are some questions 
I have been sitting here mulling over, listening to the testimony, and 
listening to the questions of my colleagues on the panel, and I am 
wondering if you can comment a couple of these. It is not about do we 
need more research for this or that, or--tempting as--though it may be, 
stem cell research.
    Instead, I was thinking about when you talked early in your 
testimony, and it is this slide here, which your staff kindly provided 
me with, the key authorities that the NIH has, prioritizing research, 
mandating biomedical research, providing grant-making authority, 
mandating peer review, mandating training, mandating dissemination of 
information, mandating human subject protections, and mandating the 
solicitation of public advice. Do you think all of those areas should 
be included in a reauthorization of the NIH?
    Mr. Zerhouni. Yes. I think those are the basic authorities, and 
they have served NIH very well.
    Ms. DeGette. And I would agree with that. But really, in your view, 
when we do this reauthorization in the committee, we should try to work 
in a bipartisan way to look and see if the NIH current mandate is 
adequate in all of these areas, and whether it can be beefed up or 
expanded or improved, correct?
    Mr. Zerhouni. The privilege of the committee, absolutely.
    Ms. DeGette. Okay. The reason I ask that is, I have a particular 
interest, which you know. In this list of items, in the human subject 
protections, and as you know, Dr. Zerhouni, I have been working 
previously for many years with Jim Greenwood, who was the previous 
chairman of the Health Subcommittee, and also, I have talked with Mr. 
Barton and other members about human subject protections. I am 
wondering if, in the draft legislation, you or your staff expanded the 
human subject protection authority that the NIH currently have, as--or 
have you addressed this at all in the draft? I haven't had time to 
really delve into it.
    Mr. Zerhouni. Not to my knowledge, but I certainly will check. I 
have not personally focused on that issue, but certainly, we would be 
more than happy to share with the committee staff what the status of 
human subject protection is, and--in the context of what I know you are 
interested in.
    [The following was received for the record:]

    The NIH has a long-standing commitment to the protection of human 
subjects of research that dates to the first formal policies it 
developed for its intramural program when the Clinical Center opened in 
1953. Since then, through Congressional directive and Executive 
initiative, the agency has developed a comprehensive network of 
standards and requirements so that NIH-sponsored research, both 
intramural and extramural, meets the highest levels of human subjects 
protections.
    The legal authority for NIH oversight of human subjects protections 
in research supported or conducted by the NIH derives from the Public 
Health Service Act, which at 42 USC 289 directs the Secretary of Health 
and Human Services to establish oversight of research conducted or 
supported by HHS and its agencies. In accordance with this legal 
authority, research supported or conducted by NIH is subject to federal 
human subject protection regulations, known as the Common Rule, found 
at 45 CFR part 46, subpart A. These regulations require informed 
consent and IRB review. HHS regulations that specifically concern 
protections and considerations for pregnant women, fetuses and in vitro 
fertilization, as well as prisoners and children can be found at 45 CFR 
part 46, subparts B, C, and D. These regulations are referred to as the 
``Common Rule'' because the federal government, in June 1991, published 
them as a common policy for federal agencies conducting or supporting 
research with human subjects. Today, it governs seventeen agencies and 
most federally-supported research. Additionally, when NIH-funded 
research is regulated by the Food and Drug Administration (FDA), it is 
subject to FDA's human subjects regulations incorporated at 21 CFR 
parts 50 and 56.
    NIH has measures in place to help ensure that NIH-funded clinical 
research complies with the ethical guidelines and regulatory 
requirements for research involving human subjects and that the rights 
and welfare of human subjects participating in NIH funded studies are 
protected.
    For the NIH intramural program, a distinct office is charged with 
helping intramural investigators understand and comply with ethical and 
regulatory requirements for research involving human subjects. In the 
extramural program, NIH has regulations and policies in place to help 
NIH-funded clinical research comply with the ethical guidelines and 
regulatory requirements, including 45 CFR part 46, for research 
involving human subjects.
    Pursuant to its authority to set the terms and conditions for 
research that it funds, and consistent with the requirements of 45 CFR 
part 46, the NIH has implemented specific requirements for the 
protection of human subjects in research that it funds or conducts (see 
generally 42 CFR part 52). These include:

 A requirement that applicants or offerors describe and justify the 
        risks to the subjects, the adequacy of protection against these 
        risks, the potential benefits of the research to the subjects 
        and others, and the importance of the knowledge gained or to be 
        gained;
 The evaluation of proposed human subjects protections by peer 
        reviewers and NIH staff, and appropriate resolution of human 
        subjects issues before the study can be initiated;
 Confirmation that the institution has a current Office for Human 
        Research Protections (OHRP) ``Assurance'' on file attesting to 
        its compliance with 45 CFR part 46;
 Certification of review and approval of the research by an 
        Institutional Review Board (IRB) registered with OHRP under the 
        institution's Assurance.
 Education in the protections of human subjects for research study 
        personnel designated as ``Key'' to human subjects research so 
        that they understand the underlying philosophy and specific 
        requirements of human subjects protections when engaged in 
        clinical research; and
 A plan for data and safety monitoring for all NIH-funded clinical 
        trials; the NIH policies specify that the level of monitoring 
        should be commensurate with the risks and the size and 
        complexity of the clinical trial. For certain types of studies 
        (phase III and many multi-center trials), the monitoring must 
        involve a group of independent experts called a data and safety 
        monitoring board (DSMB). The role of the DSMB is to review 
        accumulating safety and outcome data in order to help ensure 
        the continuing safety of current trial participants and those 
        yet to be recruited.
    These requirements are included in the NIH Grants Policy Statement, 
which is a standard term of award for grants and cooperative 
agreements. These requirements are also incorporated into research 
contracts. An NIH Institute or Center also has the authority to include 
additional conditions on the award for specific studies (see 45 CFR 
part 52.9). Also, because of special risks and societal concerns, 
trials involving human gene transfer that are conducted at or sponsored 
by institutions receiving NIH funding for recombinant DNA research must 
be registered with the NIH. Investigators responsible for those trials 
must report adverse events and other pertinent information to the NIH, 
as outlined in Appendix M of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Ms. DeGette. Yes, because a couple of things I am 
interested in with the legislation, I am interested in, for 
example, the common rule, which now applies in all research 
that is funded by the NIH, but does not necessarily apply in 
other types of research. Am I correct?
    Mr. Zerhouni. I am not totally briefed on this, and----
    Ms. DeGette. Okay.
    Mr. Zerhouni. [continuing] current, but I think you are 
right.
    Ms. DeGette. And I am wondering if this might be an area 
that we could explore in a bipartisan way, beefing up the 
application of the common rule more broadly, into research that 
is either directly or indirectly affected by the NIH 
activities.
    Mr. Zerhouni. Be happy to, you know, to work with the 
committee----
    Ms. DeGette. Okay.
    Mr. Zerhouni. [continuing] and the staff, your staff, to 
look at that. Obviously, the Office of Human Research 
Protection at the Department also has jurisdiction over that.
    Ms. DeGette. Exactly. Right.
    Mr. Zerhouni. So you have to look at that issue.
    Ms. DeGette. Okay. But that is certainly a topic that you 
think would be appropriate in the NIH reauthorization bill. 
Thanks, Doctor, and I yield back.
    Mr. Deal. Thank the gentlelady. Dr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman.
    Dr. Zerhouni, when you were here earlier this year, I think 
one of the things that came up was the--when we restructured 
the intelligence agencies last year, one of the big discussions 
around town was if you don't have the budgetary authority, then 
you don't have the authority.
    Do you feel that this reauthorization that we are doing 
currently, does it provide you with the budgetary authority 
that you need in order to exercise the appropriate authority 
over the NIH?
    Mr. Zerhouni. I think the important component of the 
reauthorization is this ability for the Director to have an 
instrument by which all of NIH comes together, for at least a 
small portion of the total budget, and looks at what I call the 
glue areas, the synergy areas. That is an important 
institutionalized process that needs to happen for any complex 
agency. That would provide that.
    In terms of budget area, currently, obviously, the Director 
can always make an administration budget, and through 
interaction with the department and OMB, present a budget to 
Congress. That authority is there. But typically, what happens 
is everything goes in lockstep, and the reason it goes in 
lockstep is because of all of the stakeholders and different 
pressures and programs that you have, unless there is an 
emergency, or something that changes the equilibrium. What I am 
talking about is instead of having this, is to look at a small 
layer of the budget, and plan it together, not dictate or 
direct it. I don't think the NIH is an agency--it is a 
knowledge organization. You really need to manage it according 
to that.
    So I think the reauthorization will provide marginal budget 
authority for a very specific purpose, but overall, the budget 
authority in the current authorization does allow you to make 
some marginal changes, but not a lot.
    Mr. Burgess. I must admit, when I first looked at that 
organizational chart that you showed us early in the year, and 
knew that we were coming to this reauthorization, my feeling 
was that there would be significant consolidation between the 
various departments, and I guess I won't say that I am 
disappointed that there is not some consolidation, because 
after having been onsite, and watched some of the great work 
that you do, I realize how little Congress should, in fact, 
meddle in the system that you have. But do you feel that there 
is enough along the lines of consolidation in the 
organizational chart that you maintain with this 
reauthorization?
    Mr. Zerhouni. I think this allows for a greater degree of 
functional consolidation that is not there today. I don't think 
it allows for structural consolidation. I think structural 
consolidation does happen over time, as science will--changes. 
I think a reauthorization, in my view, should be done 
regularly. It shouldn't be a one time event every 12 to 15 
years. So I think we should really look at this, and see how it 
works, and adjust in 3 years time. I don't think this is an 
impractical proposal, but I do believe you need to show that 
you have the mechanisms of functional integration, before you 
can go ahead and destroy structure, and combine structures in a 
way that may not be productive.
    Mr. Burgess. The--Ms. Wilson, who was here a minute ago, 
talked about the ability to get information to the public, and 
I must admit, after 20 odd years in clinical practice, I did 
not know about clinicaltrials.gov. Maybe there is an 
opportunity there to do some public service announcements to 
medical societies across the country. I thought I saw the AMA 
here earlier today. That would be, I think, a good thing, 
because I can remember times, being in the treatment room and 
being absolutely baffled about what do I do next. It would have 
been great to know that I could have gone online and gone to 
clinicaltrials.gov, and gotten that rare cucumber virus tended 
to.
    And then, finally, I just can't help myself. What do you 
see on the horizon, looking over the horizon, as some of the 
new scientific areas of study that your organization may be 
working on in the near future?
    Mr. Zerhouni. Dr. Burgess, you should see the progress we 
are making. Every month, there is a new discovery, a new 
breakthrough. Recently the National Cancer Institute reported 
on a research study that showed that by looking at 16 cancer-
related genes, in women who have breast cancer sensitive to 
estrogen hormones--you know, in the past, we had about 100,000 
women with that, and all of them underwent surgery and 
chemotherapy. By looking at that--those 16 cancer-related 
genes, you can see that 70,000 of these women will not benefit 
from chemotherapy, whereas the other 30,000 do. So that 
research is going to completely transform the way we practice 
medicine in the next year or 2, and we will save about $8,000 
per year of treatment, because we will avoid chemo, unnecessary 
chemotherapy. And I think that is the trend. We--a month before 
that, we reported in Science and PNAS, three of our grantees 
discovered a gene for age related macular degeneration, which 
will affect 7 to 10 million Americans over time, that will lose 
vision because of this. We never knew what the cause was until 
this research, but it has to do with a blood protein called 
Factor H, and no one had any clue that this could have come 
from not your eye but your blood. So this is a breakthrough 
that is going to make it possible for us to prevent blindness 
in the aged population. The acceleration and the momentum that 
I think we have been able to demonstrate with the funding that 
you have provided us is, in my career, remarkable, my own 
personal experience. I have never seen such a rapid fire of 
discoveries that can really change the way we practice 
medicine.
    Mr. Burgess. I appreciate that. Could you give the 
committee just a little flavor of what is the magnitude of 
scientific throughput that is required to come up with one of 
these genetic determinations?
    Mr. Zerhouni. I see--I can see you really enjoyed the 
briefing, sir. Basically, that is the key. The key, for 
example, the cancer research, they looked at 250 genes in 
thousands of patients, put that into a large data base, 
analyzed the data base through a high throughput system, come 
down on to 16, then did trials on thousands of women. So it 
really is a scale and complexity that required more than the 
NCI itself could do, but multiple collaboration. So that is the 
trend, interdisciplinary, collaborative, large scale, but yet, 
still, coming from the scientists, and bottom up, rather than 
control and--command and control.
    Mr. Deal. Ms. Baldwin, would you defer to Mr. Stupak. He is 
just dying to get back to the conference committee, I can tell. 
I will come back to you, if you will do so. Mr. Stupak.
    Mr. Stupak. Thank you, and thank you, Ms. Baldwin, for 
yielding.
    Dr. Zerhouni, you mentioned that the need to ensure 
clinicaltrials.gov is accessible as possible, and that results 
of trials are also accessible as possible. Do you support the 
making the results mandatory, having them published?
    Mr. Zerhouni. Basically, we do believe that it is important 
to connect clinicaltrials.gov to what we have been trying to do 
through public access publishing, so that any report that comes 
out in the public domain be linked, so that when someone looks 
at clinicaltrials.gov, they know what that trial, what the 
results of that trial eventually were. So I think we are in 
favor of more transparency and more reporting, and more 
registration of all trials. The issue of whether or not you can 
do reporting on the fly about adverse events or other things, 
that needs to be looked into, because it goes beyond our 
jurisdiction. That is an FDA issue, but yes, we are in favor of 
trials being connected to their results in some fashion, and 
accessible to the public.
    Mr. Stupak. Do you have subpoena power to information that 
you might find interesting in these trials?
    Mr. Zerhouni. No, I do not.
    Mr. Stupak. You talked a lot about the fingers and the palm 
of a hand, and how do you get the information you need from 
these trials that raise a flag with you, if you don't have 
any----
    Mr. Zerhouni. If it is a trial that is----
    Mr. Stupak. Yes, I am sorry. Enforcement power.
    Mr. Zerhouni. If it is a trial that is funded by NIH, we 
have, obviously, the mechanisms to look to what we call a data 
monitoring and safety board, which is an independent board that 
looks at what the investigators and what we are funding. That 
is how, for example, we reported on the issue of Celebrex in a 
trial of the National Cancer Institute, and other trials that 
we were looking at. So for NIH funded trials, we have 
authority----
    Mr. Stupak. Well, how about non-NIH funded?
    Mr. Zerhouni. With non-NIH funded trials, we have no 
authority. We are not a regulatory agency. The FDA does.
    Mr. Stupak. So you may be aware of clinical trials that may 
be detrimental to human health, but if they are not published, 
you really can't have access to them, to check the credibility, 
or their--any evidence.
    Mr. Zerhouni. We have access to our own, and when--and as I 
said publicly, our threshold for stopping a trial is, 
obviously, greater than--I mean more sensitive than others, 
because we are doing research, so we never know that there is a 
defined benefit. The FDA is the agency charged for regulatory 
oversight of other trials.
    Mr. Stupak. Right. Well, as I said in my opening, both you 
and the FDA have this responsibility to make sure we have sound 
clinical trials to protect the health and safety of the 
American people, but neither one of you have any kind of 
subpoena power, so how do you enforce it? What----
    Mr. Zerhouni. NIH----
    Mr. Stupak. Well, take Celebrex. You mentioned it yourself. 
There were other trials out there you knew of, but you didn't 
have access to them, because they weren't your own. So how do 
you obtain that information?
    Mr. Zerhouni. NIH does not have subpoena power, but I am 
not an expert on the regulatory----
    Mr. Stupak. FDA doesn't either--that is fine.
    Mr. Zerhouni. I think that is--I haven't thought about that 
question, of how you connect the enforcement powers with the 
oversight powers. I would be happy to come back on record for 
you.
    [The following was received for the record:]

    NIH has access to safety information for the clinical 
trials we fund. In addition, NIH policy requires data 
monitoring in all clinical trials and, for certain types of 
studies, depending on stage, level of risk, design, and 
organization, the monitoring must involve a group of 
independent experts, called a data and safety monitoring board 
(DSMB, see NIH Guide for Grants and Contracts, June 10, 1998 
and June 5, 2000). The DSMB's role is to review accumulating 
safety and outcome data in order to help ensure the continuing 
safety of current trial participants and those yet to be 
recruited as well as the continuing validity of the trial.
    Safety information on clinical trials funded by the private 
sector must be reported to the FDA when those trials are 
conducted as part of the development of drugs, devices, or 
biologics and data is intended to be submitted to FDA for 
regulatory approval purposes (see 21 CFR parts 312 and 812). 
NIH does not have direct access to adverse event information 
about such private sector trials. However, we work closely with 
FDA and are able to factor information FDA makes publicly 
available into our own decision-making about the continuing 
safety of clinical trials we support and conduct. In this 
regard, our work will be aided by FDA's efforts to ensure that 
established and emerging drug safety data are quickly available 
in an easily accessible form. In addition, we have established 
a working group to help consider and, if necessary, make 
improvements in our assessment and response to emerging safety 
information from clinical trials or in post-marketing product 
surveillance that has implications for NIH clinical studies and 
study participants. The goal of the effort is to ensure that 
NIH's response to such events is timely, coordinated and well 
considered.
    We are also working on longer term efforts to promote 
greater transparency and awareness through enhanced clinical 
trial registration and access to published articles and results 
summaries in ClinicalTrials.gov, NIH's database of clinical 
trials. In establishing ClinicalTrials.gov, Congress mandated 
the registration of all treatment trials subject to FDA 
regulation, regardless of funding, that address life-
threatening and serious diseases and conditions (see 42 USC 
282(j)).

    Mr. Stupak. Sure. It has always amazed me that the--some of 
the regulatory agents, like FDA and--not that you are 
necessarily a regulatory agency, but when you are responsible 
for basic health needs, you have no power to get the 
information you need to help make the decisions.
    Mr. Zerhouni. Except for what we fund.
    Mr. Stupak. Except for what we--you fund, right. And while 
we wish you had more money, it is not all the money that is 
going into research. There is a lot of research out there.
    I mentioned in my opening the importance of one program, 
pediatric research, and the consequences of striking its 
authorization. Is there anything else in the committee draft 
that may have been stricken that you would like to see? What is 
missing in this committee draft that you would like to see, 
besides subpoena power?
    Mr. Zerhouni. Any special authorities that were removed, 
you mean?
    Mr. Stupak. Yes.
    Mr. Zerhouni. Well, that is--I haven't really thought about 
what was removed that would be of critical importance. I 
think--I am not sure what it is that I would--I am just 
thinking through as--think, but----
    Mr. Stupak. Sure. Sure.
    Mr. Zerhouni. Can I get back to you, and look at that, 
specifically?
    Mr. Stupak. One more, since my time is just about up. How 
are we doing on the flu vaccine for next year?
    Mr. Zerhouni. We, just last week, had the results of the 
first phase of our clinical trials. As you know, NIH has gone 
forward in developing a vaccine on H5N1, which is the variant 
of the virus that we suspect will be the--if it mutates to the 
point of becoming transmissible. We have good results. There is 
a dose response we know we have a vaccine. Now, we need to go 
to the other phase, but we are very, very pleased with the 
Phase I results.
    Mr. Stupak. Thank you, and thank you, Mr. Chairman, for 
your courtesy.
    Mr. Deal. Thank you. Mr. Ferguson.
    Mr. Ferguson. Thank you, Mr. Chairman. Dr. Zerhouni, I 
apologize. I have been out, as I know a number of other members 
have been. So I may have missed if you have addressed some of 
these questions.
    Mr. Deal. Well, we have all been here. We have all been 
here.
    Mr. Ferguson. Yes. You, Mr. Chairman, I know, have been 
here. We talked--I talked a little bit about, and you have 
referred to the 27 fingers--you need the palm. In your review 
of the draft, do you feel like we have--the draft adequately 
addresses your need, as the Director, or the need of any 
Director to properly coordinate what is going on, to provide 
the adequate palm, if you will, for management purposes?
    Mr. Zerhouni. I think it is a good draft, and I think we 
need to clarify some details. As I said, I don't know if you 
were here, I said 27 fingers without a palm is not a good hand, 
but a strong palm with no fingers is not a good hand, either.
    Mr. Ferguson. Right. Right.
    Mr. Zerhouni. So we need to find the balance between the 
two, but I think we are getting there, and I think the 
committee staff and the committee draft are going in the right 
direction.
    Mr. Ferguson. And if you have, obviously, as you are 
talking about, some of this, specifics or the details, I am 
certain that we will be talking with you further as you have 
advice or thoughts, input for us as we continue to go through 
the process. I hope you will.
    Mr. Zerhouni. I will certainly do that.
    Mr. Ferguson. Wouldn't you share that with us? Like Mr. 
Stupak, I am particularly interested in childhood diseases, as 
well, and I think it is--I feel strongly that we need to make 
sure that our agencies are really working together properly, 
and working toward research on diseases for, frankly, one of 
our, probably our quietest constituency is our kids. How do you 
feel like this draft, and as we are--the direction that NIH may 
be heading, and how will that improve your ability, with regard 
to the cutting edge research, and translating that research 
into actual cures, for some of the childhood diseases that we 
have talked about?
    Mr. Zerhouni. As you know, the fundamental authority of NIH 
allows NIH to do research in every field, including pediatric 
research. I believe that having an instrument like this 
division of program coordination is going to allow all of us to 
prospectively, rather than retrospectively or after a lot of 
lobbying, to understand what disease process is doing what, to 
truly prospectively look at the evolution of childhood diseases 
of particular concern. I think that, to me, will be the result 
of a modern reauthorization bill that would institutionalize 
not only the mechanism but the obligation to look at the 
landscape of public health for children, or for any other 
population.
    Mr. Ferguson. And will further enable the agencies to, and 
the Institutes to kind of get out of their silo, to get out of 
their, perhaps, more narrow, necessarily narrow view?
    Mr. Zerhouni. Well, I think the Institutes have done a good 
job when it came from their specific mission needs. I think we 
should really not think that the Institutes have not 
collaborated. The Roadmap is a collaboration. What I think I am 
talking about is when there is an area of science or public 
health where no Institute has either the resources or the 
expertise, or the ability, if you will, to look across, and 
this is where, I think, that would be very helpful.
    Mr. Ferguson. Well, I--these are just a couple of the 
points that have been kicking around in my head.
    Mr. Zerhouni. Right.
    Mr. Ferguson. And I think a number of the points that some 
of the others on the committee have raised today are equally 
important. So I appreciate very much your insights and your 
advice, and not only your work at NIH, but as we go through 
this process, looking to the future, your continued input is 
going to be very important for us, so we appreciate very much 
your time today, and----
    Mr. Zerhouni. Thank you.
    Mr. Ferguson. Chairman, I yield back.
    Mr. Deal. Thank the gentleman. Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman.
    I have, first, a narrow question, and then some broader 
questions on reauthorization. In your testimony, you talked 
about the mission specific division relating to research around 
disease or organs or life stages, versus what has been called 
the science enabling division, having more cross cutting 
issues. And I just looked at the list of Institutes that would 
be congregated, as proposed in the draft, I noticed that the 
National Institute of Environmental Health Sciences, is under 
the disease, organ, and life stage specific grouping. I wonder 
if you could tell me a little bit more about what is happening 
in that Institute, so I could derive whether that is an 
appropriate placement of that institute, versus the other 
divisions that it could be possibly placed under?
    Mr. Zerhouni. I have to say that you are very observant, 
and I--we have been----
    Ms. Baldwin. Well, thank you.
    Mr. Zerhouni. [continuing] actually, thinking about the 
NIEHS being, again, as--if you look at the fundamental 
definition, does research in NIEHS apply to all organs, all 
disease, all life stages, and the answer is yes, so you could 
think of NIEHS being a cross cutting Institute.
    Ms. Baldwin. We will take--I am sure we will take a closer 
look at that, and have greater discussion.
    On some broader questions, with the establishment of four 
specific appropriation line items for NIH, that we have gone 
over what those are, I am concerned about the impact that 
lumping the Institutes and Centers, most of them in two line 
items, will have, in terms of pitting them against each other 
for the available funding. In a worst case scenario, you would 
see a competition that would result in the loss of cross-
institutional collaboration and cooperation that we have 
recently enjoyed. I wonder if you could comment on that, and 
talk about ways to prevent the pitting of institutions against 
each other, what we might want to have as safeguards in this 
legislation to prevent that.
    Mr. Zerhouni. That is a very good question. The way you 
structure a reauthorization structure drives culture. Structure 
drives culture, and therefore, you can't really look at that 
issue in isolation. You really look at the total structure that 
I think is being envisioned here. There is no doubt that losing 
the identity of a mission is not necessarily a good thing, so 
you need to find balance between the two, and clearly, you 
don't want to have a zero sum game that occurs. You really want 
to, therefore, have what I call a common fund for common good, 
for funding when there is a need to do it. But again, I mean 
you have programs that sometimes don't need to move out of a 
particular Institute to be coordinated with another Institute. 
So to me, the most important thing is to keep the planning 
process, the ability to present a logical plan to Congress, to 
the--I mean to Congress in general, and the appropriators in 
particular, that keeps that identity for the mission. 
Otherwise, what you end up with is no one is responsible for 
anything. So you need to strike that balance between the two.
    Ms. Baldwin. Are you comfortable with legislation that 
places a limit on the number of Institutes in each division? 
Right now, I think they are looking at 15 in the mission-
driven, and nine----
    Mr. Zerhouni. There is no doubt that, you know, the way 
Institutes and Offices and Centers have been created has been, 
I wouldn't say haphazard, but frankly, driven by factors other 
than pure science. I do believe that, you know, there is a 
particular law in--that every time you add one, you double the 
complexity, and every time you add another one. I think it is 
not a good idea to have so many structures, and I do believe we 
need to have a limit, and if anything, think about 
reorganizing. I was just reading the New York Times this 
weekend, and General Electric went from 11 divisions to six. 
And obviously, it is a completely different environment, 
completely different, but we do need to have a limit to the 
number of direct reports and units that are independent, that 
duplicate their own administrative structures and so on. So 
yes, I think every observer, including the IOM, by the way, 
would say you need to be very careful in adding any. I think we 
should subject all of this to a public process, as recommended 
by the IOM, but I do believe that limits are a good thing. If--
we need to have the discipline of recognizing a mission, but 
not at the expense of complexity of management, and 
unwieldiness of the agency.
    Ms. Baldwin. Dr. Zerhouni, I see that amber light, which 
means my time is almost done, in fact, I think it is done, but 
there are two questions that I want to pose, and you don't have 
to answer right now. They are both following on questions 
previously asked by Mr. Waxman and Mr. Brown.
    First, there is the blank by the authorized appropriation 
level. Any guidance you can provide us, in terms of how we 
should be considering opportunities as we deliberate over what 
the optimum rate of increase for NIH is appropriated, and 
second, following up on Mr. Waxman's questions, whether we 
should have specific language in this draft, or in the final 
bill, for the next Director of NIH, who will be a political 
appointee, to direct them in terms of composing the advisory 
committees and the institutes?
    Mr. Zerhouni. I will submit my answer in the record.
    Ms. Baldwin. Thank you.
    Mr. Deal. Thank the gentlelady. Mr. Buyer.
    Mr. Buyer. I want to cover a couple of questions. One, in 
particular, that deals with your Roadmap, and a followup off of 
Mr. Ferguson's question that he had to you about how this 
legislation, will it really permit you to implement your 
Roadmap? And so that I can understand that better, I think 
anyone that wants to take on an organization like--that you 
have--functional consolidations of an organization, to 
integrate activities, to meet strategic goals based on 
priorities, that is noble. I--that is your job. That is what 
you want to be able to do. And as I was listening to you 
testify, I was thinking about a couple years ago, you came up, 
and you testified about your Roadmap. A lot of us got pretty 
excited. I remember asking you a question about sexually 
transmitted diseases in America, and I was pretty stunned--
correct me if I am wrong, but I thought your testimony was that 
there are 80 million Americans, is that about right? Or 65 
million?
    Mr. Zerhouni. Sixty-five million, growing by 4 million a 
year.
    Mr. Buyer. Wow. Sixty-five million Americans have been 
infected with a sexually transmitted disease. If you actually--
take of our population of 295 million people, and say of that 
population, then, what is the highest in sexual activity, you 
are almost looking at a one in three, one in four perhaps.
    Mr. Zerhouni. This is--lifetime, yes.
    Mr. Buyer. Yes, in a lifetime, have dealt with a sexually 
transmitted disease. And the reason I remember that is because 
you, then, said Congressman, this is an epidemic. All right. It 
is an epidemic. I would think that is an epidemic. If you think 
about it, our society, and this is a problem that--it is sort 
of the problem in the closet. It is sort of the problem in the 
basement, a problem that nobody really wants to talk about 
somehow, until we have to deal with it. So I look at this, and 
you could pick a disease. It doesn't have to be a sexually 
transmitted disease, but I brought that up, because I 
remembered you talking about it, and I look at you now trying 
to do this consolidation. You have got your Roadmap, and--so my 
specific question for you would be can you give us some actual 
examples from your experience on how the current individual 
Institute and Center-oriented structure of NIH, or limited 
authorities results in missed opportunities, or significantly 
impeded your ability to respond to opportunities and public 
health challenges, such as the one that you called the 
epidemic?
    Mr. Zerhouni. Right. That is a very good question. You have 
seen the example of the Roadmap. The Roadmap was not designed 
to address any particular public health challenge--it was 
really the first time that all Directors said, ``We really need 
to do better in cross-investment.'' So they came together, and 
if you look at, I think I have this--this is the investment of 
the Roadmap.
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    Mr. Zerhouni. We decided to have three topics, pathways to 
discovery, research teams, clinical research, things that we 
identify as gaps in our investment, and commit to a 5-year 
process. Now, at the time, funding was a lot easier. It is 
about 1 percent of the NIH budget, over time. But when you were 
done with this, what you realize is that you hadn't been 
necessarily responsive to obesity, for example. So the next 
year, we asked Dr. Allen Spiegel, from the National Institute 
of Diabetes and Digestive and Kidney Diseases, Dr. Nabel from 
the National Heart, Lung and Blood Institute--at the time, Dr. 
Lenfant, to come up with a trans-NIH plan on obesity. That is 
how it works, but you know what? We never really had the 
mechanisms or the idea of having a process that would be 
prospectively looking at that. And I have been trying to 
instill this in my interactions with the agency, because I do 
believe, from my previous experience in the private sector, 
that science requires that now. It is too complex, but you need 
to have a crosscut of exactly what you are doing.
    So what other opportunities? Neuroscience. If you look at 
the disease burden in patients from 25 to 44, mental health 
becomes the major problem that affects the population, drug and 
addiction, alcohol abuse, behavioral problems, 
neurodegeneration, and mental health. You take those five, it 
is a $500 billion healthcare cost. So we decided to have a 
Neuroscience Blueprint this year, which we are presenting in 
2006, but guess what? You couldn't fund it, because there was 
no prospective mechanism by which you would say here is a set 
aside fund. This is our opportunity fund. This is our common 
fund. Let us just make sure that every time there is an 
emergency out there, that we react to it. So the question you 
are asking is, this will provide you a mechanism to look at 
public health burden, what is rising, what is not rising. We 
knew about obesity all these years, but we really didn't have a 
mechanism to A, plan for it, and then, allocate resources. The 
mechanism that usually happens is an office is created in law, 
like the Office of AIDS research, because there is a public 
health emergency, or this is more language that is put in the 
bills, because a particular disease process or constituency 
wants that served. I think having this process would 
continuously allow NIH to be responsive, nimble, and proactive.
    Mr. Deal. Thank the gentleman. Mr. Rush.
    Mr. Rush. Thank you, Mr. Chairman.
    Dr. Zerhouni, the last time that you appeared before our 
committee, the question that I asked was what could NIH do to 
better promote the inclusion of minorities and women in 
clinical research, both as subject and researchers. And can you 
tell us now how exactly NIH dollars are being used to promote 
racial and gender inclusion, and also, include in your answer 
whether or not NIH dollars are being used to promote minorities 
and women as researchers themselves, and also, included in your 
answer, would you give us some idea about how can NIH encourage 
private sector companies, such as pharmaceutical firms and 
medical device manufacturers to include minorities and women in 
their clinical research, as both subjects and also, as 
researchers? Can you give me a quick answer on those, please?
    Mr. Zerhouni. Well, first of all, let me say that if you 
have attended some of my presentations, health disparities is 
one of our top five priorities, and remains one of our top five 
priorities. No. 2, there are two parts to your question. One is 
what are we doing in terms of having a scientific workforce, a 
medical workforce, that is able to study and research these 
conditions? Our basic philosophy is that, from the scientific 
standpoint, it is very clear that the diversity of those who 
conduct the research has to mirror the diversity of those who 
participate in the research as subjects. So we have this 
philosophy that to penetrate communities, you have to be there, 
and you have an interaction that is constructive with a 
diversity that reflects that population. That is a challenge, 
because when you look at the number of women or minorities in 
science careers, what you find is difficulties there. I mean, 
it is an opportunity issue. Young African-Americans, for 
example, who are very successful, may not necessarily see 
science as a maximizing opportunity for their own career. On 
the other hand, I think NIH has been consistently proactive in 
building minority training programs. The new Center on Minority 
Health and Health Disparities spends quite a bit of resources 
on building the infrastructure for that, and you can see it is 
paying off.
    The other issue is participation. That is an issue that 
relates to the Roadmap, and the concept that you need to 
conduct research at the community level. So we funded, for 
example, the Jackson Heart Study. The National Center for 
Primary Care that Morehouse has funded, with 136 community 
centers, having a presence in the communities. That is the 
answer. The answer is you have to be on that ground, with 
trained people that are connected to all the trials that are 
ongoing, if you really want to have participation.
    Mr. Rush. I want to quickly move to another one of my 
interests. A Newsweek magazine that highlights the problem of 
uncertainty within the medical profession when it comes to 
prescribing drugs for children. According to the article, 
because drug companies have not invested in clinical research 
involving children, apparently, it is not very profitable, the 
doctors are basically flying blind with nothing but speculation 
when prescribing drugs to children. The results can lead to 
both inadequate treatment and even death, and Mr. Chairman, 
there is an article that I would like to submit for the record, 
a Newsweek article that I would like to submit for the record.
    Dr. Zerhouni, what should NIH do to correct this problem, 
and what can Congress do to ensure NIH is addressing the 
problem, and is the solution including children in clinical 
trials?
    Mr. Zerhouni. Well, as you know, the BPCA, the Better 
Pharmaceuticals for Children Act, mandates that we look and 
rank all of the medications that need testing in children, 
because we do believe that we need, there is a need for making 
sure that we understand how--what is the dose, what are the 
side effects, which may be different. So we have a process 
through the National Institute of Child Health and Human 
Development, that looks at the drugs. There is a committee that 
meets at the departmental level, and in conjunction with the 
Foundation for NIH and the FDA, essentially prioritizes the 
trials that need to be undertaken in particular--adult drugs 
that are used for children. So we have a mechanism, and I think 
that mechanism leads to----
    Mr. Rush. Well, how effective is that mechanism? Because we 
still have a very serious issue, and a serious problem with 
children who are getting inadequate dosage, or maybe too much 
dosage?
    Mr. Zerhouni. I know it is, can I get back to you on that, 
because I know we have about 11 drugs that are being tested, or 
on the list of being tested, but I don't know the specifics at 
this point.
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    Mr. Deal. The gentleman's time has expired. Ms. Blackburn.
    Ms. Blackburn. Thank you, Dr. Zerhouni. If you get down to 
me, you know you are getting pretty close to the end. I am the 
only one left over here.
    Just a couple of quick things, and you--Mr. Ferguson and 
Mr. Buyer both talked a little bit about your organization, and 
you mentioned where you would have put some focus this year if 
you had had funding. But I want to go back to something that 
Dr. Varmus, who was your predecessor, had said in 2001. He 
mentioned that he felt like you could add 10 Institutes a 
decade, and what I am hearing from you is you probably would 
opt not to that--not to do that, but would work within your 
framework, and use the flexibility from the proposed 
legislation to allow you to meet those needs. Is that a correct 
understanding?
    Mr. Zerhouni. Right. I know Dr. Varmus well, and what he 
was referring to, what he told me, is that unless we have a 
mechanism to prevent proliferation, we will end up with 10 per 
decade, and then make the agency less manageable. He has 
advocated, actually, consolidation of all Institutes into five 
Institutes. So he is clearly one who has been very concerned 
about the rapid growth of the number of Institutes.
    Ms. Blackburn. Excellent, and thank you for the 
clarification on that. A little bit on flexibility and 
collaboration, and let me use, to make the point, use the SARS 
outbreak, because I have read that you all did some research 
and some work on SARS in 2003. Now, we are hearing about avian 
flu, and the possibility of avian flu. So using SARS as our 
real life example, and our experience, talk to me just a little 
bit about how quickly you were able to put funding into the 
Institute for Allergy and Infectious Diseases, and the old 
structure, what your turnaround was on meeting the need for 
research, and then, the new structure, how you would plan to do 
that, and if St. Jude's, which is right in Shelby County, 
which--one of the counties I represent--is doing some avian flu 
work. So how quickly would the new legislation allow you to 
respond, and how would it make it easier than the old 
legislation?
    Mr. Zerhouni. Very important points. In the SARS case, we 
had invested NIAID, the National Institute of Allergy and 
Infectious Diseases, invested in Asia years ago, in having 
laboratories in Asia, to, in fact, be our sort of warning 
stations for flu. We actually thought it was flu at the 
beginning. When we identified, CDC identified that this was a 
different disease, we then collaborated with CDC, and very 
quickly, were able to identify the virus. Now, you are asking 
what did you then do to develop a vaccine to--for SARS? The 
Institute then reallocated resources, because of the doubling, 
we have built a Vaccine Research Center, which is extremely 
capable, so that the fundamental investment was there, and then 
the Director of the Institute reallocated dollars within its 
Institute to develop the early prototypes of two, and now, 
three SARS vaccines, one of which is in trial.
    In the case of pandemic flu, this is a much larger problem. 
The Secretary Levitt has appointed a taskforce that is being 
coordinated across the government. There is no doubt that we 
need to be able to move resources. In the current context, it 
is not that easy to do. I can use transfer authority if I need 
to. It is 1 percent of that. We can also, obviously, use a 1 
percent transfer authority the Secretary has, to be able to 
move dollars in that category. You can use contracts. So in the 
case of flu, we have been able--over a year ago, we knew that 
there was a risk of flu, to develop a prototype vaccine, and we 
have a prototype vaccine. We have 2 million doses, and it has 
been tested last--this past few months.
    Ms. Blackburn. And under your existing structure, how 
quickly were you able to do that, and under the proposed 
structure, how quickly would you anticipate being able to do 
that?
    Mr. Zerhouni. The current structure that is being proposed 
is really to be more strategic and proactive in known public 
health problems----
    Ms. Blackburn. Okay. So it would not affect that. One quick 
thing, one last question. I like your mission statement, and 
basically, what it is saying is science in pursuit of knowledge 
to improve health. So as you look at your mission, and we talk 
about the proposed legislation, does the legislation improve 
your ability to meet your mission?
    Mr. Zerhouni. I believe so. I think improvements in our 
ability to coordinate and synergize the 27 Institutes and 
Centers is very important to science today. If you look at the 
key elements of science today, one, it has become 
interdisciplinary. You need people from physical sciences, 
computer science, mathematics, working with biologists. So they 
cannot be locked into silos.
    Second, the scale of experiments that we do is larger, and 
there is--and when I started research, we had three members of 
my team, myself and two co-investigators. You go to any 
scientific meeting today, or look at a publication in any 
journal, you will have 15 collaborators. So collaboration is 
very important as well. This means that Institutes and NIH in 
general needs to be more nimble and more aggressive in 
stimulating and incubating these sorts of approaches, and I 
think it will do that.
    Ms. Blackburn. Thank you.
    Mr. Deal. Ms. Capps.
    Ms. Capps. Thank you, Mr. Chairman, and Dr. Zerhouni, thank 
you very much for spending this entire afternoon here with us. 
I appreciate your testimony.
    In it, you referred several times to the report of the 
Institute of Medicine, and I want to refer to the Institute's 
recommendation No. 4, regarding the ability to respond to new 
challenges, for enhancing and increasing trans-NIH strategic 
planning, the D part of that, which designates, or they 
recommend a percentage of each Institute to be preserved for 
trans-NIH research. Today, in your testimony, you have spoken 
several times, and have referred in some of your responses to 
questions about a common fund for trans-NIH research. I would 
like to give you the opportunity to spell out what you mean. Do 
you see this as a standalone pot of money, or is it sufficient 
to require, as the IOM suggests, and just elaborate as to how 
you talk about that common fund?
    Mr. Zerhouni. So effectively, you can handle it in, like I 
said, in three different ways. I think what the IOM is 
recommending is what I call the common fund.
    Ms. Capps. Right.
    Mr. Zerhouni. So in other words, you know that 5 percent of 
your budget is going to be not determined by you, as NIH 
Institute--I mean, as, by an Institute Director, but it will be 
put in a common pool, to be jointly planned, jointly decided 
for, initiatives that are important, emerging, and so on. That 
is the common fund concept.
    Ms. Capps. I understand. Now, that is part of the--each 
Institute's budget.
    Mr. Zerhouni. It is part of the mission----
    Ms. Capps. That they are going to set aside for that.
    Mr. Zerhouni. Yes. I don't think it is necessary, No. 1, to 
take away from the Institutes.
    Ms. Capps. Right.
    Mr. Zerhouni. In their base. Second, I don't think it is 
necessary for the Director to have grant-making authority. I 
think--I don't think you need to be grant making. You don't 
want to create an Institute----
    Ms. Capps. That is what I wanted to really be clear about.
    Mr. Zerhouni. Right.
    Ms. Capps. Do you want the Office of the Director, whether 
it is you or whoever it is, to have direct grant making 
authority?
    Mr. Zerhouni. No. I think grant coordination, resource 
allocation decision, planning authorities, to be able to look 
across and not be told, well, this is not really your money, it 
is my money.
    Ms. Capps. Right. So but you----
    Mr. Zerhouni. That phenomenon needs to go away.
    Ms. Capps. But what role would you play, or the Director 
play, in this?
    Mr. Zerhouni. Coordination.
    Ms. Capps. Just coordination.
    Mr. Zerhouni. Yes, strategic coordination, just what it 
says, program coordination across the silos, strategic 
initiatives, create a transparent process, that is based on an 
analytical framework that is good for analysis, good reporting.
    Ms. Capps. Okay.
    Mr. Zerhouni. This is just basically decision support----
    Ms. Capps. Okay.
    Mr. Zerhouni. [continuing] mechanism. Not take the money 
away, not--nor become, in--a twenty-eighth Institute. I don't 
think----
    Ms. Capps. Right.
    Mr. Zerhouni. I don't think that is a good idea.
    Ms. Capps. I see. It--and do you have ideas about--is it a 
permanent set aside of this funding mechanism, or----
    Mr. Zerhouni. If you don't make it permanent, you will 
never change the culture. They don't----
    Ms. Capps. So you are using this as a way of changing the 
culture, getting at your ideas of responsibility----
    Mr. Zerhouni. Of the margins, yes, to instill the fact, and 
the need to coordinate better for scientific challenges that 
have become bigger and larger.
    Ms. Capps. So I want--I am going to turn to another topic, 
but I wanted to make sure--this is something that you really 
have pulled out of the Institute of Medicine report, and you 
really want to see that as a focus of the new NIH, as your 
envisioning it----
    Mr. Zerhouni. Right.
    Ms. Capps. [continuing] as being more flexible.
    Mr. Zerhouni. Well, from my standpoint on the IOM report, 
this recommendation No. 4 is critical.
    Ms. Capps. All right.
    Mr. Zerhouni. And I support it.
    Ms. Capps. Okay. Great. Another topic, since I have a 
little bit of time left, there--in the draft legislation that 
the committee is preparing, there is a new division, the 
Division of Program Coordination, Planning, and Strategic 
Initiatives, to oversee and coordinate the offices currently 
located within the Office of Director, and so forth. In other 
words, in a way, you could say a new bureaucracy, but I, you 
know, I don't want to cast a negative word on that.
    I have heard some concern that creating a new division to 
carry out these functions could weaken the authority of the 
existing Office. It could make for more reporting, when you are 
talking about that there is already a lot, and--so can you 
comment on what you see as the ideal model for managing 
coordination and strategic planning at NIH, since this is such 
an important focus for the future?
    Mr. Zerhouni. Again, I don't think that division should be 
in charge of all strategic planning for all missions at NIH.
    Ms. Capps. Okay.
    Mr. Zerhouni. That should be left to the Institutes. It is 
really the synchronization and coordination that this division 
should be doing. As far as the Offices, remember, the Offices 
were created because there was somewhere, somehow, a need, felt 
by many people in the community, including Congress, for better 
coordination.
    Ms. Capps. Okay.
    Mr. Zerhouni. That is why they were created in law. So I 
think they should continue their role. They should be 
coordinated, but the problem that you are talking about, 
bureaucracy, is every time you create a new structure----
    Ms. Capps. Yes.
    Mr. Zerhouni. [continuing] you have created a new 
bureaucracy, and that is what I think we need to avoid. We need 
to find ways of preserving their role and continue their 
mission. I mean, the Office of AIDS Research plays a very 
important role.
    Ms. Capps. Right.
    Mr. Zerhouni. Look at the authorities of that office.
    Ms. Capps. Right.
    Mr. Zerhouni. I mean, OAR looks at the AIDS budget across 
NIH. That should be continued.
    Ms. Capps. Just to be clear, and kind of as a way of giving 
us advice on designing this legislation, would existing Offices 
need to report to the division? Is there a chain of command 
here?
    Mr. Zerhouni. Well, I think the division should be pulling 
from their staff, division of the Director. So to me, the 
Director should really take a role here, because he or she is 
accountable. The problem is, if she is accountable, shows up at 
hearings like this----
    Ms. Capps. I see.
    Mr. Zerhouni. [continuing] when there is a problem, but 
they don't necessarily have the authority to be able to be 
accountable, so I think the divisions should be part of the 
Office of the Director.
    Ms. Capps. And when you say coordinator, you give a lot of 
authority to coordinator. I mean, that is--you are saying that 
is where your responsibility lies, or the Director's 
responsibility.
    Mr. Zerhouni. That is right. Yes, over a----
    Ms. Capps. Kind of a bottom line.
    Mr. Zerhouni. Well, that is--portion of the budget that 
should be jointly planned and jointly executed.
    Ms. Capps. Thank you, Dr. Zerhouni.
    Mr. Zerhouni. Thank you.
    Mr. Deal. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I ask unanimous consent 
to have a statement placed in the record.
    Dr. Zerhouni, the current organization at NIH affords the 
Institute in Cancer, and Center Directors, with a great amount 
of autonomy in priority setting, Director of the National 
Cancer Institute is arguably an even greater autonomy, since he 
has the ability to take the NCI budget directly to the OMB. 
This structure has enabled cancer research to develop new 
therapies, and to make great strides toward cancer. Under the 
organization structure proposed in this draft legislation, 
would have the NIH Director have sole responsibility for 
priority setting. While the draft remains silent on budgetary 
bypass authority for NCI, do you envision the NCI retaining 
that authority to go directly to the OMB?
    Mr. Zerhouni. First of all, the NIH Director should have 
the sole priority setting authority. I hope I made myself 
clear, Mr. Chairman and Mr. Green, that it needs to be 
balanced. It needs to be part of a coordinating effort that 
should not be subject to the veto of every 27 Institutes and 
Centers. That is what I mean by the reason to do that, but 
beyond that percentage of trans-NIH initiatives, I think the 
Institutes should retain their fundamental missions and 
authorities, and in the case of the National Cancer Institute, 
I think it has been very important to the NCI, and to its 
community, from what I hear, this authority to go and have a 
bypass budget and so on is critical to their mission. So I 
think it should be preserved, provided that they also 
participate in the common fund for the common good.
    Mr. Green. The draft legislation strikes a number of 
authorizations that are either expired or never been 
appropriated. It is clear from the intent that the bill is to 
strike expired authorizations of appropriations, while 
maintaining authority to carry out these programs. I am 
interested how the NIH views these authorizations in setting 
priorities. For instance, in 2000, Congress passed the Clinical 
Research Enhancement Act, which included a clinical research 
loan repayment program, to encourage investigators with medical 
school debt to pursue a career in clinical research. However, 
during the Congressional consideration of that legislation, NIH 
made clear to us that the loan repayment program needed 
specific authorization in order to make the program available 
to extramural researchers--NIH campus. Would the strikes 
contained in this bill lead you to discontinue the Clinical 
Research Loan Program, and can you speak to the overall impact, 
if any, on these strikes to the NIH continuing the Clinical 
Research Program?
    Mr. Zerhouni. That is a good question. I really--this is 
obviously a technical issue. I am not clear about the 
authorities that we have, but I do know that we do have the 
authority to do loan repayment in PHS, authority, as I 
testified. I would--definitely would like to have my legal 
people help me with that, and get back to you on the record.
    [The following was received for the record:]

    Removal of the ``authorization of appropriation'' 
provisions would not affect the NIH's ability to conduct 
clinical research programs, including loan repayment programs, 
authorized by statute, so long as appropriations are deemed 
available. The changes and additions to the authorizing 
legislation to enable extramural clinical researchers to apply 
for loan repayment made by the Clinical Research Enhancement 
Act were necessary because prior NIH statutory authority only 
provided for a loan repayment program for clinical researchers 
from disadvantaged backgrounds who agreed to conduct clinical 
research as employees of the NIH.

    Mr. Green. Well, the biggest concern I have about that is 
their impact on the goal of attracting health professionals to 
careers in clinical research.
    Mr. Zerhouni. Absolutely. I understand very well.
    Mr. Green. And my last question, Mr. Chairman, the bill 
contains four broad authorization levels, that authorize 
appropriation for individual Institutes or Centers. If this 
draft bill were to become law, and the Appropriations Committee 
continued to provide line item appropriations for individual 
Centers and Institutes, would--the result would essentially be 
unauthorized appropriations. Of course, this scenario happens 
quite frequently here in Congress, that we have approved money, 
but appropriation for money that is not authorized. Is it your 
preference to receive four different appropriated amounts, or 
would you prefer that Congress provide individual Institutes 
and Centers with line item appropriations, and can you speak to 
that role, that increased transfer authority plays in that 
scenario? For example, I know you talked about the certain 
percentage in--for example, if NIH were to receive 
appropriations that mirror these four authorization groups, why 
is it individual transfer necessary? You are already deviating, 
or divvying up the money individually.
    Mr. Zerhouni. As I mentioned in my previous, I think it is 
very--from my standpoint and my experience, I think it is 
extremely important that whatever we do, we do it 
progressively, and whatever happens, we can't overnight make 
wholesale changes at NIH. It is not possible. So whatever the 
committee eventually decides to do, we need to retain the 
ability to maintain the momentum, and whatever I am talking 
about, in terms of transfer authorities, or common fund, or 
opportunity, however it settles, we need to really, also, make 
sure that there is a smooth transition from State A to State B. 
And I guess I am being--I am answering both questions at once.
    Mr. Green. Yes.
    Mr. Zerhouni. There is value to making sure that this goes 
to that mission, for that amount, and that it doesn't change 
erratically from year to year, because we have to maintain 
these programs over time, and second, I think it is important 
to understand the difference between a transfer authority which 
is post facto, a common fund, which is prospective, an 
opportunity fund, which is responsive to--and this is where I 
think we need to have more interactions with the committee, 
which I think we have had, and refine that concept.
    Mr. Green. Mr. Chairman, since my time has run out, and I 
just appreciate, Dr. Zerhouni, for your patience this 
afternoon. Obviously, there is a lot of interest on both sides 
of the aisle, because so many of us are proud of what NIH is 
doing with all the Institutes, although I understand the 
organizational chart can be a nightmare. We just don't want to 
lose all the success we have had.
    Thank you, Mr. Chairman.
    Mr. Deal. Thank the gentleman. Mr. Engel.
    Mr. Engel. Thank you. Thank you, Mr. Chairman, Dr. 
Zerhouni. I saw, I listened to your presentation, your 
testimony, and the slideshow, and I have to say that you make a 
very good case for the need for change.
    I have two specific questions regarding that that I would 
like to ask, but I do think that the slides and your 
presentation were on the money. I mean, some of us have some 
questions about some of the nuances, but I think overall, I 
think the vision is a good one.
    I want to talk to you first about the Office of AIDS 
Research. That has been very much praised as a model for 
strategic planning for many years, and for budgeting, because 
the OAR has the statutory authority and responsibility to 
develop a comprehensive strategic plan, with input from the NIH 
ICs, and from nongovernmental scientists, and community 
advocates, and everyone involved with AIDS. The OAR director 
has the authority to move resources across the different 
Institutes to address scientific priorities that may change 
from year to year, and the draft bill, I think, and correct me 
if I am wrong, implies that the NIH Director would now, and I 
have a quote, ``be responsible for strategic planning and 
priority setting of all research activities conducted or 
supported by the NIH.'' That is the quote. Lots of people have 
expressed concern to me that the expanded authority of the NIH 
Director could undermine the existing statutory authorities of 
the Office of AIDS Research provided by Congress, and I am 
wondering if you could comment on that.
    Mr. Zerhouni. A very good question. I think there is a 
tremendous amount, sometimes, of anxiety about any change, so 
you can hear, but I think we need to be responsive to that. 
First of all, I consider the model at OAR has been a good 
model. Think about it. The Director of NIH never had that 
authority over any part of the portfolio of NIH. Yet, OAR has 
it. OAR can look strategically, get counsel from the 
Institutes, look at the portfolio, reassign the portfolio. 
Like, for example, Dr. Jack Whitescarver changed the priority 
to vaccines over the past 2 years, because we have now vaccines 
candidates we want to try. It is changed to what drugs, at the 
time; that was progressive. Likewise, I think it is 
understandable, and I think the committee is sort of 
paralleling my own thoughts, and the thoughts of the IOM and 
others, to say why wouldn't the Director of NIH also have that 
same sort of OAR type authority over a common fund--what is 
wrong with that--without taking away from the important mission 
of OAR?
    So my view is that these are complementary, not 
exclusionary of each other. I think the NIH Director needs to 
have what I would call generic authority over a small portion 
of the budget, just like OAR has specific authority over 10 
percent of the NIH budget, which is the AIDS portfolio.
    Mr. Engel. But you can certainly understand why there would 
be some transition.
    Mr. Zerhouni. Absolutely. Absolutely, and I believe that, 
as I said in my slideshow, that those Institutes should retain 
their role--I mean those Offices.
    Mr. Engel. Thank you. My second question is about 
translational research. It has been a major priority, 
obviously, of the NIH, and I have a very specific question. How 
would the legislation affect the agency's ability to promote 
and conduct translational research, especially in areas such as 
research on Charcot-Marie-Tooth Disorder, which has the 
potential to translate into direct benefits for other--research 
into other neurodegenerative disorders, such as ALS and 
multiple sclerosis?
    Mr. Zerhouni. I think that is a very interesting question, 
of what would happen, if the only way this structure will 
change, if Charcot-Marie-Tooth is obviously a disease that we 
are responsible for, and we have a mission to help. But let us 
suppose something new happened in either the therapeutic world, 
or--and something that no single Institute could put in place. 
That new structure would basically look at that, and 
potentially, allocate common resources for an emerging area of 
opportunity that would be relevant to that disease, but this 
structure is not dedicated or designed to serve special purpose 
outcomes. Diseases, organs, life stages, cross cutting science, 
should be primarily done in its great majority by the 
Institutes in their missions as specified. The structure should 
only be the glue for things that are of common interest to all. 
So it may not be relevant to a specific disease, but it could 
be relevant to something that is emerging, that is affecting 
the landscape of science in one way that may be relevant to 
Charcot-Marie-Tooth for that particular case. So sometimes, for 
example, we have in trial right now a drug, to potentially be 
important for ALS. It is an antibiotic. No one knew that it 
could have a role. Well, reacting quickly to that would 
require, perhaps, a discussion, a coming together of all the 
Institutes, and say this is something novel, this is something 
we need to try. That might be impacted at that point.
    Mr. Engel. Well, thank you, and let me just conclude by 
thanking you for staying this long, and thanking you for the 
great job you are doing. Thank you, sir.
    Mr. Zerhouni. Thank you.
    Mr. Deal. Dr. Zerhouni, we likewise reiterate our 
appreciation for your being here today. I think you can tell 
the committee has great interest in what we are doing. By our 
accounts, some 29 members have spent at least some quality time 
with us this afternoon, and I appreciate your patience, and if 
you wish to supplement or add additional information for the 
record, you may certainly be free to do so.
    I would like to also pay tribute to Cheryl Jaeger, who is 
our staff person primarily responsible for this major 
undertaking, and express our appreciation to her for her hard 
work, as we try to finalize this product, and to my colleague, 
Mr. Brown, for his patience as well.
    There being nothing further to come before the committee, 
this hearing is adjourned.
    Mr. Zerhouni. Thank you, Mr. Chairman.
    [Whereupon, at 4:40 p.m., the committee was adjourned.]
    [Additional material submitted for the record follows:]

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