    [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

     Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                     house

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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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