[Senate Hearing 109-56]
[From the U.S. Government Publishing Office]



                                                         S. Hrg. 109-56

                    NOMINATION OF MICHAEL O. LEAVITT

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                                   ON

MICHAEL O. LEAVITT, OF UTAH, TO BE SECRETARY, DEPARTMENT OF HEALTH AND 
                             HUMAN SERVICES

                               __________

                            JANUARY 18, 2005

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions

                    U.S. GOVERNMENT PRINTING OFFICE
97-983                      WASHINGTON : 2005
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092250 Mail: Stop SSOP, Washington, DC 20402ï¿½090001


          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                   MICHAEL B. ENZI, Wyoming, Chairman

JUDD GREGG, New Hampshire            EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee                CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
RICHARD BURR, North Carolina         BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia              JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio                    JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada                  PATTY MURRAY, Washington
ORRIN G. HATCH, Utah                 JACK REED, Rhode Island
JEFF SESSIONS, Alabama               HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas

               Katherine Brunett McGuire, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                       Tuesday, January 18, 2005

                                                                   Page
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming..     1
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts..................................................     3
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......     4
Frist, Hon. Bill, a U.S. Senator from the State of Tennessee.....     5
Bennett, Hon. Robert F., a U.S. Senator from the State of Utah...     7
Leavitt, Michael O., Governor of Utah, nominated to be Secretary, 
  U.S. Department of Health and Human Services, opening statement    22
    Prepared statement...........................................    25
Burr, Richard, a U.S. Senator from the State of North Carolina...    34

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Letters of support from various organizations and Governors..     9
    Questions of the Safe Food Coalition for Governor Leavitt....    21
    Response to questions of Senator Bingaman....................    53
    Response to questions of Senator Clinton.....................    61
    Response to questions of Senator Dodd........................    69
    Response to questions of Senator Harkin......................    73
    Response to questions of Senator Jeffords....................    76
    Response to questions of Senator Kennedy.....................    76
    Response to questions of Senator Mikulski....................    86
    Response to questions of Senator Murray......................    87
    Response to questions of Senator Reed........................    90

                                 (iii)

  

 
                    NOMINATION OF MICHAEL O. LEAVITT

                              ----------                              


                       TUESDAY, JANUARY 18, 2005

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:03 a.m., in 
room SD-106, Dirksen Senate Office Building, Senator Enzi 
(chairman of the committee) presiding.
    Present: Senators Enzi, Gregg, Frist, Alexander, Burr, 
Isakson, Hatch, Kennedy, and Dodd.

                   Opening Statement of Senator Enzi

    The Chairman. I will call the hearing to order. Good 
morning and welcome to today's hearing on the nomination of 
Michael Leavitt to serve as the Secretary of Health and Human 
Services. It is my pleasure to welcome the former Governor, now 
Secretary Leavitt, and all those in attendance. I want to thank 
Governor Leavitt--I have had more contact with him as Governor 
than I have as Administrator, and I really appreciated the 
effort that he did in our neighboring State of Utah. And I want 
to thank him for his willingness to serve in this capacity. I 
know that you have been through nomination hearings for your 
previous job, and now to go through a second one is very much 
appreciated. And this one there will actually be two hearings 
on because the committee of final jurisdiction on it is the 
Finance Committee. So we are glad to have you do this extra 
duty and be with us today. I have known you for a long time and 
appreciate all the effort you have done. Back in my legislative 
career, you were working on the Western Governors University 
and did an outstanding job of putting that high-tech bit 
together. And you have served as the Governor of Utah, and that 
has a very rural capacity, as well as Salt Lake City. So you 
come with some diverse experience that will do our Nation well.
    During the President's first term, we had some important 
health care reforms. Medicare reform is now on the books, an 
option that will have a dramatic effect on the costs borne by 
our Nation's seniors for medical care. In addition, the option 
of health savings accounts has been expanded to provide seniors 
and the young with an incentive to invest in these tax-free 
health insurance alternatives. And, finally, more than 600 
community health centers have been opened or expanded to serve 
low-income and uninsured people across this country.
    There is still much left to do. Fortunately, you have the 
skills and the ability to help keep our health care system 
responsive and our safety net intact to protect the most 
vulnerable among us. It is clear from your record that you have 
a great appreciation for the importance of the family unit, the 
most local level from which we can address problems in this 
Nation. Our families are the cornerstone of our society and the 
building blocks of our communities, and it is where all of 
health and human services starts.
    As you work on the health care issues that affect our 
families so directly, I want to assure you that Congress will 
work with you. In fact, we must work together and focus on the 
results if we are to keep the promises we made for the work on 
health initiatives.
    When you are sworn in, you will be overseeing a budget of 
several hundred billion dollars and administering the operation 
of more than 230 programs that affect all Americans of every 
age. You will also have more people looking over your shoulder 
as you work than anyone else. Since every American takes his or 
her health care personally, you will have more bosses than any 
other worker in the world. We need to ensure their continued 
access to their family doctor, keep the treatments their doctor 
prescribes available and affordable, and make sure that health 
insurance companies do not forget about care as they work to 
control costs.
    Now, President Bush has set forth his vision for improving 
health care and patient safety through better and more 
widespread use of information technology. Senator Kennedy and I 
share the vision, and we have already begun our discussions on 
how we can help to make that a reality. I look forward to 
working with you, who also has a lot of information technology 
background, and Senator Kennedy and our colleagues on this 
committee to bring health care information into the 21st 
century. I intend to focus on bioterrorism and public health 
preparedness with the help of subcommittee Chairman Burr. This 
will build upon the great work this committee did last year to 
pass President Bush's Project Bioshield into law. President 
Bush has proposed placing a community health care center or 
rural health clinic in every poor county in the United States. 
Such an effort will be a key part of any effort to address the 
problem of expanding access to low-cost health care to those 
who lack health insurance.
    I think you will find the members of this committee to be 
supportive of your efforts in that matter, too. In Wyoming we 
have one community health center right now. That means we have 
a lot of counties that need one, but we do not have the money 
to provide them because most of our counties are the size of 
Connecticut. Fortunately, the unique challenges of providing 
services to the areas that have great distances between them is 
something that is well known to you. I am looking forward to 
working with you on how we can best address that problem.
    Most people are concerned about their health insurance 
coverage and the cost. They want policies that are more 
affordable and accessible with more options. I also believe we 
can come up with creative solutions to make our medical 
liability system work better for patients and providers.
    And then there are the front-page issues. At the forefront 
is our system of approving drugs and ensuring their safety. We 
must be sure the Food and Drug Administration is able to 
completely review and monitor the use of medications they 
approve in a timely manner. We also need to review the flu 
vaccine shortage and find out what happened and come up with a 
plan that will prevent it from happening again. We have to 
encourage more companies to come back to the vaccine business. 
Relying on a couple of companies to produce one of the most 
critical and popular vaccines is a recipe for disaster.
    I do not want to get into a laundry list of all of the 
issues. That is just a touch on a few of them. But there is a 
lot on our mutual to-do list. I appreciate the committee's 
willingness to work with you and also your volunteering to 
later have some informal sessions with us. I think that will 
achieve a lot. We appreciate your being here today and look 
forward to working with you.
    Senator Kennedy.

                  Opening Statement of Senator Kennedy

    Senator Kennedy. Thank you very much, Mr. Chairman, and 
thank you for having these hearings this morning. I want to 
commend Mike Leavitt for his nomination. I look forward to 
working with him as Secretary.
    No domestic agency of the Federal Government has a broader 
and deeper impact on the lives of the American people than the 
Department of Health and Human Services. Its programs reflect 
the ideals of our Nation and commitment to provide help to all 
those who need our help the most. HHS comforts and helps the 
elderly through Medicare and the Older Americans Act. It 
nurtures the young through Head Start, CHIP, and the maternal 
and child health programs. It sustains poor families through 
the Temporary Assistance to Needy Families Act. It brings 
health care to all in poverty through Medicaid. It offers help 
and hope to patients suffering from a host of diseases through 
the National Institutes of Health. And it guarantees every 
American that the medicines they take are safe and effective 
and the foods they eat are healthful through the Food and Drug 
Administration. It protects the health of every American 
against the epidemics of disease through the Centers for 
Disease Control.
    Mr. Leavitt brings impressive skills to this critical post. 
As a former Governor, he knows how HHS works and does not work. 
At EPA, he confronted health issues similar to many of those 
dealt with by HHS. Everyone who knows him respects his 
intelligence, his high energy, and his experience as a manager 
and problem solver.
    His new position will test all those skills, and he will 
face an especially heavy challenge this year. Many of the most 
important programs he oversees get lavish praise but little 
real support. Last year, the administration was able to push 
through the Congress a flawed Medicare drug bill that benefited 
drug companies and insurance companies at the expense of 
patients. Governor Leavitt will now have to implement that 
flawed bill. Press reports say the administration intends to 
block grant Medicaid and cut it deeply and to deeply cut 
Medicare as well. More than 50 million of the Nation's poor 
elderly, poor disabled, poor families and children depend upon 
Medicaid for health care. Forty-two million senior citizens and 
disabled Americans depend on Medicare. The administration's tax 
cuts for the wealthy and its misguided war in Iraq has created 
a catastrophic deficit, but it would be unconscionable to solve 
the budget crisis by penalizing the poor and the elderly who 
did nothing to create it and to ask the wealthy and powerful to 
make no contribution at all.
    We will continue our work this year on Head Start, the 
foundation of the Federal support for the Nation's most 
vulnerable children. Head Start has a 40-year track record of 
success, and reauthorization this year is an opportunity to 
build on that success, and to do more to open the American 
dream to many more children who deserve our help. A block grant 
for Head Start would be, I believe, a giant step backwards. We 
cannot turn Head Start into Slow Start or No Start.
    The current extension of welfare reform expires at the end 
of March. Our ability to move the welfare debate forward will 
require more flexibility from an administration willing to work 
in good faith with Congress on this basic issue of what kind of 
country we are. We are impressed with what you Governor 
Leavitt, did in your State in terms of flexibility.
    Other priorities facing the Department include the need to 
move the health care system into the modern age, using 
information technology, as the chairman has mentioned, and 
improve FDA's ability to detect and respond promptly to warning 
signals on the effects of new drugs. We must also continue the 
fine work of Secretary Thompson of putting disease prevention 
and health promotion higher on the national agenda.
    So I welcome you. I was just looking over, Mr. Chairman, 
the public health legislation we have in this committee's 
jurisdiction the NIH, CDC, FDA, community health centers which 
you mentioned, bioterrorism, Head Start, LIHEAP, the 
Administration on Aging, Meals on Wheels, child care, child 
protection and many of those are in your Department. We work 
together with the Finance Committee, but we are very, very 
grateful to you for your willingness to come here and speak to 
us about not only these issues but also how you intend to lead 
the Department. You are very welcome to the committee, and we 
look forward to working with our Chair to make sure that we get 
you into your responsibilities as soon as we can.
    The Chairman. Now it is my pleasure to recognize my friend 
and colleague from Utah, who has just returned to the 
committee, who used to chair this committee. We appreciate all 
of your efforts on all of the committees you have been on, and 
we look forward to your introduction of your fellow Utahan.

STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM THE STATE 
                            OF UTAH

    Senator Hatch. Thank you, Mr. Chairman, Senator Kennedy, 
other members of the committee. It seems rather odd to be at my 
first hearing back on the HELP Committee and to be on this side 
of the dais. But it is for the best of purposes.
    It is both Senator Bennett's and my honor and privilege to 
introduce to you our good friend and fellow Utahan, Governor 
Mike Leavitt, and to urge that his nomination be approved on an 
expedited basis. Although his wife is not here today because of 
illness, I would like to recognize his beautiful wife, Jackie; 
and he has five wonderful children. And he is a wonderful 
family man, and Jackie has herself assembled quite a record in 
working on issues that this committee is interested in such as, 
just to mention one, childhood vaccines.
    I have also known Mike Leavitt for a long time and have 
worked closely with him on many key issues, not only Utah 
issues but national issues as well. In short, Governor Leavitt 
is bright, energetic, dedicated, and fair.
    Now, I say with all respect to those who have gone before 
him, I can think of no better Secretary of Health and Human 
Services and no better candidate for it. Mike has devoted a 
considerable part of his life and time to public service, first 
in our home State of Utah and, of course, more recently here in 
Washington. He has proven himself to be an excellent manager, a 
smart decisionmaker, a tireless worker, and a successful 
executive. He has an established record of fiscal management, a 
demonstrated knowledge of health care, and a solid reputation 
as a decent, energetic, good family man.
    His wife is a tremendous partner to him. I might mention 
that she comes from a little town in northern Utah named 
Newton. It used to be a town of about 300 people. That is where 
my wife comes from, too. It is a very well-represented city in 
Utah.
    Now, an important hallmark of Mike Leavitt's service that I 
wish to commend to this committee is his fairness. You can 
count on him looking at all sides of an issue before making a 
policy decision, and I think you can count on him making the 
right decision. His record as EPA Administrator bears this out, 
but also his record as head of the Governors Association. This 
should also give great comfort not only to those of us in 
Government, but also to the hundreds of millions of people that 
HHS serves so well.
    As our time is short, Mr. Chairman, I just want to leave 
you with one short story. After attending several briefings 
with this Secretary-designate, a senior official at the FDA 
told me the other day, ``At our first briefing, Governor 
Leavitt was good. At the second meeting, he was excellent. And 
at the last briefing, he was teaching us.'' And that is typical 
of Mike Leavitt. This is the kind of man that Mike Leavitt is. 
He will be a great Secretary.
    I take a great interest in this agency, always have, always 
will. I think both of you have outlined how important it is to 
the health and well-being of our country. And so with pride and 
admiration, along with Senator Bennett, I introduce to this 
committee Governor Mike Leavitt. So I would just ask of the 
committee let us get him confirmed and in the job as soon as 
possible because I think he will do a terrific job there.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    We have been joined by the Majority Leader, Senator Frist, 
so unless there is objection, we will allow him to give a 
statement at this time.

                   Opening Statement of Senator Frist

    Senator Frist. Mr. Chairman, thank you, and I will be 
brief.
    Before we begin, let me take this opportunity to say how 
much I look forward to working with our new chairman as well as 
our ranking member for what I know is going to be an exciting 
year and really entire Congress.
    Just as an aside, it is interesting, as we went through all 
of our committee assignments, that this was probably the most 
popular committee for people to try to join from the Republican 
side this year. I think it reflects the confidence in the 
committee's leadership and our support for the issues that our 
nominee today will be leading on over the next Congress.
    I also just very briefly want to recognize the tremendous 
leadership of Senator Gregg, who has done an outstanding job on 
this committee, and as we all reflected back over the last 
Congress, the tremendous strides we made on a number of issues. 
To be able to walk in the door a few moments ago and see our 
two members, Richard Burr of North Carolina and Johnny Isakson 
of Georgia, our new members, gives me a great deal of pride. I 
have had the opportunity to talk to both of them about issues 
that this committee will be addressing over the course of this 
Congress, and both are committed to and passionate about those 
issues.
    Today's hearing is vital to ensuring our commitment to 
protecting the safety, health, and well-being of the American 
people. I am pleased that such a strong leader, Michael 
Leavitt, has been nominated by President Bush for this role. As 
members of this committee know better than anybody, the 
Department of Health and Human Services is the second largest 
Federal Department, overseeing more than 300 programs with a 
budget of $580 billion. The programs that you will oversee, 
Governor Leavitt, are critical, as you well know, to the 
everyday lives of every single American, and the impact will be 
tremendous on future generations.
    You bring, as Senator Hatch just said, considerable 
experience to this post with your past positions of Governor of 
Utah, Chairman of the National Governors Association, and most 
recently Administrator of the EPA. Your leadership has been 
steady, demonstrated in Utah, as you addressed issues that we 
are so committed to on this particular committee, and that is 
access to health care for children and adults and keeping 
rising health care costs under control, which will be a huge 
topic and focus of this committee over the next Congress. The 
fact that Utah's uninsured rate remains below the Nation's 
average is a goal and a standard that we should use in this 
committee as we look at various policy proposals. Your 
experience as host of the 2002 Olympic Winter Games and co-
chair of the National Governors Association Homeland Security 
Task Force makes you an ideal candidate.
    We begin this 109th Congress with a real record of 
progress, having signed into law over a dozen pieces of 
critical health care initiatives which touch the lives of each 
American, the Medicare Modernization Act, which guarantees 
Medicare beneficiaries access to more affordable medicines, 
better health care choices, and higher-quality care. For the 
first time we really put a demonstrable emphasis on preventive 
care, and for the first time tied payments to quality of care, 
doors that had been opened, but doors that we need to explore 
much further in our policies in this Congress. The Project 
Bioshield Act of 2003, an issue that I have worked on and we 
have all worked on with the leadership of Senator Kennedy, has 
been an appropriate and timely investment that we are going to 
have to build upon when we look to the future and recognize one 
of the greatest existential threats that the world will have to 
face, this country will have to face, is the challenge of 
bioterrorism. The Pediatric Research Equity Act of 2003, which 
we passed last year, addressed pharmaceuticals prescribed in 
children.
    That is the past. We have more work to do. In addition, 
issues such as the Medicare prescription drug benefit which has 
been the single largest expansion of the Medicare program since 
its creation, will require a lot of work with implementation by 
the Centers for Medicare and Medicaid Services. We need to make 
health care more affordable. We need to eliminate the huge gaps 
in health care quality that we have today, and most of that 
work is done by this particular committee. We need to advance 
health care research, making sure that we get those discoveries 
from the laboratory bench all the way to the people where they 
will have their direct impact. And we must, as this committee 
does first and foremost, protect and improve the public health.
    I mention all that, Governor, because as a physician and as 
an active member of this committee, in addition to being 
Majority Leader, I am excited and enthusiastic about your 
leadership. It will require bold leadership, courageous 
leadership, leadership with great definition, and you are 
absolutely in my mind the perfect person to provide that 
leadership.
    At your first inauguration, you pledged to take the State 
of Utah to, and I quote, ``a whole new level of performance.'' 
And you succeeded. I am confident that in this new capacity you 
will succeed once again. Congratulations.
    The Chairman. I would like to recognize my other friend and 
colleague from Utah, Senator Bennett. You have had the 
opportunity to watch and work with Governor Leavitt, and I 
welcome your perspective for this committee.

 STATEMENT OF HON. ROBERT F. BENNETT, A U.S. SENATOR FROM THE 
                         STATE OF UTAH

    Senator Bennett. Thank you very much, Mr. Chairman. I 
appreciate the opportunity.
    I first met Mike Leavitt as we worked on school issues, 
which used to be part of the jurisdiction of the Department of 
Health, Education, and Welfare. And then we both entered the 
lists of electoral politics at the same time in 1992, he for 
Governor and I for Senator, and we both managed to finish 
second in the State convention in the State of Utah, which 
meant that we had to come from behind to win our respective 
primaries, and then ultimately our respective offices.
    So we have seen an awful lot of Utah together and all the 
small towns and distant counties. We have heard a lot of 
terrible speeches given by our opponents, brilliant speeches 
given by each of us, as we have moved through this process 
together, and I consider him once of my best friends and one of 
the public servants I know the best.
    I have a list before me prepared of all of his 
accomplishments. I think the committee has the same list, and 
so I will not bore you with reading them. But as I contemplated 
this, my mind went back to an exchange I had here on the floor 
of the U.S. Senate with Pat Moynihan. There isn't anyone I 
admire more among the Senate than Pat Moynihan and his insight. 
But on this particular occasion, we were on opposite sides of 
the issue. The question was welfare reform. To listen to 
current commentators, welfare reform was one of the crown 
jewels of the Clinton administration, one of the crowning 
accomplishments that occurred under President Clinton's 
leadership. I remember that it took us a lot of time on the 
Republican side of the aisle to convince President Clinton that 
this was worthwhile, and he vetoed it twice before Dick Morris 
finally told him that if he did not pass it, he would not win 
the 1996 election, if he did not sign it, he would not win the 
1996 election.
    In that setting, we were on the floor debating welfare 
reform, and you will remember that Senator Moynihan was very, 
very adamantly against it. And he stood on the floor of the 
Senate, and he said, ``If we pass welfare reform, we will have 
a race to the bottom. Everybody will compete to see how little 
they can do.''
    And I had watched Governor Leavitt deal with welfare reform 
in the State of Utah prior to that debate, and so I was bold 
enough to stand up in the Senate and disagree with Pat Moynihan 
and said, ``I think quite the contrary. If we turn 
responsibility for welfare reform over to the States in the way 
this bill contemplates, we will see experimentation, 
innovation, and ultimately great improvement in the way welfare 
is handled. I don't think we will have a race to the bottom.'' 
Whereupon, Senator Moynihan said, ``I agree with the Senator 
from Utah that you will not have a race to the bottom in Utah, 
but I guarantee we will have it in New York.''
    I cite that because it demonstrates that even outside the 
boundaries of the State of Utah, while Governor Leavitt was 
Governor, is efforts to bring innovative and creative and 
forward-looking reform to a very difficult problem were 
recognized--recognized by people from different States, from 
the different party, from different structure, because New York 
is quite different from Utah. This is a man who has proven that 
he knows how to get things done. He knows how to move in 
directions that are different when it is necessary to do that, 
and he knows how to reinforce established principles that need 
to be reinforced when it is necessary to do that.
    I commend him to the committee with full and complete 
confidence that he will make an outstanding Secretary of Health 
and Human Services.
    The Chairman. Thank you.
    Governor Leavitt, we welcome you to this meeting of the 
Health, Education, Labor, and Pensions Committee. To date, the 
committee has received more than 35 letters of support for your 
nomination from a wide cross-section of business and advocacy 
groups as well as from individuals, and I anticipate we will be 
receiving more letters of support in the coming days.
    I do ask unanimous consent to have the letters entered in 
the record. Without objection.
    [The letters follow:]
                           The 60 Plus Association,
                                       Arlington, VA 22209,
                                                  January 14, 2005.
Hon. Michael B. Enzi (R-WY),
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy (D-MA),
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Enzi and Senator Kennedy: The 60 Plus Association is 
pleased to announce its strongest support possible for the President's 
nomination of former Utah Governor, Michael O. Leavitt, to be Secretary 
of the Department of Health and Human Services (HHS).
    60 Plus counts just over 5 million seniors as its base of support, 
with more than 5,000 in Wyoming and some 7,500 in Massachusetts, as 
well as 7,500 in Utah. 60 Plus has closely followed the compassionate 
career of this dedicated public servant. President Bush could not have 
chosen a more able leader than Governor Leavitt. The Governor has an 
intimate working knowledge of challenges that face him at HHS from 
shoring up Medicare-Medicaid and making sure the Nation's health care 
delivery system continues to function as smoothly as possible.
    60 Plus had hoped that Secretary Thompson would remain at the helm 
of HHS but after nearly 4 decades of service to his Nation, he and Mrs. 
Thompson deserve a chance to ``rest on their laurels'' if you will. 60 
Plus could not have recommended a better choice to be Secretary 
Thompson's successor than his fellow former Governor, Mike Leavitt.
            Sincerely,
                                           James L. Martin,
                                                         President.
                                 ______
                                 
        American Association of Nurse Anesthetists,
                                      Washington, DC 20003,
                                                  January 12, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.

    Dear Mr. Chairman and Ranking Member: On behalf of the more than 
33,000 Certified Registered Nurse Anesthetists (CRNAs), who administer 
more than two-thirds of the Nation's anesthetics, I encourage Members 
of the Senate to confirm the President's nominee for Secretary of 
Health and Human Services (HHS), Michael Leavitt.
    As a three-term Governor of the State of Utah, Mr. Leavitt was 
responsible for several important healthcare programs including his 
State's Medicaid program, for making government services more 
accessible via the internet, and for signing a proclamation proclaiming 
a National Nurse Anesthetists Week. We look forward to working with Mr. 
Leavitt to promote anesthesia patient safety, keep Medicare strong for 
seniors, support educational funding for nurses, advance access to 
quality healthcare that is affordable, and enact meaningful medical 
liability reform. The Administration has been more than gracious in 
extending us the open door to address issues of concern to our 
profession and our patients, so that we might together improve 
healthcare for Americans. I am sure that Mr. Leavitt will continue such 
a relationship.
    If we can ever be of service during this process, please feel to 
contact Frank Purcell, Senior Director of Federal Government Affairs in 
our Washington, D.C. office at (202) 484-8400.
            Sincerely,
                        Frank T. Maziarski, CRNA, MS, CLNC,
                                                         President.
                                 ______
                                 
     American Association of Neurological Surgeons,
                                 Rolling Meadows, IL 60008.
                 Congress of Neurological Surgeons,
                                      Schaumburg, IL 60173,
                                                  January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
    Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the 
American Association of Neurological Surgeons and the Congress of 
Neurological Surgeons, we are pleased to endorse the nomination of 
Governor Mike Leavitt for Secretary of the Department of Health and 
Human Services (HHS) and we urge the Senate to approve his appointment 
as soon as possible.
    Throughout his years in government service, Governor Leavitt has 
demonstrated his ability to be a leader and innovator on many 
healthcare issues. A results oriented leader, he has a proven track 
record of tackling and solving difficult healthcare problems, including 
expanding healthcare coverage for the uninsured and changing the 
welfare system. These initiatives have had a particularly positive 
impact on some of our Nation's most vulnerable citizens, our children. 
Governor Leavitt has also demonstrated his ability to work in a 
collegial and bipartisan fashion, which will clearly be vital to 
advancing some very challenging healthcare policy issues such as 
medical liability reform and the implementation of the Medicare 
Modernization Act.
    America's neurosurgeons are confident that Governor Leavitt will be 
an outstanding Secretary of HHS.
            Respectfully,
                                 Robert A. Ratcheson, M.D.,
                                    President, American Association
                                          of Neurological Surgeons.
                            Nelson M. Oyesiku, M.D., Ph.D.,
                                             President, Congress of
                                             Neuorlogical Surgeons.
                                 ______
                                 
American Health Information Management Association 
                                           (AHIMA),
                                      Washington, DC 20036,
                                                  January 21, 2005.
Hon. Mike Enzi,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.

    Dear Senator Enzi: I am writing to express our strong support for 
the confirmation of Governor Michael O. Leavitt as the Secretary of 
Health and Human Services. Governor Leavitt's roles as the 
Administrator of the Environmental Protection Agency and as Utah's 
Governor has provided him with a critical understanding of our 
government's executive operations at the national and State level, 
including first-hand involvement with Utah's healthcare program.
    Governor Leavitt's unique experience makes him an ideal choice to 
lead the Department of Health and Human Services (DHHS). As you know, 
DHHS is moving forward with a range of critical initiatives that 
include the implementation of the Medicare prescription drug program, 
Medicare reform, increased medical research and enhanced bioterrorism 
and public health efforts. In addition, DHHS is addressing many issues 
critical to AHIMA and its more than 50,000 members, including the 
development and adoption of health information technology, migrating 
from our outdated and broken 30-year-old ICD-9-CM coding system to ICD-
I0-CM and ICD-10-PCS, protecting the privacy and security of health 
information, and expanding the health information management and allied 
health workforce. AHIMA believes that Governor Leavitt is the right 
choice to lead these efforts, at the right time.
    AHIMA remains committed to its goal of ``quality healthcare through 
quality information'' and is dedicated to enhancing and improving 
healthcare. Founded in 1928 to improve the quality of medical records, 
AHIMA works diligently to advance the health information management 
profession in an increasingly electronic and global environment. AHIMA 
has a reputation for working on a bipartisan basis with elected 
officials and health policymakers and we look forward to working with 
you to confirm Governor Leavitt and to advance health information 
management and technology issues.
    If I can provide you with any further information, please do not 
hesitate to call me in the AHIMA Washington, D.C. Office at 202-659-
9440 or at [email protected].
            Sincerely,
                                            Daniel F. Rode,
                                                    Vice President,
                                   Policy and Government Relations.
                                 ______
                                 
            American Osteopathic Association (AOA),
                                 Washington, DC 20005-4949,
                                                  January 12, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Chairman Enzi and Ranking Member Kennedy: As President of the 
American Osteopathic Association (AOA), I write to express our strong 
support for the nomination of Governor Michael O. Leavitt to be 
Secretary of the Department of Health and Human Services (HHS).
    The AOA represents the Nation's 54,000 osteopathic physicians 
practicing in 23 specialties and subspecialties. We applaud his 
nomination and encourage the Senate to approve his appointment at its 
earliest opportunity.
    Throughout his career, Secretary-Designate Leavitt has demonstrated 
sound and disciplined leadership. These traits will benefit HHS as the 
agency addresses the numerous health care challenges facing our Nation. 
Additionally, he has a strong health care background and understands 
the access, workforce and financial challenges facing Medicare and 
Medicaid. We are especially appreciative of his efforts as Governor of 
Utah to improve the physician workforce in rural and underserved 
communities.
    The AOA applauds his nomination and stands ready to work with 
Secretary Leavitt on improving the Nation's health care delivery 
system. Please contact the AOA's Department of Government Relations at 
(202) 414-0140 for additional information.
            Sincerely,
                                       George Thomas, D.O.,
                                                         President.
                                 ______
                                 
                    Alliance of Specialty Medicine,
                                                  January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Chairman Enzi and Ranking Member Kennedy: The undersigned 
members of the Alliance of Specialty Medicine wholeheartedly support 
the nomination of Governor Mike Leavitt for Secretary of the Department 
of Health and Human Services (HHS). We urge the Senate to approve his 
appointment as soon as possible.
    The Alliance is a coalition of 12 national medical specialty 
societies representing more than 220,000 physicians. Our non-partisan 
group is dedicated to the development of sound federal health care 
policy that fosters patient access to the highest quality specialty 
care.
    Governor Leavitt has the experience and leadership skills needed to 
take the helm of HHS at a crucial time. He will be tasked with the 
implementation of the Medicare prescription drug plan and solving 
physician reimbursement and medical liability challenges. Governor 
Leavitt knows the value of building a consensus to solve tough 
challenges together. He is a common-sense leader who knows how to 
deliver results.
    The Alliance is ready to work with Secretary Leavitt on improving 
the health care and well-being for America's citizens. Please contact 
the Alliance at (202) 728-0610 for additional information.
            Sincerely,
               American Academy of Dermatology Association,
 American Association of Neurological Surgeons/Congress of 
                                     Neurological Surgeons,
              American Association of Orthopaedic Surgeons,
                  American College of Emergency Physicians,
       American College of Obstetricians and Gynecologists,
                  American Gastroenterological Association,
   American Society for Therapeutic Radiology and Oncology,
         American Society of Cataract & Refractive Surgery,
                           American Urological Association,
                 National Association of Spine Specialists,
                              Society of Thoracic Surgeons.
                                 ______
                                 
The Council for Affordable Health Insurance (CAHI),
                                      Alexandria, VA 22314,
                                                  January 17, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Kennedy: I wanted to take this opportunity to express 
the Council for Affordable Health Insurance's (CAHI) strong support for 
Governor Leavitt's nomination as secretary of the Department of Health 
and Human Services.
    CAHI is a research and advocacy association of insurance carriers 
active in the individual, small group, HSA and senior markets. CAHI's 
membership includes health insurance companies, small businesses, 
physicians, actuaries, and insurance brokers. Since 1992, CAHI has been 
an advocate for market-oriented solutions such as HSAs to the problems 
in America's health care system.
    As a three-term governor, Mike Leavitt is a proven leader and 
administrator who has successfully led his State in several health care 
and welfare reform initiatives. That is important because the country 
faces several health care challenges: reducing the number of uninsured; 
ensuring that people, especially those with pre-existing medical 
conditions, have access to affordable health coverage; and addressing 
the growing financial problems facing Medicare and Medicaid.
    The country needs a strong, innovative leader who has the patience 
to listen to others about how to effectively address our health care 
challenges and motivate the department, the health care community, and 
State and Federal elected officials to adopt legislation and best 
practices that will solve the problems.
    We at the Council believe that Governor Leavitt is the right person 
at the right time for a very big job, and we encourage you to approve 
his nomination in a timely manner.
            Faithfully,
                                   Merrill Matthews, Ph.D.,
                 Director, Council for Affordable Health Insurance.
                                 ______
                                 
               Federation of American Hospitals TM,
                                 Washington, DC 20004-2604,
                                                  January 14, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Charles Grassley,
Chairman,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Max Baucus,
Ranking Member,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.

    Dear Chairmen and Ranking Members: The Federation of American 
Hospitals is pleased to support strongly the nomination of Governor 
Mike Leavitt as Secretary of the Department of Health and Human 
Services (HHS). Governor Leavitt will be a wonderful addition to the 
President's cabinet, and the Federation urges quick approval of his 
nomination.
    Governor Leavitt's demonstrated leadership and organizational 
skills, his vision, and his public policy expertise in health care make 
him exceptionally qualified to lead HHS. In addition, his ability to 
work with diverse groups and across party lines paired with his 
congenial manner qualify him as an outstanding choice to serve as HHS 
Secretary, particularly when considering the often contentious issues 
before the Department.
    America's investor-owned hospitals know Governor Leavitt as a 
champion for constructive and thoughtful leadership. Again, we commend 
him and encourage the committees and the Senate to rapidly approve his 
nomination.
            With warm regards,
                                       Charles N. Kahn III,
                                                         President.
                                 ______
                                 
                                   Galen Institute,
                                      Alexandria, VA 22320,
                                                  January 16, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Kennedy: I am writing to express strong support for 
President Bush's nomination of Governor Michael O. Leavitt to serve as 
Secretary of the Department of Health and Human Services.
    Governor Leavitt has demonstrated his extraordinary leadership 
abilities as a governor and as Administrator of the Environmental 
Protection Agency, abilities that will be essential in managing a 
department as large and with as many responsibilities as DHHS.
    Serving as a governor his given him valuable experience with key 
programs managed by the department. For example, he demonstrated both 
skill and creativity in implementing the State Children's Health 
Insurance Program. And he has been a leader in developing new ways to 
extend health coverage to the citizens of Utah through Medicaid 
waivers. Those skills will be invaluable in advancing President Bush's 
health policy agenda to provide health insurance to millions of 
uninsured Americans and to make coverage more affordable and 
accessible.
    Governor Leavitt will serve the Department and the Nation well, and 
I strongly urge the committee to recommend to the U.S. Senate his 
confirmation as Secretary of Health and Human Services.
            Sincerely,
                                        Grace-Marie Turner,
                                                         President.
                                 ______
                                 
                                                  January 19, 2005.
Hon. Charles E. Grassley,
Chairman,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Max Baucus,
Ranking Minority Member,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. ``Ted'' Kennedy,
Ranking Minority Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Chairman Grassley, Senator Baucus, Chairman Enzi, and Senator 
Kennedy: We strongly support the confirmation of current EPA 
Administrator Michael Leavitt for U.S. Secretary of Health and Human 
Services. As former colleagues, we have all worked with him in a 
bipartisan manner and found him to be an individual of great 
intelligence, honesty, and integrity, Furthermore, be has a thorough 
understanding of both welfare and Medicaid, which are two programs of 
major importance to our Federal-State partnership.
    We urge your committees to support Governor Leavitt's confirmation 
and look forward to a quick vote by the Senate.
            Sincerely,
                                   Governor Mark R. Warner,
                                                          Virginia.
                                Governor Jennifer Granholm,
                                                          Michigan.
                                Governor Thomas J. Vilsack,
                                                              Iowa.
                                        Governor Jim Doyle,
                                                         Wisconsin.
                                 ______
                                 
               Healthcare Leadership Council (HLC),
                                      Washington, DC 20004,
                                                  January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.

    Dear Chairman Enzi: On behalf of the members of the Healthcare 
Leadership Council--chief executives of the Nation's premier health 
care companies and institutions--strongly urge you to support President 
Bush's nomination of Michael Leavitt to serve as Secretary of the U.S. 
Department of Health and Human Services,
    Governor Leavitt is a sound choice to serve as HHS Secretary and 
has the skills and experience to serve the Nation well in this 
challenging position.
    Governor Leavitt is an innovator. As governor of the State of Utah 
and as chairman of the National Governors Association, he was a strong 
advocate for giving States more creative flexibility in using Federal 
funds to better serve the health needs of their citizens. At a time 
when we must strive to make health insurance coverage more accessible 
to the tens of millions of citizens who are without it, Governor 
Leavitt's openness to new ideas and his determination to meet the 
health care heeds of the American people are welcome qualities.
    He has a reputation as a pragmatic consensus-builder. This, too, is 
a welcome characteristic at a time when Washington, all too often, 
finds itself gridlocked on critical health care priorities. We need 
progress on issues ranging from the uninsured to health information 
technology dissemination to medical liability reform and we believe 
Governor Leavitt can be effective in finding common ground on these 
matters.
    And, finally, Governor Leavitt has established himself as a strong 
manager, both in Utah and at the Environmental Protection Agency. This 
is no small credential for someone who will assume the reins of an 
institution as large and complex as HHS. And, as we move toward full 
implementation of the Medicare Modernization Act, a strong 
administrator at the HHS helm is a necessity.
    In short, we believe that President Bush has made the right choice 
for a cabinet position of extraordinary importance and we encourage you 
to vote for Governor Leavitt's confirmation.
            Sincerely,
                                            Mary R. Grealy,
                                                         President.
                                 ______
                                 
       Chamber of Commerce of the United States of 
                                           America,
                                 Washington, DC 20062-2000,
                                                  January 12, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Chairman Enzi: The U.S. Chamber of Commerce, the world's 
largest business federation representing more than 3 million businesses 
of every size, sector and region, strongly supports the nomination of 
Mike Leavitt to be Secretary of Health and Human Services.
    Mike Leavitt has an exemplary track record for addressing the 
issues of healthcare access and affordability as the former Governor of 
Utah. As the Administrator of the Environmental Protection Agency, he 
worked diligently to bring all sides together and address the public 
health risks posed by emissions in a manner that cleaned the air 
without disrupting the economy.
    The Chamber looks forward to working with the nominee in 
implementing the Medicare Modernization Act, particularly as it 
pertains to retiree health benefits, in advancing proposals making 
health coverage more affordable and accessible to all Americans, and in 
improving the safety and efficiency of our Nation's health delivery 
system.
    We urge the committee's quick approval of this nomination and 
favorable recommendation for confirmation by the full United States 
Senate.
            Sincerely,
                                           R. Bruce Josten,
                                          Executive Vice President,
                                                Government Affairs.
                                 ______
                                 
             National Alliance for Hispanic Health,
                                 Washington, DC 20036-1401,
                                                  January 14, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510-6300.

    Dear Senator Enzi: On behalf of the membership of the National 
Alliance for Hispanic Health (the Alliance), I am pleased to offer our 
full support for the swift confirmation of Mike Leavitt as the next 
Secretary of Health and Human Services. The Alliance is the Nation's 
largest and oldest organization committed to improving the health of 
Hispanics. Alliance members reach over 12 million Hispanics every year 
through the provision of direct services.
    The Alliance worked with Administrator Leavitt when he was Governor 
of Utah and Chairman of the Western Governor's Association (WGA). As a 
founding board member of the Patient Safety Institute (PSI), the 
Alliance witnessed first hand then-Governor Leavitt's work with WGA to 
move forward new technology to realize the benefits of electronic 
patient health information. We look forward to his leadership on this 
issue as Secretary of Health and Human Services.
    Our Utah-based community organization members describe Mike Leavitt 
as an effective advocate for Hispanic issues who has also been very 
supportive in the health arena. They describe him as a listener and 
quick learner who tempers his search for solutions with his knowledge, 
insight, and commitment to balance. For example, when he established 
his health policy commission in Utah he made sure that the group was 
diverse and included strong community advocates. Most impressive was 
his work with the health community to be proactive with the Children's 
Health Insurance Program (CHIP).
    We are fortunate to have a person of the caliber and commitment of 
Mike Leavitt in public service. Our Nation's health system will benefit 
from his stewardship and the Alliance looks forward to his 
confirmation.
            Sincerely,
                              Jane L. Delgado, Ph.D., M.S.,
                                                 President and CEO.
                                 ______
                                 
                  Republican Governors Association,
                                      Washington, DC 20004,
                                                  January 13, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.
Hon. Edward Kennedy,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
    Dear Chairman Enzi and Senator Kennedy: We are writing to express 
our strong support for Administrator Mike Leavitt to be the next U.S. 
Secretary of Health and Human Services.
    As Governor of Utah, Administrator Leavitt improved health care in 
numerous ways. His work to enact the Children's Health Insurance 
Program (CHIP) in Utah helped reduce the uninsured rates for children 
to its lowest point ever. His administration worked to increase the 
number of Utahans with health insurance by 400,000 and raise 
immunization rates by nearly 75 percent. He also was a leader in using 
technology to enhance the quality of health care and reduce costs.
    Mike Leavitt was chosen by his gubernatorial colleagues to lead 
numerous organizations during his time as Governor. In those roles, he 
was a critical voice in the national discussions on the reform of 
Medicaid and welfare and in the crafting of CHIP. He was chosen for 
these leadership positions because of his command of the issues, his 
bipartisan temperament and his ability to listen to all sides and 
fairly synthesize different viewpoints.
    His reputation for seeking consensus has served him well as EPA 
Administrator. We believe that this leadership style will be put to 
good use in working with the country's Governors toward the 
implementation of the permanent Medicare prescription drug benefit in 
2006, improving the Medicaid program, ensuring an adequate supply of 
vaccines, holding the line on health care costs and other important 
health care causes.
    For his record of leadership, his steadiness of purpose and ability 
to get results, we heartily endorse Administrator Mike Leavitt to be 
the next Secretary of Health and Human Services.
            Sincerely,

            
            
            
                                 ______
                                 
National Association of Health Underwriters (NAHU),
                                       Arlington, VA 22201,
                                                  January 17, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Kennedy: On behalf of the National Association of 
Health Underwriters and our entire Board of Trustees, I would like to 
wholeheartedly support the nomination of Governor Mike Leavitt for 
Secretary of the Department of Health and Human Services. Our Utah 
chapter has worked with Governor Leavitt extensively on health issues 
of all kinds and has given us their strongest vote of confidence in his 
knowledge, strength of character, and ability to get things done.
    One of the most critical concerns in selecting the right person to 
lead a government agency as large as the Department of Health and Human 
Services is the ability not only to personally communicate well, but 
the ability to find ways to facilitate that type of communication with 
others both within the agency and among the citizens the agency serves. 
While governor of Utah, Governor Leavitt's ability to strategize 
effectively on technology resulted in an e-government initiative that 
made more than 110 State Government services available over the 
Internet.
    Governor Leavitt has also shown himself to be an effective leader 
and communicator within organizations such as the National, Western, 
and Republican governors associations. He has been repeatedly chosen by 
his peers to lead them, and that same leadership ability also resulted 
in Utah being recognized six times as one of America's best-managed 
states.
    Our NAHU leaders in Utah know firsthand that Governor Leavitt's 
health care experience will result in innovative ideas being proposed 
and implemented. In 1994, Governor Leavitt proposed a comprehensive 
incremental approach to health care improvement that has resulted in 
400,000 more Utahans having health insurance than did before, better 
use of the children's health insurance program, and improved 
immunization rates, all while decreasing the per capita cost of health 
care in his State to 25 percent below the national average. Certainly 
these types of skills are just what is needed at the Department of 
Health and Human Services.
    We are confident that the Senate will recognize the tremendous 
potential Governor Leavitt has to offer and we look forward to working 
together with him and the Senate HELP Committee to improve access to 
affordable health care for Americans from coast to coast. Should you 
need any additional information or if we can move this process forward 
in some other way, please let me know. I can be reached at (703) 276-
3806.
            Sincerely,
                                           Janet Trautwein,
                              Vice President of Government Affairs.
                                 ______
                                 
       National Association of Manufacturers (NAM),
                                 Washington, DC 20004-1790,
                                                   January 6, 2005.
Hon. Michael B. Enzi,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.

    Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the 
members of the National Association of Manufacturers (NAM), the 
Nation's largest industrial trade association, representing small and 
large manufacturers in every industrial sector and in all 50 States, I 
write to express our strong support for the nomination of former Utah 
Governor Michael Leavitt to serve as Secretary of Health and Human 
Services.
    Governor Leavitt is superbly qualified to serve as the Nation's 
Secretary of Health and Human Services (HHS). President Bush has chosen 
a leader who has been a successful manager of complex organizations 
like the State of Utah and the EPA. Governor Leavitt understands well 
the importance of building a more affordable health care system and the 
impact of health care costs on America's economic competitiveness in a 
challenging global economy. As Governor, I worked closely with Governor 
Leavitt on Medicaid and Welfare reform. Governor Leavitt was one of the 
lead Governors in the National Governors Association during the 
historic reforms of 1995-96. I know first-hand that he is a creative 
problem-solver who excels at innovation and management.
    Governor Leavitt's leadership will be critical on the myriad 
complex issues before HHS, including deploying health information 
technology, promoting disease prevention and management and securing 
America's food and drug needs. He is the right choice at the right time 
to lead our Nation's health and human services agenda.
    I hope that you will act promptly and favorably upon Mike Leavitt's 
nomination. If there is any way that the NAM can be of assistance to 
you, please do not hesitate to contact us.
            Sincerely,
                                               John Engler,
                                                 President and CEO.
                                 ______
                                 
                               Safe Food Coalition,
                                      Washington, DC 20036,
                                                  January 14, 2005.
Hon. Mike Enzi,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Enzi: On behalf of the diverse group of Americans we 
represent, the Safe Food Coalition respectfully requests that you 
submit the attached questions to EPA Administrator Mike Leavitt to 
answer during his confirmation hearing as U.S. Secretary of Health and 
Human Services scheduled for Tuesday, January 18, 2005.
    Thank you for considering our request on this very important issue. 
If you have any questions please respond directly to Ken Kelly at (202) 
332-9110 ext. 319 and he will share your response with the 
organizations below.
            Sincerely,
                                              Carol Tucker,
                           Foreman, Consumer Federation of America.
                                     Caroline Smith DeWaal,
                         Center for Science in the Public Interest.
                                     Karen Taylor Mitchell,
                                          Safe Tables Our Priority.
                                                Tony Corbo,
                                                    Public Citizen.
                                                Tom Devine,
                                 Government Accountability Project.
                                               Alison Rein,
                                         National Consumers League.
                                           Sally Greenberg,
                                                   Consumers Union.
     Questions of the Safe Food Coalition for Governor Mike Leavitt

Modernizing Food Safety Laws

    The National Academy of Sciences has said that food safety and 
quality in the U.S. is governed by a fragmented and overlapping system. 
It is based on laws, several of which were adopted in 1906, which means 
they are nearly 100 years old.
    Question 1. Given how much the food industry has changed in the 
last 100 years, do you think that the food laws should be modernized to 
address new issues and hazards, like food borne pathogens, mad cow 
disease and genetically modified food?

Mandatory Recall

    Currently, the Food and Drug Administration (FDA) does not have 
mandatory authority to recall contaminated food products. FDA must rely 
on voluntary cooperation by food companies to get contaminated food out 
of supermarkets, restaurants, and consumers' homes. FDA identified 
3,248 recalls of non-meat and poultry foods from 1986 to 1999 and GAO 
identified nine instances during that time where companies delayed 
compliance with an FDA recall request.
    Question 2. Do you think that FDA should have mandatory recall 
authority in order to protect American, consumers from unintentional 
contamination by food that is imported into the country?

Bioterrorism

    The outgoing Secretary of Health and Human Services Tommy Thompson 
recently stated that ``I, for the life of me, cannot understand why the 
terrorists have not attacked our food supply, because it is so easy to 
do.'' Secretary Thompson's concerns seem justified: Since 1994, food 
imports have grown five-fold to six million food import shipments, but 
the Food and Drug Administration (FDA) inspects only around 2 percent 
of these shipments. In addition, FDA does not have mandatory authority 
to recall contaminated food that it regulates.
    Question 3. How would you improve FDA's oversight to imported food? 
For example, do you support the allocation of additional inspectors to 
the FDA in order to bolster food inspections at ports of entry in order 
to protect American consumers from the threat of both intentional and 
unintentional contamination of the U.S. food supply?
    Question 4. Do you think that FDA should have mandatory recall 
authority to protect consumers from contaminated food that is 
distributed around the country?

Feed Ban

    On January 26, 2004, HHS Secretary Tommy Thompson and then-FDA 
Commissioner Mark McClellan held a press conference to announce a new 
interim final rule that would tighten the feed regulations for bovines 
as a strengthening of the firewalls against bovine spongiform 
encephalopathy (BSE). This rule was to prohibit mammalian blood, 
poultry litter and plate waste as feed ingredients for ruminant 
animals. It would also require animal feed manufacturers to maintain 
segregated production lines to ensure that ruminant feed is not 
contaminated. A year later, this interim final rule has not been issued 
and none of these loopholes have been closed, leaving American 
consumers vulnerable to mad cow disease.
    Question 5. What actions will you take to ensure that the measures 
announced by Secretary Thompson and FDA Commissioner McClellan are 
implemented immediately?

Trade With Canada

    Two additional cases of mad cow disease have been identified in 
Canada in the last 2 weeks. In a recent letter sent by Senator Kent 
Conrad and Congressman Henry Waxman to USDA Secretary-designate Mike 
Johanns, they quoted from recent FDA ``import alerts'' and found that 
over the past 15 months, 17 Canadian feed companies have been cited by 
FDA for not meeting our current bovine feed regulations.
    Furthermore, the Vancouver Sun on December 16, 2004 published an 
investigative report in which it cited Canadian Food Inspection Agency 
documents that showed seven Canadian feed mills with ``major non-
compliance issues.'' Three mills failed to ``prevent the contamination 
of ruminant feeds with non-ruminant feeds'' and in one of these cases 
the contaminated feed was actually consumed by other cattle.
    Question 6. In light of these findings, do you believe that it is 
wise for the United States to resume beef and cattle trade with Canada 
at this time?

Anti-Microbial use in Animals

    Anti-resistant strains of toxic pathogens, like Salmonella Super 9, 
have been increasing in recent years. Many scientific groups, like the 
CDC, cannot form valid risk assessments without information from drug 
companies on anti-microbial use of their drugs in animals, but current 
disclosure restrictions thwart real attempts to improve or design 
appropriate preventive measures.
    Question 7. What course will you follow in getting drug companies 
to release information on anti-microbial use in animals? Are you 
willing to work towards building more open disclosure policies for all 
levels of animal production?

Traceability

    Recently, departing Secretary of Health and Human Services Tommy 
Thompson made alarming comments regarding our food supply, claiming 
that it was vulnerable to attack by terrorists. Currently, there is no 
uniform traceability system in place for meat and poultry (USDA) and 
other contaminated foods (FDA) that would enable an effective and 
timely recall. Without a traceability system in place, it is almost 
impossible to trace contaminated food, both backwards to the source and 
forward through its distribution into the marketplace, allowing timely 
notification to the public.
    Question 8. In the absence of uniform traceability, if a 
bioterrorism attack were to occur within our food supply, how does the 
government intend to respond? Should the government be developing 
traceability regulations that would result in contaminated food being 
recalled more effectively and completely, and which would include 
providing the public with complete information in a timely manner?

    The Chairman. Governor Leavitt, proceed.

   STATEMENT OF MICHAEL O. LEAVITT, OF UTAH, NOMINATED TO BE 
    SECRETARY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Mr. Leavitt. Chairman Enzi, thank you very much, and 
Senator Kennedy, for your graciousness. Leader Frist, thank 
you, and members of the committee. May I say that my heart 
requires that I express appreciation--appreciation to the 
President for his confidence, appreciation to this committee 
for the graciousness with which I've been received as I have 
had a chance to move about and get acquainted with each of you, 
appreciation of the committee staff on both sides of the aisle 
who have been extraordinarily helpful in being able to go 
through the process that is necessary, an advise-and-consent 
constitutional process.
    I would also like to express directly my admiration for 
Secretary Tommy Thompson. Tommy Thompson is a man who was a 
friend of mine while we were Governors. We served together not 
only as Governor, but he was a friend of the State of Utah 
while he was Secretary of HHS, allowed and empowered a number 
of important innovations and helped us solve problems. I 
believe America is stronger as a result of his service. I think 
the Department of HHS is stronger. People at HHS love Tommy 
Thompson. He is well respected on Capitol Hill, and I 
understand why. I want to pledge to him and to you that I will 
build on the legacy that he has built.
    I would also very much like to acknowledge and express 
appreciation for the sentiments of my friends Senator Hatch and 
Senator Bennett, and the others who have expressed support for 
my confirmation. Their expressions this morning are warming 
impressions of a friend as well as professional colleagues, and 
I deeply appreciate it.
    Mr. Chairman, I have prepared and submitted a written 
statement. In the interest of time and with an anxiousness to 
get to your questions, I am going to submit that and ask it be 
included in the record. But I would like to just cover, if I 
could, a few observations about the things I believe, about the 
vision or the feelings I have for the mission of the 
Department, and perhaps some of the things that we will need to 
face together.
    First of all, let me say that I believe public service is a 
trust, and the most important thing I believe I can say to you 
today is that I give you my commitment that I will conduct that 
trust with fidelity.
    I would also like you to know that I believe that this 
Nation has a responsibility to care for the truly needy, but it 
is also our generational responsibility to foster and to teach 
self-reliance. Self-reliance is a prerequisite of freedom and 
of prosperity.
    I would like to also acknowledge the deep belief I have in 
the mission of the Department of Health and Human Services. It 
is clear to me that when families gather around their table at 
night that in this Nation they are able to do so with 
confidence knowing that their food is protected and safe. We 
live in a nation that when we awake in the middle of the night 
and administer medicine to a child, we do so with the 
confidence that it is safe.
    I would also like to acknowledge the profound importance I 
think that this Department has on the administration and the 
development of health care policy in this country. It affects 
us all from the moment we enter this life until the moment we 
leave.
    I am also quite conscious and feel very sensitive about the 
importance this Department plays in allowing us to meet our 
most noble aspirations as a society to care for those who are 
in need, the welfare of families, the health of families, and 
the ongoing capacity for us to assure that the truly needy in 
our society are, in fact, cared for.
    In the course of the last several years, we have become 
more conscious of a new role that HHS plays, and that is its 
new important role in the fight for a safe homeland.
    I would like to just, if I could, review a couple of the 
subjects that I know we will want to talk more about and that I 
feel confident that we will deal with over the course of our 
time if I am successful in my nomination and confirmed. The 
first is Medicare.
    May I just say that successful implementation of the 
Medicare Modernization Act will be the main event at HHS in the 
year 2005. The time frames are short. The expectations are 
high. The interest is wide. The implications are long. There 
will inevitably be flaws, but we will not fail.
    Senator Kennedy and others mentioned the reauthorization of 
welfare. I believe this is an American success story. What we 
have accomplished in the last 6 years is something that must be 
continued and improved upon, and I look forward to working 
together with all of you to see the reauthorization of this 
important program.
    Medicaid. I believe Medicaid is a vital program. I believe 
it is a remarkably important means by which we serve the poor 
in this country. But it is not meeting its potential to do good 
in the lives of the poor that it can. I mentioned to one of you 
in a meeting that I had with you privately in your office, when 
asked what it was about this responsibility that appealed to 
me, I reflected that some 6 years ago or 7 years ago, I 
appeared many times before this committee and others when we 
were working on welfare reform and Medicaid. We succeeded, I 
believe, well with Medicare--rather, with welfare. We did not 
succeed on Medicaid, and I vowed if I ever had a chance to work 
on it again, I would. And I look forward to working with you to 
find ways in which we can serve this very important population 
in ways that will meet its full potential.
    I would also like to recognize the importance of protecting 
three very important American brands: the FDA, the CDC, and 
NIH. Those I refer to as ``brands'' because a brand is a 
promise. It is a reputation. And it is clear to me that the 
American people depend on that promise. And we need to protect 
the integrity of those American treasures.
    Large-scale discussions in my mind are beginning to grow on 
the whole subject of health care policy and how we deliver it. 
I welcome it. That discussion needs to be bold and it needs to 
be transformational, and we start with medical liability, 
something that badly needs to be improved.
    I will also recognize this morning in my introduction the 
role I believe the United States of America has in influencing 
the rest of the world as a good humanitarian voice.
    Now, Mr. Chairman, when I entered public service, I adopted 
three goals, perhaps consistent with our Western roots: I 
committed that I would leave it a better place than I found it, 
that I would plant seeds for a future generation, and that I 
would give it all I have. It is that pledge I leave with you 
today and look forward to interacting with you on the issues I 
have spoken of and many others that I am sure you will raise 
today and in the future. I look forward to an opportunity.
    Thank you.
    [The prepared statement of Mr. Leavitt follows:]

            Prepared Statement of the Honorable Mike Leavitt

    Good morning Mr. Chairman, Senator Kennedy, and members of 
this committee. Thank you for inviting me to discuss my 
nomination to be Secretary of Health and Human Services.
    I would like to begin by expressing my immense admiration 
for Tommy Thompson. We have been friends for many years, but my 
admiration is broader than just friendship. I admired his 
leadership as Governor of Wisconsin. The two of us worked 
together on many of the issues we will talk about today. He 
also brought an aggressive agenda to HHS, and his 4 years at 
the helm have made America healthier and safer.
    Consider: Medicare is providing more comprehensive care to 
more American seniors than ever before. HHS is better prepared 
than ever to respond to public health emergencies. More 
children receive immunizations and health care, and fewer use 
drugs. The Food and Drug Administration is inspecting seven 
times as much imported food as it did 4 years ago. And, thanks 
to the leadership of President Bush and Secretary Thompson, the 
United States leads the struggle against AIDS around the world.
    Tommy has earned the affection and respect of the people of 
HHS, and I pledge to him and to you that, if confirmed, I will 
build on his legacy.
    I have enjoyed every stage in my career, from business, to 
being Governor of Utah, to protecting the environment as 
Administrator of EPA. Now, President Bush has asked you to 
confirm me as Secretary of Health and Human Services. I want to 
thank him for his confidence and thank you for assessing my 
fitness to serve.
    As a prelude to answering your questions it may be helpful 
if I tell you what I believe, what issues and opportunities I 
see confronting our Nation, and how I view the Department of 
Health and Human Services.
    I believe conducting the public's business is a sacred 
trust. I pledge that I will serve with fidelity and full 
effort.
    I believe collaboration trumps polarization every time and 
that solutions to complex problems have to transcend political 
boundaries.
    I believe that information technology is challenging old 
institutions, bridging great distances, and giving people more 
control over their own lives. To survive, governments will have 
to be more flexible and more competitive.
    I believe market forces are superior to mandates. People do 
more, and do it faster, when they have an incentive to do the 
right thing.
    I believe we should reward results, not efforts. Our focus 
should always be the outcomes we are striving to achieve.
    I believe that to change a nation, you have to change 
hearts. And you change hearts through education and example.
    I believe government must care for the truly needy and 
foster self-reliance and personal charity. Helping others is 
good for the soul. Government can augment this compassion and 
provide services, but it can never replace the love that makes 
us help each other.
    I expect the Department of Health and Human Services to 
achieve our Nation's noblest human aspirations for safety, 
compassion, and trust.
    When we gather our families for dinner at night, we rely on 
HHS to ensure the food we put on the table is safe.
    When we are alone at night caring for a sick child, we 
trust HHS to ensure that the medicine we give her is effective.
    Our poor, disabled, and elderly have health insurance 
because this Nation has made it a priority; another powerful 
stewardship that has been given to HHS.
    The Department of Health and Human Services helps to 
strengthen marriages and families, protects children, and 
fights disease. For example, we are often called upon to 
protect neglected and abused children. But we can never replace 
the love of a parent.
    And if, God forbid, terrorists should ever unleash a 
biological agent on American soil, we would rely on the 
dedicated men and women of HHS and the plans they have 
developed already to stop the disease in its tracks and protect 
Americans.
    We all know that HHS spends nearly one out of every four 
dollars collected by the Federal Government in taxes. I am 
humbled by the prospect of shouldering that responsibility.
    I would like to thank the members of this committee for the 
kindness you showed me as I visited your offices. Our 
conversations have been helpful as I contemplate this task. One 
of you said, only partly joking, ``Why would you want a hard 
job like that.'' There are so many reasons. Let me mention a 
few, beginning with welfare and Medicaid.

Welfare Reform

    In the late 1990s, in my role as Chairman of the National 
Governors Association, I worked closely with Congress and other 
governors in building the federal-state partnership we called 
welfare reform. We can all be proud of this dramatic American 
success story. We set a tone of compassion for this country by 
caring for those in need and fostering self-reliance. Now I 
look forward to working with you to ensure that welfare reform 
is reauthorized and improved.

Medicaid

    During the same period, Congress worked hard at reforming 
Medicaid, but ultimately failed. I vowed then that if the 
opportunity ever arose again, I would seize it. Delivering 
health care to the needy is important, but Medicaid is flawed 
and inefficient. We can do better. We can expand access to 
medical insurance to more people by creating flexibility for 
our State partners and transforming the way we deliver it.

Medicare

    When you and your colleagues approved the Medicare 
Modernization Act, Mr. Chairman, that was a great achievement. 
And you asked us to implement the Medicare prescription drug 
benefit on January 1, 2006. This is a great challenge.
    I have no illusions about the size of the task. It is 
immense. But I recognize that the President and the Congress 
made a solemn commitment to America's seniors. I have the 
responsibility of delivering on that commitment. Our work will 
not be without flaw, but we will not fail.

Global

    This Nation's compassion is not limited to America. We live 
in a prosperous country. And our prosperity is not only a 
blessing--it's also an obligation. While the world sometimes 
envies or resents us, it always respects us. And when we do the 
right thing, others emulate our example.
    In international health, one of our Nation's greatest 
strengths is our considerable convening power--it's our ability 
to inspire, to set an example, and to call upon the best 
knowledge, experience, and resources, from individual experts, 
private institutions, and government agencies.
    I resolve to use this convening power to meet our 
obligation as human beings to improve health and well-being. We 
will reach out to reduce suffering, to promote understanding, 
and to inspire compassionate action.

FDA, NIH, and CDC Brands

    HHS is the trustee for a number of our Nation's most 
treasured brands. A brand is a promise. Over decades, the 
dedicated scientists and researchers of HHS have earned the 
public's trust, especially in three brands: FDA, NIH, and CDC. 
To millions of people, these brands are seals of quality, 
safety, and best in the world research. If they lost their 
reputations, they would take years to recover. HHS always needs 
to keep in mind the ethical implications of its decisions, to 
ensure that Americans can be proud, not only of the 
Department's scientific expertise, but also of the moral 
judgment of its leaders.
    At FDA, our goal must be to inform consumers about risks 
and benefits. Our foundation must be sound science. Our motto 
must be independence.
    At NIH, we must march forward with life-saving research, 
and always hold the scientists, universities, and laboratories 
accountable for results.
    At CDC, our guiding focus must be disease prevention and 
control, sharing generously the best health and safety 
information in the world.

Liability

    Most doctors make a sincere effort to do a good job, but 
medical errors do occur. People who are harmed by medical 
errors absolutely deserve prompt and fair compensation. 
Unfortunately, the capricious liability system that prevails in 
many States helps no one. Senators, I look forward to working 
with you to pass comprehensive medical liability reform.

Twenty-First Century Health Care

    Most broadly, Americans deserve the health care of the 21st 
century. We've earned it. That includes modern medical 
technology. Modern information technology. And modern, 
consumer-focused delivery systems.
    I see a world that is rapidly moving toward personalized 
medicine. People will own their own health savings, health 
insurance, and health records.
    I see a world in which a doctor can write a prescription on 
a handheld device and transmit it to the patient's pharmacist, 
who can start filling it before the patient leaves the doctor's 
parking lot--and with less chance of error or delay.
    I see a world where doctors heal our loved ones when they 
are sick, but focus more of their energies on keeping them well 
in the first place.
    I see a world where good health care makes America more 
productive, not less competitive.
    And I see a world where premier health research serves the 
betterment of mankind.

Conclusion

    Mr. Chairman, I have always had three goals in public 
service. I followed them as Governor of Utah. I've followed 
them as Administrator of EPA. And I will follow them as 
Secretary of Health and Human Services.
    The first goal is to leave things better than I found them.
    The second goal is to plant seeds for future generations.
    And the third goal is to give it all I have.
    I promise to work with this committee in a responsive and 
transparent manner so we can do just that.
    Thank you for your attention, Mr. Chairman. I look forward 
to answering your questions.
    The Chairman. Thank you very much. I appreciate the brevity 
of your statement and want to assure you that your full 
statement will be a part of the record. I would also say that 
our prayers are with your wife for a speedy recovery and for 
your children who are flying in for a safe arrival.
    Mr. Leavitt. It is just an isolated epidemic of the flu in 
the Leavitt family. I am hopeful I can demonstrate my prowess 
as head of health, in my home at least, and get her better.
    The Chairman. So I will not have to ask you any questions 
about vaccines because you will have a specific interest in 
that.
    I did mention some front-page issues that are up, and one 
of those is the FDA's drug approval process, and I am sure you 
will be reviewing the authority and the resources of FDA.
    How can we best work with you to ensure that the FDA has 
the proper authority and sufficient resources to perform the 
regulatory function that we have assigned to them in an 
effective and timely manner?
    Mr. Leavitt. Senator, I have become increasingly aware, as 
I know you and other members of the committee have, on the 
constant tension that exists between our desire to have 
innovation and speed to market and safety. Those are intuitive 
to all of us on both sides and create a natural tension. It 
will be finding the balance and working together to find ways 
to expedite innovation, but at the same time being able to 
protect it. I recognize that there are many, many issues still 
remaining. I look forward to working and working through with 
both those who manufacture and those who are responsible to 
assure their safety that we can do so.
    The Chairman. Well, I hope that America realizes that a 
successful clinical trial does not guarantee the safety of a 
drug through the life of the drug. Some rare but serious side 
effects do not show up until after the drug is in wide 
circulation. What role should the FDA play in identifying these 
problems once a drug is on the market?
    Mr. Leavitt. Senator, I believe we are moving into a 
remarkable and powerful new era in medicine and particularly in 
prescription drugs. I would refer to it as a personalized--an 
era of personalized medicine where we will have the capacity in 
the future to determine the effect of drugs not just on broad 
populations but on specific cohorts and specific phenotypes 
among populations of human beings.
    This will require a focused, disciplined review over time 
of the basic constructs and standards to which we hold 
ourselves. It is an exciting thing and part of a larger 
personal vision that I think this country can have of where we 
begin to focus our medicine not on institutions and not on 
broad populations but on people and on individuals and the way 
things can affect them directly. The treasures that have been 
unlocked in genetic research are very exciting and will change 
the way we look at matters at the FDA as well as in our broad 
policies that will need to be visited by this committee in a 
broad public debate.
    The Chairman. Thank you. I want to shift the focus just a 
little bit. I know that you have been the cyber Governor and 
have a huge interest in information technology. Last year 
President Bush announced an ambitious plan to assure that every 
American has electronic health records, and he called on 
Secretary Thompson to appoint the first ever National 
Coordinator of Health Information Technology. I applaud the 
President for this emphasis on increasing the use of 
information within our health care system, and Senator Kennedy 
and I are intensely interested in doing some things to expedite 
that.
    What are the next steps that Congress and HHS should take 
to make the vision of robust health care IT a reality?
    Mr. Leavitt. Senator, I share with you the day--a vision of 
the day when a physician will write a prescription on his 
personal hand-held electronic device, that it will be 
transmitted electronically to the patient's pharmacist who will 
be filling it before he leaves the parking lot of his doctor's 
office, and the health record will immediately be part of the 
permanent record that that person takes with them when they go 
to the next doctor's office for whatever purpose. I see that as 
having enormous--just as a symbol of the enormous amount of 
potential that we have in technology to streamline and make 
efficient the whole system of medical delivery. When you 
consider that medical services now approximates 15 percent of 
the gross national product of this country, this is not just a 
function of better health care; it is also a matter of economic 
competitiveness.
    I believe that the area of interoperability of systems, of 
being able to sort through the very difficult, complex, and 
sometimes thorny issues related to personal privacy and related 
to assuring that those records are not used improperly will be 
among the most important work that this committee can do in 
order to facilitate that discussion and that promise.
    The Chairman. Thank you. I am going to shift focus once 
again to Medicaid because I know of your great work on that in 
Utah. A longstanding concern of mine has been that there are 
adults and children that are not enrolled, so they wind up in 
that 43 million Americans that are uninsured, but really they 
are just unenrolled. What do you think are the reasons for 
this? And do you believe there is anything we can do to rectify 
that situation?
    Mr. Leavitt. Senator, I do. I feel passionately there are 
things we can do to remedy that.
    When I became Governor, only 86 percent of our children had 
access to health insurance. Now virtually every child has 
access, but 94 percent have health insurance. The CHIP program, 
SCHIP program, has been a great success in our State and other 
States. Some things have been revealed there to me that give me 
great promise.
    For example, many worried that we would not be able to 
reach enrollment online among that population. In our State, 
over 50 percent of our enrollees or nearly 50 percent have 
enrolled online. We have also been able to reach into our rural 
populations with that program. We have used our schools as a 
method of being able to approach and find those who needed it. 
It is simply a matter of finding them and helping them, making 
it easy and helping them understand.
    The Chairman. Thank you.
    Senator Kennedy.
    Senator Kennedy. Thank you.
    Welcome, Governor I join you in your the great support for 
the SCHIP program. I acknowledge the excellent leadership of my 
friend and colleague, Senator Hatch, on that program.
    Just a quick note and I want to keep moving. There was a 
billion dollars that was returned last year that was not used 
in the SCHIP program. There is a need in that program. In the 
past when we had money that is returned, we have had a 
bipartisan effort, which we do have now in the Congress. The 
administration has been somewhat slow in giving us their 
judgment, whether they would support returning those funds to 
SCHIP as they have in the past, and I would hope maybe we could 
work with you on this. I do not know whether you have a view on 
this now. If it is not going to be encouraging, I would rather 
not hear it.
    [Laughter.]
    But if you are open on it, if we could work with you on it, 
there is a strong bipartisan effort to try and restore the 
funds to get other children covered.
    Mr. Leavitt. Senator, I am very optimistic about the sense 
of value that exists in SCHIP, and I know that there is an 
ongoing budget discussion that will be conducted between 
Congresses.
    Senator Kennedy. Just to pick up what the chairman said--
about IT. I am continually impressed with an article out of the 
New England Journal of Medicine. I had not planned to bring 
this up here, but since you mentioned, since our chairman did. 
This is the data from the Latter Day Saints Hospital, and it 
shows what has happened with improved IT: better outcomes such 
as drug doses of medicine per patient, stays in the ICU, cost 
per patient, mortality when this is replicated in system after 
system. We need it in terms of interoperability, better quality 
care, saving resources--although we may dispute how those 
resources ought to be allocated. But let us get about it. I 
would love to continue that conversation with the chairman, and 
we talked about that in the past, but I thank you for your 
strong interest in it.
    If I could get to Medicaid. We know what we are facing in 
terms of the 50 million Americans depending on Medicaid for 
their health care. It is the poorest of the poor. The number of 
Americans living in poverty has grown by 8 million in the last 
4 years. We have about 800,000 more children that are living in 
poverty. We see, in spite of increased need, that 38 States 
have cut the Medicaid eligibility, 34 States have cut the 
Medicaid benefits. Many States have not recovered from the 
recession's impact on their revenues, and we hear that the 
administration is planning to cut Federal support of Medicaid. 
My own view of this is that it would be a move in the wrong 
direction. You are a former governor. Do you think it is time 
that we ought to be cutting Medicaid?
    Mr. Leavitt. Senator, I have been one of those States who 
have been in a situation of very difficult budget 
circumstances, and it has always been my belief that we can 
expand the number of people that we serve with available 
resources. I have seen that happen many, many times, and I 
believe our focus should be to take what is available and 
expand the number of people who are provided with care.
    Senator Kennedy. I agree. No one differs as long as the 
people that need the help will receive the help, and it will be 
quality help, if that is what you are saying, and doing it more 
efficiently and effectively. But if you come to the point where 
you are going to have a reduction in services, if you cannot 
stretch it out, I would imagine you would be concerned about 
that.
    Mr. Leavitt. Senator, my purpose, if I am confirmed as 
Secretary, will be take the resources that are available to us 
and make certain that we are serving with basic quality health 
care the broadest population possible. It is clear to me we can 
serve a broader population if we allow the States greater 
flexibility to use those resources to make sure that they are 
devoting the resources, that they are putting up real dollars, 
making real commitments, and that we are too, and doing it in 
the most efficient way possible.
    Senator Kennedy. I want to move on. There are increased 
sorts of demands in terms of numbers of needy people on 
Medicaid. I am all for getting a better bang for our dollar, 
but I think there is real concern about whether we are going to 
be squeezing and denying health benefits, which would be 
unfortunate.
    Let me move to Head Start. It has been an extraordinary 
success. We are going to be reauthorizing it. We are always 
interested in how it can be strengthened. We are always 
interested in how it can be tied on into the No Child Left 
Behind Program more effectively. We have 38 States now that 
have even gone into pre-Head Start programs. But Head Start 
works, and there are many of us who think that since it does 
work why we should be trying to limit it. We have enough 
challenges out there for different kinds of undertakings that 
are not working. I am just interested in your view on that 
program, on the Head Start, and any comments that you wanted to 
make on the block grant, maintaining services or anything else 
expanse that you want to address.
    Mr. Leavitt. I share with you the belief that Head Start 
works. I share with you that it serves a very important 
preschool population and others. I share with you the view that 
we can improve its effectiveness by better coordination with 
other existing State programs.
    Senator Kennedy. My time is up, Mr. Chairman.
    The Chairman. Would you like to ask another question?
    Senator Kennedy. I will wait till I get a second round. 
Thank you.
    The Chairman. Senator Frist.
    Senator Frist. Thank you, Mr. Chairman.
    Health care disparities, I continue to be troubled by the 
obvious disparities in our health care system, the gaps that 
this committee will hopefully continue to focus on aggressively 
over the next Congress.
    Just last week the Office of Minority Health of the CDC 
reported that nonHispanic blacks bear a disproportionate burden 
of disease, whether it is injury, death, morbidity, or 
disability. In the CDC's report, just as an example, 
nonHispanic blacks who died from HIV disease had approximately 
11 times as many age-adjusted years of potential life lost 
before age 75 years--that is on a per hundred thousand 
population basis--than did nonHispanic whites. Non-Hispanic 
blacks also had substantially more years of potential life lost 
than nonHispanic whites for homicide, nine times as many I 
believe. Stroke was three times as many. Perinatal diseases, 
it's either three to four times as many, somewhere in that 
range. The report documents disparities one after another. The 
documentation phase is not over because it is very important to 
do, but now is the time for action and for solutions. I 
appreciate the administration's commitment to reducing these 
disparities, the social disparities, the socioeconomic 
disparities, the racial disparities, the geographic disparities 
that plague our health care system and result in these very 
disappointing gaps.
    I have cosponsored legislation, bipartisan legislation 
entitled ``Closing the Health Care Gap Act.'' I think we need 
to continue to work together to eliminate these disparities. My 
question focuses on that. As Secretary, what actions can you 
take to build upon the administration's record during the past 
4 years and work toward a day when such disparities will truly 
be eliminated?
    Mr. Leavitt. Senator, I share your concern and your feeling 
of inequity when I see that health outcomes are different, both 
in a defined way, and predictably among certain groups of 
people, particularly ethnic differences. I would mention two or 
three things. The first is best practices. The use of 
technology to assure that best practices can be deployed across 
the board at every hospital when they are known, and that is a 
function of technology and providing a means by which best 
practices can in fact be delivered. Second would be the 
disparities that exist in health coverage. I mentioned earlier 
my belief that we can serve more of those who are currently 
uninsured with the resources that we are currently devoting. I 
passionately believe that.
    I will use again SCHIP as an example. One of the brilliant 
things that I believe that Congress did in writing SCHIP was to 
give the States the capacity, if they chose, to develop their 
own plan, both benefits and administration, as opposed to 
requiring them to fall under Medicaid. In my State--we were one 
of 13 who did so--and we were able to provide basic health 
care, the same health care essentially that my children 
received while I was governor, for nearly 30 percent more 
people than if we had had them on Medicaid. That to me 
demonstrates that we can deliver basic health care to more 
people using the same resources. Many of them fall into the 
categories that you have spoken of, either because of their 
geographic location or their ethnicity.
    Senator Frist. Thank you, Governor. I think what you 
pointed out in terms of the flexibility required, that not all 
populations are the same. We used to think of health care 
disparities as just being straight out racial inequities, 
disparities, which is a huge and important component, but part 
of it is socioeconomic. I think of the Appalachian Mountains in 
Eastern Tennessee, and every State is a little bit different. I 
just want to encourage both this committee, in working with 
you, with your leadership, to make real progress on these 
issues.
    I have been in the Senate now 10 years and very early on we 
had to define those disparities. Now I feel like we have them 
defined, and now is the time, through an approach such as you 
mentioned, first of all recognizing the emphasis, providing the 
appropriate resources, and as you said, having the flexibility 
of being able to go to different areas, targeting different 
populations, and adjusting accordingly. Thank you, Governor.
    Mr. Chairman, thank you.
    The Chairman. Senator Alexander.
    Senator Alexander. Thank you, Mr. Chairman. I am glad to be 
here to say how proud I am of Governor Leavitt's nomination. I 
have made a habit for the last 30 years of watching governors 
in other States, and there have been a handful of what I would 
call transformational governors, those who have understood 
their State's uniqueness and celebrated that and found ways to 
actually change and improve it to transform it. Governor Dupont 
was one of those, Governor Engler, Governor Thompson was one of 
those, and Governor Leavitt was one of those. I think for him 
to come to this Department at this time, especially when the 
Medicaid challenge is going to require finding ways to take the 
available resources and give States as much flexibility as 
possible, and meet the needs, entrusting them to do that is 
very important. Understand that at governors' meetings, people 
do not sit around and talk about, ``I can do it worse than you 
can do it.'' They sit around and talk about it and say, ``I can 
do it better than you can do it.'' That is what the competition 
does.
    So, I am delighted you are here. I want to thank you for 
your work with the Environmental Protection Agency and for your 
efforts to pay attention to the air pollution we have in the 
Great Smoky Mountains of East Tennessee. You have taken some 
steps which I hope will take us even further.
    I want to ask these questions. You have talked some about 
the States, and I have confidence that you will pay attention 
to the States. Senator Frist and I are very aware of what is 
happening in Tennessee. When I left the governor's office in 
1987, 51 cents out of every State tax dollar was being spent on 
education, 14 cents on health care. Today it is 40 cents on 
education, instead of 51, and 26 cents on health care, going 
up. We are not going to have any first class universities or 
excellent schools in our State if the State cannot afford to 
fund them. So the governors need that flexibility.
    I want to move on to another area that you have had some 
background in in your work as Chairman of the National 
Governors Association, and that is to look at early childhood 
education, early education. In another hearing with Dr. 
Condoleezza Rice this morning, it was pointed out that her 
parents, in the segregated town of Birmingham, made sure she 
had music lessons from the day she was 3-years-old, and they 
recognized her talent. There are 69 Federal programs already 
existing which spent 18 to 21 billion dollars other than 
Medicaid on behalf of early education for children, and several 
of those are in your Department. Those are programs that, not 
just Head Start, which we often talk about, but the Child Care 
and Development Block Grant is another one of those programs. 
The programs that you have in your Department, although there 
are only six, are 15 of the 18 to 21 billion dollars that have 
to do with early childhood education.
    So what I would like to do, working with the chairman, is 
to use our oversight responsibility in this committee, and take 
a look at the Federal dollars that we are already spending on 
early childhood education, and find out where we are spending 
it well, where there may be gaps, and then report to the full 
committee and to the Congress about what else we need to do.
    What are your thoughts on what you might do in your new 
position when you are confirmed to help Senator Enzi, Senator 
Kennedy, me and other members of this committee, to take a look 
at the dollars we are already spending on early childhood 
education and suggesting to us where needs exist and how we 
might be able to improve that through legislation?
    Mr. Leavitt. Senator, I have strong feelings, as I know you 
do, about the importance of dealing with this problem and 
dealing with it soon, because there are generations of children 
who are not being as well served as they could by a 
proliferation of programs. We do make a substantial investment 
in this country. As you suggest, maybe it should be greater, 
maybe it is adequate, but it is not as well coordinated as it 
should be. The number of programs--I will use in my own State--
that do not coordinate, many of them serving the very same 
children. I would simply say providing the flexibility so that 
there could be on a State-by-State basis a commitment for 
better coordination and delivery of services in a fashion that 
looks at the whole child and not simply programmed needs.
    Senator Alexander. Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Senator Burr.

                   Opening Statement of Senator Burr

    Thank you Mr. Chairman, it is a pleasure to be here today 
for this committee's second nomination hearing of the year.
    Mr. Leavitt, thank you for being here. I am aware of your 
impressive work as the Governor of Utah and, more recently, as 
the Administrator of the Environmental Protection Agency. Under 
both jobs you demonstrated an excellent ability to manage and 
improve the lives affected by your position. We will be 
fortunate to have you as our Secretary of the Department of 
Health and Human Services.
    As you are aware from your tenure as the Governor of Utah, 
the issues you will be responsible for at the Department of 
Health and Human Services are broad and complex. Our Nation's 
health care system is at a critical point and decisions by HHS 
will determine our path and the wellness of Americans in the 
coming century.
    I sincerely believe that without cures for several chronic 
diseases, including diabetes, and a serious focus on 
preventative health care, we will not be able to stop our 
health care delivery system from hitting a brick wall. As a 
government, we must not pass laws or create an environment that 
hinders medical device and pharmaceutical research on new 
technology and medication, which can greatly impact quality of 
life. It is only through that important work that the world 
will be able to cure diseases that we currently can only treat 
as chronic conditions.
    As a government, we must also help every American access 
affordable health insurance. But it needs to be smarter health 
insurance than what is currently available to most Americans. 
Smarter health insurance would allow individuals to be true 
participants in accessing and managing their health care needs. 
Individuals would be more knowledgeable and they would see the 
long-term benefit of preventative care; not only with their 
family budget in mind, but from a quality of life perspective.
    Depending on individuals' situations, sometimes community 
health care centers are the best health care access point. I am 
very proud of North Carolina's community health care centers 
and as a Member of Congress I worked hard for the last 10 years 
to provide community health centers with necessary resources 
and assistance. Not only should the President continue his push 
for more community health centers, but he should also encourage 
existing centers to follow Greene County, NC's lead and 
implement electronic medical records and telemedicine 
capabilities throughout community health center networks.
    These are very broad, but important goals. While we strive 
to reach these goals, we must also deal with the day-to-day 
threats faced by this country. Outgoing Secretary Tommy 
Thompson did an excellent job jumpstarting bioterrorism 
preparedness at HHS. I will look for you to continue his 
dedicated work in that area. The only way we can continue to 
work on our long-term goals for this country's health care 
system is if our Nation stays safe and secure from bioterrorism 
threats.
    Mr. Leavitt, I look forward to asking you some questions 
and working with you in the future.
    Senator Burr. Thank you, Mr. Chairman.
    Governor, welcome.
    Mr. Leavitt. Thank you.
    Senator Burr. And indeed a thanks to you for your 
commitment to public service, for the incredible leadership you 
showed at EPA, and most importantly for the creativity to 
problem solving, not only that you showed as governor, but in 
the administration. It is, I am sure, not easy to say no when 
the President calls, and I think that your commitment to do 
this shows how wise the decision was by the President in 
seeking you to come to HHS.
    My first opportunity to meet you was in 1995 when you 
testified in front of the Energy and Commerce Committee. At 
that committee hearing you talked about States needing more 
control over Medicaid. Let me ask you, today do you still 
believe that that is the case?
    Mr. Leavitt. Senator, I have deep, and I believe well-
informed views that it is even more true today. We continue to 
see Medicaid escalate as a function of American investment. It 
is broadly now known, but I will say it for emphasis, that this 
year our expenditures on Medicaid will exceed our public 
expenditures in States on education. When I became governor 12 
years ago, that was not even close. But our expenditures 
continue to rise, and our capacity to meet other demands 
continues to diminish.
    I believe we have substantial obligation to care for the 
poor, but I believe that we can expand the number of people who 
are served with quality basic care by allowing additional 
flexibility and assuring that we have a partnership where both 
partners are putting up real, making real commitments and using 
real dollars to fund them. This is an important part of what I 
believe will become the larger medical debate in this country 
over the next couple of years. We could and should use Medicaid 
as part of a transformation movement in the delivery of health 
care generally.
    Senator Burr. I certainly agree with you, and I think 
members would not serve on this committee if there was not a 
passion for health care, and I am sure you would not be at HHS 
if there was not also a passion on your part.
    A personal concern is that we are moving from what has been 
up till this point a debate about affordability, and that the 
lack of solutions on our part means that we will very quickly 
be faced with an accessibility problem from the provider 
standpoint. We will feel it first in the rural markets and then 
it will spread to the urban markets.
    Let me shift if I could over to SCHIP and follow up on 
Senator Kennedy's inquiry. When we wrote SCHIP it was the 
intentions of that legislation that States that did not use 
their allocation, that that money would then be freed up for 
the States that had fully implemented the money that they had 
available. North Carolina would have been the beneficiary of 
additional funds because we did an excellent job at SCHIP 
enrollment. I am not asking you to be a prophet as it relates 
to the budget or to the disposition of this money. But are we 
at a situation where States who do excel should have an 
incentive to grow the population even bigger?
    Mr. Leavitt. As you suggest, Senator, there is an ongoing 
budget discussion about what the disposition of those dollars 
should be, and I am going to leave that between the Congress 
and the White House. I will tell you this: that whatever amount 
of money is allocated to SCHIP, I can assure you it is having a 
profound and important impact, and to whatever extent HHS has 
an opportunity to administer money, we will assure that it is 
done in a way that will reach out, find those populations of 
children and provide them with basic health care.
    Senator Burr. Thank you. Last question. Senator Alexander 
talked about the academic institutions and their need to stay 
vibrant. One of the areas that is beneficial across this 
country today is the extramural research dollars that come out 
of NIH. Tell me if you can, do you see a growth in the 
extramural side versus the intermural side at NIH, and which is 
more beneficial to the long-term breakthroughs in this country?
    Mr. Leavitt. Senator, I do not know the answer to that. We 
were dealing with that same question at the Environmental 
Protection Agency, who has an extended research and laboratory 
capacity, and the issue was should we do it inside or do it 
outside, and it was clear to me that there needed to be a 
healthy dose of both. The balance of it at NIH is not something 
I am in a position to make a knowledgeable suggestion on, but I 
am very well acquainted with the pressures, the debates and the 
tension, and I feel some confidence, if confirmed, that I will 
be able to work through that with you.
    Senator Burr. Thank you, Governor.
    Thank you, Mr. Chairman.
    The Chairman. Senator Isakson.
    Senator Isakson. Governor, welcome.
    Mr. Leavitt. Thank you.
    Senator Isakson. I have to tell you, last night when I got 
on the airplane about 8:15 to fly to Washington, much to my 
surprise, I sat next to the former director of the Department 
of Medical Assistance in Georgia, an old friend of mine, Russ 
Towles, who in the course of the conversation I told him where 
I would be at 10 o'clock. He said, ``Well, you tell Governor 
Leavitt that he is the best choice the President of the United 
States could have possibly made.'' He is a big fan.
    Mr. Leavitt. Thank you.
    Senator Isakson. Because he said that, and it gave me a 
great opening, I decided I would ask him, ``Well, if you could 
ask the Governor any question, what would you ask him?'' And he 
was very complimentary of what we did in the Prescription Drug 
Medicare Modernization Bill, but he asked the question, in 
Medicaid there is a rebate program on pharmaceuticals based on 
volume. As you implement through this year the prescription 
drug plan for Medicare beneficiaries, can we do the same thing?
    Mr. Leavitt. Senator, that is a well-informed question, and 
one that I am not sure, given the limited exposure that I have 
had at HHS on the nature of it on this side of the equation, 
that I am in a position to really knowledgeably respond to. I 
will tell you that, again, as a question we referred to 
earlier, these are tensions I am very well acquainted with, 
having dealt with them as governor, and my experience has been 
there is a balance that has to be found. We have to provide 
means by which we can create both the incentives necessary and 
the economic structure for continued innovation. At the same 
time people deserve to have safe pharmaceuticals, to have them 
delivered in an innovative way, and to do it. I would seek 
balance. I do not think I can give you an answer beyond that. I 
am just not well acquainted enough yet with the issue.
    Senator Isakson. Well, as you work on it, I will be happy 
to work with you. I supported the program. I think it is a 
brilliant move in terms of the future of health care 
pharmaceutical coverage for seniors. In the long run they 
actually save us money over the higher cost of hospitalization 
and more intensive care.
    Second, as Governor of Utah your use of technology was 
nothing short of tremendous, in distance in your education 
department, which I am familiar with, and other areas. I want 
to go back to what Senator Kennedy said and Chairman Enzi, 
talking about health information and using technology. It seems 
to me that as we have spiraling costs of health care, one of 
the embedded costs that is growing is the paperwork cost and 
the redundancy of doing the same thing over and over again 
almost to the level of insanity.
    I mean I recently made two trips to the doctor, and it is 
after January, so I filled out health information forms ad 
infinitum, which could have been available on a health ID card 
that could be just as secure as my ATM card. And I know you 
indicated earlier, and I want to applaud you for it, we need to 
work as far as we can. That is one component of the cost of 
health care, that it seems to me we could foster quickly to 
help bring down some of the costs and actually improve the 
qualify of both information and care for those who receive it.
    Mr. Leavitt. Senator, I have heard estimates that range as 
high as 20 percent, that there could be 20 percent additional 
efficiency, and I believe them. It is everywhere I look in the 
health care delivery system. I do not think there is a person 
on the planet who has not dealt with a health care issue.
    Last night I was looking through a medical bill of mine on 
a medical device that I bought in July, and I have, first of 
all, found that the health insurance company was charged $900 
for this device. I could have bought it online, the same device 
and the same person for $400. We have been going back and 
forth.
    There is a more efficient way to do this, and it all comes 
down to technology and coming up with interoperable systems. 
This is a problem that the entire economy is going through. We 
have come through a period of industrialization. We have gone 
through the information age. We are now moving into the age of 
interoperability. We have learned to make machines work 
together. Now it is can we get the people to work together? Can 
we find systems from Government agencies and private providers 
and hospitals and physicians, and cause them to work together 
in a way that will create that efficiency?
    This is a complex, demanding problem, and I believe there 
is an entirely new set of skills that we are having to learn as 
a society, but the efficiencies are there to gather. I believe 
we can and must pursue it because it is not just a function of 
good health care. It is a matter of economic competitiveness as 
a nation when 15 percent of our entire gross national product 
is being consumed in health care services. Unless we are able 
to do it efficiently, it could become a drag on our 
productivity as opposed to the boost that it can be.
    Senator Isakson. Thank you very much.
    My time is up, Mr. Chairman.
    The Chairman. Thank you.
    Senator Hatch.
    Senator Hatch. Thank you, Mr. Chairman.
    Governor Leavitt, as you are well aware, Utah is a State 
where we have tremendous capacities in health care, medical 
device companies, pharmaceutical companies, and many, many 
dietary supplement companies as well.
    There are some in this town who believe that supplements 
are unregulated, which I hope you know is absolutely not true. 
We gave more power under the Dietary Supplement Health in 
Education Act than previously existed to the FDA. Now, many 
also believe that you will go easy on supplements because of 
our home State connection, which I also believe is not true; I 
believe that you will implement the law as it should be 
implemented. That is my understanding.
    Mr. Leavitt. Senator, your assumptions are correct.
    Senator Hatch. The law in this area is tremendously 
complicated, and I will not put you on the spot today by trying 
to pin you down on anything. I just want to note that the past 
two commissioners and the acting commissioner, I believe, agree 
with me and Senator Harkin, that the law is adequate to take 
care of those supplements that may pose a concern, be it a 
safety concern or one related to labeling or content.
    Now, when you come on board, it would be well if you could 
speed up the Good Manufacturing Practice Guidelines that we 
approved well over 10 years ago, or I should say were 
authorized by law over 10 years ago, and which have been held 
up for several years. I think it is critical to that industry 
that this organization that you are going to head take care of 
that. I believe they are almost ready to be published now.
    But on a more general note, I wanted to put these concerns 
on record, and I will be asking for your viewpoint in coming 
months as you assume the reigns of HHS, but if you want to make 
any comments now, we would love to hear them.
    Mr. Leavitt. Senator, I think your statements approximate 
my own views. It is clear to me that we have an obligation to 
assure safety, but at the same time to provide innovation and 
choice. And while my approach will be rigor, I also recognize 
the value that is there and the fact that much thought has been 
given to it, and I will look forward to working with you.
    Senator Hatch. Thank you. Well over 10 years ago, I think 
Senator Kennedy and I passed the FDA Revitalization Act, which 
was to create a central campus for FDA with State of the art 
equipment and a place where we could attract some of the top 
scientists in the world to come and help us with this very, 
very important organization that handles upwards of 25 percent 
of consumer products in America. December of 2003 we dedicated 
the first building. We now have FDA and some 30 plus buildings 
all over this area. Some of them are converted chicken coops, 
and without the best equipment in the world and so forth, I am 
asking you to really push the revitalization act. I think had 
we immediately started when we passed the bill, it probably 
would have cost us a billion dollars. I think it is now 
estimated to cost us about $3 billion. But the importance of 
that is to be able to reduce the safety and efficacy time at 
FDA so that drug prices will come down, while giving the people 
at FDA the very best tools and facilities to administer the 
programs.
    So I am hopeful that you will be one of the most dynamic 
pushers of this, and I do compliment Tommy Thompson for the 
work he has done not only here but in other areas as well. But 
I would appreciate your help on that.
    Mr. Leavitt. Thank you, Senator. I will look forward to 
working with you and others on it.
    Senator Hatch. Thank you. As one of the original authors of 
the Ryan White CARE Act, I am interested in what direction the 
Agency will be taking on domestic and international AIDS 
policy. So this is also an area that I know you are going to 
get into and I know that you can play a dramatic and I think 
constructive role in this particular area. Our country is the 
leading country in the world in trying to resolve these 
dilemmas, and hopefully we can live up to what the President 
said we would do for the rest of the world.
    There are so many other questions I have, but I will wait 
until the second round before I ask them. Thank you so much.
    Mr. Leavitt. Thank you, Senator. I will just comment that I 
am aware of the President's commitment to invest up to $15 
billion, and I know both his commitment to do it and his intent 
to see it carried out.
    The Chairman. Senator Gregg.
    Senator Gregg. Thank you, Mr. Chairman.
    Governor, I greatly appreciate your public service. It has 
been extraordinary for many, many years. I do have a number of 
specific questions I would like to ask you. I will start with 
the FDA Commissioner. FDA is regrettably an agency that has had 
some serious issues recently. It has always been a premier 
agency in this Nation, something that the American people can 
take great pride in. When they walk into a grocery store or a 
drug store, the products that they get are protected and the 
FDA has played the major role in doing that.
    Since it is an agency in crisis, can we expect to get an 
FDA Commissioner nominee up here before the end of this month?
    Mr. Leavitt. Senator, I share with you the view that the 
Agency needs permanent leadership, and if confirmed, I give you 
my commitment I will press hard to see that that slot is filled 
on a permanent basis rapidly.
    Senator Gregg. Does that mean before the end of the month?
    Mr. Leavitt. As you know, that is a decision the President 
of the United States makes, and what you have is a commitment 
from me that I will do all I can to see that it occurs, and it 
is my sense that it will happen soon.
    Senator Gregg. Obviously, we are facing a difficult budget 
situation. The Medicare Modernization Act has been passed. When 
it was proposed it was stated that the drug component of that 
would be a $400 billion item over 10 years. The majority--not 
the majority, but the plurality, the most significant element 
of that spending actually goes to subsidize corporations, the 
purpose of which is to keep them from shifting their drug 
burden over to the public sector. It is now estimated as a 
result of anticipated usage of that section of the bill by the 
administration actuary, that the drug program will cost 
approximately $555 billion. That is an increase of almost 40 
percent, and I suspect it is an underestimate, even though the 
program is not even in place yet.
    I am wondering if the administration will be sending up to 
us directions as to how to bring that program in line with the 
original $400 billion estimate, or is it the administration's 
position that $532 billion, which is what the administration 
actuary actually estimated this to be, is a reasonable number 
now, and $400 billion is no longer the cost of the program over 
10 years?
    Mr. Leavitt. Senator, I suspect if I am confirmed I will 
have an opportunity to answer that question in a more informed 
way than I can today, given the fact that I was not part of 
that discussion, nor have I been part of their discussions on 
forward-leaning budgets. I do not know the answer to it.
    But I am aware of the responsibility to implement the 
program. As I indicated earlier, it will be the main event at 
HHS during the year 2005. The expectations are very high. The 
timeframes are very short.
    Senator Gregg. Let me just cut in. My time is limited. Do 
you expect to implement this program within the price that was 
estimated for the Congress, which was $400 billion, or do you 
expect this program to exceed that number, as estimated by your 
actuaries?
    Mr. Leavitt. Senator, I am just not in a position at this 
moment to know because I have not had briefings on the estimate 
that was made originally. I am aware of the controversy. I am 
aware of the fact that the cost estimates have changed, but I 
am simply not in a position at this moment to know because I 
have not been at HHS. When I do, I will be very happy to be 
responsive to your question.
    Senator Gregg. Well, let me ask you another way. Would it 
be your intention to implement it under the terms as it was 
passed, or would it be your expectation to exceed the original 
number of $400 billion?
    Mr. Leavitt. It has been my practice as a manager to 
operate within my budget.
    Senator Gregg. That would be great. That is exactly what we 
need in that area.
    There is another element of that bill which is sort of 
interesting, which is that it did not allow the Federal 
Government to negotiate prices with drug companies, something 
that the Veterans Administration is allowed to do, something 
that the State of New Hampshire is doing. I do not know if Utah 
has that program. Do you believe that the Federal Government 
should be able to negotiate drug prices to benefit seniors 
under this Medicare program?
    Mr. Leavitt. I believe that the best way in which to keep 
drug prices competitive is to have a rigorous and active 
market, and that the best negotiation would be between those 
who are providing coverage and those--rather, those who are 
providing the care, and those who are manufacturing it. I am 
aware that there are cases in which the National Government, in 
the case of the Veterans Administration and other situations, 
or in some cases State Governments, are the providers of the 
care, and in that case it is an appropriate thing for them to 
be negotiating. I do not believe it is a good role for the 
National Government to be providing as the setter of prices, 
and there are ways in which I believe if we become the so-
called negotiator of prices, we are actually setting prices, 
and I think a market does a better job of doing that.
    Senator Gregg. Thank you.
    The Chairman. For our second round of questions, I know 
that you have a rural State and that you recognize that Wyoming 
probably has the smallest population in the United States, and 
I am concerned about the HHS grants. Our population is so small 
that the dollars wind up correspondingly small, and by the time 
we take care of the regulation and the administration necessary 
for the regulation, we do not have much left to provide any of 
the assistance, and I would like to see much greater 
administrative flexibility for rural grant recipients, and I am 
hoping that you will work with me on that as we get into 
legislation and as you can do it administratively.
    Mr. Leavitt. Senator, you will find me to be sympathetic 
with that view.
    The Chairman. Thank you. I also have some concerns, as I am 
sure everybody does, over what the medical liability crisis can 
add to medical costs and the ability to have access and quality 
programs. I have drafted a bill that provides for some other 
mechanism, such as an early offers, demonstration program, and 
some special courts demonstration program, and I hope you will 
take a look at that. And as I mentioned before, I hope you will 
hold some informal sessions with members of the committee that 
are willing to take the time to sit down and discuss some of 
these things so that we can come up with the best plan 
possible.
    Mr. Leavitt. This is a subject on which I both have 
experience and passion, and I know that the President has set 
this as one of his most important priorities, and I will look 
forward to being a participant in that conversation.
    The Chairman. Thank you.
    Senator Kennedy.
    Senator Kennedy. Thank you, Mr. Chairman.
    Governor, I listened carefully to these questions of 
Senator Isakson and Senator Gregg about negotiating these costs 
in price, and this is a hornets nest. We have a very divided 
Senate on this. We have seen, as you pointed out, in the 
Veterans Administration where we have seen dramatic reductions 
in terms of the costs as compared to others. Many of us believe 
that Medicare ought to be able, or you ought to be able to at 
least be involved in those kinds of negotiations for the 
benefit of the seniors to lower prices. That is for a different 
time, to debate that. Negotiating rebates is an authority that 
the Secretary does not have at this time that many of us 
believe you should have in order to lower costs.
    I appreciate the mentioning of the AIDS relief at $15 
billion. I appreciate you mentioning that. I hope you will look 
again at what percent of that $15 billion is being used to pay 
for generic drugs and what percent is being used for the high 
cost drugs. You will find out that because of the influence of 
the drug companies, that the greatest percentage is the higher 
cost drugs. Many of us believe that they could have greater 
kinds of impact in terms of peoples lives with generic drugs. 
That is a policy issue I know you will want to visit with. I do 
not want to get into that at this time.
    I want to underline the importance of a new Director for 
FDA. The last 4 years we have had one Director, Mark McClellan, 
who was superb. But it has been vacant. We have had an Acting 
Director. That is not right for that Agency. I mean my State, 
like other States, has a very active and involved 
pharmaceutical industry and a biotech-industry, and they as you 
would well understand, want to be able to get decisions that 
are going to be lasting and effective so that they can plan, 
and they just cannot get that. And I join with Senator Gregg in 
urging that we get that position filled. There are a number of 
enormously gifted and talented people outside the industry that 
can do the job and have our confidence, and I hope that that 
can be done.
    I listened to my friend, Senator Hatch, talk about the diet 
supplements, and I know his strong view about it, except we 
have had the experience of ephedra that was taken off the 
market but it took a long time to get that off, and it was a 
real health danger, so having the top person over there at FDA 
to be able to do the job is important. The bill is quite 
specific, as Senator Hatch pointed out, but there are issues 
that are involved in it.
    I want to just cover two issues very quickly. One is 
affecting my State and that is LIHEAP. We have 671,000 families 
in Massachusetts eligible for LIHEAP, and only 146,000 families 
receive LIHEAP funding, so this is about 1 in 5 families that 
are receiving it now. Massachusetts used up the entire $7 
million released in December. We only had enough to cover about 
20 percent of the estimated families without emergency funds, 
and there is no help now for anyone. There is wind chill of 2 
below in Massachusetts, been there, well, for the last 4 days. 
There is $200 million in LIHEAP emergency funding at HHS, and I 
would hope that--we are going to do all we can to get you into 
that office, and I would hope at least you would look at this, 
not just for Massachusetts but for other hard-pressed areas. We 
have a number of States.
    Mr. Leavitt. Thank you, Senator. That is both noted, and I 
will follow on it, and give you what response----
    Senator Kennedy. If you can, as an early priority because 
it is a real priority here.
    Just finally, we had talked about what you had done on the 
welfare in Utah. Utah's program is flexible in dealing with a 
number of barriers. Treatment services count as TANF 
participation. Mental health and substance abuse. Counselors 
are available in TANF offices for short term counseling, or for 
long-term treatment concurrent with employment. Some have 
disabilities, others are caring for sick children. You have had 
really important flexibility in responding to enormous human 
needs. I am wondering whether this would be your position, to 
support those kinds of efforts in our deliberation of this bill 
when it comes before the Senate? I know the administration is 
going to speak to this, but I would be interested in your own 
experience about the effectiveness of the programs and what you 
might hope would be in legislation that we would consider along 
these lines.
    Mr. Leavitt. Senator, I will just say that I have had 
occasion as Governor to sit at the table with a person being 
counseled and to work through the entire process with them. I 
know that it is a process of essentially helping a person put 
their life back together. In most cases it has been a hardship 
and they have some short-term problems they have to deal with, 
and often it is a matter of doing something simple.
    I remember one case where we, rather than put them on to 
the whole program, we just needed to provide them with some 
steel-toed shoes and help them with some other kinds of things 
that otherwise would not have been--under the old program we 
would have had to put them on welfare for several months, but 
we were able to solve the problem. They went to work, and it 
was a good thing for them. So I found flexibility in dealing 
with the individual needs is a very important part, and I would 
hope we could preserve that and what I think is a great 
American success story.
    Senator Kennedy. May I have one last one? My time is up, 
and I thank the Chair. On the flexibility in the waiver, we 
have had now with the changing of the administration--
Massachusetts had a waiver for the last 8 years on Medicaid. We 
have saved Medicaid $1.8 billion. It was always used for health 
care issues--Medicaid. Governor Romney has been down seeing 
Thompson. That part has been worked out, and as a result of it, 
our Governor is going to have a lot less flexibility than he 
would have had previously.
    So I know this point that has been made here in terms of 
the flexibility, we have seen in our own State where we have 
had the waiver and it has been done under Republican and 
Democratic Governors, been done very, very effectively in terms 
of the purposes of Medicaid and the savings that have been 
provided. So you are going to have a different kind of 
framework to operate in, but I just wanted to add that.
    I thank the Chair very much for his indulgence.
    The Chairman. Thank you.
    Additional questions, Senator Isakson.
    Senator Isakson. Just one, and a comment. One of the 
largest contributors to the rising cost of health care for 
those who are covered in terms of the cost of their insurance 
and their co-payment is the rising cost of the uninsured. The 
CHIP program--and you did a great job in reaching out to get 
those children insured who were a large number of the uninsured 
in Utah. But do you have any suggestions as to what you would 
recommend or think we ought to focus on to try and increase the 
number of insured and decrease that burden on the number of 
those who are insured and paying at higher rates?
    Mr. Leavitt. Senator, I do have, and I want to describe 
something for you that I do not intend to imply as a solution 
on a national basis. But it troubled me greatly that we had 
400,000 people in our State who did not have any health care 
insurance at all. In my State, if you want to have the richest 
health benefit program, you will go to Medicare. It is about 
143 percent in terms of benefits of what a person would earn if 
they went to work at a car dealership or a mill. If you want 
the second richest, you go to Medicaid. It is about 139 
percent. Or at least those were the percentages when I was 
dealing with this.
    We went through a period of time, a very difficult period, 
like most States, where we were simply pressed to balance our 
budget, and we actually had to reduce benefits for vision and 
dental on a small population of our Medicaid recipients. I 
noticed today in the paper that the new Governor has money now, 
and he is going to go put those back, and I am glad for that.
    But at the same time, we concluded what if we were to have 
that program on Medicaid not be 139 percent richer but what if 
it were only 125 percent richer and we were to take those 
dollars and provide a benefit to people who are without 
coverage at all. I got a waiver from HHS. We now have 18,000 
families who are working at one or two or three jobs, who had 
no health insurance, who now have it. We took the same dollars. 
We provided them with health care, frankly, that was not the 
kind of health care we would aspire to have them receive. But 
they have health care. They have basic health care. We used our 
community health centers to provide it, created a policy that 
provided preventative care, basic health care. The community 
got together. It was a very solid success, and we are learning 
from that.
    So I do not represent it to be the wave of the future. I 
simply just hold it out to be what it was: an effort on our 
part to take limited resources and to provide basic health care 
to all of those who don't have it.
    Senator Isakson. Well, it is a good example of why you are 
the appointment of the President, too. It is thinking outside 
the box, and I appreciate that.
    I just have a comment, Mr. Chairman, and that is, you 
cannot come from Georgia and talk to the future Secretary of 
Health and Human Services without thanking him for 
acknowledging CDC's brand and making the statement that the 
Congress and the President during the last 4 years have done a 
remarkable job in funding the new construction, the laboratory 
work, and the hardening of what is really the world's public 
health asset. And I appreciate very much your acknowledging 
that, and I look forward to working with you to continue to 
grow CDC and its capability and its reach around this country 
and around the world.
    Thank you very much.
    Mr. Leavitt. Thank you.
    The Chairman. Senator Dodd.
    Senator Dodd. Well, thank you, Mr. Chairman. And, Governor, 
welcome. I apologize for being late. Dr. Rice is appearing two 
or three floors up before the Foreign Relations Committee, so 
it is one of those mornings where we are sort of scurrying back 
and forth. I apologize that I was not here for your opening 
comments.And I gather a number of my colleagues here already 
have gone into some detail, Mr. Chairman, on Medicaid funding 
and other questions, so I will rely on that record.
    I should point out, Mr. Chairman, that my family, the side 
that I married into is a Utah family, and so I am very much 
aware of Mike Leavitt and his stewardship of that State. When I 
go out for family holidays, I am often called the third Senator 
from Utah. And those ten Democrats out there deserve a Senator.
    [Laughter.]
    My good friend Orrin Hatch likes to tease me about that.
    Senator Hatch. We are very proud to have you. However, we 
could suggest some changes.
    Senator Dodd. I think now you could. I have suggested 
several for you along the way.
    Senator Hatch. You have.
    Senator Dodd. Neither of us has had any success in that 
regard, I might point out. But I always enjoy going out to Utah 
and seeing my wife's family out there. So it is a pleasure to 
have you before the committee.
    Let me raise a couple of questions. One, I mentioned my 
good friend Senator Hatch because one of my proudest moments in 
this body over the last quarter of a century occurred almost 20 
years ago, when Senator Hatch and I, along with many others, 
initiated the concept of the Child Care Development Block 
Grant, which was a revolutionary idea in its time to try and 
assist working families particularly who were struggling, as 
you have just pointed out, many of them single parents, or 
intact families with both people working trying to make the 
economics work, with young children, and the importance of 
having a quality, safe, available child care structure that 
would allow them to be able to do what they had to do and know 
that the individuals they care most about, their children, 
would be under safe quality conditions.
    But we have had an awful problem over the last number of 
years in the freezing of funds, and as a result we now have 
some 600,000 children who are on waiting lists all across this 
country waiting to get into a decent child care setting. Too 
often the parents are relying on the worst of circumstances for 
these kids, and we need to do something about it, clearly, as 
we move forward on welfare reform. And you will be asked to 
play a major role in that.
    And so what I would like to ask you this morning--I do not 
expect you to lay out anything in detail at this point, but we 
need to sit down, if you could, with those of us up here who 
have worked on this issue over the years--and, again, I want to 
thank my colleague from Utah. He was just invaluable to 
understanding this issue early on, the importance and the role 
that we could play at the national level of being supportive of 
our States and our families in this regard. But we need to sit 
down--if we are going to move forward on a welfare reform bill, 
we cannot have the working poor being pitted against those on 
the welfare rolls when it comes to getting this kind of 
support. If we end up reducing the child care assistance for 
the working poor only for those who would be on the welfare 
rolls, then we are going to find the working poor tumbling back 
into the rolls of the very people we have been trying to move 
out of that system into working relationships.
    So I would hope that we could sit down soon, if we could, 
with you and see if we cannot get some movement on unfreezing 
these funds, in my view, and providing some additional 
assistance as we move forward. And I wonder if you might share 
some overall comments on that point.
    Mr. Leavitt. I would be happy to, Senator. I had the 
privilege, as you have indicated, of serving as Governor during 
a period when welfare reform was enacted. When I began as 
Governor, we had just under 20,000 families that would be 
considered on welfare. When I left, there were about 7,000. 
During the more difficult times, we saw that edge up, as we 
should, because more people needed help.
    But it was clear as we went through that process of helping 
people realign their lives that it was unrealistic to send a 
mother, a single mother with two or three children, off to work 
without the capacity for her to have high-quality care for her 
children. It was not in our interest or hers or the children's.
    The good news here is that we have accomplished much. We 
have been able to reduce the number of cases that we are 
dealing with in the country. There are fewer people who are in 
that circumstance than were before, and I feel optimistic that 
we can find a solution to this because I think the principle is 
sound. People need good-quality child care. The question is how 
do we provide it. I would add my experience has been when you 
sit down with people and actually get down to it, you just need 
the flexibility to find a solution to their problem.
    Senator Dodd. The affordability issue obviously is 
critical. I do not need to tell you. Now, per child it costs, 
and I am not exaggerating when I tell you this, between $6,000 
and $10,000 per child per year. And you start with people of 
incomes of $20,000, $25,000 a year trying to hold on to those 
jobs with two kids, you do not have to have a Ph.D. in 
mathematics to know it just does not work. So that is a 
critical constituency. And I hope you will work with us and not 
only ensure that child care is more affordable but also that 
low income parents have access to quality care. It is very, 
very important.
    The drug safety issue has received a lot of attention. 
Again, I gather, Mr. Chairman, we haven't spent a lot of time 
on this issue, again a subject matter I know my friend from 
Utah has a lot of interest in, but a lot of stories over the 
last few weeks about the FDA and drug safety. We know of these 
patients who have been hurt or killed by widely used pain 
medication. We have heard those stories recently.
    Several of us in Congress are considering legislation to 
reform the Food and Drug Administration's approach to drug 
safety and ensure the results of clinical trials are made 
public. I wonder if you might comment, particularly on the last 
point dealing with the public information, making available to 
the public about these clinical trials and public safety.
    Mr. Leavitt. I believe that the process of Government ought 
to be conducted in the most transparent possible way, and when 
it comes to drug safety, people do have a reason to expect 
safety. We want it also to be--for industry and for Government 
to be innovative. We want to have access. We want to have 
independence in assuring that it is.
    I recognize the tension that exists perpetually, 
intuitively between wanting innovation and speed and at the 
same time wanting safety. And sometimes those conflict. It is a 
function of finding balance and getting better at it.
    Senator Dodd. Well, I represent a significant number of 
companies in my State, some 35,000, 40,000 people in 
Connecticut are employed in the pharmaceutical industry, and 
they are tremendous companies and they do a wonderful, 
wonderful job in many, many ways. And it is also a great 
source--we have a tremendous imbalance in trade, and our 
pharmaceutical industry contributes significantly to U.S. 
exports.
    One of the reasons they do is because that stamp on it, FDA 
approved, means so much all over the globe. That Good 
Housekeeping Seal of Approval that these products are effective 
and safe has been tremendous, first of all, on a human level 
very important, but also economically. It is really important 
we get this right early. If we end up with a reputation that 
this very important agency is no longer reliable, I think it 
would do great, great damage to a very important industry in 
this country.
    Now, I see time is--well, I have a couple more questions, 
and I will be glad to wait until my colleagues go around, if 
that is the way you are doing this. Are you, Mr. Chairman?
    The Chairman. Yes.
    Senator Dodd. Fine. I will come back.
    Mr. Leavitt. Mr. Chairman, could I just make one brief 
response?
    The Chairman. Yes.
    Mr. Leavitt. I referred earlier to FDA and CDC and NIH as 
important brands. A brand is a promise, and if we ever lose the 
value of that brand, the American people lose a great treasure.
    Senator Dodd. You bet.
    Mr. Leavitt. And I see the guarding of the integrity of 
those brands as a fundamental part of this responsibility.
    Senator Dodd. Thank you.
    The Chairman. Senator Hatch.
    Senator Hatch. Thank you.
    Governor Leavitt, one issue that I think all of us are 
deeply interested in--I certainly am--you know, is building up 
our Nation's defense, especially against biological and 
radiological weapons. Last year the Senate Judiciary Committee, 
which I chaired at the time, and the HELP Committee, this 
committee, held a joint hearing on how the 2003 bioshield law 
may be improved upon and what Bioshield II needs to have 
included.
    Now, we need to encourage rather than discourage 
pharmaceutical and biological companies to develop products to 
help us combat bioterrorism. Unfortunately, current policy 
discourages companies to develop these products. I think this 
has to change. We have got to make headway in this area, and 
knowing you, I am sure that you are the guy who can help do 
this--not that people at HHS have not been trying.
    I want the Department to work with us in developing policy 
to address these very serious concerns, so I am hopeful that we 
can work together to do this. I am working currently on 
legislation with regard to this with my good friend, Senator 
Lieberman from Connecticut. And so we would appreciate your 
assistance on this.
    I also want to thank my colleague from Connecticut, Senator 
Dodd, who has been such a great leader on this committee, for 
his kind remarks about me. It is a privilege to be back on this 
committee and to work on some of these issues that I have taken 
such an interest in. And I have to say for everybody, I know 
you as well as anybody knows you, and I know what a great 
policy person you are and how much you really do care about 
getting things right and working them through. It is a 
tremendous ability that not too many people have. But you do, 
and I think you were recognized as one of the great Governors 
in this country, as you should have been. And I know that you 
have done a tremendous job over at EPA, which is almost an 
incomprehensibly difficult job, especially for a Republican, to 
do. And I think virtually everybody has given you credit for 
doing that, and with aplomb and with dignity and with fairness.
    Now, what I hope is that this committee will put Governor 
Leavitt out quickly so that he can get busy and do some of the 
things we all know he can do. And we have got to be very much 
concerned about helping you. And I think this committee will 
be, and I have been really pleased with the nice way you have 
been treated here today by members of the committee.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Senator Gregg.
    Senator Gregg. Governor, have you had a chance to spend any 
time--and I can understand if you have not, just moving over--
on this whole issue of how we revitalize the vaccine industry 
in America? The whole concept of Bioshield was that we needed 
to prepare ourselves for a biological attack, and we have no 
significant domestic vaccine industry because most of our 
vaccine industry had been pushed out of business by basically 
trial lawyers. And so to try to create such an industry, or at 
least incentivize people to move into this area, we passed 
Bioshield I.
    We have now seen the flu vaccine problem, which shows that 
if you rely on a single supplier, whether domestic or 
international--but obviously international raises issues, too--
you have got serious problems. And I am wondering how you are 
viewing this issue of how we get, first, our domestic vaccine 
business up and running, an enterprise up and running, what we 
need to do beyond Bioshield I; and, second, how we expand, for 
example, the flu vaccine purchasing process so that we use the 
Canadian vaccines that are available and other international 
vaccines that are available and not find all our eggs being in 
one basket as they were?
    Mr. Leavitt. Senator, this was an obvious area of interest 
to me given the fact that we are moving into the flu season and 
the prospect and the potential of being confirmed. Just a 
couple of observations.
    One, we cannot expect that we will have people stepping up 
to manufacture unless there is a market. There needs to be a 
market. Sometimes it may need to be the Federal Government to 
make certain that there is a market.
    Second, despite the fact that there has been substantial 
work on the liability issues by the Congress, I suspect by this 
committee, it is also clear to me that there remain some issues 
that need to be resolved. This is a very serious problem and 
one that in my judgment needs to be dealt with and dealt with 
promptly.
    Senator Gregg. Do you have any thoughts about whether we 
should look for other suppliers from other countries besides 
just the one we were using for the flu vaccine, such as 
Canadian suppliers?
    Mr. Leavitt. My thoughts have not matured to the point that 
I could express them adequately or properly. I am aware of that 
as a possibility. I am working to gather the information 
necessary to form a viable opinion. I look forward to an 
opportunity to talk with you about it.
    Senator Gregg. There is a bill bouncing around the Congress 
right now, which, again, you may not have had time to get up 
on, called the Patient Safety Act, which is essentially an 
attempt to give--which passed out of this committee 
unanimously, passed the Senate, was held up in the House on an 
ancillary issue which had nothing to do with patient safety. 
Are you familiar at all with that bill?
    Mr. Leavitt. By title.
    Senator Gregg. OK. Well, anyway, I would hope that you 
might have a chance to take a look at it at some point and see 
if we could not encourage its passage. It will allow hospitals 
and doctors to exchange information more efficiently, which is 
a key part of this whole process of getting health care 
delivered more effectively, and we hope that we can restart it 
in this Congress in a prompt way.
    Again, I thank you for your willingness to participate in 
public service the way you have. It is extraordinary, your 
career is extraordinary, and we are very lucky to have someone 
like you being willing to take this position on.
    Mr. Leavitt. Thank you, Senator. Could I just respond with 
respect to the issues related to the extent--or the supplying 
of information and interoperability issues. I do believe those 
are issues that we will have to work together to resolve, 
because much of the efficiency, much of the protection we seek 
can be hampered until we are able to work through those very 
thorny issues.
    Senator Gregg. Well, you are absolutely right, and this 
bill takes a fairly significant step forward in that exact area 
in that it allows hospitals and doctors to exchange information 
without putting the patient's information or the patient at 
risk and do so in a way that gets around the competition 
issues, which we have had problems with the antitrust issues, 
and protects the doctors and the hospitals from arbitrary 
lawsuits which would be brought as a result of an exchange of 
that information. And that information will lead to a more 
efficient delivery of service, and what it most importantly 
will lead to is less medical errors, hopefully.
    Mr. Leavitt. Yes.
    Senator Gregg. Which is very important. That is why this 
committee passed it unanimously. That is why the Senate passed 
it on, I think, a voice vote. We are still wondering why the 
House has not passed it.
    The Chairman. Senator Dodd.
    Senator Dodd. Thanks, Mr. Chairman. Just a couple of quick 
other questions that I would just like to raise, if I may.
    We pay a lot of attention obviously to drug abuse among 
young people. The largest killer among these kids, though, when 
it comes to substances, is alcohol, underage usage of alcohol. 
The numbers are just staggering. About 7,000 kids under the age 
of 16 today will take their first drink, and for many of them 
it becomes a serious problem. In fact, we lose over 4,000--
close to between 4,000 and 5,000 young people every year in 
deaths related to alcohol in this country.
    Well, in 2003, the Institute of Medicine released a study 
called ``Reducing Underage Drinking: A Collective 
Responsibility,'' that laid out the national problems presented 
by the consumption of alcohol by youth and established a 
multitiered national strategy to reduce underage drinking's 
toll. Sadly, there has been very little progress on this at the 
Federal level in instituting this important report's 
recommendations, and I do not expect you have had a chance 
necessarily to become familiar with these recommendations, but 
I would urge you to do so, if you could, so that we might begin 
to talk about establishing national policy in this area.
    I have had countless meetings with people from the 
alcoholic beverage industry, and I must say many of them are 
fully supportive of what we are trying to do in coming up with 
some intelligent responses to this, including how they 
advertise. And we all know the First Amendment issues, and the 
industry has as a matter of its own decision refrained to a 
large extent from advertising, at least on television and other 
places. But, nonetheless, we have seen some real problems with 
some of the efforts. Again, just watching any major sporting 
event and you watch the advertising that comes on, too often 
you see exactly what age group they are appealing to when they 
are using Play Stations to advertise beer and so forth, as one 
industry did. They have stopped it, by the way, but they 
certainly did for a while. You get a clear indication of the 
age group they are trying to appeal to.
    There have been some very good recommendations in these 
reports. Some of them may be a little more than the 
administration and others may want to accept, but I think there 
are some good ideas, and I would really urge you to take a good 
look at this early on and see if we cannot take some good 
steps. I think you will find a lot of cooperation up here. The 
American public cares about it. Considering the loss of life, 
the damage, the illness, the permanent damages to those who 
don't lose their lives is just overwhelming. And so I would 
urge you to become involved in it as early as you can. I don't 
know if you want to make any particular comment.
    Mr. Leavitt. Well, I would just comment that you indicated 
early you have spent a fair amount of time in Utah, and as a 
result you would know that that is a State that takes this 
issue quite seriously.
    Senator Dodd. Well, good. We hope you will do that.
    This last one I want to raise with you is, again, an issue 
that there is nothing like a personal experience, I suppose, to 
bring your attention to an issue. Three years ago, my wife and 
I had our first child and discovered when she was born that 
there were only about eight newborn screening tests available 
in the State of Virginia where she was born. Only one State 
provided testing in 32 areas, which was the State of 
Massachusetts at the time. We passed legislation to try to 
increase support for additional newborn screening for these 
newborns given, again, the problems that can emerge very, very 
quickly with these kids.
    There has been a report that has come out from the 
Committee on Heritable Disorders and Genetic Diseases in 
Newborns and Children--it is going to release a report, I 
should point out, recommending that all States test for 29 
disorders in these infants. We have had hearings in this 
committee, very compelling hearings, where parents have come 
forward and said had there just been some of those tests--they 
are very inexpensive to do, but we need some additional 
cooperation. The States would like to do a lot more in this 
area. Some of the equipment necessary is not inexpensive, but 
the cost of not doing it, I do not need to tell you, is 
overwhelming when you look at children experiencing lifelong 
disorders that require millions of dollars being spent in some 
cases.
    So it is another one of these areas that, again, I do not 
expect you necessarily to be deeply familiar with the subject 
matter, but it is one where we can, with a small amount of 
effort, make a huge difference for people. And I would urge you 
to take a look at this, and your staff, and see if we cannot 
sit down and maybe talk about some ideas and how we promote 
this expanded use of newborn screening.
    Mr. Leavitt. Thank you.
    Senator Dodd. Mr. Chairman, I thank you. I have taken a 
little more time, and I appreciate it.
    The Chairman. Thank you very much.
    I want to thank all the members of the committee for their 
participation. I want to thank Secretary Leavitt for his 
straightforward answers and wealth of knowledge that he brings 
to this job and the willingness to go through two of these 
nomination hearings. We are not the primary committee, as I 
explained before. As a result, the record will remain open for 
10 days or until the Finance Committee takes action, whichever 
is less. And we will be polling the members of this committee 
on an appropriate question for our advice and consent.
    With that, this hearing is adjourned.
    [Additional material follows:]

                          Additional Material

               Response to Questions of Senator Bingaman
                             The Uninsured

    Question 1. The uninsured rate has increased from 40 million to 44 
million people during the past 3 years. To put that in prospective, 
that is equivalent to having every single person go from full health 
coverage to nothing in the following places: Milwaukee, Wisconsin; 
Memphis, Tennessee; Tuscon, Arizona; Albuquerque, New Mexico; Miami, 
Florida; Pittsburgh, Pennsylvania; Des Moines, Iowa; and the entire 
State of Montana. What steps will you take to reduce the number of 
uninsured Americans, especially low-income pregnant women, children, or 
those with chronic illnesses?
    Answer 1. My experience as Governor taught me that there is no one-
size-fits-all solution to reduce the number of uninsured Americans. 
Simply expanding eligibility for government programs may in fact 
overlook market based solutions for the working uninusred. The Covered 
at Work program is an example of a public-private parternship to help 
low-income working families access the health insurance that is 
available to them through their employer, but may be out of reach due 
to the expense. The program provides subsidies for up to 6,000 Utah 
residents who are not eligible for Medicaid but also struggled to meet 
their share of the expense for employer-sponsored insurance. I very 
much look forward to working with you and the Congress to advance the 
President's multi-faceted approach to reducing the number of uninsured. 
As you know, the President is committed to making quality health 
insurance more affordable and more accessible for millions of American 
working families. The President's plan will help reduce the rising cost 
of health care; provide new and affordable health coverage options for 
all Americans; and provide not just a government program, but a path to 
greater opportunity, more freedom, and more control over your own 
health care and your own future. For low-income families, the proposal 
includes refundable tax credits to enable families to buy coverage. It 
also includes $4 billion in Federal grants to States to establish 
purchasing pools--or to expand existing pools--where people could use 
their tax credits to buy coverage. In addition, he's proposed to allow 
tax credit recipients to divide their assistance between a premium 
subsidy and a government contribution to a health savings account. This 
account, which they could use to pay routine medical expenses and to 
save for future health care needs, would belong to them, not to the 
government. These and other proposals would help reduce the number of 
people who lack health insurance coverage.

                          Healthcare Workforce

    Question 2. With 76 million baby boomers aging upward and the 
average lifespan continuing to increase, the aged 65 and over 
population is expected to double over the next 30 years. Our society 
currently faces significant health care workforce shortages. What 
strategies and actions do you foresee that will help to ensure an 
adequate number of providers who are fully-trained and capable of 
meeting the health care needs of an aging population, now and in the 
future?
    Answer 2. By continuing to focus on the problem of maldistribution 
of health professionals across the country, we will help ensure that 
the aging population has access to the health care they need. As you 
are aware, HHS administers a successful program that specifically 
addresses this issue ? the National Health Service Corps (NHSC). This 
program provides financial incentives, through scholarships and loan 
repayments, to health professions students and providers who agree to 
serve in underserved areas. This program has supported more than 24,500 
health professionals committed to service to the underserved, and 
approximately 6 million people now have access to care from NHSC 
clinicians. HHS also continues to expand the Community Health Center 
program to ensure that affordable health care is available in 
underserved areas across the country.
    There continues to be a serious shortage of nurses across the 
United States and a shortage of nursing faculty that is limiting the 
number of students that can be admitted to schools of nursing. HHS 
administers several programs that specifically focus on alleviating 
this nursing shortage, including comprehensive geriatric education to 
prepare nursing personnel to care for the aging population. Funding for 
these activities has increased by 75 percent since fiscal year 2001.
    The Department's efforts to ensure an adequate supply of health 
care providers are guided by studies carried out by the National Center 
for Workforce Analysis. This center continues to conduct studies that 
help develop strategies to meet the health workforce needs of an 
increasingly diverse and aged population. Over the past two decades, 
HHS has invested over $6 billion in general health professions training 
grants. HHS is in the process of compiling detailed information on the 
effectiveness of these health professions programs and we will be sure 
to share that information with your committee when it is available.

    Question 3. Would you support a study examining the role of U.S. 
medical schools in meeting the physician needs within the country?
    Answer 3. I understand your concern about the lack of growth in the 
number of students graduating from medical schools in the United States 
and the increasing dependence on foreign medical schools in the 
training of American medical students. The Department will continue to 
monitor and evaluate the impact of the health professions programs and 
the state of the health care workforce in general. From what I 
understand, the fiscal year 2005 appropriation did not include funds to 
support such a study, but if I am confirmed as Secretary, I will stand 
ready to work with you to evaluate this situation.

                                  NIH
    Question 4. The scientists and researchers at the National 
Institutes of Health (NIH) are responsible for cutting-edge medical 
breakthroughs that are improving the lives of Americans every day. 
Unfortunately, the value of their research has on occasion been called 
into question outside of the agency. As Secretary of the Department 
Health and Human Services, would you continue to support the peer 
review process for NIH grants whereby researchers work is evaluated by 
their fellow scientists?
    Answer 4. Yes. The peer review process is the essential ingredient 
that protects the integrity and value of research supported by NIH.

                     Plan B Emergency Contraception
    Question 5. Last December, the FDA's Independent Expert Advisory 
Committees overwhelmingly recommended approval of the Plan B OTC 
application with a 23-4 vote. The committees were, however, unanimous 
in their determination that Plan B is safe enough for over-the-counter 
use, and that there is no data to show that Plan B leads to 
substitution of EC for other methods of contraception. Despite the 
Advisory Committees' review of hundreds of studies on Plan B, and that 
recent research, including a JAMA study, continues to support the 
committees' original favorable recommendation, the FDA denied Plan B 
OTC status and overrode the overwhelming scientific evidence. Why has 
the FDA delayed approval of this drug?
    Answer 5. As you know, the FDA previously denied an application to 
change this drug to over-the-counter status. I understand that FDA did 
not approve a switch of this prescription drug to OTC status on the 
first review of the application for two reasons. First, the sponsor did 
not provide adequate data to support the conclusion that young 
adolescent women can safely use Plan B for emergency contraception 
without the professional supervision of a licensed practitioner. 
Second, a proposal from the sponsor to change the indication requested 
in their application to allow for marketing of Plan B as a 
prescription-only product for women under 16 years of age and allow 
non-prescription marketing to women 16 years and older was incomplete 
and inadequate for a full review.
    In July 2004, Barr Laboratories resubmitted their application after 
FDA determined it could not approve Barr's initial application based on 
the information submitted by the company. The Agency currently is 
reviewing the resubmitted application.

                         Indian Health Service
    Question 6. Despite double digit growth in health care spending in 
both private and public sectors, the Administration's fiscal year 2005 
budget submission for IHS includes just $45 million, or a 1.6 percent, 
increase. This follows a 3 percent increase in fiscal year 2004 and a 
2.5 percent increase in fiscal year 2004--none of which covered even 
basic medical inflation. The result has been a dramatic decline in 
spending power for the Indian Health Service (IHS) during the 
Administration's term in office.
    Consequently and not surprising, this disparity in funding 
translates into severe health disparities for Native Americans. For 
example, life expectancy is six years less than the rest of the United 
States citizens. Tuberculosis rates are four times the national 
average. Complications due to diabetes are almost three times the 
national average and death rates exceed the Health People 2010 targets 
by 233 percent. Infant mortality rates are 1.7 times higher than the 
rate for white infants. These figures are both shocking and 
unacceptable. What will you do to address the health disparities faced 
by Native Americans?
    Answer 6. Over the last 40 years, there have been significant 
health improvements among Indian people related to control of 
infectious diseases, expanded access to primary health care, and 
fundamental community infrastructure such as safe drinking water. 
Today, injuries, chronic diseases and behavioral related diseases such 
as alcoholism, substance abuse and mental health have emerged as 
leading challenges in Indian communities. One of the keys to addressing 
these problems is ensuring access to health care. I look forward to 
working with Congress and the Indian Health Service, which plays a key 
role for the Department of Health and Human Services in providing 
access to care to American Indian and Alaska Native communities, to 
address these issues and reduce and eliminate health disparities. In 
doing so, it is critical that the IHS identify and collaborate with 
outside organizations with the capacity, capability, and interest to 
assist in addressing these diverse health problems. The IHS has 
developed partnerships and collaborations with other Federal Government 
agencies as well as academic, professional and other non-governmental 
partners. These partnerships cover a broad array of programs, including 
on health promotion and disease prevention.

    Question 7. The Indian Health Care Improvement Act is critical for 
providing health care services to 1.6 million federally-recognized 
Native Americans through IHS, as well as Tribal and urban Indian health 
programs, and has been pending before the Congress for far too long. 
Will you work to push for reauthorization of the Indian Health Care 
Improvement Act (IHCIA)?
    Answer 7. Over the last 40 years, there have been significant 
health improvements among Indian people related to control of 
infectious diseases, expanded access to primary health care, and 
fundamental community infrastructure such as safe drinking water. 
Today, injuries, chronic diseases and behavioral related diseases such 
as alcoholism, substance abuse and mental health have emerged as 
leading challenges in Indian communities. HHS, working through the 
Indian Health Service, has a key role to play in working with American 
Indian and Alaska Native communities to improve health conditions 
through improved access to quality health care services, enhanced 
health care promotion and disease prevention, and focuses on new and 
emerging health issues facing these communities. The reauthorization of 
the Indian Health Care Improvement Act, which Congress was 
unfortunately unable to complete last year, could further support the 
efforts of HHS and IHS in these endeavors. As Secretary, I look forward 
to examining any reauthorization proposals and hope to work with 
Congress on these critical issues.

                             Mental Health
    Question 8. In July, 2003, President Bush's New Freedom Commission 
on Mental Health completed its final report. Describing the country's 
mental health system as one in ``shambles,'' the Commission documented 
the crisis:
     In the United States, suicide claims approximately 30,000 
lives a year.
     In the United States, about 2/3 of people with mental 
illness are unemployed.
     In 2001, parents were forced to place more than 12,700 
children in the child welfare or juvenile justice systems in order to 
get them mental health treatment.
     More than 750,000 people with mental illnesses will end up 
in jails or prisons over the coming year, most of them for nonviolent 
offenses related to their mental illness.
     And worldwide, mental illness is the leading cause of 
disability worldwide, accounting for nearly 25 percent of all 
disability across major industrialized countries.
    Notwithstanding the urgency, the President has never endorsed the 
Commission's Report or even acknowledged its existence. Nor has HHS 
issued an action plan for implementing the Commission's 
recommendations. What is the status of the Department's work on this 
issue? Will you make mental health policy a priority?
    Answer 8. The President's New Freedom Commission on Mental Health's 
report, issued in July 2003, called for profound change and 
transformation of the current system, recommending new service delivery 
patterns and incentives to ensure that every American with mental 
illness has easy access to the most current treatments and best support 
services.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) was tasked by the Department to review the Commission's report 
and to lead the development of an Action Agenda for that transformation 
to create a more recovery-focused mental health services delivery 
system. An executive team at SAMHSA-along with senior staff from six 
Federal departments and the Social Security Administration-are working 
collaboratively to conduct a thorough review and assessment of the 
Report.
    A hallmark of the Action Agenda is the unprecedented collaboration 
and partnership across the Federal Government to work together and make 
every effort to keep consumers and families at the center of care. I 
look forward to working with you to continue this excellent effort.

    Question 9. Perhaps the most significant finding in the report is 
the recognition that the service system is hopelessly fragmented and 
uncoordinated across multiple, disconnected programs, including those 
related not only to mental health specifically, but also public health 
and health care financing, housing, employment, rehabilitation, 
criminal and juvenile justice, substance abuse, education, and child 
welfare. In response, the Commission recommended that the relevant 
departments--HHS, the Social Security Administration, Justice, Veterans 
Affairs, Education, HUD--align their programs to improve access and 
accountability for mental health services. [Commission Recommendation 
2.3, page 37]. Will you work for White House leadership on mental 
health and implementation of the Commission's recommendations?
    Answer 9. As stated before, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) was tasked by the Department to review 
the Commission's report and to lead the development of an Action Agenda 
for that transformation to create a more recovery-focused mental health 
services delivery system. An executive team at SAMHSA--along with 
senior staff from six Federal departments and the Social Security 
Administration--are working collaboratively to conduct a thorough 
review and assessment of the Report. A hallmark of the Action Agenda is 
the unprecedented collaboration and partnership across the Federal 
Government to work together and make every effort to keep consumers and 
families at the center of care. The result has been commitment for a 
true Federal Action Agenda that is informed by the final report of the 
New Freedom Commission and aligned with the President's priorities.
    I understand that an announcement from the Substance Abuse and 
Mental Health Services Administration on the availability of these 
funds and how to apply will be issued in the near future. The purpose 
of these grants is to help States overcome fragmentation by pulling 
together State government offices and engaging multiple systems of care 
together in a coordinated manner to focus on improving outcomes for 
adults with serious mental illness and children with serious emotional 
disturbance.

                                Obesity
    Question 10. Overweight and obesity are major risk factors for 
heart disease and stroke, two of the top three leading causes of death 
in the United States. There have been many alarming reports about the 
rate at which Americans are becoming obese. A Surgeon General's report 
has called this problem an epidemic. Recent estimates indicate the 
direct medical cost attributable to overweight and obesity is $78 
billion dollars annually. And approximately half that amount, about $40 
billion, is paid for with public dollars through the Medicare and 
Medicaid programs. We must prevent Americans, and especially American 
children, from becoming overweight. What do you think is the role of 
the Secretary of Health and Human Services in getting the problem of 
obesity and the related costs under control?
    Answer 10. Seven of nine of the major causes of death in the United 
States are caused by chronic diseases. The underlying causes of these 
diseases are often behaviors that can be successfully modified thereby 
reducing illness and death. Three factors--lack of physical activity, 
poor nutrition, and tobacco use--are major contributors to the Nation's 
leading killers; heart disease, cancer, stroke, chronic obstructive 
pulmonary disease and diabetes. Too, the prevalence of overweight has 
more than doubled in children and tripled in adolescents; indicators 
suggest that diabetes too is increasing among children. This is 
particularly troubling given obesity is a co-morbidity factor leading 
to significantly increased risk of death due to cancer, heart disease 
and diabetes.
    In June 2002, President Bush launched the HealthierUS initiative to 
utilize the combined expertise of the Federal Government to help 
Americans live longer and healthier lives through simple changes in 
their everyday lives. The four pillars of the HealthierUS initiative 
are: 1) be physically active every day; 2) eat a nutritious diet; 3) 
get preventive screenings; and 4) make healthy choices concerning 
alcohol, tobacco, drugs and safety.
    HHS is currently engaged in a number of key activities, two of 
which are listed below. I look forward to examining what has been done 
and what is underway, and working to continue this tremendous progress.
    Current Activities:
     Steps to a HealthierUS Initiative (Steps). Steps 
specifically targets diabetes, asthma and obesity. In fiscal year 2003 
Steps funded 23 communities. In fiscal year 2004 the program awarded 
$44 million to help 16 additional communities develop action plans to 
implement programs that promote disease prevention and health; the 
total number of funded communities is 40. Steps also received $1.5 
million to fund one national program, YMCA's Activate America. Fiscal 
year 2005 appropriations budget for Steps is approximately $47 million.
     National Coverage Decision--Earlier this year, HHS 
announced a new Medicare coverage policy that would permit Medicare to 
cover anti-obesity interventions if scientific and medical evidence 
demonstrate their effectiveness in improving Medicare beneficiaries' 
health outcomes. The new policy removes language in the Medicare 
Coverage Issues Manual stating that obesity is not an illness, allowing 
Medicare to determine if specific obesity-related treatments should be 
covered by Medicare.

                     Nutrition and Dietary Concerns
                                 Sodium
    Question 11. Research over the last half-century has demonstrated 
that high-sodium diets (due mostly to the salt in packaged and 
restaurant foods) are a major cause of high blood pressure. For the 
past quarter-century, Dietary Guidelines for Americans, which is 
published by USDA and HHS, has advised consumers to consume less 
sodium. Notwithstanding that advice and similar advice from the 
National Institutes of Health and the National Academy of Sciences, 
Americans' consumption of sodium has not decreased, but increased. 
Though mandatory nutrition labeling, begun in 1994, on packaged foods 
has been useful to millions of people, it has had little apparent 
effect in reducing Americans' average sodium intake, according to HHS's 
National Health and Nutrition Examination Surveys (NHANES) in 1988-94 
and 1999-2000. In 1994, the National High Blood Pressure Education 
Program (part of the National Heart, Lung, and Blood Institute) said 
that ``it is critical that the food industry reduce (or continue to 
reduce, in some cases) the content of sodium in generally available 
processed foods.'' The NHBPEP has said that reducing sodium levels 
could save tens of thousands of lives per year. However, judging from 
current trends, the goal in HHS's Healthy People 2010 (published in 
2000) of increasing the percentage of people consuming 2,400 mg or less 
of sodium per day from 21 percent to 65 percent will never be met. What 
will you do to reduce the sodium content of packaged and restaurant 
foods and reduce the incidence of high blood pressure?
    Answer 11. I believe that HHS has done a tremendous job in focusing 
public attention on the issues relating to wellness, prevention and 
obesity, and that these efforts are bearing fruit. As part of these 
efforts, HHS has been able to work collaboratively with outside 
stakeholders, including the food and restaurant industry, to make 
important progress. An example of this is the improved nutritional 
labeling information that is available through many restaurants. I hope 
to continue this collaborative approach and work with all interested 
parties to improve the health of the Nation.

           Trans Fat in Partially Hydrogenated Vegetable Oils
    Question 12. Trans fat in partially hydrogenated vegetable oils is 
a major public health problem because it promotes heart disease. In 
July 2002 the Institute of Medicine (``IOM'') of the National Academy 
of Sciences concluded that the consumption of Trans fat is at least as 
unhealthful as the consumption of saturated fat and that consumption of 
trans fat in any amount increases the risk of heart disease. In 
December 2003 the IOM concluded that it is feasible to exclude from the 
diet trans fat from partially hydrogenated vegetable oil.
    In April 2004 the Nutrition Subcommittee of the Food and Drug 
Administration (``FDA'') Food Advisory Committee concluded that trans 
fat is more conducive to coronary heart disease than is saturated fat. 
In August 2004 the Dietary Guidelines Advisory Committee reported to 
Secretary Thompson and Secretary Veneman that consumption of trans fat 
from both partially hydrogenated oils and meat and dairy products 
should be limited to one percent of total calories. Do you believe that 
it would promote the public health if partially hydrogenated vegetable 
oils were eliminated from both packaged and restaurant foods? If so, 
what steps will you take as Secretary to bring this about?
    Answer 12. Saturated fat, trans fat and cholesterol intake are 
associated with risk of cardiovascular disease. As indicated in the 
Dietary Guidelines for Americans, controlling the intake of all three 
of these lipids is important for managing health risk. In response to 
FDA's rule that trans fat must be on food labels by January 2006, the 
food industry has taken significant steps to lower the trans fat 
content of food products. These steps include the development of 
products that can replace partially hydrogenated oils as well as 
improvements in the hydrogenation process to prevent formation of trans 
fatty acids. During this transition in product formulation, it is 
important that the reduction of trans fat from certain oils not be 
achieved simply by switching to fats that are high in saturated fatty 
acids but by development of healthier alternatives to these fats. FDA 
is currently reviewing proposals for making claims about the trans 
fatty acid content of foods, and once finalized such claims could 
provide additional incentives to the food industry to lower the trans 
fat content of certain foods. If confirmed, I will work to advance 
these initiatives to address health concerns associated with the use of 
partially hydrogenated vegetable oils in packaged and restaurant foods.

                              Food Safety
    Question 13. The safety and quality of the U.S. food supply is 
governed by a fragmented and overlapping system. That system is based 
on more than 30 laws, over 50 inter-agency agreements, and administered 
by 12 agencies. These agencies work to ensure basic food safety, 
address human and animal nutrition, deal with naturally-occurring food 
borne pathogens, protect the environment, monitor the incidence of 
disease, and develop effective research programs. President Bush, 
former Secretary of Health and Human Services Tommy Thompson and 
Homeland Security Director Tom Ridge all have publicly discussed 
combining Federal food-safety responsibilities into a single agency. Do 
you support consolidating food safety authority by modernizing food 
safety laws and creating a single agency responsible for protecting the 
American food supply?
    Answer 13. As you know, in 2002, President Bush signed into law the 
Public Health Security and Bioterrorism Preparedness and Response Act 
(Bioterrorism Act) which gave FDA new authorities to ensure the safety 
of the food supply. I believe the current food safety system is 
working. The American food supply continues to be among the safest in 
the world. Federal agencies with food safety authorities are working 
together effectively. As Secretary, I will continue to support this 
enhanced cooperation among all of our food safety partners that can 
increase the effectiveness of our food safety system.

    Question 14. How would you improve FDA's oversight of imported 
food?
    Answer 14. Through the authorities under the Bioterrorism Act, FDA 
was recently equipped with significantly enhanced tools to ensure the 
safety of the food supply. If confirmed as Secretary, I plan to work to 
ensure that FDA is effectively using the ample authorities recently 
enacted by Congress relating to imported foods. These authorities 
include requirements that prior notice of imported food shipments be 
submitted to FDA. FDA is currently receiving about 30,000 advance 
notices per day. FDA uses this information to make risk-based decisions 
about the admissibility of imported food shipments before the food may 
proceed into commerce. To implement the Prior Notice requirement, FDA 
established and staffed the Prior Notice Center, a first-of-its-kind 
activity which operates on an around-the-clock basis to accommodate the 
global economy.
    The Bioterrorism Act also requires that the owner, operator, or 
agent in charge of a domestic or foreign facility to register with FDA. 
Now, for the first time, FDA has a roster of foreign and domestic food 
facilities, allowing timely notification and response in the event of a 
food safety threat.
    The Act also requires that records be created and maintained to 
enable FDA to determine the immediate previous sources and the 
immediate subsequent recipients of food. In the event of credible 
threats of serious adverse health consequences or death to humans or 
animals, this requirement will enable FDA to identify the source of the 
contamination and to remove adulterated food from commerce, thus 
preventing foodborne illnesses and deaths.
    The Bioterrorism Act also contains authority to order the 
administrative detention of food if there is credible evidence or 
information indicating that an article of food presents a threat of 
serious adverse health consequences or death to humans or animals.
    With these new tools, FDA can continue to improve its oversight of 
imported food.
    In addition to those protections discussed above, FDA and U.S. 
Customs & Border Protection (CBP) signed a Memorandum of Understanding 
(MOU) in December 2003 that allows ORA to commission thousands of CBP 
Officers in ports and other remote locations to conduct, on FDA's 
behalf, investigations and examinations of imported foods. This 
agreement provides a contingency plan to assure adequate regulatory 
coverage at the 300 ports through which imported food may be offered 
for entry into domestic commerce. Moreover, to ensure prompt access for 
specified analytical testing of imported foods at U.S. ports of entry, 
FDA and the U.S. Army's Edgewood Chemical Biological Forensic 
Analytical Center designed, constructed, and equipped two mobile 
laboratories. FDA is now deploying these labs and will soon start 
operation.
    In tandem with those protections discussed above, FDA continues to 
improve its food import program. This continuing improvement effort 
focuses on evaluation of risk associated with imported food shipments 
based on several factors: the source(s) of a finished product, 
intelligence information gathered from both foreign and domestic 
sources, adherence to good manufacturing practice requirements, the 
compliance history of all of those entities involved in the 
distribution chain, and shipping conditions. This risk-based approach 
will enhance FDA's effectiveness and efficiency by enabling FDA to 
target shipments for further investigation and/or testing and will 
complement FDA's traditional examination activities at the border.

    Question 15. Do you think that FDA should have mandatory recall 
authority to protect consumers from contaminated food that is 
distributed around the country?
    Answer 15. It is my understanding that FDA has authority under the 
Federal Food, Drug, and Cosmetic Act to remove a violative product from 
the market by using its seizure authority. In addition, in 2002, 
President Bush signed into law the Public Health Security and 
Bioterrorism Preparedness and Response Act (Bioterrorism Act) which 
gave new powers to FDA to administratively detain foods for which there 
is credible evidence or information that the food presents a threat of 
serious adverse health consequences or death to humans or animals. This 
domestic authority is coupled with the authority to detain imported 
foods at ports of entry for a period of time sufficient to ensure their 
compliance with FDA standards and safety. FDA has been working hard to 
implement these and other provisions of the Bioterrorism Act.

                   Effects of Nuclear Weapons Testing
    Question 16. The Radiation Exposure Compensation Act makes 
available modest compensation to some downwinders in some high-fallout 
counties in Utah, Nevada, and Arizona. Since passage of RECA, a 1997 
National Cancer Institute report found that US atmospheric nuclear 
testing exposed nearly everyone who lived in the US in the 1950s and 
early 1960s to radioactive fallout. People who lived in many counties 
in Idaho, Montana, North Dakota, South Dakota, Kansas, Nebraska, Iowa, 
Missouri, and Arkansas were severely exposed. Will you support just 
redress for additional people who have been made sick from fallout by 
expanding RECA coverage?
    Answer 16. Thank you for your continued support for the RECA 
programs and your focus on using the best science possible in the 
administration of these programs. As the former Governor of Utah, this 
is an issue with which I am very familiar. As you know, the Department 
of Justice administers the Radiation Exposure Compensation Program, 
which provides compassionate compensation to individuals, or their 
beneficiaries, who contracted certain cancers or other serious diseases 
as a result of their exposure to radiation from U.S. nuclear testing 
and uranium mining. Since 1990, when the RECA legislation was enacted, 
coverage has been expanded based on available scientific information. 
The Department of Energy also administers a program that provides 
benefits to Department of Energy employees and contractors who have 
been approved for an award under RECA.
    Through HHS, individuals in Utah, Colorado, New Mexico, and Arizona 
have access to cancer screening, early detection, medical referrals, 
education, and assistance with compensation claim documentation. This 
program, the Radiation Exposure Screening and Education Program, 
provides grants to six health care organizations in these States. HHS 
is also overseeing a research project by the National Academies' 
National Research Council on whether other classes of individuals or 
additional geographic areas should be covered under RECA, and on how 
services can be improved based on the most recent scientific 
information. The report is expected to be delivered to Congress this 
summer.

    Question 17. Following release of the 1997 NCI study, the Senate 
Appropriations Committee asked the Department of Health and Human 
Services (HHS) to conduct an initial assessment of the feasibility and 
public health implications of a study concerning the health 
consequences to the American population of radioactive fallout from 
nuclear weapons testing. In 2002, HHS transmitted to the Senate 
Appropriations Committee a progress report and an extensive, two-volume 
draft Feasibility Study. The draft was also sent to the National 
Academy of Sciences Committee on Assessment of CDC Radiation Studies, 
which released a report in February 2003. Despite repeated requests HHS 
has not released the Feasibility Study. Will you work to expedite 
release of the final Feasibility Study, which we understand has been 
complete for some time?
    Answer 17. Yes, if I am confirmed, I will ensure that the release 
of the final report will be expedited. HHS transmitted to the Senate 
Appropriations Committee a progress report and draft report in 2002. 
The draft report was also posted on the CDC website for public comment 
and was sent to the National Academy of Sciences for review. The NAS 
Committee issued a report in February 2003. CDC and NCI have been 
working together to carefully review and respond to all comments from 
NAS and the public. Because of the length and complexity of the report, 
making and reviewing the changes have been quite time consuming. 
However, the basic technical content and findings have not changed 
since the draft report was published. The final report will present 
little information that was not already available to the public in the 
draft report.

    Question 18. One of the key obligations growing out of the 1997 NCI 
study was to inform people exposed to radioactive fallout and their 
health care providers of the potential health impacts. But HHS has done 
very little in this regard. What will you do as Secretary of HHS to 
insure that people exposed to high levels of radiation without their 
knowledge first are informed about their potential exposures and health 
consequences and second that they receive adequate health care?
    Answer 18. As the former Governor of Utah, this is an issue with 
which I am very familiar. As you know, HHS administers a community 
grant screening and education program, the Radiation Exposure Screening 
and Education Program, which provides access to cancer screening, 
education, and medical referrals. The program, administered by the 
Health Resources and Services Administration (HRSA), provides grants to 
six health care organizations in Utah, Colorado, New Mexico, and 
Arizona. These organizations screen for the early warning signs of 
cancer, provide medical referrals, educate individuals on prevention 
and treatment of radiogenic diseases, and assist with compensation 
claim documentation. HRSA also oversees a research project by the 
National Academies' National Research Council on whether other classes 
of individuals or additional geographic areas should be covered under 
RECA, and on how services can be improved based on the most recent 
scientific information. The report is expected to be delivered to 
Congress this summer.
    In addition to this grant program, HHS has developed extensive 
information for individuals about assessing their risk for thyroid 
disease--which is the most important harmful radioactive material and 
can lead to thyroid cancer--and what to do if they are concerned about 
this possibility. If I am confirmed, I will stand ready to work with 
you to ensure that these and other HHS activities continue to educate 
and treat people exposed to high levels of radiation.

                   The Safety of Dietary Supplements
    Question 19. Do you believe that the current law regulating the 
safety of herbal dietary supplements is adequate? Do you think that it 
would be useful to commission the National Academy of Sciences to 
review the safety and efficacy of dietary supplements?
    Answer 19. In November 2004, FDA published a regulatory strategy 
that lays out the Agency's direction in implementing all the provisions 
of the Dietary Supplements Health and Education Act (DSHEA). The 
strategy is designed to give consumers a higher level of assurance 
about the safety of dietary supplement products and the reliability of 
their labeling, as well as to improve the transparency, predictability, 
and consistency of the Agency's scientific evaluations and regulatory 
actions to protect consumers against unsafe dietary supplements and 
dietary supplements making unauthorized, false, or misleading claims. 
The Agency will continue its ongoing efforts of monitoring and 
evaluating product safety, ingredient safety, and product labeling, as 
well as ensuring product quality. Recently, the Agency took action on 
ephedrine alkaloid-containing dietary supplements because they present 
an unreasonable risk of illness or injury. The courts are now reviewing 
this decision.
    In 2001, FDA funded an Institute of Medicine/National Academy of 
Sciences (IOM/NAS) study on the safety evaluation of dietary 
supplements. FDA considered this report, along with other information, 
in developing the initiative for full implementation of DSHEA. The NIH 
has recently funded an IOM/NAS study on complementary and alternative 
medicine. In light of this recent study, we do not believe that another 
study would provide additional benefits to the Agency.

                Underage Drinking Legislation (STOP Act)
    Question 20. As Secretary, what would you do to elevate underage 
drinking prevention as a national public health priority? Would you 
include an underage drinking prevention initiative in your fiscal year 
2006 or 2007 budget request?
    Answer 20. Under Secretary Thompson, SAMHSA convened the 
Interagency Coordinating Committee on the Prevention of Underage 
Drinking (ICCPUD), that is made up of representatives from the Office 
of the Surgeon General, the Centers for Disease Control and Prevention, 
the Administration for Children and Families, and the Office of the 
Assistant Secretary for Planning and Evaluation, the National Institute 
on Alcohol Abuse and Alcoholism, the Department of Justice/Office of 
Juvenile Justice and Delinquency Prevention, the Department of 
Education/Office of Safe and Drug Free Schools, the Department of 
Transportation/National Highway Traffic Safety Administration, the 
Office of National Drug Control Policy, the Department of the Treasury, 
the Department of Defense, and, ex officio, the Federal Trade 
Commission.
    The Department, in consultation with the ICCPUD, is to develop a 
comprehensive Federal plan for addressing the issue of underage 
drinking. An interim plan has been submitted to Congress for their 
consideration. The interim plan includes the following three goals:
    Goal 1: Strengthen a national commitment to address the problem of 
underage drinking.
    Goal 2: Prevent underage drinking and its negative consequences.
    Goal 3: Use research, evaluation, and surveillance to improve the 
effectiveness of programs and policy designed to reduce underage 
drinking.
    These are important goals, and I look forward to working with you 
to help achieve them.

                   Fetal Alcohol Syndrome Prevention
    Question 21. Would you support the re-issuance of a Surgeon 
General's advisory on the dangers of drinking during pregnancy?
    Answer 21. On 4 December 2004, the Surgeon General released an 
updated advisory on the dangers of drinking during pregnancy. This 
advisory updates the one issued in 1981 to reflect scientific evidence 
amassed since that time on trends in alcohol use among pregnant women 
and the consequences of prenatal alcohol exposure.
                                 ______
                                 
                Response to Questions of Senator Clinton
                       Kinship Care/Child Welfare

    Question 1. As you well from your experience as Governor, there has 
been a significant rise in the number of children living in kinship 
care arrangements--living with their grandparents, aunts, uncles, 
siblings or other relatives because their parents are unable to care 
for them. You oversaw the establishment of Utah's subsidized 
guardianship program to support these families. Today that program is 
serving about 117 children. We think this is a terrific model--one that 
should be supported through the Federal Government's foster care 
system. But as you know, States may not use their Title IV-E funds to 
assist kinship care families, and HHS has not granted a State waiver 
for this purpose since President Bush took office. Senator Clinton has 
introduced legislation with Senator Snowe to expand the uses of IV-E to 
include subsidized guardianship arrangements.
    Can we count on your support of this proposal as we reauthorize 
Title IV-E?
    Answer 1. Thank you very much for your comments on Utah's 
guardianship program. I am extremely proud of the work we did in Utah 
to strengthen our foster care program. I understand that HHS recently 
approved a waiver for one State to fund kinship care and that there are 
others in process. However, I am a strong proponent of maximum State 
flexibility and believe the President's Child Welfare Program Option 
provides a much better approach for supporting State innovation than 
the existing waiver process.
    Under the President's proposal, States would be offered the 
opportunity to receive their foster care funding as a flexible grant to 
develop a seamless child welfare system that supports a continuum of 
services to families in crisis and children at risk. States that choose 
the option would be able to use the funds for foster care payments, 
prevention activities, permanency efforts (including guardianship) and 
administrative and other service related child welfare activities.
    I strongly urge you to support the President's proposal and look 
forward to working with you on this key legislative initiative to 
support innovation and strengthen child welfare programs and the 
critical services they provide to this vulnerable population.

                            Family Planning
    Question 2. As you know, Title X is the cornerstone of our Nation's 
family planning program. For millions of low-income women it is the 
only access to healthcare they have. It is also cost effective--saving 
three dollars in Medicaid costs for every dollar expended. Yet, the 
Title X appropriation has lost significant value since the early 80s. 
If the program had only kept pace with inflation--experience no 
increase at all--since 1981, the funding level would be double what it 
is today. Can we count on you to strongly support Title X by increasing 
the budget proposal for Title X funds?
    Answer 2. Title X, as you pointed out, has a long history of 
providing family planning services and there were considerably fewer 
family planning options for low-income women when the program was 
created 35 years ago than there are today. For example, in 1970 very 
few States had dedicated funds for family planning. Since then, 
however, virtually all States have committed resources to help women 
plan for healthy families. In addition, the growth of more avenues of 
support in the Federal and private sector have made it possible for 
many, many more low-income women in the United States to have access to 
free or affordable family planning services.
    Title X funding itself has increased from $162 million in 1981 to 
its current level of more than $280 million. In addition, the Maternal 
and Child Health Block Grant programs and Community Health Centers are 
among the new resources though which low-income women can and do 
receive subsidized care. By far the largest expenditures for family 
planning services, however, are made under the Medicaid program and, in 
particular, the Medicaid waivers granted to States to provide family 
planning assistance. In 2004, over $810 million in Federal funds were 
expended for fee-for-service family planning services under Medicaid. 
With the expansion of Medicaid waivers, more women than ever are able 
to have access to family planning services. We need to continue to 
access program effectiveness and determine how we can best serve our 
target population with the resources at our disposal.
    As the Nation's healthcare funding continues to change, I am 
committed to ensuring that low-income women and men continue to have 
access to basic family planning services and care, including those 
services necessary to prepare for planned, healthy pregnancies. I am 
sensitive to the need for both fiscal discipline and the assurance that 
we are meeting our current program funding obligations. As Secretary, I 
will work very hard to ensure that women are able to receive adequate 
access to necessary services.

                                 Plan B
    Question 3. We are am deeply concerned that the FDA's process for 
determining over the counter status became politicized during the 
``Plan B'' application process. The FDA's own advisory committee voted 
23-4 in December of 2003 to approve Plan B for over-the-counter status. 
The panel also unanimously agreed that Plan B is safe for use in the 
non-prescription setting and unanimously rejected the claim (voting 0-
28) that use of Plan B leads to substitution of emergency contraception 
for the regular use of other methods of contraception. Over 70 
organizations, including the American Academy of Pediatrics and the 
American Associations of American College of Obstetricians and 
Gynecologists, have recommended that it be available over the counter.
    What principles do you believe should guide the FDA when it makes 
decisions about what drugs may be available over the counter? Under 
what circumstances do you believe it is appropriate for the FDA to 
override such strong scientific evidence in making such decisions?
    Answer 3. As you know, the FDA previously denied an application to 
change this drug to over-the-counter status, because the supplemental 
application did not meet the criteria for approval in that it did not 
demonstrate that Plan B could be used safely by young adolescent women 
for emergency contraception without the professional supervision of a 
licensed practitioner.
    I understand that the sponsor has subsequently submitted a new 
application, and that the application is being reviewed by the 
scientists at FDA--and that action is due on this application soon.

                               Head Start
    Question 4. I understand HHS is moving forward with its plan to 
test every four-year-old in Head Start via the National Reporting 
System. As you know, many childhood development experts have raised 
concerns about the NRS. On February 28, 2003, a number of experts sent 
a letter to senators expressing their concerns about the implementation 
of the NRS. In an October 28 joint press release, Dr. John Meier, 
Ph.D., Dr. Lonnie Sherrod, Ph.D., and Dr. Susanne A. Denham, Ph.D., 
respected professors and researchers in the field of early childhood, 
suggested that the proposed outcomes are too rigid and that the 
National Academy of Sciences (NAS) should have the ``flexibility to 
design both the test (or tests) and the outcome standards.'' They also 
believe it be detrimental to tie any type of program funding to the 
outcomes of this test. Can we have your assurance that the NRS will 
never be used to make decisions about which programs receive funding? 
What plan does HHS have to ensure that children with special needs and 
those from Limited English Proficient households will be assessed using 
measures that are appropriate? Have HHS made progress in identifying 
and training LEP individuals to administer the NRS to children from LEP 
households?
    Answer 4. I share the President's commitment to accountability and 
to measuring the outcomes of program efforts, including the Head Start 
program. We must do a better job of determining how well Head Start 
children across the country are being prepared for academic success 
once they enter school and the National Reporting System (NRS) is 
critical to this effort.
    The results will be useful in planning new approaches for 
strengthening Head Start program quality and effectiveness. The 
information also can be used to identify common national, regional and 
local needs for training and technical assistance as well as help in 
identifying programs that are unusually effective in promoting 
children's progress. However, it is my understanding that there are a 
number of ways in which Head Start programs are monitored and 
evaluated, and I can assure you funding decisions for Head Start 
programs will not be based solely on the information in the NRS.
    I understand your concerns about the needs for sensitivity in 
assessing children with special needs and those from Limited English 
Proficient households. It is my understanding and expectation that 
appropriate and required adaptations will be made to allow special 
needs children to fully and fairly participate in the NRS assessment. 
Currently, the child assessment is available in both English and 
Spanish and only trained and certified assessors, including those 
fluent in Spanish, will be used. Given the wide and ever-increasing 
diversity of Head Start children and families, I look forward to 
reviewing the recommendations from the newly formed advisory Committee 
on Head Start Accountability and Educational Performance Measures on 
this specific issue as well as other Head Start questions of 
accountability.

                                Medicaid
    Question 5. New York State has the second highest Medicaid 
population in the Nation, and the Medicaid program ensures that 
millions of New Yorkers are able to access crucial health care 
services. I would like to stress the importance of preserving such 
benefits, and I was pleased to see that in your opening statement, you 
recognized the importance of providing access to care for our Nation's 
poor, elderly and disabled populations. I have specific questions about 
your views on some of the possible proposals for Medicaid reform.
    In 1997, you were one of the architects of the National Governors 
Association's Medicaid reform package. In that package, you opposed 
placing Federal spending caps upon the Medicaid program. However, the 
Administration has stated that it favors such a proposal. What is your 
current position on Federal Medicaid spending caps, and how do you 
propose to offer States fiscal relief from rapidly increasing Medicaid 
costs?
    Answer 5. The Administration has not proposed to block grant the 
program. It is committed to maintaining the entitlement of mandatory 
populations to mandatory services. At the same time, I believe that 
States can be given more flexibility to extend health insurance 
coverage to more low-income individuals and families.

    Question 6. As part of your Medicaid reform package in Utah, you 
cut benefits for recipients in order to expand the program to cover 
low-income uninsured individuals. Yet the expanded program failed to 
provide comprehensive coverage and did so through a model in which 
Federal and State dollars were used to subsidize private insurance 
companies. How will you increase the flexibility given to States within 
Medicaid while ensuring that there remains an adequate benefit package 
that is so desperately needed by so many Medicaid recipients?
    Answer 6. First and foremost, I believe strongly that waivers 
provide States with the flexibility to implement innovative ways to 
extend health coverage to more people. This is a goal we should all 
support. The waiver that I implemented in Utah did not make any changes 
to the benefit for mandatory populations. Instead, the waiver expanded 
preventive and primary care coverage to an additional 25,000 uninsured 
adults. To do so, a $50 enrollment fee was instituted, but with 
exemptions for vulnerable optional populations (including the elderly, 
blind, disabled, children and pregnant women).
    States are not required by the Medicaid law to cover optional 
populations, yet hundreds of thousands of people in this country--who 
would otherwise be uninsured--now have access to healthcare because 
States have been granted modest flexibility in designing and 
implementing Medicaid expansions. I simply disagree with the suggestion 
that the better policy would be to leave all of these people without 
any health care.

                   Information Technology and Health
    Question 7. As governor of Utah, you were a pioneer in efforts to 
increase efficiency through the use of interoperable information 
technology systems within the State government. During your testimony 
before the HELP Committee, you reaffirmed your interest in using 
information technology to improve the quality of care and reduce 
overall health care costs. However, the Office of Healthcare 
Information Technology within HHS did not receive any funding in the 
recent omnibus appropriations bill.
    As Secretary, how will you support the efforts of the National 
Coordinator for Health Information Technology and work with Congress to 
provide increased access to and use of information technology in 
healthcare? In addition, how do you plan to promote and implement 
health care information technology as a tool for improving overall 
healthcare quality?
    Answer 7. The President believes that better health information 
technology is essential to his vision of a health care system that puts 
the needs and the values of the patient first and gives patients 
information they need to make clinical and economic decisions. I 
believe that the Federal Government can play a critical role in 
encouraging and facilitating the adoption and use of health information 
technology, and I am keenly interested in this issue. Innovations in 
electronic health records and the secure exchange of medical 
information can help transform health care in America--improving health 
care quality, preventing medical errors, reducing health care costs, 
improving administrative efficiencies, reducing paperwork, and 
increasing access to affordable health care. The goal is to encourage 
widespread private adoption of health it without heavy-handed 
regulation or upheaval in the health care sector. HHS is currently 
undertaking efforts in four areas identified under its strategic 
framework--informing clinical practice, interconnecting clinicians, 
personalizing care, and improving population health--and we should and 
will continue these efforts. I look forward to the opportunities that 
lie ahead in the area of health information technology, and will work 
with Congress in that process.

                    HIV/AIDS and Ryan White Funding
    Question 8. There are over 900,000 people in the United States who 
are infected with HIV/AIDS. New York State has borne the brunt of this 
epidemic, and has had both the highest cumulative number of total AIDS 
cases and the highest number of new AIDS cases in 2003. I cannot stress 
the importance of Ryan White funding to people living with HIV/AIDS in 
New York, many of whom are poor, disabled, uninsured, or underinsured. 
The dedicated funding stream provided by this bipartisan-supported law 
allows people living with HIV/AIDS to access services that are not 
covered under the Medicaid or Medicare programs. While the President 
has already announced his support for reauthorization, I would like to 
gain a greater understanding of your commitment to the Ryan White 
program, and the priority that this reauthorization will have within 
your agency. Specifically:
    How will you ensure that the epidemiological profile of the 
epidemic, which shows that New York City is one of the epicenters of 
this epidemic in the United States, is adequately reflected in funding?
    Answer 8. Thank you for your support for the Ryan White CARE Act. I 
understand your concern for the people of New York who are living with 
HIV and AIDS. The Administration continues to finalize its assessment 
of the successes and drawbacks of the current Ryan White CARE Act 
(RWCA) statute. Through the reauthorization process, there are 
opportunities to strengthen the various RWCA programs and to make them 
more effective. Treatment for people living with HIV/AIDS has changed 
significantly since the last RWCA reauthorization. If I am confirmed as 
Secretary, I will work hard to ensure a successful reauthorization. As 
I am sure you are aware, the President laid out the principles that 
will be used in guiding this process: (1) focus Federal resources on 
life-extending care and a core set of clinical services, (2) provide 
greater flexibility to better target resources to address areas of 
greatest need, (3) encourage participation of any provider, including 
faith based and community organizations, that show results, recognizing 
the need for State and local planning, and ensuring accountability by 
measuring progress.
    With regard to ensuring that funding adequately reflects the 
profile of the epidemic, the President's second reauthorization 
principle is to ensure that the Secretary has greater flexibility to 
target resources to areas of greatest need. This will be an important 
aspect of any reauthorization discussions. As you know, RWCA grants 
that are distributed by formula are currently based on estimated living 
AIDS cases. Under the formulas for Title II grants to States and Title 
I grants to Eligible Metropolitan Areas, New York State and New York 
City have each received over $1 billion between 1991 and 2004. The 
Institute of Medicine (IOM) issued a report in 2003 that examined 
whether States' HIV surveillance systems could provide adequate and 
reliable information on the number and demographic characteristics of 
cases of HIV infection on which to base RWCA formula grants. The study 
considered issues of State capability, comparability of data across 
jurisdictions, whether HIV data would be a more accurate measure of 
disease burden, and whether material variation and equitable 
allocations would result. While the IOM supported Congressional intent 
to incorporate data into the allocation formulas that reflect the 
evolving needs of the epidemic, their overall finding was ``that 
States' HIV reporting systems are neither ready nor adequate for 
purposes of the Ryan White CARE Act allocation.'' Therefore, Secretary 
Thompson concluded that HIV data should not be used for purposes of 
making formula grants under Titles I and II of the RWCA, and that 
estimated living AIDS cases should continue to be utilized until such 
time as HIV data is judged to be useful. HHS will continue to work with 
States to support an HIV surveillance system that ensures the 
collection of such data.

    Question 9. How will you ensure that Ryan White Funding is able to 
provide the appropriate mix of support and treatment services for the 
many conditions faced by people with HIV, including everything from 
homelessness to increased rates of Hepatitis C infection?
    Answer 9. When the RWCA was originally enacted, people living with 
AIDS had little hope. Treatment focused on support services for people 
who were severely disabled and dying. Medical advances and new 
medications have enabled people to live longer, healthier lives and 
treatment has shifted toward helping people live with a chronic 
disease. At the same time, those entering care are more likely to be 
poor, minority, and have other complex issues, such as substance abuse 
and mental health issues. As we consider the successes and drawbacks of 
the current RWCA statute in the context of reauthorization, and discuss 
ways to make the program more effective, we will identify strategies 
that enable HHS to meet these changing needs and provide more 
flexibility to target resources to the areas with the greatest need.

                            EPA and Industry
    Question 10. While you were serving as EPA Administrator, the 
agency was forced to suspend implementation of its Children's 
Environmental Exposure Research Study (CHEERS), a program partially 
funded by the American Chemistry Council, in response to concerns over 
potential harm to participants. Opponents of the study are concerned 
that industry involvement would influence the methodology and outcomes 
of the study, and EPA has taken the step of re-examining the study's 
protocol in response to these charges. While I appreciate the 
responsiveness of the agency to these concerns, I am deeply concerned 
about the safety of research participants, as well as the children who 
would eventually be affected by the outcome of this study.
    At HHS, similar concerns have been raised about the influence of 
private companies, particularly the pharmaceutical industry, upon the 
activities of HHS agencies. The recent withdrawal of Vioxx and the 
controversy surrounding side effects of pediatric antidepressant use 
have called attention to the industry's influence on the FDA drug 
approval process and the inability of the agency to guarantee the 
safety of these drugs after they are marketed to the public.
    What actions will you take as Secretary to ensure that the FDA 
operations are not influenced by drug company financing, and how will 
you guarantee the safety of drugs after they become available on the 
market?
    Answer 10. If confirmed, I will work to ensure that FDA performs 
its important statutory responsibility to monitor the safety of 
approved drugs. The enhanced post-marketing surveillance provisions in 
the Prescription Drug User Fee Act provide new tools and opportunities 
to accomplish this goal.

                 EPA and the Safety of Nuclear Workers
    Question 11. The Energy Employees Occupational Illness Compensation 
Act (EEOICPA) was passed by Congress in 2000. This law is intended to 
compensate former nuclear weapons workers whose illnesses were caused 
by exposure to radiation during weapons production-related activities. 
This program is extremely important to my constituents, as a 
considerable amount of this work was performed in New York during the 
1940s and 1950s. Under EEOICPA, the Secretary of HHS has significant 
direct responsibilities, as does the National Institute for 
Occupational Safety and Health (NIOSH). One of the direct 
responsibilities of the Secretary under EEOICPA is to act on 
recommendations of the Advisory Board on Radiation and Worker Health. 
And the next several months, the Advisory Board will be forwarding to 
the Secretary of HHS a set of recommendations about the Bethlehem Steel 
site in Lackawanna, NY. Hundreds of claimants who worked at the 
Bethlehem Steel site have been waiting for years to have their claims 
considered fairly, which will depend in part on your reaction to 
Advisory Board's recommendations.
    If confirmed, will you act promptly on these recommendations after 
you receive them? In addition, if confirmed, will you work with me to 
address concerns about implementation of the program by NIOSH as they 
arise?
    Answer 11. NIOSH responsibilities under Energy Employees 
Occupational Illness Compensation Program Act of 2000 had to be 
fulfilled before NIOSH could begin processing claims. NIOSH had to hire 
staff, establish procedures and promulgate three rules to create the 
process and systems to run the program; a backlog was created because 
the program was receiving claims before processes were in place.
    As of January 20, 2005, NIOSH has completed more than 50 percent of 
the claims from New York and nearly 40 percent of all claims received 
from the Department of Labor. In addition, the promulgation of the 
Special Exposure Cohort rule in May 2004 will speed determination of 
claims for which it is not possible to perform a dose reconstruction 
with sufficient accuracy. NIOSH will continue to strive to improve its 
performance.

            World Trade Center Expert Technical Review Panel
    Question 12. While you served as the Administrator of the 
Environmental Protection Agency, we worked together to form and launch 
the World Trade Center Expert Technical Review Panel. I appreciate the 
attention that you gave to this important issue during your time at 
EPA. As you know, the Department of Health and Human Services is 
represented on the panel. As its work continues in 2005, the panel will 
shift its focus to examining the health consequences of exposure to 
contamination released from the collapse of the World Trade Center. I 
believe that HHS is uniquely suited among the Federal agencies 
represented on the panel to address these issues.
    Will you work with me to strengthen the role of HHS on the panel to 
help ensure that the panel addresses these issues in a timely and 
comprehensive manner?
    Answer 12. As Secretary of HHS I would continue the commitment I 
made as Administrator of EPA to the important work of the World Trade 
Center Expert Technical Review Panel. As you know, the Centers for 
Disease Control and Prevention, the Agency for Toxic Substances and 
Disease Registry, and the National Institutes of Health are working in 
collaboration with other public and private entities, such as the New 
York City Department of Health and Mental Hygiene, and academic and 
health care institutions, many of which also are represented on the 
Panel, on projects relating to the health consequences of exposure to 
contamination released in the World Trade Center disaster.

                              Food Safety
    Question 13. Listeria monocytogenes is the most virulent of 
foodborne pathogens, killing 20 percent of those infected, with 
pregnant women and their unborn children being particularly 
susceptible. While the U.S. Department of Agriculture (USDA) and HHS 
had publicly committed in 2000 to reducing the rate of listeria 
poisoning by half by 2005, the deadline for this halving has since been 
pushed back to 2010. Will you reinstate the goal of halving the 
Listeria food poisoning rate by the end of 2005, rather than 2010?
    Answer 13. The goal has always been stated in the Healthy People 
2010 document as a 50 percent reduction in illness attributed to 
Listeria monocytogenes by 2010. In FDA's Listeria monocytogenes Action 
Plan document, FDA stated its own goal would be to achieve this 
reduction by 2005. The baseline for calculating the reduction is 0.47 
illnesses per 100,000 population with the goal of 0.25 illnesses/
100,000. My understanding is that we are on target for reaching the 50 
percent reduction with a current incidence rate of 0.26 illnesses per 
100,000 population.

    Question 14. The FDA is given the mission of ensuring the safety of 
our food supply, and I was pleased of hearing of your commitment to 
maintaining the FDA brand. However, I am concerned about the manner in 
which the FDA is handling the threat of bovine spongiform encephaly 
(BSE), several cases of which have emerged recently in Canada. Both 
Secretary Thompson and former FDA Administrator Mark McClellan have 
affirmed the importance of FDA action in regards to the contents of 
bovine feed. However, the USDA, which is not charged with ensuring the 
safety of our food, has largely taken the lead on this issue. What 
specific FDA action will you take to remove the threat of BSE-
contaminated cows from our food supply, and how will you work with USDA 
to strengthen the regulations in this area?
    Answer 14. On July 14, 2004, FDA published an Interim Final Rule, 
effective immediately, banning use of specified risk materials (SRMs) 
and other prohibited cattle materials in all FDA-regulated foods and 
cosmetics. Prohibited cattle materials include SRMs from cattle 30 
months of age and older, small intestine of all cattle, materials from 
nonambulatory disabled cattle, material from cattle not inspected and 
passed for human consumption, and mechanically separated beef--these 
are the cattle materials at highest risk of containing prions. The FDA 
foods regulation parallels the USDA Interim Final Rule, also effective 
immediately, for meats and meat products. The agencies cooperated in 
the development of these documents and continue to cooperate to 
maintain a harmonized U.S. food safety policy for BSE.
    Both the FDA regulation covering foods and cosmetics and the USDA 
regulation covering meat and meat products augment the preventive 
measures already in place to reduce or eliminate the threat of BSE in 
the U.S. and in the U.S. food supply. These measures include FDA's 1997 
regulation that prohibits, with some exceptions, the use of protein 
derived from mammalian tissues in feed for cattle and other ruminant 
animals--the basis of the agency's efforts to prevent the spread of BSE 
in U.S. cattle. They also include the import prohibitions imposed by 
USDA/APHIS.

                          Science and Ideology
    Question 15. The National Academy of Sciences recently issued a 
report on how the Administration screens nominees for advisory panels 
in areas of science and technology. Specifically, the report 
recommended the following:
    ``When a Federal advisory committee requires scientific or 
technical proficiency, persons nominated to provide that expertise 
should be selected on the basis of their scientific and technical 
knowledge and credentials and their professional and personal 
integrity. It is inappropriate to ask them to provide nonrelevant 
information, such as voting record, political-party affiliation, or 
position on particular policies.''
    How will you ensure that scientific expertise, rather than 
political views, is the crucial factor in determining whether a 
candidate is qualified for an advisory panel?
    Answer 15. Although I have not had an opportunity to review the 
report you cited, I believe that scientific expertise is critical to 
ensuring appropriate input on scientific advisory committees, and I 
will work to ensure that HHS advisory committees are appropriately 
assembled.


                      Mental and Behavioral Health
    Question 16. What do you see as the role of mental and behavioral 
health services in federally supported health care programs?
    Answer 16. In its report entitled ``Achieving the Promise: 
Transforming Mental Health Care in America'' issued in July of 2003, 
the President's New Freedom Commission on Mental Health established six 
goals as a foundation for transforming mental health care in America. 
The first goal was that ``Americans Understand that Mental Health Is 
Essential to Overall Health.'' In its discussion of that goal, the 
Commission discussed what a transformed mental health delivery system 
would look like. Part of that discussion included the following 
passage:
    Effective mental health treatments will be more readily available 
for most common mental disorders and will be better used in primary 
care settings. Primary care providers will have the necessary time, 
training, and resources to appropriately treat mental health problems. 
Informed consumers of mental health service will learn to recognize and 
identify their symptoms and will seek care without the fear of being 
disrespected or stigmatized. Older adults, children, and adolescents, 
individuals from ethnic minority groups, and uninsured or low-income 
patients who are treated in public health care settings will receive 
care for mental disorders.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) was given lead responsibility for preparing a response to the 
Commission's findings and recommendations. An Action Agenda was 
prepared after consultation with 15 different Federal agencies. The 
Action Agenda is expected to be released shortly.
    Incorporated in this agenda are goals for integrating behavioral 
health care into the primary health care system to provide greater 
access to quality mental health care in keeping with goal 1 of the 
Commission Report.
    I look forward to sharing the Agenda with Congress as soon as it is 
released.

    Question 17. How can we ensure that the Medicaid waiver process 
does not undermine critically needed mandatory mental health services, 
such as those provided through Early and Periodic Screening, 
Diagnostic, and Treatment (EPSDT)?
    Answer 17. In general, I believe that EPSDT is a very important 
benefit that must be preserved and protected for the most vulnerable 
children--those with disabilities and those in families at the lowest 
income levels. I also believe strongly that waivers provide States with 
the flexibility to implement innovative ways to extend health coverage 
to more people. This is a goal we should all support.

                              Flu Vaccine
    Question 18. As you are well aware, our Nation recently suffered 
its third flu vaccine shortage in four years. In order to forestall 
such shortages, I have asked Secretary Thompson and HHS to implement 
some of the recommendations of the Government Accountability Office 
(GAO) regarding flu vaccine development and distributions. I would like 
to know what measures you will take to ensure an adequate and safe flu 
supply, in particular:
    How will you develop a flu vaccine supply cushion, or otherwise 
enable the Government to stockpile flu vaccine in case of emergency? In 
what ways will you work to encourage increased research of alternative 
vaccine production methods at the National Institutes of Health? How 
will you improve the CDC's ability to track and distribute vaccine 
throughout the United States in times of shortage? How will you improve 
the ability of the FDA to expedite approval and safe importation of 
excess flu vaccine from other nations? What are your plans for 
encouraging drug companies to enter the flu vaccine market?
    Answer 18. Preparation for the annual flu season has been a 
priority at HHS. I will ensure that it continues to be a priority. I 
believe that the CDC and FDA have successfully taken great strides 
toward responding to an unforeseeable shortage of vaccine, through the 
creation of tools to help States identify additional vaccine, through 
the identification and purchase of additional vaccine under an 
investigational new drug (IND) application, and through effective 
public communication about the prioritization of high-risk groups who 
should receive the available vaccine. Looking forward to the future, we 
will continue to work with vaccine manufacturers to encourage them to 
bring their vaccine for licensure and sale in the United States, as 
well as taking longer-range steps to encourage the development of a 
domestic vaccine supply, to ensure appropriate supplies of influenza 
vaccine.

                             Pediatric Rule
    Question 19. In 1998, the FDA adopted a ``Pediatric Rule'' that 
required drug manufacturers to provide guidelines for the safe use of 
their products by children. In order to codify the FDA authority to 
require such action on behalf of companies, several of us from the HELP 
Committee introduced the ``Pediatric Research Equity Act of 2003, which 
has now become law. This law strengthens the FDA's power to ensure that 
drugs that are marketed for pediatric populations are safe for use in 
those populations. In February 2004, I sent a letter to Secretary 
Thompson asking him how he planned to implement the Pediatric Rule 
after concerns were raised in regards to the safety of antidepressant 
use in children. I would like to learn about your position on these 
issues as well. Specifically:
    How can we further improve the FDA's current statutory 
authorization to strengthen the safety and efficacy of pediatric drugs?
    Answer 19. The Pediatric Research Equity Act of 2003 and the Best 
Pharmaceuticals for Children Act of 2002 have provide FDA with valuable 
tools to ensure the development of information on the safe and 
effective use of pharmaceuticals products in pediatric populations. I 
hope to more closely review these if confirmed as Secretary

    Question 20. What steps do you plan to take to ensure that clinical 
trial information resulting from pediatric studies will be available to 
the children and families who would greatly benefit from such access?
    Answer 20. FDA is committed to including appropriate information 
related to the safe and effective use of drugs in pediatric patients in 
approved drug labeling. In addition, when pediatric studies are 
submitted to FDA as part if the pediatric exclusivity program under the 
Best Pharmaceuticals for Children Act of 2002, within 180 days, the 
agency publishes on the web () a summary of the medical and clinical pharmacology 
reviews of the pediatric studies. In addition, when pediatric-specific 
changes are made to drug labeling as a result of studies conducted for 
pediatric exclusivity, FDA highlights these changes on its pediatric 
web-site at http://www.fda.gov/cder/pediatric/labelchange.htm.

                              Open Access
    Question 21. This past fall, NIH released a draft rule to improve 
access to federally funded research literature. While I have supported 
the concept of open access throughout this process, I think it is very 
important that a deliberate and inclusive process is pursued to ensure 
adoption of a policy that thoughtfully considers and appropriately 
addresses the views of all those affected by it.
    What will you do to ensure that this is the case, particularly in 
light of suggestions that the delay of an announcement about the final 
rule was designed to postpone any controversy over this issue until 
after your confirmation?
    Answer 21. I am not familiar with the details of the proposal, or 
of where NIH stands as it works to finalize the proposal. Nonetheless, 
in general, I believe that encouraging transparency and a public 
dialogue in managing the taxpayer's investments at NIH are critical 
steps to ensuring that the trust Congress has shown is maintained.

                       Comparative Effectiveness
    Question 22. Comparative Effectiveness studies were included in the 
final Medicare prescription drug law based on an amendment that 
Senators Johnson and Bingaman joined me in offering during debate on 
the bill. In December, AHRQ released its initial list of priorities for 
this work.
    In light of recent concerns over post approval drug safety, what 
will you do to ensure that comparative effectiveness research is used 
to help address this critical issue?
    Answer 22. As you know, the MMA directed HHS to take important new 
steps with regards to the comparative clinical effectiveness of 
prescription drugs and other therapies. However, the MMA did not 
include appropriations for these efforts. Accordingly, AHRQ and CMS 
have taken steps to move forward as quickly as possible within those 
constraints. This research is a priority for both AHRQ and CMS, and I 
look forward to working with you as HHS moves forward on this.
                                 ______
                                 
                 Response to Questions of Senator Dodd
                     Ryan White CARE Act--Title IV

    Question 1. The highly effective approach of family-centered care, 
as practiced by grantees under Title IV of the Ryan White CARE Act, is 
a model of efficiency that provides comprehensive medical and support 
services to women, children, youth and families affected by HIV/AIDS. 
Across the country, more than 53,000 people are served by 91 programs, 
including specialized programs for HIV-positive adolescents and youth. 
It is a critical program that must be maintained. If you prioritize the 
reauthorization of the Ryan White CARE Act? Will you support 
maintaining Title IV as an independent program that emphasizes the 
importance of ``family-centered'' care? The past two fiscal years have 
brought cuts to Title IV, despite its burgeoning caseload. Do you 
support funding increases for Title IV? The HIV epidemic is growing 
among young people in the United States, yet primary HIV prevention 
programs at CDC targeting youth have been cut in recent funding cycles. 
Do you agree we need additional resources for CDC's HIV prevention 
programs for young people?
    Answer 1. Thank you for your support for the Ryan White CARE Act, 
which provides for the treatment of over 500,000 individuals living 
with HIV/AIDS in the United States. The Administration continues to 
finalize its assessment of the successes and drawbacks of the current 
Ryan White CARE Act (RWCA) statute. Through the reauthorization 
process, there are opportunities to strengthen the various RWCA 
programs and to make them more effective. Treatment for people living 
with HIV/AIDS has changed significantly since the last RWCA 
reauthorization. If I am confirmed as Secretary, I will work hard to 
ensure a successful reauthorization. I would expect that the structure 
of the RWCA Titles may be part of the discussion during the 
reauthorization process. As I am sure you are aware, the President laid 
out the principles that will be used in guiding this process: 1) focus 
federal resources on life-extending care and a core set of clinical 
services, 2) provide greater flexibility to better target resources to 
address areas of greatest need, 3) encourage participation of any 
provider, including faith based and community organizations, that show 
results, recognizing the need for State and local planning, and 
ensuring accountability by measuring progress. The President's budget 
will be delivered to Congress next month and will include continued 
funding for all Titles of the Ryan White CARE Act.
    As for HIV prevention programs at CDC, this is a high priority for 
HHS and CDC and is reflected in the ongoing funding of State and local 
health departments, community based organizations, and school health 
programs. Much of the funding provided to State and local health 
departments, as well as community organizations, for HIV prevention 
efforts is directed towards programs serving youth and young adults. 
HHS encourages community organizations serving youth to work with their 
health departments to determine the best way to meet the HIV prevention 
needs of young people in their communities. If I am confirmed, I will 
stand ready to work with you to ensure that these programs continue to 
help at-risk youth to stay healthy, reduce their risk, and remain free 
of HIV infection, and to help young people already infected with HIV to 
access the care, treatment, and support they need.

                           Pediatric Devices
    Question 2. Governor Leavitt, as you may know, for almost the past 
decade, this committee has taken the lead in ensuring that the drugs 
children need are tested specifically for their use. Beginning with 
legislation enacted in 1997 which created incentives for pediatric 
studies (authored by myself and Senator DeWine) and continuing through 
legislation enacted in 2003 requiring pediatric testing of certain 
drugs (championed by myself, Senators Gregg, Kennedy, DeWine, Clinton, 
and others) we have been working hard to ensure that children have the 
same assurance of drug safety and efficacy that we expect as for 
ourselves as adults.
    As we're beginning to learn, however, this problem isn't confined 
to drugs. Like with drugs, where for too long we assume that children 
were small adults and could just take reduced doses of adult products, 
we're finding that many essential medical devices used extensively by 
pediatricians are not designed and sized for children's special needs. 
Because the number of children needing a particular device is often 
quite small, there's simply little financial incentive for 
manufacturers to make pediatric appropriate devices. As a result, 
health care providers are forced to use adult devices ``off-label'' 
without a clear understanding of the risks involved or to use older, 
less optimal, or more invasive interventions. Pediatricians tell us 
that the development of cutting-edge medical devices suitable for 
children's smaller and growing bodies can lag 5 or 10 years behind 
those for adults.
    In my view, this is an issue that demands our attention. As 
technology for prolonging and saving lives continues to advance at a 
rapid pace, children are at risk of being left further and further 
behind. It is my strong hope that this year we can come together on 
bipartisan legislation to ensure that children are not an afterthought 
when it comes to life-saving medical devices.
    Governor Leavitt, I would be very interested in your views on this 
issue. It would be my hope, if you are confirmed, that we could work 
closely together on this very critical problem.
    Answer 2. As you know, bringing pediatric medical devices to market 
can be challenging for a number of reasons. Children are often smaller 
and more active than adults, body structures and functions change 
throughout childhood, and children may be long-term device users--
bringing new concerns about device longevity and long-term exposure to 
implanted materials. In addition, modifying an adult device for 
pediatric use may require significant re-designing of the device and 
re-tooling of the manufacturing process. Conducting clinical trials in 
children can also be more difficult due to the small patient population 
and the variation within the population. I believe it is critical that 
we work with FDA to encourage and support the development and 
availability of safe and effective pediatric medical devices, and hope 
to work with you in this area.

               Medicare Modernization Act Implementation
    Question 3. The new Medicare Part D prescription drug program will 
begin in January 2006. To succeed, Medicare beneficiaries must receive 
specific information regarding the plans available to them. The 
information must be mailed to beneficiaries and include the drug 
formularies in the plans available to each individual, what the co-
payments will be for each covered drug, how to enroll, and the 
consequences of failing to enroll. Without this information 
beneficiaries cannot make an informed choice.
    Please tell me what you plan to do in order to provide this 
information directly to each Medicare beneficiary. If you do not know 
at this time, please confirm that you will mail specific information to 
each beneficiary, that the information mailed will be particular to the 
options available to each individual and that the information will be 
detailed enough to allow the beneficiary to make an informed choice.
    Answer 3. CMS will mail detailed comparison information about the 
new prescription drug plans to all beneficiary households no later than 
October 15, 2005, as required by the MMA, and will include the 
information in our annual Medicare & You handbook, which allows CMS to 
employ a tested production process and a trusted and recognizable 
communication vehicle to get this information into the hands of 
beneficiaries and help them make an informed choice. Handbooks have 
specific comparison information for each beneficiary's geographic area 
and the comparison data that is included is garnered from data that the 
plan itself submits to CMS and has the opportunity to preview before 
the mailing occurs. Additional detail will be available through the 
individual plans, www.medicare.gov and 1-800-MEDICARE.

    Further to the implementation of the Part D program:
    Question 4. What particular outreach efforts will be made for hard-
to-reach populations, including those in nursing homes, those who are 
eligible for both Medicaid and Medicare, those who speak other than 
English as their first language, and those in rural areas?
    Answer 4. Medicare's community-based outreach will work through the 
Social Security Administration (SSA) and other Federal agencies, 
States, employers, providers, pharmacists and other health care 
stakeholders to reach beneficiaries through the various networks where 
they obtain health care information. This local outreach will encompass 
the hard-to-reach Medicare populations including those in nursing 
homes, those who are eligible for both Medicaid and Medicare, those who 
speak other than English as their first language, and those in rural 
areas.
    CMS will continue this local outreach through an expansive 
grassroots campaign to educate Medicare beneficiaries at the local 
level about the Medicare drug benefit. For example, CMS enhanced its 
partnership with the State Health Insurance Assistance Programs 
(SHIPs). HHS awarded $21.1 million in fiscal year 2004 and will award 
another $31.7 million in fiscal year 2005 to the SCHIPs, thereby 
reflecting the increased emphasis on one-on-one advice and counseling 
for Medicare beneficiaries. The SCHIPs are among the most effective 
resources in helping beneficiaries learn about the changes to Medicare 
and will be able to use the additional funds to equip local 
organizations with the tools needed to answer beneficiaries' questions. 
CMS will also support an expansive network of local, community based 
organizations to help educate and assist low-income beneficiaries who 
may otherwise be hard to reach.

    Question 5. What additional funding will be made to the State 
Health Insurance Programs (SCHIPs) so that they will have sufficient 
resources to help older people and people with disabilities understand 
the new Part D program and make informed choices?
    Answer 5. CMS has increased the funding for SCHIPs by awarding 
$21.1 million in fiscal year 2004 and will award another $31.7 million 
in fiscal year 2005 to the SCHIPs, thereby reflecting the increased 
emphasis on one-on-one advice and counseling for Medicare 
beneficiaries.
     Global HIV/AIDS--Appropriate Pharmaceuticals for Pediatric Use
    Question 6. Currently, few programs specifically target the 
treatment of children with HIV/AIDS in developing countries. One of the 
reasons for this is the lack of appropriate pharmaceuticals for their 
use. Children are not small adults and treating them that way 
jeopardizes their lives. With 2.5 million children infected with HIV 
around the world, it is essential that we have appropriate medications 
to treat them. How will you ensure that the HIV/AIDS drugs (both 
generic and brand name) being approved by the FDA expedited process 
will also include pediatric formulations, as well as important dosing 
information needed for treating different age groups?
    Answer 6. The pediatric exclusivity provision of the 1997 FDA 
Modernization Act and the subsequent 2002 Best Pharmaceuticals for 
Children Act have generated many clinical studies and useful 
prescribing information for many products, including several for the 
treatment of HIV infection. FDA has an HIV Written Request Template to 
facilitate the development of products. Following are a few examples of 
products that have been approved for treatment of HIV infection in 
children. These approvals resulted from studies submitted in response 
to a Written Request from FDA.
    Ziagen (abacavir), Zerit (stavidine), Videx (didanosine), and 
Viracept (nelfinavir mesylate), in combination with other 
antiretroviral agents, are indicated for the treatment of HIV-1 
infection in children. Use of Ziagen in pediatric patients aged 3-
months to 13 years is supported by pharmacokinetic studies and evidence 
from adequate and well-controlled studies of Ziagen in adults and 
pediatric patients. Use of Zerit in pediatric patients from birth 
though adolescence is supported by evidence from adequate and well-
controlled studies of Zerit in adults with additional pharmacokinetic 
and safety data in pediatric patients. Use of Videx in pediatric 
patients two weeks of age through adolescence is supported by evidence 
from adequate and well-controlled studies of Videx in adults and 
pediatric patients. Use of Viracept in pediatric patients from age 2 to 
age 13 is supported by evidence from adequate and well-controlled 
studies of Viracept in adults with additional pharmacokinetic and 
safety data in pediatric patients.
    In addition, in March 2003, the Pediatric Subcommittee of the 
AntiInfective Drugs Advisory Committee, of the Food and Drug 
Administration, Center for Drug Evaluation and Research discussed the 
development of antiretroviral drugs in HIV-infected and HIV-exposed 
neonates younger than four weeks of age. The Advisory Committee 
supported the continued need for development of products for neonates.
    These are just a few examples demonstrating FDA's commitment to the 
principle that product development should include pediatric studies 
when pediatric use of the product is intended. In addition, through 
efforts to make safe and effective antiretrovirals available for 
treatment of HIV across much of the developing world, we expect to 
reduce the number of children born with HIV infection and thus 
significantly impact global health.
    If confirmed as Secretary of HHS, I will work to ensure that FDA 
builds on this strong record of review of HIV treatments suitable for 
children.

                      Mercury/Environmental Health
    Question 7. The Environmental Protection Agency (EPA), under your 
leadership, is poised to finalize a regulation that would establish a 
market-based trading program for the regulation of mercury emissions 
from coal-fired power plants. The trading regime would reduce emissions 
from the industry overall, but would allow some plants actually to 
increase their mercury emissions. Unlike emissions of substances like 
carbon dioxide, mercury emissions are believed to have at least some 
local impacts. In addition, mercury is believed to be toxic to 
children.
    Governor Leavitt, there is a growing body of evidence that 
environmental factors have a profound impact on children's health. I am 
concerned that your actions as EPA Administrator in regards to mercury 
suggest insensitivity to this issue. As Secretary of HHS, what would 
you do to protect children from mercury and other environmental hazards 
that cause conditions from asthma to impaired neurological development?
    Answer 7. During my tenure at EPA, and especially during the 
development of the first-ever rule to regulate mercury emissions from 
power plants, I have been committed to protecting the public health of 
all citizens and the environment. To that end, I outlined five 
principles that provided a context for additional inquiry and help 
focused the Agency's deliberations as it moves toward the mercury final 
rule in March of this year. The protection of children and pregnant 
women from the health impacts of mercury were at the forefront of these 
five principles.
    As you may know, we have coordinated the implementation of the cap-
and-trade approach for regulating mercury from utility units with the 
Clean Air Interstate rule proposal (CAIR), which is designed to 
dramatically reduce and permanently cap the emissions of sulfur dioxide 
(SO2) and nitrogen oxides (NOx) in 29 Eastern States. We believe that a 
multi-pollutant approach to regulating SO2, NOx, and mercury from the 
utility sector provides a cost-effective and environmentally beneficial 
strategy for reducing air pollution from the sector.
    As a general matter, a cap-and-trade system requires emissions 
reductions on a concrete timeline of declining caps, thus leading to 
continual reduction of emissions and promotion of new technologies. 
Further, the largest emitters typically will be the first to reduce 
their mercury emissions and will generally achieve the greatest level 
of reductions. More specifically, it is my understanding that in 
implementing cap-and-trade programs in the past, we have not observed 
the creation of hot spots. Even so, the proposed trading programs 
provide legal mechanisms to ensure that should hot spots be identified, 
appropriate Federal and/or State actions are allowed to address them. 
Historically, EPA has seen the largest emitters attempt to control 
emissions sooner in a cap-and-trade program because of the economies of 
scale and the ability to bank allowances for later years. Thus, we 
believe such a program creates incentives for the utility sector to 
aggressively seek reductions in NOx and SO2, which ultimately provide 
early mercury reductions.
    As Secretary of HHS I would continue the Department's commitment to 
safeguard the environmental health of children, through support of 
several ongoing programs to advance the scientific understanding of 
health impacts from exposure to hazardous substances, including 
mercury, and to protect children from exposure to environmental 
contaminants with potentially adverse health impacts.
                                 ______
                                 
                Response to Questions of Senator Harkins
                             Obesity Crisis

    Question 1. Health care costs are skyrocketing and chronic 
conditions like obesity and smoking are major contributors. We have one 
of the best medical systems in the world to treat people but 
unfortunately it does little in terms of prevention. Obesity has become 
an epidemic in this country and is especially worrisome when it comes 
to children. The direct and indirect costs of obesity are more than 
$117 billion annually according to the Department you will now lead. 
Yet, there is no single Federal agency with the responsibility and 
authority to handle the crisis. While obesity is a complex public 
health problem, many agree that a comprehensive plan is necessary to 
combat the growing epidemic.
    Do you envision creating a command and control center at CDC to 
develop a Federal game plan for preventing and controlling obesity and 
related chronic diseases like diabetes and heart disease? If not, how 
do you propose to address the Nation's obesity epidemic? How 
specifically will you work with other Federal agencies?
    Answer 1. Seven of nine of the major causes of death in the United 
States are caused by chronic diseases. The underlying causes of these 
diseases are often behaviors that can be successfully modified thereby 
reducing illness and death. Three factors--lack of physical activity, 
poor nutrition, and tobacco use--are major contributors to the Nation's 
leading killers; heart disease, cancer, stroke, chronic obstructive 
pulmonary disease and diabetes. Too, the prevalence of overweight has 
more than doubled in children and tripled in adolescents; indicators 
suggest that diabetes too is increasing among children. This is 
particularly troubling given obesity is a co-morbidity factor leading 
to significantly increased risk of death due to cancer, heart disease 
and diabetes.
    In June 2002, President Bush launched the HealthierUS initiative to 
utilize the combined expertise of the Federal Government to help 
Americans live longer and healthier lives through simple changes in 
their everyday lives. The four pillars of the HealthierUS initiative 
are: 1) be physically active every day; 2) eat a nutritious diet; 3) 
get preventive screenings; and 4) make healthy choices concerning 
alcohol, tobacco, drugs and safety.
    HHS is currently engaged in a number of key activities, two of 
which are listed below. I look forward to examining what has been done 
and what is underway, and working to continue this tremendous progress.
    Current Activities:
     Steps to a HealthierUS Initiative (Steps). Steps 
specifically targets diabetes, asthma and obesity. In fiscal year 2003 
Steps funded 23 communities. In fiscal year 2004 the program awarded 
$44 million to help 16 additional communities develop action plans to 
implement programs that promote disease prevention and health; the 
total number of funded communities is 40. Steps also received $1.5 
million to fund one national program, YMCA's Activate America. Fiscal 
year 2005 appropriations budget for Steps is approximately $47 million.
     National Coverage Decision--Earlier this year, HHS 
announced a new Medicare coverage policy that would permit Medicare to 
cover anti-obesity interventions if scientific and medical evidence 
demonstrate their effectiveness in improving Medicare beneficiaries' 
health outcomes. The new policy removes language in the Medicare 
Coverage Issues Manual stating that obesity is not an illness, allowing 
Medicare to determine if specific obesity-related treatments should be 
covered by Medicare.

            Parity Between Disease Prevention and Treatment
    Question 2. As you know, the United States spends more than $1.5 
trillion each year on health care. That figure has doubled over the 
past 5 years, and if current patterns hold, is expected to double again 
within 6 years.
    The consequences of future increases are clear: More Americans will 
be left without access to health care, and more communities will suffer 
the closure of local hospitals and clinics. As a result, many Americans 
will forgo basic health maintenance visits, making it more likely that 
illnesses will go undiagnosed at early stages--a situation that will 
send health care costs spiraling even further.
    In my view, one way to reduce the long-term burden of disease is to 
invest in preventing disease at the outset. This involves research to 
determine the best methods to convince Americans to adopt healthy 
lifestyles and grassroots programming to get the results of that 
research into our communities.
    To what extent will you focus the efforts of the Department on 
population-based public health research and prevention programs such as 
that conducted by CDC and NIH?
    Answer 2. I believe, as you do, that disease prevention is an 
important tool that we can use to reduce the long-term burden of 
disease. You raise an important question of focusing efforts in this 
area that I will consider carefully if confirmed as Secretary.

    Question 3. A brief glance at the Department's budget proves that 
Federal resources are disproportionately skewed away from disease 
prevention and toward treatment of illness and disease. In 2003, 
Federal spending on health care programs run by the Centers for 
Medicare and Medicaid services totaled $414 billion. In 2003, federal 
spending on major disease prevention and health promotion programs 
totaled $42 billion, or just about ten 10 percent.
    A greater investment in prevention will ultimately yield tremendous 
savings in human suffering and financial cost. Have you given any 
thought as to how you might make disease prevention a centerpiece of 
the Department's vast and diverse portfolio?
    Answer 3. As you know, many of our Nation's leading health 
challenges are preventable diseases. Focusing efforts on prevention can 
pay key dividends. I know that the recently enacted MMA included 
important provisions in this area, and that prevention has been a 
growing area of focus for HHS. I look forward to carefully examining 
this issue more fully if confirmed as Secretary.

  Need to Increase Access to Community Based Services for People With 
                    Disabilities and Older Americans
    Question 4. We are currently spending approximately 70 percent of 
our long-term care Medicaid dollars on institutional settings and only 
30 percent on home and community based services. There needs to be 
increased access to home and community based services so Americans with 
disabilities and older Americans can choose where they want to live and 
not be forced into segregated settings away from family and friends.
    How will you expand the long term care system to assure no person 
is forced into a nursing home or other institution because of the lack 
of home and community service and support options? What policies will 
you propose?
    Answer 4. I firmly believe that individuals who are able to receive 
long term care services and supports in the community have increased 
satisfaction, lower incidence of care neglect, lower incidence of 
adverse effects and health problems; and lower unmet needs. While 
community-based care is not for everyone, I support policy options to 
make the choice available to individuals with disabilities and the 
elderly population.
    CMS is currently working with several States interested in using 
the 1115 waiver authority to develop long-term care systems that 
tighten the standard for institutional care while making home and 
community-based services more readily available. As States have 
developed effective ways to rebalance State long-term care systems, CMS 
is sharing that information with other States to enable them to 
rebalance their systems. As Secretary, I will work with States to use 
the flexibilities permitted in Medicaid to rebalance State long-term 
care systems.

    Question 5. The Supreme Court ruled in the Olmstead case that 
people with disabilities have a right to services and supports ``in the 
most integrated setting''. What will you do as Secretary to assure that 
States are complying with the Olmstead decision and that Medicaid long 
term care funds are spent so people with disabilities have a choice to 
receive services and supports in the most integrated setting?
    Answer 5. As Secretary I will ensure that the Department continues 
to take a leading role in carrying out the President's New Freedom 
Initiative, including its commitment through Executive Order 13217 to 
implement the Olmstead decision to ensure that individuals with 
disabilities receive services in the most integrated setting. The 
Executive Order commits the United States to a policy of community 
integration for individuals with disabilities and calls upon the 
Federal Government to work with States to implement the Supreme Court's 
decision in Olmstead v. L.C. As part of the Executive Order, the 
President directed the Secretary of HHS to coordinate the activities of 
other Federal agencies. This coordinated effort led to the production 
of Delivering on the Promise, a comprehensive compilation of the 
reports of nine Federal agencies outlining more than 400 specific steps 
the agencies will implement to support community living for the nearly 
54 million Americans living with disabilities. The Office on Disability 
was created at HHS to coordinate the Department's commitments, and I 
will ensure that the Department continues to place these activities 
among its highest priorities. Additionally, OCR will continue to 
provide technical assistance to States as they continue developing 
comprehensive, effectively-working plans to integrate persons with 
disabilities into communities and to resolve voluntarily complaints 
filed by or on behalf of persons with disabilities.

                                Medicare
    Question 6. Iowa ranks at the bottom of all 50 States on per 
beneficiary Medicare reimbursement, even though medical facilities in 
Iowa provide high quality care. While I understand that this is due in 
large part to the relative cost of performing these services, I am 
concerned that this reimbursement provides a disincentive for health 
care professionals to remain in the State. In addition, I am concerned 
that any further cuts in provider payments will make this situation 
untenable.
    How do you plan to link Medicare reimbursement with quality 
services and outcomes?
    Answer 6. Encouraging improved health care quality is a top 
priority of mine and of the President's. The Administration has 
promoted accountability for quality, creating incentives to collect 
data from Medicare providers on quality measures. I am intrigued by the 
possibility of approaches to link Medicare reimbursement to provider 
performance. While I certainly am not versed in the variety of ways 
that pay-for-performance could be incorporated into the Medicare and 
Medicaid payment systems, I am excited to be involved in conversations 
regarding the issue. If I were to be confirmed, I would expect the 
Department would continue to review this issue and I would want us to 
work with the provider and beneficiary communities and the Congress in 
doing so.

    Question 7. Do you think, from the administration's perspective, in 
order to reduce the budget deficit in half in five years, that provider 
payments cuts will be part of any administration proposal to change 
Medicare? And, if so, what can be done to mitigate this problem for 
rural providers.
    Answer 7. As you know, I have not been part of discussions on 
forward-leaning budgets, but I am aware of the sensitivities 
surrounding provider payments and the challenges that rural providers 
face and will be sensitive to those issues.

                          Dietary Supplements
    Question 8. As an author with Senator Hatch of the Dietary 
Supplement Health and Education Act of 1994, I wanted to get your 
response to several questions regarding the regulation of dietary 
supplements. First, as you know, after many years of delay, final good 
manufacturing practices regulations are near completion. Can you assure 
me that these regulations will be published in the next 30 days?
    Answer 8. If confirmed, I will look into the status of these 
regulations and work with FDA to see them completed as quickly as 
possible.

    Question 9. Second, as you may know, DSHEA was passed unanimously 
by both the House and Senate. This unanimity of support reflected the 
Act's careful balance of maintaining consumer access to a range of 
healthful products, improving the quality and availability of reliable 
scientific information on supplements, and providing regulatory 
authority adequate to assure the protection of the public health. Do 
you agree with me that DSHEA provides an appropriately balanced 
regulatory structure when fully implemented and enforced? Or do you 
believe it should be amended to provide the Department with additional 
regulatory authority over the manufacture and sale of dietary 
supplements?
    Answer 9. If confirmed as Secretary, I will carefully evaluate the 
need for any additional authority relating to this issue.
    As you may know, FDA recently published a new strategy to 
strengthen its regulation of dietary supplements. FDA's strategy for 
dietary supplements outlines the steps it plans to take to continue 
implementing and enforcing the Dietary Supplement Health and Education 
Act of 1994 (DSHEA). The strategy sets forth a series of research and 
measures, including guidance, regulations, and science-based compliance 
and enforcement mechanisms.
    The strategy focuses on three areas: monitoring and evaluating 
product and ingredient safety, ensuring product quality, and monitoring 
and evaluating product labeling. With this strategy, FDA hopes to 
improve the transparency, predictability, and consistency of the 
Agency's scientific evaluations of dietary supplement product and 
ingredient safety. The actions outlined in the strategy are also 
designed to protect consumers against unsafe dietary supplements and 
dietary supplements making unauthorized, false, or misleading claims. 
FDA expects that this improved transparency will help engage 
stakeholders in the development of further measures to implement DSHEA.
                                 ______
                                 
               Response to Questions of Senator Jeffords

    Question 1. Last December, the FDA's Independent Expert Advisory 
Committees were unanimous in their determination that Plan B is safe 
enough for over-the-counter use, and that there is no data to show that 
Plan B leads to substitution of emergency contraception for other 
methods of contraception. Despite this determination by the Advisory 
Committees, the FDA denied Plan B Over-The-Counter status and overrode 
the overwhelming scientific evidence.
    I am concerned that the FDA decision was based more on ideology 
than science. Governor Leavitt I am interested in what actions you 
would take to ensure that FDA decisions are based on scientific 
evidence and not political ideology?
    Answer 1. I am committed to the principle that regulatory decisions 
should be based on the best scientific information that is available. 
As you know, the FDA previously denied an application to change this 
drug to over-the-counter status, because adequate data were not 
provided to support a conclusion that young adolescent women can safely 
use Plan B for emergency contraception without the professional 
supervision of a licensed practitioner.
    I understand that the sponsor has subsequently submitted a new 
application, and that the application is being reviewed by the 
scientists at FDA--and that action is due on this application soon.

    Question 2. In August of 2004, the Drug Enforcement Administration 
(DEA) forwarded a petition to reschedule marijuana to the Department of 
Health and Human Services (HHS). The DEA requested from HHS a 
scientific and medical evaluation of marijuana, upon which it would 
base its decision as to whether to reschedule marijuana. By law, the 
Secretary of HHS is required to conduct this evaluation ``within a 
reasonable time.''
    As you may know, 10 States, including my home State of Vermont, 
currently allow for the medical use of marijuana, while the Federal 
Government does not. To address this discrepancy, the HHS evaluation 
needs to move forward. Governor Leavitt, can you work to ensure that 
this evaluation is completed by August 2005, 1 year after the request 
was received by HHS? If not, could you please explain what you would 
consider a ``reasonable time'' for this evaluation to be?
    Answer 2. FDA is currently reviewing the scientific data and must 
conduct a scientific and medical evaluation of marijuana in accordance 
with the statutory criteria and make a recommendation to DEA. We will 
make every effort to complete the evaluation by August 2005.
                                 ______
                                 
                Response to Questions of Senator Kennedy
                                Medicaid

    Question 1. At the hearing you talked about your desire to give 
governor's greater flexibility in Medicaid, so that they can cover more 
people. Covering more people is a laudable objective and additional 
resources to do it are essential, but flexibility that results in 
reduced services or coverage for the most needy and sickest members of 
our society is not desirable. Specifically, some who advocate increased 
flexibility have favored abolishing EPSDT services for poor children. 
EPSDT requires the coverage of medically necessary services for 
children even if those services are not normally covered under the 
State Medicaid plan. The children who benefit from this rule are 
typically children with disabilities or special needs who need services 
that are not normally covered by a typical insurance policy.
    Do you think that removing a guarantee of needed health services 
for poor children with serious disabilities is the right priority for 
our country?
    Answer 1. EPSDT is a very important benefit that should be 
preserved and protected for the most vulnerable children--those with 
disabilities and those in families at the lowest income levels who meet 
the federally mandated eligibility groups in Medicaid.

                             Women's Health
    Question 2. Congressman Henry Waxman recently released a report 
showing that the curricula used in the largest abstinence-only 
education program, and other federally funded programs are not reviewed 
for accuracy by the Federal Government. The report finds that over 80 
percent of the abstinence-only curricula, used by over two-thirds of 
the Community Based Abstinence Education grantees in 2003, contain 
false, misleading, or distorted information about reproductive health.
    It is essential to separate ideology from sound science and provide 
clear and accurate sex education for our children. What will you do to 
provide effective oversight of these programs and ensure accuracy and 
integrity of the sex education curricula?
    Answer 2. I share your interest in the Community-Based Abstinence 
Education programs and the need to provide sound and medically accurate 
information to our Nation's youth. I also agree with the President that 
the only 100 percent sure way to prevent unwanted pregnancies and 
sexually transmitted diseases is sexual abstinence. I look forward to 
working with you on helping our Nation's youth make the best choices 
for themselves.

    Question 3. Title X of the Public Health Service Act, the 
cornerstone our Nation's family planning program, serves 5 million 
women each year at more than 4,500 clinics across the Nation that are 
run by abroad range of local providers, including hospitals, health 
departments, and local non-profit agencies. Investments in 
contraception are among the most cost-effective health services. For 
every dollar spent on publicly funded family planning services, three 
dollars are saved in pregnancy-related and newborn care costs to 
Medicaid.
    Despite the proven cost-effectiveness of family planning services, 
Title X has a very small appropriation of only $288 million, even 
though the program has an excellent track record of providing low 
income Americans with subsidized, confidential health care services 
such as pap tests, birth control, and screening and treatment for STDs 
and helps women to avoid over one million unintended pregnancies each 
year.
    Can you give us your assurance that maintaining the integrity of 
Title X and its commitment to providing critical contraceptive and 
related services to low income women will be a top priority for you and 
the department?
    Answer 3. I can assure you that I will require the highest degree 
of accountability and integrity from Title X, and other Federal 
programs that provide family planning, and that reducing health care 
disparities for minority populations and low income families will 
continue to be a priority for the department during my tenure as 
Secretary.

                             Public Health
    Question 4. Two-thirds of Americans are overweight or obese, and 
the problem is growing, particularly in minority populations. Rates of 
obesity in children have doubled, and even tripled in some age groups 
over the past 20 years. As a result, children are increasingly 
developing diseases like diabetes and hypertension that used to be seen 
mostly in adults.
    Last week, HHS and the Department of Agriculture released ``Dietary 
Guidelines for Americans'', which recommend eating more fruits and 
vegetables, low-fat milk, whole grains, and exercising more often. The 
guidelines specifically recommend limiting consumption of sugars and 
trans fats. However, as the report states, the publication is not aimed 
at the general public, unlike previous versions, and no funds are 
designated to promote the guidelines or disseminate the information to 
the public in useful ways.
    What steps will you take to make the information in these 
guidelines available in ways that help people practice what the 
guidelines preach?
    Answer 4. The Dietary Guidelines, based on the latest scientific 
and medical information, provides authoritative advice about how proper 
dietary habits can promote health and reduce risk for major chronic 
diseases. Consumer-friendly materials such as brochures and Web sites 
will assist the general public in understanding the scientific language 
of the 2005 Dietary Guidelines and the key points that they can apply 
in their lives. To highlight those points, a consumer-oriented brochure 
accompanies the 2005 Dietary Guidelines. USDA's Food Guidance System 
also will serve as a tool to educate consumers on the Dietary 
Guidelines for Americans. The Food Guidance System, currently called 
the Food Guide Pyramid, is undergoing revision and will be released in 
the spring of 2005.

    Question 5. The National High Blood Pressure Education Program at 
the NIH has said that the food industry must reduce the sodium content 
of processed foods because such reductions could save tens of thousands 
of lives per year by lowering high blood pressure. How do you intend to 
work with the food industry to reduce the salt in processed foods?
    Answer 5. I believe that HHS has done a tremendous job in focusing 
public attention on the issues relating to wellness, prevention and 
obesity, and that these efforts are bearing fruit. As part of these 
efforts, HHS has been able to work collaboratively with outside 
stakeholders, including the food and restaurant industry, to make 
important progress. An example of this is the improved nutritional 
labeling information that is available through many restaurants. I hope 
to continue this collaborative approach and work with all interested 
parties to improve the health of the Nation.

    Question 6. In a 2004 report on the labeling of sugars and other 
nutrients, the Institute of Medicine recommended that providing 
information to consumers about sugars or added sugars in the context of 
a total daily diet ``should be an urgent consideration of the cognizant 
regulatory bodies.'' How do you believe the FDA should respond to this 
IOM recommendation?
    Answer 6. The 2005 Dietary Guidelines for Americans recommends that 
consumers limit consumption of added sugars in foods and beverages. The 
Dietary Guidelines present the concept of ``discretionary calories'' as 
a way for consumers to understand the amount of added sugars that could 
be incorporated into a healthful diet and also the concept of nutrient 
dense foods as a way to choose products that are good sources of 
nutrients compared to their calorie content. The Nutrition Facts panel 
of food labels provides consumers with information on the total sugars 
in a product and the ingredient list provides information on what is in 
a product, including ingredients that are sources of added sugars. FDA 
can help consumers respond to the recommendations in the IOM report as 
well as the Dietary Guidelines by educating consumers on how to use the 
Nutrition Facts panel and ingredient list to determine which foods are 
high in added sugars.

    Question 7. The Centers for Disease Control released a 
comprehensive report on the state of health of African Americans, which 
outlined severe and pervasive disparities in health between African 
Americans and whites Americans. You mentioned that expansion of health 
insurance coverage would be one way to reduce health disparities. What 
additional programs and policies will you support to eliminate racial 
and ethnic disparities in health and health care? What work has been 
conducted or completed by the HHS Disparities Council in this area? Who 
are the members of the HHS Disparities Council?
    Answer 7. We have experienced remarkable achievements in the health 
of this Nation. However, some Americans have not benefited equally. As 
you correctly indicate, it is well documented that racial and ethnic 
minorities, as well as some geographically and socio-economically 
disadvantaged populations, suffer a greater burden of illness and 
premature death in this country. These disparities in health are 
persistent, in some cases are widening, and are simply unacceptable. We 
must take action if we are to remain healthy, strong, and vibrant as a 
nation. I want you to know that disparities in health is a challenge 
that I have taken to heart.
    The President and his Administration have made the elimination of 
health disparities in our country a priority, and I am also committed 
to making this happen. I intend to work with the Department's Health 
Disparities Council, which consists of senior representatives of each 
agency and staff division of HHS, to focus time and attention on ways 
to make sure communities of color and other disadvantaged populations 
have access to quality health care and are getting the very best health 
information. We will continue to expand on those efforts that have 
resulted in improved health outcomes as well as identify new approaches 
to closing critical health gaps.

    Question 8. Approximately half the U.S. supply of flu vaccine is 
unusable because of manufacturing problems at a facility in Britain 
operated by the Chiron Corporation. I am concerned that FDA appears to 
have known of problems in vaccine production at the facility many 
months before it was shut down by the British regulatory agency, but 
took little action to correct the problems. To determine what actions 
FDA took or failed to take, I requested documents to show FDA's 
communications with Chiron regarding its production of flu vaccine. I 
was disappointed to receive only 229 pages of documentation, which 
included 26 pages that were blank or contained material, such as press 
releases, that were already in the public domain. Over 850 additional 
pages--more than 80 percent of the total relevant documents--were 
withheld and not released to me. That is the nature of the withheld 
documents and why have you deemed them to be ``not releasable?''
    Answer 8. Your request for documents relating to the suspension of 
Chiron Corporation's influenza vaccine manufacturing license by the 
United Kingdom's Medicine and Healthcare Products Regulatory Agency 
covered a very large volume of documents. I understand that FDA 
provided a partial response to your request on January 10, 2005.
    The information redacted from the documents enclosed in the January 
10 letter was commercial confidential and other privileged information 
protected from disclosure under the Freedom of Information Act (Title 
5, United States Code section 552) and FDA regulations.

    Question 9. What steps did the FDA take to monitor Chiron's 
production process after the delay in shipping due to contaminated lots 
in August 2003? Please describe in detail any inspections of the 
Liverpool plant and communication with Chiron employees and British 
regulators.
    Answer 9. I believe that your question relates to contaminated lots 
identified in August 2004, not August 2003. On August 25, 2004, Chiron 
informed FDA that the company had discovered bacterial contamination in 
eight lots of final vaccine product for this year's flu season supply 
and advised that they were investigating the problem. They shared with 
FDA an overview of their planned investigation to determine root causes 
of the problem as well as their plan to retest all other lots produced. 
Chiron quarantined all influenza vaccine lots during its investigation, 
including those that had passed all required testing, and did not 
release any of the product.
    In September 2004, FDA, CDC and Chiron scheduled weekly conference 
calls to discuss the status of the firm's investigation. Chiron stated 
to FDA that the company thought it had identified the cause of the 
contamination and that the contamination was confined to the identified 
vaccine lots. Nonetheless, FDA concurred with the need for Chiron to 
thoroughly retest all final lots, complete a thorough investigation of 
the manufacturing process and provide a complete investigation report 
to FDA. While the investigation was ongoing, Chiron informed FDA that 
results of the retesting were negative and that the company would 
submit its final investigative report to FDA during the week of October 
4-8.
    In late September, Chiron advised that it would substantially meet 
its obligations to supply influenza vaccine to the United States. On 
September 28, Chiron's CEO affirmed this in testimony to the Senate 
Committee on Aging when he stated: ``As of September 27th, it remains 
Chiron's expectation that between 46 million and 48 million Fluvirin 
doses will be delivered to the U.S. market beginning in early October 
as compared to the 50 million doses projected in July.''
    FDA inspected the Liverpool, U.K. facility where this vaccine is 
produced in 1999, 2001, 2003, and 2004. Under Agency enforcement 
policy, FDA inspects U.S. licensed vaccine manufacturing facilities 
every two years. Please note that Chiron acquired the facility in July 
2003 after FDA conducted the biennial inspection. During the 1999 
inspection, FDA identified various concerns and, as a result, issued a 
warning letter regarding the Liverpool facility. The most significant 
issues identified in 1999 were the lack of validation for its 
manufacturing processes, including establishing proper limits for 
bioburden (including bacteria) and issues related to assuring sterility 
in the manufacturing process. During the 2001 and 2003 inspections, 
although FDA found that the company made improvements, we also made 
observations related to current Good Manufacturing Practice (cGMPs). In 
each case, FDA reviewed the corrective measures and plans in response 
to these deficiencies. If fully implemented, the company's plans 
appeared adequate to correct deficiencies identified at the facility.

1999 and 2001 Inspections

    An inspection of the firm on July 13 through July 21, 1999, 
resulted in the issuance of a Warning Letter on October 21, 1999. The 
firm responded to the Warning Letter on November 15, 1999. A response 
review letter was issued to the firm on March 1, 2000, which included 
requests for additional information. The firm provided the additional 
information in a letter dated April 6, 2000. A second response review 
letter was issued to the firm on May 24, 2000, which included 
additional comments and also stated that the adequacy of the firm's 
responses would be verified during the next inspection.
    The inspection of Evans Vaccines Ltd., operating as a division of 
PowderJect Pharmaceuticals Plc., performed February 26 through March 9, 
2001, was conducted in part as a follow-up inspection to the Warning 
Letter and as a routine CGMP inspection. As stated in the establishment 
inspection report (EIR) for this inspection, the firm's corrective 
actions taken in response to the Warning Letter were reviewed and 
evaluated and appeared to be adequate with the exception of the 
cleaning validation of a filtration unit. The cleaning validation was 
not complete and further studies were needed to assure the completeness 
of sterility test failure investigations.
    The February 26 through March 9, 2001, inspection was classified 
voluntary action indicated (VAI). On March 9, 2001, a 31-item, Form FDA 
483 was issued to the firm. The CGMP deviations included no data to 
support holding times, inadequate cleaning validation studies, failure 
to follow SOPs, inadequate failure investigations, inaccuracies noted 
in the Master Production Records, tubing used for transfer touching the 
floor, no SOP for Biological Product Deviations, inadequate validation 
for a vial filler, inadequate preventive maintenance program, 
inadequate validation for vial and stopper washing, process 
qualification for WFI system not reviewed and approved by the Quality 
Control Unit and testing to determine compatibility of equipment.
    The firm responded to the Form FDA 483 items on April 20, 2001. The 
response stated corrective actions including the modification and 
enhancement of SOPs, purchasing of new equipment, enhancement of 
Quality Control Unit, and training/retraining of personnel. A response 
review letter was issued to the firm on July 19, 2001, which included 
comments and also stated the firm's responses appeared adequate and 
that the implementation and effectiveness would be verified during the 
next inspection.
    The inspectional observations made during the February 26 through 
March 9, 2001, inspection were deviations from CGMP and were adequately 
addressed by the firm in the April 20, 2001, response.

2003

    The inspection of Evans Vaccine, Ltd., operating as a division of 
PowderJect Pharmaceuticals Plc., performed June 2 through June 10, 
2003, was conducted as a routine CGMP inspection. As stated in the EIR, 
the inspection disclosed that the firm had corrected most of the 
observations cited during the February 26 through March 9, 2001, 
inspection with the exception of the cleaning validation of a 
filtration unit, inaccuracies in the Master Production Records, 
validation for a vial filler, and testing to determine compatibility of 
equipment.
    The June 2 through June 10, 2003, inspection was classified VAI. On 
June 10, 2003, a 20-item, Form FDA 483 was issued to the firm. The 
majority of observations cited during the inspection were regarding 
issues and lots manufactured in 2000, 2001 and 2002. The CGMP 
deviations included reprocessing of monovalent blends for 2001/2002 
campaign lots without prior approval, inadequate failure investigations 
for 2000/2001 and 2001/2002 campaign lots, incomplete sterility failure 
investigations for monovalent blend pools for 2000/2001 and 2001/2002 
campaign lots, deficiencies in product contact equipment compatibility, 
incomplete Biological Product Deviation (BPD) reporting, inadequate 
cleaning validation studies, failure to follow SOPs, deficiencies in 
filling room operations, inadequate validation of sanitizer efficacy, 
deficiencies in media fill simulations, and no documentation of adverse 
events for 2002/2003 campaigns.
    The firm responded to the Form FDA 483 on June 27, 2003. The 
response stated corrective actions including a commitment to quality 
system improvements, an enhanced program to ensure consistency of 
application of CGMPS across all sites, ongoing global initiative for 
the company, incorporation of ``Quality System Improvement Program'' 
(QSIP), and the use of a U.S. consultant to assist the firm. In 
addition, the response stated that as of April 12, 2002, no 
reprocessing of monovalent blend lots had occurred for lots destined 
for U.S. market and committed to revising the SOP. Moreover, as stated 
in the firm's response and as the evidence collected during the 
inspection clearly showed, there was a steady decrease in bioburden 
level excursions from 2001 up to June 2003. This indicated that 
corrective actions taken as a result of the bioburden level excursions 
seemed to be effective.
    A response review letter was issued to the firm on September 3, 
2003, which stated the adequacy of the firm's responses would be 
verified during the next inspection.
    The inspectional observations made during the June 2 through June 
10, 2003, inspection were deviations from CGMP and were adequately 
addressed by the firm in the June 27, 2003, response.

2004

    The inspection of Evans Vaccines Ltd., operating as an affiliate of 
Chiron Corporation, performed October 10 through October 15, 2004, was 
conducted in part as a follow-up to the MHRA flu vaccine license 
suspension and as a routine CGMP inspection. As stated in the EIR, the 
inspection disclosed that 5 out of the 20 observations made during the 
June 2003 inspection had not been adequately corrected which included 
inadequate failure investigations for 2000/2001 and 2001/2002 campaign 
lots, incomplete sterility failure investigations for monovalent blend 
pools for 2000/2001 and 2001/2002 campaign lots, deficiencies in 
product contact equipment compatibility, deficiencies in media fill 
simulations, and no documentation of adverse events for 2002/2003 
campaigns.
    The October 2004 inspection disclosed deficiencies in the control 
of bioburden in the manufacturing and production areas, which were not 
seen during the June 2003 inspection. The October 2004 inspection 
disclosed that over 50 percent of the monoblend pools used from March 
2004 through October 2004 exceeded the firm's bioburden alert level. In 
addition, nine batches of final product were rejected for sterility 
failures, and four other batches of final product were rejected within 
two months, from September 2004 to October 2004, due to environmental 
excursions.
    The October 10 through October 15, 2004, inspection was classified 
official action indicated (OAI). On October 15, 2004, a 14-item, Form 
FDA 483 was issued to the firm. The inspection resulted in the issuance 
of a Warning Letter on December 9, 2004. The CGMP deviations included 
failure to establish an adequate quality control unit, failure of the 
quality control unit to review records to assure no errors have 
occurred, or, if errors have occurred, that they are fully 
investigated, failure to follow written procedures applicable to the 
function of the quality control unit, and failure to establish, 
implement, and follow scientifically sound and appropriate 
specifications, standards, sampling plans, and test procedures.
    The firm responded to the investigational findings by meeting with 
the FDA on November 9, 2004, and with a written response on November 
13, 2004. Comments to the firm's response and requests for additional 
information were included in the December 9, 2004, Warning Letter. 
Chiron responded to the Warning Letter on January 7, 2005. The response 
is under review at FDA.

Communications With MHRA

    On the morning of October 5, 2004, MHRA announced a three-month 
suspension of Chiron's license to manufacture influenza vaccine. FDA 
had no prior knowledge of the MHRA's intention to suspend the firm's 
U.K. license. MHRA's Chief Executive, Professor Kent Woods, indicated 
that MHRA did not have the legal authority to notify FDA about the 
suspension announced on October 5 until after MHRA instituted its 
administrative action. Dr. Woods has also stated that, ``Contrary to 
some reported statements, MHRA, as the responsible regulatory authority 
in the United Kingdom, made the decision to suspend Chiron's license 
after an internal meeting on October 4 and first informed the company 
and the FDA of this decision on October 5. At the same time, we 
informed other drug regulatory authorities via an intergovernmental 
rapid information alert.''
    Upon learning of the MHRA's suspension, FDA communicated with both 
Chiron and the MHRA. While Chiron indicated to FDA that it believed it 
had satisfactorily addressed MHRA's inspectional findings and provided 
to FDA a copy of those findings and the company's response, MHRA 
expressed serious concerns about Chiron's vaccine stocks and the 
company's ability to assure the safety of the vaccine.
    FDA will continue to work with Chiron and the U.K. government to 
ensure that the company corrects the deficiencies in the Liverpool 
plant so that it can eventually resume production of a safe and 
effective influenza vaccine. Subsequent to MHRA taking its action to 
suspend Chiron's license to manufacture influenza vaccine at the 
Liverpool facility, Chiron gave MHRA and FDA permission to discuss the 
issues related to Chiron that are considered confidential commercial, 
trade secret and proprietary. FDA is also working to implement an 
information sharing agreement with MHRA that would, among other things, 
permit advance communication on important issues.

    Question 10. During the weekly telephone calls with Chiron in 
September 2003, did the FDA have the opportunity to review the actual 
data obtained from the re-testing of the lots? If so, what did the data 
show, and did it confirm Chiron's weekly statements that the re-testing 
indicated that they would be able to ship approximately 46 million 
doses in October?
    Answer 10. On August 25, 2004, FDA investigators were on site 
conducting a prelicense inspection and were informed of the 
contamination of the vaccine. FDA inspectors met with Chiron's staff 
and reviewed the preliminary findings and the approach that Chiron was 
taking to its investigation and retesting at multiple points in its 
process. FDA investigators in Liverpool faxed to CBER preliminary data 
and information regarding the scope and plans for the sterility failure 
investigation being conducted by Chiron. The results of these 
evaluations were needed and essential for any regulatory assessment. 
Chiron's investigation was in the earliest stage and, therefore, only 
preliminary information was available; however at the time the 
additional testing on other lots were negative. Chiron did believe it 
had identified the root cause for the contamination and that it was 
limited to the affected lots. FDA performed a comprehensive review of 
the retesting data during its October 10-15, 2004, inspection of the 
Liverpool facility. The retesting results were indeed negative; 
however, FDA's inspection found issues related to the adequacy of the 
statistical sampling plan used for the retesting. These findings, 
coupled with the other issues uncovered during the inspection, led FDA 
to conclude that it could not assure the safety of the vaccine.

    Question 11. Were FDA officials aware of the Medicines and 
Healthcare Products Regulatory Agency's findings from their inspection 
of Chiron's plant in March 2004? If so, what actions did the FDA take 
to follow up on the British agency's concerns and ensure that Chiron 
improved their manufacturing conditions?
    Answer 11. FDA was not aware of MHRA's March 2004, inspection at 
the time of the inspection. FDA recognizes the need to further 
strengthen mechanisms for real-time communication with our foreign 
regulatory counterparts. We are in the process of evaluating and 
expanding agreements so that this type of information so that 
government agencies can readily share such information in the future.

                      Food and Drug Administration
    Question 12. The FDA has a special public trust to see that the 
medicines that American patients take are safe and effective. I am 
concerned that the Administration has not given the dedicated 
professionals at FDA the support and leadership they need to do the 
essential job that Americans count on them to do.
    FDA must have the authority to require--not just to request--that 
drug companies complete post-approval studies to assure that drugs put 
on the market are safe and effective over the long haul for their 
actually conditions of use. And it's clear that the passive monitoring 
system that FDA now realizes on to monitor the safety of drugs after 
they are approved isn't good enough.
    Will you work to give FDA the leadership, resources, and authority 
it needs to do its job? Will you work to see that FDA has the authority 
to and resources it needs for post-market studies and surveillance, and 
will you nominate a strong Commissioner who is free of ties to 
industry? What other measures will you propose to help FDA enhance drug 
safety?
    Answer 12. I recognize that FDA has a special public trust to see 
that the medicines Americans take are safe and effective. I am 
committed to working with FDA to fulfill its mission to protect the 
public health by assuring the safety, efficacy, and security of human 
drugs; helping to speed innovations that make medicines more effective, 
safer, and more affordable; and helping the public get the accurate, 
science-based information they need to use medicines and to improve 
their health.
    Nominating an FDA Commissioner committed to the Agency's mission 
will be one of my top priorities.
    On November 5, 2004, FDA announced a five-step plan to strengthen 
its drug safety program. Key among these steps is IOM study on FDA's 
drug safety system, with an emphasis on the drugs as they are actually 
used. These are important and ambitious steps designed to enhance drug 
safety. I will work to see that FDA proceeds with this five step plan 
and will consider additional steps that may further enhance drug 
safety.

    Question 13. American pay 60 percent more for prescription drugs 
that the British or Swiss, two-thirds more than Canadians, 75 percent 
more than Germans, and more than twice as much as Italians. This is 
often for FDA approved drugs made by American companies in FDA approved 
plants. Do you think this is fair? What will you do about it?
    Answer 13. In recent years the Administration has worked to make 
prescription drugs more affordable for U.S. consumers. FDA has taken 
steps to encourage greater generic competition and speed access to 
generic drugs as well as streamline the drug development and approval 
process. As Secretary of HHS, I will work with Congress to continue to 
address the high costs of health care.

    Question 14. Secretary Tommy Thompson recently stated: ``I, for the 
life of me, cannot understand why the terrorists have not attacked our 
food supply, because it is so easy to do.'' Do you share Secretary 
Thompson's concerns, and if so, how do you propose addressing the 
problem?
    Answer 14. I certainly share Secretary Thompson's concerns about 
the safety of the food supply. Ensuring the safety of the food supply 
has been a priority for Secretary Thompson, for the Administration and 
will be a priority for me. I do know that a great deal has been done in 
the past few years to improve security. For example, in 2002, the 
President signed the Public Health Security and Bioterrorism 
Preparedness and Response (Bioterrorism Act). This landmark legislation 
represents the most fundamental enhancement to FDA's food safety 
authorities in many years. FDA has been working hard to implement this 
important legislation. In addition to implementing the Bioterrorism 
Act, FDA has many other ongoing counterterrorism activities. However, 
we must continue to be vigilant in these efforts. Ensuring the full and 
effective continued implementation of the food safety regulations will 
be a continued priority of mine and of HHS.

    Question 15. Do you believe that Congress should require 
manufacturers of dietary supplements to report serious adverse events 
related to use of their products to the Food and Drug Administration? 
Do you believe there are other steps FDA or the Congress should take to 
better enable the agency to remove unsafe dietary supplements from the 
market?
    Answer 15. If confirmed as Secretary, I will carefully evaluate the 
need for any additional authority relating to this issue.
    As you may know, FDA recently published a new strategy to 
strengthen its regulation of dietary supplements. FDA's strategy for 
dietary supplements outlines the steps it plans to take to continue 
implementing and enforcing the Dietary Supplement Health and Education 
Act of 1994 (DSHEA). The strategy sets forth a series of research and 
measures, including guidance, regulations, and science-based compliance 
and enforcement mechanisms.
    The strategy focuses on three areas: monitoring and evaluating 
product and ingredient safety, ensuring product quality, and monitoring 
and evaluating product labeling. With this strategy, FDA hopes to 
improve the transparency, predictability, and consistency of the 
Agency's scientific evaluations of dietary supplement product and 
ingredient safety. The actions outlined in the strategy are also 
designed to protect consumers against unsafe dietary supplements and 
dietary supplements making unauthorized, false, or misleading claims. 
FDA expects that this improved transparency will help engage 
stakeholders in the development of further measures to implement DSHEA.

    Question 16. Medically valuable antibiotics are often used 
indiscriminately in animal agriculture to promote growth rather than to 
treat disease. This misuse gives rise to drug-resistant pathogens that 
can cause illness in people through contaminated food. FDA has taken 
some important steps to scrutinize the public health impact of this 
misuse of antibiotics by issuing guidelines for the evaluation of new 
antibiotics proposed to be used as feed additives. These guidelines, 
however, fail to address the public health concerns raised by 
antibiotics already on the market as feed additives. hat do you plan to 
do to protect the public from the danger of drug-resistant bacteria 
that result from the misuse of antibiotics in animal agriculture?
    Answer 16. FDA is concerned about antimicrobial resistance and the 
use of antimicrobial drugs in food-producing animals. FDA agrees with 
the Government Accountability Office's recommendation that it is 
important to review animal drugs that are critical to human health and 
to collect antibiotic use data.
    Guidance for Industry #152, ``Evaluating the Safety of 
Antimicrobial New Drugs with Regard to their Microbiological Effects on 
Bacteria of Human Health Concern,'' addresses the pre-approval safety 
assessment for new antimicrobial drugs intended for use in food-
producing animals. This guidance also is used for re-evaluating 
currently approved veterinary antimicrobial drugs. FDA's Center for 
Veterinary Medicine (CVM) has finished the assessment for the growth-
promoting uses of penicillin-containing antimicrobial drugs. CVM is 
currently in the process of re-assessing the growth-promotion uses of 
tetracycline-containing antimicrobial drugs.
    In addition, CVM has re-evaluated the use of virginiamycin, a 
streptogramins used in five species of food-producing animals, for its 
potential to cause Synercid-resistant Enterococcus faecium in humans. 
FDA has posted the draft risk assessment on its CVM website. In 
addition, FDA published an announcement in the Federal Register on 
November 23, 2004, that the risk assessment was available and that FDA 
would accept comments for 60 days. FDA subsequently extended the 
comment period an additional 30 days to February 23, 2005. The draft 
risk assessment is available at: http://www.fda.gov/cvm/antimicrobial/
SREF--RA--FinalDraft.pdf.
    My understanding is that FDA can pursue a number of regulatory and 
administrative enforcement options if its reviews uncover a human 
health risk. Any new antimicrobial drugs with animal feed claims will 
be subject to review under the above-referenced guidance as well as 
review by FDA's Veterinary Medicine Advisory Committee.

                          Occupational Health
    Question 17. The National Institute for Occupational Safety and 
Health in the Centers for Disease Control plays a pivotal role in 
protecting our Nation's workers and thus in safeguarding our Nation's 
public health. Last year's Omnibus Appropriations conference report 
concurred in Senate language directing that NIOSH's role must not be 
impeded or diminished through the CDC reorganization process.
    As Secretary, what will you do to ensure, in keeping with Congress' 
direction, that (1) no funds or personnel are transferred from NIOSH to 
other parts of CDC, (2) NIOSH's current procedures and structure are 
preserved; and (3) the Director of NIOSH continues to report directly 
to the Director of CDC? Will you commit to these actions to ensure that 
occupational safety and health remains a top agency priority?
    Answer 17. CDC will make no changes to NIOSH's current operating 
procedures or organizational structure and will ensure that no funds or 
personnel will be transferred from NIOSH. The NIOSH Director will 
continue to report directly to the Director of CDC and the NIOSH 
Headquarters Office will remain in Washington, D.C. In addition, the 
NIOSH Director will continue to have direct access to the Department of 
Labor, the Occupational Safety and Health Administration, and the Mine 
Safety and Health Administration as authorized by Congress. CDC is 
committed to supporting NIOSH's success and its impact on preventing 
work-related injuries, illnesses, and deaths.

                 Welfare/Community Services Block Grant
    Question 18. Utah's program has been praised for its emphasis on 
education and training. I understand recipients can participate in such 
programs for up to 24 months to improve their chances of not just 
finding immediate work, but building a career.
    As Secretary will you continue to support an emphasis on education 
and training in welfare reform? Will you support similar flexibility 
for recipients to participate in education and training programs for up 
to 24 months?
    Answer 18. I support flexibility for States to tailor activities to 
the needs of individuals while continuing to maintain the emphasis on 
work that has been the cornerstone of the success of welfare reform. In 
Utah, we designed our program to constantly emphasize the importance of 
work as the best path toward self-sufficiency. Our TANF program, known 
as the Family Employment Program, was one of the first in the Nation to 
be integrated into the workforce development system.
    The Administration's proposal for welfare reform emphasizes 
increased flexibility for short-term education and training while 
maintaining a strong emphasis on work. This approach is consistent with 
research findings that show that intensive activities with a focus on 
work produce the best result. Longer term education and training can be 
counted toward the work requirement when they are performed in 
conjunction with work.

    Question 19. In addition, as you know, the Federal welfare reform 
law imposed harsh restrictions on public benefits for legal immigrants. 
Over 20 States now use State funds to replace the missing Federal 
benefits for such immigrants.
    As Chairman of the National Governor's Association you were 
involved in urging the Federal Government to show more flexibility on 
this issue. Would you support including more flexibility for States to 
use Federal funds to provide social and medical services to legal 
immigrants?
    Answer 19. As you will recall, a number of the restrictions on non-
citizen eligibility have been eased over the years since the passage of 
the 1996 law, particularly in the area of food stamps. In 2002, 
President Bush proposed changes in the Food Stamp program that were 
incorporated in the Farm Bill of 2002 (PL 107-171). The 2002 bill 
expanded food stamp eligibility to legal immigrants who had resided in 
the United States for five years or more, bringing the eligibility 
provisions of the food stamp program more in line with TANF and 
Medicaid. It also provided that children or disabled immigrants are 
immediately eligible for food stamps, without a five-year waiting 
period.
    Under current law, States have the flexibility to provide federally 
funded benefits for many qualified non-citizens including refugees, 
political asylees, and, after five years, legal permanent residents. 
Others can be served with State funds, and these expenditures may count 
toward the TANF Maintenance of Effort requirement. I think these 
provisions provide considerable flexibility to States while maintaining 
the basic principle that regular immigrants should not enter the United 
States expecting to receive welfare benefits, and that the individuals 
who sponsor immigrants to enter the country should be held responsible 
for meeting their basic needs, if necessary.

    Question 20. You have described the 1996 Welfare Reform as a 
``dramatic American success story.'' I agree that many Americans have 
left the welfare rolls successfully, and they deserve great credit for 
the independence and self-sufficiency they've achieved. But there 
remains a need to improve upon current law, particularly to address the 
recent increase in poverty as welfare caseloads continue to shrink. The 
Administration says the decline is a good sign, but it seems that 
welfare recipients are being dropped from the rolls, even though they 
can't find a job. The Administration's welfare proposal would further 
restrict the ability of States to address the variety of needs of 
welfare recipients, and lead to more recipients being forced off of 
welfare despite their need for work supports and other assistance.
    Many of the successful aspects of Utah's welfare program that you 
helped implement, such as increased support for education and training, 
flexibility in dealing with barriers to work, and a wide variety of 
countable work activities, differ from the provisions supported by the 
Administration's welfare proposal. Will you commit to working with 
Congress to address these issues in the Administration's welfare 
proposal, ensuring that States like Utah have the flexibility they need 
to help welfare recipients lift out of poverty, and to address the 
individual needs of each family without being penalized by the Federal 
Government?
    Answer 20. I agree that State flexibility is a key to the past and 
future success of welfare reform. TANF continues to be one of the best 
examples of the power of State innovation and flexibility. In creating 
the Temporary Assistance for Needy Families (TANF) program, Congress 
acknowledged the immense capacity of States and localities to design 
and conduct effective social programs, and incorporated the lessons 
learned from State waivers into the TANF program. Utah, and many other 
States, used this flexibility to design programs that respond to 
individual needs, providing whatever services are needed to help 
families put their lives back together and achieve self-sufficiency.
    The Administration's welfare reauthorization plan gives States 
increased flexibility to count certain activities as meeting the work 
requirement for limited periods of time. States could receive credit 
for families engaged in short term substance abuse treatment, 
rehabilitation and work-related training designed to maximize self-
sufficiency through work. Such activities could also count for longer 
periods when combined with work. The proposal also would allow States 
to spend TANF funds carried over from previous years on any benefit, 
service or other allowable TANF activity. This change, which would 
greatly increase State flexibility, is based on the recognition that 
cash benefits represent only one part of the services funded by TANF.
    I look forward to working with the Congress to achieve the goals of 
flexibility while retaining the results-oriented focus of the program 
that is important to our success.

    Question 21. I have seen the good work of the Community Services 
Block Grant, or CSBG, in communities throughout Massachusetts. 
Community Action Agencies use CSBG funds to coordinate and leverage the 
resources of other programs to provide comprehensive services such as 
Head Start, child care, energy assistance, employment and training, 
food and nutrition services, literacy programs, and other low-income 
programs. These agencies are on the front lines of service delivery for 
the poor.
    Congress is very supportive of the Community Services Block Grant 
and the Community Action network. As you know, the Salt Lake Community 
Action Program does good work for Utah's low-income families. I have 
heard that the Administration's budget will not include funding for 
CSBG. Will you pledge to work with Congress to revisit this decision?
    Answer 21. I agree that there are good examples of work done by 
Community Action Agencies using Community Service Block Grant funds, as 
well as funds from other programs. I also think that accountability for 
measurable results is something we must be concerned with in all 
programs. I look forward to the opportunity to discuss with you issues 
related to CSBG in the coming months as we work to improve key services 
to low income families.

                             Mental Health
    Question 22. In July of 2003, the final report of the President's 
New Freedom Commission on Mental Health was released. It called for a 
fundamental restructuring of how we care for families facing mental 
illness, but Congress still hasn't acted. Mental illness is a crisis 
for millions of children and adults and families who face it everyday. 
It's a national crisis.
    Can you commit to me to make this debate an HHS-wide priority, not 
just a priority for the Substance Abuse and Mental Health Services 
Administration within HHS, and when can we expect an Action Plan to 
implement the reports recommendations?
    Answer 22. The President's New Freedom Commission on Mental 
Health's report, issued in July 2003, called for profound change and 
transformation of the current system, recommending new service delivery 
patterns and incentives to ensure that every American with mental 
illness has easy access to the most current treatments and best support 
services.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) was tasked by the Department to review the Commission's report 
and to lead the development of an Action Agenda for that transformation 
to create a more recovery-focused mental health services delivery 
system. An executive team at SAMHSA-along with senior staff from six 
Federal departments and the Social Security Administration-are working 
collaboratively to conduct a thorough review and assessment of the 
Report. As expected, developing the Action Agenda has proven to be a 
tremendous undertaking. The result, however, has been commitment for a 
true Federal Action Agenda that is informed by the final report of the 
New Freedom Commission and aligned with the President's priorities.
    A hallmark of the Action Agenda is the unprecedented collaboration 
and partnership across the Federal Government to work together and make 
every effort to keep consumers and families at the center of care.

    Question 23. Would you consider establishing an Inter-Agency 
Council much like the Inter-Agency Council on Homelessness to 
coordinate Federal programs that care and treat people with mental 
illness?
    Answer 23. In response to the President's New Freedom Commission on 
Mental Health Report entitled ``Achieving the Promise: Transforming 
Mental Health Care in America,'' the Substance Abuse and Mental Health 
Services Administration (SAMHSA) convened representatives from 15 
different Federal agencies to develop an Action Agenda Federal plan on 
how to achieve mental health systems transformation. This Action Agenda 
is being reviewed by those agencies and should be released shortly. 
Contributing to the Agenda in addition to SAMHSA were the National 
Institutes of Health, the Health Resources and Services Administration, 
the Centers for Disease Control and Prevention, the Administration on 
Aging, the Administration on Children and Families, the Centers for 
Medicaid and Medicare Services, the Indian Health Service, the Social 
Security Administration, the Department of Housing and Urban 
Development, the Department of Education, the Department of Justice, 
the Department of Transportation, The Department of Labor, and the 
Department of Veterans Affairs. These agencies will continue to provide 
continuing input and participate in our efforts to transform the mental 
health delivery system.
    The Action Agenda, besides making recommendations for change, is 
itself an example at the Federal level of better coordination and 
cooperation among programs and agencies serving those with mental 
illness. It serves as an example to States and local governments on how 
to improve the delivery of quality services to those among us who need 
help in finding and living a life in the community, a life of recovery.
                                 ______
                                 
               Response to Questions of Senator Mikulski

    Question 1. Over six million poor senior Americans and 71,000 
senior citizens in Maryland currently receive their prescription drugs 
though the Medicaid program. When the new Medicare program begins in 
2006, Medicaid will no longer be allowed to provide any drug coverage 
for these Medicare beneficiaries.
    Since you just referred to the new Medicare prescription drug law 
as the ``main event of 2005,'' how would you ensure that no low-income 
Medicare beneficiary loses drug benefits next year as a result of the 
implementation of the Medicare law?
    Answer 1. Starting on January 1, 2006, full-benefit dual eligible 
and other low-income individuals will be provided drug coverage at 
little or no cost through the new Medicare drug benefit. Approximately 
six million full-benefit dual eligible individuals will automatically 
qualify for subsidies of premiums and cost-sharing amounts under the 
Medicare prescription drug benefit. I agree that it is critical that we 
work to ensure as smooth a transition as possible for the dual eligible 
population. As Secretary, this will be a priority of mine, and I hope 
to work with you as we move forward in these efforts.

    Question 2. Right now, if someone needs long-term care they must 
work their way through a fragmented, patchwork array of programs to 
piece together their long-term care needs. Given your experience as 
Governor of Utah and managing many of the elements of this system, what 
is your vision for a comprehensive national approach for strengthening 
America's long-term care system?
    Answer 2. Planning and paying for long-term care--and ensuring that 
services are high quality--are among the biggest challenges America 
will face as the population continues to age. Indeed, the array of 
Federal, State and local programs, faith based services, self-funded 
care, and long-term care insurance, combined with informal care by 
family members and friends can be difficult to maneuver. We should 
focus long-term care on the individual; people should be aware of the 
need to plan for their long-term care needs, increase their savings, 
purchase long-term care insurance, and take other steps to be prepared. 
For some people this may not be possible and Medicaid will remain a 
critical part of the system. Here too individuals should have more 
control, building on the experience of Cash and Counseling. Medicaid 
options that support consumer direction, such as Cash and Counseling, 
are promising and represent a win-win for consumers, their personal 
assistance workers, and States. On the awareness side, I look forward 
to the results of the Department's new long-term care awareness 
campaign and hope we can use those results to pursue additional 
activities to help individuals plan for their own independence as they 
age.
                                 ______
                                 
                Response to Questions of Senator Murray
                                Medicare

    Question 1. As you point out in your prepared statement, 
implementation of the Medicare prescription drug legislation will be 
immense and very challenging. I believe we have an obligation to assist 
our seniors and disabled in making very difficult and complex decisions 
in choosing a new MA plan or Drug Only Plan. It would be easy for those 
of us who opposed final passage to simply refer confused and concerned 
seniors, the disabled and their families to CMS. But, I do not think 
this is helpful for anyone and would ask for your commitment to meeting 
the challenges of outreach and education. I would also be interested in 
your plans for moving forward with implementation. What resources would 
be available? How can we work in a bipartisan fashion to educate and 
help our seniors and disabled make informed decisions?
    Answer 1. CMS will work with a broad array of partners, including 
SSA and other federal agencies, States, employers and unions, and 
national and community-based organizations to educate people with 
Medicare, their caregivers and other who help them about the new 
Medicare prescription drug benefit and other new Medicare benefits and 
options. Importantly, CMS will conduct an integrated education campaign 
and will reach out at the grass roots level to help people with 
Medicare understand their options to access Medicare prescription drug 
coverage. CMS is investing more than $300 million in this integrated 
and multi pronged education effort including simple language fact 
sheets, more detailed publications including the annual ``Medicare & 
You'' handbook, direct mail, community based grassroots efforts to 
target the different populations with messages directed to their 
specific needs, e.g., low income, people with retiree drug coverage, 1-
800-MEDICARE, www.medicare.gov.
    In the fall of 2005, the ``Medicare & You 2006'' handbook will 
outline the specifics of Medicare prescription drug plans and list the 
Medicare prescription drug plans available in each beneficiary's area 
and people with Medicare will be able to get customized local Medicare 
plan information, including cost, pharmacy, and formulary information, 
at www.medicare.gov on the web, or by calling 1-800-MEDICARE.

    Question 2. As you are aware, in the MMA legislation in 2003 we 
took great strides to close the inequity in Medicare reimbursement 
between rural and urban providers. This $25 billion investment will 
reduce these inequities and provide relief to many rural providers. 
However, Washington State remains at the bottom of per beneficiary 
reimbursement for Medicare which puts our providers at an economic 
disadvantage. Doctors and hospitals in Washington State receive far 
less from Medicare because they are more efficient and have 
significantly lower utilization rates. I believe we should provide 
incentives to encourage more efficient use of care and begin to base 
reimbursement on performance. I would be interested in knowing of your 
plans for providing greater regional equity in Medicare and would like 
to work with you to implement real reforms that reward performance as 
opposed to over-utilization.
    Answer 2. I certainly appreciate and understand the unique 
challenges faced by rural providers. This Administration has made a 
strong commitment to rural health issues and has implemented many 
significant regulatory and Departmental reforms to promote rural health 
care providers. Also, as you mention, the MMA included several 
provisions to enhance beneficiary access to quality health care 
services and improve payments in rural areas. As Secretary, I will 
ensure that rural health care issues remain a top priority and continue 
to receive the attention they deserve.
    Encouraging improved health care quality is a top priority of mine 
and of the President's. The Administration has promoted accountability 
for quality, creating incentives to collect data from Medicare 
providers on quality measures. I am intrigued by the possibility of 
approaches to link Medicare reimbursement to provider performance. 
While I certainly am not versed in the variety of ways that pay-for-
performance could be incorporated into the Medicare and Medicaid 
payment systems, I am excited to be involved in conversations regarding 
the issue. If I were to be confirmed, I would expect the Department 
would continue to review this issue and I would want us to work with 
the provider and beneficiary communities and the Congress in doing so.

                        Title X Family Planning
    Question 3. As Governor of Utah you made statements and took 
actions to reduce access to safe and effective family planning services 
for all women, including minors. We know the cost of unintended 
pregnancy, especially for teenagers. We know the importance of 
comprehensive family planning that offers health care services and 
access to safe and effective family planning. Unintended pregnancy is a 
public health issue that needs to be addressed with sound, public 
health strategies. Title X providers offer low income women access to a 
whole range of reproductive health care services beyond simply 
contraception. As the Secretary of HHS, will you support Title X 
funding that provides the greater access possible to effective family 
planning services? Are you aware of the importance of Title X in 
meeting the reproductive health care needs of millions of low income 
women?
    Answer 3. Helping women to prevent unwelcome pregnancies is indeed 
a public health concern, particularly when we are talking about our 
young people. I am aware of the role that Title X has played in 
providing family planning services to low-income women. As Secretary, I 
will ensure that all of our programs, including Title X, are sensitive 
and responsive to the needs of low-income Americans and that we 
carefully assess concerns about access to care.

                               HEAD START
    Question 4. President Bush has included in past budgets funding for 
a block grant pilot program to States. However, funding of Head Start 
has not kept up with the rising costs in Head Start while the funding 
dedicated to a block grant could provide funding for services for 
thousands of children. In such tight budget years, how can you justify 
siphoning funding for a demonstration program that is unproven?
    Head Start is one of the few Federal programs where funding goes 
directly to locals. By block granting funding at the State level, you 
would be adding bureaucracy to a highly successful program. What is the 
Administration's intention in adding in this extra level of bureaucracy 
to the program?
    Answer 4. I share your interest in the Head Start program and the 
contribution it has made to American's poorest children and families 
for almost 40 years. Nevertheless, research continues to indicate that 
too many children are leaving Head Start without certain key skills 
needed for success in early schooling. One way to address this issue is 
to strengthen Head Start's coordination efforts with local schools and 
other pre-school programs.
    However, I can assure that the President's reauthorization 
proposal, which would allow States the option of administering Head 
Start and making changes to improve child outcomes and better 
coordinate services, is quite different from a block grant. States will 
have to follow very specific procedures in applying. There will be 
continuing Federal oversight of the State's delivery of Head Start 
services. Moreover, States will be required to continue to serve at 
least as many Head Start eligible children as are currently served 
while maintaining the comprehensive nature of Head Start.
    I am committed to ensuring that implementation of the President's 
proposal will provide an opportunity for more children to be served by 
local Head Start programs at the highest level of quality.

    Washington State 1915(b) Waiver Services for People With Mental 
                               Illnesses
                  Medicaid Capitation Savings Question
    Question 5. Mr. Leavitt, as I understand the situation, the 
department is prohibiting the State of Washington from using its 
Medicaid savings to finance community-based and inpatient psychiatric 
hospital services for adults with severe and persistent mental 
illnesses.
    Specifically, CMS used negotiations over a 1915(b) waiver renewal 
to bar the State from using Medicaid capitation savings--achieved by 
Washington's quasi-governmental regional managed care entities--to pay 
for community-based and inpatient care for extremely vulnerable people. 
This was a disturbing development because the State for more than a 
decade had reasonably relied upon the agency's previous position, which 
permitted such payments. CMS's new stance caused the loss of $80 to 
$100 million in combined Federal and State spending, and threatened 
mental health care for 127,000 Washingtonians. CMS has allowed the 
State a 14-month extension in which to realign its system and funding 
mechanisms with the new CMS policy and, for that, the State is 
extremely appreciative.
    However, since the prohibition does not apply to savings generated 
by for-profit managed care companies, I find the CMS position to be 
bewildering. Can you please explain the rationale behind this policy? 
And can you tell me how CMS's recently announced position is consistent 
with President Bush's public commitment to give States more flexibility 
over the Medicaid program?
    Answer 5. Medicaid statute and regulations do not restrict a 
managed care organization's use of capitated payments as long as the 
health care of Medicaid enrollees, per the managed care contract, is 
met. However, CMS is working with Washington and other States to assure 
that rate setting data, based on previous Medicaid services, is 
consistent with Medicaid statute and regulations. These provisions, 
which apply equally to both public and private entities, require that 
program contract rates be developed based on Medicaid services to 
Medicaid eligibles only (per 42 CFR 438.6). This means that rates must 
be developed exclusive of non-approvable expenditures such as funds 
expended for persons in an Institution for Mental Disease (IMD) (per 42 
CFR 435.1008). During CMS review of Washington State's waiver renewal 
application, the cost for non-Medicaid eligibles and non-state plan 
services were included in the State's calculations for determining 
future rates for this program, which is not permissible under Federal 
law.
    The Balanced Budget Act of 1997 included very specific provisions 
concerning contract requirements to assure appropriate levels of 
payment to Medicaid managed care entities. In response, CMS implemented 
the Medicaid Managed Care Rule, which includes contract requirements 
that prevent the CMS from approving contracts in which Medicaid rates 
include non-state plan services and services to non-Medicaid 
beneficiaries. These provisions, which changed how States previously 
calculated their program's cost effectiveness, ensure the fiscal 
integrity of the Medicaid program. States were required to be in 
compliance with these regulations by August 13, 2003.
    As Secretary, I assure you that the Department will work with the 
State of Washington to provide the most flexibility possible within the 
Medicaid program, while meeting all statutory and regulatory 
requirements.

            Institution for Mental Diseases (IMD) Exclusion
    Question 6. Current CMS policy prohibits Medicaid reimbursement for 
adults with serious mental illnesses served in inpatient psychiatric 
hospitals, which are known in Medicaid parlance as ``Institutions for 
Mental Diseases'' or IMDs. The prohibition specifically applies to 
facilities with sixteen (16) or more beds.
    In Washington, the rule complicates the ability of the State to 
move people out of public hospitals and into community-based 
residential services. Apparently, the IMD rule specifically applies to 
non-hospital, residential facilities which are essential to the web of 
services necessary to sustain adults with severe and persistent mental 
illnesses in the community.
    Upon your confirmation as Secretary of DHHS, will you look into 
this outdated regulation with an eye toward at least raising the 
sixteen (16) bed limit, or alternatively exempting residential 
facilities from the IMD exclusion?
    Answer 6. Since the IMD exclusion is rooted in legislation, not 
regulation, congressional action is needed to change this provision. 
However, I understand that CMS has been working with States and 
providers to develop community-based alternatives and find ways to make 
the current mental health system to operate more effectively.
                                 ______
                                 
                 Response to Questions of Senator Reed

    Question 1. Many health experts, including infectious diseases 
physicians, predict that the next influenza pandemic is imminent. 
During the past century, pandemics of influenza occurred in 1918, 1957, 
and 1968, with significant morbidity and mortality in both high risk 
and normal children and adults. In 1918 alone, more than 500,000 people 
died in the United States, and 20 million to 50 million people may have 
died worldwide. It is estimated that the next influenza pandemic could 
cause an average of up to 200,000 deaths in the United States alone. 
The recent influenza vaccine shortage has demonstrated that our Nation 
is not adequately prepared to deal with the next flu pandemic. 
Challenges such as a limited influenza vaccine market, too few 
dedicated manufacturers, a lack of adequate coordination among Federal 
agencies, and the absence of an international influenza research agenda 
compound the list of inadequacies our Nation is facing. Influenza 
represents a global danger that cannot be underestimated, and I hope 
you will consider it a public health priority. If confirmed, how do you 
plan to address these challenges?
    Answer 1. Preparation for the annual flu season has been a priority 
at HHS. I will ensure that it continues to be a priority. I believe 
that the CDC and FDA have successfully taken great strides toward 
responding to an unforeseeable shortage of vaccine, through the 
creation of tools to help States identify additional vaccine, through 
the identification and purchase of additional vaccine under an 
investigational new drug (IND) application, and through effective 
public communication about the prioritization of high-risk groups who 
should receive the available vaccine.
    I will also ensure that efforts to prepare against a possible 
influenza pandemic continue to be a priority, including through the 
continued review and finalization of the national pandemic response 
plan, as well as through the utilization of the $100 million recently 
allocated to these efforts in the Omnibus appropriations bill.
    Looking forward to the future, we will continue to work with 
vaccine manufacturers to encourage them to bring their vaccine for 
licensure and sale in the United States, as well as taking longer-range 
steps to encourage the development of a domestic vaccine supply, to 
ensure appropriate supplies of influenza vaccine. I look forward to 
working with the committee on this issue--any steps that we take should 
be careful to remove disincentives that may have hindered manufacturers 
from entering or remaining in the U.S. vaccine market.

    Question 2. The National Bone Marrow Donor Registry (Registry) 
operated by the National Marrow Donor Program (NMDP) is a critically 
important national resource. As an original sponsor of the legislation 
authorizing the National Bone Marrow Donor Registry, the continuation 
of this national resource remains a top priority to me. We created this 
program to provide patients and their doctors with a single point of 
access to locate volunteer, unrelated marrow donors. However, I am 
extremely concerned that the authorization for this highly successful 
program has been allowed to expire. What additional support can the 
Department provide to ensure the continuation of this model Federal 
program?
    Answer 2. Bone marrow transplants offer the possibility of a cure 
for many people suffering from blood and genetic diseases, such as 
leukemia. The National Bone Marrow Donor Registry is an important 
program that helps transplant candidates, who cannot locate a donor 
related to them, to search for a suitable unrelated donor. The Registry 
is the largest system connecting patients and physicians with volunteer 
donors. And this year, the Registry received a good assessment from 
OMB. Thank you for your support for this successful program. If I am 
confirmed as Secretary, I will stand ready to work with you to ensure 
the continuation of this program.

    Question 3. I have recently heard from a number of my constituents 
who are concerned about tobacco companies marketing flavored tobacco 
products that could be attractive to children. More generally, tobacco 
companies are increasing their marketing and promotional expenditures. 
According to the most recent data from the Federal Trade Commission, 
the companies now spend $12.7 billion annually on marketing, an 
increase of 84 percent since 1998. At the same time, the resources to 
fund anti-smoking education efforts targeting children are 
disappearing. For example, the Legacy Foundation, which is responsible 
for the truth media campaign, has been funded through the tobacco 
industry's Master Settlement Agreement with the States since 1998. 
However, due to the terms of the settlement, nearly all of the industry 
payments to the Legacy Foundation ended in 2003--a reduction in funding 
of $300 million per year. If you are confirmed, what steps will you 
take to protect our kids from tobacco marketing and prevent them from 
smoking? Can you make a commitment that as Secretary of HHS you will do 
everything in your power to support initiatives that science tells us 
are essential to protect our kids?
    Answer 3. Tobacco-related deaths are the leading preventable cause 
of death and disease in the United States. Each year, smoking causes 
about 440,000 premature deaths and costs the Nation $75 billion in 
direct health care expenses. Our first priority should be to keep 
tobacco products out of the hands of America's children and to 
encourage all Americans not to smoke, including by helping them quit 
smoking.
    Last year, the President proposed $701 million for HHS activities 
related to tobacco. I intend to continue plans announced recently by 
Secretary Thompson to help Americans quit smoking. The initiatives 
include the opening of a national quitline number (1-800-QUITNOW) that 
puts users in touch with programs that can help them give up tobacco. 
In addition, a new HHS Web site (www.smokefree.gov) offers online 
advice and downloadable information to make cessation easier.
    The Office on Smoking and Health (OSH) is the Nation's lead Federal 
agency for tobacco use prevention efforts and plays a critical role in 
the fight to reduce the health effects of tobacco use. OSH's program 
efforts are directed toward achieving progress in the following goal 
areas: preventing initiation of tobacco use among youth and young 
adults; eliminating exposure to secondhand smoke; identifying and 
eliminating tobacco-related disparities; and promoting tobacco use 
cessation among adults and youth to promote a comprehensive approach 
for tobacco use prevention and control. All OSH activities directly or 
indirectly support these goal areas.

    Question 4. In 1995, you stated your disapproval of the Federal 
Government creating new areas of eligibility and benefits under 
Medicaid. In fact, you stated that the average Medicaid recipient in 
Utah had a benefit package 30 percent richer than the average working 
person. Unfortunately, these are often very ill or disabled individuals 
who require a disproportionate amount of care and are unable to pay 
substantial out-of-pocket expenses such as deductibles and co-pays for 
care. Cindy Mann, a research professor at the Health Policy Institute 
of Georgetown University, was quoted in the New York Times as saying 
that the coverage under the Utah waiver was ``well below any generally 
accepted standard of what it means to be insured.'' Can you address 
this assessment? Can you summarize the services that the Utah program 
actually covered and what it excluded? As Secretary of HHS, how would 
you define basic Medicaid benefits?
    Answer 4. First and foremost, I believe strongly that waivers 
provide States with the flexibility to implement innovative ways to 
extend health coverage to more people. This is a goal we should all 
support. The waiver that I implemented in Utah did not make any changes 
to the benefit for mandatory populations. Instead, the waiver expanded 
preventive and primary care coverage to an additional 25,000 uninsured 
adults. To do so, a $50 enrollment fee was instituted, but with 
exemptions for vulnerable optional populations (including the elderly, 
blind, disabled, children and pregnant women).

    Question 5. Do you support the President's Medicaid reform proposal 
that would give States the option of getting a capped amount of money 
for ``optional'' populations? As a former Governor and Medicaid work 
group leader, you know the National Governors Association continues to 
oppose such a step to shift the fundamental partnership between State 
and Federal Governments. As Secretary of HHS, how would you work with 
governors to maintain our commitment to low-income and medically needy 
Americans who rely on Medicaid as their only option for health care? 
Would you favor extending further flexibility to States without capping 
federal matching funds? How would you justify removing Federal 
beneficiary protections in exchange for this flexibility?
    Answer 5. Reform itself should be designed to give States the tools 
they need to bring Medicaid into the 21st century on a cost effective 
basis. Medicaid remains under rules designed specifically for the 
1960s. Its mission has changed and expanded but the rules have not. 
People with disabilities especially want better choices than what 
Medicaid currently offers them for long term care services. It is clear 
when you talk to any governor or State legislator, regardless of 
political affiliation, that they believe the rate of growth in Medicaid 
is unsustainable.
    I want to work with Congress and the Nation's Governors to examine 
the Medicaid program and to change it to give States the tools to 
provide basic health coverage to the most low-income people possible.

    Question 6. As you know, there have been ongoing issues with regard 
to the redistribution of unused SCHIP funds. This year, $1 billion in 
unexpended funds actually reverted back to the Treasury. Rhode Island 
is one of several States that exhausts its allocation of funds each 
year and is deeply concerned about reallocated, unexpended funds. My 
State was one of the first States to expand coverage to kids prior to 
the creation of the SCHIP program. It is my understanding that the 
Administration is interested in SCHIP reauthorization in the coming 
years. In what ways do you think the program needs to be changed?
    Answer 6. First, published in the Federal Register recently is the 
notice for the redistribution of fiscal year 2002 SCHIP funds which 
were unexpended at the end of fiscal year 2004. This has assured that 
no State will experience a funding shortfall this fiscal year.
    The Federal Register notice details the methodology used, as well 
as the list of States that will receive redistributed funds. In the 
notice the five States which would have had shortfalls (Arizona, 
Minnesota, Mississippi, New Jersey and, most notably for you, Rhode 
Island), will first receive sufficient funds to cover their shortfalls. 
After these shortfall States are made whole, 28 States (including the 5 
shortfall States) will receive redistributions. Rhode Island received 
over $23 million from this redistribution.
    I look forward to working with Congress to re-authorize SCHIP, to 
assure stability in the program.

    Question 7. As Secretary of HHS, you will be charged with 
overseeing the administration's abstinence-only programs, which are 
slated to receive an unprecedented $168 million in Federal taxpayer 
funding this year. A recent report by the House Committee on Government 
Reform revealed that many of the most common federally funded 
abstinence-only curricula contain errors, distortions and stereotypes 
while other recent reports have called into question the effectiveness 
of abstinence-only programs. For example, in 2001 the National Campaign 
to Prevent Teen Pregnancy found no credible studies of abstinence-only 
programs showing any significant impact on participants? initiation or 
frequency of sex. The National Academy of Sciences' Institute of 
Medicine has criticized the investment of hundreds of millions of 
dollars in unproven abstinence-only programs as ``poor fiscal and 
public health policy.'' What steps will you take as secretary to 
evaluate the accuracy and effectiveness of these programs and ensure 
that science, not ideology, is driving administration policy?
    Answer 7. I share the President view that . . .``Abstinence is the 
surest way and the only completely effective way to prevent unwanted 
pregnancies and sexually transmitted diseases.'' I also agree with the 
President that we must promote public policies that are medically 
accurate. I also am committed to continuing to support the rigorous 
evaluation efforts currently underway in the Department.

    Question 8. What were EPA's considerations in accepting $2 million 
from the American Chemistry Council to help fund the Children's 
Environmental Exposure Research Study? In light of recent challenges 
faced by the FDA, how would you balance the collection of user fees by 
FDA under the Prescription Drug User Fee Act (PDUFA) and FDA's 
regulatory role in ensuring the safety of drugs seeking approval?
    Answer 8. Because protecting the health and well-being of children 
is of paramount importance, EPA has decided to send the Children's 
Environmental Exposure Research Study (CHEERS) for another external, 
independent review by an expert panel made up of members of the Science 
Advisory Board, the Science Advisory Panel, and the Children's Health 
Protection Advisory Committee. It is anticipated that this review will 
be completed and that a report will be forwarded to the Administrator 
in the spring of 2005. [Based on this review, the Agency will reassess 
the study.]
    EPA scientists need to fully understand how children are exposed to 
pesticides and through what media (air, water, soil, etc.) EPA is 
particularly concerned about childhood exposure, because children may 
be more vulnerable than adults to the effects of environmental 
contaminants due to their smaller body sizes and rapid physical 
development. There is insufficient research to define pathways of 
exposure--the routes by which pesticides may enter a child's body. 
Possible pathways that could be investigated are ingestion (food and 
drink), inhalation, residue from crops, soil and ingestion of household 
dust.
    CHEERS was designed to fill these critical data gaps in our 
understanding of children's exposure to pesticides and chemicals in 
household environments, ultimately leading to actions that would lower 
children's exposures to pesticides. The study design was externally 
reviewed for scientific merit and ethical protections by four 
Institutional Review Boards (IRBs) for the Protection of Human 
Subjects. The IRBs and the dates they approved the study are: Battelle 
Memorial Institute (August 2004), University of North Carolina 
(September 2004), Duval County (Florida) Health Department (conditional 
approval) and University of Florida (May 2004).
    If confirmed, I will work to ensure that FDA performs its important 
statutory responsibility to monitor the safety of approved drugs. The 
enhanced post-marketing surveillance provisions in the Prescription 
Drug User Fee Act provide new tools and opportunities to accomplish 
this goal.

    [Whereupon, at 11:56 a.m., the committee was adjourned.]

                                    
