[Congressional Record Volume 152, Number 134 (Thursday, December 7, 2006)]
[Senate]
[Pages S11442-S11451]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
COMBATING AUTISM ACT OF 2006
Mr. SANTORUM. Mr. President, I ask the Chair lay before the Senate a
message form the House of Representatives on the bill (S. 843) to
combat autism through research, screening, intervention and education.
The PRESIDING OFFICER laid before the Senate the following message
from the House of Representatives.
S. 843
Resolved, That the bill from the Senate (S. 843) entitled
``An Act to amend the Public Health Service Act to combat
autism through research, screening, intervention and
education'', do pass with the following amendment:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Combating Autism Act of
2006''.
[[Page S11443]]
SEC. 2. CENTERS OF EXCELLENCE; IMPROVING AUTISM-RELATED
RESEARCH.
(a) Centers of Excellence Regarding Research on Autism.--
Section 409C of the Public Health Service Act (42 U.S.C.284g)
is amended--
(1) in the section heading, by striking ``autism'' and
inserting ``autism spectrum disorder'';
(2) by striking the term ``autism'' each place such term
appears (other than the section heading) and inserting
``autism spectrum disorder''; and
(3) in subsection (a)--
(A) by redesignating paragraph (2) as paragraph (3); and
(B) by striking paragraph (1) and inserting the following:
``(1) Expansion of activities.--The Director of NIH (in
this section referred to as the `Director') shall, subject to
the availability of appropriations, expand, intensify, and
coordinate the activities of the National Institutes of
Health with respect to research on autism spectrum disorder,
including basic and clinical research in fields including
pathology, developmental neurobiology, genetics, epigenetics,
pharmacology, nutrition, immunology, neuroimmunology,
neurobehavioral development, endocrinology, gastroenterology,
and toxicology. Such research shall investigate the cause
(including possible environmental causes), diagnosis or rule
out, early detection, prevention, services, supports,
intervention, and treatment of autism spectrum disorder.
``(2) Consolidation.--The Director may consolidate program
activities under this section if such consolidation would
improve program efficiencies and outcomes.''.
(b) Centers of Excellence Generally.--Part A of title IV of
the Public Health Service Act (42 U.S.C. 281 et seq.) is
amended by adding at the end the following:
``SEC. 404H. REVIEW OF CENTERS OF EXCELLENCE.
``(a) In General.--Not later than April 1, 2008, and
periodically thereafter, the Secretary, acting through the
Director of NIH, shall conduct a review and submit a report
to the appropriate committees of the Congress on the centers
of excellence.
``(b) Report Contents.--Each report under subsection (a)
shall include the following:
``(1) Evaluation of the performance and research outcomes
of each center of excellence.
``(2) Recommendations for promoting coordination of
information among centers of excellence.
``(3) Recommendations for improving the effectiveness,
efficiency, and outcomes of the centers of excellence.
``(c) Definition.--In this section, the term `center of
excellence' means an entity receiving funding under this
title in its capacity as a center of excellence.''.
SEC. 3. DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH
PROGRAM.
(a) In General.--Title III of the Public Health Service Act
(42 U.S.C. 241 et seq.) is amended by adding at the end the
following:
``PART R--PROGRAMS RELATING TO AUTISM
``SEC. 399AA. DEVELOPMENTAL DISABILITIES SURVEILLANCE AND
RESEARCH PROGRAM.
``(a) Autism Spectrum Disorder and Other Developmental
Disabilities.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
may award grants or cooperative agreements to eligible
entities for the collection, analysis, and reporting of State
epidemiological data on autism spectrum disorder and other
developmental disabilities. An eligible entity shall assist
with the development and coordination of State autism
spectrum disorder and other developmental disability
surveillance efforts within a region. In making such awards,
the Secretary may provide direct technical assistance in lieu
of cash.
``(2) Data standards.--In submitting epidemiological data
to the Secretary pursuant to paragraph (1), an eligible
entity shall report data according to guidelines prescribed
by the Director of the Centers for Disease Control and
Prevention, after consultation with relevant State and local
public health officials, private sector developmental
disability researchers, and advocates for individuals with
autism spectrum disorder or other developmental disabilities.
``(3) Eligibility.--To be eligible to receive an award
under paragraph (1), an entity shall be a public or nonprofit
private entity (including a health department of a State or a
political subdivision of a State, a university, or any other
educational institution), and submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require.
``(b) Centers of Excellence in Autism Spectrum Disorder
Epidemiology.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall, subject to the availability of appropriations, award
grants or cooperative agreements for the establishment of
regional centers of excellence in autism spectrum disorder
and other developmental disabilities epidemiology for the
purpose of collecting and analyzing information on the
number, incidence, correlates, and causes of autism spectrum
disorder and other developmental disabilities.
``(2) Requirements.--To be eligible to receive a grant or
cooperative agreement under paragraph (1), an entity shall
submit to the Secretary an application containing such
agreements and information as the Secretary may require,
including an agreement that the center to be established
under the grant or cooperative agreement shall operate in
accordance with the following:
``(A) The center will collect, analyze, and report autism
spectrum disorder and other developmental disability data
according to guidelines prescribed by the Director of the
Centers for Disease Control and Prevention, after
consultation with relevant State and local public health
officials, private sector developmental disability
researchers, and advocates for individuals with developmental
disabilities.
``(B) The center will develop or extend an area of special
research expertise (including genetics, epigenetics, and
epidemiological research related to environmental exposures),
immunology, and other relevant research specialty areas.
``(C) The center will identify eligible cases and controls
through its surveillance system and conduct research into
factors which may cause or increase the risk of autism
spectrum disorder and other developmental disabilities.
``(c) Federal Response.--The Secretary shall coordinate the
Federal response to requests for assistance from State
health, mental health, and education department officials
regarding potential or alleged autism spectrum disorder or
developmental disability clusters.
``(d) Definitions.--In this part:
``(1) Other developmental disabilities.--The term `other
developmental disabilities' has the meaning given the term
`developmental disability' in section 102(8) of the
Developmental Disabilities Assistance and Bill of Rights Act
of 2000 (42 U.S.C. 15002(8)).
``(2) State.--The term `State' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, American Samoa, Guam, the Commonwealth of the Northern
Mariana Islands, the Virgin Islands, and the Trust Territory
of the Pacific Islands.
``(e) Sunset.--This section shall not apply after September
30, 2011.
``SEC. 399BB. AUTISM EDUCATION, EARLY DETECTION, AND
INTERVENTION.
``(a) Purpose.--It is the purpose of this section--
``(1) to increase awareness, reduce barriers to screening
and diagnosis, promote evidence-based interventions for
individuals with autism spectrum disorder or other
developmental disabilities, and train professionals to
utilize valid and reliable screening tools to diagnose or
rule out and provide evidence-based interventions for
children with autism spectrum disorder and other
developmental disabilities; and
``(2) to conduct activities under this section with a focus
on an interdisciplinary approach (as defined in programs
developed under section 501(a)(2) of the Social Security Act)
that will also focus on specific issues for children who are
not receiving an early diagnosis and subsequent
interventions.
``(b) In General.--The Secretary shall, subject to the
availability of appropriations, establish and evaluate
activities to--
``(1) provide information and education on autism spectrum
disorder and other developmental disabilities to increase
public awareness of developmental milestones;
``(2) promote research into the development and validation
of reliable screening tools for autism spectrum disorder and
other developmental disabilities and disseminate information
regarding those screening tools;
``(3) promote early screening of individuals at higher risk
for autism spectrum disorder and other developmental
disabilities as early as practicable, given evidence-based
screening techniques and interventions;
``(4) increase the number of individuals who are able to
confirm or rule out a diagnosis of autism spectrum disorder
and other developmental disabilities;
``(5) increase the number of individuals able to provide
evidence-based interventions for individuals diagnosed with
autism spectrum disorder or other developmental disabilities;
and
``(6) promote the use of evidence-based interventions for
individuals at higher risk for autism spectrum disorder and
other developmental disabilities as early as practicable.
``(c) Information and Education.--
``(1) In general.--In carrying out subsection (b)(1), the
Secretary, in collaboration with the Secretary of Education
and the Secretary of Agriculture, shall, subject to the
availability of appropriations, provide culturally competent
information regarding autism spectrum disorder and other
developmental disabilities, risk factors, characteristics,
identification, diagnosis or rule out, and evidence-based
interventions to meet the needs of individuals with autism
spectrum disorder or other developmental disabilities and
their families through--
``(A) Federal programs, including--
``(i) the Head Start program;
``(ii) the Early Start program;
``(iii) the Healthy Start program;
``(iv) programs under the Child Care and Development Block
Grant Act of 1990;
``(v) programs under title XIX of the Social Security Act
(particularly the Medicaid Early and Periodic Screening,
Diagnosis and Treatment Program);
``(vi) the program under title XXI of the Social Security
Act (the State Children's Health Insurance Program);
``(vii) the program under title V of the Social Security
Act (the Maternal and Child Health Block Grant Program);
``(viii) the program under parts B and C of the Individuals
with Disabilities Education Act;
``(ix) the special supplemental nutrition program for
women, infants, and children established under section 17 of
the Child Nutrition Act of 1966 (42 U.S.C. 1786); and
``(x) the State grant program under the Rehabilitation Act
of 1973.
``(B) State licensed child care facilities; and
``(C) other community-based organizations or points of
entry for individuals with autism spectrum disorder and other
developmental disabilities to receive services.
``(2) Lead agency.--
``(A) Designation.--As a condition on the provision of
assistance or the conduct of activities under this section
with respect to a State,
[[Page S11444]]
the Secretary may require the Governor of the State--
``(i) to designate a public agency as a lead agency to
coordinate the activities provided for under paragraph (1) in
the State at the State level; and
``(ii) acting through such lead agency, to make available
to individuals and their family members, guardians,
advocates, or authorized representatives; providers; and
other appropriate individuals in the State, comprehensive
culturally competent information about State and local
resources regarding autism spectrum disorder and other
developmental disabilities, risk factors, characteristics,
identification, diagnosis or rule out, available services and
supports, and evidence-based interventions.
``(B) Requirements of agency.--In designating the lead
agency under subparagraph (A)(i), the Governor shall--
``(i) select an agency that has demonstrated experience and
expertise in--
``(I) autism spectrum disorder and other developmental
disability issues; and
``(II) developing, implementing, conducting, and
administering programs and delivering education, information,
and referral services (including technology-based curriculum-
development services) to individuals with developmental
disabilities and their family members, guardians, advocates
or authorized representatives, providers, and other
appropriate individuals locally and across the State; and
``(ii) consider input from individuals with developmental
disabilities and their family members, guardians, advocates
or authorized representatives, providers, and other
appropriate individuals.
``(C) Information.--Information under subparagraph (A)(ii)
shall be provided through--
``(i) toll-free telephone numbers;
``(ii) Internet websites;
``(iii) mailings; or
``(iv) such other means as the Governor may require.
``(d) Tools.--
``(1) In general.--To promote the use of valid and reliable
screening tools for autism spectrum disorder and other
developmental disabilities, the Secretary shall develop a
curriculum for continuing education to assist individuals in
recognizing the need for valid and reliable screening tools
and the use of such tools.
``(2) Collection, storage, coordination, and
availability.--The Secretary, in collaboration with the
Secretary of Education, shall provide for the collection,
storage, coordination, and public availability of tools
described in paragraph (1), educational materials and other
products that are used by the Federal programs referred to in
subsection (c)(1)(A), as well as--
``(A) programs authorized under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000;
``(B) early intervention programs or interagency
coordinating councils authorized under part C of the
Individuals with Disabilities Education Act; and
``(C) children with special health care needs programs
authorized under title V of the Social Security Act.
``(3) Required sharing.--In establishing mechanisms and
entities under this subsection, the Secretary, and the
Secretary of Education, shall ensure the sharing of tools,
materials, and products developed under this subsection among
entities receiving funding under this section.
``(e) Diagnosis.--
``(1) Training.--The Secretary, in coordination with
activities conducted under title V of the Social Security
Act, shall, subject to the availability of appropriations,
expand existing interdisciplinary training opportunities or
opportunities to increase the number of sites able to
diagnose or rule out individuals with autism spectrum
disorder or other developmental disabilities and ensure
that--
``(A) competitive grants or cooperative agreements are
awarded to public or nonprofit agencies, including
institutions of higher education, to expand existing or
develop new maternal and child health interdisciplinary
leadership education in neurodevelopmental and related
disabilities programs (similar to the programs developed
under section 501(a)(2) of the Social Security Act) in States
that do not have such a program;
``(B) trainees under such training programs--
``(i) receive an appropriate balance of academic, clinical,
and community opportunities;
``(ii) are culturally competent;
``(iii) are ethnically diverse;
``(iv) demonstrate a capacity to evaluate, diagnose or rule
out, develop, and provide evidence-based interventions to
individuals with autism spectrum disorder and other
developmental disabilities; and
``(v) demonstrate an ability to use a family-centered
approach; and
``(C) program sites provide culturally competent services.
``(2) Technical assistance.--The Secretary may award one or
more grants under this section to provide technical
assistance to the network of interdisciplinary training
programs.
``(3) Best practices.--The Secretary shall promote research
into additional valid and reliable tools for shortening the
time required to confirm or rule out a diagnosis of autism
spectrum disorder or other developmental disabilities and
detecting individuals with autism spectrum disorder or other
developmental disabilities at an earlier age.
``(f) Intervention.--The Secretary shall promote research,
through grants or contracts, to determine the evidence-based
practices for interventions for individuals with autism
spectrum disorder or other developmental disabilities,
develop guidelines for those interventions, and disseminate
information related to such research and guidelines.
``(g) Sunset.--This section shall not apply after September
30, 2011.
``SEC. 399CC. INTERAGENCY AUTISM COORDINATING COMMITTEE.
``(a) Establishment.--The Secretary shall establish a
committee, to be known as the `Interagency Autism
Coordinating Committee' (in this section referred to as the
`Committee'), to coordinate all efforts within the Department
of Health and Human Services concerning autism spectrum
disorder.
``(b) Responsibilities.--In carrying out its duties under
this section, the Committee shall--
``(1) develop and annually update a summary of advances in
autism spectrum disorder research related to causes,
prevention, treatment, early screening, diagnosis or rule
out, intervention, and access to services and supports for
individuals with autism spectrum disorder;
``(2) monitor Federal activities with respect to autism
spectrum disorder;
``(3) make recommendations to the Secretary regarding any
appropriate changes to such activities, including
recommendations to the Director of NIH with respect to the
strategic plan developed under paragraph (5);
``(4) make recommendations to the Secretary regarding
public participation in decisions relating to autism spectrum
disorder;
``(5) develop and annually update a strategic plan for the
conduct of, and support for, autism spectrum disorder
research, including proposed budgetary requirements; and
``(6) submit to the Congress such strategic plan and any
updates to such plan.
``(c) Membership.--
``(1) In general.--The Committee shall be composed of--
``(A) the Director of the Centers for Disease Control and
Prevention;
``(B) the Director of the National Institutes of Health,
and the Directors of such national research institutes of the
National Institutes of Health as the Secretary determines
appropriate;
``(C) the heads of such other agencies as the Secretary
determines appropriate;
``(D) representatives of other Federal Governmental
agencies that serve individuals with autism spectrum disorder
such as the Department of Education; and
``(E) the additional members appointed under paragraph (2).
``(2) Additional members.--Not fewer than 6 members of the
Committee, or 1/3 of the total membership of the Committee,
whichever is greater, shall be composed of non-Federal public
members to be appointed by the Secretary, of which--
``(A) at least one such member shall be an individual with
a diagnosis of autism spectrum disorder;
``(B) at least one such member shall be a parent or legal
guardian of an individual with an autism spectrum disorder;
and
``(C) at least one such member shall be a representative of
leading research, advocacy, and service organizations for
individuals with autism spectrum disorder.
``(d) Administrative Support; Terms of Service; Other
Provisions.--The following provisions shall apply with
respect to the Committee:
``(1) The Committee shall receive necessary and appropriate
administrative support from the Secretary.
``(2) Members of the Committee appointed under subsection
(c)(2) shall serve for a term of 4 years, and may be
reappointed for one or more additional 4 year term. Any
member appointed to fill a vacancy for an unexpired term
shall be appointed for the remainder of such term. A member
may serve after the expiration of the member's term until a
successor has taken office.
``(3) The Committee shall meet at the call of the
chairperson or upon the request of the Secretary. The
Committee shall meet not fewer than 2 times each year.
``(4) All meetings of the Committee shall be public and
shall include appropriate time periods for questions and
presentations by the public.
``(e) Subcommittees; Establishment and Membership.--In
carrying out its functions, the Committee may establish
subcommittees and convene workshops and conferences. Such
subcommittees shall be composed of Committee members and may
hold such meetings as are necessary to enable the
subcommittees to carry out their duties.
``(f) Sunset.--This section shall not apply after September
30, 2011, and the Committee shall be terminated on such date.
``SEC. 399DD. REPORT TO CONGRESS.
``(a) In General.--Not later than 4 years after the date of
enactment of the Combating Autism Act of 2006, the Secretary,
in coordination with the Secretary of Education, shall
prepare and submit to the Health, Education, Labor, and
Pensions Committee of the Senate and the Energy and Commerce
Committee of the House of Representatives a progress report
on activities related to autism spectrum disorder and other
developmental disabilities.
``(b) Contents.--The report submitted under subsection (a)
shall contain--
``(1) a description of the progress made in implementing
the provisions of the Combating Autism Act of 2006;
``(2) a description of the amounts expended on the
implementation of the particular provisions of Combating
Autism Act of 2006;
``(3) information on the incidence of autism spectrum
disorder and trend data of such incidence since the date of
enactment of the Combating Autism Act of 2006;
``(4) information on the average age of diagnosis for
children with autism spectrum disorder and other
disabilities, including how that age may have changed over
the 4-year period beginning on the date of enactment of this
Act;
``(5) information on the average age for intervention for
individuals diagnosed with autism spectrum disorder and other
developmental disabilities, including how that age may have
[[Page S11445]]
changed over the 4-year period beginning on the date of
enactment of this Act;
``(6) information on the average time between initial
screening and then diagnosis or rule out for individuals with
autism spectrum disorder or other developmental disabilities,
as well as information on the average time between diagnosis
and evidence-based intervention for individuals with autism
spectrum disorder or other developmental disabilities;
``(7) information on the effectiveness and outcomes of
interventions for individuals diagnosed with autism spectrum
disorder, including by various subtypes, and other
developmental disabilities and how the age of the child may
affect such effectiveness;
``(8) information on the effectiveness and outcomes of
innovative and newly developed intervention strategies for
individuals with autism spectrum disorder or other
developmental disabilities; and
``(9) information on services and supports provided to
individuals with autism spectrum disorder and other
developmental disabilities who have reached the age of
majority (as defined for purposes of section 615(m) of the
Individuals with Disabilities Education Act (20 U.S.C.
1415(m)).''.
(b) Repeals.--The following sections of the Children's
Health Act of 2000 (Public Law 106-310) are repealed:
(1) Section 102 (42 U.S.C. 247b-4b), relating to the
Developmental Disabilities Surveillance and Research Program.
(2) Section 103 (42 U.S.C. 247b-4c), relating to
information and education.
(3) Section 104 (42 U.S.C. 247b-4d), relating to the Inter-
Agency Autism Coordinating Committee.
(4) Section 105 (42 U.S.C. 247b-4e), relating to reports.
SEC. 4. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--Part R of title III of the Public Health
Service Act, as added by section 3, is amended by adding at
the end the following:
``SEC. 399EE. AUTHORIZATION OF APPROPRIATIONS.
``(a) Developmental Disabilities Surveillance and Research
Program.--To carry out section 399AA, there are authorized to
be appropriated the following:
``(1) For fiscal year 2007, $15,000,000.
``(2) For fiscal year 2008, $16,500,000.
``(3) For fiscal year 2009, $18,000,000.
``(4) or fiscal year 2010, $19,500,000.
``(5) For fiscal year 2011, $21,000,000.
``(b) Autism Education, Early Detection, and
Intervention.--To carry out section 399BB, there are
authorized to be appropriated the following:
``(1) For fiscal year 2007, $32,000,000.
``(2) For fiscal year 2008, $37,000,000.
``(3) For fiscal year 2009, $42,000,000.
``(4) For fiscal year 2010, $47,000,000.
``(5) For fiscal year 2011, $52,000,000.
``(c) Interagency Autism Coordinating Committee; Certain
Other Programs.--To carry out section 399CC, 409C, and
section 404H, there are authorized to be appropriated the
following:
``(1) For fiscal year 2007, $100,000,000.
``(2) For fiscal year 2008, $114,500,000.
``(3) For fiscal year 2009, $129,000,000.
``(4) For fiscal year 2010, $143,500,000.
``(5) For fiscal year 2011, $158,000,000.''.
(b) Conforming Amendment.--Section 409C of the Public
Health Service Act (42 U.S.C. 284g) is amended by striking
subsection (e) (relating to funding).
Mr. SANTORUM. Mr. President, I ask unanimous consent that the Senate
concur in the House amendment, the motion to reconsider be laid upon
the table, and any statements relating to the bill be printed in the
Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. SANTORUM. Mr. President, we just passed the combating autism bill
that we have been working on for 16 months. I thank Senator Dodd for
his tremendous work on that. I thank all of the autism groups. I thank
Jennifer Vesey for the tremendous work she did and the hours and hours
and patience it takes to put together complex and important pieces of
legislation.
Later today, or tomorrow, we are going to pass the abandoned mine
lands bill. I would love to say that was Rick Santorum, but it was
Ashley Horning; it wasn't Rick Santorum. She did all the work. I pretty
much knew what was in there, and I would negotiate the parts in
disagreement. That is what we all do. But on 90 percent of the bills
that most of us know about, we didn't hammer out the details; it was
done by folks who have the commitment and vision and effort and work
the long hours to make the legislation possible. It is important that
in Pennsylvania now we will get a billion dollars to clean up abandoned
mines--it is a tremendous contribution to the environment--or miners
will have health care coverage paid because, in part, I had a terrific
staff person. I can go down through issue after issue and look at these
accomplishments that would be great to stand up and say that I did, but
I had a tremendous amount of help. I had incredibly talented, gifted
people who worked incredible hours.
What most people across America don't realize is how hard our people
around here work. They don't do it for the money. They don't do it
because they have some agenda to accomplish. They do it because they
want to improve America, make America a better place. They want to
leave this place better than how they found it. They want to serve
because they love this country and they believe in what will make this
country better. They work long hours. They don't get paid as much as
they could make if they wandered off the Hill. I will put my folks,
both in Washington and across the State, up against anybody. They are
sitting in the gallery and here along the railing. They have given
their all and I thank them. They served the people of Pennsylvania.
Looking at Kevin Roy over there, I think of all of the earmarks--that
is a dirty word--that we were able to get to help the people in
Pennsylvania in so many ways. I look at work we did for the nonprofit
community and welfare and families, and Melanie Looney and her team
worked on that.
It has been an incredible group. Our Senate conference, the message
folks--it was awfully hard. Republicans are not good on the old message
issue. We don't follow our talking points very well. We try. We try. We
have a lot of independent thinkers on our side. God bless them. They
always have a better way of saying things than what we suggest or
actually not even saying things, thinking things than what we suggest.
That is the beauty of our party. We have a lot of diversity within our
party.
We have some very talented people who work very hard, not just a dry
message to spin, but to try to move the debate, try to get our causes
articulated in a way that is communicated effectively to people across
America. They worked hard. They built coalitions. They did their best,
and I thank them for their effort and the tremendous service they have
given our conference.
I thank the folks in my district offices. Most of those folks have
been with me 16 years. We don't have a lot of turnover in our office. A
lot of folks in Pittsburgh have been with me 16 and others around the
State have been with me 12 years. They are dedicated people who go out
and do those security checks and veterans benefits and medals.
I will always remember one story that happened this last year. There
was a man, a World War II vet named Patrick. I was at a ribbon-cutting
for a VA facility in Oakland in Pittsburgh. While I was there, we
arranged a little medal presentation to a veteran who had sought a
medal and was never given that medal. That is all I knew about it. I
showed up. There was this older gentleman sitting in the front row. His
name was Patrick.
Patrick was a World War II veteran who served in Patton's army and
was sent on a secret mission to try to liberate a POW camp. In that
mission, he was captured. He was imprisoned for several months, I
believe, in a German POW camp. When he got out of the Army, he
requested a POW medal, but the paperwork didn't show he had been
captured. It was a secret mission, and it never appeared on his
military record.
For 60 years, Patrick fought to get his designation as a POW. He
never married. In fact, later in his life after he retired from work,
he became somewhat of a recluse because he was kidded by some of his
buddies about being a POW. It affected him dramatically, so much so
that one of his friends and relatives contacted us to say: Is there
anything you can do? Could it possibly be true?
Ann Blocksidge in my office in Pittsburgh, wizard that she is with
these issues that she has been working on now for 16 years, knew the
places to call and put the records together. We found out, yes, he was,
and that was in one place in one record and not in the same place as
the other record, and A didn't talk to B. So we were able to get him
his POW medal.
I remember pinning it on him. This older man walked to the
microphone. He said: There is one thing I want to say. He said: I
finally feel welcomed home.
It is a great story, but the folks in my office and offices all over
this Capitol do this every day because they care, because the people
call with impossible things, and our folks do impossible things to help
them.
[[Page S11446]]
I thank all of them for all the service they have done, for doing
what I ask them to do when they come into the office: Treat every
caller as if it is your grandmother calling. If you treat every caller
as if it is your grandmother--hopefully they get along with their
grandmother--then things will be fine.
I thank my colleagues. This place gets a lot of ridicule. It is very
easy to criticize people in the fishbowl. It is very easy to take shots
at people for not living up to expectations, and certainly we all do
not live up to expectations. But I think I can say without any
reservation that the men and women in this body are good and decent
people who are doing what they believe is best for this country.
I know many people find that hard to believe because they look at
people and they have beliefs so diametrically opposed to people in this
Chamber. I certainly have views--and have demonstrated that on many
occasions on the floor of the Senate--that are diametrically opposed to
many people in this Chamber. But in my heart, I never questioned the
integrity and the sincerity of the people who articulated their
opinions, that they were not sincere. I believed them to be sincere and
I believed them to believe that it was in the best interest of the
country. That is what is supposed to happen here. Ideas are to be
debated, points of view are to be discussed, and the prevailing thought
of the day will move the country in that direction.
There are very good people here. I tell the people of America: There
are very good people here. There are people here on both sides of the
aisle who pray every single day for God's guidance. There are people
here today who, while we fight and argue, do so out of a passion for
doing what is right.
I thank my colleagues for the courtesies they have shown me, and
particularly my Republican colleagues for the honor they have given me
to serve in the leadership for 6 years. I know that was not an easy
decision back in 2001 to elect someone who had a reputation of being
somewhat of a bomb thrower in the House and in my early Senate days to
a position of leadership in the Senate. They took a risk. I hope they
feel it has paid off.
It has certainly been a great blessing to me to have been able to
serve my colleagues in the capacity of conference chairman.
It is an incredible group of people. I think of John, who is my
tennis partner. We played our first match after I was defeated, and he
beat me 6-love, 6-1. He thinks it is because he played better, but I am
just preparing for other employment.
We have prayer groups here. One of the most important things in my
life over the past 12 years has been the Senate prayer group, the
Senate Bible study, and the prayer breakfasts, the small prayer group
with which I have been involved. I don't know how people do it. I don't
know how people do this business without prayer, without an
understanding that there is something bigger than us here, something
that will help us, guide us, lift us up at times when there seems to be
no other reason to be lifted up.
I thank all of those who prayed with me and prayed for me. Lloyd
Ogilvie, a chaplain here for many years, and Barry Black, our Chaplain
now--they are prayer warriors for all of us. I know they pray for us
every day. I know Lloyd still prays for us every day, and I know
millions of Americans pray for us every day. I thank all of them for
helping me through and helping us and helping our country through these
difficult times.
I thank our leader, Bill Frist, my first leader I served under as a
member of the leadership, Trent Lott, and the leader I served under
when I came to the Senate, Bob Dole. Each and every one of them in
their own way led differently. But in the case of Senator Dole, he was
a larger-than-life figure to me, coming over to the Senate as a 36-
year-old Senator. He was on his way to run for the Presidency. He took
the time to be concerned about the issues that were important to me. He
put me on the committees I needed to be on and gave me the opportunity
that I will never forget and certainly will always be thankful for--to
manage and work on the welfare reform bill back in 1996.
Of all the things I accomplished in the Senate, there is nothing I am
more proud of than what we did in 1996 to reform the welfare system and
transition it so millions and millions would fall off the rolls, find
gainful employment, and change their lives and the lives of their
families. I owe that to Bob Dole. He gave me the opportunity to stand
at that manager's chair for months in my second year in the Senate and
taking on what I would argue was the most important piece of
legislation in that session of the Congress, the Republican revolution.
I thank Trent Lott not only for his tutelage and mentoring me in the
time I have been here as a leader, but for helping me in gaining
leadership and being involved in the leadership in the Senate.
I thank Bill Frist for his friendship. His coming in as a leader when
I was already in the leadership was a little different. He didn't come
in and point the finger and boss around, but he came in to learn. He
came in to engage, to try to take the knowledge that was in the
leadership group and use it to build a stronger group. I appreciate
that.
There is a humility in Bill Frist. It is a very attractive quality
and, I might also add, a rather rare quality if one is in the Senate,
but a very attractive one and a very important one in Senators and
leaders.
I thank, I guess finally, the people of Pennsylvania. I was talking
to Jim Towey. Jim is the new president of Saint Vincent College in
Latrobe, PA. Jim is the former director of the faith-based office for
the President. I called him the other day. He said: You know, Rick, I
have been here--I think he said 6 months. He said: I really like the
State, like the area, good people. But the more I study the State and
the more I get the feel of Pennsylvania, I have one question: It is not
how did you lose the election, but how did you get elected here twice?
I got elected twice because I had a lot of wonderful people who
campaigned hard, worked hard, and believed in me and were able to maybe
see past some of the differences with me to give me an opportunity to
serve here, and I am eternally grateful.
It is an incredible State. It is one I got to know very well and,
obviously, got to know thousands of people. I had the opportunity to
serve them. I had the opportunity to be scolded by them, reprimanded by
them. But I always understood they were my employers. I work for them.
And when you work for somebody, sometimes they are going to tell you
they don't like the job you are doing. And you better act like someone
who is an employee instead of an employer or you are not going to find
yourself as an employee very much longer. Well, I tried to act like an
employee. But that doesn't mean I always had to agree with my employer,
and a lot of times I didn't. And maybe I spoke up too often too loudly
and too boldly on some of the things that my employer didn't agree
with. I hope they respect the fact that it was a heartfelt disagreement
and that I did what I did and I said what I said because I believed it
was in their best interests, even though they may not have thought so.
I respect the fact that I didn't win this election and that the
people of Pennsylvania made a different decision. I had an opportunity
to meet with my successor today in my office and get a chance to talk
with him about some of the ins and outs of the Senate. He is a good
man, and he will do a good job. I hope the people of Pennsylvania will
give him and extend to him the same courtesies and trust and
cooperation that so many Pennsylvanians who didn't agree with me on a
lot of things but knew that it was important to work together--such as
our Governor, Ed Rendell, whom I worked with as mayor and as Governor,
as well as I did with any Republican that I know--I hope that
Republican officeholders in Pennsylvania treat my opponent with the
same kind of respect and the same kind of cooperation that Governor
Rendell and I have had over the years.
That brings me to my colleague, Senator Specter. It was very kind of
Arlen to come and say a few words. He said that we are not only
colleagues in the Senate and, obviously, colleagues from Pennsylvania,
but we are friends. I have to tell my colleagues, when I first came to
the Senate, I thought it was a very long shot that I would be friends
with Arlen Specter. All I had
[[Page S11447]]
heard about Arlen Specter was how prickly a character he is, how
difficult he is, sort of cold and tough. But he is a pretty soft guy.
He really is. He gets those granddaughters around him and he just
melts. No, he is a good man. I don't agree with Arlen a lot, and of
course everybody knows that, but Arlen has been a good partner. We have
worked on a lot of things together. And even when we disagreed, we
understood and respected the disagreement and didn't let it affect us,
or certainly our relationship, or if it was important enough to us and
important enough to the State and important enough to the country, we
worked hard to try to bridge those differences. I think that is a good
model. I recommend it to my successor. I recommend it to all my
colleagues.
This place doesn't have to be as personally confrontational as it is.
I say that as someone who was pretty personally combative when I first
came here. I know that I have had some pretty strident debates on the
floor of the Senate, but I will tell my colleagues that in my heart, it
was never personal, it was always about what the issue was about. And
it is hard for a lot of people in America who look at it in a culture
that takes everything personally--people have asked me why I have been
so comfortable and at ease with what has happened, and it is because I
don't take it personally. People disagree with where I wanted to take
this country, and that is fine. They will have an opportunity to take
it someplace else, for now.
But I don't take it personally. I look at the empty desks of my
colleagues on the other side of the aisle, and I look at each and every
one and I can see them all sitting there, and I can't think of one that
I would take a disagreement with personally--and I have had
disagreements with virtually every one but all of them have disagreed,
hopefully without being personally disagreeable. That is how this place
works. It is the only way it can work and be successful for America.
In closing, I want to say that I always come back to the word
``gratitude.'' To God, to my family, to my colleagues, to the wonderful
people who have worked for me and with me over the years, to the people
of the 18th Congressional District, to the people of Pennsylvania:
Thank you. Thank you. I don't know what I will be doing next, but I
cannot imagine that anything I do in the future will rival the kind of
blessings I have felt from all of the folks whom I have mentioned. The
relationships and the wonderful accomplishments and the great spirit I
have experienced over these last 16 years is something that I am
eternally grateful for to all of those involved. It has been a great
blessing.
I thank my colleagues, I thank those who came and listened, those who
might be listening in other ways, but I thank them, personally, for the
great kindness they have shown me. I leave a very happy and contented
former Senator from Pennsylvania who feels very blessed.
Exhibit 1
Senate Personal Office Employees
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Baldwin, Todd A; Barbera, Vincent M; Barron, Bruce A;
Bashore, Keith E; Beresnyak, Allison M; Beresnyak, Thomas E
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A; Bertuola, Lawrence J; Beynon, Matthew E; Bickhart, Robert
G; Blocksidge, Anne M; Bonesso, Rozzanna J; Bowman, Patricia
Dianne; Bowser, Julia E; Boyd, Allison J.
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Michael; Brown, Brian T; Burkhalter, Colin J; Butler, Timothy
R; Caldwell, Stanley D; Calka, Courtney JO; Carlson, Michael
R; Carter, Andrew C; Castillo, Michael J; Chapman, Elizabeth
R; Christman, David R; Clater, Michael D; Cognato,
Christopher; Cognato, Michael H; Coleman, Samuel E; Collins,
Leah R; Conklin, Jennifer M; Coppolo, Stephen D.
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Samuel W; Dougherty, Kara A; Doyle, Lyda A; Dutkowski,
Margaret C; Ely, Ramona J; Ensslin, Mary T; Evans, Andrea L;
Faulk, Page C.
Faustino, Mary A; Feenstra, Paul A; Feller, Meredith L;
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French, John M III; Galko, Vincent A; Garver, Nancy L;
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J; Gerry, Keith M; Gorman, Victoria Lynn; Greco, Michael P;
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Harbula, David Scott; Harvey, Marcus W; Hershey, Jill E;
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Howard, Jaime L; Hybels, Amy R; Irvine, Walter G Jr.; Irwin,
Christine E; Ivanov, Florina D; Johnson, Thomas O II;
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Kennedy, Brian D; Kinsman, Chelsea M; Kitchen, Michelle L;
Kocan, Sheila T; Koutsiouroumbas, Athan; Kuklis, Joseph V;
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Lyle, Stephen T; Lynch, Stephanie F; Maclean, Heather Marie.
Maddox, Audrey C; Maguire, Erin K; Mahon, Emmet M; Maines,
Laura A; Martin, David; Martin, John E Jr.; Mattei, Thomas J
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Mcelwee, George S; Mcginley, Christopher P; Mckeon, Meredith;
Mcnamara, Kevin M; Medina, Wanda I; Meyer, Christine M;
Mihalke, Michael H.
Miller, Eric R; Miller, Jennifer L; Miller, Manda B;
Miller, Nicole M; Miller, William A; Mitchell, Anna K;
Mitchell, Marcus P; Mizer, Erica L; Molineaux, Peter J;
Moore, Thomas; Moore, Zachery P; Morinigo, Nicholas; Morton,
Bylly Jo; Mullen, James G; Narcavage, Michael III; Navin,
Lawrence M; Ohara, Gerald J; Oshea, Joseph J; Pallotto, Adam
R; Palmer, Wayne D.
Park, Victoria P; Parrick-Cox, Susan; Patel, Kajal A;
Pavlik, Bonnie M; Peacock, Deborah A; Pearson, Tim; Perez,
Janet M; Petraglia, Amy W; Poteet, Paul W; Preate, Alexandra
V; Pugh, Jennifer S; Quinn, Christine Marie; Rajsic,
Michelle; Ramos, Josephina; Reilly, Sean M; Reyes, Jeremy;
Rhodes, Allison L; Riegel, Ellen J; Rockwell, Russel A; Rode,
Katherine R.
Rodgers, Lincoln R C; Roman, Lisa M; Romaniello, Catherine
M; Roscoe, Abigail; Rossi, Connie J; Rossman, Eleanor T; Roy,
Kevin F; Ryan, Maureen; Sailhamer, Brent A; Salvesen, Erling
R III; Sanborn, Alden R; Sanders, Joseph E Jr.; Sarmir,
Danielle; Scanlan, Tricia L; Scaringi, M Anthony; Schmidt,
Keith A; Schmidt, Michele E; Sears, William P; Sechler,
Michael W; Shaner, Mathias R.
Sharp, Crystal N; Sharp, Trudy R; Shelby, Melissa B;
Sheriff, Marie A; Shirk, Jamie E; Shott, Christine M;
Simodejka, Jill L; Sinha, Sushant K; Smith, Brian A; Smith,
Jacob W; Solfanelli, Matthew; Soroka, Suzanne M; Sosar,
Edward D; Spangler, Courtney Leigh; Sparvero, Emily S;
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Alexis A; Stuart, Robert R; Swain, Tooshar K; Swartz, Barbara
K; Sweeny, Jennifer Mahurin; Sybyl, Julie M; Szy, Daniel J;
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Joy J; Traynham, Robert L; Trego, Joshua S; Tulyasathein,
Charnsin; Turner, Michelle D; Urguhart, E Randy; Valdes,
Stephen G; Vanderpool, Kristen R.
Vesey, Jennifer L; Voinski, John A; Vulakovich, Randolph P;
Walker, Patricia B; Wall, Toni B; Walters, Christopher F;
Watson, D Dexter; Weaver, Chad A; Weber, David; Weiss, Todd
M; White, Jennifer S; Wiesenfeld, Michael A; Williamson, N
Kathy; Willis, Jessica R; Wittman, Anne E; Wright, Erica
Clayton; Wusinich, Maria T; Yanoshak, Erica M; Younger,
Anita.
Senate Republican Conference Employees
Amy Marie Adams; Jeff Hunt; Garrett Fahy; Joel Digrado;
Kate Harris; Shonda Werry; Cris Clapp; Melissa Seckora
Anderson; Elizabeth Keys; Barbara Ledeen; Chrissy Shott;
Sarah Berk; Mark Rodgers; Randy Brandt; Katherine Gonzalez;
Carlos Gonzalez; Lane Marshall; Cyrus Pearson; Robert
Traynham; Henry Peterson; Chris Angrisani; Laura Gill.
Nick Schweich; Aaron Broughton; Tim Petty; Curtis Swager;
Nate Green; David Song; Michael Bleicher; Jen Sweeney; Joy
Schmidt; Eden Gordon; Susana Levenson; Eric Miller; Chris
Myers; Rebecca Cotton; Drew Cantor; Alex Kaufman; John
Rankin; Dan Ronayne; Eric Ruiz; Loredana Vouto; Deidre
Woodbyrne.
The PRESIDING OFFICER. The Senator from Kentucky is recognized.
Mr. McCONNELL. Mr. President, I wish to say to my good friend from
Pennsylvania, before he leaves the floor, what an extraordinary 16
years he has had representing the people of his State and what a truly
outstanding Member of the Senate he has been and what a moving farewell
address I had an opportunity to witness. Good luck, good friend, and
Godspeed.
Mr. President, I ask unanimous consent that the vote on the pending
nomination occur at 5:45 today and that prior to the vote, Senator
Grassley be recognized to speak for up to 10 minutes, Senator Enzi for
up to 5 minutes, and Senator Kennedy for up to 5 minutes.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. FEINGOLD. Mr. President, I am pleased that the Food and Drug
Administration will finally have a confirmed
[[Page S11448]]
Commissioner. And I am glad that the President's nominee, Dr. Andrew
von Eschenbach, has acted to address concerns that have been raised
about his nomination. He addressed conflict-of-interest concerns by
resigning his position as head of the National Cancer Institute. The
FDA also approved access to emergency contraception without a
prescription. This decision should have been made when the FDA's expert
panel recommended it, and I was disappointed at the shameless
politicizing of science over emergency contraception. With those issues
now resolved, I will vote for his nomination.
Mr. HATCH. Mr. President, I rise in strong support of the nomination
of Dr. Andrew von Eschenbach to be Commissioner Food and Drugs.
I am pleased that the Senate is considering Dr. von Eschenbach's
nomination and I strongly urge my colleagues to support him because the
FDA needs a permanent Commissioner to lead the agency. The FDA has been
criticized time and time again over this. To me, the first step toward
promoting stability in the agency is for the Senate to confirm an FDA
Commissioner. Dr. von Eschenbach is a capable administrator, extremely
knowledgeable about health care and food and drug policy, and we can
count on him to do the right thing. It is past the time that he be
confirmed.
I had the opportunity to work with Dr. von Eschenbach when he was the
Director of the National Cancer Institute and found him to be
personable and engaging. I also had a long meeting with Dr. von
Eschenbach before his Senate confirmation hearing and was very
impressed with his in depth knowledge on matters before the Food and
Drug Administration. But even more impressive, Dr. von Eschenbach truly
listened to my ideas regarding the FDA, and I greatly appreciated it.
It is clear that he intends to work closely with the Congress.
The bottom line is that I am convinced Dr. von Eschenbach is the best
person for the job, and the sooner we get him confirmed, the better.
I would like to take a moment to talk about FDA-related issues facing
my home State of Utah and where Dr. von Eschenbach's strong involvement
will be crucial.
As my colleagues are aware, Utah is home to the largest concentration
of dietary supplement companies in our Nation, so ensuring that the
Dietary Supplement Health and Education Act, DSHEA, law is strongly and
appropriately enforced is a high priority of mine.
I have been told by every FDA Commissioner since Dr. Kessler that the
FDA has adequate authority under DSHEA to make certain the supplement
marketplace is safe, so it is my hope that Dr. von Eschenbach will make
this a priority during his tenure as FDA Commissioner.
In addition, as I have told him on more than one occasion, it is
essential for Dr. von Eschenbach to work to finalize and implement good
manufacturing practices--GMPs--for supplements as authorized by DSHEA.
It is 12 years since they were authorized. And, despite the repeated
contacts Senator Harkin and I have made, the reportedly drafted
regulations have still not been issued. I want to encourage strongly
Dr. von Eschenbach to address this matter once and for all.
We will also be counting on the good doctor to implement the new
system of mandatory reporting of serious adverse events--AERs--for
nonprescription drugs and dietary supplements that is contained in S.
3546, the Hatch-Durbin bill we passed last night. It is my hope the
House will pass the bill today--and it can be sent to the President for
signature. When enacted, the Hatch-Durbin-Harkin-Enzi-Kennedy bill will
require manufacturers of supplements and over-the-counter drugs to
report to FDA any reports of serious problems associated with the use
of the products. This is an important consumer protection bill, and it
is important that FDA seek the funding to implement the program as
Congress intends. I stand ready to work with the agency on this.
Another concern I have expressed to Dr. von Eschenbach and his agency
is the need to look out for the ``little guy'' once he becomes
Commissioner. Utah is the home to more than 100 medical device
companies, many of them small, and I want Dr. von Eschenbach and his
staff to treat these companies fairly, especially when the FDA
officials conduct inspections. There have been several complaints from
manufacturers about the tactics that the FDA inspectors have taken. I
think these complaints have merit. All I ask of Dr. von Eschenbach is
that Utah companies be treated fairly by the FDA.
I also am deeply concerned about the agency's lack of funding. This
has been a growing concern, especially as it affects implementation of
DSHEA, the new AEER system, and also the review of generic drug
applications. While I realize that FDA has a lot of responsibilities,
ranging from ensuring the safety of drugs and medical devices to
protecting our country's food supply, it simply isn't fair to continue
to pile on these responsibilities without providing the FDA with
adequate funding. I assure Dr. von Eschenbach that I will work with him
and my colleagues on the Senate Appropriations Committee and the Senate
HELP Committee to ensure that the agency is provided with sufficient
funding.
I urge my colleagues to vote in favor of Dr. von Eschenbach today so
that the agency will finally have a permanent leader who will look out
for the best interests of both the American people and an important
Federal agency--the FDA.
Ms. MIKULSKI. Mr. President, I rise before you today to discuss the
nomination of Andrew Von Eschenbach as Commissioner of the FDA.
I first want to say that I love the FDA. FDA is in my home state of
Maryland. It employs over 10,000 of my constituents. It is right down
the road from the NIH. I am proud to have all that research at NIH and
then have FDA in Maryland standing up for the food safety of the
American people, looking out to make sure that the drugs and the
technologies that we use are safe.
Over the years, I have fought for the right facilities, the right
resources, and now the right leadership at the FDA. Dr. Von Eschenbach
is an experienced clinician and researcher and as the former Director
of National Cancer Institute, NCI, I presume he is committed to the
mission of FDA. However, I have concerns. I have yellow flashing light
about his commitment to reform over drug safety, to not politicize
science, and to establish a channel where employees can speak truth to
power.
This is important. As we consider the nomination of Dr. Von
Eschenbach, we must address one of the most important issues facing our
Nation: the loss of confidence in our Government's ability to ensure
the safety of our food, our drugs, and our medical devices. The FDA has
always been the gold standard in maintaining the safety and efficacy of
our drugs and medical devices.
Yet today the Agency is being politicized and degraded. The current
administration has shown a persistent pattern of placing politics
before science; making appointments based on ideology instead of
competency; stifling scientists whose findings do not meet political
objectives; making decisions based on politics, rather than sound
science.
Nowhere is this more evident than at the FDA. Today, FDA is facing a
crisis: There is a crisis of morale. There is a crisis of confidence in
the reliability of FDA decisions. There is a crisis about whether there
are scientists operating under a gag rule, putting politics above
science. There is a crisis ensuring the reliability and safety of our
drugs.
This summer, Union of Concerned Scientists released its survey of the
scientists at the FDA. These scientists are my constituents. They found
the morale of trusted and respected employees has been battered by
years of weak leadership. This survey is important because it gives a
public voice to scientists who aren't in a position to place their jobs
on the line to suffer retaliation for speaking the truth and to
potentially jeopardize their families.
The FDA needs a major overhaul and a culture change at the highest
levels in order to continue to meet its mission. The FDA needs to
reestablish its relationship with its own scientists. The FDA's focus
should be only on science and the public good. And I am hoping that Dr.
Von Eschenbach will be the strong leader the FDA needs to accomplish
this overhaul.
My criterion for looking at every nomination are competence,
integrity,
[[Page S11449]]
commitment to the mission of the Agency.
Competence: Management expertise is essential to effectively run FDA
without redtape and bureaucracy. The FDA has over 10,000 dedicated
employees and has a budget of nearly $2 billion. Strong management
skills and leadership are essential to ensure that FDA can efficiently
and effectively carry out its many responsibilities.
Integrity: The individual must be well-respected by patient/consumer
groups and the industry so that FDA commands the respect of the public
and the industry it regulates. The FDA Commissioner must also be an
honest broker and listener who can make tough calls on contentious
issues.
Commitment to the mission of the Agency: Decisions must be made based
on sound science and public health, not ideology. The nominee must
maintain the FDA gold standard of safety and efficacy, ensuring timely
approval of new therapies to save lives, help patients live longer and
improve their quality of life and ensuring safety of our food supply.
The FDA needs strong leadership. Dr. Von Eschenbach is an experienced
and respected scientist. We need his leadership to help Congress
establish the legislative framework needed to reform FDA: We need to
restore the morale at FDA; we need to restore confidence in the FDA for
all Americans; and we need to restore FDA to the world's premier food
and safety regulatory agency.
We need his commitment to ensure that the best possible science
informs the decisions the FDA makes every day. We need him to ensure a
culture of openness so that management listens to and addresses the
concerns of your employees. We need him to make significant changes to
transform the Agency to the gold standard it once was.
FDA sets the gold standard. Yet today we have ideology over science,
ideology over competence. I strongly believe the FDA needs a strong
permanent Director. I will therefore vote for Andrew Von Eschenbach in
the hopes that he can become that strong leader FDA needs and the
American public deserves.
Mr. McCONNELL. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Mr. President, at 5:45, in just 15 minutes, we will have
an opportunity to vote on the nominee to head the Food and Drug
Administration. I want to first of all commend my friend, the chairman
of our human resource committee, Senator Enzi, for his leadership over
this period of time in giving the assurance to the agency, and much
more importantly to the American people, that we are going to have
someone in charge of this agency able to exercise executive decisions,
to make sure the agency itself is going to fulfill its role in
protecting the health of the American people. So first of all, I thank
my colleague and friend, Senator Enzi, for making sure we are going to
get an opportunity to vote.
I thank the majority leader, Senator Frist, for making sure that we
were not going to leave this session without having a final vote on the
nominee.
In the last 5 years, only in one of those years did we have a head of
the FDA. The rest of the time, they were ``acting.'' A good deal of the
time, there was virtually no presence. This is the most important
health agency that guides and guards American's health, the health of
our children, the health of the elderly, and the health of families in
our Nation. So this is a very important point, and I welcome the
opportunity to urge the Senate to approve Andrew von Eschenbach for
this position.
As I mentioned, the Food and Drug Administration oversees the
products that account for fully a quarter of the entire U.S. economy.
Every day, the agency makes decisions that mean the difference between
life and death for countless patients. Millions of Americans rely on
drugs the FDA approves to protect them from sickness, and every family
in America counts on the FDA to see that the food they eat is free from
contamination.
Now we are in the life science century, and the opportunities for
breakthroughs with new drugs is unlimited. With the progress we have
made in the Human Genome Project and the sequencing of the genes, the
research that is being done across this Nation, the possibilities are
virtually unlimited. But it is all new science. We have to make sure
that this agency which is going to make the judgments and decisions
about approval or disapproval is going to have the best in terms of
scientists, the best in terms of leadership. That is at issue here if
we do not have someone who is going to be the head of the FDA to make
sure the agency that has responsibility for the safety of prescription
drugs is going to work in ways to protect the American consumer; that
the agency that is in charge of the food safety in this country is
going to work to ensure that it is going to be effective for the
American people.
Now the agency itself, the FDA, urgently needs treatment. For too
long, it has been without a confirmed leader. It has become a ship
without a captain, lacking the initiative and confidence that only a
confirmed commissioner can bring. Year after year, under this
administration, the FDA has been allowed to drift, and year after year
the challenges that face the agency have grown.
Think of the controversies--about antidepressants, about the
withdrawal of Vioxx, about the sale of Plan B over the counter, about
adequate review of drugs on the market. The agency has had to struggle
unfairly with difficult scientific questions, inadequate resources and
authority, and political pressures to ignore the science that must be--
good science has to be at the heart of its mission.
Finally, the day is here when the Senate can act to confirm a
commissioner whose job No. 1 will be to restore the leadership to this
essential agency and begin the process of addressing the many major
concerns that have gone unmet for so long.
Dr. von Eschenbach is a good choice to lead the FDA. At the National
Cancer Institute, he led bold initiatives on the human genome and
nanotechnology. As a physician for patients with cancer and a survivor
of cancer himself, he brought an indispensable patient-centered
perspective to the Cancer Institute, and he will bring that to the Food
and Drug Administration as well.
Dr. von Eschenbach was able to find a solution to the controversy
about allowing the over-the-counter sales of Plan B. We may never know
the battles he had to fight and win to achieve that solution, but his
integrity and tenacity in achieving a solution speak volumes for his
character and his commitment to public health.
FDA has long been regarded as the gold standard in regulatory work.
That will continue to be true only if it makes independent, science-
based decisions, in both fact and appearance, and under Dr. von
Eschenbach's leadership, we expect FDA to make those discussions solely
on the basis of science and in the best interests of public health. To
do the job we expect----
The PRESIDING OFFICER. The time of the Senator has expired.
Mr. KENNEDY. I ask, if there is no objection, that I be able to
proceed for another 4 minutes?
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Mr. President, we have to make sure the agency itself is
going to have the adequate resources that are going to be necessary to
protect the public interest. What we are talking about here is making
sure they have the best, in terms of science--in terms of prescription
drugs and the new breakthroughs. We have the whole range of new medical
devices which are out there. The United States is leading the way. We
want to make sure they are safe and effective. The agency has important
responsibilities in terms of the safety of our food supply. We have
given it additional kinds of responsibilities to deal with the
challenges of the war on terror.
This agency has enormous responsibilities in terms of the consumers
and the families of this Nation. It needs the strong leadership which I
think the nominee can bring, and it needs the kind of support from the
Congress that
[[Page S11450]]
will permit it to be the true gold standard for safety and for
improving the health of the American people.
As other agencies are set up around the world--in Western Europe and
now even in Asia--the place they look is at the FDA, and for very good
reason. We want this agency to be the best. It can be the best. With a
new leader and hopefully with the new Congress giving the agency the
kind of support it should have, we can make sure the health of the
American people in these important areas is going to be secure for the
future.
Again, I thank my friend and colleague from Wyoming for his
persistence and tenacity in making sure where we are this evening. We
would not be here if it had not been for his good work on this issue,
as in so many others. I thank him, and the American people ought to
know that this is an enormously important vote to protect their
interests. I hope this nominee is approved overwhelmingly.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Mr. President, I thank the Senator from Massachusetts, Mr.
Kennedy, for his tremendous effort over the last 2 years as we have
worked on health issues but particularly as we have worked on the FDA.
The Food and Drug Administration is critical to the people of this
country, and Senator Kennedy and I have been asking to have a fully
confirmed person heading that up every opportunity we have had. We have
been reminding people they did not want to be the one objecting if
there happened to be a national safety crisis in food or health. It is
just so critical.
People say he is ``acting.'' When you are the acting person in a
position, you really do not have the authority. It means people are
looking over your shoulder, seeing what you are doing, making sure you
are dotting every ``I'' and crossing every ``t'' and following every
rule and listening to every agency that has any control over you.
Someone who is fully confirmed can be the boss.
A lot of people would say: Why would this highly qualified doctor
take this job?
I am sure now that he has been through the confirmation process, he
is probably thinking: Why I would take that job? I am hoping he is not.
In fact, earlier today I called him to let him know that the delay in
getting a final vote on his confirmation had nothing to do with him,
that we had some other logistical process things we were going through,
that there would be a final vote today, and that I suspected, in light
of the cloture vote, there would not be any problem. I am pleased that
it still looks that way. I am anxious to call him and let him know he
is fully confirmed as a commissioner and he can start to work on some
of the morale problems that he talked about, can start to work on some
of the other vision things he has in mind, and people will know he has
the full authority to do that.
I do want to remind people that the FDA's mission is broad. It
regulates food, it regulates drugs, it regulates biologics--and I wish
I had time to explain all of what that is--medical devices. You
probably didn't know that he handles animal feed, and that is because
animals are ingested and could cause a problem, too. He is also in
charge of cosmetics. For every dollar Americans spend, this agency
regulates 25 cents of that dollar in products.
As science progresses, the challenges to regulation will grow. The
FDA regulates a host of new products that blur the FDA's traditional
boundaries, and that is one of the reasons the Senator from
Massachusetts and I have been working on a FDA reform bill for a year
and a half. We have now held hearings on that.
It is a very bipartisan bill. We have had some outstanding comments.
There is a possibility to make the agency better, and we are going to
continue to work on that so that all the new innovations that require a
nimble and responsive agency to regulate them, and resources to match,
will be in place so that he can do the kind of job he needs to do.
This is such a critical role in our Nation's public health, it is
such an important agency, I do ask for people to give him a resounding
vote in this confirmation.
Again, I thank Senator Kennedy, who is the ranking member on the
committee and soon to be the chairman of the Health, Education, Labor,
and Pensions Committee, for his hard work and support during the
process. I think it is time to bring this process to a close so we can
get him confirmed as quickly as possible and have a true, fully
confirmed Commissioner of Food and Drug.
I thank Dr. von Eschenbach for his patience with our process and for
the work he has done in spite of the process. I look forward to getting
to see the kind of job he will do as a fully confirmed physician. I ask
for your vote in support of him.
I yield the floor.
The PRESIDING OFFICER. The majority leader.
Mr. FRIST. Mr. President, in a couple of minutes we are going to turn
to a very important vote, a vote that to me is significant because it
touches every single American in some shape or form. Much has been said
over the course of today about the scope of the FDA, the importance of
having an FDA Commissioner, a permanent FDA Commissioner, and we will
realize that shortly.
Earlier this year we celebrated the 100th anniversary of the Food and
Drug Administration, which is an administration that I have used
professionally in my previous profession in everything from the
thousands of prescriptions I have written, to investigational drugs, to
left ventricular devices, to lasers and artificial hearts. I have seen
first hand how important it is to have an appropriate regulatory agency
there. The Food and Drug Administration, as we all know, as we have
said this afternoon, is America's first scientific regulation body.
While the agency has adapted and changed with the times, it has
remained true to its purpose of protecting interests of everyone who is
listening to me, the American consumer.
In a few minutes we will vote on the nomination of a very good
friend, Dr. Eschenbach, to the position of Commissioner of the Food and
Drug Administration.
I have known Dr. Eschenbach, again professionally, and I have had
mutual patients with him. And he has assisted in many ways as we have
looked at appropriate therapy for individuals from across the country.
He is currently serving as Acting Commissioner. I have interacted with
him in that regard. He has demonstrated a capacity to lead and to
administer in an exceptional way the Food and Drug Administration with
sensitive issues on a daily basis. It is important that we have a
permanent person in that position, and he is the ideal person, the
ideal candidate to do just that.
In both his professional and personal life, Dr. Eschenbach has
experience: as a cancer survivor, as Director of the National Cancer
Institute, literally a nationally renowned urologic surgeon and
oncologist, which all attest to the superlative qualifications to
handle that challenging job, as we all know, as FDA Commissioner.
I hope colleagues will join me in supporting Dr. Eschenbach's
nomination.
The PRESIDING OFFICER. All time has expired.
The question is, Will the Senate advise and consent to the nomination
of Andrew von Eschenbach, of Texas, to be Commissioner of Food and
Drugs, Department of Health and Human Services?
Mr. ENZI. Mr. President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There is a sufficient second.
The clerk will call the roll.
The legislative clerk called the roll.
Mr. McCONNELL. The following Senators were necessarily absent: the
Senator from Montana (Mr. Burns), the Senator from South Carolina (Mr.
Graham), the Senator from Utah (Mr. Hatch), the Senator from Arizona
(Mr. McCain), and the Senator from Virginia (Mr. Warner).
Further, if present and voting, the Senator from Utah (Mr. Hatch)
would have voted ``yea.''
Mr. DURBIN. I announce that the Senator from Delaware (Mr. Biden),
the Senator from Connecticut (Mr. Dodd), the Senator from Vermont (Mr.
Jeffords), and the Senator from Nevada (Mr. Reid), are necessarily
absent.
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
[[Page S11451]]
The result was announced--yeas 80, nays 11, as follows:
[Rollcall Vote No. 274 Ex.]
YEAS--80
Akaka
Alexander
Allard
Allen
Bayh
Bennett
Bingaman
Bond
Boxer
Bunning
Burr
Byrd
Cantwell
Carper
Chafee
Chambliss
Clinton
Coburn
Cochran
Coleman
Collins
Conrad
Cornyn
Craig
Crapo
Dayton
Dole
Domenici
Dorgan
Durbin
Ensign
Enzi
Feingold
Feinstein
Frist
Gregg
Hagel
Harkin
Hutchison
Inouye
Isakson
Johnson
Kennedy
Kerry
Kohl
Kyl
Landrieu
Lautenberg
Leahy
Levin
Lieberman
Lincoln
Lott
Lugar
Martinez
McConnell
Menendez
Mikulski
Murkowski
Murray
Nelson (FL)
Nelson (NE)
Obama
Pryor
Reed
Roberts
Rockefeller
Salazar
Sarbanes
Schumer
Sessions
Shelby
Smith
Specter
Stabenow
Stevens
Sununu
Thomas
Thune
Wyden
NAYS--11
Baucus
Brownback
DeMint
DeWine
Grassley
Inhofe
Santorum
Snowe
Talent
Vitter
Voinovich
NOT VOTING--9
Biden
Burns
Dodd
Graham
Hatch
Jeffords
McCain
Reid
Warner
The nomination was confirmed.
Mr. ENZI. I ask unanimous consent that the President be immediately
notified of the Senate's action and that the Senate return to
legislative session.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________