    [Senate Hearing 107-559]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 107-559

    PROTECTING OUR KIDS: WHAT IS CAUSING THE CURRENT SHORTAGE IN CHILDHOOD
                                   VACCINES?
    =======================================================================

                                    HEARING

                                   before the

                                  COMMITTEE ON
                              GOVERNMENTAL AFFAIRS
                              UNITED STATES SENATE

                          ONE HUNDRED SEVENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                 JUNE 12, 2002

                                   __________

          Printed for the use of the Committee on Governmental Affairs

                              U.S. GOVERNMENT PRINTING OFFICE
    80-606                             WASHINGTON : 2002
    _____________________________________________________________________________
    For Sale by the Superintendent of Documents, U.S. Government Printing Office
    Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800
    Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001

                       COMMITTEE ON GOVERNMENTAL AFFAIRS

                   JOSEPH I. LIEBERMAN, Connecticut, Chairman
    CARL LEVIN, Michigan                 FRED THOMPSON, Tennessee
    DANIEL K. AKAKA, Hawaii              TED STEVENS, Alaska
    RICHARD J. DURBIN, Illinois          SUSAN M. COLLINS, Maine
    ROBERT G. TORRICELLI, New Jersey     GEORGE V. VOINOVICH, Ohio
    MAX CLELAND, Georgia                 THAD COCHRAN, Mississippi
    THOMAS R. CARPER, Delaware           ROBERT F. BENNETT, Utah
    JEAN CARNAHAN, Missouri              JIM BUNNING, Kentucky
    MARK DAYTON, Minnesota               PETER G. FITZGERALD, Illinois
               Joyce A. Rechtschaffen, Staff Director and Counsel
                           Lee Ann Brackett, Counsel
                 Kiersten Todt Coon, Professional Staff Member
                Michelle McMurray, Fellow for Senator Lieberman
            Sandy Fried, Legislative Assistant for Senator Carnahan
                  Richard A. Hertling, Minority Staff Director
                   Elizabeth A. VanDersarl, Minority Counsel
                         Darla D. Cassell, Chief Clerk

                                C O N T E N T S

                                     ------
    Opening statement:
                                                                       Page
        Senator Lieberman............................................     1
        Senator Carnahan.............................................     2
        Senator Bunning..............................................     4

                                   WITNESSES
                            Wednesday, June 12, 2002

    Timothy F. Doran, M.D., F.A.A.P., Chairman, Department of
      Pediatrics, Greater Baltimore Medical Center, on behalf of the
      American Academy of Pediatrics.................................     6
    Mary Anne Jackson, M.D., Chief, Pediatric Infectious Diseases
      Section, Children's Mercy Hospitals and Clinics................     7
    Wayne F. Pisano, Executive Vice President, Aventis Pasteur North
      America, on behalf of Pharmaceutical Research and Manufacturers
      of America.....................................................     9
    Walter A. Orenstein, M.D., Director, National Immunization
      Program, Centers for Disease Control and Prevention, U.S.
      Department of Health and Human Services........................    21
    Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner, Food and
      Drug Administration, U.S. Department of Health and Human
      Services.......................................................    24

                         Alphabetical List of Witnesses

    Crawford, Lester M., D.V.M., Ph.D.:
        Testimony....................................................    24
        Prepared statement...........................................    69
    Doran, Timothy F., M.D., F.A.A.P.:
        Testimony....................................................     6
        Prepared statement...........................................    33
    Jackson, Mary Anne, M.D.:
        Testimony....................................................     7
        Prepared statement...........................................    39
    Orenstein, Walter A., M.D.:
        Testimony....................................................    21
        Prepared statement with an attachment........................    54
    Pisano, Wayne F.:
        Testimony....................................................     9
        Prepared statement...........................................    43

                                    Appendix

    Robert J. Hoffman, M.D., F.A.A.P., NW Pediatrics, prepared
      statement......................................................    83
    Harold Bengsch, MSPH, REHS/RS, Director of Public Health and
      Welfare, Springfield/Greene County Health Department, prepared
      statement......................................................    85
    Cindi Kapica, RN, BSN, Immunization Coordinator, Springfield/
      Greene County Health Department, prepared statement............    88

    PROTECTING OUR KIDS: WHAT IS CAUSING THE CURRENT SHORTAGE IN CHILDHOOD
                                   VACCINES?

                                  ----------

                            WEDNESDAY, JUNE 12, 2002

                                           U.S. Senate,
                             Committee on Governmental Affairs,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 9:37 a.m., in
    room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
    Lieberman, Chairman of the Committee, presiding.
        Present: Senators Lieberman, Carnahan, and Bunning.

                OPENING STATEMENT OF CHAIRMAN LIEBERMAN

        Chairman Lieberman. Good morning. I apologize for being
    breathless. I did my walk up the stairs to beat the slow
    elevator. I apologize for being late, Washington traffic.
        I want to thank all of you for coming to this hearing on
    this very disturbing subject of the shortage of childhood
    vaccines. The truth is, what could be worth more of our time
    and energy than trying to figure out how to fully protect the
    smallest among us--the children who are so innocent--from
    disease and from death?
        This is a topic that could easily be overlooked in the rush
    of what seem to be more critical stories these days, and the
    fact that this Committee has not overlooked it is solely the
    work of our colleague, Senator Jean Carnahan, whose
    longstanding commitment to children's health issues is perhaps
    not as well known as it should be, but certainly most
    admirable. Today's hearing was her idea. I thank her for
    focusing this Committee's attention on this area. I want to say
    a few words in introduction and then I am happy to turn the
    gavel over to Senator Carnahan to conduct the hearing. I also
    thank Senator Bunning for the interest that he shows by being
    here, as well.
        In this medically advanced world we live in, it is all too
    easy to forget the real value of traditional vaccines, that is
    to say, when we are so focused on miracle cures, etc. Many of
    today's parents, and it pains me to say this, are too young to
    remember what some of us who are just a bit older remember, and
    that is the awful days when diseases such as polio or measles
    were incurable.
        In 1900--I was not alive then, I want to make the record
    clear on that---- [Laughter.]
        It is just a statistically significant date. Twelve out of
    every 100 infants died from preventable diseases. Today, the
    number of children afflicted by these illnesses has fallen by
    more than 99 percent. The reason, of course, is the invention
    of the modern vaccine.
        The overwhelmingly successful public health campaign to
    innoculate all children against disease is a story of
    cooperation between public health agencies, scientists,
    government, and hundreds of thousands of local health care
    providers. In 1993, President Clinton extended the success
    story to include uninsured and under-insured children through
    the Vaccine for Children program.
        But there is a danger now which this hearing will
    highlight, and I know Senator Carnahan is very concerned about,
    that we are slipping backwards. Just as we have reached
    vaccination rates that are quite high, we now face alarming
    shortages of these priceless serums. In the last 2 years, we
    have seen shortfalls in the supply of five of the eight
    vaccines that fight the major childhood illnesses. Some school
    systems have even been forced to adjust their mandatory
    vaccination schedules because of inadequate supply.
        So our task today is to examine the scientific, financial,
    and practical obstacles to maintaining an adequate and safe
    supply of vaccines. But in the richest, most powerful Nation in
    the history of the world, there really is not an acceptable
    excuse that can justify immunizing fewer children today than we
    did 5 years ago.
        This is a very distinguished group of witnesses that
    Senator Carnahan has assembled. I urge them to be frank in
    telling the Committee what we can do to help you do your job,
    because this really is a labor of love. Clearly, we have got to
    continue to uphold high standards in approving new vaccines and
    monitoring the production of the more established ones, and we
    have got to ensure that the Vaccine Injury Compensation Fund
    cares for those affected by the rare complications of
    vaccinations.
        Dr. Jonas Salk, in administering the experimental polio
    vaccine to himself, his wife, and three sons in 1955 said, ``It
    is courage based on confidence, not daring, and it is
    confidence based on experience.'' I think we have got to show a
    similar courage, for experience has clearly informed us of the
    value of vaccines.
        Again, I thank Senator Carnahan for her extraordinary
    leadership here. I thank Senator Bunning for being a partner in
    that leadership, and I am happy now to turn the gavel over to
    you, Senator Carnahan. Thank you.

                 OPENING STATEMENT OF SENATOR CARNAHAN

        Senator Carnahan [presiding]. Thank you, Senator Lieberman.
    Thank you for being here today and for permitting me the
    opportunity to hopefully shed some light on this very, very
    important subject.
        Chairman Lieberman. I am sure you will.
        Senator Carnahan. Thank you. I am going to make an opening
    statement at this time, and then Senator Bunning will make an
    opening statement, and then we will turn to our witnesses who
    are with us today.
        I would like to read you something. ``To Our Patients:
    Recently, all pediatric practices nationwide have been
    experiencing shortages of required immunizations. It was not
    until the first week of December 2001 that this shortage
    directly affected our patients at Northwest Pediatrics. Despite
    a great effort on our part, we have been unable to obtain some
    of the vaccines recommended and required. It has become
    necessary to alter the present immunization schedule. A phone
    log will be kept to inform you as soon as adequate supplies
    become available. Please address specific questions to your
    provider. Thank you for your understanding.''
        Well, this notice is dated December 2001. It is now June
    2002 and the sign continues to hang in the examining room of
    the Northwest Pediatric Clinic in St. Louis, Missouri. To not
    have these basic vaccines available for our children is a
    national disgrace. Unfortunately, it is a sad reality for both
    private and public health facilities throughout Missouri and
    across the Nation.
        For over a year, routine childhood vaccines have been in
    short supply. The precise impact depends on the specific
    community and what day you talk to them. In late May, public
    and private health providers in Springfield, Missouri, were
    experiencing a shortage in pneumoccal, which protects against
    meningitis and pneumonia; varicella, which protects against
    chicken pox; and the tetanus booster shot for adolescents.
        The Cole County Public Health Department in Central
    Missouri was experiencing a shortage in DTaP, and MMR, as well
    as varicella and tetanus.
        And when my office spoke to a pediatrician in Poplar Bluff,
    Missouri, her practice happened to be having a good week where
    no vaccine was in short supply. However, the medical staff we
    spoke to said that next week could, once again, bring a
    shortage.
        The current supply crisis, if it continues, would lead to a
    giant step backwards in public health in this country. Young
    parents have not seen these terrible diseases that vaccines
    prevent. They do not remember polio or whooping cough because
    vaccines have accomplished their mission.
        I can tell you that I remember these diseases. I know from
    personal experience the value of vaccines, and we do not want
    to move backwards. When I was a young girl, the vaccine for
    whooping cough was developed. This was a new vaccine and my
    mother was afraid to give it to me. At 4 years old, I developed
    the disease, and I can still remember that awful experience.
        I also remember what it was like when polio was a day-to-
    day part of our lives. I remember my mother not permitting me
    to swim in the public pool because she was concerned that I
    might contract polio. As a child, I was frustrated, of course,
    because I wanted to learn how to swim. But as a mother, I can
    appreciate how frightened she was of the threat of polio.
        The good news is that parents today do not have to worry
    about their children getting some of these preventable
    diseases. However, when parents cannot get the vaccines, they
    may doubt their necessity, since they have never seen the
    diseases for themselves.
        The bad news is that we could be creating a situation where
    a generation of children are not fully vaccinated, a generation
    of children that is susceptible to diseases, diseases that our
    country has not seen in decades. We simply cannot let this
    happen.
        Over the last several months, numerous constituents have
    raised the issue of shortages. Parents, doctors, and public
    health experts are all expressing frustration. They are asking
    the key question, what is going on here? I want to know the
    answer to that myself. Given the progress we have made in this
    country toward immunizing children, and given what diseases
    could reemerge if vaccines are not consistently available, we
    need to shine the national spotlight on this issue.
        That is why I approached Senator Lieberman about having
    this hearing, and I appreciate his leadership on this issue and
    the hard work that his staff has put into this. The purpose of
    today's hearing is to examine what is causing the shortage?
    What is the extent of the shortage across the country? And what
    is the government doing to address the problem and prevent
    future shortages?
        Let me be clear. I see a role for the Federal Government in
    addressing the shortage, but this is a shared responsibility.
    Pharmaceutical companies, physicians, the public health system,
    and officials at all levels of government should play a role in
    ensuring that there is an adequate supply of vaccines. We need
    to work together to develop strategies and incentives to
    increase the vaccine supply in this country.
        This is a complex issue with no easy solution. While the
    current shortage is likely to improve for next year, the
    underlying problems that have contributed to it will remain.
    That is why it is imperative that Congress take a hard look at
    this problem now. We need to work together with industry,
    physicians, and public health officials to find solutions that
    will ensure children's health and prevent vaccine shortages in
    the future. We cannot afford to ever let a generation of kids
    susceptible to these horrific diseases go unvaccinated.
        I want to thank all the witnesses for being here today, and
    I look forward to learning from you how the shortage is
    affecting our Nation and hearing your suggestions on how we
    might be able to prevent shortages in the future.
        At this time, I would like to call on Senator Bunning, if
    he would like to make an opening statement.

                  OPENING STATEMENT OF SENATOR BUNNING

        Senator Bunning. Thank you, Madam Chairman. The United
    States has done an exceptional job of eradicating and
    decreasing the prevalence of many of the life-threatening and
    debilitating diseases of the past, including polio, smallpox,
    rubella, measles, and others. Vaccinations are one of the most
    important things parents can do for their children and the
    health and well-being of their children.
        Professionals spend a lot of time working with parents to
    make sure they know the proper vaccination schedules. However,
    the current vaccination shortage is risking the lives and
    health of many children, as doctors' offices and hospitals are
    delaying administration of certain vaccines because they simply
    are not in stock. This could cause many children to go without
    the necessary shots, which could lead to serious health
    problems in the future.
        According to the CDC, there is currently a shortage of five
    vaccines that protect against eight diseases. It would be a
    tragedy if we saw a resurgence of any of the diseases we
    thought we had conquered.
        As the witnesses today will testify, there are several
    reasons for the vaccine shortages, including increased
    liability, production problems, and changes in manufacturing
    requirements. I hope that Congress can do its part to ensure
    that an adequate vaccine supply is available to parents and the
    doctors and health care facilities across this country.
        While we work to address the current vaccine shortage,
    Congress also needs to make sure that families can afford them
    when they are available. In fact, this is an issue that I have
    been working on for the past several years, and last year I
    introduced legislation called the Vaccinate America's Children
    Act Now. This bill reduces the tax on vaccines to 25 cents per
    dose from its current 75 cents per dose and is designed to make
    vaccines more affordable to many American families, giving them
    one more incentive to adequately protect their children.
        I am looking forward to hearing from our witnesses today
    about this important issue and appreciate the time and effort
    they have taken to be here today. Thank you, Madam Chairman.
        Senator Carnahan. Thank you, Senator Bunning.
        I would like now to proceed to our witnesses and to call
    our first panel. Joining us today are Dr. Timothy Doran from
    the American Academy of Pediatrics; Dr. Mary Anne Jackson from
    Children's Mercy Hospitals in Kansas City; and Wayne Pisano,
    Executive Vice President of Aventis Pasteur North America,
    representing the Pharmaceutical Research and Manufacturers of
    America. We welcome you.
        Dr. Doran has been a practicing pediatrician for 20 years.
    Since 1999, he has chaired the Department of Pediatrics at the
    Greater Baltimore Medical Center in Maryland. Dr. Doran served
    as the President of the Maryland Chapter of the American
    Academy of Pediatrics from 1996 to 1998 and was honored as
    Pediatrician of the Year by the Maryland Chapter.
    Congratulations. He is currently the Chairman of the National
    Nominating Committee at the American Academy of Pediatrics.
        Dr. Jackson has been a staff pediatrician at Children's
    Mercy Hospitals and Clinics in Kansas City, Missouri, since
    1984. In 1996, she was appointed as Chief of the Pediatric
    Infectious Diseases Section. She is also a Professor of
    Pediatrics at the University of Missouri-Kansas City College of
    Medicine. Dr. Jackson is a fellow of the American Academy of
    Pediatrics and the Infectious Diseases Society of America, as
    well as a member of the Pediatric Disease Society.
        Mr. Pisano, an Executive Vice President for Aventis Pasteur
    North America, has overall responsibility for both the United
    States and Canadian businesses. He joined the firm in 1997 as
    Vice President of Marketing and was promoted to Senior Vice
    President of Marketing and Sales the next year. Under his
    leadership, two of the company's key vaccines for polio and flu
    each achieved milestone sales levels.
        Thank you all for being here. Dr. Doran, we have your
    prepared statement along with all the other statements from
    today's witnesses and they will be entered fully in the record.
    But I ask that you proceed with your oral statements for
    approximately 5 minutes. We have a light system here, as you
    can see, and it will let you know when you have 1 minute
    remaining. So we welcome your testimony today, Dr. Doran.

      TESTIMONY OF TIMOTHY F. DORAN, M.D., F.A.A.P.,\1\ CHAIRMAN,
    DEPARTMENT OF PEDIATRICS, GREATER BALTIMORE MEDICAL CENTER, ON
              BEHALF OF THE AMERICAN ACADEMY OF PEDIATRICS

        Dr. Doran. Thank you. Good morning, Madam Chairwoman and
    Senator Bunning. I am Dr. Tim Doran, a practicing pediatrician
    and Chairman of Pediatrics at the Greater Baltimore Medical
    Center, Community Hospital in Baltimore, Maryland. On behalf of
    the American Academy of Pediatrics, thank you for the
    opportunity to testify today about the current shortage of
    childhood vaccines.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Dr. Doran appears in the Appendix on
    page 33.
    ---------------------------------------------------------------------------
        My practice consists of about 1,800 children from
    predominately middle-class families. In the past, however, I
    have practiced in many different locales, from a poor island in
    the West Indies to the inner city of Baltimore. In the 20 years
    I have been practicing, I have never before experienced any
    vaccine shortage for a required childhood vaccine in this
    country.
        This morning, I want to address three key points. First, I
    will describe the consequences of the vaccine shortage to
    patients and their families. Second, I will tell you about the
    administrative impact on pediatric practices which you alluded
    to before, Senator Carnahan. And finally, I will summarize the
    Academy of Pediatrics' recommendations to address this problem.
        The heart and soul of a pediatrician's job is disease
    prevention. The predictable delivery of safe and effective
    vaccines is central to our goal of keeping children healthy. In
    recent months, my practice has seen shortages in several
    routinely administered vaccines, reflecting a national trend.
    In fact, currently, I am out of the new pneumococcal vaccine.
    This vaccine protects children from life-threatening
    meningitis, pneumonia, and blood infections. Many of my
    pediatric colleagues, such as those in Wisconsin, are also
    completely out of this vaccine.
        A pediatrician from New Mexico reports that his high-risk
    population of American Indian infants is also currently out of
    this vaccine. This is especially troublesome because he
    recently diagnosed a 4\1/2\-month-old Navajo infant with a case
    of pneumococcal meningitis--a vaccine preventable, potentially
    fatal childhood illness.
        The parents of my patients have been understandably anxious
    when they have learned that a vaccine is unavailable. They know
    that there is a small but finite chance that their child might
    become ill with an otherwise easily preventable illness because
    of a delayed or missed vaccine.
        Because of recent media publicity and campaigns by anti-
    vaccine groups, I spend a significant amount of time with many
    parents reassuring them that our vaccines are safe and
    beneficial. They do not have the years of knowledge that the
    Senators on the Committee have. I cannot help but wonder that
    my credibility suffers when I then have to explain that these
    important vaccines are not available for their child.
        In addition to the major risk to patients and worry to
    parents, the vaccine shortage has had an administrative impact
    on my practice, as well. We must now create a system of
    callback lists to reach those most in need of missed vaccines
    when they become available. My experience and that of other
    pediatricians has been that these systems are not very reliable
    or effective. Even in my relatively affluent practice, the
    level of compliance with these callbacks is far from perfect,
    and clearly inferior to immunizing at routine checkups.
        I have also had to explore creative and time-consuming
    alternative methods to procure the full supply of vaccines that
    my practice needs. For instance, my recent experience is that
    buying directly from the pharmaceutical representatives is more
    fruitful than buying through the hospital pharmacy, which was
    my usual source. It is another reminder to me of the lack of a
    coordinated distribution system that has led to spotty
    supplies.
        The bottom line is that the public requires a secure supply
    of all the recommended pediatric vaccines, vaccines that save
    children's lives and are the most cost-beneficial medical
    intervention in history. We must safeguard our children from
    preventable interruptions in vaccine delivery. This can never
    happen again in this country.
        One immediate step is for the Federal Government to
    adequately fund the creation of stockpiles for all recommended
    vaccines, stockpiles of sufficient size to ensure that
    significant and unexpected interruptions in manufacture do not
    result in shortages for children.
        Another step is to preserve and strengthen the liability
    protections for consumers, manufacturers, and physicians
    through the Vaccine Injury Compensation Program. The VICP has
    been an integral part of maintaining the vaccine market.
    Enacted in the late 1980's with the support and guidance of the
    American Academy of Pediatrics, the VICP has helped to
    stabilize what was then, and appears to be again, a fragile
    vaccine market.
        The American Academy of Pediatrics has participated in the
    work of the National Vaccine Advisory Committee. We have seen
    the draft report presented at NVAC's recent meeting. That
    report offers a good starting point toward fixing an absolutely
    fixable problem.
        Universal immunization made a profound improvement in the
    health of our Nation. It would be tragic to let this hard-won
    advance slip away and jeopardize such a fundamental public
    health measure. The health of our children depends on it. Thank
    you for your time and attention.
        Senator Carnahan. Thank you, Dr. Doran. Dr. Jackson.

       TESTIMONY OF MARY ANNE JACKSON, M.D.,\1\ CHIEF, PEDIATRIC
      INFECTIOUS DISEASES SECTION, CHILDREN'S MERCY HOSPITALS AND
                                CLINICS

        Dr. Jackson. Madam Chairwoman and Mr. Bunning, I am Dr.
    Mary Anne Jackson, Professor of Pediatrics and Chief of the
    Section of Infectious Diseases at the Children's Mercy
    Hospitals and Clinics in Kansas City, Missouri. Our
    pediatrician center is the only children's hospital between St.
    Louis and Denver. We serve a 140-county region and we see over
    300,000 children per year.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Dr. Jackson appears in the Appendix
    on page 39.
    ---------------------------------------------------------------------------
        My role is as a pediatric infection specialist. I provide
    care and consultation for a variety of children, many of whom
    are otherwise healthy children, hospitalized with serious and
    sometimes life-threatening infections, such as meningitis. Some
    are children with underlying diseases such as AIDS, cancer,
    prematurity, those with transplanted organs, who have a variety
    of complex infections. I am a clinical researcher and my
    research focus is on emerging infections, bacterial resistance,
    overuse of antibiotics, and prevention of communicable
    diseases.
        My third role, and possibly my most important role, is as
    an advocate and educator for children's health issues. As a
    community resource, my colleagues and I speak formally to
    groups of pediatricians locally, regionally, and nationally. On
    a daily basis, community pediatricians call us with specific
    questions regarding their patients, perhaps about the diagnosis
    and treatment of a child with a diagnostic dilemma, questions
    regarding antibiotics, but fully 25 percent of those phone
    calls sometimes are related to immunization issues.
        When I lecture on immunizations, one of my key messages is
    that physicians must maintain timely immunizations as a high
    priority in the care of infants, children, adults, and
    adolescents. I am preaching to the choir when I tell
    pediatricians that we have eradicated or nearly eradicated
    diseases, as you all know, diphtheria, measles, mumps, polio,
    rubella, and tetanus.
        Ask any pediatrician who trained in the 1970's and 1980's
    and they will no doubt remark to you that one of the most
    remarkable accomplishments of their career is the eradication
    of Haemophilus influenzae Type B infection, which was the most
    common cause of meningitis up to approximately 1993. Within 3
    years of the implementation of that vaccine, this disease
    virtually was eliminated and I have not seen a case in almost
    10 years. However, I remind pediatricians that these pathogens
    continue to persist in the United States and in other countries
    and that our immunization program, I would consider fragile, at
    best.
        In the United States, only 80 percent of children are
    adequately immunized. In the State of Missouri, we are at the
    national average. In the Kansas City area, devoted efforts from
    organizations such as the Partnership for Children and the Mid-
    America Immunization Coalition have worked tirelessly, and we
    have raised immunization rates from a pitiful 50 percent in
    1990 to 85 percent in the year 2000, but we still have
    disparities where counties have immunization rates as low as 66
    percent.
        I remind pediatricians that we cannot be complacent,
    because I continue to see children with vaccine-preventable
    diseases. Since I have come to Children's Mercy Hospital, we
    have diagnosed over 300 children with whooping cough. Most
    recently, we had a 2-month-old in our intensive care unit for
    over a month with complications of this infection. In the last
    year or so in my community, a child has died with chicken pox
    complications, a child has died of pneumococcal meningitis at
    the age of 5 months, and a very sweet 15-year-old boy in May
    2001 died of liver cancer, a complication of hepatitis B virus
    that was transmitted at birth. All of these were vaccine-
    preventable diseases.
        This unprecedented and unanticipated shortage of routinely
    recommended vaccines has resulted in inadequate supplies of
    actually 8 of the 11 routinely administered vaccines, and
    shortages are more acute in the public sector than the private
    sector, and this is important for us, Senator Carnahan, because
    50 percent of the children in the State of Missouri are covered
    under the public sector Vaccines for Children program.
        The vaccine shortage has impacted the physicians' ability
    to provide a consistent recommendation and practice for vaccine
    implementation. We also keep a log, and we try to call back. We
    have tried to follow the CDC's guide for prioritization of
    vaccines, but we cannot do this. Most physicians in our areas
    do not. Forty percent of physicians nationally do not.
    Suddenly, physicians realize that they are out of a certain
    vaccine or it is not practical to triage vaccines in the course
    of a busy pediatric practice. We have also changed our
    immunization requirements in the State such as we tell
    pediatricians in July 2001, you must have varicella vaccine to
    go to day care. Less than a year later, we tell them, never
    mind.
        What is the impact of the vaccine shortages? We estimate
    that the negative impact is a decline of almost 10 percent at
    this point. I tell pediatricians that children who start their
    vaccines on time are clearly more likely to be current
    throughout their first year. Our message to the public and
    professionals becomes muddled, though, when we document the
    scope of disease that can be prevented by immunization and then
    delay and defer opportunities.
        Prevention of infectious diseases by immunization has been
    one of the great public achievements of the 20th Century.
    Whether our current vaccine shortage is related to companies
    leaving the market, manufacturing and production problems, or
    insufficient stockpiles, it is clear that one of the indelible
    marks of this shortage is that parents and professionals are
    confused and frustrated and all strides made in the last decade
    may go by the wayside. Our goals should be to maintain a supply
    of licensed vaccines that are safe and effective. These
    vaccines should be available for every child and adult in the
    United States. Vaccine research development and production must
    be enhanced.
        And last but not least, we must renew our educational
    efforts following the correction of this shortage to ensure
    that our children are healthy now and as we face the challenges
    of the future.
        Our promise to parents should be resolute. A strong
    immunization program needs to be ensured. It is the right
    action and one of the most cost-effective means of ensuring the
    health of children in our country.
        Senator Carnahan. Thank you very much. We will move on to
    Mr. Pisano.

      TESTIMONY OF WAYNE F. PISANO,\1\ EXECUTIVE VICE PRESIDENT,
      AVENTIS PASTEUR NORTH AMERICA, ON BEHALF OF PHARMACEUTICAL
                 RESEARCH AND MANUFACTURERS OF AMERICA

        Mr. Pisano. Good morning, Chairman Carnahan, and Senator
    Bunning. On behalf of the Pharmaceutical Research and
    Manufacturers of America, PhRMA, I am pleased to appear at this
    hearing today on childhood vaccines. I am Wayne Pisano,
    Executive Vice President of Aventis Pasteur.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Mr. Pisano appears in the Appendix on
    page 43.
    ---------------------------------------------------------------------------
        PhRMA represents the country's major research-based
    pharmaceutical and biotechnology companies which are leading
    the way in the search for new cures and treatments that enable
    patients to live longer, healthier and more productive lives.
    More specifically, PhRMA represents the four companies
    supplying 100 percent of childhood vaccines in this country and
    90 percent of all vaccines. Many people are surprised that the
    industry is so small, but the fact is, the liability crisis of
    the 1980's drove many companies out of the market. I will talk
    more about that later in my testimony.
        We are all keenly aware of the vaccine shortages facing our
    Nation today. The good news is that most of these shortages
    have been or will be resolved this year. In the long term, we
    need to understand what causes vaccine shortages and what can
    be done over the long term to alleviate them. I will outline
    six proposals to alleviate shortages in the long-term.
        But first, I want to talk about the vaccine industry and
    what is unique about it. First, unlike pills, vaccines require
    the use of biological organisms, viruses and bacteria, which
    will not always grow or respond on demand.
        Second, vaccines are difficult and time consuming to
    produce and the regulatory approval process for new vaccines
    and for changes to existing vaccines is highly complex and
    lengthy, with timetables that are difficult to predict. The
    process is regulated such that every lot of vaccine must be
    approved by the manufacturer and released by the FDA. Taking
    into account that production schedules can run 12 months and
    longer, any abrupt change in policy that can influence demand
    or move a company to leave the field can result in supply
    interruptions.
        A good example is the decision to remove thimerosal, a
    preservative, from vaccines. The decision was made to remove
    thimerosal, which had consequences exacerbating a shortage of a
    childhood vaccine, DTaP. Thimerosal is a preservative which
    allowed health care providers to purchase and use multi-dose
    vials. Without thimerosal, single-dose packaging must be used.
    The manufacturing process for Aventis Pasteur had to be changed
    and approved by the FDA. The process changes lengthened the
    manufacturing time lines and manufacturing yields dropped,
    since it is necessary to over-fill every single vial to assure
    the provider can remove a full dose.
        The resulting shortage should be alleviated by the fall, if
    not this summer, and providers should be able to provide all
    five doses require for the pertussis schedule. In part, this is
    because the FDA recently licensed Aventis Pasteur's Canadian
    DTaP product, DAPTACEL, for use in this country.
        Third, vaccines are tremendously undervalued as
    preventative measures. Prices can best be categorized as
    commodity-like, compared to much higher prices for other forms
    of medicine. Public purchasing entities continually endeavor to
    drive down the price the government will pay for vaccines
    despite the fact that, in many cases, a dose or series of doses
    of vaccines provides a lifetime of protection against a
    disease. This is occurring at a time when manufacturers are
    investing significant resources to meet the current good
    manufacturing practices standards set by FDA.
        Before I outline the six steps to a stronger vaccine
    supply, let me state what is not needed. First, what is not
    needed is a government-built vaccine facility, GOCOs. These
    would take years to develop and face the same problems as
    private facilities. In addition, they would dampen incentives
    for new private entrants to enter the vaccine business. It is
    often forgotten that it is science, not manufacturing, that is
    the limiting factor in developing new vaccines. All the
    manufacturing capacity in the world cannot produce a vaccine
    until the science is there.
        Nor do we need a new centralized vaccine authority. The FDA
    and CDC's regulatory regimen is comprehensive and well-
    established, and there is no compelling reason to develop a
    wholly new system.
        We do have a number of suggestions which we believe would
    help meet our vaccine supply needs in the future. Here are the
    six initial proposals. We support expanded stockpiles for use
    if supplies are disrupted. We support additional funding for
    the CDC to establish stockpiles for both single- and multi-
    source products. For example, had there been a national tetanus
    stockpile, we would not have had the shortages we recently
    experienced when one company left the manufacturing process,
    leaving it to a single manufacturer.
        No. 2, use the expertise of the vaccine manufacturers to
    help formulate sound immunization policy. Manufacturers can
    provide realistic assessments and expertise about how vaccines
    are developed and produced, the challenges in doing so, as well
    as a view into how providers practice and use vaccines. It is
    important that those making vaccine policy in government have
    this expertise available to them. However, in more formalized
    settings, this is no longer occurring. An example is CDC
    working groups where industry representatives are no longer
    permitted to participate in discussions. Industry does not
    expect to participate in decisionmaking issues, but given the
    limited universe of vaccine expertise, governments can benefit
    from the use of vaccine expertise in this industry.
        No. 3, government and advisory bodies need to act with
    greater flexibility. Continued uninterrupted manufacturing and
    distribution of vaccines is dependent upon predictable action
    by government agencies and advisory committees. Specifically,
    we suggest that government agencies and advisory committees
    need to allow adequate advance notice whenever manufacturing
    changes are necessary. Simply put, if change is required before
    manufacturers can make them and the FDA can approve them,
    shortages will occur.
        No. 4, the Vaccine Injury Compensation Program, VICP,
    should and needs to be strengthened. The Vaccine Injury
    Compensation Program stabilized our national immunization
    program since the late 1980's, reducing the frequency of
    liability uncertainty that has destabilized our industry. VICP
    provides a system of compensation for injury claims should they
    be litigated within the VICP system.
         Recently, new strategies have emerged to circumvent the
    program. Once again, manufacturers are facing liability
    exposure that measures in the billions of dollars. Already, we
    are facing millions of dollars in costs to defend against
    specious claims. Recently, Senator Frist introduced a
    thoughtful and comprehensive vaccine bill, S. 2053, which
    contained a section on VICP. It adopted the recommendations of
    the Advisory Commission on Childhood Vaccines to make the
    system more user friendly. In addition, it reiterated the
    intent of the VICP that claims processed should proceed
    initially through this program. We strongly commend the
    provisions of the Frist bill to you. We are pleased that last
    Thursday, ACCV adopted virtually all of Senator Frist's
    proposals.
        No. 5, to strengthen our message that prevention is the
    most desirable intervention, a reorientation of health care
    priorities to emphasize prevention over cure will provide
    incentives to doctors to immunize patients and to manufacturers
    to maintain their commitment to vaccine production. There needs
    to be sufficient payment for preventative services. Recent
    reductions in CMS reimbursement are disincentives to
    physicians. Reimbursement rates should reflect the full value
    of vaccines, including a realistic administration fee for
    physicians.
        And No. 6, heed the warning signs of a real and present
    danger, increasing lack of confidence in immunization. The good
    news is that parents no longer fear many infectious diseases
    because of the success of our immunization programs. They also
    have lost the respect for the importance of immunization as
    they have lacked the firsthand experience or knowledge of the
    devastating damage vaccine-preventable diseases can cause. We
    urge you to look at ways to bring the public into the process
    and boost its confidence in the immunization system.
        The vaccine enterprise in this country is a remarkable
    success story. I do not believe it is fragile, yet it clearly
    has several areas that can be strengthened. I hope you will
    give consideration to the proposals we have laid out.
    Fortunately, we have an industry that wants to partner with
    government and with all elements of our Nation's immunization
    enterprise to achieve even greater successes.
        Thank you very much for your attention and your commitment
    to the immunization system in this country.
        Senator Carnahan. Thank you, Mr. Pisano.
        I would like now to open our questioning by addressing the
    impact of the shortage is on children. I would like to raise
    the issue of what happens to children when they miss their
    vaccines.
        Dr. Doran, I am concerned about the issue of children
    slipping through the cracks. I know from personal experience,
    most private physicians do not have a system to make sure that
    a kid who has missed a vaccination gets back into the office
    once the vaccine does become available. This issue is
    particularly problematic for children whose only health care is
    through the public health system. They may visit different
    health clinics for their medical needs and so the physician
    helping them will not have access to a complete medical record
    of that child.
        Can you comment on your own experience with this issue and
    what you are hearing from other physicians as to what they are
    experiencing, and are you receiving any Federal guidance or
    assistance to help with this problem?
        Dr. Doran. Thank you, Senator Carnahan. It is a multi-
    faceted answer, and I will begin by saying that one of the
    problems in this whole past year of shortages has been the
    spottiness and the fact that we have had multiple vaccines
    available or not available for different lengths of time. So
    planning has become problematic in that we cannot set out a
    plan without changing it in a month because a vaccine either
    becomes available or not available.
        The current practice and those of the colleagues I have
    talked to, both in the public and private sector, has been to
    create lists of patients when they come in, to take their phone
    numbers and keep them in a log, and as the vaccine comes in, to
    try to contact those patients to bring them back in. As you can
    imagine, that is a difficult task. Parents have to take off
    work to come in and get the vaccine. It is not part of their
    regularly scheduled vaccination schedule and it is difficult. I
    cannot give you specific numbers in terms of how effective that
    system is other than to tell you it is far from perfect.
        I have created a system in my office. I actually have a web
    page and people can register on that web page and I can then E-
    mail them, sort of broadcast E-mail them to notify them when
    vaccines are in, but that is very new and, obviously, not
    everybody has access to the Internet.
        It is just a problem. I think, talking to all my
    colleagues, my impression is that the majority of kids are
    probably waiting until their next scheduled visit before they
    get the vaccine, so if they have missed a pneumococcal vaccine
    at 2 months of age, they are probably not receiving it until
    their 4-month check-up, which is the next regularly scheduled
    visit, rather than at 3 months if the vaccine happened to come
    in in the interim. Most parents will probably wait.
        I have a bunch of anxious parents who will come in very
    quickly, but for most parents, it is a lot of work to get to
    the office, both working class parents or middle class parents.
    It is very difficult to spend the time and get to the office in
    order to get that vaccination.
        Senator Carnahan. So it is a lot better to do it on a
    regularly scheduled basis than to have to make the time.
        Dr. Doran. Absolutely.
        Senator Carnahan. Dr. Jackson, I think parents are
    receiving something of a mixed message about vaccines. They are
    being told how important they are for their children's health,
    and then when they go to a doctor's office, they are being
    turned away. Can you address the impact that this is having
    both on parents and public health overall?
        Dr. Jackson. Well, I think I can start by saying that as
    new vaccines have been licensed and we have educated parents
    and professionals in our community about those vaccines, there
    have sometimes been a lag period before these immunizations are
    even embraced when we have them available. The examples I would
    give you would be hepatitis B vaccine and varicella vaccine,
    where it took 2 to 5 years before parents and professionals
    really embraced these vaccines and they began to be reliably
    used.
        I think you are entirely correct that I call this a muddled
    message. We cannot tell parents that we continue to see
    vaccine-preventable disease, that we continue to see vaccine-
    preventable deaths, and make no mistake, this is not a Kansas
    City phenomena. This is not a Missouri phenomena. This is a
    national phenomena. We cannot tell them that this risk is just
    for their child and then tell them that we do not have vaccines
    available, to come back when we call them on the telephone. In
    the public sector, we are lucky to even have patients with
    telephones or with an accurate telephone number.
        So I think that one of our greatest problems will be, if we
    are able to correct this, and I feel that we are, we will have
    the American public that has lost confidence or become
    complacent about immunizations and that our efforts to educate
    both parents and professionals will have to be renewed. We will
    have to remind people that not only are there communicable
    diseases in this country that can be prevented by vaccine, but
    we will have to remind them once again that timely immunization
    should be a high priority for all.
        Senator Carnahan. I understand that there are a number of
    collaborative efforts that are going on around the country to
    increase immunization, and it is my understanding that Kansas
    City is about to launch such a campaign. I was wondering if you
    could discuss the ``Give Life a Shot'' campaign, what its
    purpose is and what impact you think it will have considering
    the current vaccine shortage.
        Dr. Jackson. The Hallmark Foundation in Kansas City has
    awarded a grant to both the Children's Mercy Hospital and to
    the KU Medical Center pediatricians to develop an educational
    plan for our community. It will consist of public service
    spots. There will be signage on public transit systems,
    basically to remind families to insist that their children
    start vaccines on time at 2 months of age.
        There was one or more individuals within our group who
    suggested that perhaps this is not a good time to educate the
    public because how can we say, immunize on time, start at 2
    months, and then have them come in and say, we do not have
    these vaccines available? My response to that, though, is we
    must continue our efforts to educate the public, and as we do
    see perhaps an end to this by the end of the year, perhaps by
    summer for many of these vaccines, by the end of the year 2003,
    I think we must continue to educate the public and our campaign
    will start in August.
        Senator Carnahan. Thank you. Next, I would like to address
    a few of the factors that affect the supply of children's
    vaccines. One important issue is the amount of production
    capacity that exists and whether it is sufficient to meet the
    demand.
        Mr. Pisano, some pediatricians say that the current
    shortage in childhood vaccines is the worst shortage they have
    seen in their entire careers. I think Dr. Doran expressed that.
    Twenty years ago, there were 18 companies manufacturing
    vaccines, and in the 1980's, there were seven companies. Today,
    we have only four companies making vaccines for children in the
    United States.
        I am concerned whether the country's physical
    infrastructure to manufacture vaccines is sufficient to meet
    the demand for the long term. Does our country have enough
    production capacity to make the demands that we need, and if
    more companies do not enter the market, will we be able to meet
    demands for vaccines in the future?
        Mr. Pisano. I think that the current manufacturing capacity
    in some situations is inadequate. I think the example of Td met
    that definition, where one manufacturer left the industry and
    the remaining manufacturer did not have the capacity at that
    time.
        Now, I think what we have seen from the four manufacturers
    is a renewed commitment and expansion of capacity. We have seen
    one manufacturer expand their capacity for pertussis vaccine,
    another manufacturer license a second facility for pertussis
    vaccine. We have seen expansion on Td vaccine capacity, and we
    are also seeing now further expansion for the pneumococcal
    vaccine.
        So I think the industry is responding, and I think we also
    will be seeing other manufacturers looking to enter the U.S.
    market and will be taking their products through the clinical
    and development process and filing for registrations with the
    FDA. So I think the problem is on the table now, and I think
    the industry is responding. The immediate shortage should be
    over for most of the vaccines this summer, and definitely by
    year end for all the pediatric vaccines, and then the
    infrastructure will continue to expand from there.
        Senator Carnahan. As you pointed out, the immediate
    shortage is likely to be over sometime during the summer, but I
    am concerned that the underlying factors that have contributed
    to the shortage will remain. Supply and demand will remain
    tight with little room for error. There will still be only four
    companies manufacturing all the childhood vaccines in the
    country and there will still be several vaccines that only one
    company will produce. So any problem will have a significant
    effect on the supply.
        I think a key to finding a long-term solution to this is
    increasing the number of the vaccine manufacturers in the
    market. What can be done to encourage more companies to enter
    the vaccine market?
        Mr. Pisano. I think there are a number of factors on why
    companies enter and leave markets. One has to do with the risk
    and liability associated with--that the vaccine manufacturers
    are subject to, and the Vaccine Injury Compensation Program is
    something that needs to be strengthened so manufacturers are
    not threatened by these specious claims and billions of dollars
    of lawsuits, because that clearly discourages people from
    entering the marketplace.
        Another is, I think we need to have an appreciation in the
    United States of the value of vaccines. Vaccines are not valued
    the way pharmaceutical products are valued, and so prices are
    driven down. They are very commodity-like, and in order to meet
    the current good manufacturing practice standards that are set,
    companies have to invest in their manufacturing facilities.
    Many of these facilities are old facilities for vaccines that
    were licensed 20, 30, or 40 years ago, and it is not cost-
    effective for the manufacturer to do that. It is too costly
    because there is just not enough return for them on making that
    investment.
        Senator Carnahan. If a company is experiencing a production
    problem or they know that they will stop manufacturing a
    vaccine, could a shortage be avoided if the government and
    other manufacturers were given advance notice? Could you
    explain how you would propose this would be addressed?
        Mr. Pisano. I can speak on behalf of Aventis Pasteur
    specifically on that. A proposal that we have brought forward
    to the other vaccine manufacturers that is still in discussion
    is allowing the CDC to be a clearinghouse for confidential
    information in terms of manufacturing issues such that they
    would have the ability to do one of two things. They could ask
    another manufacturer to increase production when we have multi-
    source products, or they could draw on their stockpile, and I
    think stockpile has been mentioned by several people today.
        We truly believe that we need to have an adequate
    stockpile, because when you are dealing with biologics, there
    is always the risk that there will be a manufacturing issue
    somewhere in the future and having a stockpile provides us the
    cushion necessary to get through those types of issues.
        Senator Carnahan. Thank you. I had just one other question
    and then I will turn the questioning over to Senator Bunning.
        For Dr. Jackson, are you seeing vaccine-preventable
    diseases reemerge, and if not and the shortage continues, how
    long do you think it would be until we do begin to see these
    diseases again?
        Dr. Jackson. It is hard to say of vaccine-preventable
    diseases reemerging at this point. We clearly continue to see
    vaccine-preventable diseases. I used pertussis as one example.
    We continue to see children with complications of chicken pox,
    albeit fewer than we did, say, in the early 1990's.
        I think as immunization coverage rates fall, though, and I
    think as they fall below 80 percent is when we risk the
    emergence of vaccine-preventable diseases. I mentioned to you
    that nationally, we are at about 80 percent, in Kansas City,
    perhaps 85 percent. That is why I described our program as
    fragile. I think that if we decrease by 10 percent, then we are
    at 70 percent, and then I think that, clearly, we will see the
    emergence of vaccine-preventable diseases.
        What is even worse is that we have recently had the
    licensing of the new pneumococcal vaccine, and it has been
    embraced very quickly by pediatricians who do see children with
    pneumococcal pneumonia bloodstream infection and meningitis.
    They recognize that disease and the need to prevent it. Almost
    months after we start the implementation of that vaccine, it is
    taken away from us, and it is probably our greatest shortage
    right at this point. We currently have none at the Children's
    Mercy Hospital for our Vaccines for Children Program.
        Senator Carnahan. Thank you. Senator Bunning.
        Senator Bunning. Thank you, Senator.
        Dr. Doran, in your practice, how often do you not have the
    necessary vaccines? You told us about how you try to follow up,
    but knowing full well, having had nine children and having gone
    through the vaccination process with those nine children, and
    fully aware of the fact that a smallpox vaccination only lasts
    10 years, and so all of us sitting in this room are not immune
    to smallpox because if you have not had one recently, you are
    not immune, so tell me about how often do you not have the
    necessary vaccine.
        Dr. Doran. I would be delighted to. If I could just mention
    one thing about Senator Bunning. As a 7- or 8-year-old, my very
    first major league baseball game was at Fenway Park when
    Senator Bunning threw a no-hitter.
        Senator Bunning. You are a New Englander, then?
        Dr. Doran. As a 7-year-old, I was----
        Senator Bunning. From the State of Maine.
        Dr. Doran. As a 7-year-old, I was upset that the Red Sox
    lost, but that has been a chronic problem. [Laughter.]
        Over the past year, I have not had a reliable supply of
    tetanus vaccine. Actually, I was mentioning to the other panel
    members, this past week, I received my first shipment of adult
    tetanus vaccine that I have had in months and months. I have
    had shortages of varicella vaccine, of MMR, of DTaP, and the
    worst has been the pneumococcal vaccine.
        They have been for varying periods of time. The tetanus has
    been for the entire period. I have been out of the pneumococcal
    vaccine probably 20 percent of the time. Varicella was brief
    for me. It was probably 3 to 4 weeks over the past year, and
    MMR and DTaP, probably of similar length of time that I have
    had shortages.
        Senator Bunning. Did you have problems with the flu vaccine
    last year?
        Dr. Doran. Yes.
        Senator Bunning. Because we had problems here in the
    Capitol with it.
        Dr. Doran. Yes. In my testimony, I mention the required
    childhood vaccines. Flu vaccines have been a problem off and on
    over the years, and I certainly have had shortages of flu
    vaccine. But of the potentially lethal diseases in childhood
    and the required--it is not one of the required childhood
    vaccinations. It is for high-risk children that we see, so we
    do have recommendations----
        Senator Bunning. And for seniors.
        Dr. Doran [continuing]. For seniors and for health care
    workers, actually, who work with immuno-compromised patients.
    So I have seen those vaccine shortages, but I think that, for
    pediatricians, the shock this year is that not just one vaccine
    has been short, but as you mentioned, five vaccines containing
    eight preventable illnesses in them have been short, and it has
    clearly been--we have depended on this. It has been so
    reliable, and then to have such a disruption in the supply has
    been very frustrating and very difficult to deal with.
        Senator Bunning. Dr. Jackson, let me ask you, parents and
    confidence, there seems to be a disconnect. Our parents, or my
    parents, there was no hesitation at all as far as polio, as far
    as smallpox or whooping cough or whatever it was. When we went
    to the doctor and the vaccination was available, they gave it
    to us, and on a systematic basis. If public health facilities
    were available, those who could not afford it privately got it
    at public health facilities. Tell me if the same confidence
    exists now between parent and physician and vaccinations,
    because I suspect that it does not.
        Dr. Jackson. And it is somewhat different, Senator Bunning.
    Nowadays, parents are part of the health care system. So when a
    child comes to your office for immunizations, we do not just
    give the vaccines, we tell them what vaccines they are
    receiving, we tell them why they are receiving their vaccines,
    we discuss risks and benefits of vaccines, and so perhaps that
    is better in this day and age.
        But the confidence issue comes into call when we tell them
    why they are receiving vaccines, the risks and benefits of
    vaccines, that we recommend these vaccines and then we are
    unable to provide them those vaccines. So that is the
    confidence issue that has occurred.
        Complacency, I think, is the big risk, and it is not
    because the professionals will lose their focus. It is not
    because the parents will lose their focus, which is keeping
    children healthy and preventing communicable diseases. It is
    because we have developed this routine of promising something
    that we cannot make good on, and so I think we need to make
    good on our promise.
        Senator Bunning. I agree with that 100 percent, but the
    fact of the matter is, the parents' awareness and the trust
    factor in the vaccinations, without having, in other words,
    like the anthrax in the military, for instance. A lot of people
    were required by the military to get anthrax vaccinations and
    they said, no, we do not want to take the risk because we think
    this vaccination or vaccine is not something that we should do.
    How much do you have with parents as far as children's diseases
    and vaccinations are concerned?
        Dr. Jackson. I see your question. When we say to a family,
    this vaccine is safe and effective, do they believe us? Do they
    have confidence?
        Senator Bunning. That is right.
        Dr. Jackson. Exactly. I would say the vast majority of
    parents that we encounter do have confidence in their
    pediatrician to provide them with the best information
    possible. We have a segment of the population, perhaps 10
    percent, who are highly concerned and need more reassurances
    that we are convinced that this is the right thing to do, and
    then there is a small segment of the population that are truly
    anti-immunization and may not be willing to hear evidence-based
    information that science tells us that there is no connection
    between, for instance, autism and MMR. I think that is a small
    segment of the population. I think the vast majority of parents
    have confidence in their pediatricians, like Dr. Doran, like
    pediatricians through our Children's Health Care Center.
        Senator Bunning. The only people we miss are those who
    never get there.
        Dr. Jackson. Correct, and that is----
        Senator Bunning. In other words, we do have a segment of
    the population that does not have them available to them
    because they do not get the public health links or they do not
    get the private physicians.
        Dr. Jackson. And that is where I think prioritization is an
    issue and falling through the cracks. In some of our
    populations in the public health sector, we have children who
    are living in circumstances that are unbelievable. They do not
    have electricity. They may not have a meal that day. They do
    not have clothing. I mean, for you to tell them that it is a
    priority for them to get their immunization gets washed out by
    the really important issues in their lives.
        Senator Bunning. The only time probably we see them is when
    they get to school.
        Dr. Jackson. Exactly, and that is why our Give Life a Shot
    program is going to focus, hopefully, on that hard-to-reach
    population.
        Senator Bunning. Mr. Pisano, let me talk to you. You
    mentioned the fact that the threat of class action lawsuits
    against manufacturers could threaten vaccination or vaccine
    production. You also said that the Vaccine Injury Compensation
    Program needs some changes. I would like for you to expand on
    that.
        Mr. Pisano. I think it is important for any litigation in
    terms of harm from vaccines or perceived harm from vaccines
    must go through the Vaccine Injury Compensation Program, and
    today, we are finding the lawyers working around the system and
    going directly into the State court systems and suing the
    manufacturers directly. Right now, there are class action
    lawsuits that total in the billions of dollars that the vaccine
    manufacturers are facing. The defense for these lawsuits is
    well into the millions of dollars already and we have just
    begun, and these are popping up every day across the country.
        Senator Bunning. Let me also ask, did you mention the fact,
    or did I read it in your testimony, that the industry
    representatives are no longer permitted to fully participate in
    CDC's working groups?
        Mr. Pisano. That is correct.
        Senator Bunning. Give me some kind of background and
    explanation on that.
        Mr. Pisano. I think we are in an era where there is concern
    about manufacturers' interests and bias. Obviously, we are in
    business to manufacture pharmaceuticals and vaccines, and we
    have been distanced from these working groups. We are allowed
    to make a statement in a public forum, but we are not allowed
    to participate in the discussions that go on behind closed
    doors. We believe that we have information that would help the
    working groups make better decisions.
        We also realize we should not be part of the decisions,
    because we do have an interest in the outcome of the decision.
    But information in terms of manufacturing capacity, information
    in terms of how fast we can change a formulation to take a
    preservative out of a vaccine and go to a preservative-free
    formulation. We had working groups that made recommendations to
    remove thimerosal. That was implemented before manufacturers
    could complete that removal and before the FDA had time to
    review that new formulation.
        Senator Bunning. Did that slow down, then, the manufacture
    of that vaccine, when you had to convert? Or were your
    production facilities, whoever it might have been, able to
    adjust to that in a reasonable manner?
        Mr. Pisano. The removal of the preservative definitely
    slowed down the manufacturing process. We had to reformulate
    the vaccine, which, in essence, is like a full development
    program. It took 2 years. The recommendations went in place in
    about 15 months, and so there was a gap and that contributed to
    the shortage of the pertussis vaccine, which is where we
    believe the industry can help advisory bodies, working groups,
    by bringing that type of knowledge to the table. We do not
    disagree with the decision of the working group. We simply
    believe that we have information that will help them make a
    better sound decision.
        Senator Bunning. This is the last question I have for the
    two doctors. What will need to be done to make sure that all
    children are properly vaccinated once the shortage is over,
    especially for families who do not have a regular doctor and
    instead rely upon health clinics and hospitals for their care?
    Either of you can try to help us out so we can do something.
        Dr. Doran. There clearly needs to be the kind of outreach
    programs that Dr. Jackson mentioned. The American Academy of
    Pediatrics, for instance, has joined with McDonald's to promote
    vaccinations, and there really has to be a much more proactive
    public health sector campaign to bring these children in.
        We need to, obviously, as part of that, shore up the issues
    with preventing shortages, and the other thing that was
    mentioned by Mr. Pisano which will be important is to make sure
    that physicians' time and energy is adequately compensated.
    There are proposals to reduce the administration fee for
    vaccines to a level that would be, for pediatricians and for
    public health clinics, where they would be losing a significant
    amount of money every time they are giving a vaccine. So those
    types of reimbursement issues are key, too.
        But in terms of reaching those hard-to-reach children, it
    is a matter of public will and campaigns to reach those
    children and to get them in.
        Senator Bunning. Dr. Jackson, do you have anything to add?
        Dr. Jackson. I agree that in this country, we need to prove
    to the American public that we value vaccines, and in doing so,
    we need to commit funds to the research and development of new
    and better vaccines. We, of course, need to continue our
    efforts to educate the public. We need to have immunization
    registries which are available which will allow us to share
    information confidentially about the immunizations that a child
    has had.
        For instance, you are so right when you say that a child
    may be immunized in three different health departments and
    maybe two different physicians' offices. We see physicians'
    offices now not stocking vaccines because they are not being
    fairly compensated. It costs them $58 to buy the vaccine. The
    insurance company will reimburse them $48. And you multiply
    that by the number of patients that are seen in a pediatric
    practice and you can see why some practices are doing this.
        And so we will have a child who comes in where we have no
    clue the number of vaccines they have received, the timing of
    those vaccines, and so I think that is one thing that we can
    do, also.
        Senator Bunning. Thank you, Madam Chairman.
        Senator Carnahan. Thank you, Senator Bunning, and I thank
    our distinguished panel today, Dr. Doran, Dr. Jackson, and Mr.
    Pisano. Your willingness to be here has certainly helped us to
    have a better understanding. You have shed light on a very
    critical and very important issue in our Nation, and we
    appreciate you sharing your expertise with us. Thank you.
        Our second panel will have two witnesses, one of which has
    not arrived yet but is on his way. One will be Dr. Lester
    Crawford. I will proceed with introducing him, even though he
    has not joined us yet. He is from the Food and Drug
    Administration, and Dr. Orenstein from the Centers for Disease
    Control and Prevention.
        Dr. Crawford is the Deputy Commissioner for the Food and
    Drug Administration and has extensive experience in FDA
    matters. His previous government experience included serving as
    the head of the FDA Center of Veterinarian Medicine and as
    Administrator of the Department of Agriculture's Food Safety
    and Inspection Service. During his 10 years at FDA and the
    Agriculture Department, Dr. Crawford has played major roles in
    mandatory nutrition labeling, the General Agreement on Tariffs
    and Trade, and the control of chemical and microorganisms in
    the food supply.
        Dr. Orenstein is the Director of CDC's National
    Immunization Program and has a background in pediatrics and
    pediatric infectious diseases. Dr. Orenstein has spent more
    than 24 years at the CDC working in immunization and has been
    Director of the National Immunization Program since its
    founding in May 1993. He also serves on the National Vaccine
    Advisory Committee and the Committee on Infectious Diseases of
    the American Academy of Pediatrics.
        Thank you for being here, and we will start, Dr. Orenstein,
    with you for an opening statement.

     TESTIMONY OF WALTER A. ORENSTEIN, M.D.,\1\ DIRECTOR, NATIONAL
         IMMUNIZATION PROGRAM, CENTERS FOR DISEASE CONTROL AND
        PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Dr. Orenstein. Thank you very much. Good morning, Senator
    Carnahan and Senator Bunning. I am Dr. Walt Orenstein, Director
    of the National Immunization Program at the Centers for Disease
    Control and Prevention. Thank you for inviting me to testify
    about the current childhood vaccine shortages.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Dr. Orenstein appears in the Appendix
    on page 54.
    ---------------------------------------------------------------------------
        There are currently supply problems with five vaccines that
    provide protection against 8 of the 11 vaccine-preventable
    diseases of childhood. The current childhood vaccine shortages
    are unprecedented, and health care providers and parents have
    been justifiably frustrated. The Department of Health and Human
    Services takes these concerns very seriously, and CDC is
    monitoring the situation in a variety of ways.
        I would like to point out some good news. Current
    information from the manufacturers indicates that many of these
    shortages will be over before the end of the summer.
        The causes of the childhood vaccine shortages are multi-
    factorial and complex. Economic issues are clearly critical to
    the long-term viability of the vaccine industry. There is no
    single characteristic at the root of the current shortages.
    Some contributing factors include manufacturers' production
    capacity, regulatory compliance issues, manufacturers' business
    decisions to stop producing certain vaccines, and decreases in
    production yields caused by changing to single-dose vials to
    remove the preservative thimerosal from one of the vaccines.
        The impact of the shortage is being felt by health care
    providers, schools, and parents. The vaccines most affected are
    the tetanus and diphtheria and pneumococcal vaccines, which
    both show about a 40 percent decrease in doses distributed
    nationally. School immunization requirements have also been
    affected because supplies have not been adequate to ensure that
    children in need of immunizations can get them.
        While it is impossible to predict the larger public health
    impact of the current childhood vaccine shortages, there is
    clearly an increase in vulnerability to disease when children
    remain unvaccinated.
        In general, manufacturer projections indicate that the
    situation is rapidly improving. The most serious and enduring
    problem appears to be with the pneumococcal conjugate vaccine.
    According to manufacturer projections, this vaccine may be in
    short supply into 2003.
        CDC and its partners are addressing these shortages in
    several ways. The Advisory Committee on Immunization Practices,
    with concurrence from the American Academy of Family Physicians
    and the American Academy of Pediatrics, has made several
    temporary changes in routine immunization recommendations.
    These changes prioritize limited vaccine supplies to the most
    critical doses in the schedule to the most vulnerable children.
    CDC is also monitoring State vaccine orders to help assure that
    vaccines in shortage purchased through our contracts are
    distributed equitably.
        The CDC is in frequent communication with a wide range of
    partners regarding the status of vaccine production. CDC
    provides weekly vaccine supply updates on its website. This
    information is intended to help States and health care
    providers plan their immunization strategies.
        In addition to working with other HHS agencies, such as the
    FDA and the Centers for Medicare and Medicaid Services, CDC is
    working with its partners in industry and with other groups to
    better understand the current shortages, identify potential
    short-term solutions, and prevent future shortages.
        For some vaccines, CDC has maintained storage and rotation
    contracts, frequently referred to as stockpiles, which have
    been very effective in the past in alleviating brief
    disruptions in vaccine supply. These stockpiles are an
    important resource to maintain. Between 1984 and 2002, CDC
    stockpiles were drawn on multiple times when supplies of four
    different vaccines were interrupted. However, managing
    stockpiles effectively presents unique challenges and
    stockpiles are not available for four of the five vaccines with
    current vaccine supply problems.
        In addition to the input CDC is gathering from its
    partners, the National Vaccine Advisory Committee and the U.S.
    General Accounting Office are conducting independent reviews.
    CDC looks forward to reviewing their final reports.
        In conclusion, the current childhood vaccine shortages are
    complex, unprecedented in scope, and result from a number of
    factors. CDC has implemented several short-term measures to
    facilitate the efficient and effective use of available
    vaccines, and CDC is also receiving input from external
    organizations regarding strategies to prevent such shortages in
    the future.
        Thank you for the opportunity to tell you about the current
    shortages. At this time, I would be happy to answer any
    questions.
        Senator Carnahan. All right. Thank you.
        Joining our panel will be Dr. Jesse Goodman. He is Deputy
    Director for Medicine at the Center for Biologics Evaluation
    and Research at the Federal Food and Drug Administration and he
    will be speaking on behalf of FDA. Thank you, Dr. Goodman, for
    joining us in place of Dr. Crawford this morning.
        Dr. Orenstein, I would like to ask you about the low prices
    of vaccines. There are several factors that affect the market
    for vaccines and influence whether manufacturers want to enter
    or even remain in the market. One of those factors is the price
    that is paid for the vaccines.
        We welcome you, Dr. Crawford.
        Dr. Crawford. Thank you very much indeed.
        Senator Carnahan. We have already introduced you and we
    were glad you were able to join us.
        Dr. Crawford. Thank you very much.
        Senator Carnahan. One of the factors, as I said, is the
    price for the vaccines. The Federal Government purchases over
    one-half of our country's vaccines through the Vaccines for
    Children Program. The prices have not increased substantially
    since the program was implemented.
        In Dr. Crawford's written statement, he makes this comment,
    that ``Although the manufacture of biologic products is complex
    and demanding, and the need to update and maintain modern
    facilities is costly, the current prices paid for many vaccines
    are low compared with the prices of many other drugs.'' Could
    you comment on this and whether CDC or HHS has examined this in
    your discussions on how to alleviate future shortages?
        Dr. Orenstein. I think there has been substantial concern
    that vaccines are undervalued. In the past, vaccines had to
    pass a more rigorous test than most other products. That is,
    they needed to be cost-saving to society.
        However, I think the issue of vaccine prices cannot fully
    explain the problems we are seeing today. For example, there is
    an inverse correlation between vaccines that we are having
    supply problems with and price. We are having more problems
    with the higher-priced vaccines than we are with the lower-
    priced vaccines at the moment. Another example is influenza
    vaccine, which there is very little public sector purchase, and
    for that price is the lowest of all of the vaccines, at about
    $7.
        I think, in part, it deals with a society value issue, and
    as Mr. Pisano said, these are complex products, and I think the
    concern we have is the vulnerabilities, because in order to
    continue keeping up with good manufacturing practices, updating
    plants, making sure that all of the vaccines, including the
    older vaccines, have state-of-the-art technology supplied to
    them requires investments. And so I think economic incentives
    are going to be a key factor in trying to assure we have a
    long-term viable vaccine industry.
        Senator Carnahan. Thank you. We will back up at this time
    and hear from Dr. Crawford, give him an opportunity to make his
    opening statement before we proceed.

       TESTIMONY OF LESTER M. CRAWFORD, D.V.M., PH.D.,\1\ DEPUTY
    COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF
                       HEALTH AND HUMAN SERVICES

        Dr. Crawford. Thank you very much. I appreciate your
    gracious granting of me this time. I appreciate it very much,
    indeed. I am Dr. Lester Crawford, Deputy Commissioner of the
    Food and Drug Administration. Thank you for the opportunity to
    testify today.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Dr. Crawford appears in the Appendix
    on page 69.
    ---------------------------------------------------------------------------
        I appreciate the Committee's interest in the current
    shortage of childhood vaccines and welcome the opportunity to
    participate in this hearing. FDA is concerned about the
    fragility of the Nation's vaccine supply and is committed to
    the availability of safe and effective vaccines. FDA-licensed
    vaccines have been protecting our Nation's children from deadly
    infectious diseases for almost 100 years. In fact,
    immunizations represent one of the most significant public
    health achievements of the 20th Century. Vaccines can be
    credited with saving more lives and preventing more illnesses
    than any medical treatment. Without question, continuing to
    ensure the availability of safe and effective vaccines is
    critical to protect the public health and prevent disease
    outbreaks.
        FDA's regulation of vaccine manufacturing is essential to
    maintaining public confidence in U.S.-licensed vaccines. The
    importance of public confidence must be stressed. No other
    single health intervention has had the impact on disease
    prevention and our Nation's health as immunization with U.S.-
    licensed vaccines. For this reason, FDA carefully evaluates
    each licensing and regulatory action, balancing the importance
    of product availability while working with manufacturers to
    help assure that products are as safe as current technologies
    will allow.
        Vaccines are different from most drugs in several respects,
    and achieving the highest quality in manufacturing is
    especially challenging and critical. First, they are most often
    produced from or use living cells and organisms as well as
    complex growth materials derived from living sources. Thus, the
    potential for contamination is higher than from most drugs, so
    the quality and purity of all source materials must be
    carefully monitored.
        Second, the production of most preventative vaccines
    requires growing the immunizing agent in the production
    facility and the subsequent purification of complex molecules
    from these organisms. Growth conditions are complex. Subtle
    changes in materials and in the process itself or in
    conditions, such as temperature, can result in changes in the
    final vaccine that can affect its safety, its effectiveness, or
    both.
        Third, the final vaccine itself is usually not, like most
    drugs, a simple molecule that can be tested for its purity and
    potency using simple chemical and physical methods. Instead,
    each lot of vaccines must be carefully tested for its
    composition and potency through the lot release process.
        Finally, unlike most drugs which are given to people to
    treat an illness, vaccines are administered to large numbers of
    healthy people to prevent infectious diseases. For this reason,
    even very rare adverse events are generally not viewed as
    acceptable to healthy children and adults.
        Vaccine shortages can stem from a number of causes and the
    more recent shortages are not due to any single factor. In
    fact, the recent shortages stem from a number of factors,
    including the withdrawal from the market of one manufacturer,
    difficulties in manufacturing processes, temporary shutdowns of
    facilities for upgrades or maintenance or to correct
    manufacturing deficiencies, other factors, such as transition
    to thimerosal-free vaccine formulations.
        When FDA inspects a vaccine manufacturer and finds
    deficiencies, the agency carefully considers the impact on
    product availability before taking action. In some situations,
    the agency may determine, after balancing all factors, that a
    decrease in the availability of a medically-necessary product
    could pose a substantial risk to patients. In such cases, FDA
    regulatory action may allow manufacturing of the critical
    product to continue, provided that certain conditions are
    established to ensure product safety.
        The agency evaluates each circumstance on its own facts,
    balancing the medical need for the product against the safety
    assurances in place before a product is released for use.
    Whenever possible, FDA informs manufacturers of potential
    shortages to allow them to reallocate product to those who need
    it most and to take action to increase product inventory. In
    addition, FDA works with manufacturers that want to correct
    manufacturing deficiencies in order to avoid shortages of
    critical products. FDA works proactively and interactively with
    manufacturers to arrest shortage issues.
        However, FDA does not have the authority to require
    manufacturers to stay in the market and produce a given
    vaccine, nor does FDA have the authority to direct
    manufacturers to increase production when a shortage occurs.
        Thank you. I am happy to follow up with your questions or
    whatever else you would have me do. Thank you.
        Senator Carnahan. Thank you very much.
        Dr. Orenstein, I would like to get your comment on the
    issue of companies withdrawing from the market, an issue that I
    brought up with Mr. Pisano just moments ago. Would you comment
    on whether a shortage could be avoided if the government and
    other manufacturers were given advance notice and would you
    discuss how you would propose this matter to be addressed? In
    your experience, how far in advance can a manufacturer identify
    potential problems with the supply and when is the government
    usually notified by a manufacturer?
        Dr. Orenstein. I think in terms of trying to deal with your
    questions, I think if we could get advance notice, I think it
    would certainly help. I cannot say it would avoid all
    shortages, but it certainly could mitigate them.
        For example, if we had known that one company was dropping
    out of the Td vaccine production well in advance, we could have
    alerted that other company. It would be nice to get at least 12
    months' notice, because it takes about 12 months, for example,
    to produce a dose of tetanus diphtheria toxoids. If we could be
    notified and could share that information with the other
    companies, I think that would be a substantial benefit.
        In terms of the issues about how long, the longer the
    better. What has happened in the past, as in the recent past,
    we have not had much advance notice when companies have left
    and we would hope we would get that notice in the future for a
    company that is voluntarily leaving.
        As Mr. Pisano said, Aventis Pasteur did present at a
    National Vaccine Advisory Committee workshop in February that
    they would pledge to give us substantial voluntary notification
    should they leave the market, and we would like to see the
    other manufacturers follow suit.
        Senator Carnahan. Thank you. Dr. Crawford, I realize that
    safety is a No. 1 priority for vaccines, as it should be. Right
    now, we have several single source suppliers of vaccines. In
    your testimony, you mentioned that when you make a
    recommendation to a company to upgrade its facilities and it
    will affect production, you take into account the impact on
    supply.
        But I have heard from some vaccine manufacturers who have
    expressed frustration that this is not always the case. They
    have concerns about how FDA is interpreting the current good
    manufacturing practices. Specifically, they are concerned in
    situations where there is not a safety concern that FDA is not
    taking into account the effects on supply when making a
    recommendation for upgrading their facilities.
        Could you address this concern and expand on what criteria
    you use to make these decisions? In addition, would you comment
    on whether FDA tracks the impact of its regulatory decisions on
    the supply of a particular vaccine.
        Dr. Crawford. Yes. As you well know, the productive tension
    between the regulator, in our case, FDA, and the regulated is
    always somewhat tenuous. Vaccines, though, are a special
    product category that FDA regulates. We realize the effect not
    only on the public health in general, but in children's health
    in particular, so we try very hard to take into account all of
    these considerations.
        Just a very few years ago, we had three times as many
    vaccine manufacturers as we do today, so we recognize this as a
    precious commodity and one that we have to do everything we can
    in our power to, first of all, assure that the vaccines are
    safe and effective, but second, to be sure that we still have
    manufacturers that are producing the vaccines that we
    absolutely have to have, and hopefully that these manufacturers
    will be in this country producing these vaccines.
        So what we do when a decision has to be reached, either on
    the volition of the company or at the behest of FDA, is we
    offer what might be called technical assistance or technical
    service to those manufacturers to help them meet the
    requirements. Sometimes, a manufacturer will make a business
    decision to get out of the vaccine business or to stop
    manufacturing a certain vaccine and we try very hard, indeed,
    to make sure that we do not create some bureaucratic
    entanglement that makes that decision easy and not based on
    public health.
        The criticism that has been voiced abroad about good
    manufacturing practices, not just in this area but across all
    of FDA, is that the good manufacturing practices presuppose
    that if a company is in conformity with these so-called GMPs,
    that the product then will be inherently safe and effective.
    Some companies and also some experts in the field are beginning
    to raise questions about whether or not the premise upon which
    GMPs are based is always correct.
        We have heard those criticisms and we are examining GMPs
    not just in vaccines but in drugs and foods and the other areas
    we regulate to see if we do not need an overall reform of this
    particular means of regulation. FDA must stand four-square. In
    fact, our only real statutory role is to be sure that the
    vaccines are safe and that they are capable of immunizing
    America's children and others, and that is what we must stick
    to.
        But in carrying out that function, we have to be absolutely
    certain that the means, mechanisms, and processes that we use
    to accomplish that are consonant with the latest research
    findings and that we are up to date with methodology that is
    being used in other countries and in other groups of countries.
    To that end, I can tell you that we have not only heard them,
    but we are seriously looking at GMPs as a means for
    accomplishing your statutory mission and I would hope, as
    everything can be improved, that we will improve these over the
    next couple of years.
        Senator Carnahan. One final question--I thank you, Dr.
    Crawford, and then we will turn the questioning over to Senator
    Bunning.
        I would like for both of you, if you would, to address the
    government's plan to deal with future shortages. As I have
    already stated, I am concerned about the underlying factors
    that have contributed to this shortage and the fear that they
    will remain even after the current shortage is alleviated. What
    are CDC and FDA doing to find long-term solutions to prevent
    future childhood vaccine shortages and what are your proposals
    on how to achieve those goals?
        Dr. Orenstein. The National Vaccine Advisory Committee has
    been looking at five areas for long-term changes. One deals
    with economic incentives and the need to assure a viable
    vaccine industry. A second deals with streamlining of the
    regulatory process. A third deals with government supported
    vaccination. A fourth deals with stockpiles. And a fifth deals
    with liability.
        We are looking forward to their final report as well as the
    report from the General Accounting Office, and when those come,
    we will be looking at what those recommendations are and
    determining which of those areas we need to take action in. One
    of the ones that we have certainly used in the past that has
    been helpful have been stockpiles as a way of dealing with
    year-to-year changes in production. As Mr. Pisano mentioned,
    production disruptions will happen. In the past, we have had
    stockpiles that have taken care of them. We did not have
    stockpiles for many of the vaccines in shortage today, and
    those are some of the issues we will be evaluating.
        Senator Carnahan. Thank you.
        Dr. Crawford. Yes. Within the Department of Health and
    Human Services family, the Food and Drug Administration has the
    lead in the integrity and availability of the vaccine supply.
    We cooperate closely and intimately with CDC and also to do the
    job of regulation that the statutes and also the national
    public health requires.
        So the productive cooperation between us and CDC continues.
    We are very sensitive to whatever we can do to improve
    availability and effectiveness of vaccines. We cooperate with
    CDC and that cooperation is willing and, hopefully, productive.
        Senator Carnahan. Thank you. Senator Bunning.
        Senator Bunning. Thank you, Madam Chairman.
        This can be answered by either or both. Are there some
    areas of the country more affected by the vaccine shortage than
    others, and if so, why?
        Dr. Orenstein. The shortages are spotty and it depends on
    the distribution systems. It is not like there is one uniform
    national distribution system. So as you heard from the earlier
    testimony, different doctors may have different shortages for
    different vaccines.
        The Federal Government purchases about 52 percent, on
    average, of the vaccines and distributes them to the States,
    but the other 48 percent is in the private sector and it will
    vary.
        For four of the five vaccines, the distribution appears to
    be fairly equal between public and private sectors. The biggest
    problem in the public sector, or disproportionate factor
    affecting public clinics has been the DTaP vaccine, and that is
    because one of the companies that had very limited supplies
    chose to focus that supply into the private sector. Hopefully,
    all of that will be relieved with the licensure of the new
    vaccine.
        Senator Bunning. Dr. Crawford, do you have anything to add?
        Dr. Crawford. I have nothing to add.
        Senator Bunning. Do either of you have an estimate on how
    many children are not receiving the necessary vaccine at the
    proper time because of the shortage?
        Dr. Orenstein. That is a question we would like to have an
    answer for, but we do not. We measure--we will, in my opinion,
    see decreases in immunization coverage, but part of the problem
    is when we measure that coverage. The immunization series can
    begin as early as birth, but the basic series tends to be
    completed by 18 months of age, so we begin our measurements at
    19 months of age. So many of the kids who are currently
    impacted by this shortage have not yet entered our measurement
    system.
        We do have data from the Commonwealth of Puerto Rico,
    where, because of their problems in gaining access to the DTaP
    vaccine, they made a decision to defer the fourth dose of DTaP,
    and what happened is their coverage dropped from the mid-90's
    to the mid-30's as a result of that. Now, their DTaP-3 coverage
    is still very high. This is action they took to try to mitigate
    the results of the shortage. So we have some data there that
    are really concerning and we will have to see what happens in
    the other States as children age into our system.
        We are also monitoring disease and we have not seen, as
    yet, outbreaks of disease as a result of these shortages, but
    certainly we remain very concerned.
        Senator Bunning. Dr. Crawford.
        Dr. Crawford. Just one little thing to add. We would be
    prepared to use various interpretations of our law to help with
    these spotty shortages that might develop because no one wants
    to see vaccine schedules be disrupted and children not being
    able to be vaccinated on time and maybe disruptions in the
    school system.
        We have a process called the Investigational New Drug
    Process where if a certain kind of vaccine is approved in
    another country, for example, and CDC sends us a signal that
    this might help ameliorate some of these problems, we are
    certainly willing to invoke that. It is not used for that
    normally because it actually was created by Congress as a means
    to develop the investigational aspects of vaccine production,
    but we certainly want to send a signal here that we are willing
    to be as creative as we can be about helping with these
    shortages and also applaud CDC's work in this regard. We would
    be interested in the figures that are accumulated.
        Senator Bunning. Since the earlier testimony from others
    said that sometimes there is only one manufacturer maintaining
    a certain vaccine, has the CDC or whoever, the FDA, looked to
    foreign sources, foreign supplies? Are there not other foreign
    companies making the same vaccines?
        Dr. Crawford. CDC would probably have a better fix on this
    than we do, but our understanding is that in other countries,
    although there might not be shortages, generally, just enough
    is produced in order to meet their own supply and demand.
        Senator Bunning. The reason I bring that up is that HHS,
    when we are looking at the war against terrorism and the
    potential of a smallpox problem, looked to foreign sources to
    manufacture enough of that so that we could have a supply to
    fit the population.
        Dr. Crawford. Absolutely.
        Senator Bunning. I am looking at other types of children
    diseases.
        Dr. Orenstein. Two of the four manufactures that produce
    for the U.S. market have their headquarters actually abroad.
    One of the major suppliers, Glaxo Smith Kline, has helped for
    several of the vaccines I did not mention today, because even
    though there are some production disruptions, they have been
    able to cover the gaps.
        There is a problem when you bring in an investigational
    vaccine to be used in a routine program, an ``experimental''
    vaccine, even if it is used and approved abroad. We have had
    problems with trust, as you have mentioned earlier, and so
    using an investigational vaccine, particularly if there is some
    of the approved vaccine, is problematic for----
        Senator Bunning. In other words, you tend not to bring one
    that we have not had tested here in the United States?
        Dr. Orenstein. Exactly. What I think we need to do is, are
    there ways of facilitating other companies coming and getting
    their vaccines licensed----
        Senator Bunning. That was one of my questions, about how
    long the FDA takes to approve a vaccine, or for that matter, if
    we went outside the United States, for a foreign vaccine for
    children to be approved.
        Dr. Crawford. We take a shorter amount of time on vaccines,
    particularly given the current situation, than virtually any
    other thing we regulate, including food additives, for example.
    We are very sensitive to developing companies. With them, we
    have to work with them from the earliest onset to make sure
    their facilities are capable of producing safe and effective
    vaccines within the time table. So the sooner we can get with
    them as they are beginning to enter the market, the better it
    is, and we are available for that. I want the word to go forth
    that we will provide consultation with them, meet with them at
    their behest, and also help as far as we can within the meaning
    of the law to provide the technical assistance that is needed.
        Senator Bunning. Last, Mr. Orenstein, on the first panel,
    Mr. Pisano mentioned that industry representatives are no
    longer fully permitted to participate in CDC's working groups.
    Why is that?
        Dr. Orenstein. First of all, the Pharmaceutical Research
    and Manufacturing Association is a liaison member to our
    Advisory Committee, so they are able to make comments and
    participate in the full deliberations of the Committee.
        Senator Bunning. I understand the comments, but the working
    groups----
        Dr. Orenstein. I think the major issue on the working
    groups has been concern about perceptions of conflict of
    interest. These tend to be small meetings. They tend to be
    closed. The manufacturers can now be invited, and are usually
    invited, to present and discuss and answer questions for them.
    They are not there for the deliberative process, because as Mr.
    Pisano mentioned, there is a conflict of interest with regard
    to how vaccine recommendations are made.
        Certainly, I think we have all learned from the thimerosal
    episode and others that manufacturers have a very valuable
    information base that is critical to adequate policy making.
    The goal is to have them present that information, but not be
    there during the actual deliberations.
        Senator Bunning. Would it not help, though? Would they not
    have the availability to tell you if they were going to stop
    manufacturing like you would like to have a year ahead of time,
    or would it not be better if there was a hands-off but a close
    relationship so that you would know? In other words, if they
    are not going to manufacture a given childhood vaccination or
    vaccine, that you would know it up front?
        Dr. Orenstein. I think we certainly would like to know it
    up front. I am not sure the working group actually is the
    place. I think that would be a one-on-one relationship between
    us and the companies, I think, that is what we have done, and
    we did that with influenza, where each of the companies
    provided confidential proprietary information to us and then we
    were able to aggregate it and share it.
        I think the issue on the working groups is differentiating
    provision of information, where I think the manufacturers are
    absolutely critical, and the actual deliberation decisionmaking
    process, and that is what we have tried to do, is to keep the
    information side flowing, but when deliberations take place, to
    limit that.
        Senator Bunning. Is it both of your opinions that the
    critical shortage, except for one vaccine, will be over by the
    end of this summer and probably all of the critical five will
    be over sometime in 2003?
        Dr. Orenstein. Based on the projections we have gotten from
    the vaccine industry, yes.
        Dr. Crawford. I agree.
        Senator Bunning. Thank you very much, Madam Chairman.
        Senator Carnahan. Thank you, Senator Bunning, and I
    certainly thank all of those who have testified today. I also
    want to thank Dr. Goodman for his willingness to stand in for
    us here at the last minute. Your written statements and your
    oral testimony and your responses to the questions have been
    very helpful.
        As we have seen today, this is a very complicated issue.
    The shortage of childhood vaccines has been caused by many
    different factors, so there is no ``quick fix.'' But by
    highlighting this situation today, I hope that we have moved a
    step further to finding a solution. We need to continue to keep
    the spotlight on this issue. Communications is key here, and by
    joining together to talk about the issue, we are participating
    in a process that will ultimately lead to a system that will
    work better to prevent vaccine shortages from occurring. We
    need to continue the national dialogue until the underlying
    problems that have contributed to the shortage are addressed.
    It is important for all of our children's health and their
    future.
        Once again, I would like to thank all of our witnesses for
    participating in the discussion. I also extend my thanks to the
    physicians and others in Missouri who helped us prepare for the
    hearing, some of whom have submitted written testimony. I ask
    that the testimony of Dr. Robert Hoffman from St. Louis and
    Harold Bengsch, Director of the Springfield-Greene County
    Health Department, be entered into the official record.\1\
    ---------------------------------------------------------------------------
        \1\ The prepared statements of Drs. Hoffman and Bengsch appear in
    the Appendix on pages 83 and 85 respectively.
    ---------------------------------------------------------------------------
        We will keep the record of this hearing open for 1 week in
    case the witnesses would like to submit any additional comments
    or if other Members would like to submit any questions to you
    in writing.
        Thank you very much. This hearing is adjourned.
        [Whereupon, at 11:23 a.m., the Committee was adjourned.]
                                A P P E N D I X

                                  ----------

    [GRAPHIC] [TIFF OMITTED] 80606.001

    [GRAPHIC] [TIFF OMITTED] 80606.002

    [GRAPHIC] [TIFF OMITTED] 80606.003

    [GRAPHIC] [TIFF OMITTED] 80606.004

    [GRAPHIC] [TIFF OMITTED] 80606.005

    [GRAPHIC] [TIFF OMITTED] 80606.006

    [GRAPHIC] [TIFF OMITTED] 80606.007

    [GRAPHIC] [TIFF OMITTED] 80606.008

    [GRAPHIC] [TIFF OMITTED] 80606.009

    [GRAPHIC] [TIFF OMITTED] 80606.010

    [GRAPHIC] [TIFF OMITTED] 80606.011

    [GRAPHIC] [TIFF OMITTED] 80606.012

    [GRAPHIC] [TIFF OMITTED] 80606.013

    [GRAPHIC] [TIFF OMITTED] 80606.014

    [GRAPHIC] [TIFF OMITTED] 80606.015

    [GRAPHIC] [TIFF OMITTED] 80606.016

    [GRAPHIC] [TIFF OMITTED] 80606.017

    [GRAPHIC] [TIFF OMITTED] 80606.018

    [GRAPHIC] [TIFF OMITTED] 80606.019

    [GRAPHIC] [TIFF OMITTED] 80606.020

    [GRAPHIC] [TIFF OMITTED] 80606.021

    [GRAPHIC] [TIFF OMITTED] 80606.022

    [GRAPHIC] [TIFF OMITTED] 80606.023

    [GRAPHIC] [TIFF OMITTED] 80606.024

    [GRAPHIC] [TIFF OMITTED] 80606.025

    [GRAPHIC] [TIFF OMITTED] 80606.026

    [GRAPHIC] [TIFF OMITTED] 80606.027

    [GRAPHIC] [TIFF OMITTED] 80606.028

    [GRAPHIC] [TIFF OMITTED] 80606.029

    [GRAPHIC] [TIFF OMITTED] 80606.030

    [GRAPHIC] [TIFF OMITTED] 80606.031

    [GRAPHIC] [TIFF OMITTED] 80606.032

    [GRAPHIC] [TIFF OMITTED] 80606.033

    [GRAPHIC] [TIFF OMITTED] 80606.034

    [GRAPHIC] [TIFF OMITTED] 80606.035

    [GRAPHIC] [TIFF OMITTED] 80606.036

    [GRAPHIC] [TIFF OMITTED] 80606.037

    [GRAPHIC] [TIFF OMITTED] 80606.038

    [GRAPHIC] [TIFF OMITTED] 80606.039

    [GRAPHIC] [TIFF OMITTED] 80606.040

    [GRAPHIC] [TIFF OMITTED] 80606.041

    [GRAPHIC] [TIFF OMITTED] 80606.042

    [GRAPHIC] [TIFF OMITTED] 80606.043

    [GRAPHIC] [TIFF OMITTED] 80606.044

    [GRAPHIC] [TIFF OMITTED] 80606.045

    [GRAPHIC] [TIFF OMITTED] 80606.046

    [GRAPHIC] [TIFF OMITTED] 80606.047

    [GRAPHIC] [TIFF OMITTED] 80606.048

    [GRAPHIC] [TIFF OMITTED] 80606.049

    [GRAPHIC] [TIFF OMITTED] 80606.050

    [GRAPHIC] [TIFF OMITTED] 80606.051

    [GRAPHIC] [TIFF OMITTED] 80606.052

    [GRAPHIC] [TIFF OMITTED] 80606.053

    [GRAPHIC] [TIFF OMITTED] 80606.054

    [GRAPHIC] [TIFF OMITTED] 80606.055

    [GRAPHIC] [TIFF OMITTED] 80606.056

    [GRAPHIC] [TIFF OMITTED] 80606.057

    [GRAPHIC] [TIFF OMITTED] 80606.058

                                       -