[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







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                   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

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