[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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80-606 WASHINGTON : 2002
_____________________________________________________________________________
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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?
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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.
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\1\ The prepared statement of Dr. Doran appears in the Appendix on
page 33.
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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.
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\1\ The prepared statement of Dr. Jackson appears in the Appendix
on page 39.
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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.
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\1\ The prepared statement of Mr. Pisano appears in the Appendix on
page 43.
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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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