[Senate Hearing 107-691]
[From the U.S. Government Publishing Office]
S. Hrg. 107-691
LOSING MOMENTUM: ARE CHILDHOOD VACCINE SUPPLIES ADEQUATE?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON PUBLIC HEALTH
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
ON
EXAMINING THE ADEQUACY OF CHILDHOOD VACCINE SUPPLIES, FOCUSING ON THE
EXTENT THAT RECENT SHORTAGES HAVE AFFECTED IMMUNIZATION POLICY AND
PROGRAMS, WHAT FACTORS HAVE CONTRIBUTED TO RECENT SHORTAGES, AND WHAT
STRATEGIES ARE FEDERAL AGENCIES CONSIDERING TO HELP MITIGATE THE
DISRUPTIONS IN SUPPLY
__________
SEPTEMBER 17, 2002
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut JUDD GREGG, New Hampshire
TOM HARKIN, Iowa BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington PAT ROBERTS, Kansas
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York MIKE DeWINE, Ohio
J. Michael Myers, Staff Director and Chief Counsel
Townsend Lange McNitt, Minority Staff Director
______
Subcommittee on Public Health
EDWARD M. KENNEDY, Chairman
TOM HARKIN, Iowa BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland JUDD GREGG, New Hampshire
JAMES M. JEFFORDS, Vermont MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico TIM HUTCHINSON, Arkansas
PAUL D. WELLSTONE, Minnesota PAT ROBERTS, Kansas
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York CHRISTOPHER S. BOND, Missouri
David Nexon, Staff Director
Dean A. Rosen, Minority Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
TTUESDAY, SEPTEMBER 17, 2003
Page
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island... 1
Heinrich, Janet, Director, Health Care-Public Health Issues, U.S.
General Accounting Office, Washington, DC...................... 2
Doran, Timothy F., M.D., Chairman of Pediatrics, Greater
Baltimore Medical Center, Baltimore, MD, on behalf of the
American Academy of Pediatrics; and Wayne F. Pisano, Executive
Vice President, Aventis Pasteur North America, Swiftwater, PA.. 9
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Janet Heinrich............................................... 18
Timothy F. Doran, M.D........................................ 30
Wayne Pisano................................................. 37
(iii)
LOSING MOMENTUM: ARE CHILDHOOD VACCINE SUPPLIES ADEQUATE?
----------
TUESDAY, SEPTEMBER 17, 2002
U.S. Senate,
Subcommittee on Public Health,
of the Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:34 p.m., in
room SD-430, Dirksen Senate Office Building, Senator Reed,
presiding.
Present: Senators Reed and Murray.
Opening Statement of Senator Reed
Senator Reed [presiding]. Let me call the hearing to order.
Good afternoon. Today's hearing will examine a critical
issue for the health of our Nation--the stability and adequacy
of our childhood vaccine supply.
Indeed, shortages of 8 of the 11 recommended childhood
vaccines have plagued our health care system for the past 12 to
18 months and have affected every segment of our society. We
will hear today that too many children are going without timely
vaccinations. Physicians have been forced to turn away young
patients. State and local public health officials have been
left scrambling for vaccine supplies, and school departments
have had to waive immunization requirements for entry, leaving
young children vulnerable to potentially devastating, yet
entirely preventable, diseases such as measles, rubella, and
even chicken pox.
Last year, I had the opportunity to chair a hearing of the
HELP Committee that explored some of these issues. Since then,
several members of this committee and others concerned about
the critical shortage of vaccines commissioned a report by the
General Accounting Office to get a better handle on the root
causes for the recent shortage.
It is clear from this report that we have a system that
cannot guarantee an adequate supply of vaccines from year to
year and is unprepared to handle a potential outbreak of many
routine childhood diseases. We are putting our children in
danger. Congress, the administration, medical providers and
manufacturers must work together to ensure an adequate and
reliable supply of vaccines.
Vaccines are one of the greatest public health
accomplishments of the 20th century, reducing once common
diseases by 95 to 99 percent. Yet the campaign to protect our
Nation's children from the ravages of these contagions has in
many ways been the victim of its own success. Today, most
parents have never heard of these diseases, except when they
bring their children in for well-baby visits, and providers
have limited experience actually treating them in the practice
setting.
In addition, significant consolidation in the vaccine
manufacturing industry over the past two decades has resulted
in a decline in the number of producers in the market. Over a
dozen manufacturers existed prior to 1980. Today, only four
manufacturers produce almost all of the routine childhood
vaccines on the United States market.
The GAO report outlines the factors that contributed to the
recent shortages and paints a disturbing picture for the future
of our vaccine supply. We are clearly at a point where swift
action must be taken to preserve and strengthen our
immunization system.
I am particularly concerned that the recent vaccine supply
disruptions will inevitably have a negative impact on vaccine
coverage rates in this country. The public health community
must remain vigilant in tracking this data so that the
appropriate response can be taken to protect public health.
We simply cannot allow decades of tremendous progress in
reducing vaccine-preventable diseases to become undone.
In addition to Jan Heinrich of the GAO, also testifying
before the subcommittee today are Dr. Timothy Doran, a
physician from Baltimore and a member of the American Academy
of Pediatrics, and Wayne Pisano, of Aventis Pasteur, one of the
four remaining vaccine manufacturers in the United States
market.
I look forward to hearing each of your perspectives on the
recent vaccine shortages and your reactions to the findings and
recommendations articulated by the GAO.
I would like to thank all of our witnesses for taking the
time to be here today to discuss this important issue, one
which affects each and every one of us.
Now, as my colleagues arrive, I will recognize them, but
Ms. Heinrich, please go ahead.
STATEMENT OF JANET HEINRICH, DIRECTOR, HEALTH CARE-PUBLIC
HEALTH ISSUES, U.S. GENERAL ACCOUNTING OFFICE, WASHINGTON, DC
Ms. Heinrich. Mr. Chairman, we are pleased to be here this
afternoon to discuss findings from a report which we are
releasing today that you and several others in Congress
requested on the recent incidents of vaccine shortages.
Immunizations, as you said, are considered one of the
leading public health achievements of the 20th century.
Immunization programs have eradicated polio and smallpox in the
United States and much of the world and reduced the number of
deaths from several childhood diseases, such as measles, to
near zero.
A consistent supply of many different vaccines is needed to
support this effort. The Centers for Disease Control and
Prevention recommends that routine immunizations be given
against 11 childhood diseases, four of which were added to the
schedule in the last 10 years.
The recent incidents of vaccine shortages began in the fall
of 2000 when supplies of the tetanus and diphtheria booster
fell short. As you can see on this chart, supplies of other
vaccines also declined, and by fall 2001, CDC reported
shortages of five vaccines that protect against eight childhood
diseases.
Recent reports suggest that most supplies are now beginning
to return to normal.
In response to these shortages, State immunization programs
rationed the amount of vaccines distributed to providers and
recommended deferred immunizations for some children so that
available supply could be directed to those at highest risk.
Many States also suspended immunization requirements, allowing
children to attend day care and school with fewer of the
previously recommended vaccinations.
No single reason explains the recent shortages. Rather,
multiple factors coincided that affected both the supply and
the demand for vaccines. We identified four key factors--
problems in the manufacturing process due to several factors,
including changes to assure compliance with good manufacturing
practices; the removal of thimerosal from vaccines;
manufacturers' sudden decision to discontinue production; and
unanticipated demand for new product.
Manufacturing and production problems such as slowdowns or
plant maintenance activities taking a bit longer than expected
contributed to the shortage of several vaccines. Changes over
the last several years in FDA inspection practices may have
resulted in the identification of more or different instances
of manufacturers' noncompliance with good manufacturing
practices. These inspection program changes were not well-
communicated by FDA to manufacturers.
As a precautionary measure, in July of 1999, the American
Academy of Pediatrics and the U.S. Public Health Service issued
a joint statement advising that thimerosal, a mercury compound
used as a preservative in vaccines, be eliminated or reduced as
soon as possible. Efforts to remove thimerosal affected the
production of several vaccines and contributed in particular to
the shortages of DTaP. Removing the preservative was complex,
and for some manufacturers just not possible.
Another major factor in the shortage of DTaP and tetanus
toxoid was the decision of one manufacturer to discontinue
production of all products containing tetanus toxoid. This
company experienced difficulties removing thimerosal from its
vaccine and also in responding to a consent decree requiring
significant upgrades in its facilities involved in producing
tetanus toxoid. The manufacturer had produced approximately
one-quarter of the tetanus toxoid and about one-quarter to one-
third of all DTaP distributed in the United States.
A new pneumococcal conjugate vaccine was added to the
recommended schedule in January of 2001 and was accompanied by
an extensive education campaign by the company prior to its
availability. The company was only able to provide about half
the needed doses during the first part of 2002, and the demand
continues to outstrip the supply.
While the recent shortages have been largely resolved, the
vaccine supply remains vulnerable to disruptions that could
occur in the future. Although there may be some excess
manufacturing capacity, the production of vaccines is a lengthy
process and prevents the quick production of more vaccine when
disruptions occur.
The limited number of manufacturers poses another problem.
Five of the eight childhood vaccines have only one company
producing the vaccine for the U.S. market. Several new
formulations under development, once approved by FDA, could
reduce the number of sole source vaccines.
In conclusion, Federal efforts to strengthen the vaccine
supply have taken on greater urgency with the recent incidents
of shortages. The Federal role in the supply and demand of
vaccines is extensive, including the development of the
schedule, the purchase of over 50 percent of the childhood
vaccines administered in the United States each year, and the
regulatory oversight to ensure safety, efficacy, and compliance
with good manufacturing practices.
Several strategies for strengthening the supply are being
put forward. While many of these hold promise, ensuring an
adequate supply for the future poses continuing challenges.
Mr. Chairman, this concludes my remarks, and I am happy to
answer any questions.
[The prepared statement of Ms. Heinrich may be found in
additional material.]
Senator Reed. Thank you very much.
I should point out that not only being director of the
health care group at the U.S. General Accounting Office, Dr.
Heinrich has an extensive resume--she is a graduate of the
University of Michigan School of Nursing and a master's of
public health from Johns Hopkins University. This experience is
quite evident not only in your report but in your presentation.
So thank you very much, Dr. Heinrich.
Let me ask a question or two. One of the aspects of the GAO
report is the indication that vaccine stockpiles are considered
to be a potential short-term strategy that could help mitigate
crises. The report also goes on to note that supply at least
the CDC has the authority under the National Vaccine Program as
well as the Vaccines for Children Program to stockpile. Yet,
only two vaccines are currently stockpiled, and we are
uncertain as to how many doses are there--they are the MMR and
the IPV.
To me, this underscores the very basic issue, of how do we
urge HHS to develop a strategy uniting all the disparate
elements--CDC, FDA, manufacturers, health care providers--to
deal with not only the stockpile issue but also the other
issues we discussed. HHS--and you might comment--is in the best
position to put this strategy in place. Without this strategy,
we will continue to deal with some symptoms of the issues but
not the whole, systemic cause of the vaccine shortages.
Could you elaborate, Dr. Heinrich?
Ms. Heinrich. The National Vaccine Policy Office is charged
with coordination of all the different elements of the
Department of Health and Human Services that are involved in
policies related to vaccines, both in terms of the supply,
demand, and the regulatory safety issues.
They are also charged with including the other important
stakeholders, that being States as well as the manufacturers.
I think there are questions about how effective the
National Vaccine Program Office has been able to be. They have
recently moved the office from CDC to the office of the
Assistant Secretary for Health, but we know that there has been
limited funding, for example, in the past.
Certainly in terms of stockpiling, we say in our report
that the authority that CDC has to stockpile is clear for the
program for vaccines for children. That program has eligibility
requirements, so it does not cover all children, so there is a
need, we feel, for clarification of the authority that CDC has
to stockpile.
In terms of your question on overall strategy, we feel that
that is absolutely critical, and we then outline many
components of that strategy that have to be thought about,
everything from how much and in what form it is stored, who
stores it. Currently, the two vaccines that are stockpiled are
stored by the manufacturer, and that vaccine is rotated through
their ongoing inventory so there is always an updated supply.
So do not think of it as just sitting on a shelf; it is vaccine
that is in constant rotation.
But if a stockpile is going to be effective, there has to
be that strategic perspective that you note.
Senator Reed. And just for the record, your view would be
that HHS is the appropriate agency to develop this strategic
approach?
Ms. Heinrich. Yes, certainly, we do think it is HHS,
because other than, for example, the Department of Defense,
which has other needs, it is the Department of Health and Human
Services that is responsible.
Senator Reed. Again, I appreciate your insights and
comments, and if there are other things that you feel the
Congress should do--and from your response to questions, to
clarify some of the authority of CDC and ensure that the Office
of Vaccine Policy is funded and robustly supported are the two
principal recommendations--is that correct?
Ms. Heinrich. Those certainly are important. We also make
recommendations that focus on the role of the Food and Drug
Administration because, as we have said, those vaccines that
are in the review process have the potential to alleviate some
of the stress in the system in terms of having other
manufacturers supplying some of the recommended vaccines for
children.
The FDA does have procedures that they could use to
expedite the review of these vaccines. It is their current
policy that vaccines that are currently used in the market do
not qualify for this expedited review, and we are suggesting
that they look at that policy because they could in fact find
that when we have supplies that are fragile, that is enough
rationale for the expedited review of those vaccines that could
add available products for children's vaccines.
Senator Reed. Thank you.
I understand that several of the childhood vaccines are
price-capped under Federal purchase contracts. Did you find
that these price caps played a direct role in causing any of
the recent shortages?
Ms. Heinrich. We certainly did not find that they played a
direct role, and that is because some of the vaccines that are
capped were not in short supply. Some of the more recent
vaccines that cost more and are not under caps were in short
supply. The only vaccine that is at the cap that was in short
supply was MMR.
Senator Reed. Thank you.
The report also talks about the Vaccine Injury Compensation
Program, and offers some recommendations to streamline it to
make it more effective. However, I would note on page 8 of your
testimony that the working group did not conclude that this
program was a cause of any of the shortages. Is that accurate?
Ms. Heinrich. Certainly in the data that we obtained, we
did not hear people saying that this shortage that we have just
experienced was directly linked to the problems and concerns
about vaccine liability. However, we certainly did hear from
manufacturers that it is a growing problem, and we certainly
did check into the Vaccine Injury Compensation Program to see
what claims they have received, and we did find out that there
are over 800 claims that have been added to the Vaccine Injury
Compensation program, many of them related to the thimerosal
and removal of thimerosal issues.
Senator Reed. Let me ask you a final question before I
recognize Senator Murray for her opening comments any
questions.
Among the several areas of concern is the manufacturing
capacity. I think you have commented on the FDA's role in
ensuring that capacity. Is there a consideration for some type
of Government-owned or operated company? I know some of these
private companies have very checkered histories, but have you
considered that at all in your review?
Ms. Heinrich. Certainly when we were talking with people
and collecting data, we asked them what they thought of the
proposal for a Government-owned program and also checked with
an organization in Massachusetts that is a Government-sponsored
manufacturer of DTaP and tetanus, as a matter of fact. Our
conclusion is that, one, not too many people that we were
talking with advocated this, but second, the Government-owned
facility would be under the same regulatory processes and
procedures that the private sector is and would have the same
challenges in meeting those good manufacturing practices.
We also heard that having a Government-owned facility,
certainly where there are viable products in the market, would
be a rather chilling effect to the private sector.
Senator Reed. Thank you very much, Dr. Heinrich.
Senator Murray?
Senator Murray. Mr. Chairman, thank you very much for
having this really important hearing. I appreciate it, and I
certainly appreciate Ms. Heinrich's testimony and her being
here today as well.
There has been a lot of speculation about the delays and
shortages, and I think this report gives us a much better basis
for understanding what the scope of the problem was and what
happened, and I think it is not because of one specific thing,
but a number of things happened that together over the last 3
years created this problem, and I hope that all of us will look
at ways that we can provide a better infrastructure in the
future so we do not have these kinds of delays.
In my State, I was hearing from a lot of different sectors,
certainly from schools, which require immunizations before they
allow kids to come in, and kids were coming in and saying, ``I
cannot get them''; obviously, from pediatricians and public
health officials, who were really concerned because they were
not getting their supplies on time; and lots of other people.
So I am glad that we are now hearing that there is no
shortage particularly right now, although in my State, we are
still hearing that there is a problem with some of the catch-up
kids who did not get their immunizations on time and are now
trying to go back and get them and get back in line, and I
think that is going to cause us some problems for a while that
we need to address.
So Mr. Chairman, I really appreciate this opportunity, and
I just have a few questions that I wanted to ask Ms. Heinrich
while she is here today.
Your report indicates that vaccine shortages have peaked,
and most supplies are returning to normal. I wanted to know how
you documented that. Do you collect data from State and local
health officials? Are they private providers or physicians'
offices? How do you calculate that?
Ms. Heinrich. Certainly the work that we did and reflected
in the report was on our survey of States. In terms of there
being a supply that is available now, we obtained that
information from the Centers for Disease Control and
Prevention.
It should be noted that although CDC is saying that
overall, there are adequate supplies, they footnote that there
is not enough for aggressive catch-up campaigns as you
suggested. It is also very clear that the pneumococcal
conjugate, the PVC, is still in short supply.
Senator Murray. The reason I ask is because I am still
hearing from some parts of my State that there is a shortage,
so I am just wondering who CDC is asking in order to get the
information back to you that the problem has been solved.
Ms. Heinrich. They would be in contact with those State
immunization programs. And I think that to understand what the
private sector is experiencing, we would need to go to
organizations such as the American Academy of Pediatrics.
Senator Murray. Did you do that in your report?
Ms. Heinrich. We did not.
Senator Murray. OK. In reviewing the data on the impact of
the shortages, did you find any particular increases in the
reported cases of some of the childhood illnesses, like
measles?
Ms. Heinrich. We actually looked very aggressively to see
if there would be any evidence of increased infectious diseases
as a result of the delay in children obtaining these
immunizations. We could not find any evidence.
On the other hand, there will always be a lag time in terms
of the reporting of those infectious diseases, so we may not
know about this for another period of time, even up to a year.
Senator Murray. The other question I have is why there are
such discrepancies in the number of vaccines in short supply
and why some States and local public health offices experienced
longer and more supply distractions. It appears in your report
that 52 of the programs experienced shortages of two or more
vaccines, but 31 of the programs reported shortages of five or
more vaccines, and nine programs had shortages of one or more
vaccines for 12 months or longer. Is that a matter of
population? Are there other factors that contribute to these
kinds of discrepancies that you report?
Ms. Heinrich. Each State has its own immunization program
and its own policies and procedures and its own ability to buy
and stockpile vaccines. So part of what you are seeing is that
each State is unique in terms of what stockpiles they might
have had.
What happens is that CDC gives grants to States under their
317 Program. The States can then purchase vaccines through that
program and through State moneys, as a matter of fact, if they
so choose. Then, it really is again up to the State policy in
terms of whom they distribute that to, who participates in
their program. Oftentimes, you will have private sector as well
as public sector providers involved.
Senator Murray. I appreciate your input on that. Thank you.
Thank you, Mr. Chairman.
Senator Reed. Thank you very much, Senator Murray.
Again, Dr. Heinrich, thank you so much for your testimony
and for your excellent report.
Ms. Heinrich. Thank you.
Senator Reed. Let me now call the second panel to the
witness table.
We are joined today by Dr. Timothy F. Doran. Dr. Doran
lives in Baltimore, MD. He has been a practicing pediatrician
for nearly 20 years, and has chaired the Department of
Pediatrics at the Greater Baltimore Medical Center in Baltimore
since 1999. Dr. Doran received his Bachelor of Arts degree from
Harvard College, in Cambridge, MA, and his medical degree from
Tufts University School of Medicine in Boston. He completed his
pediatric residency at Montefiore Hospital and Medical Center,
the Bronx, NY, and was chief resident at the Albert Einstein
School of Medicine's Department of Pediatrics at Montefiore.
Dr. Doran served as 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 in
1998. Dr. Doran is the current chairman of the AAP's National
Nominating Committee.
In addition to his work at the State and national levels
for the American Academy of Pediatrics, Dr. Doran has held
numerous board and committee positions advocating for
underserved populations of children, including victims of
sexual abuse and children with disabilities and other special
health care needs.
Dr. Doran is married and has two children.
I want to thank you for being here. Dr. Doran also grew up
in North Attleboro, MA, which is almost as good as being in
Rhode Island, and his father worked in Rhode Island, so that
makes up for it. We welcome you particularly, Dr. Doran.
Wayne F. Pisano, our next witness, is the executive vice
president for Aventis Pasteur North America. He has overall
responsibility for both the United States and Canadian
businesses. Additionally, he serves as the head of the global
market process team and chairs several North American executive
committees.
Mr. Pisano joined Aventis Pasteur in 1997 as vice president
of marketing and was promoted to senior vice president of
marketing and sales during April of 1998. Mr. Pisano has played
a strategic role in resolving vaccine supply issues and
recommending approaches to prevent recurrences.
Mr. Pisano holds a bachelor's degree in biology from St.
John Fisher College and a master's degree in marketing from the
University of Dayton.
Thank you both for joining us. Let me ask Dr. Doran if he
would proceed. Your testimony will be made a part of the record
by unanimous consent. If you would like to abbreviate it or
summarize, that would be accepted and appreciated.
Dr. Doran?
STATEMENTS OF DR. TIMOTHY F. DORAN, CHAIRMAN OF PEDIATRICS,
GREATER BALTIMORE MEDICAL CENTER, BALTIMORE, MD, ON BEHALF OF
THE AMERICAN ACADEMY OF PEDIATRICS; AND WAYNE F. PISANO,
EXECUTIVE VICE PRESIDENT, AVENTIS PASTEUR NORTH AMERICA,
SWIFTWATER, PA
Dr. Doran. Thank you, Senator.
Good afternoon, Mr. Chairman and Senator Murray. As you
mentioned, I am Dr. Tim Doran, a practicing pediatrician and
chairman of pediatrics at Greater Baltimore Medical Center, a
community hospital in Baltimore, MD.
On behalf of the American Academy of Pediatrics, I thank
you for the opportunity to testify today about the current
shortage of childhood vaccines.
My practice consists of about 1,800 children from
predominantly middle-class families. In the past, however, I
practiced in many different locales, from a poor island in the
West Indies to inner-city Baltimore.
In the 20 years that I have been practicing, I have never
experienced the severe shortage of required immunizations as I
have in the past year.
This afternoon, 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. And finally, I
will summarize the American 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, as you have heard, reflecting
a national trend. In fact, just last week, I again ran out of
the new pneumococcal vaccine, Prevnar. This vaccine protects
children from life-threatening meningitis, pneumonia, and blood
infections.
A pediatrician from New Mexico reported that his high-risk
population of American Indian infants is also currently out of
this vaccine. This is especially troublesome because this past
spring, he diagnosed a 4-1/2-month-old Navajo infant with a
case of pneumococcal meningitis--a vaccine-preventable and
potentially fatal childhood illness.
The parents of my patients have been understandably anxious
when they learn 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 media coverage of anti-vaccine groups, I spend a
significant amount of time with many parents, reassuring them
that our vaccines are safe and beneficial. I cannot help but
wonder how my credibility and that of my colleagues suffers
when I then have to explain that these important vaccines are
not available for their child.
In addition to the major risks 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. Our experience has been that these systems
are not very reliable or effective. Even if 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 vaccine that
my practice needs. It is another reminder to me of the lack of
a coordinated distribution system that has led to spotty
supplies.
At the same time as the shortages of 8 of the 11 required
vaccines occurred, one vaccine for older adolescents and adults
to prevent Lyme disease was pulled from the market because it
was unprofitable. Although this was not a required
immunization, its disappearance reminds pediatricians that
vaccine decisions can sometimes be driven more by economics
than by public health considerations.
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 should never happen
again in this country.
One immediate step is necessary. The Federal Government
should provide and adequately fund the creation of stockpiles,
as mentioned, for all recommended vaccines, stockpiles of
sufficient size to ensure that significant and unexpected
interruptions in manufacturing do not result in shortages for
children.
The GAO report recognizes and the Academy supports the
importance of this stockpile for childhood vaccines, including
the development of a comprehensive strategic plan to implement
the vaccine stockpile.
Another crucial step is to preserve and strengthen the
liability protection for consumers, manufacturers, and
physicians through the Vaccine Injury Compensation Program. The
VICP has become 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 again to be a
fragile vaccine market. We reiterate our strong support that
claims for vaccine-related injury or death must be filed first
with the VICP. We appreciate the efforts by Dr. Frist and
others to craft modifications as necessary to ensure that the
VICP is working to its full potential.
The American Academy of Pediatrics participates in the work
of the National Vaccine Advisory Commission. The
recommendations of NVAC, coupled with some of the other GAO
recommendations, create an excellent starting point to address
a system that must be fixed.
Universal immunization is a fundamental public health
measure that has profoundly improved the health of our Nation.
It would be tragic to let this hard-won advance slip away. The
health of our children depends on it.
Thank you for your time and attention.
Senator Reed. Thank you very much, Doctor.
[The prepared statement of Dr. Doran may be found in
additional material.]
Senator Reed. Mr. Pisano?
Mr. Pisano. Mr. Chairman, Senator Murray, good afternoon.
I am Wayne Pisano. I am the executive vice president for
Aventis Pasteur North America, and I would like to thank the
committee for providing us this opportunity to offer input on
issues that are so vital to the health of our Nation.
Aventis Pasteur is one of the leading developers and
manufacturers of vaccines, with U.S. headquarters in
Swiftwater, PA. Vaccines have been produced at Swiftwater, PA
since 1897.
Aventis Pasteur is one of four global vaccine companies
supplying pediatric vaccines in the United States. Many people
are surprised that the industry is so small, but that is a
direct result of the 1980's liability crisis that drove many
companies out of the market.
We have in this country a unique and amazing vaccine
enterprise that has resulted in freedom from disease for
millions of children. Many physicians would be treating some
tens of thousands of cases of rubella, diphtheria, pertussis,
and other potential killers if not for our successful efforts.
Vaccines in the hands of a robust, cooperative public and
private health delivery system have made these diseases
historical artifacts.
The country is now emerging from an 18-month period during
which there were a number of vaccine shortages. Today I am
pleased to report that there is ample tetanus vaccine for all
needs, and there is ample pertussis vaccine. It is our
understanding that supplies of varicella and MMR vaccine are
returning to normal.
In the face of numerous factors, the fact that the private
sector can and has responded to supply issues demonstrates its
underlying strength and vitality. Having said that, we need to
establish a national policy addressing how best to prevent or
minimize the likelihood of recurrences. Our company offered a
series of recommendations earlier this year. This hearing
offers an excellent opportunity to discuss these with this
committee.
While my full testimony provides a more comprehensive look
at the vaccine enterprise, including the underlying causes of
the recent shortages as well as the additional threats in the
future, the basics can be succinctly stated.
First, vaccines are extremely difficult to produce. I said
there were only for global manufacturers of pediatric vaccines
in the United States, and some of these are single-source
providers. If one of the manufacturers unexpectedly experiences
production difficulties or leaves the market, it can cause
supply disruption.
Second, the lengthy and costly process of new product
development combined with time-consuming production cycles adds
up to a complex regulatory process that discourages new
entrants.
Third, despite their undisputed value, vaccines
historically have been extremely low or commodity-priced.
Federal programs that cap vaccine prices may produce short-term
savings for the Government but ultimately contribute to the
supply problem. If return on a manufacturer's investment is
unacceptably low, that business cannot survive.
Fourth, as some members of this committee will recall, the
liability crisis of the 1980's drove many manufacturers out of
the market. We are today facing liability problems that dwarf
what we saw two decades ago, which potentially pose a threat
for future supplies.
I would like to talk about what can be done to improve the
immunization enterprise, effectively presenting a vaccine
supply agenda for your consideration.
We have offered a number of legislative and policy
proposals during the past year that we believe will provide a
tune-up for the system and a coherent approach for the long-
term stability. These proposals are consistent with both the
GAO report and the draft recommendations now under review by
Secretary Thompson's National Vaccine Advisory Committee.
First, it is time to seriously consider building a
strategic vaccine reserve by creating stockpiles for use if
supplies are disrupted. Had this been the case when one company
recently discontinued tetanus vaccine production, a shortage
would have been unlikely.
Second, manufacturers should voluntarily pledge to provide
advance notice if they plan to cease production. Several months
ago, Aventis Pasteur publicly pledged to give at least 6 months
of notification before discontinuing any production. We believe
that this pledge, as with other good business practices, need
not be legislated. We understand that a bipartisan group of
Senators on this committee is attempting to shape an
appropriate advance notice provision. We look forward to
working with you on this issue.
Third, we urge you to reform the Vaccine Injury
Compensation Program in two ways. It can and needs to be made
more family-friendly, and second, we need to reaffirm the
original intent of the Vaccine Injury Compensation Program so
that all vaccine claims initially proceed through the program.
My full testimony outlines in some depth the creative ways
in which the law you enacted in the 1980's is being
circumvented. In an industry with total U.S. revenues of $2.5
to $3 billion, Aventis Pasteur alone faces over 100 lawsuits,
with more being filed every week, that seek far beyond this
amount in damages. Tease cases should be moved back to the
Vaccine Injury Compensation Program as Congress intended.
We support Senator Frist's bill, S. 2053, which
accomplishes the twin goal of making the program more family-
friendly for claimants while bringing such claims back within
the Vaccine Injury Compensation Program. We are now spending
millions of dollars defending against these suits, suits in
which we believe we will ultimately prevail but at an enormous
cost to the viability of the industry and to the immunization
enterprise.
Frankly, the liability issue dwarfs all others as a threat
to the stability of the vaccine supply, and we urge you to pass
this bill before you adjourn.
Fourth, FDA funding in the area of vaccine testing research
needs to be increased. Budget cuts in recent years threatened
FDA's competency in this important area. With CBER currently
undergoing organizational changes, the time is right for
restoration of these resources.
There are also a number of nonlegislative actions that can
have real and lasting impact on vaccine supply. For example, we
have urged that the CDC be encouraged to act on confidential
information in ways that can provide for managing and
stimulating alternative supply to minimize shortages. We
believe that the CDC can act under its current authority as a
confidential facilitator of critical supply information with
the manufacturer's permission.
Other nonlegislative initiatives include adequate
reimbursement to providers for immunization services. This is
also outlined in my written testimony.
Several proposals in Congress would actually undermine
incentives for manufacturers to produce vaccines. Whether
called the National Vaccine Authority, a GOCO or a GOGO, each
of these proposals results in the Federal Government getting
into the business of manufacturing vaccines. We do not believe
that any of these approaches would be constructive measures for
addressing supply issues.
The vaccine enterprise in this country is a remarkable
success story. I do not believe that it is fragile at its core,
but it clearly has several areas that can be strengthened.
Thank you for your attention and your commitment to the
immunization system in this country.
[The prepared statement of Mr. Pisano may be found in
additional material.]
Senator Reed. Thank you very much, Mr. Pisano, for your
testimony. Thank you both for excellent testimony.
Let me proceed to questions. Dr. Doran, the GAO report
suggests that there are a number of vaccines under development
which could mitigate potential shortages in the future, but
often, these new vaccines are very expensive--the PCV, the
pneumococcal vaccine, is an example of a rather expense
vaccine.
Do you anticipate the cost of these new vaccines as a
potential barrier to access to immunization?
Dr. Doran. The barrier certainly comes in terms of the
number of vaccines given versus the cost, and obviously, most
pediatricians will opt for whatever is the most convenient and
most effective vaccine strategy, and most pediatricians will
abide by the ACIP and the CDC recommendations, and the
financing is not generally the major consideration.
The liability issues are serious. Influenza vaccine is now
on the docket in terms of 24-month-olds. It is not currently
covered under the VICP, so pediatricians from a personal
liability standpoint have some trepidation going forward unless
there is clear coverage from the liability standpoint.
Senator Reed. Thank you.
Let me follow up with another question on an issue that you
alluded to in your testimony. There is the administrative
disruption of calling children back and determining who has
missed a vaccination. I fear it might lead to what is really a
lost generation of children who have missed their routine
vaccine, they have moved, or you cannot get them back, and we
now have a cohort of unvaccinated children because of these
shortages.
How are you and your colleagues trying to manage to avoid
that lost generation?
Dr. Doran. The majority of the immunizations that we give
are in the first 2 years of life. There are a number of
regular, routine visits, and any pediatrician or family
practitioner or someone delivering health care to children
should be checking their vaccination records. In terms of
losing them over years, I do not anticipate that that would be
a problem. The fear for pediatricians is if you have missed the
first couple of doses, and the child comes down with a
preventable illness.
But the problem is there, and I think we will just have to
see how much of a problem from those lost vaccinations over
this period of time, how effective we are at recapturing those
children. My anticipation is that there is adequate room in
terms of the periodicity schedule of when children come to see
physicians that it can be rectified. However, I think your
point is well-taken.
Senator Reed. Thank you very much.
Mr. Pisano, you and Dr. Doran and the GAO conclude that
there is merit in some kind of stockpiling, but the GAO report
identifies some key questions, and I wonder how industry can
help answer questions like, for example, what quantity to
stockpile, the form and storage of stockpiled vaccines,
insuring that vaccine quantities are in addition to normal
supplies.
Can you give us a response to these questions? I know you
are speaking in behalf of your company, but could you give an
indication of potential industry response and also, obviously,
ongoing cooperation on this matter?
Mr. Pisano. I think the current guidelines recommend a 6-
month stockpile for the VFC program. This is what CDC has
authorized to do and obviously, as has been pointed out, we are
not quite there.
We would actually recommend that NVPO form working groups
with CDC, FDA, and the vaccine manufacturers to address each
individual vaccine. In some cases, we have multiple
manufacturers; in some cases, we have single manufacturers; in
some cases, we have second vaccines in the development process
such that there will be a second manufacturer in the future. I
think each vaccine ought to be looked at individually to
determine how much vaccine should be in a safety reserve, who
should do that in terms of which manufacturer or multiple
manufacturers. And in fact, there are other vaccines that
potentially could actually be kept at bulk level and not into
finished goods, and you may have a longer shelf life than I
think was earlier recognized. There is a shelf life, and the
current stockpile shave to be rotated because of the expiration
date on the production lots.
Senator Reed. Thank you, Mr. Pisano.
Aventis Pasteur has publicly stated its support for a
notification requirement. Let me commend you for that. I think
that is a sensible approach. And the GAO report indicates that
no manufacturer would object to a 6-month notice requirement
similar to what they do now for other drugs.
What kind of notification requirement do you think all the
manufacturers could agree on, and what would it look like in
practice? Would it be 6 months? Would it be longer? Could you
give us any indication?
Mr. Pisano. It is difficult for me to speak on behalf of
the other manufacturers, and I think that is something that it
would be worthwhile hearing from them on. Aventis Pasteur
believes that a minimum of 6 months would be necessary. We also
see that linked into the stockpile, so there is basically a
safety reserve there.
In terms of the need to legislate versus volunteering
pledges, I think that is something that the committee needs to
discuss further.
Senator Reed. Good.
Both of you and the GAO report have concluded that two of
the major responses to this shortage would be a notice
requirement to at least let the market and all the providers
know if a manufacturer is going off line, and also some type of
stockpile.
Is there another major recommendation that you would add to
those two?
I will ask you, Mr. Pisano, and then you, Dr. Doran.
Mr. Pisano. I think it is important for the CDC to be able
to share confidential information as well as work
collaboratively with the FDA. There are times when the
Government policymakers know that there is a potential problem
or a problem occurring with one manufacturer. If they have the
ability to notify the other manufacturers at that time, we can
adjust manufacturing production schedules.
I think a good example of that was 2 years ago with
influenza, when one manufacturer left the marketplace, and
another was experiencing significant difficulties in
manufacturing. Had CDC notified the other manufacturers, we
could have adjusted production schedules. It would not have
totally eliminated the problem, but it would have basically
reduced the magnitude that this country experienced.
So we need the CDC to share this information in the best
interest of the immunization enterprise.
Senator Reed. Thank you, Mr. Pisano.
Dr. Doran?
Dr. Doran. The additional items that I would include would
be the liability issues that we discussed, but also the
administration fee for providers. It was proposed to reduce the
administration fee for pediatricians to a level where they
would actually be losing money with each vaccination. That is
in discussion right now, is my understanding, with CMS and
stakeholders in that, and they are hopefully arriving at a
suitable solution to that, but the original proposal was to
make the administration fee so low as to be prohibitive to
providers.
I spend a tremendous amount of time with parents explaining
about the issues of MMR and autism, of thimerosal. It is an
enormous undertaking in terms of my time. So the administration
fee needs to be commensurate with the time and effort and
syringes and storage and all those other factors. So that is
something that needs to be on the radar screen as well.
Senator Reed. I know there are some who propose or suggest
that to support the reduction that many times, nurses
administer these vaccines. But your point would be that that is
in cooperation with the physician who spends other time
explaining and counseling; is that fair?
Dr. Doran. Senator Reed, I have many lawyer parents, and
they do not want a 20-second answer on the relationship of MMR
and autism. These are discussions that can be prolonged, and
you cannot walk out of the room and say, ``I cannot answer
that. You just have to get your vaccine.''
So these are serious matters and would impact; if the
reductions were made, I would predict they would have a serious
adverse impact on the whole immunization program.
Senator Reed. Let me ask a final question. I think this has
been an excellent hearing, beginning with an excellent report
from GAO which was very substantive and very thorough. Both of
your testimony has been on point and very helpful. I will give
you an opportunity to look ahead into the future. What do you
believe is the greatest challenge to the vaccination program,
either something that we have discussed or that we might not
have touched on?
Mr. Pisano?
Mr. Pisano. I think the liability issues that we are facing
going forward really dwarf anything we have ever faced before.
I think it is critical that the Vaccine Compensation Program be
strengthened, be made more family-friendly. Clearly, there are
enough complaints from parents that it is problematic getting
through the system and needs to be reexamined. And we need to
make sure that when problems occur, the parents and the
claimants go through the Vaccine Injury Compensation program,
as Congress intended.
So I think that strengthening those two components is
absolutely critical for keeping manufacturers in the market and
also for encouraging other manufacturers to come back into the
marketplace.
Senator Reed. Dr. Doran?
Dr. Doran. Senator Reed, on the issue of the NVPO or
whatever agency has central responsibility, I think there needs
to be a very strong center based at a Federal level that can
coordinate this and tease out these problems and bring
solutions to the table that we can all agree on.
Senator Reed. Thank you both very much, gentlemen.
I would like to thank all the witnesses. Again, we began
with a very substantive and very thoughtful report by the GAO,
and I want to thank Dr. Heinrich for her excellent testimony.
Thank you, Dr. Doran and Mr. Pisano, for your insights. I
am encouraged, actually, that HHS seems to be agreeing with the
GAO's recommendations and beginning to implement them. But as
you just pointed out, Dr. Doran, we need a strategy, not just
good will and good wishes, and I hope they can develop that
strategy quickly.
I hope also that we can move forward on the issue of
stockpiling, which seems to be a consensus position of all the
witnesses this afternoon. We must play a more active role in
Congress to ensure this is done, because we have had hearings
before, and we have looked at these issues, and we have a
wonderful report, but reports and hearings do not vaccine
children. Consistent, concerted efforts to get them vaccinated,
working with providers, manufacturers and the administration
will get it done, and we have to get it done.
There has been an impact of these shortages. School entry
criteria have been changed. You and your colleagues are working
to bring children back into your offices and make sure they
have vaccinations that they did not get on time, which comes
with a cost. I will be watching closely to ensure that we do
not have a lost generation, that we do not have significant
numbers of children who have missed their opportunity and did
not get a second chance. That would be detrimental to them and
also to the public health.
We have made great progress through immunization because of
this partnership between the industry, between the Government,
and between the medical profession, and we want to continue
that partnership and that progress. As I said, one of the great
marquis accomplishments of the 20th century has been the
vaccination and immunization programs of the United States and
of the world. We want to maintain that for the benefit of our
children and our grandchildren and generations to come.
Thank you all for an excellent hearing. I will now call the
hearing adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
[Whereupon, at 3:28 p.m., the committee was adjourned.]