[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.]

                                    

      
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