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S. Hrg. 107–559

PROTECTING OUR KIDS: WHAT IS CAUSING THE

CURRENT SHORTAGE IN CHILDHOOD VACCINES?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENTAL AFFAIRS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

JUNE 12, 2002

Printed for the use of the Committee on Governmental Affairs

(

(II)

COMMITTEE ON GOVERNMENTAL AFFAIRS

JOSEPH I. LIEBERMAN, Connecticut, Chairman

CARL LEVIN, Michigan

DANIEL K. AKAKA, Hawaii

RICHARD J. DURBIN, Illinois

ROBERT G. TORRICELLI, New Jersey

MAX CLELAND, Georgia

THOMAS R. CARPER, Delaware

JEAN CARNAHAN, Missouri

MARK DAYTON, Minnesota

FRED THOMPSON, Tennessee

TED STEVENS, Alaska

SUSAN M. COLLINS, Maine

GEORGE V. VOINOVICH, Ohio

THAD COCHRAN, Mississippi

ROBERT F. BENNETT, Utah

JIM BUNNING, Kentucky

PETER G. FITZGERALD, Illinois

JOYCE A. RECHTSCHAFFEN, Staff Director and Counsel

LEE ANN BRACKETT, Counsel

KIERSTEN TODT COON, Professional Staff Member

MICHELLE MCMURRAY, Fellow for Senator Lieberman

SANDY FRIED, Legislative Assistant for Senator Carnahan

RICHARD A. HERTLING, Minority Staff Director

ELIZABETH A. VANDERSARL, Minority Counsel

DARLA D. CASSELL, Chief Clerk

(III)

C O N T E N T S

Opening statement: Page

Senator Lieberman ........................................................................................... 1

Senator Carnahan ............................................................................................ 2

Senator Bunning ............................................................................................... 4

WITNESSES

WEDNESDAY, JUNE 12, 2002

Timothy F. Doran, M.D., F.A.A.P., Chairman, Department of Pediatrics,

Greater Baltimore Medical Center, on behalf of the American Academy

of Pediatrics .......................................................................................................... 6

Mary Anne Jackson, M.D., Chief, Pediatric Infectious Diseases Section, Children’s Mercy Hospitals and Clinics .................................................................... 7

Wayne F. Pisano, Executive Vice President, Aventis Pasteur North America,

on behalf of Pharmaceutical Research and Manufacturers of America ........... 9

Walter A. Orenstein, M.D., Director, National Immunization Program, Centers for Disease Control and Prevention, U.S. Department of Health and

Human Services ................................................................................................... 21

Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner, Food and Drug

Administration, U.S. Department of Health and Human Services ................. 24

ALPHABETICAL LIST OF WITNESSES

Crawford, Lester M., D.V.M., Ph.D.:

Testimony .......................................................................................................... 24

Prepared statement .......................................................................................... 69

Doran, Timothy F., M.D., F.A.A.P.:

Testimony .......................................................................................................... 6

Prepared statement .......................................................................................... 33

Jackson, Mary Anne, M.D.:

Testimony .......................................................................................................... 7

Prepared statement .......................................................................................... 39

Orenstein, Walter A., M.D.:

Testimony .......................................................................................................... 21

Prepared statement with an attachment ....................................................... 54

Pisano, Wayne F.:

Testimony .......................................................................................................... 9

Prepared statement .......................................................................................... 43

APPENDIX

Robert J. Hoffman, M.D., F.A.A.P., NW Pediatrics, prepared statement ........... 83

Harold Bengsch, MSPH, REHS/RS, Director of Public Health and Welfare,

Springfield/Greene County Health Department, prepared statement ............. 85

Cindi Kapica, RN, BSN, Immunization Coordinator, Springfield/Greene County Health Department, prepared statement ...................................................... 88

(1)

PROTECTING OUR KIDS: WHAT IS CAUSING

THE CURRENT SHORTAGE IN CHILDHOOD

VACCINES?

WEDNESDAY, JUNE 12, 2002

U.S. SENATE,

COMMITTEE ON GOVERNMENTAL AFFAIRS,

Washington, DC.

The Committee met, pursuant to notice, at 9:37 a.m., in room

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding.

Present: Senators Lieberman, Carnahan, and Bunning.

OPENING STATEMENT OF CHAIRMAN LIEBERMAN

Chairman LIEBERMAN. Good morning. I apologize for being

breathless. I did my walk up the stairs to beat the slow elevator.

I apologize for being late, Washington traffic.

I want to thank all of you for coming to this hearing on this very

disturbing subject of the shortage of childhood vaccines. The truth

is, what could be worth more of our time and energy than trying

to figure out how to fully protect the smallest among us—the children who are so innocent—from disease and from death?

This is a topic that could easily be overlooked in the rush of what

seem to be more critical stories these days, and the fact that this

Committee has not overlooked it is solely the work of our colleague,

Senator Jean Carnahan, whose longstanding commitment to children’s health issues is perhaps not as well known as it should be,

but certainly most admirable. Today’s hearing was her idea. I

thank her for focusing this Committee’s attention on this area. I

want to say a few words in introduction and then I am happy to

turn the gavel over to Senator Carnahan to conduct the hearing.

I also thank Senator Bunning for the interest that he shows by

being here, as well.

In this medically advanced world we live in, it is all too easy to

forget the real value of traditional vaccines, that is to say, when

we are so focused on miracle cures, etc. Many of today’s parents,

and it pains me to say this, are too young to remember what some

of us who are just a bit older remember, and that is the awful days

when diseases such as polio or measles were incurable.

In 1900—I was not alive then, I want to make the record clear

on that—— [Laughter.]

It is just a statistically significant date. Twelve out of every 100

infants died from preventable diseases. Today, the number of chilVerDate 11-MAY-2000 16:15 Dec 02, 2002 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 80606.TXT SAFFAIRS PsN: SAFFAIRS
2

dren afflicted by these illnesses has fallen by more than 99 percent.

The reason, of course, is the invention of the modern vaccine.

The overwhelmingly successful public health campaign to

innoculate all children against disease is a story of cooperation between public health agencies, scientists, government, and hundreds

of thousands of local health care providers. In 1993, President Clinton extended the success story to include uninsured and under-insured children through the Vaccine for Children program.

But there is a danger now which this hearing will highlight, and

I know Senator Carnahan is very concerned about, that we are

slipping backwards. Just as we have reached vaccination rates that

are quite high, we now face alarming shortages of these priceless

serums. In the last 2 years, we have seen shortfalls in the supply

of five of the eight vaccines that fight the major childhood illnesses.

Some school systems have even been forced to adjust their mandatory vaccination schedules because of inadequate supply.

So our task today is to examine the scientific, financial, and practical obstacles to maintaining an adequate and safe supply of vaccines. But in the richest, most powerful Nation in the history of the

world, there really is not an acceptable excuse that can justify immunizing fewer children today than we did 5 years ago.

This is a very distinguished group of witnesses that Senator

Carnahan has assembled. I urge them to be frank in telling the

Committee what we can do to help you do your job, because this

really is a labor of love. Clearly, we have got to continue to uphold

high standards in approving new vaccines and monitoring the production of the more established ones, and we have got to ensure

that the Vaccine Injury Compensation Fund cares for those affected

by the rare complications of vaccinations.

Dr. Jonas Salk, in administering the experimental polio vaccine

to himself, his wife, and three sons in 1955 said, ‘‘It is courage

based on confidence, not daring, and it is confidence based on experience.’’ I think we have got to show a similar courage, for experience has clearly informed us of the value of vaccines.

Again, I thank Senator Carnahan for her extraordinary leadership here. I thank Senator Bunning for being a partner in that

leadership, and I am happy now to turn the gavel over to you, Senator Carnahan. Thank you.

OPENING STATEMENT OF SENATOR CARNAHAN

Senator CARNAHAN [presiding]. Thank you, Senator Lieberman.

Thank you for being here today and for permitting me the opportunity to hopefully shed some light on this very, very important

subject.

Chairman LIEBERMAN. I am sure you will.

Senator CARNAHAN. Thank you. I am going to make an opening

statement at this time, and then Senator Bunning will make an

opening statement, and then we will turn to our witnesses who are

with us today.

I would like to read you something. ‘‘To Our Patients: Recently,

all pediatric practices nationwide have been experiencing shortages

of required immunizations. It was not until the first week of December 2001 that this shortage directly affected our patients at

Northwest Pediatrics. Despite a great effort on our part, we have

3

been unable to obtain some of the vaccines recommended and required. It has become necessary to alter the present immunization

schedule. A phone log will be kept to inform you as soon as adequate supplies become available. Please address specific questions

to your provider. Thank you for your understanding.’’ Well, this notice is dated December 2001. It is now June 2002

and the sign continues to hang in the examining room of the

Northwest Pediatric Clinic in St. Louis, Missouri. To not have

these basic vaccines available for our children is a national disgrace. Unfortunately, it is a sad reality for both private and public

health facilities throughout Missouri and across the Nation.

For over a year, routine childhood vaccines have been in short

supply. The precise impact depends on the specific community and

what day you talk to them. In late May, public and private health

providers in Springfield, Missouri, were experiencing a shortage in

pneumoccal, which protects against meningitis and pneumonia;

varicella, which protects against chicken pox; and the tetanus

booster shot for adolescents.

The Cole County Public Health Department in Central Missouri

was experiencing a shortage in DTaP, and MMR, as well as

varicella and tetanus.

And when my office spoke to a pediatrician in Poplar Bluff, Missouri, her practice happened to be having a good week where no

vaccine was in short supply. However, the medical staff we spoke

to said that next week could, once again, bring a shortage.

The current supply crisis, if it continues, would lead to a giant

step backwards in public health in this country. Young parents

have not seen these terrible diseases that vaccines prevent. They

do not remember polio or whooping cough because vaccines have

accomplished their mission.

I can tell you that I remember these diseases. I know from personal experience the value of vaccines, and we do not want to move

backwards. When I was a young girl, the vaccine for whooping

cough was developed. This was a new vaccine and my mother was

afraid to give it to me. At 4 years old, I developed the disease, and

I can still remember that awful experience.

I also remember what it was like when polio was a day-to-day

part of our lives. I remember my mother not permitting me to swim

in the public pool because she was concerned that I might contract

polio. As a child, I was frustrated, of course, because I wanted to

learn how to swim. But as a mother, I can appreciate how frightened she was of the threat of polio.

The good news is that parents today do not have to worry about

their children getting some of these preventable diseases. However,

when parents cannot get the vaccines, they may doubt their necessity, since they have never seen the diseases for themselves.

The bad news is that we could be creating a situation where a

generation of children are not fully vaccinated, a generation of children that is susceptible to diseases, diseases that our country has

not seen in decades. We simply cannot let this happen.

Over the last several months, numerous constituents have raised

the issue of shortages. Parents, doctors, and public health experts

are all expressing frustration. They are asking the key question,

what is going on here? I want to know the answer to that myself.

4

Given the progress we have made in this country toward immunizing children, and given what diseases could reemerge if vaccines

are not consistently available, we need to shine the national spotlight on this issue.

That is why I approached Senator Lieberman about having this

hearing, and I appreciate his leadership on this issue and the hard

work that his staff has put into this. The purpose of today’s hearing is to examine what is causing the shortage? What is the extent

of the shortage across the country? And what is the government

doing to address the problem and prevent future shortages?

Let me be clear. I see a role for the Federal Government in addressing the shortage, but this is a shared responsibility. Pharmaceutical companies, physicians, the public health system, and officials at all levels of government should play a role in ensuring that

there is an adequate supply of vaccines. We need to work together

to develop strategies and incentives to increase the vaccine supply

in this country.

This is a complex issue with no easy solution. While the current

shortage is likely to improve for next year, the underlying problems

that have contributed to it will remain. That is why it is imperative

that Congress take a hard look at this problem now. We need to

work together with industry, physicians, and public health officials

to find solutions that will ensure children’s health and prevent vaccine shortages in the future. We cannot afford to ever let a generation of kids susceptible to these horrific diseases go unvaccinated.

I want to thank all the witnesses for being here today, and I look

forward to learning from you how the shortage is affecting our Nation and hearing your suggestions on how we might be able to prevent shortages in the future.

At this time, I would like to call on Senator Bunning, if he would

like to make an opening statement.

OPENING STATEMENT OF SENATOR BUNNING

Senator BUNNING. Thank you, Madam Chairman. The United

States has done an exceptional job of eradicating and decreasing

the prevalence of many of the life-threatening and debilitating diseases of the past, including polio, smallpox, rubella, measles, and

others. Vaccinations are one of the most important things parents

can do for their children and the health and well-being of their

children.

Professionals spend a lot of time working with parents to make

sure they know the proper vaccination schedules. However, the current vaccination shortage is risking the lives and health of many

children, as doctors’ offices and hospitals are delaying administration of certain vaccines because they simply are not in stock. This

could cause many children to go without the necessary shots, which

could lead to serious health problems in the future.

According to the CDC, there is currently a shortage of five vaccines that protect against eight diseases. It would be a tragedy if

we saw a resurgence of any of the diseases we thought we had conquered.

As the witnesses today will testify, there are several reasons for

the vaccine shortages, including increased liability, production

problems, and changes in manufacturing requirements. I hope that

5

Congress can do its part to ensure that an adequate vaccine supply

is available to parents and the doctors and health care facilities

across this country.

While we work to address the current vaccine shortage, Congress

also needs to make sure that families can afford them when they

are available. In fact, this is an issue that I have been working on

for the past several years, and last year I introduced legislation

called the Vaccinate America’s Children Act Now. This bill reduces

the tax on vaccines to 25 cents per dose from its current 75 cents

per dose and is designed to make vaccines more affordable to many

American families, giving them one more incentive to adequately

protect their children.

I am looking forward to hearing from our witnesses today about

this important issue and appreciate the time and effort they have

taken to be here today. Thank you, Madam Chairman.

Senator CARNAHAN. Thank you, Senator Bunning.

I would like now to proceed to our witnesses and to call our first

panel. Joining us today are Dr. Timothy Doran from the American

Academy of Pediatrics; Dr. Mary Anne Jackson from Children’s

Mercy Hospitals in Kansas City; and Wayne Pisano, Executive Vice

President of Aventis Pasteur North America, representing the

Pharmaceutical Research and Manufacturers of America. We welcome you.

Dr. Doran has been a practicing pediatrician for 20 years. Since

1999, he has chaired the Department of Pediatrics at the Greater

Baltimore Medical Center in Maryland. Dr. Doran served as the

President of the Maryland Chapter of the American Academy of Pediatrics from 1996 to 1998 and was honored as Pediatrician of the

Year by the Maryland Chapter. Congratulations. He is currently

the Chairman of the National Nominating Committee at the American Academy of Pediatrics.

Dr. Jackson has been a staff pediatrician at Children’s Mercy

Hospitals and Clinics in Kansas City, Missouri, since 1984. In

1996, she was appointed as Chief of the Pediatric Infectious Diseases Section. She is also a Professor of Pediatrics at the University of Missouri-Kansas City College of Medicine. Dr. Jackson is a

fellow of the American Academy of Pediatrics and the Infectious

Diseases Society of America, as well as a member of the Pediatric

Disease Society.

Mr. Pisano, an Executive Vice President for Aventis Pasteur

North America, has overall responsibility for both the United

States and Canadian businesses. He joined the firm in 1997 as Vice

President of Marketing and was promoted to Senior Vice President

of Marketing and Sales the next year. Under his leadership, two

of the company’s key vaccines for polio and flu each achieved milestone sales levels.

Thank you all for being here. Dr. Doran, we have your prepared

statement along with all the other statements from today’s witnesses and they will be entered fully in the record. But I ask that

you proceed with your oral statements for approximately 5 minutes. We have a light system here, as you can see, and it will let

you know when you have 1 minute remaining. So we welcome your

testimony today, Dr. Doran.

6

1The prepared statement of Dr. Doran appears in the Appendix on page 33.

TESTIMONY OF TIMOTHY F. DORAN, M.D., F.A.A.P.,1 CHAIRMAN,

DEPARTMENT OF PEDIATRICS, GREATER BALTIMORE MEDICAL CENTER, ON BEHALF OF THE AMERICAN ACADEMY OF

PEDIATRICS

Dr. DORAN. Thank you. Good morning, Madam Chairwoman and

Senator Bunning. I am Dr. Tim Doran, a practicing pediatrician

and Chairman of Pediatrics at the Greater Baltimore Medical Center, Community Hospital in Baltimore, Maryland. On behalf of the

American Academy of Pediatrics, thank you for the opportunity to

testify today about the current shortage of childhood vaccines.

My practice consists of about 1,800 children from predominately

middle-class families. In the past, however, I have practiced in

many different locales, from a poor island in the West Indies to the

inner city of Baltimore. In the 20 years I have been practicing, I

have never before experienced any vaccine shortage for a required

childhood vaccine in this country.

This morning, I want to address three key points. First, I will describe the consequences of the vaccine shortage to patients and

their families. Second, I will tell you about the administrative impact on pediatric practices which you alluded to before, Senator

Carnahan. And finally, I will summarize the Academy of Pediatrics’ recommendations to address this problem.

The heart and soul of a pediatrician’s job is disease prevention.

The predictable delivery of safe and effective vaccines is central to

our goal of keeping children healthy. In recent months, my practice

has seen shortages in several routinely administered vaccines, reflecting a national trend. In fact, currently, I am out of the new

pneumococcal vaccine. This vaccine protects children from lifethreatening meningitis, pneumonia, and blood infections. Many of

my pediatric colleagues, such as those in Wisconsin, are also completely out of this vaccine.

A pediatrician from New Mexico reports that his high-risk population of American Indian infants is also currently out of this vaccine. This is especially troublesome because he recently diagnosed

a 41⁄2-month-old Navajo infant with a case of pneumococcal meningitis—a vaccine preventable, potentially fatal childhood illness.

The parents of my patients have been understandably anxious

when they have learned that a vaccine is unavailable. They know

that there is a small but finite chance that their child might become ill with an otherwise easily preventable illness because of a

delayed or missed vaccine.

Because of recent media publicity and campaigns by anti-vaccine

groups, I spend a significant amount of time with many parents reassuring them that our vaccines are safe and beneficial. They do

not have the years of knowledge that the Senators on the Committee have. I cannot help but wonder that my credibility suffers

when I then have to explain that these important vaccines are not

available for their child.

In addition to the major risk to patients and worry to parents,

the vaccine shortage has had an administrative impact on my practice, as well. We must now create a system of callback lists to reach

those most in need of missed vaccines when they become available.

7

1The prepared statement of Dr. Jackson appears in the Appendix on page 39.

My experience and that of other pediatricians has been that these

systems are not very reliable or effective. Even in my relatively affluent practice, the level of compliance with these callbacks is far

from perfect, and clearly inferior to immunizing at routine checkups.

I have also had to explore creative and time-consuming alternative methods to procure the full supply of vaccines that my practice needs. For instance, my recent experience is that buying directly from the pharmaceutical representatives is more fruitful

than buying through the hospital pharmacy, which was my usual

source. It is another reminder to me of the lack of a coordinated

distribution system that has led to spotty supplies.

The bottom line is that the public requires a secure supply of all

the recommended pediatric vaccines, vaccines that save children’s

lives and are the most cost-beneficial medical intervention in history. We must safeguard our children from preventable interruptions in vaccine delivery. This can never happen again in this country.

One immediate step is for the Federal Government to adequately

fund the creation of stockpiles for all recommended vaccines, stockpiles of sufficient size to ensure that significant and unexpected

interruptions in manufacture do not result in shortages for children.

Another step is to preserve and strengthen the liability protections for consumers, manufacturers, and physicians through the

Vaccine Injury Compensation Program. The VICP has been an integral part of maintaining the vaccine market. Enacted in the late

1980’s with the support and guidance of the American Academy of

Pediatrics, the VICP has helped to stabilize what was then, and appears to be again, a fragile vaccine market.

The American Academy of Pediatrics has participated in the

work of the National Vaccine Advisory Committee. We have seen

the draft report presented at NVAC’s recent meeting. That report

offers a good starting point toward fixing an absolutely fixable

problem.

Universal immunization made a profound improvement in the

health of our Nation. It would be tragic to let this hard-won advance slip away and jeopardize such a fundamental public health

measure. The health of our children depends on it. Thank you for

your time and attention.

Senator CARNAHAN. Thank you, Dr. Doran. Dr. Jackson.

TESTIMONY OF MARY ANNE JACKSON, M.D.,1 CHIEF, PEDIATRIC INFECTIOUS DISEASES SECTION, CHILDREN’S MERCY

HOSPITALS AND CLINICS

Dr. JACKSON. Madam Chairwoman and Mr. Bunning, I am Dr.

Mary Anne Jackson, Professor of Pediatrics and Chief of the Section of Infectious Diseases at the Children’s Mercy Hospitals and

Clinics in Kansas City, Missouri. Our pediatrician center is the

only children’s hospital between St. Louis and Denver. We serve a

140-county region and we see over 300,000 children per year.

8

My role is as a pediatric infection specialist. I provide care and

consultation for a variety of children, many of whom are otherwise

healthy children, hospitalized with serious and sometimes lifethreatening infections, such as meningitis. Some are children with

underlying diseases such as AIDS, cancer, prematurity, those with

transplanted organs, who have a variety of complex infections. I am

a clinical researcher and my research focus is on emerging infections, bacterial resistance, overuse of antibiotics, and prevention of

communicable diseases.

My third role, and possibly my most important role, is as an advocate and educator for children’s health issues. As a community

resource, my colleagues and I speak formally to groups of pediatricians locally, regionally, and nationally. On a daily basis, community pediatricians call us with specific questions regarding their

patients, perhaps about the diagnosis and treatment of a child with

a diagnostic dilemma, questions regarding antibiotics, but fully 25

percent of those phone calls sometimes are related to immunization

issues.

When I lecture on immunizations, one of my key messages is

that physicians must maintain timely immunizations as a high priority in the care of infants, children, adults, and adolescents. I am

preaching to the choir when I tell pediatricians that we have eradicated or nearly eradicated diseases, as you all know, diphtheria,

measles, mumps, polio, rubella, and tetanus.

Ask any pediatrician who trained in the 1970’s and 1980’s and

they will no doubt remark to you that one of the most remarkable

accomplishments of their career is the eradication of Haemophilus

influenzae Type B infection, which was the most common cause of

meningitis up to approximately 1993. Within 3 years of the implementation of that vaccine, this disease virtually was eliminated

and I have not seen a case in almost 10 years. However, I remind

pediatricians that these pathogens continue to persist in the

United States and in other countries and that our immunization

program, I would consider fragile, at best.

In the United States, only 80 percent of children are adequately

immunized. In the State of Missouri, we are at the national average. In the Kansas City area, devoted efforts from organizations

such as the Partnership for Children and the Mid-America Immunization Coalition have worked tirelessly, and we have raised immunization rates from a pitiful 50 percent in 1990 to 85 percent

in the year 2000, but we still have disparities where counties have

immunization rates as low as 66 percent.

I remind pediatricians that we cannot be complacent, because I

continue to see children with vaccine-preventable diseases. Since I

have come to Children’s Mercy Hospital, we have diagnosed over

300 children with whooping cough. Most recently, we had a 2-

month-old in our intensive care unit for over a month with complications of this infection. In the last year or so in my community,

a child has died with chicken pox complications, a child has died

of pneumococcal meningitis at the age of 5 months, and a very

sweet 15-year-old boy in May 2001 died of liver cancer, a complication of hepatitis B virus that was transmitted at birth. All of these

were vaccine-preventable diseases.

9

1The prepared statement of Mr. Pisano appears in the Appendix on page 43.

This unprecedented and unanticipated shortage of routinely recommended vaccines has resulted in inadequate supplies of actually

8 of the 11 routinely administered vaccines, and shortages are

more acute in the public sector than the private sector, and this is

important for us, Senator Carnahan, because 50 percent of the children in the State of Missouri are covered under the public sector

Vaccines for Children program.

The vaccine shortage has impacted the physicians’ ability to provide a consistent recommendation and practice for vaccine implementation. We also keep a log, and we try to call back. We have

tried to follow the CDC’s guide for prioritization of vaccines, but we

cannot do this. Most physicians in our areas do not. Forty percent

of physicians nationally do not. Suddenly, physicians realize that

they are out of a certain vaccine or it is not practical to triage vaccines in the course of a busy pediatric practice. We have also

changed our immunization requirements in the State such as we

tell pediatricians in July 2001, you must have varicella vaccine to

go to day care. Less than a year later, we tell them, never mind.

What is the impact of the vaccine shortages? We estimate that

the negative impact is a decline of almost 10 percent at this point.

I tell pediatricians that children who start their vaccines on time

are clearly more likely to be current throughout their first year.

Our message to the public and professionals becomes muddled,

though, when we document the scope of disease that can be prevented by immunization and then delay and defer opportunities.

Prevention of infectious diseases by immunization has been one

of the great public achievements of the 20th Century. Whether our

current vaccine shortage is related to companies leaving the market, manufacturing and production problems, or insufficient stockpiles, it is clear that one of the indelible marks of this shortage is

that parents and professionals are confused and frustrated and all

strides made in the last decade may go by the wayside. Our goals

should be to maintain a supply of licensed vaccines that are safe

and effective. These vaccines should be available for every child

and adult in the United States. Vaccine research development and

production must be enhanced.

And last but not least, we must renew our educational efforts following the correction of this shortage to ensure that our children

are healthy now and as we face the challenges of the future.

Our promise to parents should be resolute. A strong immunization program needs to be ensured. It is the right action and one of

the most cost-effective means of ensuring the health of children in

our country.

Senator CARNAHAN. Thank you very much. We will move on to

Mr. Pisano.

TESTIMONY OF WAYNE F. PISANO,1 EXECUTIVE VICE PRESIDENT, AVENTIS PASTEUR NORTH AMERICA, ON BEHALF OF

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF

AMERICA

Mr. PISANO. Good morning, Chairman Carnahan, and Senator

Bunning. On behalf of the Pharmaceutical Research and ManufacVerDate 11-MAY-2000 16:15 Dec 02, 2002 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 80606.TXT SAFFAIRS PsN: SAFFAIRS
10

turers of America, PhRMA, I am pleased to appear at this hearing

today on childhood vaccines. I am Wayne Pisano, Executive Vice

President of Aventis Pasteur.

PhRMA represents the country’s major research-based pharmaceutical and biotechnology companies which are leading the way in

the search for new cures and treatments that enable patients to

live longer, healthier and more productive lives. More specifically,

PhRMA represents the four companies supplying 100 percent of

childhood vaccines in this country and 90 percent of all vaccines.

Many people are surprised that the industry is so small, but the

fact is, the liability crisis of the 1980’s drove many companies out

of the market. I will talk more about that later in my testimony.

We are all keenly aware of the vaccine shortages facing our Nation today. The good news is that most of these shortages have

been or will be resolved this year. In the long term, we need to understand what causes vaccine shortages and what can be done over

the long term to alleviate them. I will outline six proposals to alleviate shortages in the long-term.

But first, I want to talk about the vaccine industry and what is

unique about it. First, unlike pills, vaccines require the use of biological organisms, viruses and bacteria, which will not always grow

or respond on demand.

Second, vaccines are difficult and time consuming to produce and

the regulatory approval process for new vaccines and for changes

to existing vaccines is highly complex and lengthy, with timetables

that are difficult to predict. The process is regulated such that

every lot of vaccine must be approved by the manufacturer and released by the FDA. Taking into account that production schedules

can run 12 months and longer, any abrupt change in policy that

can influence demand or move a company to leave the field can result in supply interruptions.

A good example is the decision to remove thimerosal, a preservative, from vaccines. The decision was made to remove thimerosal,

which had consequences exacerbating a shortage of a childhood

vaccine, DTaP. Thimerosal is a preservative which allowed health

care providers to purchase and use multi-dose vials. Without thimerosal, single-dose packaging must be used. The manufacturing

process for Aventis Pasteur had to be changed and approved by the

FDA. The process changes lengthened the manufacturing time

lines and manufacturing yields dropped, since it is necessary to

over-fill every single vial to assure the provider can remove a full

dose.

The resulting shortage should be alleviated by the fall, if not this

summer, and providers should be able to provide all five doses require for the pertussis schedule. In part, this is because the FDA

recently licensed Aventis Pasteur’s Canadian DTaP product,

DAPTACEL, for use in this country.

Third, vaccines are tremendously undervalued as preventative

measures. Prices can best be categorized as commodity-like, compared to much higher prices for other forms of medicine. Public

purchasing entities continually endeavor to drive down the price

the government will pay for vaccines despite the fact that, in many

cases, a dose or series of doses of vaccines provides a lifetime of

protection against a disease. This is occurring at a time when manVerDate 11-MAY-2000 16:15 Dec 02, 2002 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 80606.TXT SAFFAIRS PsN: SAFFAIRS
11

ufacturers are investing significant resources to meet the current

good manufacturing practices standards set by FDA.

Before I outline the six steps to a stronger vaccine supply, let me

state what is not needed. First, what is not needed is a government-built vaccine facility, GOCOs. These would take years to develop and face the same problems as private facilities. In addition,

they would dampen incentives for new private entrants to enter the

vaccine business. It is often forgotten that it is science, not manufacturing, that is the limiting factor in developing new vaccines. All

the manufacturing capacity in the world cannot produce a vaccine

until the science is there.

Nor do we need a new centralized vaccine authority. The FDA

and CDC’s regulatory regimen is comprehensive and well-established, and there is no compelling reason to develop a wholly new

system.

We do have a number of suggestions which we believe would

help meet our vaccine supply needs in the future. Here are the six

initial proposals. We support expanded stockpiles for use if supplies

are disrupted. We support additional funding for the CDC to establish stockpiles for both single- and multi-source products. For example, had there been a national tetanus stockpile, we would not

have had the shortages we recently experienced when one company

left the manufacturing process, leaving it to a single manufacturer.

No. 2, use the expertise of the vaccine manufacturers to help formulate sound immunization policy. Manufacturers can provide realistic assessments and expertise about how vaccines are developed

and produced, the challenges in doing so, as well as a view into

how providers practice and use vaccines. It is important that those

making vaccine policy in government have this expertise available

to them. However, in more formalized settings, this is no longer occurring. An example is CDC working groups where industry representatives are no longer permitted to participate in discussions.

Industry does not expect to participate in decisionmaking issues,

but given the limited universe of vaccine expertise, governments

can benefit from the use of vaccine expertise in this industry.

No. 3, government and advisory bodies need to act with greater

flexibility. Continued uninterrupted manufacturing and distribution of vaccines is dependent upon predictable action by government agencies and advisory committees. Specifically, we suggest

that government agencies and advisory committees need to allow

adequate advance notice whenever manufacturing changes are necessary. Simply put, if change is required before manufacturers can

make them and the FDA can approve them, shortages will occur.

No. 4, the Vaccine Injury Compensation Program, VICP, should

and needs to be strengthened. The Vaccine Injury Compensation

Program stabilized our national immunization program since the

late 1980’s, reducing the frequency of liability uncertainty that has

destabilized our industry. VICP provides a system of compensation

for injury claims should they be litigated within the VICP system.

Recently, new strategies have emerged to circumvent the program. Once again, manufacturers are facing liability exposure that

measures in the billions of dollars. Already, we are facing millions

of dollars in costs to defend against specious claims. Recently, Senator Frist introduced a thoughtful and comprehensive vaccine bill,

12

S. 2053, which contained a section on VICP. It adopted the recommendations of the Advisory Commission on Childhood Vaccines

to make the system more user friendly. In addition, it reiterated

the intent of the VICP that claims processed should proceed initially through this program. We strongly commend the provisions

of the Frist bill to you. We are pleased that last Thursday, ACCV

adopted virtually all of Senator Frist’s proposals.

No. 5, to strengthen our message that prevention is the most desirable intervention, a reorientation of health care priorities to emphasize prevention over cure will provide incentives to doctors to

immunize patients and to manufacturers to maintain their commitment to vaccine production. There needs to be sufficient payment

for preventative services. Recent reductions in CMS reimbursement

are disincentives to physicians. Reimbursement rates should reflect

the full value of vaccines, including a realistic administration fee

for physicians.

And No. 6, heed the warning signs of a real and present danger,

increasing lack of confidence in immunization. The good news is

that parents no longer fear many infectious diseases because of the

success of our immunization programs. They also have lost the respect for the importance of immunization as they have lacked the

firsthand experience or knowledge of the devastating damage vaccine-preventable diseases can cause. We urge you to look at ways

to bring the public into the process and boost its confidence in the

immunization system.

The vaccine enterprise in this country is a remarkable success

story. I do not believe it is fragile, yet it clearly has several areas

that can be strengthened. I hope you will give consideration to the

proposals we have laid out. Fortunately, we have an industry that

wants to partner with government and with all elements of our Nation’s immunization enterprise to achieve even greater successes.

Thank you very much for your attention and your commitment

to the immunization system in this country.

Senator CARNAHAN. Thank you, Mr. Pisano.

I would like now to open our questioning by addressing the impact of the shortage is on children. I would like to raise the issue

of what happens to children when they miss their vaccines.

Dr. Doran, I am concerned about the issue of children slipping

through the cracks. I know from personal experience, most private

physicians do not have a system to make sure that a kid who has

missed a vaccination gets back into the office once the vaccine does

become available. This issue is particularly problematic for children

whose only health care is through the public health system. They

may visit different health clinics for their medical needs and so the

physician helping them will not have access to a complete medical

record of that child.

Can you comment on your own experience with this issue and

what you are hearing from other physicians as to what they are experiencing, and are you receiving any Federal guidance or assistance to help with this problem?

Dr. DORAN. Thank you, Senator Carnahan. It is a multi-faceted

answer, and I will begin by saying that one of the problems in this

whole past year of shortages has been the spottiness and the fact

that we have had multiple vaccines available or not available for

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different lengths of time. So planning has become problematic in

that we cannot set out a plan without changing it in a month because a vaccine either becomes available or not available.

The current practice and those of the colleagues I have talked to,

both in the public and private sector, has been to create lists of patients when they come in, to take their phone numbers and keep

them in a log, and as the vaccine comes in, to try to contact those

patients to bring them back in. As you can imagine, that is a difficult task. Parents have to take off work to come in and get the

vaccine. It is not part of their regularly scheduled vaccination

schedule and it is difficult. I cannot give you specific numbers in

terms of how effective that system is other than to tell you it is far

from perfect.

I have created a system in my office. I actually have a web page

and people can register on that web page and I can then E-mail

them, sort of broadcast E-mail them to notify them when vaccines

are in, but that is very new and, obviously, not everybody has access to the Internet.

It is just a problem. I think, talking to all my colleagues, my impression is that the majority of kids are probably waiting until

their next scheduled visit before they get the vaccine, so if they

have missed a pneumococcal vaccine at 2 months of age, they are

probably not receiving it until their 4-month check-up, which is the

next regularly scheduled visit, rather than at 3 months if the vaccine happened to come in in the interim. Most parents will probably wait.

I have a bunch of anxious parents who will come in very quickly,

but for most parents, it is a lot of work to get to the office, both

working class parents or middle class parents. It is very difficult

to spend the time and get to the office in order to get that vaccination.

Senator CARNAHAN. So it is a lot better to do it on a regularly

scheduled basis than to have to make the time.

Dr. DORAN. Absolutely.

Senator CARNAHAN. Dr. Jackson, I think parents are receiving

something of a mixed message about vaccines. They are being told

how important they are for their children’s health, and then when

they go to a doctor’s office, they are being turned away. Can you

address the impact that this is having both on parents and public

health overall?

Dr. JACKSON. Well, I think I can start by saying that as new vaccines have been licensed and we have educated parents and professionals in our community about those vaccines, there have sometimes been a lag period before these immunizations are even embraced when we have them available. The examples I would give

you would be hepatitis B vaccine and varicella vaccine, where it

took 2 to 5 years before parents and professionals really embraced

these vaccines and they began to be reliably used.

I think you are entirely correct that I call this a muddled message. We cannot tell parents that we continue to see vaccine-preventable disease, that we continue to see vaccine-preventable

deaths, and make no mistake, this is not a Kansas City phenomena. This is not a Missouri phenomena. This is a national phenomena. We cannot tell them that this risk is just for their child

14

and then tell them that we do not have vaccines available, to come

back when we call them on the telephone. In the public sector, we

are lucky to even have patients with telephones or with an accurate telephone number.

So I think that one of our greatest problems will be, if we are

able to correct this, and I feel that we are, we will have the American public that has lost confidence or become complacent about

immunizations and that our efforts to educate both parents and

professionals will have to be renewed. We will have to remind people that not only are there communicable diseases in this country

that can be prevented by vaccine, but we will have to remind them

once again that timely immunization should be a high priority for

all.

Senator CARNAHAN. I understand that there are a number of collaborative efforts that are going on around the country to increase

immunization, and it is my understanding that Kansas City is

about to launch such a campaign. I was wondering if you could discuss the ‘‘Give Life a Shot’’ campaign, what its purpose is and what

impact you think it will have considering the current vaccine shortage.

Dr. JACKSON. The Hallmark Foundation in Kansas City has

awarded a grant to both the Children’s Mercy Hospital and to the

KU Medical Center pediatricians to develop an educational plan for

our community. It will consist of public service spots. There will be

signage on public transit systems, basically to remind families to

insist that their children start vaccines on time at 2 months of age.

There was one or more individuals within our group who suggested that perhaps this is not a good time to educate the public

because how can we say, immunize on time, start at 2 months, and

then have them come in and say, we do not have these vaccines

available? My response to that, though, is we must continue our efforts to educate the public, and as we do see perhaps an end to this

by the end of the year, perhaps by summer for many of these vaccines, by the end of the year 2003, I think we must continue to

educate the public and our campaign will start in August.

Senator CARNAHAN. Thank you. Next, I would like to address a

few of the factors that affect the supply of children’s vaccines. One

important issue is the amount of production capacity that exists

and whether it is sufficient to meet the demand.

Mr. Pisano, some pediatricians say that the current shortage in

childhood vaccines is the worst shortage they have seen in their entire careers. I think Dr. Doran expressed that. Twenty years ago,

there were 18 companies manufacturing vaccines, and in the

1980’s, there were seven companies. Today, we have only four companies making vaccines for children in the United States.

I am concerned whether the country’s physical infrastructure to

manufacture vaccines is sufficient to meet the demand for the long

term. Does our country have enough production capacity to make

the demands that we need, and if more companies do not enter the

market, will we be able to meet demands for vaccines in the future?

Mr. PISANO. I think that the current manufacturing capacity in

some situations is inadequate. I think the example of Td met that

15

definition, where one manufacturer left the industry and the remaining manufacturer did not have the capacity at that time.

Now, I think what we have seen from the four manufacturers is

a renewed commitment and expansion of capacity. We have seen

one manufacturer expand their capacity for pertussis vaccine, another manufacturer license a second facility for pertussis vaccine.

We have seen expansion on Td vaccine capacity, and we are also

seeing now further expansion for the pneumococcal vaccine.

So I think the industry is responding, and I think we also will

be seeing other manufacturers looking to enter the U.S. market

and will be taking their products through the clinical and development process and filing for registrations with the FDA. So I think

the problem is on the table now, and I think the industry is responding. The immediate shortage should be over for most of the

vaccines this summer, and definitely by year end for all the pediatric vaccines, and then the infrastructure will continue to expand

from there.

Senator CARNAHAN. As you pointed out, the immediate shortage

is likely to be over sometime during the summer, but I am concerned that the underlying factors that have contributed to the

shortage will remain. Supply and demand will remain tight with

little room for error. There will still be only four companies manufacturing all the childhood vaccines in the country and there will

still be several vaccines that only one company will produce. So any

problem will have a significant effect on the supply.

I think a key to finding a long-term solution to this is increasing

the number of the vaccine manufacturers in the market. What can

be done to encourage more companies to enter the vaccine market?

Mr. PISANO. I think there are a number of factors on why companies enter and leave markets. One has to do with the risk and liability associated with—that the vaccine manufacturers are subject

to, and the Vaccine Injury Compensation Program is something

that needs to be strengthened so manufacturers are not threatened

by these specious claims and billions of dollars of lawsuits, because

that clearly discourages people from entering the marketplace.

Another is, I think we need to have an appreciation in the

United States of the value of vaccines. Vaccines are not valued the

way pharmaceutical products are valued, and so prices are driven

down. They are very commodity-like, and in order to meet the current good manufacturing practice standards that are set, companies have to invest in their manufacturing facilities. Many of these

facilities are old facilities for vaccines that were licensed 20, 30, or

40 years ago, and it is not cost-effective for the manufacturer to do

that. It is too costly because there is just not enough return for

them on making that investment.

Senator CARNAHAN. If a company is experiencing a production

problem or they know that they will stop manufacturing a vaccine,

could a shortage be avoided if the government and other manufacturers were given advance notice? Could you explain how you

would propose this would be addressed?

Mr. PISANO. I can speak on behalf of Aventis Pasteur specifically

on that. A proposal that we have brought forward to the other vaccine manufacturers that is still in discussion is allowing the CDC

to be a clearinghouse for confidential information in terms of manVerDate 11-MAY-2000 16:15 Dec 02, 2002 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 80606.TXT SAFFAIRS PsN: SAFFAIRS
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ufacturing issues such that they would have the ability to do one

of two things. They could ask another manufacturer to increase

production when we have multi-source products, or they could draw

on their stockpile, and I think stockpile has been mentioned by several people today.

We truly believe that we need to have an adequate stockpile, because when you are dealing with biologics, there is always the risk

that there will be a manufacturing issue somewhere in the future

and having a stockpile provides us the cushion necessary to get

through those types of issues.

Senator CARNAHAN. Thank you. I had just one other question

and then I will turn the questioning over to Senator Bunning.

For Dr. Jackson, are you seeing vaccine-preventable diseases reemerge, and if not and the shortage continues, how long do you

think it would be until we do begin to see these diseases again?

Dr. JACKSON. It is hard to say of vaccine-preventable diseases reemerging at this point. We clearly continue to see vaccine-preventable diseases. I used pertussis as one example. We continue to see

children with complications of chicken pox, albeit fewer than we

did, say, in the early 1990’s.

I think as immunization coverage rates fall, though, and I think

as they fall below 80 percent is when we risk the emergence of vaccine-preventable diseases. I mentioned to you that nationally, we

are at about 80 percent, in Kansas City, perhaps 85 percent. That

is why I described our program as fragile. I think that if we decrease by 10 percent, then we are at 70 percent, and then I think

that, clearly, we will see the emergence of vaccine-preventable diseases.

What is even worse is that we have recently had the licensing

of the new pneumococcal vaccine, and it has been embraced very

quickly by pediatricians who do see children with pneumococcal

pneumonia bloodstream infection and meningitis. They recognize

that disease and the need to prevent it. Almost months after we

start the implementation of that vaccine, it is taken away from us,

and it is probably our greatest shortage right at this point. We currently have none at the Children’s Mercy Hospital for our Vaccines

for Children Program.

Senator CARNAHAN. Thank you. Senator Bunning.

Senator BUNNING. Thank you, Senator.

Dr. Doran, in your practice, how often do you not have the necessary vaccines? You told us about how you try to follow up, but

knowing full well, having had nine children and having gone

through the vaccination process with those nine children, and fully

aware of the fact that a smallpox vaccination only lasts 10 years,

and so all of us sitting in this room are not immune to smallpox

because if you have not had one recently, you are not immune, so

tell me about how often do you not have the necessary vaccine.

Dr. DORAN. I would be delighted to. If I could just mention one

thing about Senator Bunning. As a 7- or 8-year-old, my very first

major league baseball game was at Fenway Park when Senator

Bunning threw a no-hitter.

Senator BUNNING. You are a New Englander, then?

Dr. DORAN. As a 7-year-old, I was——

Senator BUNNING. From the State of Maine.

17

Dr. DORAN. As a 7-year-old, I was upset that the Red Sox lost,

but that has been a chronic problem. [Laughter.]

Over the past year, I have not had a reliable supply of tetanus

vaccine. Actually, I was mentioning to the other panel members,

this past week, I received my first shipment of adult tetanus vaccine that I have had in months and months. I have had shortages

of varicella vaccine, of MMR, of DTaP, and the worst has been the

pneumococcal vaccine.

They have been for varying periods of time. The tetanus has been

for the entire period. I have been out of the pneumococcal vaccine

probably 20 percent of the time. Varicella was brief for me. It was

probably 3 to 4 weeks over the past year, and MMR and DTaP,

probably of similar length of time that I have had shortages.

Senator BUNNING. Did you have problems with the flu vaccine

last year?

Dr. DORAN. Yes.

Senator BUNNING. Because we had problems here in the Capitol

with it.

Dr. DORAN. Yes. In my testimony, I mention the required childhood vaccines. Flu vaccines have been a problem off and on over

the years, and I certainly have had shortages of flu vaccine. But

of the potentially lethal diseases in childhood and the required—

it is not one of the required childhood vaccinations. It is for highrisk children that we see, so we do have recommendations——

Senator BUNNING. And for seniors.

Dr. DORAN [continuing]. For seniors and for health care workers,

actually, who work with immuno-compromised patients. So I have

seen those vaccine shortages, but I think that, for pediatricians, the

shock this year is that not just one vaccine has been short, but as

you mentioned, five vaccines containing eight preventable illnesses

in them have been short, and it has clearly been—we have depended on this. It has been so reliable, and then to have such a

disruption in the supply has been very frustrating and very difficult to deal with.

Senator BUNNING. Dr. Jackson, let me ask you, parents and confidence, there seems to be a disconnect. Our parents, or my parents, there was no hesitation at all as far as polio, as far as smallpox or whooping cough or whatever it was. When we went to the

doctor and the vaccination was available, they gave it to us, and

on a systematic basis. If public health facilities were available,

those who could not afford it privately got it at public health facilities. Tell me if the same confidence exists now between parent and

physician and vaccinations, because I suspect that it does not.

Dr. JACKSON. And it is somewhat different, Senator Bunning.

Nowadays, parents are part of the health care system. So when a

child comes to your office for immunizations, we do not just give

the vaccines, we tell them what vaccines they are receiving, we tell

them why they are receiving their vaccines, we discuss risks and

benefits of vaccines, and so perhaps that is better in this day and

age.

But the confidence issue comes into call when we tell them why

they are receiving vaccines, the risks and benefits of vaccines, that

we recommend these vaccines and then we are unable to provide

18

them those vaccines. So that is the confidence issue that has occurred.

Complacency, I think, is the big risk, and it is not because the

professionals will lose their focus. It is not because the parents will

lose their focus, which is keeping children healthy and preventing

communicable diseases. It is because we have developed this routine of promising something that we cannot make good on, and so

I think we need to make good on our promise.

Senator BUNNING. I agree with that 100 percent, but the fact of

the matter is, the parents’ awareness and the trust factor in the

vaccinations, without having, in other words, like the anthrax in

the military, for instance. A lot of people were required by the military to get anthrax vaccinations and they said, no, we do not want

to take the risk because we think this vaccination or vaccine is not

something that we should do. How much do you have with parents

as far as children’s diseases and vaccinations are concerned?

Dr. JACKSON. I see your question. When we say to a family, this

vaccine is safe and effective, do they believe us? Do they have confidence?

Senator BUNNING. That is right.

Dr. JACKSON. Exactly. I would say the vast majority of parents

that we encounter do have confidence in their pediatrician to provide them with the best information possible. We have a segment

of the population, perhaps 10 percent, who are highly concerned

and need more reassurances that we are convinced that this is the

right thing to do, and then there is a small segment of the population that are truly anti-immunization and may not be willing to

hear evidence-based information that science tells us that there is

no connection between, for instance, autism and MMR. I think that

is a small segment of the population. I think the vast majority of

parents have confidence in their pediatricians, like Dr. Doran, like

pediatricians through our Children’s Health Care Center.

Senator BUNNING. The only people we miss are those who never

get there.

Dr. JACKSON. Correct, and that is—— Senator BUNNING. In other words, we do have a segment of the

population that does not have them available to them because they

do not get the public health links or they do not get the private

physicians.

Dr. JACKSON. And that is where I think prioritization is an issue

and falling through the cracks. In some of our populations in the

public health sector, we have children who are living in circumstances that are unbelievable. They do not have electricity.

They may not have a meal that day. They do not have clothing. I

mean, for you to tell them that it is a priority for them to get their

immunization gets washed out by the really important issues in

their lives.

Senator BUNNING. The only time probably we see them is when

they get to school.

Dr. JACKSON. Exactly, and that is why our Give Life a Shot program is going to focus, hopefully, on that hard-to-reach population.

Senator BUNNING. Mr. Pisano, let me talk to you. You mentioned

the fact that the threat of class action lawsuits against manufacturers could threaten vaccination or vaccine production. You also

19

said that the Vaccine Injury Compensation Program needs some

changes. I would like for you to expand on that.

Mr. PISANO. I think it is important for any litigation in terms of

harm from vaccines or perceived harm from vaccines must go

through the Vaccine Injury Compensation Program, and today, we

are finding the lawyers working around the system and going directly into the State court systems and suing the manufacturers directly. Right now, there are class action lawsuits that total in the

billions of dollars that the vaccine manufacturers are facing. The

defense for these lawsuits is well into the millions of dollars already and we have just begun, and these are popping up every day

across the country.

Senator BUNNING. Let me also ask, did you mention the fact, or

did I read it in your testimony, that the industry representatives

are no longer permitted to fully participate in CDC’s working

groups?

Mr. PISANO. That is correct.

Senator BUNNING. Give me some kind of background and explanation on that.

Mr. PISANO. I think we are in an era where there is concern

about manufacturers’ interests and bias. Obviously, we are in business to manufacture pharmaceuticals and vaccines, and we have

been distanced from these working groups. We are allowed to make

a statement in a public forum, but we are not allowed to participate in the discussions that go on behind closed doors. We believe

that we have information that would help the working groups

make better decisions.

We also realize we should not be part of the decisions, because

we do have an interest in the outcome of the decision. But information in terms of manufacturing capacity, information in terms of

how fast we can change a formulation to take a preservative out

of a vaccine and go to a preservative-free formulation. We had

working groups that made recommendations to remove thimerosal.

That was implemented before manufacturers could complete that

removal and before the FDA had time to review that new formulation.

Senator BUNNING. Did that slow down, then, the manufacture of

that vaccine, when you had to convert? Or were your production facilities, whoever it might have been, able to adjust to that in a reasonable manner?

Mr. PISANO. The removal of the preservative definitely slowed

down the manufacturing process. We had to reformulate the vaccine, which, in essence, is like a full development program. It took

2 years. The recommendations went in place in about 15 months,

and so there was a gap and that contributed to the shortage of the

pertussis vaccine, which is where we believe the industry can help

advisory bodies, working groups, by bringing that type of knowledge to the table. We do not disagree with the decision of the working group. We simply believe that we have information that will

help them make a better sound decision.

Senator BUNNING. This is the last question I have for the two

doctors. What will need to be done to make sure that all children

are properly vaccinated once the shortage is over, especially for

families who do not have a regular doctor and instead rely upon

20

health clinics and hospitals for their care? Either of you can try to

help us out so we can do something.

Dr. DORAN. There clearly needs to be the kind of outreach programs that Dr. Jackson mentioned. The American Academy of Pediatrics, for instance, has joined with McDonald’s to promote vaccinations, and there really has to be a much more proactive public

health sector campaign to bring these children in.

We need to, obviously, as part of that, shore up the issues with

preventing shortages, and the other thing that was mentioned by

Mr. Pisano which will be important is to make sure that physicians’ time and energy is adequately compensated. There are proposals to reduce the administration fee for vaccines to a level that

would be, for pediatricians and for public health clinics, where they

would be losing a significant amount of money every time they are

giving a vaccine. So those types of reimbursement issues are key,

too.

But in terms of reaching those hard-to-reach children, it is a

matter of public will and campaigns to reach those children and to

get them in.

Senator BUNNING. Dr. Jackson, do you have anything to add?

Dr. JACKSON. I agree that in this country, we need to prove to

the American public that we value vaccines, and in doing so, we

need to commit funds to the research and development of new and

better vaccines. We, of course, need to continue our efforts to educate the public. We need to have immunization registries which are

available which will allow us to share information confidentially

about the immunizations that a child has had.

For instance, you are so right when you say that a child may be

immunized in three different health departments and maybe two

different physicians’ offices. We see physicians’ offices now not

stocking vaccines because they are not being fairly compensated. It

costs them $58 to buy the vaccine. The insurance company will reimburse them $48. And you multiply that by the number of patients that are seen in a pediatric practice and you can see why

some practices are doing this.

And so we will have a child who comes in where we have no clue

the number of vaccines they have received, the timing of those vaccines, and so I think that is one thing that we can do, also.

Senator BUNNING. Thank you, Madam Chairman.

Senator CARNAHAN. Thank you, Senator Bunning, and I thank

our distinguished panel today, Dr. Doran, Dr. Jackson, and Mr.

Pisano. Your willingness to be here has certainly helped us to have

a better understanding. You have shed light on a very critical and

very important issue in our Nation, and we appreciate you sharing

your expertise with us. Thank you.

Our second panel will have two witnesses, one of which has not

arrived yet but is on his way. One will be Dr. Lester Crawford. I

will proceed with introducing him, even though he has not joined

us yet. He is from the Food and Drug Administration, and Dr.

Orenstein from the Centers for Disease Control and Prevention.

Dr. Crawford is the Deputy Commissioner for the Food and Drug

Administration and has extensive experience in FDA matters. His

previous government experience included serving as the head of the

FDA Center of Veterinarian Medicine and as Administrator of the

21

1The prepared statement of Dr. Orenstein appears in the Appendix on page 54.

Department of Agriculture’s Food Safety and Inspection Service.

During his 10 years at FDA and the Agriculture Department, Dr.

Crawford has played major roles in mandatory nutrition labeling,

the General Agreement on Tariffs and Trade, and the control of

chemical and microorganisms in the food supply.

Dr. Orenstein is the Director of CDC’s National Immunization

Program and has a background in pediatrics and pediatric infectious diseases. Dr. Orenstein has spent more than 24 years at the

CDC working in immunization and has been Director of the National Immunization Program since its founding in May 1993. He

also serves on the National Vaccine Advisory Committee and the

Committee on Infectious Diseases of the American Academy of Pediatrics.

Thank you for being here, and we will start, Dr. Orenstein, with

you for an opening statement.

TESTIMONY OF WALTER A. ORENSTEIN, M.D.,1 DIRECTOR, NATIONAL IMMUNIZATION PROGRAM, CENTERS FOR DISEASE

CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH

AND HUMAN SERVICES

Dr. ORENSTEIN. Thank you very much. Good morning, Senator

Carnahan and Senator Bunning. I am Dr. Walt Orenstein, Director

of the National Immunization Program at the Centers for Disease

Control and Prevention. Thank you for inviting me to testify about

the current childhood vaccine shortages.

There are currently supply problems with five vaccines that provide protection against 8 of the 11 vaccine-preventable diseases of

childhood. The current childhood vaccine shortages are unprecedented, and health care providers and parents have been justifiably

frustrated. The Department of Health and Human Services takes

these concerns very seriously, and CDC is monitoring the situation

in a variety of ways.

I would like to point out some good news. Current information

from the manufacturers indicates that many of these shortages will

be over before the end of the summer.

The causes of the childhood vaccine shortages are multi-factorial

and complex. Economic issues are clearly critical to the long-term

viability of the vaccine industry. There is no single characteristic

at the root of the current shortages. Some contributing factors include manufacturers’ production capacity, regulatory compliance

issues, manufacturers’ business decisions to stop producing certain

vaccines, and decreases in production yields caused by changing to

single-dose vials to remove the preservative thimerosal from one of

the vaccines.

The impact of the shortage is being felt by health care providers,

schools, and parents. The vaccines most affected are the tetanus

and diphtheria and pneumococcal vaccines, which both show about

a 40 percent decrease in doses distributed nationally. School immunization requirements have also been affected because supplies

have not been adequate to ensure that children in need of immunizations can get them.

22

While it is impossible to predict the larger public health impact

of the current childhood vaccine shortages, there is clearly an increase in vulnerability to disease when children remain unvaccinated.

In general, manufacturer projections indicate that the situation

is rapidly improving. The most serious and enduring problem appears to be with the pneumococcal conjugate vaccine. According to

manufacturer projections, this vaccine may be in short supply into

2003.

CDC and its partners are addressing these shortages in several

ways. The Advisory Committee on Immunization Practices, with

concurrence from the American Academy of Family Physicians and

the American Academy of Pediatrics, has made several temporary

changes in routine immunization recommendations. These changes

prioritize limited vaccine supplies to the most critical doses in the

schedule to the most vulnerable children. CDC is also monitoring

State vaccine orders to help assure that vaccines in shortage purchased through our contracts are distributed equitably.

The CDC is in frequent communication with a wide range of

partners regarding the status of vaccine production. CDC provides

weekly vaccine supply updates on its website. This information is

intended to help States and health care providers plan their immunization strategies.

In addition to working with other HHS agencies, such as the

FDA and the Centers for Medicare and Medicaid Services, CDC is

working with its partners in industry and with other groups to better understand the current shortages, identify potential short-term

solutions, and prevent future shortages.

For some vaccines, CDC has maintained storage and rotation

contracts, frequently referred to as stockpiles, which have been

very effective in the past in alleviating brief disruptions in vaccine

supply. These stockpiles are an important resource to maintain.

Between 1984 and 2002, CDC stockpiles were drawn on multiple

times when supplies of four different vaccines were interrupted.

However, managing stockpiles effectively presents unique challenges and stockpiles are not available for four of the five vaccines

with current vaccine supply problems.

In addition to the input CDC is gathering from its partners, the

National Vaccine Advisory Committee and the U.S. General Accounting Office are conducting independent reviews. CDC looks forward to reviewing their final reports.

In conclusion, the current childhood vaccine shortages are complex, unprecedented in scope, and result from a number of factors.

CDC has implemented several short-term measures to facilitate the

efficient and effective use of available vaccines, and CDC is also receiving input from external organizations regarding strategies to

prevent such shortages in the future.

Thank you for the opportunity to tell you about the current

shortages. At this time, I would be happy to answer any questions.

Senator CARNAHAN. All right. Thank you.

Joining our panel will be Dr. Jesse Goodman. He is Deputy Director for Medicine at the Center for Biologics Evaluation and Research at the Federal Food and Drug Administration and he will

23

be speaking on behalf of FDA. Thank you, Dr. Goodman, for joining

us in place of Dr. Crawford this morning.

Dr. Orenstein, I would like to ask you about the low prices of

vaccines. There are several factors that affect the market for vaccines and influence whether manufacturers want to enter or even

remain in the market. One of those factors is the price that is paid

for the vaccines.

We welcome you, Dr. Crawford.

Dr. CRAWFORD. Thank you very much indeed.

Senator CARNAHAN. We have already introduced you and we

were glad you were able to join us.

Dr. CRAWFORD. Thank you very much.

Senator CARNAHAN. One of the factors, as I said, is the price for

the vaccines. The Federal Government purchases over one-half of

our country’s vaccines through the Vaccines for Children Program.

The prices have not increased substantially since the program was

implemented.

In Dr. Crawford’s written statement, he makes this comment,

that ‘‘Although the manufacture of biologic products is complex and

demanding, and the need to update and maintain modern facilities

is costly, the current prices paid for many vaccines are low compared with the prices of many other drugs.’’ Could you comment on

this and whether CDC or HHS has examined this in your discussions on how to alleviate future shortages?

Dr. ORENSTEIN. I think there has been substantial concern that

vaccines are undervalued. In the past, vaccines had to pass a more

rigorous test than most other products. That is, they needed to be

cost-saving to society.

However, I think the issue of vaccine prices cannot fully explain

the problems we are seeing today. For example, there is an inverse

correlation between vaccines that we are having supply problems

with and price. We are having more problems with the higherpriced vaccines than we are with the lower-priced vaccines at the

moment. Another example is influenza vaccine, which there is very

little public sector purchase, and for that price is the lowest of all

of the vaccines, at about $7.

I think, in part, it deals with a society value issue, and as Mr.

Pisano said, these are complex products, and I think the concern

we have is the vulnerabilities, because in order to continue keeping

up with good manufacturing practices, updating plants, making

sure that all of the vaccines, including the older vaccines, have

state-of-the-art technology supplied to them requires investments.

And so I think economic incentives are going to be a key factor in

trying to assure we have a long-term viable vaccine industry.

Senator CARNAHAN. Thank you. We will back up at this time and

hear from Dr. Crawford, give him an opportunity to make his opening statement before we proceed.

24

1The prepared statement of Dr. Crawford appears in the Appendix on page 69.

TESTIMONY OF LESTER M. CRAWFORD, D.V.M., PH.D.,1 DEPUTY

COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. CRAWFORD. Thank you very much. I appreciate your gracious

granting of me this time. I appreciate it very much, indeed. I am

Dr. Lester Crawford, Deputy Commissioner of the Food and Drug

Administration. Thank you for the opportunity to testify today.

I appreciate the Committee’s interest in the current shortage of

childhood vaccines and welcome the opportunity to participate in

this hearing. FDA is concerned about the fragility of the Nation’s

vaccine supply and is committed to the availability of safe and effective vaccines. FDA-licensed vaccines have been protecting our

Nation’s children from deadly infectious diseases for almost 100

years. In fact, immunizations represent one of the most significant

public health achievements of the 20th Century. Vaccines can be

credited with saving more lives and preventing more illnesses than

any medical treatment. Without question, continuing to ensure the

availability of safe and effective vaccines is critical to protect the

public health and prevent disease outbreaks.

FDA’s regulation of vaccine manufacturing is essential to maintaining public confidence in U.S.-licensed vaccines. The importance

of public confidence must be stressed. No other single health intervention has had the impact on disease prevention and our Nation’s

health as immunization with U.S.-licensed vaccines. For this reason, FDA carefully evaluates each licensing and regulatory action,

balancing the importance of product availability while working

with manufacturers to help assure that products are as safe as current technologies will allow.

Vaccines are different from most drugs in several respects, and

achieving the highest quality in manufacturing is especially challenging and critical. First, they are most often produced from or

use living cells and organisms as well as complex growth materials

derived from living sources. Thus, the potential for contamination

is higher than from most drugs, so the quality and purity of all

source materials must be carefully monitored.

Second, the production of most preventative vaccines requires

growing the immunizing agent in the production facility and the

subsequent purification of complex molecules from these organisms.

Growth conditions are complex. Subtle changes in materials and in

the process itself or in conditions, such as temperature, can result

in changes in the final vaccine that can affect its safety, its effectiveness, or both.

Third, the final vaccine itself is usually not, like most drugs, a

simple molecule that can be tested for its purity and potency using

simple chemical and physical methods. Instead, each lot of vaccines

must be carefully tested for its composition and potency through

the lot release process.

Finally, unlike most drugs which are given to people to treat an

illness, vaccines are administered to large numbers of healthy people to prevent infectious diseases. For this reason, even very rare

adverse events are generally not viewed as acceptable to healthy

children and adults.

25

Vaccine shortages can stem from a number of causes and the

more recent shortages are not due to any single factor. In fact, the

recent shortages stem from a number of factors, including the withdrawal from the market of one manufacturer, difficulties in manufacturing processes, temporary shutdowns of facilities for upgrades

or maintenance or to correct manufacturing deficiencies, other factors, such as transition to thimerosal-free vaccine formulations.

When FDA inspects a vaccine manufacturer and finds deficiencies, the agency carefully considers the impact on product

availability before taking action. In some situations, the agency

may determine, after balancing all factors, that a decrease in the

availability of a medically-necessary product could pose a substantial risk to patients. In such cases, FDA regulatory action may

allow manufacturing of the critical product to continue, provided

that certain conditions are established to ensure product safety.

The agency evaluates each circumstance on its own facts, balancing the medical need for the product against the safety assurances in place before a product is released for use. Whenever possible, FDA informs manufacturers of potential shortages to allow

them to reallocate product to those who need it most and to take

action to increase product inventory. In addition, FDA works with

manufacturers that want to correct manufacturing deficiencies in

order to avoid shortages of critical products. FDA works proactively

and interactively with manufacturers to arrest shortage issues.

However, FDA does not have the authority to require manufacturers to stay in the market and produce a given vaccine, nor does

FDA have the authority to direct manufacturers to increase production when a shortage occurs.

Thank you. I am happy to follow up with your questions or whatever else you would have me do. Thank you.

Senator CARNAHAN. Thank you very much.

Dr. Orenstein, I would like to get your comment on the issue of

companies withdrawing from the market, an issue that I brought

up with Mr. Pisano just moments ago. Would you comment on

whether a shortage could be avoided if the government and other

manufacturers were given advance notice and would you discuss

how you would propose this matter to be addressed? In your experience, how far in advance can a manufacturer identify potential

problems with the supply and when is the government usually notified by a manufacturer?

Dr. ORENSTEIN. I think in terms of trying to deal with your questions, I think if we could get advance notice, I think it would certainly help. I cannot say it would avoid all shortages, but it certainly could mitigate them.

For example, if we had known that one company was dropping

out of the Td vaccine production well in advance, we could have

alerted that other company. It would be nice to get at least 12

months’ notice, because it takes about 12 months, for example, to

produce a dose of tetanus diphtheria toxoids. If we could be notified

and could share that information with the other companies, I think

that would be a substantial benefit.

In terms of the issues about how long, the longer the better.

What has happened in the past, as in the recent past, we have not

had much advance notice when companies have left and we would

26

hope we would get that notice in the future for a company that is

voluntarily leaving.

As Mr. Pisano said, Aventis Pasteur did present at a National

Vaccine Advisory Committee workshop in February that they

would pledge to give us substantial voluntary notification should

they leave the market, and we would like to see the other manufacturers follow suit.

Senator CARNAHAN. Thank you. Dr. Crawford, I realize that safety is a No. 1 priority for vaccines, as it should be. Right now, we

have several single source suppliers of vaccines. In your testimony,

you mentioned that when you make a recommendation to a company to upgrade its facilities and it will affect production, you take

into account the impact on supply.

But I have heard from some vaccine manufacturers who have expressed frustration that this is not always the case. They have concerns about how FDA is interpreting the current good manufacturing practices. Specifically, they are concerned in situations

where there is not a safety concern that FDA is not taking into account the effects on supply when making a recommendation for upgrading their facilities.

Could you address this concern and expand on what criteria you

use to make these decisions? In addition, would you comment on

whether FDA tracks the impact of its regulatory decisions on the

supply of a particular vaccine.

Dr. CRAWFORD. Yes. As you well know, the productive tension between the regulator, in our case, FDA, and the regulated is always

somewhat tenuous. Vaccines, though, are a special product category that FDA regulates. We realize the effect not only on the

public health in general, but in children’s health in particular, so

we try very hard to take into account all of these considerations.

Just a very few years ago, we had three times as many vaccine

manufacturers as we do today, so we recognize this as a precious

commodity and one that we have to do everything we can in our

power to, first of all, assure that the vaccines are safe and effective,

but second, to be sure that we still have manufacturers that are

producing the vaccines that we absolutely have to have, and hopefully that these manufacturers will be in this country producing

these vaccines.

So what we do when a decision has to be reached, either on the

volition of the company or at the behest of FDA, is we offer what

might be called technical assistance or technical service to those

manufacturers to help them meet the requirements. Sometimes, a

manufacturer will make a business decision to get out of the vaccine business or to stop manufacturing a certain vaccine and we try

very hard, indeed, to make sure that we do not create some bureaucratic entanglement that makes that decision easy and not

based on public health.

The criticism that has been voiced abroad about good manufacturing practices, not just in this area but across all of FDA, is that

the good manufacturing practices presuppose that if a company is

in conformity with these so-called GMPs, that the product then will

be inherently safe and effective. Some companies and also some experts in the field are beginning to raise questions about whether

or not the premise upon which GMPs are based is always correct.

27

We have heard those criticisms and we are examining GMPs not

just in vaccines but in drugs and foods and the other areas we regulate to see if we do not need an overall reform of this particular

means of regulation. FDA must stand four-square. In fact, our only

real statutory role is to be sure that the vaccines are safe and that

they are capable of immunizing America’s children and others, and

that is what we must stick to.

But in carrying out that function, we have to be absolutely certain that the means, mechanisms, and processes that we use to accomplish that are consonant with the latest research findings and

that we are up to date with methodology that is being used in

other countries and in other groups of countries. To that end, I can

tell you that we have not only heard them, but we are seriously

looking at GMPs as a means for accomplishing your statutory mission and I would hope, as everything can be improved, that we will

improve these over the next couple of years.

Senator CARNAHAN. One final question—I thank you, Dr.

Crawford, and then we will turn the questioning over to Senator

Bunning.

I would like for both of you, if you would, to address the government’s plan to deal with future shortages. As I have already stated,

I am concerned about the underlying factors that have contributed

to this shortage and the fear that they will remain even after the

current shortage is alleviated. What are CDC and FDA doing to

find long-term solutions to prevent future childhood vaccine shortages and what are your proposals on how to achieve those goals?

Dr. ORENSTEIN. The National Vaccine Advisory Committee has

been looking at five areas for long-term changes. One deals with

economic incentives and the need to assure a viable vaccine industry. A second deals with streamlining of the regulatory process. A

third deals with government supported vaccination. A fourth deals

with stockpiles. And a fifth deals with liability.

We are looking forward to their final report as well as the report

from the General Accounting Office, and when those come, we will

be looking at what those recommendations are and determining

which of those areas we need to take action in. One of the ones

that we have certainly used in the past that has been helpful have

been stockpiles as a way of dealing with year-to-year changes in

production. As Mr. Pisano mentioned, production disruptions will

happen. In the past, we have had stockpiles that have taken care

of them. We did not have stockpiles for many of the vaccines in

shortage today, and those are some of the issues we will be evaluating.

Senator CARNAHAN. Thank you.

Dr. CRAWFORD. Yes. Within the Department of Health and

Human Services family, the Food and Drug Administration has the

lead in the integrity and availability of the vaccine supply. We cooperate closely and intimately with CDC and also to do the job of

regulation that the statutes and also the national public health requires.

So the productive cooperation between us and CDC continues.

We are very sensitive to whatever we can do to improve availability

and effectiveness of vaccines. We cooperate with CDC and that cooperation is willing and, hopefully, productive.

28

Senator CARNAHAN. Thank you. Senator Bunning.

Senator BUNNING. Thank you, Madam Chairman.

This can be answered by either or both. Are there some areas of

the country more affected by the vaccine shortage than others, and

if so, why?

Dr. ORENSTEIN. The shortages are spotty and it depends on the

distribution systems. It is not like there is one uniform national

distribution system. So as you heard from the earlier testimony,

different doctors may have different shortages for different vaccines.

The Federal Government purchases about 52 percent, on average, of the vaccines and distributes them to the States, but the

other 48 percent is in the private sector and it will vary.

For four of the five vaccines, the distribution appears to be fairly

equal between public and private sectors. The biggest problem in

the public sector, or disproportionate factor affecting public clinics

has been the DTaP vaccine, and that is because one of the companies that had very limited supplies chose to focus that supply into

the private sector. Hopefully, all of that will be relieved with the

licensure of the new vaccine.

Senator BUNNING. Dr. Crawford, do you have anything to add?

Dr. CRAWFORD. I have nothing to add.

Senator BUNNING. Do either of you have an estimate on how

many children are not receiving the necessary vaccine at the proper time because of the shortage?

Dr. ORENSTEIN. That is a question we would like to have an answer for, but we do not. We measure—we will, in my opinion, see

decreases in immunization coverage, but part of the problem is

when we measure that coverage. The immunization series can

begin as early as birth, but the basic series tends to be completed

by 18 months of age, so we begin our measurements at 19 months

of age. So many of the kids who are currently impacted by this

shortage have not yet entered our measurement system.

We do have data from the Commonwealth of Puerto Rico, where,

because of their problems in gaining access to the DTaP vaccine,

they made a decision to defer the fourth dose of DTaP, and what

happened is their coverage dropped from the mid-90’s to the mid30’s as a result of that. Now, their DTaP–3 coverage is still very

high. This is action they took to try to mitigate the results of the

shortage. So we have some data there that are really concerning

and we will have to see what happens in the other States as children age into our system.

We are also monitoring disease and we have not seen, as yet,

outbreaks of disease as a result of these shortages, but certainly we

remain very concerned.

Senator BUNNING. Dr. Crawford.

Dr. CRAWFORD. Just one little thing to add. We would be prepared to use various interpretations of our law to help with these

spotty shortages that might develop because no one wants to see

vaccine schedules be disrupted and children not being able to be

vaccinated on time and maybe disruptions in the school system.

We have a process called the Investigational New Drug Process

where if a certain kind of vaccine is approved in another country,

for example, and CDC sends us a signal that this might help ameVerDate 11-MAY-2000 16:15 Dec 02, 2002 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 80606.TXT SAFFAIRS PsN: SAFFAIRS
29

liorate some of these problems, we are certainly willing to invoke

that. It is not used for that normally because it actually was created by Congress as a means to develop the investigational aspects

of vaccine production, but we certainly want to send a signal here

that we are willing to be as creative as we can be about helping

with these shortages and also applaud CDC’s work in this regard.

We would be interested in the figures that are accumulated.

Senator BUNNING. Since the earlier testimony from others said

that sometimes there is only one manufacturer maintaining a certain vaccine, has the CDC or whoever, the FDA, looked to foreign

sources, foreign supplies? Are there not other foreign companies

making the same vaccines?

Dr. CRAWFORD. CDC would probably have a better fix on this

than we do, but our understanding is that in other countries, although there might not be shortages, generally, just enough is produced in order to meet their own supply and demand.

Senator BUNNING. The reason I bring that up is that HHS, when

we are looking at the war against terrorism and the potential of

a smallpox problem, looked to foreign sources to manufacture

enough of that so that we could have a supply to fit the population.

Dr. CRAWFORD. Absolutely.

Senator BUNNING. I am looking at other types of children diseases.

Dr. ORENSTEIN. Two of the four manufactures that produce for

the U.S. market have their headquarters actually abroad. One of

the major suppliers, Glaxo Smith Kline, has helped for several of

the vaccines I did not mention today, because even though there

are some production disruptions, they have been able to cover the

gaps.

There is a problem when you bring in an investigational vaccine

to be used in a routine program, an ‘‘experimental’’ vaccine, even

if it is used and approved abroad. We have had problems with

trust, as you have mentioned earlier, and so using an investigational vaccine, particularly if there is some of the approved vaccine,

is problematic for——

Senator BUNNING. In other words, you tend not to bring one that

we have not had tested here in the United States?

Dr. ORENSTEIN. Exactly. What I think we need to do is, are there

ways of facilitating other companies coming and getting their vaccines licensed—— Senator BUNNING. That was one of my questions, about how long

the FDA takes to approve a vaccine, or for that matter, if we went

outside the United States, for a foreign vaccine for children to be

approved.

Dr. CRAWFORD. We take a shorter amount of time on vaccines,

particularly given the current situation, than virtually any other

thing we regulate, including food additives, for example. We are

very sensitive to developing companies. With them, we have to

work with them from the earliest onset to make sure their facilities

are capable of producing safe and effective vaccines within the time

table. So the sooner we can get with them as they are beginning

to enter the market, the better it is, and we are available for that.

I want the word to go forth that we will provide consultation with

them, meet with them at their behest, and also help as far as we

30

can within the meaning of the law to provide the technical assistance that is needed.

Senator BUNNING. Last, Mr. Orenstein, on the first panel, Mr.

Pisano mentioned that industry representatives are no longer fully

permitted to participate in CDC’s working groups. Why is that?

Dr. ORENSTEIN. First of all, the Pharmaceutical Research and

Manufacturing Association is a liaison member to our Advisory

Committee, so they are able to make comments and participate in

the full deliberations of the Committee.

Senator BUNNING. I understand the comments, but the working

groups—— Dr. ORENSTEIN. I think the major issue on the working groups

has been concern about perceptions of conflict of interest. These

tend to be small meetings. They tend to be closed. The manufacturers can now be invited, and are usually invited, to present and discuss and answer questions for them. They are not there for the deliberative process, because as Mr. Pisano mentioned, there is a conflict of interest with regard to how vaccine recommendations are

made.

Certainly, I think we have all learned from the thimerosal episode and others that manufacturers have a very valuable information base that is critical to adequate policy making. The goal is to

have them present that information, but not be there during the

actual deliberations.

Senator BUNNING. Would it not help, though? Would they not

have the availability to tell you if they were going to stop manufacturing like you would like to have a year ahead of time, or would

it not be better if there was a hands-off but a close relationship so

that you would know? In other words, if they are not going to manufacture a given childhood vaccination or vaccine, that you would

know it up front?

Dr. ORENSTEIN. I think we certainly would like to know it up

front. I am not sure the working group actually is the place. I think

that would be a one-on-one relationship between us and the companies, I think, that is what we have done, and we did that with influenza, where each of the companies provided confidential proprietary information to us and then we were able to aggregate it and

share it.

I think the issue on the working groups is differentiating provision of information, where I think the manufacturers are absolutely

critical, and the actual deliberation decisionmaking process, and

that is what we have tried to do, is to keep the information side

flowing, but when deliberations take place, to limit that.

Senator BUNNING. Is it both of your opinions that the critical

shortage, except for one vaccine, will be over by the end of this

summer and probably all of the critical five will be over sometime

in 2003?

Dr. ORENSTEIN. Based on the projections we have gotten from the

vaccine industry, yes.

Dr. CRAWFORD. I agree.

Senator BUNNING. Thank you very much, Madam Chairman.

Senator CARNAHAN. Thank you, Senator Bunning, and I certainly

thank all of those who have testified today. I also want to thank

Dr. Goodman for his willingness to stand in for us here at the last

31

1The prepared statements of Drs. Hoffman and Bengsch appear in the Appendix on pages 83

and 85 respectively.

minute. Your written statements and your oral testimony and your

responses to the questions have been very helpful.

As we have seen today, this is a very complicated issue. The

shortage of childhood vaccines has been caused by many different

factors, so there is no ‘‘quick fix.’’ But by highlighting this situation

today, I hope that we have moved a step further to finding a solution. We need to continue to keep the spotlight on this issue. Communications is key here, and by joining together to talk about the

issue, we are participating in a process that will ultimately lead to

a system that will work better to prevent vaccine shortages from

occurring. We need to continue the national dialogue until the underlying problems that have contributed to the shortage are addressed. It is important for all of our children’s health and their future.

Once again, I would like to thank all of our witnesses for participating in the discussion. I also extend my thanks to the physicians

and others in Missouri who helped us prepare for the hearing,

some of whom have submitted written testimony. I ask that the

testimony of Dr. Robert Hoffman from St. Louis and Harold

Bengsch, Director of the Springfield-Greene County Health Department, be entered into the official record.1

We will keep the record of this hearing open for 1 week in case

the witnesses would like to submit any additional comments or if

other Members would like to submit any questions to you in writing.

Thank you very much. This hearing is adjourned.

[Whereupon, at 11:23 a.m., the Committee was adjourned.]

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