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THE PERPLEXING SHIFT FROM SHORTAGE TO

SURPLUS: MANAGING THIS SEASON’S FLU SHOT

SUPPLY AND PREPARING FOR THE FUTURE

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

FEBRUARY 10, 2005

Serial No. 109–1

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

GINNY BROWN-WAITE, Florida

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

C O N T E N T S

Page

Hearing held on February 10, 2005 ....................................................................... 1

Statement of:

Boozman, Dr. Fay W., president-elect, Association for State and Territorial Health Officials; Dr. Robert B. Stroube, commissioner, Virginia

Department of Health; Dr. Walter A. Orenstein, associate director,

Emory Vaccine Center; and Dr. Alan Wasserman, chairman, Department of Medicine, George Washington University Medical Center .......... 88

Boozman, Dr. Fay W. ................................................................................ 88

Orenstein, Dr. Walter A. ........................................................................... 107

Stroube, Dr. Robert B. ...................................................................................... 97

Wasserman, Dr. Alan ................................................................................ 116

Gerberding, Dr. Julie L., Director, Centers for Disease Control and Prevention; and Dr. Jesse L. Goodman, Director, Center for Biologics Evaluation and Research, Food and Drug Administration ............................... 18

Gerberding, Dr. Julie L. ............................................................................ 18

Goodman, Dr. Jesse L. .............................................................................. 52

Letters, statements, etc., submitted for the record by:

Boozman, Dr. Fay W., president-elect, Association for State and Territorial Health Officials, prepared statement of ............................................ 90

Davis, Hon. Tom, a Representative in Congress from the State of Virginia, prepared statement of ........................................................................ 4

Gerberding, Dr. Julie L., Director, Centers for Disease Control and Prevention, prepared statement of .................................................................... 22

Goodman, Dr. Jesse L., Director, Center for Biologics Evaluation and

Research, Food and Drug Administration, prepared statement of ........... 56

Miller, Hon. Candice S., a Representative in Congress from the State

of Michigan, prepared statement of ............................................................. 128

Orenstein, Dr. Walter A., associate director, Emory Vaccine Center, prepared statement of ........................................................................................ 109

Stroube, Dr. Robert B., commissioner, Virginia Department of Health,

prepared statement of ................................................................................... 100

Wasserman, Dr. Alan, chairman, Department of Medicine, George Washington University Medical Center, prepared statement of ........................ 118

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 8

(1)

THE PERPLEXING SHIFT FROM SHORTAGE

TO SURPLUS: MANAGING THIS SEASON’S

FLU SHOT SUPPLY AND PREPARING FOR

THE FUTURE

THURSDAY, FEBRUARY 10, 2005

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10 a.m., in room 2154,

Rayburn House Office Building, Hon. Tom Davis (chairman of the

committee) presiding.

Present: Representatives Tom Davis, Shays, Mica, Gutknecht,

Duncan, Marchant, Dent, Waxman, Maloney, Cummings, Clay,

Watson, VanHollen, and Norton.

Also present: Representative Boozman.

Staff present: Melissa Wojciak, staff director; David Marin, deputy staff director/communications director; Jennifer Safavian, chief

counsel for oversight and investigations; Anne Marie Turner, counsel; Rob White, press secretary; Drew Crockett, deputy director of

communications; Susie Schulte, professional staff member; Teresa

Austin, chief clerk; Sarah D’Orsie, deputy clerk; Corinne

Zaccagnini, chief information officer; Kristin Amerling, minority

deputy chief counsel; Karen Lightfoot, minority communications director/senior policy advisor; Anna Laitin, minority communications

and policy assistant; Sarah Despres, minority counsel; Josh

Sharfstein, minority professional staff member; Jean Gosa, minority assistant clerk; and Cecelia Morton, minority office manager.

Chairman TOM DAVIS. Good morning. A quorum being present,

the Committee on Government Reform will come to order.

I want to welcome everybody to today’s oversight hearing regarding this year’s U.S. influenza vaccine supply.

This hearing will consider how public perceptions and needs will

be managed and addressed for the remainder of this flu season and

discuss what actions are being taken to begin planning for next

year’s flu season.

As many of you know, this flu season has been an unusual and

difficult one. As a result of last fall’s vaccine shortage, millions of

healthy people and thousands in the high-risk population were unable to get vaccinated in a timely manner. Phones to doctors’ offices, clinics, and hospitals rang off the hook with questions of

where to seek flu vaccine, and hundreds of clinics were either

forced to turn away or cancel altogether.

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Public health authorities responded immediately, demonstrating

coordination and cooperation between Federal, State, and local

public health officials and private providers. Officials scrambled to

identify and prioritize groups for vaccination and redistribute vaccine to areas where none existed. They were also able to procure

additional vaccine from foreign sources to help compensate for the

loss of Chiron’s vaccine. The two remaining Food and Drug Administration licensed flu vaccine manufacturers increased production

capabilities to maximize the number of doses produced for the season.

Recently the Nation’s flu vaccine shortage turned into a surplus,

with approximately 4.4 million doses remaining to be administered.

The current surplus has led to confusion among Americans, with

immunization recommendations varying from State to State and

uncertainties of where ample supplies of vaccine exist.

As the peak of the flu season approaches, it appears demand for

the flu vaccine has all but disappeared and the public has lost motivation to get vaccinated. Only a few months ago our senior citizens were waiting for hours in long lines to get vaccinated, and

now there are no lines at all. We can’t afford for Americans to underestimate the seriousness of the flu or take the importance of

vaccination against the flu lightly. An unconcerned public will only

provide to make future flu seasons more difficult. Vaccines are lifesaving devices, and administering them is an easy way to prevent

contracting and spreading a disease.

In previous committee hearings we had discussed proposed solutions to fixing the supply side of the equation. We have considered

whether new mechanisms and incentives are necessary to guarantee that an adequate number of safe and effective flu vaccines are

produced and delivered annually. Today we also need to consider

the demand side of the equation. Without a steady demand from

a public that is confident the flu vaccine will be available to them

each year, precious vaccine will be thrown out at the end of each

flu season.

Questions continue to mount, and hopefully some will be answered. How did we go from a shortage of vaccine to a surplus in

just a matter of months? What happened to demand for vaccine?

Are new public awareness campaigns or programs needed to increase and stabilize demands for the flu vaccine? What are we

doing now to minimize the amount of vaccines thrown away at the

end of this flu season? As we approach next year’s flu season, will

the message on who should be vaccinated change again?

We also need to consider if new mechanisms and incentives are

necessary to guarantee that an adequate number of safe and effective flu vaccines are produced and delivered annually.

I look forward to our witnesses’ testimony today and a constructive dialog on this matter.

I said this before and reiterate today that we all share the same

goal at the end of the day: a public health system prepared to deal

with the annual influenza season. Let us not let the efforts to respond to this season’s flu shot shortage be in vain. Everyone should

continue to seek immunization, as it is not too late and the flu season has yet to peak.

3

As you will hear our witnesses testify, there are still at least two

more months of the flu season. As a result I am pleased to announce that today in Rayburn 2247 from 1 to 3 p.m., the George

Washington Medical Faculty Associations will be sponsoring a flu

shot clinic. This clinic is open to anyone and the shot is free of

charge. I would encourage those who chose to forego receiving the

flu shot because of the shortage to take advantage of this important opportunity.

The committee thanks the George Washington Medical Faculty

Associates for offering to sponsor the clinic and for its continuing

motivation to protect the public by encouraging flu vaccinations.

We have an excellent roster of witnesses today and I want to

thank all of them for appearing before the committee. I look forward to their testimony.

[The prepared statement of Hon. Tom Davis follows:]

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Chairman TOM DAVIS. I would now like to yield to Mr. Waxman

for an opening statement.

Mr. WAXMAN. Thank you very much, Mr. Chairman. I want to

thank you, Chairman Davis, for your continued interest in the flu

vaccine and the need to assure a stable vaccine supply for the

United States. Because of your leadership, our oversight on flu has

been more sustained than that of any other committee of Congress.

When we held our last hearing in November, it was a time of crisis. There was not enough vaccine to protect the most vulnerable

Americans. There were lines of panicked citizens in grocery stores

and pharmacies, and local health officials did not have a clear understanding of who had vaccine in their communities.

During that hearing we heard from administration officials about

emergency plans to cope with the shortage. The administration also

expressed a commitment to taking steps to make sure our public

health system is better prepared in the future.

Today we are meeting at a time when there is no crisis. While

there is still not enough vaccine to immunize the entire high-risk

population, there appears to be enough to meet demand. Furthermore, at least for the moment it seems that this flu season has not

been particularly severe.

This moment provides an important opportunity to make plans

to avoid future shortages. The challenges are no secret. We are

forced to rely on too few companies to produce vaccines, leaving us

vulnerable to the kind of shortage we experienced this year with

the flu vaccine. We have not been able to maintain adequate stockpiles of important pediatric vaccines. And, finally, there are major

gaps in immunization coverage because of inadequate Federal support of State and local immunization efforts.

It is a mystery what happened to this administration’s resolve.

Earlier this week the President presented his fiscal year 2006

budget to Congress. This budget cuts the Center for Disease Control’s budget by over $500 million and slashes funding for public

health preparedness at the State and local level by almost $130

million. The budget eliminates the preventive services block grant,

which has been used to support immunization activities. And while

the budget provides for some increase in funding for State and local

efforts on flu immunization, it provides no new funding for States

that cannot now provide other lifesaving pediatric vaccines. The

budget also fails to propose any solution to the problem of maintaining adequate stockpiles.

This budget ensures for another year that there will be children

who will go without access to critical vaccinations such as a lifesaving vaccine against the most common cause of childhood meningitis.

In place of vital public health programs, the President wants to

boost funding for so-called ‘‘abstinence only’’ education programs by

40 percent. Many of these programs teach erroneous and false information to thousands of teenagers, including that tears and

sweat can transmit HIV infection. These programs also teach gender stereotypes as scientific fact: for example, that boys need respect and value accomplishments while girls need financial support

and value relationships. Well, public health threats are frightening

and real. We need to confront them with the best possible science

7

and policy. We also cannot afford to have anything less than strong

oversight over vaccine manufacturing by the Food and Drug Administration.

Today’s ‘‘USA Today’’ contains a detailed analysis of what went

wrong at the flu vaccine plant at the center of this year’s shortage.

Experts who reviewed documents released publicly by this committee found a history of serious problems with the vaccine, including

contamination, improper filtering, and potency failures. ‘‘USA

Today’’ also reported that the facility had a history of failing to investigate its errors appropriately and then failing to tell FDA about

the problems promptly. Yet, despite this record and despite the fact

that our country was depending on the facility for half of our flu

vaccine, FDA’s oversight lapsed.

In June 2003, FDA rejected the initial recommendations of its

own inspectors to pursue official enforcement action against the facility. ‘‘USA Today’’ quotes a former senior executive at

GlaxoSmithKline, ‘‘If you look at what is in FDA’s own documents,

it is stunning they didn’t get a warning letter or something worse’’

after the 2003 inspection. Instead, the company received a letter

stating FDA would not return to the plant for full inspection for

2 years. ‘‘USA Today’’ concluded that problems persisted from 2003

to this year when British regulators shut the facility and triggered

the shortage.

This year’s flu vaccine shortage is not just a wakeup call for

those of us concerned about vaccine supply; it is a wakeup call for

an agency and for an administration that appears to give companies the benefit of the doubt at every turn. The next FDA commissioner must change this approach and empower expert and dedicated FDA scientists and inspectors to do their jobs well.

I look forward to the hearing today. I plan to use the information

presented at this hearing to design legislation to fix the gaps in our

vaccine system before the next crisis hits.

I look forward to working with you, Mr. Chairman, and our colleagues, and hearings such as this serve such a valuable role. I

want to thank the witnesses for coming in. I look forward to their

testimony.

Chairman TOM DAVIS. Thank you.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Chairman TOM DAVIS. Any other Members wish to make opening

statements? Yes, Mr. Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. I want to

thank you, too, for holding this critically important hearing to discuss the current status of our Nation’s influenza supply.

As we are all aware, in October 2004 Chiron Corp., one of the

three flu vaccine manufacturers licensed by the Food and Drug Administration, announced that the company would be unable to supply the United States with the flu vaccine we anticipated for the

2004–2005 flu season. Chiron was expected to provide us with some

46 to 48 million doses of flu vaccine, representing approximately 50

percent of the nationwide supply. One facility’s failure to meet

product sterility standards in Liverpool, England, did a great deal

to expose the fragility of our flu vaccine system.

As one might expect, such a shortage in flu vaccines and the resulting long lines and lotteries that followed in some areas garnered much-deserved attention. Inquiries into who knew what and

when, what was done to prevent and mitigate the flu vaccine shortage, and who should be held accountable have been thoroughly debated within this very committee. In fact, I personally asked many

of these questions, myself.

While we may continue to disagree about the answers to those

central questions, we must agree to look forward in the best interest of the Nation and achieve our ultimate objective of ensuring

that the American people have ready access to a flu vaccine that

is safe, affordable, and effective. To that end, Mr. Chairman, every

year 36,000 people die and over 200,000 more are hospitalized from

complications arising from the flu, so let us never forget the importance of getting it right this time around for the upcoming flu season.

Looking forward, we need to ensure that we have a diversity of

suppliers that can meet our flu vaccine needs so that we are not

overly reliant on any one of them. We need to explore what the

Federal Government can do to provide meaningful incentives to encourage and retain the production of flu vaccines. Some have suggested tax credits and patent extensions for companies that manufacture vaccines, and we should probably explore those options.

In the upcoming flu season, we must also address any uncertainty that may exist in the public about the availability of flu vaccines and any confusion about who should be vaccinated. I was

troubled to read in a recent survey conducted by the Harvard

School of Public Health entitled, ‘‘Experiences with Obtaining Influenza Vaccination Among Persons in Priority Groups During a

Vaccine Shortage,’’ that over 50 percent of high-risk adults believed

that they would not successfully receive a flu vaccination and

therefore never tried to get one.

The fact that we are experiencing flu surplus today is not necessarily good news. We must ask how many vulnerable seniors and

other high-risk individuals attempted to get vaccinated but were

unable to do so due to demanding waits and distribution problems.

We should also ask how many Americans are still not vaccinated

that need to be. While I am somewhat pleased that we can report

a flu vaccine surplus today, it seems too bittersweet to celebrate in

15

light of the fact that so many Americans needlessly suffered due

to poor planning for the flu season.

We must also be mindful that the Federal Government cannot

assume today’s vaccine surplus safeguards the Nation from another

potentially devastating shortage. Our Nation must be prepared to

safeguard our citizens by providing them with either the proper

treatment for disease or a means to prevent infection in the event

of an outbreak.

If the American people are to expect excellence of our public

health preparedness, then we must provide the proper means by

which this can be accomplished. With that said, I was troubled to

see that the administration’s budget for fiscal year 2006 proposes

cuts in funding to the Centers of Disease Control and Prevention

and the Health Resources and Services Administration for State

and local public health preparedness.

It should also be noted that, while the budget would positively

increase funding for pandemic influenza programs, it also proposes

an overall cut of approximately 7 percent or $530 million to the

CDC.

Our citizens depend on us to ensure that adequate vaccines or

other medicines are available to protect them.

I look forward to hearing from our witnesses.

Once more, thank you, Mr. Chairman, for holding this hearing.

I yield back the balance of my time.

Chairman TOM DAVIS. Thank you very much.

Do any other Members wish to—Mr. Mica.

Mr. MICA. Thank you, Mr. Chairman. And thank you for continuing this series of hearings that we began when there was a socalled ‘‘shortage,’’ and now we are facing a surplus. I sometimes

wonder what the public thinks when they hear all this. First they

are told not to get vaccinations. First they are told that the supply

is limited. We have women, children, people at health risk, elderly

who don’t know which way to go. And now we are told there is a

surplus.

One of the great things about serving for a number of years in

Congress is—and I am to 12 on this committee and in my service—

that you see things from the long-term perspective. I remember—

again, I repeat this—when we held hearings on lack of childhood

vaccination, immunization vaccines, and we have heard the drug

companies bashed then, that the problem was the drug companies

and that they were charging too much. Then we heard the accusations against the insurers. Well, certainly they are price gouging

and making huge profits on vaccination, vaccines. Soon we had no

drug companies or almost no one in the United States producing

these vaccines, and soon we had no one insuring. So our next round

when we found out there was an alleged shortage was to blame the

bureaucrats, blame the agencies, because certainly they should

have anticipated all of this.

It was interesting. Over the weekend I attended a conference and

heard the head of our State and local medical society. I heard their

speeches and their plea was for physicians not to leave the State

of Florida and for physicians really not to even leave their profession. I was thinking this is sort of a microcosm of what we are creating for health care. We are forcing providers and people who

16

produce things like vaccine offshore or out of our States or jurisdiction.

I think you have to go back and look at the basic things that

have created this situation: still tort medical malpractice; liability

reform for manufacturers, whether it be vaccines or other products;

the regulation of the industry and some of the things that we have

artificially imposed. Why would you manufacture if you can’t make

a profit?

I was pleased to hear the previous speaker, who I respect, Mr.

Cummings, say maybe it is time to look at incentives and some

other things. That is certainly what we need to do. But we need

to get to the core of the problem so that we are not flying people

to Great Britain or to France or some place else to see what the

problem is; that we actually manufacture and we have incentives

to produce vaccines, to provide medical services in this country.

I think we have to look at some solutions. We are going to hear

from the bureaucrats, and God bless the CDC. I think they have

done as good a job as they could. But the way we are operating is

wrong, and the lack of again reliance on domestic production or domestic medical services or domestic medical professionals, having

them here in the United States and available is the only long-term

solution. I am anxious to hear from them. We do need to plan

ahead, but we do need to look a that core of the problem.

Thank you.

Chairman TOM DAVIS. Thank you.

Do any other Members wish to make opening statements? The

gentlelady from the District of Columbia?

Ms. NORTON. Mr. Chairman, I want to thank you and Ranking

Member Waxman for focusing in on this hearing. I think it is very

important to do so, because I think what we have had is a loss of

confidence in the two agencies that have been responsible, and part

of our job is to help restore confidence across America when up became down and down became up. People were asking what happened, and they expect us to find out what happened. The reason

I want to know what happened is because if you don’t know what

happened you don’t know how to keep it from happening again.

I think that the two agencies, FDA is already undergoing great

scrutiny and huge bipartisan criticism which may, indeed, be related, or at least not unrelated, to the failure to act when they could

have acted at the manufacturing level overseas. It calls into question the competence of the agency, their diligence in pursuing any

hints of problems.

Then, of course, the public turned to the CDC, which showed it

didn’t have a clue about what to do, had no worst case scenario,

and were no further along than Members of Congress who asked

them questions as they tried literally to cobble together a way to

deal with a crisis that was absolutely predictable. Half your supply

is overseas. Guess what? Something could happen to it. What

would you do? Very troublesome.

In a real sense, it was like the anthrax scare, except that who

could have predicted that? But you would have thought that the

anthrax scare would have helped us prepare for this kind of emergency, which, indeed, was predictable.

17

Mr. Chairman, I am concerned because of larger issues raised

here and that have been raised in the Homeland Security Committee. We don’t do a lot on health systems, but I don’t see any evidence that we are able to deal with unanticipated health emergencies. This was a test case. We failed it. For those of us who

think it doesn’t matter, this is an epidemic. I don’t know what the

number of deaths are, but we do know that tens of thousands of

people die every year from flu, so it was important.

The problems at the plant in England are so deep. Inspections

still have to go on, and apparently we still don’t know whether it

will be able to produce, so I am sure we must have a plan as to

what to do next year.

I want to embrace what my colleagues have said about incentives. Nobody expects that the pharmaceutical industry is any different from any other industry: they go for the highly profitable

drugs. We have known for a long time that there is little or no

profit in flu. Why haven’t we done something about it? It is our responsibility on this side of the podium, and it is the responsibility

of the agencies and of the administration to push us to do something about it. If this crisis doesn’t do that, I don’t know what will.

I believe the most important thing the two witnesses could tell

us today would be what their worst case scenarios are given a set

of circumstances and whether they have taken themselves through

worst case scenarios so that, indeed, they are prepared for whatever comes along. That is what the American people expect from

their public health system.

I appreciate that both of you have come, and I particularly appreciate the chairman calling this early hearing.

Chairman TOM DAVIS. Thank you.

Mr. Duncan.

Mr. DUNCAN. Mr. Chairman, very briefly, I don’t have a formal

opening statement but I just would like to say this: now that this

shortage has turned into a surplus, you know, we have certainly

found out that the way to get everybody to take their flu shots is

to tell them that they can’t have one. Human nature—people always want something they don’t have or can’t have. We certainly

found that is true, even in regard to flu shots. I know the Knox

County Health Department, my largest county, gave out more than

double their ordinary number of flu shots this year.

Leading from that, we need to make sure in all of this that I

know we are going to do everything possible to make sure there is

no shortage next year, but I am wondering if, in doing that, when

people think there is no shortage will the numbers drop off once

again that get these flu shots. I think that is something we need

to take into consideration when we are going through all this.

Thank you. This is very important, and I appreciate very much

that you are continuing to hold hearings on this. Thank you.

Chairman TOM DAVIS. Thank you very much.

We are going to move now to our first panel of witnesses: Dr.

Julie Gerberding, who is no stranger to this committee, is Director

of the CDC; and Dr. Jesse Goodman, the Director of the Center for

Biologics Evaluation and Research at FDA, will discuss efforts

taken at the Federal level to manage the flu vaccine situation this

season with focus on the most recent strategies announced by CDC

18

in January. They will also describe their efforts to coordinate distribution recommendations with local and State authorities and

what steps are being taken in preparation for next year’s flu season. Additionally, Dr. Goodman will provide the committee with a

status report regarding the implementation of Chiron’s remediation

plan and how FDA is working with both British health authorities

and Chiron to ensure Chiron is capable to manufacture for next flu

season.

Let me thank both of you for reacting to this crisis. Whatever

mistakes people think that could have gone on before, it certainly

doesn’t lie with the two of you. You have been most cooperative,

and we have taken a deficit into a surplus. Maybe we will send you

over to OMB next at the administration. But I personally appreciate the efforts that you have made on this and we look forward

to your testimony and answering some questions. Thank you both

for, I think, taking something that potentially could have been

worse. I think we have been lucky so far with a mild flu season,

but turning this around and reacting. We can have a talk about

what happened and why, but most importantly where we are going

next year.

As is our policy, we swear you in first.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you both for being here. You know

the rules. Your entire statement is in the record and the questions

will be based on your entire statement. Take about 5 minutes. You

have the lights in front of you—orange after 4 minutes, red after

5. I won’t cut you off, but we want to leave time for questions and

the next panel.

Again, thanks for your efforts and thank you for being with us

this morning.

Dr. Gerberding, we will start with you.

STATEMENTS OF DR. JULIE L. GERBERDING, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION; AND DR.

JESSE L. GOODMAN, DIRECTOR, CENTER FOR BIOLOGICS

EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION

STATEMENT OF DR. GERBERDING

Dr. GERBERDING. Thank you. We really do appreciate your continued interest in this issue. It has been a very challenging flu season for all of us, and I think very frustrating for the people who

have been unable to get vaccine.

I have a map here showing the current distribution of influenza

in the United States. As you can see, there are many red States.

Those are States that are now showing widespread flu activities.

Chairman TOM DAVIS. So red States are not the good States in

this thing? I mean, Mr. Waxman would agree with that, but I just

want to get that on the record.

Dr. GERBERDING. I am not going to comment on that.

The activity——

Chairman TOM DAVIS. Who chose what is red and blue on this?

I am just kidding. Go ahead.

19

Dr. GERBERDING. We really wanted to confuse the political process.

What we are seeing is that there is an increase in widespread

flu activity across our Nation week by week by week. This morning

we checked and we know that there is widespread flu activity in

Virginia and we do not know yet whether the season has peaked,

so there still is a need to immunize people against this infection.

We have three big challenges. One is that flu, itself, is unpredictable. We can’t say at the beginning of the year what this map is

going to look like or how fast the flu is going to spread across the

country.

On the next graphic I also remind people about the evolution of

flu viruses. We don’t know from year to year what virus will

emerge. We don’t know what strain will be causing the majority of

disease. And of course now we are also worried about the avian influenza in Asia. So we are dealing with a very unpredictable virus

and one that remains a biological and sociological challenge.

We have a second big challenge, and that, of course, is the unpredictable nature of the vaccine supply, itself. That is, in part, because we are still using antiquated manufacturing methods that

impart enormous risk to the manufacturers. We also do not have

a stable market and historically we have had low prices for the

vaccine and low rates of reimbursement.

Last, we have the challenge of the unpredictable demand for vaccine, and that is something, as you pointed out, the shortage certainly drives demand. We saw last year that a severe flu season

drove demand, at least at the beginning of the season. But we also

know that no matter where we are in flu season and how much we

encourage immunization, it is very difficult to create demand late

in the season, and that is what has created this national shortage

of vaccine, but a local mismatch between supply and demand, and

in some cases excess vaccine beyond the demand of the population.

So what can we do about that? Well, first, we can’t change the

virology of the virus, per se, but we can innovate. There are a number of innovations that have occurred even in the last year that

will help us get a better handle on flu.

I will just point out that the laboratory capability for flu detection has expanded dramatically throughout our public health system this year, our ability to detect H–5 strains, the avian strain,

but in addition CDC is conducting enormous amounts of research

related to characterization of the virus, conducting the reverse genetics to look for novel ways to create vaccine strains, doing studies

to look for drugs, and trying to understand why older people are

more vulnerable and less successfully immunized against the flu.

We have also initiated a system to track in real time the emergence of vaccine in cities using biosense, which is an electronic surveillance system including data from the Department of Defense

medical facilities and the VA medical facilities. This year for the

first time we were able to see flu emerge on a jurisdiction-by-jurisdiction basis much earlier than we could through some of our traditional tracking mechanisms.

We also for the first time got proprietary information from

Aventis, now known as sanofi pasteur, to tell us who is receiving

the vaccine, where it was being utilized, and how we can do a betVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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ter job of reapportioning and reallocating that vaccine to treat people’s needs. So while we can’t change the virus, we can improve our

abilities to detect and respond to it.

On the next graphic I have illustrated the changes in funding for

flu. I know this doesn’t show up well, but I think you can see that

trends over time do show a steady and dramatic increase culminating in the President’s 2006 budget with a request for $197 million

for influenza. That is an unprecedented budget request, and it includes dollars to purchase vaccine, it includes purchase of drugs for

the stockpile, it includes expansion of the vaccine for a children’s

program to include 5,500 immunizationsites that aren’t currently

covered, and a number of other steps to support CDC and the NIH

research and science enterprises.

So we are making investments to help stabilize the supply. We

know that the manufacturers need a modern production facility capability, and we know that manufacturers need a market.

Over the last decade, the recommendations about who should receive vaccine have steadily increased so that now we recommend

vaccine to about 188 million Americans. This in itself incentivizes

manufacturers. We have also raised the reimbursement rate for administration at CMS from less than $4 to more than $18, and we

have increased the price we pay for vaccine to more than $10

through our Medicare program. So some of these efforts underway

will certainly help stabilize the market, and we think help

incentivize. That, with the advent of our capability to purchase vaccine and guarantee part of the market, at least, is something that

the manufacturers tell us is very important in their progress.

The last challenge is the challenge of demand. This has been

very difficult. I have detailed our communication efforts in my written testimony, but we do still need to work very hard to reach out

to all cultures and all people and explain the need for vaccine.

Let me end with a picture of what our achievements have been

this year. I think it is very important to notice that, compared to

last year, the vaccine coverage rates across the United States in

some cases are better for high-risk groups. For example, we have

immunized about 50 percent of children between the ages of 6 and

23 months of age, compared to a very low immunization rate last

year. Of course, it in part is due because we didn’t recommend vaccine for this group last year. Also, compared to last year we have

improved the coverage of high-risk children and we have improved

the coverage of health care workers for flu vaccine. We haven’t

quite achieved the same level of immunization of our population

over 65, but we have come close. About 60 percent of those individuals have received the vaccine.

Importantly, our targeting worked in that immunization of the

non-risk people was less than half that it was last year, and we

thank those people who stepped aside. So, despite having 50 percent of the doses we thought we needed to begin the year, we have

achieved almost the same coverage of high-risk groups this year as

we did last year. This represents a public health success and is in

large part due to our public health system, our clinicians, and the

vaccine manufacturers, and particularly the heroic people who

stepped aside to let the high-risk people go first. So we thank all

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of those individuals, as well as the team at CDC and NIH and FDA

for their efforts.

Thank you.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Gerberding follows:]

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Chairman TOM DAVIS. Dr. Goodman, thanks for being with us.

STATEMENT OF DR. GOODMAN

Dr. GOODMAN. My pleasure, Mr. Chairman. Mr. Chairman and

members of the committee, I am Dr. Jesse Goodman. I am the Director for the Center for Biologics and Evaluation at FDA. I am

also an infectious disease specialist and I think we share many

common goals here today.

I do appreciate the opportunity to be here today with Dr.

Gerberding and to update you on FDA’s efforts to address influenza

vaccine needs and what we are doing to prevent the kinds of problems we have had this year from recurring.

I do want to assure the American public also that the safety, effectiveness, and availability of vaccines are among FDA’s highest

priorities.

As we have emphasized in previous testimony, influenza vaccine

manufacturing is complex and challenging and the market is very

fragile, in part because increasing demand has been coupled by a

decline in the number of manufacturers. For the 2004–2005 season,

only three licensed manufacturers began production. As you know,

on October 5, 2004 the British Medicines and Health Care Regulatory Agency, MHRA, suspended Chiron’s license without prior notice to FDA.

FDA also concluded that the safety of Chiron’s vaccine could not

be assured. As soon as we learned Chiron’s vaccine would not be

available, we worked with great urgency and close cooperation with

CDC and the private sector—and I want to emphasize this was

really a public/private effort—to explore all viable options to get additional doses. With sanofi pasteur and MedImmune we got approximately 5 million additional doses of U.S.-licensed vaccine, increasing the availability of supply to 61 million doses. I think that

helped us come close to the kind of coverage results of previous

years.

Because there was a concern, though—and we were all very worried, because this is still a lot less vaccine than we have had in previous years, and because of that concern we sought additional vaccine licensed in other countries that, if needed, could be made

available under investigational new drug applications.

We immediately sent teams to facilities of potential sponsors in

multiple countries to evaluate their manufacturing processes, and

we reviewed a huge volume of manufacturing and clinical data, all

within a few weeks. These efforts resulted in FDA being able to approve INDs that permitted the potential use of 4 million from

GlaxoSmithKline and 1 million doses from Berna Biotech if we

needed them.

These interactions and those with other influenza vaccine manufacturers who also were highly cooperative provided valuable information, and they have created and strengthened relationships that

we think importantly will lead to successful U.S. licensure of new

vaccines.

I want to also say that is one of the constructive outcomes of the

challenges we have faced and that I am extremely proud of all this

hard work from over 50 FDA employees, as well as our colleagues

at HHS and CDC who worked very collaboratively for long hours,

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often on weekends and during vacations, to help meet this challenge. We took this quite seriously, because we share all your concerns.

I wanted to mention that it is often overlooked that pneumococcal pneumonia is one of the most important and common serious

complications of influenza, and it, itself, is preventable through use

of inexpensive yet, even more than flu vaccine, under-utilized vaccine. In cooperation with HHS, Merck tripled its production of its

vaccine from 6 to more than 17 million doses, and availability of

that vaccine can help further protect Americans from that complication.

Well, you want to know about what our plans are, what we are

doing, what the plans are for 2005 and future years. First, we are

doing everything we can to improve supply for future years. We are

doing this with a dual-track strategy. Because Chiron is a major

issue, our first track refers to trying to help Chiron be able to

produce again. We are doing everything we can to facilitate that effort of its correcting its manufacturing problems.

In a dramatic change from where we were in October, FDA and

MHRA, the British regulatory agency, now have an agreement with

Chiron that allows full information sharing. We have used that

agreement to collaboratively review Chiron’s remediation plans and

activities, and we are providing continuing and extensive feedback

to both Chiron and MHRA in all directions. We are working together and actively communicating, in addition, on inspection activities.

Only after passing MHRA and FDA inspections will Chiron be

able to provide vaccine to the U.S. market. In the spring, when

critical stages of manufacturing are taking place, we plan a comprehensive inspection to verify whether Chiron has adequately addressed its problems. While much work remains to be done, I am

pleased to report that it appears that Chiron is making progress.

While working with Chiron, it is important to emphasize that we

are also working on a second track to facilitate overall greater capacity and diversification in the U.S. influenza vaccine supply,

something several of the Members identified as important in their

remarks. It is important to recognize—and you have also remarked

on this, but I want to emphasize it—that the demand for vaccine,

the demand and other economic issues are the primary factors that

determine whether a manufacturer will seek and maintain a license in this country, the strength of our manufacturing infrastructure here, and the amount of vaccine that manufacturers will

produce.

One important and often overlooked strategy that CDC and us

are in full agreement on is to encourage vaccination throughout the

flu season, including January and February. To increase the total

doses available, manufacturers can produce vaccine over a longer

time period, and that becomes available during these months. Because influenza cases usually continue well after November and

December when most people are seeking immunization, later vaccination is beneficial. We need to better communicate this important public health message, and the clinic that you have sponsored

today is a great way to do that.

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In addition, we have also been doing everything we can to stimulate foreign license manufacturers to provide or, where needed, develop the safety and effectiveness data to get U.S. licensure. We

have actively engaged with several interested companies. We have

informed manufacturers that we are willing to consider creative approaches to licensing, such as accelerated approval based on surrogate markers like the patient’s immune response to the vaccine.

Finally, while we are doing all we can to have licensed vaccines

for next year’s needs, the experience and relationships we have

built this year will help us if we again need to obtain additional

vaccine under INDs.

I just want to conclude with a few remarks on something I think

is very important, which is we have challenged ourselves to identify other lessons learned from this year’s influenza season and

how we can use this experience to prevent similar events in the future. It is not all under our control, but we are making significant

changes in response to our sort of after-action and continuing analysis. One is that we plan to conduct inspections of influenza vaccine manufacturers on an annual basis. Another is this need to

share more information. We are completing or have completed

agreements that allow information sharing with numerous foreign

regulatory agencies. We have also initiated a vulnerability analysis

of other licensed products that we regulate that are critical to public health to identify other areas where actions to support supply

might be needed, and we have increased efforts at global regulatory

collaboration on approvals and standards.

I think it is very important, because I know you are interested

in pandemic flu, to know that the insights gained from these experiences are critical in informing us on pandemic preparedness. This

is something we all care a great deal about, given the eventual

likelihood of pandemic and the outbreaks of avian flu Julie mentioned in Asia. It is very, very important to emphasize that more

widespread vaccination during periods before pandemics has not

only its direct health benefits but it increases vaccine production

capacity and it will help America and the global community better

prepare for an influenza pandemic.

As Julie mentioned, the administration is making the largest investment ever made by the Federal Government in these areas. I

do want to mention a couple of specific things that were not in her

testimony.

In November 2004, HHS awarded a contract to sanofi pasteur to

help ensure year-round availability of increased egg supply in case

it is needed for the pandemic or for this kind of future vaccine

shortage. Research supported by HHS through the National Institutes of Allergy and Infectious Disease will help us move from eggbased production technology to newer technologies. While much

work remains, these newer technologies provide important alternatives that could potentially shorten the time needed to produce

vaccines.

We welcome the continued support of Congress for this work, and

we view preparedness as a critical responsibility and an opportunity. I see this as a teachable moment. What have we learned?

What do we need to do to prepare for the future?

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In conclusion, when an adequate vaccine supply supplemented by

effective anti-viral medicines is available, we can greatly decrease

our vulnerability and provide protection against influenza. We recognize the need to work with multiple partners, including manufacturers, to increase supply and move toward more modern, dependable methods of production. All of the steps we have described will

not only help address our current challenges, but help protect us

from flu every year and prepare us for future seasons or in the

event of a pandemic.

All of us welcome the opportunity to work with Congress to accomplish these shared public health goals.

Thanks very much.

Chairman TOM DAVIS. Thank you very much, Dr. Goodman.

[The prepared statement of Dr. Goodman follows:]

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Chairman TOM DAVIS. Let me start with you. ‘‘USA Today’’ had

an article discussing how a couple years ago some batches of the

flu vaccine might have lost their potency too soon. I know that you

can’t talk about specifics because it is against the law for you to

do that, but could you explain generally about potency and what

it would mean to an individual who had received a shot that was

less potent?

Dr. GOODMAN. I would be happy to. Every year we actually assist

the manufacturers by providing standards and the agents needed

to assess potency. The major thing there is it helps the manufacturer of the vaccine. They have to decide how much of each component to mix into the vaccine, so we help get them to the appropriate amount.

But then, in addition, they are required to perform testing on the

vaccine to show how its stability is maintained over time, that it

doesn’t lose large amounts of that potency so that a person might

not have the protective response you would want them to have. We

require them to monitor that and report those events to us.

We also require other testing. For instance, we test every new

large lot ourselves for potency, but the stability testing is then

what happens thereafter.

In this case there was a problem. The company noted

diminishments in excursions from the specified stability limits.

This is information that our inspectors found during that inspection they performed a complete analysis of, and they determined

that this is a concern, particularly that they were not reported to

us, but that, given the way this vaccine is rapidly utilized and the

nature of the excursions and all the other information available to

them, they did determine that they did not believe this was at that

time a threat to the effectiveness of the vaccine. But that is still

saying we were concerned and told them to correct that.

Chairman TOM DAVIS. Should there have been a recall of those

flu shots?

Dr. GOODMAN. That possibility was certainly examined, but,

again, because it was believed that these changes, while of concern

and outside of their specification—I want to emphasize we were not

happy with these, but the analysis was that these would not affect

the efficacy of the vaccine at that point in such a way as to make

a recall needed. I should also point out that would not affect safety

of the vaccine.

Chairman TOM DAVIS. What does FDA do to ensure a manufacturer properly tests and reports its findings to FDA?

Dr. GOODMAN. Things that we think are critical are specified in

the license, itself, of the manufacturer. In fact, there are a broad

number of tests that manufacturers are required to do as part of

their license and as part of the quality assurance, and these occur

at multiple, multiple steps during manufacturing, and then also

with the final product.

If problems develop they have certain procedures. For example,

for certain procedures they have to reject that vaccine for the U.S.

market if certain kinds of test results are obtained. For others they

are supposed to notify us within a certain amount of time or perform an analysis of those results and decide whether in their judgVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00079 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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ment the vaccine is acceptable. So all those are things that are required.

In addition, we do testing, as I mentioned, on the bulk lots and

at other parts and final vaccine and other parts of the process as

we deem needed. In this case, the manufacturer did not report

these excursions in stability to us in a timely manner as required,

and they were cited for that.

Chairman TOM DAVIS. OK. Thank you very much.

Dr. Gerberding, CDC has been telling the public that it isn’t too

late to get vaccinated, as the flu season can last through April. If

we are stuck with a surplus every year, why doesn’t the CDC consider extending the flu shot campaign through at least February or

March to avoid throwing away vaccine? Would this help, or does it

just vary with the flu season?

And another question: how many deaths have we had this year

due to flu in the United States? Can anybody tell me?

Dr. GERBERDING. The truth is we are working very hard to try

to continue to encourage vaccine. One of the things we have done

is make the emergency supply of CDC’s vaccine on loan to the

manufacturer available to clinicians, and if they don’t use it they

can get a rebate, as an effort to get them to reach out and get the

vaccine, especially for these high-risk people. So every year we put

out information and communications around late-season vaccine,

but it is human nature, apparently, not to be interested in that immunization, despite what we think is a pretty gold standard campaign.

We have to work on that. We have to do the formative research

to find out why and change our communication strategy accordingly, and we need to also work with clinicians and the public

health system to make this a visible priority.

In terms of the number of deaths overall from flu, it is too early

for us to have that accurate information. Influenza per se is not a

reportable disease. We do know that there have been at least four

pediatric deaths from influenza this year, which is less than we

saw last year but still unnecessary and tragic.

Chairman TOM DAVIS. Thank you very much.

Mr. Waxman, you have 5 minutes.

Mr. WAXMAN. Thank you, Mr. Chairman.

Before I get into the topic for today I just want to tell Dr.

Gerberding my appreciation for the work that the CDC did in coming to terms with the obesity issue and reviewing the matter internally, convening further discussions, making pledges to changes so

similar problems wouldn’t occur in the future. I just want to commend you for the work your agency did on that.

Dr. GERBERDING. I am very grateful to hear that, and I will take

that back to Atlanta, as well. Thank you.

Mr. WAXMAN. Thank you.

I want to ask you about immunization funding, because we have

seen an increase of $1.5 billion over the last decade, largely due to

the congressionally mandated vaccines for children program, but

there is another immunization program that is called the 317 program. This is run by the States, and the States are supposed to

make up for those who don’t qualify for the vaccines for children

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program to make sure they are eligible for vaccines, as well as

some adults.

I think this is an important program, and I am sure you share

that concern, as well.

Dr. GERBERDING. Absolutely.

Mr. WAXMAN. A number of States are telling us that they can’t

ensure that all kids get the vaccines they need, and we are going

to hear today from the health commissioner of Virginia who has

testified a number of times to this committee that his State cannot

provide the life-saving prevnar vaccine. Is it true that by expanding

the 317 program we could ensure that all children in the United

States get all their shots?

Dr. GERBERDING. It is very difficult to do that on the basis of

317. What is proposed but not yet approved is that we expand the

eligibility for the VFC so that we could immunize these under-insured kids in facilities that are run by State and local health delivery programs. Right now those kids have to go outside of the system and they can’t afford to pay for the vaccine so they essentially

don’t get it. So the proposal is that we add to the VFC eligibility

to achieve this kind of coverage. If that proposal doesn’t pass or

isn’t approved, then we would certainly need to rely on 317 to continue that effort.

Mr. WAXMAN. I guess my concern is I think we are not funding

adequately the 317 program, and that will provide a gap where

some people who could be covered by it are going to fall through

it. I just hope we can find more funding for that effort.

Dr. GERBERDING. Thank you.

Mr. WAXMAN. Before I go to Dr. Goodman, there is another very

peculiar issue that you are dealing with with the stockpiling of

childhood vaccines. There is some SEC issue that is preventing

some of the companies—this may be too esoteric an issue, but I just

hope that this issue is being approached with some urgency, because it looks like the money that was allocated for the stockpile

is not going to be used because the companies are not going to be

able to do this because the SEC is not allowing them.

I guess the only point I would make there is that we have to do

something to straighten this out. It seems absurd to let it go on

and start making assumptions that we are never going to get that

stockpile for those vaccines, which will assure that we have the

supply for.

Dr. GERBERDING. Thank you. That is a revenue recognition issue

and it is complicated. We have to figure a way through that, and

I know the companies are eager to do that, too. Thank you.

Mr. WAXMAN. Dr. Goodman, I have been critical of the FDA. At

our last hearing this certainly came out, and I think the ‘‘USA

Today’’ article also was pretty damning of the FDA’s inaction in

light of the FDA’s own inspectors coming back in 2003 and saying

they were learning about problems at that Chiron facility and recommending that some action, enforcement action, be taken.

Just to review the facts, the plant had a terrible record of compliance with FDA regulations, even a history of failing to report problems to the agency. This potency issue is one of the problems they

evidently failed to report to the agency. The plant was making half

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ous problems again and recommended enforcement action, yet FDA

decided not to conduct a full inspection for another 2 years. We

learned at the last hearing FDA refused to even request to meet

with the company to provide guidance on how to improve, and then

eventually the plant was shut down by the British.

I reviewed this because I think we need to learn from this, and

I appreciated your testimony that the FDA is taking that constructive approach. I think there is a silver lining. If FDA is able to increase its enforcement and if the agency can empower its inspectors and scientists, then FDA can prevent situations like this from

developing in the first place, but it is going to take a commitment

from FDA leaders like you and whoever the new Commissioner will

be. I want to underscore that point.

You don’t disagree with me, do you?

Dr. GOODMAN. No. I don’t think, unless you have specific questions, it would be constructive for me to go over the old ground. I

know Dr. Crawford answered your questions about that before. But

I would just reiterate we are—and I can speak for him and myself—totally committed to doing everything we can to get highquality manufacturing and also to get the appropriate kind of

inspectional enforcement activities. I am working closely with John

Taylor, the head of Office of Regulatory Affairs. We have considered this issue very carefully of whether the annual inspections I

talked about, which is a real change, may be helpful. We think if

it may be, given the dwindling number of manufacturers and how

vulnerable this all is, that even if it just may be and we can approach it in a very preventive manner it is a good thing to do.

Mr. WAXMAN. Let me just say I appreciate that approach and I

think it is constructive and I think there are certainly good intentions on everybody’s part, but I was very disappointed in Dr.

Crawford’s testimony. I don’t think he took responsibility for FDA’s

pretty much hands-off approach, just trusting the company and not

going out there to the British plant, itself. But I don’t think we

have time to go over all the past record. It may not be all that helpful. I just do want to register my concern.

Dr. GOODMAN. I appreciate that. One comment I would make,

without wanting to re-engage the whole thing, is that in 2003 when

the inspectors went in there they did find significant issues and

concerns. A number of the ones that were of most concern were

from 2001 and 2002, and when they were in there on the ground

a number of those problems had been corrected. The initial recommendation of the inspectors was as you discussed, but the normal FDA—they did follow the normal FDA process. They came

back, discussed those internally, looked at the company’s response,

looked at the company’s record, met with the scientists in the center and the additional scientific specialists, and they did make that

decision.

Mr. WAXMAN. But rejected the recommendation of the inspectors

to do more.

Dr. GOODMAN. Again, I would just characterize it as actually the

inspectors, themselves—this is my understanding, because I have

asked about that. I think it is a legitimate question. Everybody

looked at all the data, and my understanding is they unanimously

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portant observations, but this wasn’t a situation where they had a

safety concern at that time or—and I think it is important to say,

and I have heard this from the people who were on the ground that

the situation that we found in 2004 going in there was different by

order of magnitude and from a situation where, with an extensive

inspection such as in 2003, you would find significant observations,

you would want to make improvements in quality. We would expect

those changes. But in 2004 it was very quantitative and qualitative. The basic systems weren’t working.

Mr. WAXMAN. My time is up. I just want to make one sentence

here. From 1999 to 2001, FDA sent 36 warning letters to biologic

manufacturers for manufacturing violations. From 2002 through

2004 FDA has sent six. This is a decline of over 80 percent. I think

we need to do more, not less. That is why I believe we ran into the

problem we did. You may disagree with me, but that is my view.

Dr. GOODMAN. Well, I appreciate your input.

Chairman TOM DAVIS. Thank you.

Mr. Gutknecht.

Mr. GUTKNECHT. Thank you, Mr. Chairman.

First I will ask the question the chairman wanted to ask and

didn’t get a chance. First, will the CDC follow the lead of some of

the States and drop the remaining restrictions on who should or

can be vaccinated?

Dr. GERBERDING. The decisions about the high priority groups

are made in collaboration with the Advisory Committee on Immunization Practices, and though we see coverage rates that are close

to what we normally perceive, we still have millions of very highrisk people who haven’t been vaccinated. So from a national perspective, we have been consistent from day one. The highest priority still has to be our seniors and the people who are at very high

risk from death or severe complications.

But at a local level where some providers have it and others

don’t, it is the local health officer or the State health officer who

has to make the decision in their jurisdiction what is the most common sense way to make the best use of the vaccine. We don’t want

to waste it. So we are really encouraging them to use what they

have if they need it. If they can’t get the high-risk people, then give

it to whoever wants it.

Mr. GUTKNECHT. So that was kind of a no. It was a good answer,

but I think the answer is no, you are not going to follow the lead

of the States.

Second, doesn’t that create confusion among the public about

who should be vaccinated and who shouldn’t?

Dr. GERBERDING. The dilemma is that there are areas where

there still is a vaccine shortage. We have surveyed all the States,

and there are specific jurisdictions where they need vaccine and

they can’t get it. So for us to say it is wide open for whoever wants

it nationally really creates an additional burden on those places

that are still desperately seeking vaccine.

So we have tried to equalize that by moving vaccine from one

State to another or one jurisdiction to another, but it is not feasible

to do that with the kind of precision that would allow us to give

a single recommendation for the Nation. So our dilemma is how do

we support making sensible use of the vaccine and still protect

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those areas that have shortages and are even still talking about

using the investigational vaccine if they can’t get what they need

through the manufacturer.

So we still have a shortage, and that I think is something that—

I know the committee is talking about a surplus, and there are

areas where we have excess vaccine, but fundamentally we don’t

have enough.

Mr. GUTKNECHT. Just for my own benefit, when you move vaccine around or when it was shipped here from Germany, how did

they ship it?

Dr. GERBERDING. When we move it from jurisdiction to jurisdiction it is generally either Federal Expressed or moved through

some kind of a courier that meets the FDA’s requirements for chain

of custody, if you will. And likewise, when we move it from the

international sources to the United States, it goes through a similar process to assure that the cold temperature is maintained and

that we document the appropriate transport and storage procedures.

Mr. GUTKNECHT. So importing these vaccines from Germany

caused no concern for health?

Dr. GERBERDING. Well, I will let Jesse answer that question because it is really an FDA requirement.

Mr. GUTKNECHT. Actually, you don’t have to answer that. That

was a facetious question.

Dr. GOODMAN. Well, I think I should answer it because it is a

good question, too. Vaccines and some of the other biologics are

particularly sensitive to, for example, cold, other storage conditions,

handling, so what we want to do—and this is true with licensed

vaccine or the unlicensed vaccine under the IND because, of course,

Chiron’s vaccine would have been imported into the United States

because it would have been finished in England.

What we do is we have very detailed—the manufacturer actually

has to submit to us detailed protocols that they have validated that

show that the temperature is maintained, that the storage conditions are suitable, for example, for shock, that the temperature is

monitored. Just like those stability testing that Congressman Waxman asked me about, if there are significant deviations they need

to report those, and in certain cases they cannot use that vaccine.

Mr. GUTKNECHT. I just wanted to get on the record that it is possible to move drugs and/or vaccines across State and national borders safely as long as you follow the right protocols.

Dr. GOODMAN. And it is well controlled.

Mr. GUTKNECHT. And you can do it with FedEx. That is on another subject for another day, which we will pursue perhaps in this

committee and others.

The other issue I want to get to—and I am sorry my time is almost exhausted here, but I am very concerned about viruses that

are migrating from one species, particularly from poultry to pigs,

for example, and then to human beings. I want to know how much

research you are doing.

I have a very parochial interest in this. There is a small lab in

my District that is doing some amazing things on vaccines for pigs.

Literally you can send them a sample overnight FedEx and the

next morning they will analyze what particular virus that is and

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they will send the next day out the right vaccine for that for your

herd of animals. In many respects, they have technology at this little lab that is all world.

My interest in this is trying to bring some other researchers in

because I am concerned. I mean, I don’t like to use the term ‘‘pandemic’’ and I am not a scientist, I am not a doctor, I don’t play one

here in the Congress, but I am concerned that we are not doing

enough in the event that there were some new strain of virus that

did begin to jump from animals to human beings.

I am curious in terms of what the CDC is doing on that and what

we can do to advance that particular kind of research.

Dr. GERBERDING. Thank you for your question. I would actually

look forward to learning more about the facility in your District so

we can followup with you on that.

The problem you are describing is one that we refer to as

‘‘zoonotic infections.’’ Actually 12 out of the last 13 new infections

in people have arisen from animals, so it is an extremely high priority for CDC. In fact, we just recruited the dean of the school of

veterinary medicine from the University of Michigan to CDC to

help us, in part, with our strategies and our innovations in this

area because we think it is so important.

Mr. GUTKNECHT. I would love to have you come out and visit

these guys, because it was one of the most amazing things that I

have seen. As I say, the research stuff, the equipment that they

have is amazing, and that they can do this that quickly.

I yield back the balance of whatever time I might have.

Chairman TOM DAVIS. Thank you, Mr. Gutknecht.

Mr. Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

I just want to followup on something that Mr. Gutknecht was

talking about. As you all were answering his questions, particularly you, Dr. Goodman, about the transfer of medicine drugs from

one country to another, I want to make sure I heard you correctly,

because it seems like there are different things coming out of the

FDA. You said that could be done safely?

Dr. GOODMAN. The question that I was answering——

Mr. CUMMINGS. Then answer my question.

Dr. GOODMAN. I will. OK. Your question is: can, in this case, all

drugs? Or is your question about influenza vaccine?

Mr. CUMMINGS. Let’s just deal with vaccines right now.

Dr. GOODMAN. OK.

Mr. CUMMINGS. Because they seem to be very sensitive.

Dr. GOODMAN. Yes, I understand.

Mr. CUMMINGS. They have shelf life. They have all kinds of

issues.

Dr. GOODMAN. Yes. With all that in mind, with extremely careful

controls over transportation conditions, including monitoring, etc.,

and in this case there had to be extensive FDA and company involvement. In other words, this is normal procedures for these companies and all the resources that would be involved in that. Two

critically important things could be dealt with and protected. Those

are: is that the product you think it is? And has it been under total

custody and control? It is almost like criminal evidence. You don’t

want the consumers, the people in the District and in Maryland to

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get a vaccine and have that not be flu vaccine. And then is that

vaccine still going to be safe and effective because of how it was

handled, etc.? If it is properly made, and then with exquisite, appropriate monitored controls, and then FDA oversight of that and

all the resources that are entailed in that, I think that particular

transportation issue can be met.

I want to mention one thing here.

Mr. CUMMINGS. Let me just say why I asked the question. I have

seniors who are sitting there right now looking at C-Span and they

are hearing all this, and I have to go back to my District and explain this, that they can’t get their prescription drugs because FDA

says they can’t be done safely. But let me move on, because I only

have a minute.

Dr. GOODMAN. OK.

Mr. CUMMINGS. I, too, was disappointed with Dr. Crawford’s testimony, extremely disappointed. I want to know. Let’s say we go

through all the things we are supposed to go through in making

sure Chiron is doing what it is supposed to do, and let’s say we find

out that we do have a major problem, what exactly are our contingency plans?

Dr. GOODMAN. That is an excellent question.

Mr. CUMMINGS. Thank you.

Dr. GOODMAN. We are working with CDC and HHS—and I do

want to mention that coordinating and planning function is in the

Secretary’s office at HHS, but let me tell you what we are doing

in answer to that. You are absolutely right. While we are doing all

we can to get Chiron on board to produce, and if they do and they

do it in a timely manner that would be a good situation and it

might be able to restore supply to a reasonable level.

There is a lot of uncertainty in there. Ultimately it is up to

Chiron to succeed, and it is a really complex, demanding process.

They are making huge changes. Also, our British counterparts have

to do their job and decide that it is OK, too, and then we do. So

there is a lot of unpredictability so we need to do what we can to

prepare.

Some of the things we are doing that I mentioned; we are extensively interacting with several foreign manufacturers who have

been working with us and who have indicated their interest in

seeking U.S. licensure. We are hopeful that at least in one case

that may be possible in time for the coming year. It is not guaranteed because again it has to meet the standards of safety and effectiveness that your constituents and I as a physician would expect.

The other thing, as I mentioned—and I think it was valuable—

we did go out and get additional vaccine under all these controls

and I would say spent thousands of hours reviewing the manufacturing, the clinical records, the adverse event records in these facilities of vaccines licensed by what we would consider competent

regulatory authorities in other countries, and we did decide, as you

know, that in at least two cases our sponsors who were interested

in providing vaccine in an emergency, that it could meet standards

to be used under what we call an IND, where people would know

they are not getting licensed vaccine. They would have to consent,

but it could be available, and we believe it would be safe.

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So we have that system in place now, and if we have signals that

Chiron or the other manufacturers we are hoping to get onboard,

if that isn’t working out we would plan to engage that.

Finally, I have to say that both the other licensed manufactures,

Aventis, now known as sanofi pasteur, and MedImmune have been

incredibly cooperative and had indicated their willingness, if needed, to do what they can to increase production.

There is still uncertainty. I am very concerned about the risk.

There are bad scenarios like those that played out this year. But

what I am here to say is we are all doing everything we can to be

prepared and, in the long term, to diversify this vaccine supply,

strengthen it, and prevent those problems.

Mr. CUMMINGS. Thank you.

Chairman TOM DAVIS. Mr. Shays.

Mr. SHAYS. Thank you.

I have three organizations that are on the top of my list of

groups that I admire. One is the World Health Organization, the

other is the FDA, and the other is the CDC. I think you have extraordinarily difficult jobs and I think you do it quite well. And I

also believe we are never going to get supply and demand to be

equal. We are not a communist society. We can’t make people do

things that they don’t want to do. And so in the realm of things

I would rather have surplus rather than a shortage, but I don’t

want this surplus to be created because we encourage people not

to take a vaccine they should take.

The first question I just want to ask you is about the avian flu.

When I was at the World Health Organization this past month,

they talked about this flu basically being in 20 countries. I want

to know what kind of representation—and they said it could become a pandemic if we are not careful. I just want to know the

views that each of you have.

Dr. GERBERDING. We are very concerned about the avian virus in

West Asia right now. We know at this moment it is present in at

least nine countries, and there is a new cluster of transmission

from chickens to people, although we still have not seen efficient

transmission from one person to another. The virus has not evolved

significantly over the past year, but it could do that at any time,

and when that happens there is an increasing probability that it

could adapt and become something capable of causing a pandemic.

Mr. SHAYS. They basically said it was more likely than less likely

to happen; that the trend lines are in the wrong direction.

Dr. GERBERDING. The situation there is you have an amazing

juxtaposition of pigs, people, and poultry, and those are the three

ingredients for creating new strains of flu virus that can be very

effectively transmitted. We have so much virus there in this incubator of new strains that there is a very strong statistical probability that we will see emergence. We can’t say for sure, but we

are certainly doing everything we can to be on top of it.

Mr. SHAYS. In Thailand I am told there is one farm that has 5

million chickens, and I am told that a country like Ireland no

longer produces chickens because it is just so cheap to get it from

a place like Thailand. So it is something I just want to register my

concern to both of you.

Dr. Goodman, did you want to comment on that?

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Dr. GOODMAN. I did. When the pandemic subject came up before

I wanted to mention one thing that I think we are all involved in

doing that is very positive. I mean, first of all this is an absolutely

huge threat and we are taking it very seriously, and CDC and us

and our colleagues at NIH are at frequent communication, including the WHO, etc. We are tracking this, but we are also trying to

say what more can we do to be better prepared.

I mentioned more vaccine production capacity. I also wanted to

mention one accomplishment of HHS that I truly think is a bell

weather and remarkable, and that is that we have begun production of vaccines and testing of vaccines that may never be used.

The HHS let contracts to two different companies to produce pilot

lots of vaccine that might be able to help protect against that avian

flu were it to become pandemic.

Mr. SHAYS. Just a quick answer on this. The flu shot that people

take here, would that protect them against it?

Dr. GOODMAN. No.

Dr. GERBERDING. No.

Dr. GOODMAN. That is the whole problem is that this is a new

coat on the outside of the virus that our generation of people have

never been exposed to, so when you are exposed, you don’t have the

existing antibody, nor is it in our current vaccines.

Mr. SHAYS. Let me quickly get an answer to this. How far behind

are we in planning for the next flu season? I have been made

aware that major vaccine distributors have refrained from taking

pre-orders because they are unable to calculate next season’s market.

Dr. GERBERDING. At the moment discussions are underway about

what strains should be in the new vaccines, and that is an important step toward predicting the timing of the manufacturing.

Mr. SHAYS. Is that guesswork or is that——

Dr. GERBERDING. It is based on what strains are emerging at the

end of this season here, as well as what strains are in the southern

hemisphere as we speak. So the first step is the experts meet in

Geneva at WHO to look at all the data, and then they meet with

FDA here, I think in about 2 weeks——

Dr. GOODMAN. Yes.

Dr. GERBERDING [continuing]. To put their heads together and

pick the combination of the three strains that would go into the

vaccine.

If I can just add one very quick thing, that is that Secretary

Levitt has just been on the job for a few days as secretary of HHS,

and already I have had two opportunities to brief him about avian

flu and influenza preparedness with my colleagues, so I can tell

you that this is a very high priority for the Department and we are

all focused on it.

Mr. SHAYS. Thank you for all of your good work.

Dr. GERBERDING. Thank you.

Dr. GOODMAN. Thank you.

Chairman TOM DAVIS. Ms. Norton.

Ms. NORTON. Thank you very much, Mr. Chairman.

It is clear from both of your testimony that you are doing the

things that one would expect one to do to try to make up for probVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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lems beyond your control, things that can be planned for, and I appreciate that you are doing that.

I am interested far more in the meaning of this crisis for the future of the flu vaccine and for other similar crises that could come

up. Dr. Gerberding, I remember that when this crisis arose CDC

did not even have access to the purchaser list, even though the

purchaser list of the company that had produced vaccine, and thus

initially CDC was unable to account for who had vaccine and who

did not have vaccine in the first place. Apparently after some time

Aventis did share its list with you. Are Aventis and other such

companies required to give you their lists now as a matter of

course?

Dr. GERBERDING. I would ask Dr. Goodman to answer that from

the FDA perspective since they regulate that. But we are hoping

that, even if the law does not mandate it, that we would be able

to engage their cooperation in the future. We had a very successful

cooperation. They provided us with very important market information of a highly competitive nature. We kept it confidential, utilized

it for public health purposes, and I think established some real

trust between the public health system and the manufacturer.

I will let Dr. Goodman talk about the regulatory perspectives.

Dr. GOODMAN. Yes. We don’t actually control who they distribute

or to whom, and as Dr. Gerberding said, that is an important part

of their marketing strategy and it is protected information. So I

think you identify an issue that in a public health crisis as occurs

can be a challenge.

Dr. Gerberding could comment more because she was involved in

those difficult distribution issues, but when faced with this problem

my impression is that they have been forthcoming and shared information. But I think this is an issue. You have a system where

the private distribution system is efficient under normal circumstances, and then when it is stressed by extraordinary circumstances it is a challenge to figure out how you deal with that.

Dr. GERBERDING. I would add that I can imagine in our scenario

planning situations where we would very much like to have additional proprietary information about other products, so it is a gap

in our capability of managing a public health emergency.

Ms. NORTON. Even through your regulatory authority, even saying in the event of a finding by the FDA or the CDC or whoever

is the appropriate authority, the list had to be turned over, then

surrounding those lists with the appropriate protections in advance

seems to me would be helpful.

Again, my concern is with worst case scenarios. The fact is that

Aventis did not immediately say, ‘‘Here is my list.’’ They did eventually give it, but the fact is that should have been forthcoming instantly. And you were left there, Dr. Gerberding, without any basis

to proceed because you didn’t even know where the vaccine was.

This vaccine is going to continue to be in the private sector. This

is the United States of America. It is the kind of gap I would have

expected by now you would have begun to move on.

I would like to ask you, since I think that one is obvious, what

exercises have you gone through in the nature of worst case scenarios? I have read both of your testimony. They do indicate that

you are doing the proper planning. My concern is with unanticiVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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pated health emergencies and with restoring the confidence of this

committee and of the public that, given anthrax, now given flu, if

there is an unanticipated emergency these are the kinds of things

we do.

I hate to use this analogy, but that is how the military, for example, prepares for the unforeseen. That is how the, God help them,

Secret Service and security officials prepare for the unforeseen.

Well, some of us regard health emergencies as more likely and at

least as important, so I would like to know if you have a regimen

of what to do——

Mr. DUNCAN [presiding]. Let me just say, Ms. Norton, we have

a vote, so make this answer very, very short if you can please.

Dr. GERBERDING. The answer is we are constantly exercising scenarios. Just this week we had an anthrax scenario. This is a part

of our preparedness planning for terrorism as well as for avian influenza and other health events. So on an ongoing basis around the

tabletop and around the country we are engaged in scenario-based

exercises. That is one of the backbones of preparedness.

Mr. DUNCAN. I would like to ask just a couple of quick questions.

I am assuming that the United States has a much higher vaccination rate than most other countries, and particularly the countries

in southeast Asia, and I am wondering what that comparison is, if

you know. And second, how much higher is the rate of flu in some

of those countries where they have almost no or very low vaccination rate.

Dr. GERBERDING. We have three things: we have the best ability

to measure vaccination, we have the most vaccine, and we have the

highest vaccination rates. Totally in the world we produce each

year about 300 million doses of vaccine, and we had 61 million of

those doses in the United States this year, so you can see we really

do have very high rates compared to the developing world.

Mr. DUNCAN. Is the rate of influenza much, much higher in those

countries?

Dr. GERBERDING. It is difficult to say because the surveillance

systems aren’t there with the kind of high-tech capabilities we have

here, but flu is a ubiquitous problem in all societies, and it certainly is a problem in Asia.

Mr. DUNCAN. As far as we know, the flu shots that people have

gotten this year, are they for the strains of flu that are out there?

Dr. GERBERDING. It is a good match this year.

Mr. DUNCAN. A good match.

Dr. GERBERDING. The Fujian strain has been the dominant

strain, and that is the strain that the vaccine is targeted to.

Mr. DUNCAN. And you said earlier you will put three strains in

the vaccine for next year, but I remember from another hearing—

how many strains are there? There is a large——

Dr. GERBERDING. There is an infinite number of flu strains. It is

constantly evolving. But each year we pick two A influenza strains

and a B strain based on our scientific evidence that suggests what

the most likely circulating strains will be.

Mr. DUNCAN. All right. We are going to have to be in a very brief

recess. Chairman Davis will be back in just a very few minutes. We

will be in recess.

[Recess.]

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Chairman TOM DAVIS [presiding]. Our meeting will come to

order.

Dr. Gerberding and Dr. Goodman, let me just say thanks for

staying here, but I think I am going to do everybody a favor at this

point and allow you to go and move to the next panel. You have

been very, very helpful.

If there is anything you would like to add before you go that

maybe you didn’t get to say or answer?

Dr. GERBERDING. Just thank you. Thank you for your interest.

Chairman TOM DAVIS. Thank you very much. Thanks for the job

you are doing.

Dr. GOODMAN. I would second that thank you. This is an important subject. We are very committed to working with you.

Chairman TOM DAVIS. All right. We will get you a better microphone next time. Thank you.

We are going to move to our second panel now. I want to thank

these witnesses for appearing. We have invited our second panel.

We have Dr. Fay Boozman. We also have Dr. Robert Stroube, the

Virginia State Health Commissioner. He is here to discuss Virginia’s response to the shortage turned surplus over the past few

months. Dr. Walter Orenstein is associate director of the Emory

Vaccine Center, who will discuss recommendations. And last but

not least, Dr. Alan Wasserman, chairman of the Department of

Medicine at George Washington University Medical Center, who is

here to provide an academic perspective into issues surrounding

the annual influenza vaccine. He will also share with us his experience last month when GW sponsored a free flu clinic at the Foggy

Bottom Metro Station and they couldn’t give away all their shots.

Before we swear in, Mr. Boozman, would you like to make an introduction, the gentleman from Arkansas, our colleague from the

Third District.

Mr. BOOZMAN. Thank you, Mr. Chairman. It is a pleasure to

have my brother here with us, Dr. Fay Boozman.

Chairman TOM DAVIS. Obviously, your younger brother, right?

Mr. BOOZMAN. Obviously.

Chairman TOM DAVIS. And former State Senator.

Mr. BOOZMAN. I thought that you would say, ‘‘Isn’t this your

Dad?’’ But my brother and I, I am an optometrist and my brother

is an ophthalmologist, and we practiced together for many, many

years. We were in an area that is one of the fastest-growing areas

in the country, so whatever you did, you were successful at, and

we were blessed in that way.

His background is such he was a pediatrician before he became

an ophthalmologist. After practicing for many, many years he got

interested in public service and became the Health Department director for the State of Arkansas for Governor Huckabee. True to

form, he went back and got his master’s in public health from

Tulane. I guess he is probably one of the longest-serving continuous

public health directors in the country right now. Evidently they

don’t last very long.

It really is a pleasure to have him here, both panels talking

about such an important topic.

Thank you, Mr. Chairman.

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Chairman TOM DAVIS. That is the best you can do for your brother?

We are happy to have all of you here. Dr. Stroube has survived

a long time in Virginia, and before that in Fairfax County, my

home county, where he grew up and had our public health. We are

happy to have all of you here.

Dr. Wasserman, thank you for being here from G.W. I want to

thank the medical faculty associates for being able to offer the flu

shots this afternoon. I hope you can give them away here, Dr.

Wasserman. Thank you.

It is the policy of this committee that we swear everyone in, so

please rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Dr. Boozman, I will start with you and we

will work our way down. We have lights there. The orange light

means 4 minutes are up, red light means 5. Your entire written

statement is in the record and questions will be based on that.

Were you in the House or the Senate in Arkansas?

Dr. BOOZMAN. Senate.

Chairman TOM DAVIS. So you know how to talk. If we can keep

it to 5 minutes here, we usually have a tough time, but do your

best. Say what you need to say and then we will get on to questions. Thank you very much for being here today. Your brother is

doing a good job, by the way.

STATEMENTS OF DR. FAY W. BOOZMAN, PRESIDENT-ELECT,

ASSOCIATION FOR STATE AND TERRITORIAL HEALTH OFFICIALS; DR. ROBERT B. STROUBE, COMMISSIONER, VIRGINIA

DEPARTMENT OF HEALTH; DR. WALTER A. ORENSTEIN, ASSOCIATE DIRECTOR, EMORY VACCINE CENTER; AND DR.

ALAN WASSERMAN, CHAIRMAN, DEPARTMENT OF MEDICINE,

GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER

STATEMENT OF DR. FAY W. BOOZMAN

Dr. BOOZMAN. Thank you, Mr. Chairman and distinguished

members of the House Government Reform Committee. I am Fay

Boozman, director of the Arkansas Department of Health, and I am

honored to be testifying before you today on behalf of the Association of State and Territorial Health Officials.

I want to thank the chair and the Members for convening this

hearing on this very important public health topic.

Let me begin by noting that from the start there has been tremendous cooperation among Federal, State, and local public health

agencies. The experience this year is a classic example of how our

Nation’s governmental public health system can and should work.

In October 2004 Arkansas and every other State and territory

faced an unanticipated public health challenge when we learned

that we would receive only half of our flu vaccine orders. Over the

next few days we worked with our partners to formulate a plan to

deal with this shortage. We used the health alert network to contact health providers throughout the States, telling them about the

situation, asking them to provide us with information about how

much vaccine they had ordered, how much they had on hand, and

how much they needed for their high-risk patients.

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The Arkansas Department of Health typically purchases about

40 percent of flu vaccine supply in Arkansas, which meant that

from the start we controlled a substantial portion of the vaccine

that had been delivered to the State. I need to point out that in

many cases most flu vaccine is purchased by the private sector, so

some of my colleagues initially had much less control over the vaccine supply in their States and the distribution of that than I did.

In Arkansas we decided to exercise our mass vaccination plan

which we developed with the CDC bioterrorism preparedness funds

to distribute our supply of vaccine. November 3rd was the day that

we chose to do that. We enlisted the help of media outlets and

health care professionals to get the word out. Thousands of people

called our newly created 1–800 hotline or logged onto our Web site

to get information about where to go for the shots. Thankfully, the

plan worked. On November 3rd in a matter of hours we administered over 53,000 doses of vaccine to high-risk individuals in 83

clinics.

Despite everyone’s best efforts, we may experience future vaccine

shortages. A national plan should be developed that would provide

guidelines for Federal, State, and local health departments to follow when Federal Government determines that a shortage exists.

For example, when Health and Human Services determines that a

shortage exists, it should immediately create a secure data system

that provides each State department with reliable and up-to-date

information about vaccine orders and supplies in the States. The

sooner public health officials have that information, the sooner they

can work with their local health departments and health care providers to get information out to combat the public panic.

ASTHO agrees that we should provide incentives to manufacturers to stay in or enter the U.S. market. Under a vaccine for adult

program similar to vaccines for children program now in place, the

Federal Government would purchase flu vaccine and supply to

States for use by uninsured, high-risk adults for whom flu vaccine

is recommended. That would help needy Americans get vaccine

while creating a market entry incentive by growing and stabilizing

the flu vaccine market.

Last but not least, we need to increase the CDC’s 317 national

immunization program funding so that State and local departments

can build adult immunization infrastructure, as recommended by

the Institute of Medicine in its Calling the Shots Report.

CDC immunization funding should be sufficient to allow States

and local health departments to purchase flu and other recommended vaccines for all under-insured children, adolescents, and

adults.

I wish to thank this committee for its continuing interest in this

important issue. The public health community is committed to ensuring that all individuals in need of vaccine receive it. We look

forward to working with you to ensure that we have the resources

and tools to do our job of protecting the public’s health.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Boozman follows:]

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Chairman TOM DAVIS. Dr. Stroube, thank you for being back

with us.

STATEMENT OF DR. ROBERT B. STROUBE

Dr. STROUBE. Thank you.

Mr. Chairman, distinguished members of the committee, my

name is Dr. Robert Stroube. I am the State Health Commissioner

for Virginia. I am honored to be testifying before you today. I would

like to thank the chair and the committee members for convening

this hearing and for the amount of time you have devoted to this

critical issue.

Since news broke that British regulators suspended the license

of flu vaccine manufacturer Chiron last October, State and local

public health officials have been working to ensure the best use of

available vaccine. Initially that meant prioritizing vaccine availability to individuals at greatest risk for developing serious complications from the flu. More recently it has included responsible

relaxation of vaccine recommendations to include individuals outside the original high-risk groups to ensure the use of the remaining doses.

VDH had ordered 90 percent of its total flu vaccine from Chiron,

approximately 110,000 doses. However, the Health Department

provides a very small proportion of flu vaccine that is typically provided to the public. During our typical year, we provide about

70,000 doses of vaccine. Most of the vaccine is through the private

sector.

In response to the vaccine shortage, we immediately implemented the ACIP’s recommendations regarding the prioritization of

flu vaccine. In addition, every effort was made to educate the medical community about the recommendations and urge compliance. A

message was sent out to health care providers through our health

alert network. We issued press releases, including information

about the vaccine shortage, and encouraged prioritization of available flu vaccine.

State and local health departments received hundreds of phone

calls from concerned citizens and numerous media interviews were

conducted. We diligently worked to provide the best information

available. From the beginning of the flu vaccine shortage, CDC has

worked closely with Aventis to allocate and distribute all the remaining doses of vaccine.

In the weeks and months following, VDH received four shipments of redistributed vaccine, with each targeting a high-risk population. In November we received 80,000 doses of flu vaccine. The

decision was then made to distribute the vaccine to each health district based on its population. Local health districts in Virginia developed flu vaccine distribution plans tailored to meet the needs of

their high-risk populations in their area.

As the first doses of flu vaccine from the CDC allocations began

to arrive in late October and early November, the health districts

began to implement their plans. Individuals not included in the priority groups were asked to defer vaccination in order to preserve

the limited amount of vaccine. We received approximately 77,000

doses in mid-November, and this was primarily given to long-term

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care facilities across the State. This enabled nursing homes and assisted living facilities to vaccinate their vulnerable residents.

In mid-November we began to request vaccine through CDC’s

Web-based secure data network. This network allowed State public

health officials the ability to order flu vaccine on behalf of private

health care providers directly from CDC. As a result, we were able

to distribute approximately 98,000 doses to Virginia’s doctors and

pharmacists.

By the end of November, CDC and Aventis had distributed about

255,000 doses in Virginia. We sought to reach as many high-risk

populations as possible, providing flu vaccine to health departments, long-term care facilities, and private doctors. By late December it appeared that the majority of high-risk persons in most

parts of Virginia who wished to be vaccinated had obtained vaccine.

A late December inventory revealed an ample supply of flu vaccine in many parts of the State. To help ensure that available flu

vaccine did not go to waste, I authorized the expansion of vaccine

recommendations to include individuals age 50 to 64 and household

contacts of those in high-risk categories. This took effect on January 10th. The expansion was in agreement with the revised ACFB

recommendations. Even with expansion, there was little interest by

private providers in placing an order for Virginia’s fourth allocation

of vaccine of approximately 55,000 doses. By the time the CDC orders were due to CDC on January 13, only 30,000 doses had been

requested.

In late January, CDC began to support the expansion of vaccine

eligibility for States and localities with ample supplies; on January

26, authorized district health directors to lift their flu restrictions

in the localities if they thought the demand for vaccine within priority groups had been met.

On January 27, CDC made VFC vaccine available to health departments for non-VFC children and adults in localities where demand for flu vaccine among eligible children had been met. Local

health departments were then authorized to redistribute this vaccine to other public facilities, free clinics, community health centers, and private nonprofit facilities. Despite VDH’s effective response to unexpected shortage of flu vaccine, the continuing problems with flu vaccine availability caused great difficulties for our

State in planning for the next flu season. We do not know what the

availability of flu vaccine will be next year. Will there be enough

for everyone, or high-risk groups only? If there is a continuing

shortage, what will be the role of State and local health departments in vaccine distribution? Will things be done as in previous

years with private sector handling most of the distribution? Or do

we need to build on this year’s ad hoc system using State and local

health departments to coordinate distribution?

Historically in Virginia the private sector has administered the

great majority of flu vaccine. This crisis led to much government

intervention in the distribution and administration of vaccine. We

wonder will the private sector return to its former level of involvement.

In Virginia the trend has been for large businesses such as

WalMart, drug chains, grocery store chains to provide much of the

vaccine. Long lines, traffic congestion, unfavorable publicity this

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season may make them wary of continued participation. Private

health care providers have been less active in flu administration

over the last few years, and shortage may make them even less

willing to deliver vaccine through their practices.

The public has received many mixed messages about flu vaccines

as the crisis developed. There were public campaigns urging widespread immunization, then campaigns to ask people not at high

risk to defer vaccine. There was a severe shortage of vaccine, then

a surplus of vaccine, with changing recommendations.

Fortunately, to date we have had a light flu season; however,

this confusion has led to the belief in some of the public that there

was less vaccine but we have less flu and maybe we didn’t really

need the vaccine in the first place. How willing are they going to

be to take flu vaccine in future years?

Throughout the crisis our State and local health departments devoted incredible amounts of our time to get to our most vulnerable

citizens the vaccine they need. CDC has provided national leadership in a difficult and changing environment and worked very

closely with us to meet the needs of our citizens, and we are appreciative of their efforts.

The ultimate solution is development of adequate, secure, and

stable supply of vaccine, as we have stated in previous testimony.

We appreciate the amount of time and effort your committee has

devoted to these issues, and we thank you for the opportunity to

speak today.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Stroube follows:]

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Chairman TOM DAVIS. Dr. Orenstein, thank you for being with

us.

STATEMENT OF DR. WALTER A. ORENSTEIN

Dr. ORENSTEIN. I am Dr. Walter Orenstein, association director

of the Vaccine Center at Emory University. Prior to joining Emory

in March 2004 I was the Director of the National Immunization

Program at the CDC. I want to thank the Committee on Government Reform for the opportunity to address public health implications of the recent influenza vaccine shortages, assess strategies

used to minimize their impact, and recommend potential steps that

may be taken to avert future shortages.

Averting future shortages includes providing incentives, one to

manufacturers to enter or stay in the U.S. market, to providers to

order and administer influenza vaccine, and to people for whom influenza vaccine is recommended to seek and accept vaccination.

A critical incentive for manufacturers is to decrease financial risk

for vaccine that is produced but must be discarded each year, since

last year’s influenza vaccine cannot be used for the following season. One way to accomplish this is through a back-end guarantee

program in which the Federal Government asks manufacturers to

produce more doses than they usually would and pays the manufacturer at the end of the season for those extra doses that go

unsold on the private market.

For example, if usual production is 80 million doses and the Federal Government wants 90 million doses produced to cover more of

the 188 million persons for whom influenza vaccine is already recommended, then the Government can guarantee the companies

that they will pay some discounted price for each of the 10 million

doses that may go unsold.

As a further incentive to the companies, an effort should be undertaken to increase demand for influenza vaccine and thereby increase the size of the market. This should include at least three

components: first, a national, State, and local educational effort directed at both the medical community and the public to promote

use of vaccine; second, an adult immunization grant program modeled after the successful childhood immunization program should

be undertaken, which provides grants to States and localities to

build immunization infrastructure for immunization of adults. This

would include components such as outreach workers who can perform educational efforts, staff who can provide technical assistance

to health care providers to improve their performance, development

of data systems to track and monitor vaccine supply and use and

measure immunization coverage, and personnel who can assist

nursing homes in conducting immunization programs.

Third, influenza vaccine should be purchased by the Federal Government and supplied to States for uninsured, high-risk adults for

whom influenza vaccine is already recommended to minimize financial barriers to access and increase vaccine use.

Incentives for providers include provision of free vaccine for their

uninsured patients, decreasing their financial risk of potentially ordering vaccine that goes unused; access to technical assistance

from State and local health departments; and provision of eduVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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cational materials for their patients from those health departments.

The major concern about the present problem is the potential for

backsliding in our efforts to prevent the significant burden of influenza. While it is too early to tell if this season will be mild, if it

turns out to be, many of the people who might have received the

vaccine in the past but were unable to receive it this year may

have a false sense of security that they do not need vaccine. Unfortunately, influenza is difficult to predict, and if a mild season were

to occur this year it does not mean next year will be mild. If it

turns out the season is moderate to severe, unfortunately many

people who might have gained benefits from vaccination may suffer, either because they did not seek it or because they were unable

to obtain vaccine.

One of the more effective strategies in reducing influenza is to

reduce exposure of high-risk persons to influenza by vaccinating

their close contacts. Many more high-risk persons may be exposed

because their contacts were not vaccinated due to supply problems.

Given the shortage, could anything have been done differently to

minimize its burden? I think CDC did the best it could under the

circumstances. There was a need to prioritize vaccine and priorities

chosen by the experts on the Advisory Committee on Immunization

Practices were reasonable. This meant delivering messages to others to forego vaccination.

In conclusion, the influenza virus can cause a substantial health

burden. Influenza vaccination is the best way to prevent this burden. The shortages are a result of lack of manufacturer incentives

to enter and stay in the U.S. market. Averting future shortages

and averting the influenza burden involves providing incentives to

manufacturers to produce vaccine, providers to order and administer it, and the general public to seek and accept vaccine.

Thank you.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Orenstein follows:]

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Chairman TOM DAVIS. Dr. Wasserman, thanks for being with us.

STATEMENT OF DR. ALAN WASSERMAN

Dr. WASSERMAN. Thank you, Mr. Chairman and members of the

committee.

At the height of influenza season last year, more than 10 percent

of all deaths were related to pneumonia and influenza. In 12 of the

past 21 years, the peak month for flu activity in the United States

has been in February or March. We may get lucky this year and

see fewer cases, but the chances are the greatest threat from influenza is still before us, and yet we cannot give away flu vaccine.

We are only now seeing our offices filled with patients with flulike symptoms, and our hospitals had to close on multiple occasions

in the past week because beds are filled to capacity with patients

with flu and complications from flu. It is not just the Pope who has

been hospitalized with influenza-induced pneumonia. And yet we

cannot give away free flu vaccine.

After treating our high-risk patients, we have been left with approximately 3,600 doses of vaccine, and when the city relaxed restrictions we hastily convened an all-day flu vaccine fair at the

Foggy Bottom Metro Station on February 13th. Thanks to the local

media, we were able to publicize this event widely, with constant

radio reminders that included a live telecast onsite throughout the

day. Our doctors, nurses, interns, and residents spent the day administering free flu shots, but in the end we were left with over

half our remaining supply.

The headline in the ‘‘Washington Post’’ had it correct, ‘‘G.W.

Stuck it to 1,889 People,’’ but where were the others? Where was

the passion, the anxiety, the response that we saw in November

and December to those free sessions that were offered before restrictions were put in place?

We stood outside for over 8 hours, and yet we couldn’t give away

all our free flu vaccine. We will probably end up the year with over

1,500 doses going unused. Therefore, we and many health care organizations like us will be left with incurring the cost of unused

vaccines, but, more importantly, thousands of Americans will get

sick needlessly.

Now this has been a very unusual year and this is a complicated

issue involving the health of our community and our country, but

it is our hope that this committee could address some important

questions that have health care workers and probably the public

perplexed.

If vaccinating our population for influenza is such a priority, why

is there no safeguard in producing vaccine? Which would cost more,

redundancy in vaccine production with risk of over supply, or the

significant added cost to the Government in Medicare and Medicaid

payments for flu-related illnesses and hospitalizations? Why does

our country’s grocery stores receive their vaccine shipment well before most health care providers? Is that the way we will assure

that high-risk patients will be vaccinated?

Debilitated patients, those on oxygen, and others usually do not

have the stamina to fight their way in line and stand for hours. Is

this really a public service, or a setup for public panic?

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Can we continue giving mixed messages to the public? One year

it is, ‘‘Get your vaccine in October and November,’’ and the next

year the public is told it is still OK to get a shot in January or February.

Skepticism is very high among the public now that we are pushing vaccine at this very late date. Some may think that we are only

doing so not to look foolish ending the season with a surplus, while

others certainly may think it is just the greedy physician out to

make the extra dollar.

To add to confusion, the District of Columbia, Maryland, and Virginia each had different regulations, some with monetary penalties,

for flu vaccine distribution. In such inter-related areas where patients from one jurisdiction often see physicians in another,

shouldn’t uniform policies be considered?

There is much to be learned from what happened this year, but

this year is not over. People remain at risk for what could be a virulent next 2 months. Earlier this year Members of Congress and

their staff set the example by not being inoculated, thereby encouraging the public to refrain from getting flu shots so there would be

enough for the high-risk group. I believe now the time has come

for Congress to once again lead the way in getting inoculated now

to encourage others to come forward while there is still time.

Throwing away vaccine and filling our hospital beds would be a

sad ending to a very difficult season.

On that note, Mr. Chairman, as you mentioned, we will be administering free flu vaccine starting today at 1 p.m., upstairs in

room 2247. We will be here until we run out of vaccine. I hope that

is not too long.

Thank you very much.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Wasserman follows:]

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Chairman TOM DAVIS. Again I want to thank the generosity of

George Washington University Medical Faculty Associates for making this available. We are going to get the word out here.

I will start questioning with Mr. Dent. Mr. Dent, are you ready?

Mr. DENT. Thank you.

Dr. Orenstein, I represent eastern Pennsylvania just south of the

Aventis pasteur plant in Swiftwater, PA. I know you have talked

a lot about incentives. Are you satisfied with what has been done

to date to make sure that Aventis and perhaps any other pharmaceutical manufacturers will be ready to deal with this situation

next season?

Dr. ORENSTEIN. I think there has been some major progress that

has been done. I think very good collaborative relationships have

been developed. I think it potentially can be done. I know we are

focused very much on high-risk individuals, but if you look at for

whom the vaccine is recommended, it is recommended for contacts

of those people. There are substantially more people who need to

get vaccinated. It is not clear to me that we have enough incentives

right now in order to really boost production.

I think in essence we ought to be considering perhaps a 5-year

plan to get to close to the 188 million Americans for whom we already recommend vaccine. I think to me the people who can actually answer that question best are the manufacturers, themselves,

but I am concerned that perhaps we have some but not all the incentives we need.

Mr. DENT. I guess I am somewhat concerned, too, in that beyond

Aventis it doesn’t seem that there are too many domestic manufacturers of this particular product, and selfishly I would certainly

like to see Aventis get the business because my constituents work

in that plant where they manufacture it, it would probably be in

the public’s interest and this country’s interest to diversify the

base.

Thank you.

Chairman TOM DAVIS. Thank you very much.

Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman.

Dr. Boozman, your brother and the chairman had very nice

things to say about you, and I am pleased that you are here. I just

want to say something nice about your brother, because he and I

have been working together on legislation to protect children from

harm from contact lenses that have not been prescribed and not

appropriately placed in their eyes. He has been a great legislative

ally.

As the person in charge of the State and territorial health officials, could you tell us about the financial difficulties States have

in providing all the routinely recommended vaccines to children?

Dr. BOOZMAN. Yes, sir. Thank you.

Mr. WAXMAN. And let me follow that up with another question

at the same time. Does the President’s budget fully address the

problems that you do have at the State level?

Dr. BOOZMAN. The problems that we are having and have had—

and we have all tried to solve them in different ways—is that we

are getting more and more vaccinations, most recently prevnar,

and the cost per child keeps going up. Now, we have the vaccine

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for children’s program, which enables us to give that eligible child

a full complement of vaccination, but many children fall through

that crack, and so then we are left with the 317 side of the system

to try and serve children.

For a year in Arkansas we had a two-tiered system where we

simply couldn’t fill that gap. Now the way we solved that was

through the federally qualified community health centers. They

deputized our clinics, the health department’s clinics, and that

made children coming in to us eligible on the vaccine for children’s

side.

We have new vaccines coming even more, and so I think this

problem is going to get bigger. So the answer to your question is:

no, we don’t have enough funding right now to be able to vaccinate

everybody the way we ought to. As somebody that comes from a

pretty conservative perspective, there are not many things that

Congress can spend money on that they get a better return on.

Mr. WAXMAN. Absolutely.

Dr. BOOZMAN. Every dollar that you spend—I think I saw a fig- ure this morning of $27 in reduced medical costs, and it was mentioned about what it is costing for people to be in the hospital with

pneumonia and things like that.

Mr. WAXMAN. Certainly less expensive to prevent the disease

than to have to pay to treat a disease that could have been prevented.

Dr. BOOZMAN. That is exactly right.

Mr. WAXMAN. You testified that you would support a vaccines for

adults program modeled on the very successful vaccines for children program. That certainly seems like a sensible idea to me. If

the Federal Government could expand and guarantee a vaccine

market like it does with pediatric vaccines, this could be, I think,

a powerful incentive for the manufacturers, the companies to get

into the business and stay in the business, because we do have this

question of what business decision they will make if they have this

uncertain market.

Do you think that this would shore up our fragile vaccine supply?

Dr. BOOZMAN. I think it certainly would be a great step in the

right direction, because, as you have said, it creates a market. Our

country has a history of where there is a market people fill in. Just

as Representative Dent mentioned, I think there will be other people that see that potential and I think other manufacturers would

enter in. I think it is certainly a first step, and see what happens.

Other things may be necessary, but that certainly to me is a very

important first step.

Mr. WAXMAN. We have heard from local health officials that they

can’t provide important vaccines such as the hepatitis B vaccine

even to high-risk people such as people who come to sexually transmitted disease clinics. They can’t provide it because the cost is so

high. Do you think that a vaccines for adults program should be

broad enough to include all routinely recommended vaccines for

adults, including the hepatitis B vaccine?

Dr. BOOZMAN. Yes, sir, I do.

Mr. WAXMAN. Dr. Orenstein, you used to direct the national immunization program at CDC. You are an expert on the vaccines for

children program. In your testimony said you would also like a vacVerDate 11-MAY-2000 10:46 Apr 04, 2005 Jkt 000000 PO 00000 Frm 00125 Fmt 6633 Sfmt 6633 D:\DOCS\99512.TXT HGOVREF1 PsN: HGOVREF1
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cines for adults program. How do you think they would differ? And

do you think this would help us set up a reliable distribution system and expand the number of adults that will be vaccinated?

Dr. ORENSTEIN. What I was proposing in my testimony is a beginning vaccines for adults program. It could be expanded to cover

other groups. The big group that I am concerned about, just like

the vaccines for children program is concerned about, is uninsured

adults. The Institute of Medicine has estimated that somewhere

around 8 million high-risk uninsured adults are in need of influenza vaccination.

I think having a vaccines for adults program that would provide

vaccine to doctor’s offices, potentially other sites that are more convenient, such as grocery stores, goes a long way to reducing the financial challenges.

We made a statement when we covered influenza vaccine by

Medicare that reducing the financial barriers to access was really

critical. For the uninsured, who may very well be in some of these

high-risk groups or contacts of high-risk groups, I think we also

need to reduce that problem.

The other advantage that takes place with the vaccines for children program, and I hope with the vaccines for adults program, it

establishes a public-private partnership. If you bring vaccine to the

table and you give it to a physician, it allows you to work more effectively with that physician at trying to work on their immunization performance. That has been a big boon, I think, in terms of

the vaccines for children program in helping to cement that kind

of relationship.

Mr. WAXMAN. What vaccines should be included?

Dr. ORENSTEIN. I think the initial one I focused on is influenza.

I think certainly others could be added over time. I think the one

you raise is a very important one. Hepatitis B now is primarily a

problem among high-risk adults, many of whom we access in STD

clinics, in HIV clinics, and a variety of other places. We don’t have

the vaccine to provide it. That might be one other group to consider.

Mr. WAXMAN. Thank you very much.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you.

Dr. Boozman, millions of doses of flu vaccine are thrown away

every year at the end of the season. Have States ever considered

extending the annual shot campaign, which usually takes place in

the fall, through January or February to maximize the amount of

Americans vaccinating?

Dr. BOOZMAN. Yes, sir, we have. The problem is—and Dr.

Gerberding alluded to this—is that the demand just falls off. No

matter, it seems like, what we do, we are conditioned almost that

in October and November you get your flu shot, and after that you

don’t—again, no matter what we say. We have tried——

Chairman TOM DAVIS. Maybe at this time of year they think they

have made it.

Dr. BOOZMAN. They think they have made it. And, again, the testimony that you have just heard, this is the time we are the most

worried about is right now. But in the past we have hoped that we

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could get people covered so that they can go into this time of the

year without.

The rock and the hard place this year was we didn’t have vaccine

and so we pushed and got the high risk. I think we have a better

cover of high risk. In Arkansas anyway we have better coverage of

high-risk people than we have ever had. But then you have a little

vaccine left over and you are afraid to open it up too much because

you get a run.

Chairman TOM DAVIS. I guess, Dr. Stroube, you have the same

problem in Virginia—that there is just little interest by private

providers in placing an order after our fourth allocation?

Dr. STROUBE. Yes. And they are scared that they are going to get

stuck with the vaccine and people aren’t wanting it any more. I

know my wife hasn’t even gotten a vaccine. I haven’t been able to

talk her into getting one and she is at high risk, and she has deferred, even though she shouldn’t have. I am going to have to take

a dose home and shoot her, myself.

Chairman TOM DAVIS. I am not going to touch that one, but good

luck. If you need a place to stay, you know where I am.

Dr. STROUBE. She is from Fairfax County, too.

Chairman TOM DAVIS. Exactly.

Well, let me ask you also, Dr. Stroube, we have had problems—

and also Dr. Wasserman—Dr. Wasserman talked about confusion

of patients living in the different regions, that we really weren’t

very regionally coordinated at this point. Is there anything we can

do to try to get better regionally coordinated? A lot of Virginia patients have doctors in Maryland and vice versa. Anything we can

do on a regional basis? And I will ask Dr. Wasserman the same

thing.

Dr. STROUBE. What we tried to do was go by what the ACIP and

CDC were saying so it would be a uniform message that we would

match up with the country. I was under pressure from different

areas and different situations to do different things, and I resisted

that. I think the more all the States follow the national guidelines,

the better off you are.

Now, some of the issues had this with the regulatory part. In

Virginia we didn’t have a regulation that said that you had to give

it only to high risk. We did it only by public information and getting information out to the doctors, and other places went ahead

and made it actually a violation of the rules and regulations if you

gave it to people outside. So there is probably some need there for

uniformity.

Chairman TOM DAVIS. OK. Dr. Wasserman, have you got any

thoughts on that?

Dr. WASSERMAN. Well, there has to be some standardized policy.

We had some jurisdictions that were assigning monetary penalties

to physicians if they gave it to the wrong patients, and they had

a surplus of vaccine, and therefore they couldn’t use it for fear of

being fined.

Chairman TOM DAVIS. That is what happens when the government gets involved legislatively. You lose your flexibility, I think.

You can get the wall of unintended consequences. But you have a

lot of Virginia patients at MFA and a lot of Maryland patients that

come down.

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Dr. WASSERMAN. That is correct. Is it fair for only Virginia patients that come to us to be able to get it and not the Virginia patients that stay in Virginia? It just seems to me that we are so

closely knit here that there has to be some way to coordinate.

Chairman TOM DAVIS. Is there a consensus this has been a fairly

mild year by flu standards across the country?

Dr. WASSERMAN. Up to now, but if you look at the recent papers,

look at the recent reports, CNN just reported yesterday the Governor of Maryland has asked the public to stop calling 9–1–1 because of the overwhelming calls because of flu. I mean, we are just

starting to see a greater peak now than we have ever seen, so this

may turn out to be mild and it may not. I think the next couple

of weeks will tell.

Dr. STROUBE. It is similar in Virginia. We are beginning. This

week we went to widespread flu for the first time this year.

Chairman TOM DAVIS. So this is a good time to get your shot,

actually.

Dr. STROUBE. Sure.

Chairman TOM DAVIS. Dr. Orenstein, you state in your written

testimony that you believe CDC did its best under the circumstances earlier this year, but you still recommend establishing

an education effort at the national, the State, and the local levels.

How would the educational effort you envision add to the work of

CDC to inform the public?

Dr. ORENSTEIN. I think what it would do is develop a cadre of

people, a cadre of materials, and an ability on a year-round basis

to continue to educate.

One of the great hurdles is dealing with the medical care community. The coverage rates in the medical community have only been

about 43 percent, I think was the last data that I saw from CDC.

A few years ago it was only 38 percent. We have some real re-education to do, and that I think is where the grant program will be

helpful, because these are the kinds of people who would go into

hospitals and give grand rounds to work with Dr. Wasserman and

others in terms of trying to champion it among his staff. One of the

most effective interventions that has occurred was in Rochester a

number of years ago where staff from the health department went

in and reviewed doctors’ records and set up a target population for

them to reach in vaccination. That significantly improved their coverage.

So the educational effort is not simply a media campaign, although that is probably an important part of it. It involves a whole

series of kinds of education efforts.

Chairman TOM DAVIS. Thank you.

Ms. Watson.

Ms. WATSON. I am sorry that I wasn’t here for panel one, but

with panel two what are we doing to be able to plan for future flu

seasons? And are we doing enough here in our country to manufacture the flu vaccine so we don’t have to depend on foreign suppliers? Anyone on the panel who feels they can tackle that?

Dr. ORENSTEIN. I can talk about the manufacturing issue and

perhaps one of the health officers will talk about the other.

Ms. WATSON. OK.

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Dr. ORENSTEIN. I think at the moment it is going to be very difficult to try and get a U.S. manufacturing base back.

Ms. WATSON. Explain.

Dr. ORENSTEIN. What we have had is we had in 2000 three U.S.

manufacturers and one foreign manufacturer. Two dropped out of

the market. I think to try and bring the two that dropped out back

might be very difficult at this point because you would have to redo

their plants, you would have to give substantial investments. There

is some hope with some foreign manufacturers coming into the U.S.

market. GlaxoSmithKline has a plant in Germany, and they have

announced interest in coming into the U.S. market. I.D. Biomedical

has a plant in Canada. They are interested in coming in.

I think if we provide incentives there may be more manufacturers that come in, but we have to provide substantial incentives. I

think the 188 million person market, which is what potentially is

there, if it could begin to move forward in that way, more companies would come in. I think we are getting the interest from the

two European manufacturers—Canadian and European manufacturer—purely because they see a much bigger market here.

Ms. WATSON. Anyone from CDC at the table? Well, maybe I can

ask this of the chair. Why is it that we could not put in CDC’s

budget a line that would start to promote the manufacturing here

in this country? You said we had four and two have dropped out.

Why couldn’t we pump up American manufactures of the flu vaccine? Do you have any idea?

Chairman TOM DAVIS. I can just say on the CDC side, CDC’s

budget has gone up nine-fold, I think, nine times since 2001, but

it is really the FDA that would be responsible for that, and I think

that as a result of this year no one had planned on the Chiron

plant being closed down, which supplied about 45 percent of what

was going on, and now we are looking for other folks. But it is a

risky business, as you know. You produce vaccines, and you may

end up producing stuff that can’t be sold. It is not a high margin

material. Once you produce it, you don’t make a lot on each dose

the way you do with a prescription drug or something like that.

Ms. WATSON. Let me ask this: can the vaccines that are in the

surplus supply now be held over to another season?

Chairman TOM DAVIS. You can hold them over, but they won’t

be any good because you get a different strand every year. That is

the difficulty with this.

Ms. WATSON. It seems to me some of the big pharmaceutical

manufacturers here in this country would maybe take this on as

one of their divisions, so if it is a slow year 1 year and they lose

money it can be compensated for in another division. But I think

we need to be able to monitor the development of the vaccine right

here in this country because it was a supply that we were counting

on Chiron that had some problems. I don’t know how we anticipate

this, but I think that if we had it, if we had the supply—and I

would say at least if it is not the majority supply, a supplemental

supply—constantly being developed here by our manufacturers we

would be able to guard against the foreign manufacturers who run

into problems in their research labs. This is something that I am

just throwing out.

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Chairman TOM DAVIS. Right. FDA in their testimony earlier

talked about how they are trying to find more product and make

sure that we get more product coming in. A lot of these facilities

are done overseas because it is, frankly, cheaper to produce them

that way. Why would you overpay for something if you can produce

it and keep it as clean? And for the most part there is no evidence

that vaccines that are produced wholly or partly abroad have any

less power or potency.

Ms. WATSON. My concern in this particular era is always going

on the cheap, and I have that concern in other products that are

produced abroad and we consume here in this country. We have

very little control over the process of production. So I want to start

the debate of not always looking for the cheapest way out. I think

this flu vaccine problem heightens our motivation to start looking

at is cheaper always better and should we not invest in quality

when it comes to a life-saving or a life-sustaining product like a flu

vaccine?

I just throw that out, Mr. Chair, as food for thought and as continuing debate.

Chairman TOM DAVIS. Nothing like a crisis to get everybody to

put their thinking caps on and see what can happen on this.

Ms. WATSON. Exactly.

Chairman TOM DAVIS. I think you gentlemen have worked under

extraordinary circumstances. You said, if anything, we have done

a better job than we thought. We found supply that we didn’t think

we would find. Now the people that were demanding flu shots, we

can’t get people to take them. There is still time to tell. In a couple

months we could still hit the peak.

Let me just ask this question. Can you tell from what is happening in other parts of the world how virile and tough the flu shot

could be by what is happening in other countries, or are they just

so different when it comes up here there is no way of telling? Do

you know what I am saying?

Dr. ORENSTEIN. Last year with the Fujian strain we were hearing about outbreaks in other parts of the world that were moderate

to severe, and so that gave us a picture that we were probably

going to get a moderate to severe year in the United States, which

we wound up having.

There is some potential that what goes on there will have a similar impact here, but it is still not 100 percent predictability. As Dr.

Wasserman said, I think this still could turn out to be a problematic year. We just don’t know yet. It is still fairly early. Most flu

seasons peak in February. In fact, we have had flu seasons peak

in March, April, and even May, so that has potential to occur, but

it is difficult to predict.

What is really important in looking at what happens overseas is

to look at which strains are emerging so that we can determine

what ought to go in the vaccine. Last year we were behind on that,

and so we had—although the vaccine was effective, we had a mismatch.

Chairman TOM DAVIS. Right. I guess if anything, if I have any

quarrel with today’s testimony it wasn’t from this panel. It was the

first panel, where they had the States that had the most significant

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infestation of flu as red States. But you would have liked that, Ms.

Watson.

I think everybody has closed ranks pretty much. This has been

and hopefully stays a mild year so that the damage won’t be too

great. We can use this as a learning experience and maybe avert

something worse at a later time.

Thank you all for being here. I think it has been very, very helpful to us.

In closing I want to remind everyone of the free flu shot clinic

today in the Rayburn Building, 2247, from 1 to 3 p.m., and it is

open to the public. You don’t have to be a Capitol Hill employee.

You don’t have to be a Member of Congress. Basically, the last time

George Washington University Medical School was giving away flu

shot they couldn’t give enough away at the subway station at

Foggy Bottom. So it is open to the public today in Rayburn 2247

from 1 to 3 p.m.

Thank you. I again want to thank the witnesses for their testimony. I want to thank the committee staff that worked on this

hearing.

I ask unanimous consent that the statement of Mark Mlotek of

Henry Schein, Inc. be included in the hearing record. Hearing no

objection, it is so ordered.

This hearing is now adjourned. Thank you.

[Whereupon, at 12:35 p.m., the committee was adjourned.]

[The prepared statement of Hon. Candice S. Miller and additional information submitted for the hearing record follows:]

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