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79–620 2014

INFLUENZA: PERSPECTIVE ON CURRENT SEASON 

AND UPDATE ON PREPAREDNESS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

FEBRUARY 13, 2013 

Serial No. 113–3 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

GREGG HARPER, Mississippi 

PETE OLSON, Texas 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

BRUCE L. BRALEY, Iowa 

BEN RAY LUJAN, New Mexico 

EDWARD J. MARKEY, Massachusetts 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

PETER WELCH, Vermont 

PAUL TONKO, New York 

GENE GREEN, Texas 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

opening statement ................................................................................................ 4 

Hon. Fred Upton, a Representative in Congress from the state of Michigan, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 7 

WITNESSES

Thomas Frieden, M.D., M.P.H., Director, Centers for Disease Control and 

Prevention, Department of Health and Human Services ................................. 8 

Prepared statement .......................................................................................... 11 

Jesse L. Goodman, M.D., M.P.H., Chief Scientist, Food and Drug Administration; Department of Health and Human Services ............................................. 23 

Prepared statement .......................................................................................... 26 

Marcia Crosse, Ph.D., Director, Health Care, Government Accountability Office ......................................................................................................................... 42 

Prepared statement .......................................................................................... 44 

(1) 

INFLUENZA: PERSPECTIVE ON CURRENT 

SEASON AND UPDATE ON PREPAREDNESS 

WEDNESDAY, FEBRUARY 13, 2013 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:05 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Tim Murphy 

(chairman of the subcommittee) presiding. 

Members present: Representatives Murphy, Burgess, Gingrey, 

Harper, Olson, Griffith, Johnson, Ellmers, Barton, Upton (ex officio), DeGette, Lujan, Butterfield, Castor, Tonko, and Green. 

Staff present: Gary Andres, Staff Director; Matt Bravo, Professional Staff Member; Karen Christian, Chief Counsel, Oversight; 

Sean Hayes, Counsel, Oversight and Investigations; Sean Hayes, 

Counsel, Oversight and Investigations; Katie Novaria, Legislative 

Clerk; Andrew Powaleny, Deputy Press Secretary; Krista 

Rosenthall, Counsel to Chairman Emeritus; Alan Slobodin, Deputy 

Chief Counsel, Oversight; John Stone, Counsel, Oversight; Brian 

Cohen, Democratic Staff Director, Oversight and Investigations, 

and Senior Policy Advisor; Kiren Gopal, Counsel; Elizabeth Letter, 

Democratic Assistant Press Secretary; Anne Morris Reid, Democratic Professional Staff Member; and Stephen Salsbury, Democratic Special Assistant. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Good morning, everyone. 

Today we convene the first hearing of the Subcommittee on Oversight and Investigations in the 113th Congress. I would like to welcome back the members who served here in the 112th and welcome 

our new members joining us for 113th. I want to particularly welcome my colleague and my friend, the ranking member, Dianna 

DeGette of Colorado. I am looking forward to working with you and 

your team here. And this is the first of many hearings and issues 

that we will be dealing with in an organized, bipartisan way, and 

I appreciate the witnesses for coming here today. 

Today we are here to examine the current flu season and discuss 

the lessons that will help us prepare for seasonal influenza and 

pandemics in the future. This committee has investigated into response efforts during previous sessions, last during the H1N1 panVerDate Nov 24 2008 12:06 Jul 29, 2014 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-3 CHRIS
2 

demic in 2009, and oversight of the agencies involved will remain 

a priority going forward. 

I welcome our distinguished witnesses whose agencies play key 

roles in the federal government’s response to influenza. Dr. Thomas 

Frieden, Director of the Centers for Disease Control and Prevention, welcome here today. Dr. Jesse Goodman, Chief Scientist at 

the Food and Drug Administration, welcome here, Doctor. And I 

also thank Marcia Crosse, Director of the Health Care Division at 

the Government Accountability Office. Welcome here as well, Doctor. The GAO has done a number of reports analyzing federal response to seasonal and pandemic outbreaks. 

Well, this year’s flu season came a little earlier than expected 

and it looks as though it will have been unfortunately worse than 

average. This is particularly true in my home of southwestern 

Pennsylvania, which has the highest percentage of seniors in the 

country outside of Florida. In the Pittsburgh region, for one, this 

year’s flu season has been labeled a nightmare at local nursing 

homes that have taken to restricting visitors and quarantining sick 

patients. For seniors in southwestern Pennsylvania and across the 

country, hospitalization rates and deaths have increased sharply. 

And sadly, this season has also taken its toll on the most vulnerable. Through February 2, there have been 59 pediatric deaths. 

Today, I hope to hear how the CDC, FDA, and the vaccine manufacturers are working together through development of new medications, better surveillance to prevent shortages, and increased vaccination to protect the public from deadly flu viruses. Remember, 

all of us should consider vaccination to not only protect ourselves 

from getting sick, but also our children, grandparents, coworkers, 

and neighbors. The CDC recommends annual vaccinations for all 

persons aged 6 months and older, yet less than 50 percent of Americans actually get immunized. Today, I hope to learn what the biggest barriers are to people getting vaccinated and how can we remove them. 

Each year a new vaccine is produced and administered to protect 

against the strains expected to be most prevalent that year. Because of the increased activity this season, many have wondered 

about the process that creates this seasonal vaccine and whether 

it can be improved. Questions have also been raised about vaccine 

effectiveness. We have heard from government representatives that 

this year’s vaccine has an effectiveness rate of 62 percent, meaning 

that someone who is vaccinated is 62 percent less likely to see a 

doctor for the flu than someone who hasn’t been vaccinated. To 

some this might seem low, but we have heard that this is actually 

within the range of what is expected. How can we improve upon 

that and what efforts are currently underway in the government 

and the private sector to ensure that we do? 

This year, we have also heard reports of spot shortages of vaccine 

and certain antiviral treatments. Yet we know that, overall, vaccine and antiviral supply will still exceed demand. What role did 

the federal government play, along with its public health partners 

at the State and local level, in responding to these supply issues 

and what can we learn from these efforts going forward? 

Finally, I wish to again thank the ranking member of the Committee, Ms. DeGette. This hearing has been a bipartisan effort, and 

3 

the ranking member and I have been working together on a number of issues. I thank her for her support on this and other issues 

as we move forward. As well, I would also like to thank the witnesses, as I said before, and I had time to meet with representatives from the CDC, and staff also reports to me that all of your 

agencies have been more than helpful in addressing their concerns, 

so thank you in preparation for these complex issues. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Today we convene the first hearing of the Subcommittee on Oversight and Investigations in the 113th Congress. I’d like to welcome back the members who served 

here in the 112th and welcome our new members joining us for 113th. 

Today we’re here to examine the current flu season and discuss the lessons that 

will help us prepare for seasonal influenza and pandemics in the future. This committee has investigated into response efforts during previous sessions—last during 

the H1N1 pandemic in 2009—and oversight of the agencies involved will remain a 

priority going forward. 

I welcome our distinguished witnesses whose agencies play key roles in the federal government’s response to influenza: Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention, and Dr. Jesse Goodman, Chief Scientist at 

the Food and Drug Administration. I also thank Marcia Crosse, Director of the 

Health Care Division at the Government Accountability Office, for being here. The 

GAO has done a number of reports analyzing federal response to seasonal and pandemic outbreaks. 

This year’s flu season came a little earlier than expected and it looks as though 

it will have been worse than average. This is particularly true in Southwestern 

Pennsylvania, which has the highest percentage of seniors in the country outside 

of Florida. In the Pittsburgh region, this year’s flu season has been labeled a ‘‘nightmare’’ at local nursing homes that have taken to restricting visitors and quarantining sick patients. For seniors in Southwestern Pennsylvania and across the country, hospitalization rates and deaths have increased sharply. 

Sadly, this season has also taken its toll on the most vulnerable. Through February 2, there have been 59 pediatric deaths. 

Today, I hope to hear how the CDC, FDA, and vaccine manufacturers are working 

together—through development of new medications, better surveillance to prevent 

shortages, and increased vaccination—to protect the public from deadly flu viruses. 

Remember, all of us, should consider vaccination to not only protect ourselves 

from getting sick, but also our children, grandparents, co-workers, and neighbors. 

The CDC recommends annual vaccinations for all persons aged 6 months and older, 

yet less than 50 percent of Americans actually get immunized. Today, I hope to 

learn what the biggest barriers are to people getting vaccinated and how can we 

remove them. 

Each year a new vaccine is produced and administered to protect against the 

strains expected to be most prevalent that year. Because of the increased activity 

this season, many have wondered about the process that creates this seasonal vaccine and whether it can be improved. 

Questions have also been raised about vaccine effectiveness. We have heard from 

government representatives that this year’s vaccine has an effectiveness rate of 62 

percent—meaning that someone who is vaccinated is 62 percent less likely to see 

a doctor for the flu than someone who hasn’t been vaccinated. To some this might 

seem low, but we have heard that this is actually within the range of what is expected. How can we improve upon that and what efforts are currently underway in 

the government and the private sector to ensure that we do? 

This year, we have also heard reports of spot shortages of vaccine and certain 

antiviral treatments. Yet, we know that, overall, vaccine and antiviral supply will 

still exceed demand. What role did the federal government play, along with its public health partners at the state and local level, in responding to these supply issues 

and what can we learn from these efforts going forward? 

Finally, I wish to thank the Ranking Member of the Committee, Ms. DeGette. 

This hearing has been a bipartisan effort and the ranking member and I have been 

working together on a number of issues. I thank her for her support. As well, I 

would also like to thank the witnesses: I have had time to meet with representatives 

from the CDC, and staff also reports to me that all of your agencies have been more 

than helpful in addressing these complex issues. 

4 

# # # 

Mr. MURPHY. With that, I will now recognize Ranking Member 

Ms. DeGette for her opening statement for 5 minutes. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman, and welcome, Mr. Chairman. We are delighted to have you. And the chairman is correct. We have been working quite closely together ever 

since his appointment on issues that are facing this committee, and 

given the Energy and Commerce’s broad jurisdiction, really, the 

world is our jurisdiction on this subcommittee. Mr. Dingell and I 

think even Mr. Barton would agree, this is probably one of the 

most venerable and important committees in the U.S. House of 

Representatives, and I look forward to working very hard with you, 

Mr. Chairman, and the rest of the committee to making sure that 

we have very thorough and important investigative hearings. 

Flu preparedness is one of those issues. This committee has had 

a number of hearings over the years on preparedness, not just for 

the next flu season but also in the event, which we hope will never 

happen, of a pandemic, and I am glad that you have scheduled this 

first oversight hearing on this issue because it is one that the committee has had concern about for many years. According to the 

CDC, this was a bad flu season. The worst of it is now nearing its 

end, and fortunately, this flu season did not reach pandemic proportions. 

If you can find good news in this flu season, it has been a good 

demonstration of the public health system operating as it should. 

The FDA worked closely with manufacturers to ensure adequate 

vaccine supply, and the CDC collaborated with the States in its 

surveillance and tracking efforts. When the season peaked in January, CDC got the word out and many people who had delayed were 

still able to get vaccinated. Now, while we saw spot shortages of 

vaccine and antiviral drugs in certain areas of the country, unlike 

previous seasons, we didn’t have any serious shortages. But I must 

say, the threat of influenza is one that we cannot underestimate, 

given its potential impact on the Nation and the world’s public 

health, security and economy. 

Vaccination rates are one area in particular where we can make 

significant progress. The latest data from November shows that 

only 36.5 percent above those who are 6 months old got vaccinated. 

The most important step in protecting against the flu is to get a 

flu shot, so I am interested in hearing from the witnesses how we 

can improve our vaccination rates. The Affordable Care Act is going 

to be one way to improve flu prevention and care. Because of this 

Act, 54 million Americans can now receive a free flu shot through 

their private health care plan, and next year CBO estimates that 

14 million Americans who would otherwise be uninsured will instead have health care coverage. That number will increase to 27 

million by 2017. 

Each flu season is a practice run for how well we would do in 

a pandemic. After the H1N1 pandemic in 2009, it became really apVerDate Nov 24 2008 12:06 Jul 29, 2014 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-3 CHRIS
5 

parent that we would need more vaccine alternatives to deal with 

potential shortages. We need to be able to make vaccines faster and 

to make them more effective against the flu, and that is why I am 

excited to see that the FDA has approved numerous alternative 

vaccine technologies that hold the potential for faster startup of the 

manufacturing process in the event of a pandemic. These new approvals provide alternatives to our current decades-old use of timeintensive egg-based technology to produce vaccines. In the event of 

a pandemic, egg-based production would be too slow to meet 

heightened demand for vaccine with the potential loss of millions 

of lives around the world. In November, the FDA approved the first 

seasonal flu vaccine using cell-based technology. With cell-based 

technology, the virus strains are grown in animal cells instead of 

eggs. This is a huge step forward in expanding vaccine supply. And 

last February, FDA approved FluMist, the first vaccine to protect 

against four rather than three strains of the flu. By improving protection against the flu, these new quadrivalent vaccines will protect 

millions of Americans. 

So Mr. Chairman, these are great examples of laudable government investment, but beginning in 2005, HHS recognized a gap in 

the public health system and subsequently made investments to 

deal with this, and that is truly a government success story. While 

I am encouraged by the fact that these alternative technologies 

have come to fruition, we have a long way to go. We must remain 

vigilant against the risks of a flu pandemic. Pandemics are infrequent, highly unpredictable and come on suddenly, and so we have 

to have constant vigilance. I appreciate our witnesses coming here 

today. I am eager to hear what they have to say about the progress 

that we have made and the state of vaccine innovations and improvements because, frankly, we must do whatever we can to make 

sure that we have better flu preparedness. 

Thank you, and I yield back. 

Mr. MURPHY. I appreciate the gentlelady’s comments, and I now 

recognize the chairman of the full committee, the gentleman from 

Michigan, Mr. Upton. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman, and welcome you to 

your first chairmanship of the Oversight Subcommittee here in the 

big House. I want to welcome you to that. 

I had the opportunity, as you know, to chair this subcommittee 

a number of years ago, so I know firsthand the important work 

that can be done from that post. Oversight has a number of very, 

very important purposes, but one of the most significant is ensuring that our federal programs are working properly and efficiently, 

especially in matters relating to public health and safety. It is often 

a bipartisan role, and I appreciate the role that your ranking member has well, Ms. DeGette. 

With regard to the flu, this committee examined the response to 

the H1N1 pandemic 3 years ago and had probed influenza vaccine 

shortages in 2004. We have a tradition of doing strong oversight in 

this area and we are well aware that this has been a very tough 

flu season and we have been especially troubled by this season’s 

6 

particularly harmful impact on the elderly and some kids too. We 

have also heard reports of spot shortages, especially in hard hit 

areas, and questions about the effectiveness of this year’s vaccine. 

The good news is that while outbreaks appear to be on the decline overall, parts of the country are experiencing increases, so it 

remains important to hear the most up-to-date facts and figures on 

the current season and examine what the government is doing to 

prepare for future seasons as well as pandemics. 

Personally, some of what I have heard from my neighbors in 

Michigan about this year’s flu is similar to what we have seen in 

the national press. Lakeland Healthcare, which provides care in 

my hometown, reported to my office that while they did not have 

a shortage of vaccine, they had to help supplement their supplies 

with other health care providers. I am pleased whenever I hear 

that providers are communicating with each other to address these 

issues at the local level, but remain concerned about whether there 

is enough supplies available in the next outbreak. 

While we are still evaluating the responses to the flu season, we 

need to be prepared for the possibility of a worse outbreak or even 

a pandemic in the future. I am excited about the recent innovations 

in vaccine technology and the role they play, and I welcome our 

witnesses and I yield the balance of my time to Dr. Burgess. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

I would like to welcome you to your first hearing as Chairman of the Oversight 

and Investigations Subcommittee. 

I had the opportunity to chair this subcommittee a number of years ago, so I know 

firsthand the important work that can be done from this post. Oversight has a number of important purposes, but one of the most significant is ensuring our federal 

programs are working properly and efficiently, especially in matters relating to the 

public’s health and safety. 

With regard to influenza, this committee examined the response to the H1N1 pandemic three years ago and probed influenza vaccine shortages in 2004. We have a 

tradition of doing strong oversight in this area. We are all aware that this has been 

a tough flu season and we have been especially troubled by this season’s particularly harmful impact on the elderly and some children. We’ve also heard reports of 

spot shortages, especially in hard hit areas, and questions about the effectiveness 

of this year’s vaccine. The good news is that while outbreaks appear to be on decline 

overall, parts of the country are experiencing increases, so it remains important to 

hear the most up-to-date facts and figures on the current season and examine what 

the government is doing to prepare for future seasons as well as pandemics. 

Personally, some of what I have heard from my neighbors in Michigan about this 

year’s flu is similar to what we have seen in the national press. Lakeland 

Healthcare, which provides care in my district, reported to my office that while they 

did not have a shortage of vaccine, they had to help supplement the supplies of 

other health care providers. I’m pleased whenever I hear that providers are communicating with each other to address these issues at the local level, but remain concerned about whether there will be enough supplies available in the next outbreak. 

While we are still evaluating the response to this flu season, we need to be prepared for the possibility of a worse outbreak or even a pandemic in the future. I 

am excited to hear about recent innovations in vaccine technology and the role they 

will play in these efforts. I welcome Dr. Frieden of the CDC, Dr. Goodman of FDA, 

and Marcia Crosse of the GAO, and look forward to their testimony. 

Thank you again to the witnesses for joining us today, and again congratulations 

and good luck to our new Oversight and Investigations Chairman. 

7 

# # # 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the chairman for the recognition. I thank 

our witnesses for being here today. We have heard already that 

this flu season was one of the worst that the United States has experienced in several years. It began early and was particularly 

harsh. It is most often thought to affect infants and the elderly, but 

as we saw many times in this outbreak, all age groups are susceptible to infection and the implications of a flu infection. 

Talking about the statistics is one thing but I will tell you from 

firsthand experience, when you lose a vibrant 17 year old, a member of the golf team from one of your high schools in your hometown over the Christmas holidays, it has a profound effect on the 

entire community. Max Schwolert was that individual from Flower 

Mound, Texas. He actually became ill while on holiday with his 

family up in Wisconsin and Minnesota but ultimately succumbed. 

He became ill at Christmas and succumbed by December 29 to a 

staph infection that was superimposed on his influenza. His dad is 

a youth minister at Faith Lutheran Church and obviously a very 

high-visibility family within the community and certainly took its 

toll on members of the community. They have done good work since 

that time in encouraging vaccination, and as we have already 

heard this morning, the vaccination was available this year, was 

perhaps a little bit better, so thank you for your efforts on that to 

develop a better vaccine. It doesn’t protect everyone in every instance but it certainly improves the odds, and as we saw in this 

unfortunate case, being young and healthy does not always confer 

the immunity that we think it should. 

We have got a lot to learn yet about the future of vaccination, 

and while I recall the enthusiasm of the cell-based cultures in 2005 

and the enthusiasm for finding a vaccine that didn’t have to be 

changed every year, we are now 7 years, 8 years later and I do 

have some questions about when those things will be coming online. 

The flu season is almost done, not quite done. The overall effectiveness of the vaccine this year was good to better than we might 

have expected and preparedness was something that certainly is 

laudable, so I am grateful to all our witnesses for being here today. 

We do have a big task ahead of us and we need to keep vigilant, 

and I will yield back. 

Mr. MURPHY. I thank the gentleman from Texas. 

I would now like to introduce the witnesses testifying today. 

First, Dr. Thomas Frieden, the Director of the Center for Disease 

Control and Prevention. Dr. Frieden was appointed in 2009 and 

also serves as the Administrator for the Agency of Toxic Substances and Disease Registry. Dr. Jesse Goodman is the Chief Scientist for the Food and Drug Administration. Dr. Goodman has 

served in that position since 2009 and has previously testified before the subcommittee on influenza preparedness. Thank you. And 

Marcia Crosse. Dr. Marcia Crosse is Director of the Government 

Accountability Office Health Care Team. Dr. Crosse is responsible 

8 

for overseeing GAO evaluations in the area of biomedical research, 

bioterrorism, disease surveillance and other health issues. 

You are all aware that the committee is holding an investigative 

hearing, and when doing so has the practice of taking testimony 

under oath. Do you have any objections to testifying under oath, 

any of you? Seeing no objections, the Chair then advises you that 

under the rules of the House and the rules of the committee, you 

are entitled to be advised by counsel. Do you desire to be advised 

by counsel during your testimony today? The panel answers no. As 

chairman, I say that case, please rise and raise your right hand 

and I will swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. You are now under oath and subject to the penalties set forth in Title XVIII, section 1001 of the United States 

Code. You may now give a 5-minute summary of your written 

statement. So we will start off with Dr. Frieden. Dr. Frieden, you 

are recognized for 5 minutes. 

TESTIMONY OF THOMAS FRIEDEN, M.D., M.P.H., DIRECTOR, 

CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; JESSE L. 

GOODMAN, M.D., M.P.H., CHIEF SCIENTIST, FOOD AND DRUG 

ADMINISTRATION; DEPARTMENT OF HEALTH AND HUMAN 

SERVICES; AND MARCIA CROSSE, PH.D., DIRECTOR, HEALTH 

CARE, GOVERNMENT ACCOUNTABILITY OFFICE 

TESTIMONY OF THOMAS FRIEDEN 

Dr. FRIEDEN. Thank you very much, Mr. Chairman and members 

of the subcommittee. I am Dr. Tom Frieden, Director of the Centers 

for Disease Control and Prevention, and I appreciate this opportunity to share with you the latest information about influenza. 

I think there are four basic bottom-line issues here. First, flu is 

a deadly and costly disease. Second, this year’s season has been 

worse than average and particularly severe for the elderly. Third, 

we are making progress applying the best tools, vaccine and treatment that we have, but fourth, we still do need better tools and we 

are making some progress in that area. 

Every year in the United States on average, between 5 and 20 

percent of all Americans get influenza. That results in tens of millions of cases, more than 200,000 hospitalizations, more than $10 

billion in direct medical costs, and over $80 billion in societal costs 

including an estimated $17 million lost work days, many of which 

could be prevented by vaccination. 

Flu seasons are unpredictable and they can be severe. We estimate that in recent decades, between 3,000 and 49,000 people have 

died each year from influenza. The 1918 pandemic killed more than 

50 million people around the world, and of all of the infectious diseases that occur in nature, influenza remains the one that results 

in those of us who work in public health losing the most sleep. 

This year’s flu season began early, and for most of the country 

the 2012–2013 season has already peaked and begun to decline, 

but there are still many cases around the country, and it is likely 

that flu activity will continue for several weeks. 

9 

I would like to just show a series of slides that shows the spread 

of influenza through the country. You can see it emerging in the 

South, Southeast, spreading throughout the country until virtually 

the entire country was seeing relatively high rates. So we have 

seen a relatively hard-hitting flu season this year. The predominant virus is H3N2, which tends to cause more severe illness 

among the elderly, and the next slide shows the hospitalization 

rate among the elderly, and what you can see is that it is about 

twice as high this year as in previous years, and this is for laboratory-confirmed influenza hospitalization. 

Although it is far from perfect, flu vaccination is by far the best 

tool we have to fight the flu. Unfortunately, it is not as effective 

as we would like and is less effective for the elderly, particularly 

the frail elderly. Vaccination of health care workers and children 

not only protects these individuals but also appears to benefit the 

community. Despite some spot shortages late in the season, there 

was a good supply of vaccine this year with about 145 million doses 

and about 40 percent uptake. Individuals who have underlying 

health conditions only had a 42 percent flu vaccination rate, so we 

really need to do better for particularly the higher-risk populations. 

We can all reduce flu by staying home when we have a cough 

and covering coughs and sneezes and, importantly, for people who 

are under 2 or over 65 or have underlying conditions, getting seen 

promptly and treated can reduce the severity of influenza. 

Flu is also a great example of global collaboration. A hundred 

and ten countries track the spread of flu, and we have staff around 

the world who work with countries because if they identify it sooner, it helps us to identify what we should put in the vaccine and 

what we can do to reduce the burden of flu here. We have a unique 

role in monitoring and providing recommendations and guidance 

and supporting State and other partners but we also work very 

closely with other federal agencies including FDA, NIH, and 

BARDA to ensure an adequate and safe supply of vaccine. 

There is a great example of collaboration between federal, State 

and local levels through the 317 and VFC programs and with the 

private sector for manufacturing, distribution, treatment with 

health care systems that protect their patients by increasing health 

care worker vaccination. 

Looking to the future, I think we can see improvements in technology. In manufacturing, some progress is being made. FDA, 

BARDA, NIH and private manufacturers are coming up with new 

products. You could describe these as important and useful tweaks 

but yet no breakthroughs in terms of a better, longer lasting, more 

effective vaccine. One of the tweaks has been a potency assayed to 

speed up the process of producing flu by about a month through 

work of CDC scientists that is now being validated in collaboration 

with the FDA. We have also increasingly been unleashing the 

genomic revolution to come up with faster growing and more effective strains that we provide to the manufacturers. We are also 

looking at the next generation of diagnostics that use the genomic 

revolution again to identify strains more rapidly. 

Flu emphasizes that we are all connected by the air we breathe, 

and the emergence or spread of flu anywhere in the world is a potential risk anywhere else in the world. In conclusion, there is light 

10 

at the end of this year’s flu season tunnel but many are still at 

risk. At this point prompt treatment of those at high risk is key 

to reducing illness and death. We are already tracking flu strains 

in the southern hemisphere as we head toward developing a vaccine for next year’s flu season, and we continue to build on our 

global capacity to find and stop new pandemic threats where and 

when they emerge rather than waiting for them to reach our 

shores. 

Thank you, and I look forward to answering your questions. 

[The prepared statement of Dr. Frieden follows:] 

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Mr. MURPHY. Thank you, Dr. Frieden. 

Dr. Goodman, you are recognized for 5 minutes. 

TESTIMONY OF JESSE GOODMAN 

Dr. GOODMAN. Thank you. Mr. Chairman and members of the 

subcommittee, I am Jesse Goodman, Chief Scientist at the FDA 

and also a practicing infectious disease physician. I appreciate the 

opportunity to be here today and talk about FDA’s role in protecting the public from influenza. 

You know, flu seasons are quite unpredictable, and this year’s 

season is a very telling reminder of how seriously we have to take 

flu, and as Dr. Burgess pointed out, I too have seen or heard of instances where even very healthy young people can be struck down 

by this disease. Some people tend to think what they have is a cold 

or something but most things that are colds are not influenza and 

most influenza can be quite severe and kill even healthy young 

people. 

Our basic message is while this is a major public health problem 

we need to pay attention to, we have also made tremendous 

progress. To meet the threat of flu and other infectious diseases, 

we work very closely with our partners throughout the government 

in what we call the Public Health and Emergency Medical Countermeasures Enterprise, which includes numerous HHS partners as 

well as DOD, the VA, the USDA, etc. and the DHHS Assistant Secretary for Preparedness and Response. 

This year, in response to this flu outbreak, we have expeditiously 

approved and released all available vaccines from six different 

manufacturers, and as Dr. Frieden said, and as reflected in the 

GAO report, this 140 million doses is a dramatic improvement from 

where we were a few years ago. We also helped divert shortages 

of antiviral medicines such as Tamiflu. We authorized the rapid release of 2 million doses in manufacturers’ stockpile. We have also 

worked with the manufacturers and CDC so that pharmacists 

could use capsules to make liquid Tamiflu needed to treat small 

children, and that has been very helpful. 

Unfortunately, every time we have a bad flu season, there is a 

bunch of unscrupulous people who come out of the woodwork with 

fraudulent flu products and try to take advantage of the public. So 

we have heightened our FDA surveillance of these various scams 

including looking at Web sites. We have taken action where needed 

and we have actually put information out to the public about fraudulent flu products that includes red flags they should look for in 

assessing these kinds of claims. 

Now, with respect to vaccines, FDA doesn’t make vaccines, but 

with influenza vaccine, we have a very unique and intimate working relationship with numerous partners to get the job done every 

year. Vaccine preparation is a very intensive, year-round, coordinated response involving working closely with manufacturers on almost a daily basis as well as with our global public health partners, WHO, CDC and others. It has numerous steps. I won’t go 

through here based on time, and manufacturers exhaustively test 

their vaccines and submit results. 

Now, why we are testifying here today, in part, is because of this 

virus. This is a unique virus. It is constantly changing. It is a 

24 

crafty and unpredictable virus. The surface proteins on the virus 

are changing all the time and that helps it evade our immune systems and it also helps it evade our vaccines, which is part of the 

challenge there. Ten years ago, we had only three U.S.-licensed influenza vaccine manufacturers. We initiated significant efforts including a new accelerated approval pathway to increase the diversity and amount of vaccine supply as well as to upgrade manufacturer quality and hopefully do all we can to prevent failures in 

manufacturing. As a result, we now have seven vaccine manufacturers and an approximate doubling of supply. 

In addition, I would say as a result of substantial ASPR, BARDA 

and industry investment and very intense interactions with FDA, 

as you have heard, we have two recent innovative flu vaccine approvals. The first is Flucelvax, made by Novartis, the first U.S.-licensed cell-based flu vaccine. The advantages of the cell-based vaccine include elimination of the need for a large number of fertile 

eggs, which can be a problem if there were an avian flu outbreak, 

better growth of strains that sometimes grow poorly in eggs, and 

faster startup and scale of manufacturing. Also good news is that 

Novartis is planning to manufacture this in their new facility at 

Holly Springs, North Carolina, that was built with a lot of ASPR 

and BARDA support as well and will substantially increase U.S. 

manufacturing capacity. 

The other new vaccine is Flublok, manufactured by Protein 

Sciences, again developed with government support, and it is the 

first influenza vaccine using recombinant DNA technology. This is 

produced using an insect virus grown in insect cells to produce the 

flu virus protein. It can be manufactured just based on the genetic 

sequence of the virus. We don’t need a living virus at all in order 

to produce the vaccine, which can therefore be obtained within 

days instead of weeks. In a time-limited situation like a pandemic, 

this could be very advantageous. 

We have also worked with BARDA to retrofit existing manufacturing facilities to increase their surge capacity. Recently FDA is 

working with BARDA in a collaborative way to provide technical 

assistance in three very exciting recently funded centers called 

Centers for Innovation in Advanced Development and Manufacturing located in Texas, North Carolina, and Maryland. 

You probably have heard about the need for more effective flu 

vaccines, and this is also a high priority for FDA. There are a number of promising approaches under active research and development for this technology. They are not here today but we are hoping to get there. These include efforts to induce a stronger, more 

effective, longer lasting immune response that could protect against 

viruses that change over time. As another strategy, there are efforts going on directing vaccines against recently identified parts of 

the virus’s genes that are conserved among multiple strains. 

Another thing we are doing is trying to improve diagnostics. Accurate diagnostics are incredibly important. They can avoid 

unneeded use of antivirals and antibiotics, and as well, we are trying to facilitate development and use of the antiviral drugs. 

In conclusion, we have come a long way in enhancing our ability 

to prepare for and respond to influenza. We are fully engaged in 

an ongoing, intensive effort to enhance our Nation’s preparedness. 

25 

We are much better prepared. There have been several landmark 

recent approvals and new science is developing that promises a 

bright future. 

I did want to mention that the response to influenza is every single year a remarkable public-private partnership. We are all working together, and I am optimistic that the gains that have been 

made are on track to continue. Thank you very much. 

[The prepared statement of Dr. Goodman follows:] 

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Mr. MURPHY. Thank you, Dr. Goodman. 

Dr. Crosse, you are recognized for 5 minutes. 

TESTIMONY OF MARCIA CROSSE 

Ms. CROSSE. Thank you, Chairman Murphy, Ranking Member 

DeGette and members of the subcommittee. I am pleased to be 

here today as you examine issues related to the current influenza 

season and influenza preparedness. 

As we have already heard, this season there has been early and 

intense influenza activity throughout much of the country with 

some spot shortages of vaccine. My remarks today focus on lessons 

learned from federal responses to prior influenza outbreaks and 

federal investments to strengthen the U.S. vaccine supply. My testimony is based on multiple GAO reports on seasonal and pandemic influenza. Our prior work has identified a number of lessons 

from the response to seasonal vaccine shortages and the 2009 

H1N1 pandemic and actions the government has taken to improve 

the vaccine supply. 

The primary lessons we observed can be grouped into four broad 

interrelated categories: the value of planning, the importance of effective communication, the difficulties in predicting the predominant influenza virus strains that will be circulating in a given season, and the challenge of matching available vaccine supply with 

public demand. 

First, planning is critical to an effective response. For example, 

planning activities conducted prior to the H1N1 pandemic such as 

exercises and interagency meetings built relationships among federal, State and local governments and positioned them to respond 

effectively. This type of planning is especially important in years 

when there are vaccine shortages or when there are specific groups 

for which vaccine must be prioritized. 

Second, clear and consistent communication is key, especially regarding the availability of vaccine. The failure to effectively manage public expectations of vaccine availability can undermine government credibility and contribute to individuals’ failure to seek 

vaccination. This has been a problem in years when vaccine is in 

short supply or is delivered later than anticipated, but it can even 

be a problem in years with no shortage, such as this year, if individuals are uncertain of when or where to obtain vaccine. 

Third, predicting the influenza virus strains that will predominate in a given season and their likely severity is difficult. Because 

the selection of the three viral strains normally included in the vaccine is typically made in February, in some years the vaccine may 

not be well matched to all the strains that are circulating during 

the following winter. A positive development is that FDA recently 

approved two new vaccines that each protect against a total of four 

influenza strains, one more strain than traditional seasonal vaccines. These new vaccines are expected to be available for the next 

influenza season. 

And fourth, matching influenza vaccine supply to demand is 

challenging. Because of the lengthy production cycle, manufacturers make production decisions months in advance of a seasonal outbreak, and vaccine supply orders are generally placed before providers know what the severity of the outbreak will be. ManufacturVerDate Nov 24 2008 12:06 Jul 29, 2014 Jkt 037690 PO 00000 Frm 00048 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-3 CHRIS
43 

ers may be reluctant to produce and providers may be reluctant to 

order vaccine that exceeds their projected demand because if the 

product is not used by the end of the season, it must be destroyed. 

Over the last decade, HHS has taken steps to strengthen the influenza vaccine supply by making investments in the development 

of alternative vaccine production technologies and by enhancing domestic production capacity. Since 2005, HHS has awarded over $1 

billion in contracts to manufacturers to develop new influenza vaccines that rely on cell-based or recombinant technologies, and two 

of these alternative vaccines are expected to be available for the 

next influenza season. 

In summary, over the last decade progress has been made in the 

federal government’s preparation for and response to both seasonal 

and pandemic influenza events. Planning activities have helped 

with response efforts, communication with the public regarding 

where and when to get vaccine has been clearer and more effective, 

and manufacturers have been encouraged to enhance domestic production capacity and develop alternative production technologies. 

Yet the fact remains that when facing a typical influenza season, 

manufacturers must make decisions about how much vaccine to 

produce, providers must determine how much vaccine to order, and 

individuals who may be influenced by a particular season’s perceived severity and media reports must make their own decisions 

about whether, when and where to seek vaccination. These factors 

along with challenges inherent in the vaccine production process 

and influenza seasons that are unpredictable in terms of duration 

and severity can still present barriers to successfully making vaccine available when and where it is needed. 

Mr. Chairman, this concludes my prepared remarks. I would be 

happy to answer any questions that you or other member of the 

subcommittee may have. 

[The prepared statement of Ms. Crosse follows:] 

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Mr. MURPHY. Thank you, Dr. Crosse, and thank you to all the 

panelists here. Every member will have 5 minutes to ask some 

questions. At this point the Chair recognizes himself for 5 minutes. 

Dr. Frieden, the Centers for Disease Control recommends every 

American over the age of 6 months get a vaccine. I believe it is less 

than 50 percent of Americans actually get immunized. First of all, 

what is the optimal percentage that you hope for, for example, the 

herd effect, for people to get immunized? 

Dr. FRIEDEN. We like to see at least 80 percent vaccination rates 

and obviously higher is better. 

Mr. MURPHY. So why aren’t more people getting vaccinated? 

Dr. FRIEDEN. What we find is that the easier you make it for people, the more likely they are to be vaccinated. One encouraging 

trend in recent years is that an increasing proportion of all vaccinations are being given in workplaces and in pharmacies. In fact, 

more than a third of vaccines so far this season have been given 

in either of those settings for adults. We also find that the health 

care system can make a big difference, so things like standing orders or routinely providing it to all people who come into emergency departments, having subspecialists who see patients also recommend vaccination and arrange it, either at a pharmacy or elsewhere, sanding orders, reducing barriers, eliminating cost sharing, 

which is something that is expanding to the private insurance market through some of the provisions of the Affordable Care Act and 

also education. Hearings like this, community outreach, public education all makes a difference. 

What we found this year as an example is in the one group, pregnant women, we have looked very closely at and what we find is 

that if the obstetrician actually provides flu vaccine in the office, 

we have about a 75 percent vaccination rate among pregnant 

women whereas overall it is at about 50 percent. That is actually 

a big increase from previous years. There was a bump during the 

2009–2010 pandemic, and that has been sustained. 

The second group that we have looked at closely is health care 

workers because when someone is vaccinated, they not only protect 

themselves, they protect those who they have contact with, and we 

know that there is some evidence that suggests that low vaccination in health care workers in nursing homes in particular can 

have very severe ramifications. What we find is that pharmacists, 

nurses and doctors have vaccination rates of 80 to 90 percent, so 

quite good, but that allied health workers and people who work in 

nursing homes may be under 50 percent, so we have identified the 

areas where we need to reach out more. The bottom line is, fewer 

barriers, more convenience makes a big difference. 

Mr. MURPHY. I am just curious because you say that about the 

barriers with cost sharing. Have you done any follow-up studies? 

For example, you mentioned a pharmacy or somewhere else might 

provide these vaccines. I mean, I have seen some for free, some for 

extremely lost cost. Have you done any correlational studies to help 

understand that part? 

Dr. FRIEDEN. I am not familiar with whether we have done this 

in influenza. This has been looked at in a variety of programs and 

it is pretty consistent, that cost sharing reduces utilization, but we 

72 

can get back to you to see if that has been looked at in influenza 

specifically. 

Mr. MURPHY. And just a quick myth check. When a pregnant 

woman gets a vaccine, is that any risk to her child? 

Dr. FRIEDEN. No, there is not. We recommended the inactivated 

vaccine for pregnant women rather than the live, attenuated vaccine. 

Mr. MURPHY. Thank you. Now, we know it has been particularly 

hard on seniors, so Dr. Frieden and Dr. Goodman, why has this 

been the case for seniors this year? 

Dr. FRIEDEN. H3, for reasons that we don’t fully understand, 

years that are H3 predominant, and this season is overwhelmingly 

H3 predominant, tend to be more severe among the elderly. There 

are various theories for that but bottom line, is we are not sure 

why. It is something that we see in 2003–2004 as well as 2007– 

2008. Those were our two prior H3-predominant seasons and similarly in those years the disease is more severe among the elderly. 

That is one of the reasons we try to vaccinate around the elderly 

so that we can reduce spread in the population, and we encourage 

prompt treatment because treatment particularly in the first 48 

hours can improve outcomes. 

Mr. MURPHY. Dr. Goodman, let me add a little part to that too. 

Can you speak to any recent innovations in vaccine technology that 

can lead to more effectiveness for seniors? 

Dr. GOODMAN. Well, I think this is a big challenge, and part of 

the challenge is inherently related to the answer to your last question to Dr. Frieden, which is that we don’t respond that well even 

to the virus itself. This is why we get so sick and why so many infections end up doing badly. Part of the problem is that when you 

give the same material that is in the virus in the vaccine, we don’t 

always respond that well to that either. There are a number of approaches being taken to potentially enhance the immune response, 

and most of these are in the research and development stage. Some 

are being supported through HHS and NIH funding. For example, 

if you package the proteins of a virus in a particle that appears or 

the immune system sees as a virus, sometimes called a virus-like 

particle, that can sometimes induce a stronger immune response. 

The use of adjuvants or substances that boost the immune response 

can give a stronger immune response. So these things are all being 

examined and they need thorough examination for safety and effectiveness. 

There are also parts of the virus that have been discovered recently. For example, something called the stalk is part of the protein we immunize against but it is not normally in the vaccine. Yet, 

it seems to be conserved year after year in multiple isolates. Therefore, if we can induce a good immune response against that, it 

would help. 

I want to take one opportunity to add to Tom’s response on your 

comment about pregnancy. 

Mr. MURPHY. If you can do it quickly. I am out of time. 

Dr. GOODMAN. Yes, because I think one of the ways we can increase uptake of vaccines for people is for them to better understand the science. There was recently published a study in Norway 

that showed in 115,000 women who received influenza vaccine, 

73 

their fetal outcomes were, if anything, better than people who 

hadn’t received vaccine. The study showed that a significant reduction in influenza disease was associated with vaccine use. So, the 

science is there to support the safety of the vaccine in pregnant 

women. 

Mr. MURPHY. Thank you. I am out of time. I will now recognize 

Ms. DeGette for 5 minutes. 

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

First of all, to the panel, this is encouraging news and I am glad 

to hear it after the number of hearings we have. Dr. Crosse, you 

talked about a number of advancements that we have made and 

also the challenges that we are facing. I am wondering if you can 

just briefly tell me about intergovernmental cooperation in identifying potential pandemics and communication. Has that also improved? 

Ms. CROSSE. That has improved. CDC’s global surveillance has 

improved significantly in the last decade, and as we know, many 

of these strains emerge somewhere else in the world. In fact, people 

were surprised that the H1N1 emerged in North America. 

Ms. DEGETTE. But has that communication improved? 

Ms. CROSSE. It has improved. Across the board, we are in much 

better shape than we were 10 or 12 years ago. 

Ms. DEGETTE. That is great. 

Ms. CROSSE. There is still room for improvement. 

Ms. DEGETTE. Sure, and what about surge capacity? That was 

the other thing we have always been concerned about. 

Ms. CROSSE. Surge capacity remains a significant challenge. 

Emergency rooms every winter are flooded with patients who are 

sick with, as we saw this winter, influenza, norovirus, other kinds 

of infectious diseases and, you know, that capacity has not significantly changed. 

Ms. DEGETTE. And Dr. Frieden, is this something we are working on? Yes or no. 

Dr. FRIEDEN. Absolutely. 

Ms. DEGETTE. Thanks. If you can supplement and let me know 

what you are doing, that would be great. 

Dr. Goodman, I wanted to ask you, Dr. Crosse had said that 

these new types of vaccines, the non-egg-based ones, are coming 

into production for next season. Is that right? 

Dr. GOODMAN. Well, they have both been licensed and both manufacturers have stated they intend to produce the vaccine. 

Ms. DEGETTE. OK. And what about some of these methods for increasing the effectiveness? Are those also coming online quickly? 

Dr. GOODMAN. There we are talking about that they are in active 

research and development, However, as you know, even for a promising technology now being looked at in research that looks good, 

that will be several years at least. 

Ms. DEGETTE. OK. So that is several years, but the other ones 

are coming online? 

Dr. FRIEDEN. Yes. 

Ms. DEGETTE. Now, what would happen if we had an avian flu 

pandemic or something? Would we be able to make vaccines more 

quickly than we can now? 

74 

Dr. GOODMAN. Well, we are definitely better prepared in a number of ways. 

Ms. DEGETTE. I am sorry. I only have 5 minutes. So would we 

be able to make a large number of vaccines more quickly now with 

these new techniques, say in the next couple of years? 

Dr. GOODMAN. Yes. Between the new techniques and the increased capacity, yes, but we have a way to go. 

Ms. DEGETTE. Yes. So now I want to ask you a question in that 

direction which, as you know, next month we are supposed to have 

this sequester hit, and under the sequester, non-defense discretionary spending is going to be cut across the board by 5.2 percent. 

So I am wondering, maybe Dr. Frieden, Dr. Crosse and Dr. Goodman, if you can talk to me about what this would do for operations 

at the FDA and CDC, both in terms of the research that is going 

on and also in terms of the preparedness. If we put a 5.2 percent 

cut immediately, what would this do to our ability to do all these 

preparations? Why don’t we start with you, Dr. Frieden? 

Dr. FRIEDEN. Well, the threats to our health and influenza are 

not reduced by 5 percent, so if we have fewer resources, we have 

to do everything we can to limit the harm that that would do, and 

we are focusing on efficiencies. We have already eliminated substantial administrative costs, but more than two-thirds of our funding goes out to State and local health departments, and while we 

would try to protect the front lines, there would be no alternative 

but to reduce funding there—— 

Ms. DEGETTE. So you would have to reduce funding in the short 

term but also I would assume you would have to reduce funding 

as you are working towards increasing surge capacity and communication and interoperability and all of that, right? 

Dr. FRIEDEN. With fewer resources, we would have less capacity 

to detect, respond and develop better tools in the future. 

Ms. DEGETTE. What about your agency, Dr. Goodman? 

Dr. GOODMAN. Well, a substantial cut would have effects, and we 

certainly hope we are able to avoid that. It would affect, for example, the work we are doing to try to provide science and highly 

interactive review processes with development of these new technologies. It also affects FDA’s user fees program, so that would potentially have some effects on review process, but we are hoping 

this can be avoided. 

Ms. DEGETTE. And Dr. Crosse? And maybe you can also talk to 

the NIH since we don’t have an NIH person here. 

Ms. CROSSE. Well, I am afraid I don’t know how HHS plans to 

implement any sequester and whether or not they are going to take 

money across the board or from particular pockets. 

Ms. DEGETTE. OK. Thank you. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. I now recognize the vice chairman of 

the committee, Dr. Burgess from Texas. 

Mr. BURGESS. Thank you, Mr. Chairman. 

I actually wasn’t going to pursue this line of questioning but 

since it has already been broached, I mean, any of us who are 

charged with running a small business or a large agency understand that from time to time we are going to have to make adjustments, and part of our role as leaders in whether it be a small 

business, a medical practice or the CDC or the FDA, you have to 

75 

be able to look at those things that you do within your agency or 

your organization and decide how to prioritize, and I just—you 

know, a 5 percent cut, did I ever have to deal with that in my medical practice? You bet I did, and I had to go through every line in 

the budget and decide what is mission critical and what is not. I 

don’t think that you all are any less capable of doing that, and certainly my goal in the past had been to get the Department of 

Health and Human Services in here and talk about this last year. 

There seems to be an unwillingness to do that. But just from where 

I sit, I think if you are not already doing that within your agencies 

and organizations, I would encourage you to do so because this may 

very well be the reality and the question is not will a sequester go 

through but how many will you face over the next several years. 

So I just felt obligated to make that editorial statement. Again, it 

wasn’t part of our hearing agenda today. It is too bad we haven’t 

had anyone from HHS or Office of the Management and Budget 

come in and talk to us about their plans, and I think that certainly 

affects the governance of this committee but it also affects your role 

and your lives on a daily basis. 

Now, it is unfortunate that the National Institute of Health is 

not here because Dr. Goodman, you were asked a question about 

how quickly can you do some of these things, and I just remember 

the experience of 2009 and the H1N1, and probably one of the scariest conference calls I have ever been on was in the middle of the 

NBA playoffs, or I guess it was the NCAA playoffs when these kids 

were coming back from Mexico with this novel influenza, and all 

of the things we had been warned out with the avian flu, H5N1, 

seemed to becoming true very quickly with this new strain. Now, 

it didn’t turn out to be as devastating as that afternoon painted but 

when young populations are predominantly being affected, there 

seems to be the facility of transfer from human to human seemed 

to be well established, and the overwhelming immune response 

from a younger person being very detrimental to their health. I 

mean, these were all things we had been warned by Secretary 

Leavitt in the previous Administration and now they were coming 

true literally before our eyes. And yet you all, CDC, FDA, NIH 

worked together, and by August there were preparations for having 

this vaccination available for schoolteachers when school started 

the next month, and I thought that was an incredible accomplishment. I am old enough to remember the last swine flu epidemic 

when the complications of the vaccination were worse than the illness, so I was gratified that all parts seemed to work together. I 

am sure both of you were there at that time. Are you as good now 

as you were 4 years ago or maybe even a little bit better now? Dr. 

Frieden, we will take you first. 

Dr. FRIEDEN. I think we have continued to make progress. I do 

think a lot of the H1N1 pandemic experience is important to understand and learn from it as the GAO has summarized. You know, 

H1N1 was not a mild pandemic. About 60 million Americans got 

sick, more than a quarter of a million were hospitalized, more than 

12,000 died including more than 1,200 children, and the tragedies 

that you referred to earlier are heartbreaking. So we do everything 

we can to maximize use of existing tools. There were more than 88 

million doses of vaccine administered. We shipped vaccine to more 

76 

than 70,000 sites and more than 300,000 shipments generally the 

day after it was approved for shipping, and we think that both vaccination and treatment prevented around a million cases, roughly 

15,000 hospitalizations, hundreds of deaths and tens of millions of 

dollars of health care costs. So I do think there is a lot that went 

well in that but there is always things that we can do better, and 

coming up with a vaccine that we can develop faster, get to market 

faster, extending our global surveillance. 

So no one expected a pandemic to emerge in North America, and 

we had been focusing in places where pandemics generally emerge, 

in Asia, but we need to continue to develop our surveillance. There 

is so much we don’t know about influenza around the world, what 

the seasonality is, what the predominant strains are, what the burden is, so we are working very closely with global partners around 

the world, and that is a very important part of protecting those 

countries and protecting ourselves, and then finally of strengthening the vaccine production systems. 

Mr. BURGESS. Well, you know, I am about of time, but this committee so often focuses on what didn’t go right. I think from time 

to time we need to focus on what has gone right, and certainly the 

experience with H1N1, and I only look to improvement from that, 

but there were a lot of positives to take away from that experience. 

I will yield back, Mr. Chairman. 

Mr. MURPHY. I thank the gentleman. Next is Mr. Green of Texas. 

You are recognized for 5 minutes. 

Mr. GREEN. I thank our panel and appreciate your patience. I 

talked earlier to Dr. Frieden. I think the flu epidemic that we 

had—and I watched your map, and being in Texas, at least for 

most of the Christmas holidays, I saw it happening there. 

I guess some of the questions that I have for the panel, Dr. 

Frieden, how can public health providers and hospitals and hospitals and patients, what can we do to reduce the burden of the 

surge of the patients in our health care facilities during a bad flu 

season? I know our emergency rooms are stacked up. You know, 

typically you can’t do a whole lot about it except the vaccination, 

which gets into my other question. How can we actually do more 

than we are doing now to increase the percentage of people who are 

getting their flu shot in September instead of waiting until the end 

of December or January? 

Dr. FRIEDEN. Thank you very much. In terms of the surge, we 

have worked very closely with the Assistant Secretary for Preparedness and Response, and we have actually unified two different federally funded programs. One is the preparedness program, the Public Health Emergency Preparedness program, and 

the second is the Hospital Preparedness program. We now have a 

common application, common system, and that makes it much easier for State and localities to use federal dollars to improve their 

ability to address surge capacity. We have also seen some creative 

approaches in different States where nurse call lines have been 

used through private insurers, through HMOs, through private doctors to talk to patients and for the routine patients to address their 

needs over the phone, perhaps prescribe medications for them if 

needed, tell them when they need to come in and when they don’t 

need to come in. 

77 

We also look at what we would do in a surge. It is bad enough 

if an emergency department is getting so many patients in, but if 

we have a very severe pandemic, some of the things that would be 

really problematic is the ability to provide emergency ventilation, 

to breathe for patients who can’t breathe for themselves, so 

through the strategic national stockpile, we have been increasing 

the availability of practical, effective respirators, and in fact, 

BARDA has come up with some new designs that should be on the 

market next year, which are very encouraging, low cost, high quality, easy to roll out, because this would be the lowest common denominator. This would be the bottleneck in an emergency, or one 

of them, is being able to help people breathe for a period of time 

until they get better. 

In terms of increasing vaccination rates, I think what we have 

learned is, make as many options as possible so people can get vaccinated at school, at work, at pharmacies, but within the health 

care system make it is automatic as possible so that all too often 

people do go to the doctor but they don’t get the vaccination. The 

strongest risk factor for not being vaccinated is the doctor didn’t 

offer it or recommend it or provide it, so we want to have automatic 

systems to increase vaccination rates. 

Mr. GREEN. Did the Affordable Care Act help on that in providing vaccinations more readily available? 

Dr. FRIEDEN. One of the components is that for private insurers, 

it requires no copayment for a vaccination. 

Mr. GREEN. For either Dr. Frieden or Dr. Goodman, are we seeing resistance to Tamiflu? 

Dr. FRIEDEN. We have seen virtually no Tamiflu resistance this 

season in the circulating strains. 

Mr. GREEN. Outstanding. And again, the vaccination rate, I know 

making is more available, and I know the controversy over even 

medical facilities saying we are going to require all our staff to 

have the influenza vaccination. In the private sector, I have companies that are doing that for their employees just because it makes 

good business sense. What we are seeing on that? Is there a lot of 

resistance from folks even in the health care sector saying we don’t 

want to take the vaccine? 

Dr. FRIEDEN. I think the biggest lesson is making it easy and accessible. So 80 to 90 percent of pharmacists, doctors and nurses are 

getting vaccinated, but among allied health workers who may not 

be able to get vaccinated readily and in nursing homes which may 

not be doing as good a job as vaccinating, rates are 50 percent or 

lower. 

Mr. GREEN. And in nursing homes, you have immune-challenged 

patients. You have the elderly. It is almost like it would be an incubator for it. 

Dr. FRIEDEN. And nursing homes are particularly important to 

increase vaccination rates because there is some evidence that the 

residents of nursing homes do worse when the staff don’t get vaccinated. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. MURPHY. I thank the gentleman for yielding back. I now 

turn to the gentleman from Georgia, Dr. Gingrey. 

78 

Dr. GINGREY. Mr. Chairman, thank you, and witnesses, I apologize for coming in late, and I may end up asking you questions obviously that have already been asked. Just forgive me for that, and 

maybe if you repeat it, it will stick in all of our brains better anyway. 

Dr. Frieden, I thought I would ask you the first question. According to your Web site, the CDC Web site, and in your written testimony, manufacturers have produced 145 million doses of flu vaccine this season and have distributed roughly 135 million, which is 

almost 2 million more doses than last year. Why then do you think 

this season has been more severe despite the increase in the vaccine compliance? More folks are getting the flu vaccine, and I am 

one. I didn’t get the flu, thank goodness, but a lot of folks did. 

Dr. FRIEDEN. This year’s flu is H3N2, and seasons that are predominant for H3N2, the particular strain of flu, tend to be more 

severe. This year is quite predominant of H3N2. The last two seasons that happened were 2003–2004 and 2007–2008, and in both 

of those years they were severe flu seasons, particularly for the elderly. 

Dr. GINGREY. Were they also H3N2? 

Dr. FRIEDEN. They were. And why H3 is more severe, there are 

some interesting theories but we do not know for certain. We do 

know that our vaccine efficacy, our early season estimate was 

about 60 percent overall. We also know that in previous years, generally the elderly tend to be less protected by the flu vaccine than 

the non-elderly and the frail elderly even less so. We are only at 

around 40 percent overall vaccination rates, so being able to knock 

down influenza by vaccinating lots of people will probably require 

more vaccination than we are seeing but, you know, a reduction of 

60 percent in medically attended flu from vaccination also probably 

means significant reduction in the spread of flu from those people 

who get vaccinated. 

Dr. GINGREY. And also I guess maybe decreased severity of the 

infection, that they do better than had they not had the shot obviously. 

Dr. Goodman, I noticed that there was a lot of discussion about 

the process of cell-based or egg-based growth factor in vaccine production. I remember all that discussion several years ago when we 

had that avian flu outbreak and the great concern there. How close 

are we to developing what you would call a universal flu vaccine? 

Dr. GOODMAN. I think if you had asked me a couple of years ago, 

I would say we really can’t be that optimistic. It’s sort of a holy 

grail. I think there have been some scientific leads in the last 2 or 

3 years that are a little more promising, and if some of these pan 

out, I mentioned a couple of possible technologies—directing the 

vaccine at conserved parts of the virus. It is possible that we could 

at least have some real leads and progress in this direction in the 

next 5 to 10 years but it is not something that is just around the 

horizon. 

The good news is that the science that is out there to understand 

the immune system and understand the virus now is extraordinary, and we are all beginning to work to put that together, but 

we have a way to go. 

Dr. GINGREY. Dr. Goodman, thank you. 

79 

And Dr. Crosse, in your testimony you stated that since 2005 

Health and Human Services had awarded over a billion dollars in 

contracts to six different manufacturers who are developing the 

cell-based technology to enhance our domestic vaccine production 

capacity, and I am sure that that is a good thing. Yet only one of 

those manufacturers, Novartis, has received the FDA approval for 

vaccine production in the 2013–14 season. Is the FDA continuing 

to work with the five other manufacturers to continue its progress 

on switching to a faster and a more economic production model? I 

know I could have asked Dr. Goodman this exact same question 

but if you will? 

Ms. CROSSE. We understand that of the six, there are—in addition to the one vaccine that has just been licensed, there are two 

more that are in later stages of clinical trials and that may be able 

to complete the process and be licensed in the next year or two. I 

can’t really predict how quickly they may come along. The other 

three, they have ceased activities. I believe two of those contracts 

have already been canceled. 

Dr. GINGREY. Who are the names, Dr. Crosse or Dr. Goodman, 

if you know, that are working on this cell-based—— 

Mr. MURPHY. Is that something you can get back to the committee? 

Dr. GOODMAN. What I would say is, those who are actively working on new influenza vaccine technologies, yes, we are working in 

a highly interactive way with them and with BARDA and HHS to 

help make that happen. The intent—some of these went through 

a process where in essence the most promising technologies and the 

things that have proceeded the fastest are the ones that are continuing to be funded, and others have dropped out of the process. 

Dr. GINGREY. Thank you all, and Dr. Crosse. I think the chairman is gonging me. He has the shepherd’s hook out. Mr. Chairman, thank you for your patience. I know I went over a bit. I yield 

back. 

Ms. CROSSE. There is a table in my statement that has it. 

Mr. MURPHY. That is part of the record. Thank you, Dr. Gingrey. 

The Chair now recognizes the gentleman from New Mexico, and 

welcome to the committee, Mr. Lujan. 

Mr. LUJAN. Mr. Chairman, thank you very much. I really appreciate that. And to the witnesses, thank you for your testimony and 

for being here today. 

A different kind of a question. A critical piece of this infrastructure is the National Infrastructure Simulation and Analysis Center, or NISAC, which is a project, a program that exists at both Los 

Alamos and Sandia National Laboratories. NISAC has the capability to model global spread of flu strains and has done so in the 

past. Have you engaged the national security laboratories to use 

their predictive modeling capabilities such as NISAC to understand 

both the spread of influenza as well as to devise strategies for 

interdiction? 

Dr. FRIEDEN. We have had some interactions with them. I would 

have to get back to you with the details of those, but certainly the 

advanced computing is quite important including in some of the 

new diagnostic and genomic experiences. What we are able to do 

now is to sequence entire genomes in just a few hours and to put 

80 

that together is like putting together a jigsaw puzzle with more 

than a million pieces. So the computing power needed for that is 

quite important, and that is an area where we have collaborated 

with the national labs and where we see potential for future 

growth. 

Mr. LUJAN. Thank you. Anyone else? I would really encourage 

that we try to work with our departments, agencies to encourage 

them to closely work with the national labs in this endeavor. There 

is a huge benefit, and we saw that the last time that we had a pandemic break out. 

My State is also home to a large population of Native Americans 

like other communities across the country as well as a diverse population. What are your agencies doing to ensure that these communities are being reached out to and included in your priorities when 

it comes to pandemic flu preparations, and is there active consultation? 

Dr. FRIEDEN. In fact, just last week, we had our tribal consultation advisory committee meeting at CDC in Atlanta. We worked 

very closely with Native American groups. As you know, during the 

2009 pandemic, we identified Native Americans as one group that 

was more severely impacted by influenza for reasons that we don’t 

fully understand. We have for many years had a very productive 

relationship with the tribes on immunization issues, and vaccine 

uptake tends to be high in many of the tribes. In fact, we have collaborated with tribal leaders and tribal members to do some very 

important research on things like pneumococcal disease in the 

tribes, and that research benefited not only the tribes but the population throughout the United States and throughout the world. So 

there is a good collaboration, good consultation. We have explored 

ways to reach out and increase vaccination rates. We have also 

worked closely with the Indian Health Service on detection response and vaccination not only in influenza but other infectious 

and non-infectious diseases. For example, we recently identified 

spread in New Mexico of the Rocky Mountain spotted fever from 

one reservation to another through the dog tick, and we are working with private industry and tribal leaders to control that disease 

with some efficacy and impact. So we have a real focus on working 

effectively with higher-risk groups including Native Americans and 

Alaska Natives. 

Mr. LUJAN. I appreciate that very much and I look forward to 

learning more about that. 

One of the questions that has been asked over and over is, why 

aren’t people taking the vaccine. We know that education is important as well. Are there a lot of efforts being put behind addressing 

mistruths or misconceptions associated with getting the flu shot 

and what impacts to each of you might sequestration have associated with scale-backs that we have seen with disease surveillance 

activities or some of the work that takes place from an education 

perspective? 

Dr. FRIEDEN. In terms of your first question, increasing uptake 

we think is going to require efforts on many fronts, making vaccine 

easier for people to take, making it part of the work flow of health 

care professionals. Too many people do see a doctor during flu season but don’t get vaccinated. Increasing the options for vaccination, 

81 

and sunlight is the best disinfectant, so providing information. 

There are people who have some reluctance about vaccination and 

just providing the information openly we find to be the best way. 

We are completely open to all of the adverse events that people report after vaccination are all reported on our Web. We provide information openly so if there are any concerns, they can be addressed. 

As I noted earlier, we have made substantial administrative savings at CDC in recent years through travel conferences, leases, 

BlackBerrys, printers, computers, and we have been able to reduce 

administrative expenses but at this point further reductions will 

unfortunately translate into reductions in support that we provide 

for tribes, for States for localities for disease prevention and control 

as well as for core activities. 

Mr. LUJAN. Thank you, Chairman. I yield back. 

Mr. MURPHY. I thank the gentleman for yielding back. I now recognize another new member to the subcommittee, the gentleman 

from Mississippi, Mr. Harper. 

Mr. HARPER. Thank you, Mr. Chairman, and thank each of you 

for being here, and I appreciate the work you do. It is extremely 

important, and we certainly want to make sure that you are 

equipped to do that job in an effective way. 

You know, I hadn’t planned on touching on this, but since it has 

come up and continues to come up about the sequestration and the 

potential 5.2 percent cut, I just want to make sure that—and Dr. 

Crosse, you gave an answer that was—I will leave you alone because you said you didn’t know, so you can take a little break on 

this one. But Dr. Frieden and Dr. Goodman, you both indicated 

that it could impact actual programs to go out. It would seem to 

me, I want to make sure that you are not saying how that would 

be done or how you would operate within that, but it would seem 

to me if you got 94.8 percent of your budget, that you can work it 

out internally and administratively where that wouldn’t have an 

impact on patient care or on the folks that you would be reaching, 

and I want to make sure that I am not reading something into your 

statements as to what you said because I know built into a budget 

you have open positions that may not need to be filled, you have 

administrative costs—it may be travel, it may be advertising, it 

may things that you built in that you wanted to do that perhaps 

you can trim back but won’t have a direct impact if this does indeed kick in. And Dr. Frieden, I will let you go and then Dr. Goodman next. 

Dr. FRIEDEN. We do take very seriously being diligent stewards 

of the funds entrusted to us, and over the past few years as we 

have seen some reductions in recent years, we have gotten out of 

leases, we have reduced conferences, consulting contracts. We actually at a flat budget level sent more money out to the field. So we 

feel that we have done, I can’t say absolutely everything we can do 

but we have certainly done a great deal of what we can do. 

Mr. HARPER. But it is fair to say, Dr. Frieden, I know we have 

limited time here but it is fair to say you would make every effort 

you could and within the organization to make sure that it didn’t 

have that impact, if at all possible? That would be a fair statement, 

wouldn’t it? 

82 

Dr. FRIEDEN. We would certainly do everything we could to mitigate the negative health consequences. 

Mr. HARPER. Dr. Goodman? 

Dr. GOODMAN. Yes, I think I have a very similar response in that 

we have tried to tighten things up and be efficient stewards of our 

resources and have our resources really have the public health benefit that you and the American people want us to provide so we are 

doing that. If we were faced with a cut, it would have some consequences but certainly we are going to manage that in the most 

responsible way that we can. 

Mr. HARPER. Fair enough. Thank you, Dr. Goodman and Dr. 

Friedman, for those answers. 

You know, we are obviously concerned about the influenza situation, the virus and obviously supply and distribution are key, and 

so this would be each of you if I could get your response. You know, 

are you continuing to work with manufacturers to ensure an adequate domestic supply chain of medical countermeasures, and secondly, to improve the distribution of those medical countermeasures during the pandemic or moderate or severe seasonal flu 

epidemic like this year? 

Dr. FRIEDEN. Absolutely, and I will let Dr. Goodman discuss 

more about the work with the manufacturers. We work with them 

by providing seed strains, and what our laboratories have been 

able to do is to optimize those seed strains so that there are strains 

that grow faster and that may be more effective when used in vaccines. So we are hoping to see kind of useful and important tweaks 

without huge breakthroughs yet in the flu vaccination. We also 

work through the strategic national stockpile in an emergency to 

provide vaccines, countermeasures and medications. What we 

found in the pandemic was that the vaccinations through the vaccines for children program could be scaled up enormously, so we 

were able to provide more than 300,000 shipments, more than 80 

million doses very quickly, very effectively. We have been working 

to improve our ability to provide medications. Those are available 

but there isn’t a system to get them out there, and one of the 

things that learned about emergencies is, it is best to have an everyday system that can be scaled up, so we are looking at some 

models of doing that even more effectively in the future. 

Mr. HARPER. Thank you, Dr. Frieden. 

Dr. Goodman? 

Dr. GOODMAN. Yes, absolutely. We work extremely intensively 

with the manufacturers, and during flu season it is almost a daily 

contact with our staff scientists solving problems, working on 

issues, trying to get vaccine out quickly. I would also say through 

the Medical Countermeasure Enterprise across HHS, DOD, we are 

working together. Now FDA is involved at the earliest stages when 

the requirement for countermeasures is defined, and when requests 

for information or contracts go out to industry. The idea there is 

to avoid surprises, andspend as much effort as we can to increase 

the likelihood of success. So I think we are really helping keep that 

investment a very efficient and effective one. 

Mr. HARPER. Thank you, Dr. Goodman. 

Dr. Crosse, I am not meaning to ignore you but I am out of time, 

so I yield back. 

83 

Mr. MURPHY. I thank the gentleman. I now recognize the 

gentlelady from Florida, who is returning to the committee, Ms. 

Castor. Welcome. 

Ms. CASTOR. Well, thank you very much, Chairman Murphy, especially for calling this very important hearing, and I want to 

thank our panel and experts for doing everything in your power to 

help Americans ward off the flu. 

Before I get to my flu question, you know, when we are talking 

about the sequester, I think it is very important for everyone to remember, we have already slashed the budget of the CDC and the 

FDA. So when you are talking about additional draconian sequester cuts, you are not just asking the agency to be efficient because 

the agencies have been efficient and have cut. What you are doing 

is, you are cutting into their core missions that affect the productivity of Americans, our ability to ward off foodborne illnesses, 

SARS outbreaks. Think about the challenges with the flu. These 

things don’t happen by magic. We have a responsibility to the 

American public and businesses to get them vaccinated, to get 

them all the tools they need to ward off disease, and I think it is 

just wishful thinking to say well, can you accept more budget cuts, 

more budget cuts, more budget cuts and not expect the core missions of these very important public health agencies to remain intact. 

Back to the flu. In my home State of Florida, the nursing home 

population is critical, and the CDC has said that 90 percent of 

deaths from the flu come from people who are age 65 and older. 

This year, the flu has hit this population particularly hard. I am 

hearing more about how we are faring this season among that population, how effective our response has been and what we are doing 

to protect older Americans. So Dr. Frieden, can you talk about the 

impact of this season’s flu on older Americans? 

Dr. FRIEDEN. This year is an H3 year, and as in prior H3 years, 

it is more severe among the elderly. The hospitalization rate of laboratory-confirmed flu, which is something that provided in a graphic to the committee, is about twice or more what it has been in recent years, so overall this is a worse than average flu season and 

a particularly severe one for the elderly. Some of the things that 

we can do to reduce the severity is vaccination not only of seniors 

but if people around seniors so they are less likely to get infected 

by someone else, and then prompt treatment with a medication 

such as Tamiflu which particularly if given in the first 48 hours 

will reduce the likelihood of progression to severe disease. Also, in 

nursing homes, vaccination of health care workers is particularly 

important. There is some evidence that nursing homes that have 

lower vaccination rates among their staff have much worse outcomes in flu season. 

Ms. CASTOR. And many of these long-term-care facilities, they 

just don’t vaccinate their workforce like some hospitals do or cancer 

treatment centers. Why is that, and what can we do to promote 

greater vaccination rates among long-term-care employees? 

Dr. FRIEDEN. We have seen steady progress in the proportion of 

health care workers getting vaccinated. It is currently slightly over 

60 percent. It was in the mid 40s for many years. So we have seen 

progress and particularly among doctors, nurses and pharmacists. 

84 

We see rates of 80 to 90 percent. But working with nursing homes 

to make sure that vaccination is easy, provided, free on work time 

for their employees are all examples of things that are best practice 

and have been shown to be associated with higher rates. There are 

certainly nursing homes that do an excellent job at this, and so 

what we would like to do is see those best practices spread. 

Ms. CASTOR. OK. In addition to increasing vaccination rates for 

long-term-care workers and many others, one of the keys to reducing the severity of seasonal flu is making sure that there is a good 

match between the strains in the vaccine and the strains of flu that 

are in circulation. Dr. Goodman, how well matched were the 

strains in this year’s vaccine to what we saw circulating? 

Dr. GOODMAN. Fortunately, the strains are very well matched 

this year, so that isn’t an issue. The issue here is the severity of 

this virus, the number of unvaccinated people and then as we have 

discussed that we would like to have a vaccine that is even more 

effective, especially for the elderly. 

Ms. CASTOR. So we had good matches this year. We didn’t have 

any shortages in vaccines, even regionally? 

Dr. GOODMAN. Well, we had good matches. There are times— 

what we always see is—it is sort of like whitewashing the fence. 

When there is bad flu around, people want the flu vaccine, and 

there is a lot of demand, so we have seen and CDC has helped 

manage situations where people might have transient difficulty locating vaccine but there is still vaccine available and people can 

still get vaccinated. 

Ms. CASTOR. Well, I thank you all very much, and it is very important that we support our public health agencies so we can continue to minimize life-threatening illnesses and protect the productivity of American workers and businesses and protect the health 

of our families, so thank you very much. I yield back. 

Mr. MURPHY. I thank the gentlelady for yielding back, and I will 

recognize another new member of the committee. The gentleman 

from Dr. Texas, Mr. Olson, is recognized for 5 minutes. 

Mr. OLSON. I thank the chair, and welcome to the witnesses. 

Thank you all for your time and your expertise. 

Just a little bit of background about myself. The district I represent is Texas 22. It is a suburban Houston district. That is 

ground zero for pandemic flu outbreaks, and we are about to be the 

third largest city in America. I want to apologize to my colleagues 

from Illinois, but Chicago is going to be number four pretty quickly. 

And we have the largest foreign tonnage port in America. That 

means traffic is coming from Asia, from Africa, from Europe, right 

there, the Port of Houston. We have got these huge transportation, 

land transportation infrastructure from Latin America, all the 

trucks, all the traffic coming across from Mexico right down Highway 59, which goes right to my district, which is now I–69. And 

while it is true that my hometown’s minor league baseball team is 

called the Skeeters after mosquitoes, it is not true that the mosquito is the national bird of Texas. It is the mockingbird. But my 

point is, we have a lot of mosquitoes, we have a lot of rodents, a 

lot of birds, all sorts of transmission paths in addition to human 

beings, and while I thought that some of the comments that Dr. 

Burgess and Gene Green made about the outbreak we had, the 

85 

H1N1 outbreak in 2009, that summer we all know we had a big 

outbreak there across the country but Houston was number two, I 

think, of the national outbreak. And, I mean, 11 schools shut down 

and parents were terrified what was happening with their kids. 

And as you know, with these pandemic outbreaks, there are basically four steps we have to take care of. First we have to diagnose 

it. The CDC has to come through and say this is the virus, this is 

what it is, this is how we fix it. We have to make the vaccine. We 

have to get the vaccine manufactured out there and we have to get 

it to the people and have it delivered—I mean get it to the local 

people to deliver it to the people affected by disease. And it is pretty clear that outbreak in 2009, CDC got behind pretty quickly with 

all the tests being required, these people getting samples taken and 

all sent to you guys. I think you fixed that some, Dr. Frieden, by 

having some local regional centers set up to address this sort of explosion of tests. I also know we had big problems with delivery. I 

mean, you know, Texas Children’s Hospital had to set up basically 

a drive-through in a parking garage because so many people wanted to come get those vaccines. 

So my question is about the big picture, and this one is for you, 

Dr. Frieden, and for you, Dr. Goodman. What keeps you up at 

night? I mean, what is your base concern? What can we fix here? 

What is your biggest concern with our country dealing with these 

pandemic flu outbreaks? 

Dr. FRIEDEN. So, of all of the naturally occurring infectious diseases, it is influenza that causes us to lose the most sleep because 

of its potential to kill. During the 1918 pandemic, more than 50 

million people around the world died, and influenza can spread 

rapidly and unpredictably. One of the most predictable things 

about influenza is that it is unpredictable. So in order to do a better job of protecting Americans, we need to strengthen our global 

surveillance systems so that we can detect new strains of influenza 

soon after they arise anywhere in the world, and we have worked 

very closely with governments around the world as well as the 

World Health Organization to strengthen laboratories. In fact, during the H1N1 pandemic within literally days of the discovery of the 

virus, we had already produced a real-time PCR assay that we distributed ultimately to more than 100 countries around the world so 

we could track what was happening with it. But that virus was 

probably circulating for a couple of months before it was identified. 

So it emphasizes that if any part of the world doesn’t have good 

monitoring systems, we could miss whether it is influenza or another health threat emerging and not be able to respond as quickly 

because if we can stop it or mitigate it where it emerges, that is 

better for that part of the world and that is better for us as well. 

Mr. OLSON. There are some other institutions across America 

that do that. For example, the University of Texas medical branch 

in Galveston has its Bio 4 laboratory. I went and toured that thing. 

That is space age technology. They have these suits they dress you 

up in because they are dealing with some pretty serious diseases. 

They say exactly what you are saying, that our biggest problem is, 

we can find something somewhere in the world here. If we get the 

virus, we can probably have it done in 24 to 48 hours, they say. 

You know, we can figure out what the vaccine should be and they 

86 

have obviously got to manufacture it, but I would encourage you 

to work with them and all those different labs out there because 

they are great assets for us. 

Dr. Goodman, what keeps you up at night, sir? 

Dr. GOODMAN. Well, I think we are all sharing those same concerns of a new or different infectious agent where we don’t have a 

great vaccine or great therapies that could occur either naturally 

or potentially deliberately. So, I agree totally with Dr. Frieden. We 

need to have strong surveillance, and things really have improved 

in that area too and the molecular tools. 

I think we also need the next piece, which is the ability to develop and produce medical countermeasures—vaccines, drugs— 

much more quickly than we currently can. Normal drug development and vaccine development is a multiyear process. Among the 

things we are working with through our enterprise, HHS, DOD, 

etc., are new technologies to have a much more rapid, flexible response so that we can get vaccines much more quickly so that we 

can develop treatments. There also has been considerable progress 

as described in our testimony, in increasing our Nation’s capacity 

and being sure we have the domestic capacity in the industrial infrastructure to work with the government and respond to a public 

health crisis. So again, we are better off, but we have got to harness new science to have much faster responses and be able to face 

a new threat. This effort isn’t just for flu. It protects us from terrorism too. So for all of these, we are taking a multi-hazard approach where everything we do, whether it is surveillance or response, can be used because we can’t predict what will emerge. We 

want tools that will work for whatever will emerge. 

Mr. OLSON. Thank you. Dr. Crosse, you can sleep well at night, 

ma’am. That is the end of my questions. I do have some questions 

for the record, sir, about adjuvant vaccines are being used in Europe, sort of developing new technologies for vaccines. But thank 

you very much. 

Mr. MURPHY. The gentleman yields back. The gentleman’s time 

is expired, and we now recognize the gentleman from Virginia, Mr. 

Griffith, for 5 minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

On these new vaccines that are being worked on, and it doesn’t 

matter to me who answers the question or if people have different 

opinions. I am just curious, we know about the allergy problems for 

certain people with the eggs, but with the new vaccines that are 

done with cells, have there been any allergic reactions that we 

know of? Have there been any tests to see if folks that have other 

types of allergies are reacting to those vaccines? 

Dr. GOODMAN. Well, the good news is that first of all, many people with egg allergies have safely taken the egg-based vaccines because they are fairly pure and they don’t have tons of egg protein 

in them but there also are people who have had severe allergic reactions to the current vaccines, although it is extremely rare. For 

those who have them due to eggs, both the new recently approved 

vaccines should provide a potential advantage. One is produced in 

cells so there is no exposure to egg, and the other is produced in 

cells but using insect cells through recombinant technology, so 

these are very pure vaccines that don’t contain egg protein. So I 

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think that will be a help. I want to get back to you for the record, 

but I am not aware of any significant problem with allergic reactions to either of the new vaccines other than what we would normally expect with any flu vaccine. 

Mr. GRIFFITH. Thank you. With that, Mr. Chairman, if I can 

yield the remainder of my time to Dr. Burgess, I would do so. 

Mr. BURGESS. I thank the gentleman for yielding. 

Dr. Goodman and Dr. Frieden, at the end of 2005, an omnibus 

appropriations bill was passed that had the defense appropriations 

in it. A lot of the pandemic preparedness was contained therein 

and, again, going back to my opening statement, there was discussion about the universal vaccine. Dr. Frieden, you have talked 

about the difficulty with the surface proteins, how they are ever 

changing. I think, Dr. Goodman, you even mentioned developing a 

vaccine to the stalk or the housekeeping proteins that are contained within the coat. How close are we? This was one of the 

promises in 2005. It is 7 years ago. 

Dr. GOODMAN. Well, I would—nature is very tricky, and as I 

said, this is a very crafty virus, so I would really hesitate to predict, but as I said, I think we see some promising science. I think 

the earliest we could begin to see something where we could maybe 

examine whether it has clinical benefit might be within 5 to 10 

years. And that is if we see some of these technologies really take 

root, and I am excited about them, but I know my colleagues at 

NIH who also do this and fund this for a living, feel the same way. 

There are some exciting prospects but it has got a way to go. Certainly, you know, your support and the investments being made 

will help us get there faster, we hope. 

You know, these are—we have wonderful vaccines against all 

kinds of infectious diseases. We protect children against pneumonia, against measles, against polio, et cetera. This is not for lack 

of trying. This is because this is a hard scientific problem. As I 

said, the human immune system does not respond very well to influenza, and when it does, the influenza virus is very tricky at getting away from that response. 

Mr. BURGESS. Well, is a universal vaccine still a worthwhile 

goal? 

Dr. GOODMAN. Still a goal? 

Mr. BURGESS. A universal vaccine, is that still—— 

Dr. GOODMAN. Is it a worthwhile goal? 

Mr. BURGESS. I am asking you, is it a worthwhile goal? 

Dr. GOODMAN. Absolutely, absolutely. I mean, can you imagine if 

we could have a world where we didn’t have influenza pandemics? 

Mr. BURGESS. You can just imagine, though, the frustration in 

2005 we are told we are 3 to 5 years away. You are telling me now 

we are 7 to 10 years away, and it—— 

Dr. GOODMAN. Well, I don’t think I would have said that and I 

am not sure who did but I think, you know, we see new technology 

and we are always very hopeful, and it is kind of the way you go 

in science is to be optimistic and pursue the best leads, but one of 

the things we also certainly have seen is, this is a very challenging 

scientific problem. 

Mr. BURGESS. Well, let me ask you this. We got a good match 

this year so we are grateful for that. But still, the prevalence of inVerDate Nov 24 2008 12:06 Jul 29, 2014 Jkt 037690 PO 00000 Frm 00093 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-3 CHRIS
88 

fections in those over the age of 65 is still higher, so what is the 

difficulty there in conferring the advantage to the individual over 

65? 

Dr. FRIEDEN. One of the challenges with influenza is that our 

own natural immunity isn’t particularly good, and vaccines don’t 

usually do better than we do in nature in defending against infections. The elderly, particularly the frail elderly, who are more susceptible to severe flu, don’t in the past respond very well to the flu 

vaccine. There is a new product on the market that uses triple does 

of the antigen. We are told by the manufacturer that by the end 

of next flu season we will be able to get a sense of whether that 

makes a different or not. But influenza is one of the things that 

is quite challenging. Ninety percent or more of the deaths in most 

years tend to be among the elderly, so one of the things that we 

can do is vaccinate more people around them to tamp down the 

threat of flu. A second is to treat promptly because there is evidence that if you treat someone within the first 48 hours, they are 

less likely to end up in the intensive care unit and it may have 

other benefits as well in reducing spread. 

Mr. BURGESS. Very good. I yield back. 

Ms. DEGETTE. Mr. Chairman, I ask unanimous consent for 30 

seconds to follow up on that question. 

Mr. MURPHY. Without objection. 

Ms. DEGETTE. So the follow-up question, Dr. Goodman, is—and 

by the way, it was the CDC apparently in this 2005 hearing that 

said it was 3 to 5, and it wasn’t Dr. Frieden that said that. 

Dr. Goodman, this universal vaccine 5 to 10 years that you said, 

if we wanted to speed that up, is that a resource question or is it 

a science question, or both? 

Dr. GOODMAN. I think at this point it is mostly a science question, to be honest. 

Mr. MURPHY. Thank you. The Chair recognizes now the gentleman from Ohio, Mr. Johnson, for 5 minutes. 

Mr. JOHNSON. Well, thank you, Mr. Chairman, and first of all, 

let me say what a privilege and an honor it is to now be a part 

of the Oversight and Investigations Subcommittee. I look forward 

to serving with all of our colleagues as we address the many important issues that face us. 

And with that, let me say I received my flu vaccine this year and 

I have not gotten sick yet, so for those involved, thank you very 

much. I am very much appreciative. 

I represent a district in Ohio that is extremely rural. It takes me 

61⁄2 hours to drive from one end to the other. There are many 

places throughout my district where my constituents have to drive 

30, 40 miles to get to a physician or to get to a pharmacy or to get 

to a flu shot if they were to have a reaction. So this is, and especially given your testimony already, impacting our seniors, and I 

have a lot of seniors down in that area. 

So Dr. Goodman, can you explain a little bit more about the testing process in place to verify the safety, the sterility and the effectiveness of the vaccine? 

Dr. FRIEDEN. So, as part of each manufacturer’s approve or license, they are required to do numerous tests throughout the vaccine manufacturing. At multiple stages they have to monitor proVerDate Nov 24 2008 12:06 Jul 29, 2014 Jkt 037690 PO 00000 Frm 00094 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-3 CHRIS
89 

duction. And then when they create these large-scale bulk amounts 

of vaccine, those are all tested for their potency, their sterility to 

be sure there is no contaminants, toxins, etc. In addition, they submit samples of that to FDA, which our laboratories test, and then 

once all those tests are OK, they fill the vaccines into the final containers or the syringes or for the live vaccine, FluMist, the nasal 

spray, and they also test where appropriate those final formulations. So there is very extensive testing and quality control, among 

the most intense, I would say, for medical product. 

The other thing that we do that is very important is working 

closely with CDC. We monitor the safety of all licensed vaccines 

very carefully, and this is particularly true of influenza vaccine. We 

monitor for major side effects in real time using, for example, the 

CMS database, and this is actually some of the most novel science 

done in looking for adverse events, and we are working to stand 

up a much broader system that uses health care settings that have 

electronic medical records to monitor vaccine safety called Prism, 

and we plan to have that up and running next year. So they are 

very intensively monitored, and I would say one of the way our 

country was able to do a good job with vaccine uptake in the 2009 

pandemic is that we were able to track safety in real time when 

the public or certain people raised concerns about the safety of vaccine to be able to share the data which showed it was safe. Conversely, if there ever were, God forbid, to be a problem, we think 

we have support and test systems in place to detect it rapidly. 

Mr. JOHNSON. Sure. Do you think that the development time for 

the vaccine, because it seems to get longer and longer each year as 

the virus mutates, is harming our ability to react to a potentially 

strong flu season? 

Dr. GOODMAN. You know, the manufacturing of flu vaccine is 

complicated, and as Dr. Frieden said, flu is unpredictable. We also 

say flu vaccine manufacturing is unpredictable. Sometimes the viruses grow better than other years. Sometimes they yield more of 

the vaccine material than other years, so it can be a challenge. 

This year went relatively smoothly. We have had other years where 

vaccine is delayed. Typically, it is about a 6-month process beginning to end. We are all working to speed that up. There are parts 

the virus controls like how it grows, and that is what got us in the 

pandemic. The virus just wouldn’t grow. But there are parts that 

we can help control better. We recently approved rapid sterility 

tests that instead of taking 2 weeks take 3 to 5 days. We are working with CDC and others to make better potency tests, which now 

take weeks to develop, and we think we can shorten that. So we 

are working to shorten the portion of the time that manufacturers 

and the regulatory agencies are responsible for but we are at the 

end left with the whim of the virus, which is why some of these 

new technologies, like cell-based and recombinant, may provide us 

with a safety valve if problems occur. 

Mr. JOHNSON. One quick question before my time expires, which 

is almost here. Again, given my rural district, I am sure there must 

be scientific formulas to determine the distribution of the vaccine 

to make sure that you have got them in the right places so the population can get to them. I am sure there is a different methodology 

90 

for a big city like Columbus or Cleveland or Los Angeles than for 

rural Appalachia Ohio. 

Dr. FRIEDEN. We work closely with public and private sectors to 

make sure that vaccine is available. Other than some spot shortages, it generally was this year, and using community providers, 

senior centers, pharmacies and other places, any opportunity to 

provide vaccination—many States allow pharmacists, nurses, nurse 

practitioners to vaccinate under a doctor’s order or supervision— 

can increase access in rural and other areas. 

Mr. JOHNSON. Thank you, Mr. Chairman. I yield back. 

Mr. MURPHY. I thank the gentleman. I also forgot to mention 

welcome to the committee to you, to the gentleman who represents 

the east coast of Ohio. I appreciate it. 

Mr. JOHNSON. Yes, the very long east coast. 

Mr. MURPHY. Now I recognize another new member to our subcommittee, the gentlelady from North Carolina and a nurse. Ms. 

Ellmers is recognized for 5 minutes. 

Mrs. ELLMERS. Great. Thank you, Mr. Chairman, and again to 

our panel, thank you for being here and answering our questions. 

I happen to be the lucky recipient of the district that has 

Novartis, the new, beautiful, gorgeous Novartis facility in Holly 

Springs, North Carolina, and so my questioning is along the lines 

of what they are going to be able to do. My first question, Dr. 

Frieden, for you is, you know, considering now the advancements 

and how exciting it is that we are taking the path of new technologies in vaccinations, how is it and how can you describe to us 

the demanding or expanding the demand for facilities like this, 

manufacturing, can be a help in this area? Because we are looking 

for solutions moving forward—how can this facility be a step in 

that right direction? 

Dr. FRIEDEN. Well, as you know, the cell-based manufacturing offers advantages, possibly cutting a few weeks or even a month out 

of the time frame, not using eggs, and having one more option, and 

one of the things that has been encouraging in recent years is the 

increased number of options—intradermal vaccination, intranasal 

vaccination, high-does vaccination for seniors. So the more options 

we have, I think the more uptake we will have. But we would like 

to see a substantial increase in uptake of influenza vaccination, 

and that is going to require continued effort. 

We do really well with childhood vaccination in this country 

through the Vaccines for Children program, where we provide 

about half of all the vaccines that are used. Not only do we have 

very high rates but we have eliminated racial and ethnic disparities in childhood vaccination. But we don’t do nearly as well for 

adolescents and adults, and part of that is putting in place systems 

in our health care that make it routine, that put frankly nurses in 

charge rather than doctors to make sure that something gets done 

regularly and routinely. 

Mrs. ELLMERS. I am all about that. A little competition doesn’t 

hurt. 

Along that line, and I know Dr. Goodman touched on this as 

well, what is the advantage, if you will, speaking to the cell-based 

vaccines versus the egg? Of course, we all know about egg allergies, 

but I know you had mentioned, you know, the rapid, you know, 

91 

rate that we can be manufacturing and growing, so can you just 

touch on a couple of those as well? 

Dr. FRIEDEN. So not being reliant on eggs is quite important because you might have a shortage of eggs in the case of a pandemic, 

so that is an important advance. As Dr. Goodman mentioned, the 

egg allergy issue is less of an issue because we find that true egg 

allergy is extremely rare, and we have not generally seen problems. 

In fact, we have clarified our recommendations in the past year to 

say really it has to have been a real severe anaphylactic allergy because we found many people saying well, I don’t like eggs so I am 

not going to have the flu vaccine. 

Mrs. ELLMERS. A fear factor? 

Dr. FRIEDEN. Right. 

Mrs. ELLMERS. Dr. Goodman, I did want to ask, in this particular 

facility, the Novartis facility, it is licensed now for the pandemic 

vaccine but not yet licensed for the seasonal. Is that correct? 

Dr. GOODMAN. I have to be careful about public information 

versus their protected information. 

Mrs. ELLMERS. I see. 

Dr. GOODMAN. But it is licensed for certain operations with respect to flu vaccine. It is not finally licensed for production of seasonal vaccine, and I know Novartis is working with our staff to get 

it going and get it onboard, and that is their plan. 

Mrs. ELLMERS. In a facility like this, how long would something 

like this take? And there again, I will just say hypothetically for 

other facilities that may have taken that plan. 

Dr. GOODMAN. Yes, it sort of depends on the issues encountered 

and, you know, I know that there is really highly interactive engagement and everybody’s goal is to get it going as soon as possible, and you know, things have been going well. 

Mrs. ELLMERS. Good. And what I will say is, any help that we 

can be in that effort, I will be more than—— 

Dr. GOODMAN. No. As I said, the relations between FDA and 

with manufacturers in this area have been tremendous and very 

collaborative. 

Mrs. ELLMERS. Excellent. Well, thank you so much. I thank all 

of you so much for your input, and I yield back. 

Mr. MURPHY. I thank the gentlelady for yielding back. We have 

covered all of the members here. I just want to cover a couple 

of—— 

Ms. DEGETTE. Will the gentleman yield for 1 second? Mr. Chairman, I just want to congratulate you on your first hearing, and I 

want to congratulate all of the members for the comity that we 

have shown. This is an important issue, and I really appreciate the 

bipartisan cooperation and I think you are setting the tone for a 

really good 113th Congress. I just wanted to compliment you. 

Mr. MURPHY. I thank the gentlelady, and the same compliments 

go to the ranking member and all the members here. To those who 

testified today, we know this is a serious topic, and I know our 

hearts go out to all those families across America who lost loved 

ones during this flu epidemic, but the information you are providing, the research you are providing and recommendations for 

the future are going to be critically important to save more lives 

next year, and so we are looking forward to that. 

92 

A couple housekeeping matters. I do ask unanimous consent that 

the written opening statements of members will be introduced into 

the record. Without objection, the documents will be entered into 

the record. 

Again, I thank the witnesses for coming today and for their testimony and members for their devotion to this hearing. The committee rules provide that members have 10 days to submit additional questions for the record to the witnesses. 

This was my first hearing as chairman of the subcommittee, and 

I appreciate all the constructive and bipartisan dialog that we have 

had. When problems or issues arise that impact our public health, 

I am committed to finding out how we can effectively address them, 

and the FDA is going to continue to play a critical role in this regard. 

Dr. Goodman, I do have a request if you would do this for us, 

to take back to the Commissioner, Commissioner Hamburg. As you 

know, the committee has investigating the deadly outbreak of 

fungal meningitis linked to compound drugs since October. Almost 

2 weeks ago, this committee sent Dr. Hamburg and notified her 

that unless all responsive documents are produced by February 25, 

the committee will move to compel their production. We have not 

received any documents since the day we sent the letter. Dr. Goodman, could you please on behalf of this committee tell the Commissioner we expect the FDA’s cooperation, and the only way for HHS 

to avoid receiving a subpoena in the meningitis investigation is to 

produce all the documents we have requested by the February 25th 

deadline. I thank you for taking that message back to the FDA 

Commissioner. 

With that, I thank all the members. This hearing is adjourned. 

[Whereupon, at 11:52 a.m., the subcommittee was adjourned.] 

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