[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]



 
  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




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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania             GENE GREEN, Texas
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee          LOIS CAPPS, California
  Vice Chairman                      MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia                JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             JIM MATHESON, Utah
ROBERT E. LATTA, Ohio                G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington   JOHN BARROW, Georgia
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            DONNA M. CHRISTENSEN, Virgin 
BILL CASSIDY, Louisiana                  Islands
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
CORY GARDNER, Colorado               BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas                  PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MARSHA BLACKBURN, Tennessee          BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia                BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana             EDWARD J. MARKEY, Massachusetts
GREGG HARPER, Mississippi            JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas                    G.K. BUTTERFIELD, North Carolina
CORY GARDNER, Colorado               KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia         PETER WELCH, Vermont
BILL JOHNSON, Ohio                   PAUL TONKO, New York
BILLY LONG, Missouri                 GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina     JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California (ex 
FRED UPTON, Michigan (ex officio)        officio)


                             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


  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 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, 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 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.

                                #  #  #

    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 apparent 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 time-intensive 
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 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.

                                #  #  #

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 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.
    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 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:]

    [GRAPHIC] [TIFF OMITTED] 

    
    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 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. 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:]

    [GRAPHIC] [TIFF OMITTED] 

    
    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. Manufacturers 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:]


    [GRAPHIC] [TIFF OMITTED] 

    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 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, 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?
    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 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 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.
    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.
    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.
    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 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, 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?
    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.
    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. 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 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 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 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 infections 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 6\1/2\ 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 
production. 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 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, 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.
    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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