[Senate Hearing 111-595]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-595
 
                        THE COST OF BEING SICK:
                        H1N1 AND PAID SICK DAYS

=======================================================================

                                HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON CHILDREN AND FAMILIES

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                                   ON

                   EXAMINING H1N1 AND PAID SICK DAYS

                               __________

                           NOVEMBER 10, 2009

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming
BARBARA A. MIKULSKI, Maryland        JUDD GREGG, New Hampshire
JEFF BINGAMAN, New Mexico            LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington             RICHARD BURR, North Carolina
JACK REED, Rhode Island              JOHNNY ISAKSON, Georgia
BERNARD SANDERS (I), Vermont         JOHN McCAIN, Arizona
SHERROD BROWN, Ohio                  ORRIN G. HATCH, Utah
ROBERT P. CASEY, JR., Pennsylvania   LISA MURKOWSKI, Alaska
KAY R. HAGAN, North Carolina         TOM COBURN, M.D., Oklahoma
JEFF MERKLEY, Oregon                 PAT ROBERTS, Kansas
AL FRANKEN, Minnesota
MICHAEL F. BENNET, Colorado

           J. Michael Myers, Staff Director and Chief Counsel

     Frank Macchiarola, Republican Staff Director and Chief Counsel

                 Subcommittee on Children and Families

               CHRISTOPHER J. DODD, Connecticut, Chairman

JEFF BINGAMAN, New Mexico            LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington             JUDD GREGG, New Hampshire
JACK REED, Rhode Island              JOHN McCAIN, Arizona
BERNARD SANDERS (I), Vermont         ORRIN G. HATCH, Utah
SHERROD BROWN, Ohio                  LISA MURKOWSKI, Alaska
ROBERT P. CASEY, JR., Pennsylvania   TOM COBURN, M.D., Oklahoma
KAY R. HAGAN, North Carolina         PAT ROBERTS, Kansas
JEFF MERKLEY, Oregon                 MICHAEL B. ENZI, Wyoming (ex 
TOM HARKIN, Iowa (ex officio)        officio)

                       Jim Fenton, Staff Director

               David P. Cleary, Republican Staff Director

                                  (ii)

  
?



                            C O N T E N T S

                               __________

                               STATEMENTS

                       TUESDAY, NOVEMBER 10, 2009

                                                                   Page
Dodd, Hon. Christopher J., Chairman, Subcommittee on Children and 
  Families, opening statement....................................     1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming..     3
DeLauro, Hon. Rosa L., a U.S. Representative from the State of 
  Connecticut....................................................     7
    Prepared statement...........................................     9
Harris, Hon. Seth D., Deputy Secretary, U.S. Department of Labor, 
  Washington, DC.................................................    16
    Prepared statement...........................................    18
Schuchat, Anne, M.D., Acting Deputy Director for Science and 
  Program, Centers for Disease Control and Prevention and 
  Assistant Surgeon General, U.S. Public Health Service, U.S. 
  Department of Health and Human Services, Atlanta, GA...........    22
    Prepared statement...........................................    24
Ness, Debra, President, National Partnership for Women and 
  Families, Washington, DC.......................................    41
    Prepared statement...........................................    43
Rosado, Desiree, Worker, Groton, CT..............................    47
O'Brien, Elissa C., Vice President of Human Resources, Wingate 
  Healthcare, on Behalf of the Society of Human Resource 
  Management, Needham, MA........................................    49
    Prepared statement...........................................    51
Gottlieb, Scott, M.D., Resident Fellow, American Enterprise 
  Institute, Washington, DC......................................    59
    Prepared statement...........................................    61

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Harkin...............................................    77
    Senator Murray...............................................    78
    American Association of University Women (AAUW)..............    79
    Center for Law and Social Policy (CLASP).....................    82
    Deborah Frett, CEO, Business and Professional Women's 
      Foundation.................................................    83
    Letters:
        National Federation of Independent Business (NFIB).......    87
        National Small Business Association (NSBA)...............    88
    Response to questions of Senator Dodd by Seth Harris.........    90
    Response by Anne Schuchat to questions of:
        Senator Dodd.............................................    92
        Senator Reed.............................................    95
        Senator Enzi.............................................    95
        Senator Hatch............................................    97
    Response by Debra Ness to questions of:
        Senator Dodd.............................................    99
        Senator Enzi.............................................   100
    Response to questions of Senator Dodd by Elissa O'Brien......   101
    Questions of Senator Dodd to Scott Gottlieb..................   104
    Response to questions of Senator Enzi by Scott Gottlieb......   104

                                 (iii)

  


                        THE COST OF BEING SICK: 
                        H1N1 AND PAID SICK DAYS

                              ----------                              


                       TUESDAY, NOVEMBER 10, 2009

                                       U.S. Senate,
                     Subcommittee on Children and Families,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:35 a.m. in 
Room SD-430, Dirksen Senate Office Building, Hon. Christopher 
J. Dodd, chairman of the subcommittee, presiding.
    Present: Senators Dodd, Murray, Casey, Hagan, Merkley, and 
Enzi.

                   Opening Statement of Senator Dodd

    Senator Dodd. Order.
    Let me welcome all of you here this morning for this 
hearing. I am delighted to see such a good turnout this 
morning, and some wonderful people that we're going to hear 
from as our witnesses here to talk about the Healthy Families 
Act and the related matters affecting H1N1 flu, as well. Let me 
thank everyone for being here. We meet in the midst of an 
American emergency. According to the Centers for Disease 
Control, H1N1 flu has reached to 48 States and affected as many 
as 5.7 million Americans. Overall, 672 Americans have died, 
including at least 129 children.
    In my State of Connecticut, along with my first witness, 
Congresswoman DeLauro, our State, and across the country 
families are anxious about this pandemic and are frustrated 
that vaccines remain unavailable even to pregnant women, 
schoolchildren, and the elderly. For those at greater risk, 
H1N1 represents a serious health threat that forces changes in 
daily routines. I hope, by the way, that today we can finally 
get some answers for the folks who have asked me--and, I'm 
sure, many others--why it is taking so long to produce enough 
vaccines.
    But, I've called this hearing today because the impact that 
a pandemic like H1N1 cannot be solely measured by the number of 
people infected or the tragic lives that are lost. H1N1 is 
causing an emergency for workers and families across our 
country, as well. Again, in my State of Connecticut, we have 
had at least 10 schools close. We've even had entire school 
districts close. Some 600 schools across the country have 
closed their doors for at least some period of time. This, in 
turn, forces, of course, working parents to care for sick 
children or find ways to ensure that children whose schools 
have closed are supervised.
    Yesterday, I hosted a roundtable discussion in Connecticut 
on H1N1. A woman by the name of Jane Grady from Middletown, CT, 
told me about one Monday when she got a call from her school 
that more than 350 children were sick and another 100 got sick 
during that day. When she came to pick up her son, as she 
described it, it looked like an emergency room in a hospital.
    Meanwhile, small businesses, of course, are losing 
productivity because of worker illnesses. And for the 57 
million private-sector workers who do not have paid sick leave 
available, coming down with H1N1 means you have to make a 
choice; either you go in to work sick and risk infecting your 
co-workers or stay home and lose, of course, a very important 
day's pay.
    The Center for Disease Control has strongly recommended 
that you stay home until your fever has ended, and for at least 
another 24 hours after that. This isn't just a workers' rights 
issue, it's a public health emergency. Families shouldn't have 
to choose between staying healthy and making ends meet. But, if 
staying home means you don't get paid, that's an impossibility, 
especially for families struggling to make ends meet in this 
very tough economy. The more infected Americans who go to work, 
the more Americans who will be exposed to H1N1.
    According to the CDC, an individual who comes to work with 
H1N1 will infect 10 percent of his or her coworkers. That's 
worth repeating. According to the Center for Disease Control, 
an individual who comes to work with H1N1 will infect 10 
percent of his or her coworkers. What's troubling is, more than 
three-quarters of food service and hotel workers do not have 
paid sick days. Childcare, retail, nursing home workers are 
also less likely to have paid sick days. Some 80,000 school 
cafeteria workers cannot stay home when they are sick, and they 
come to work to serve approximately 10 million schoolchildren 
every day.
    I'm told virtually 100 percent of schoolbus drivers are 
without paid sick leave across the country. Now, that number 
maybe not quite 100 percent, but that's the number I've been 
given, it's close to 100 percent. This is simply dangerous, for 
all of the obvious reasons.
    Those most in need are also the least likely to have paid 
sick days. Only one in four low-wage workers have paid sick 
days, and they're often most likely to have jobs requiring 
frequent contact with the public. According to the Bureau of 
Labor Statistics, only 22 percent of the lowest-income workers 
have paid sick days, compared with 86 percent of some of the 
highest 25 percent of wage earners.
    I'm introducing emergency legislation to help keep 
Americans safe from the H1N1 virus. The bill that I introduce 
will guarantee paid sick days that workers can use to take care 
of themselves and loved ones if they are affected by H1N1 or 
seasonal flu. Workers should have paid sick leave as a matter 
of basic fairness, in my view.
    The FMLA, the Family Medical Leave Act, was an important 
step toward helping people balance work and family. For those 
who still have to make that impossible choice every day, and so 
many do, it's not nearly enough. That's why 145 nations around 
the globe guarantee paid leave, and why our friend, Senator Ted 
Kennedy, introduced the Healthy Families Act almost 7 years 
ago, in 2003 or 2004, along with Congresswoman DeLauro, to 
guarantee it to workers in this country, and why I'm very proud 
to carry that legislation forward in his name and the name of 
Congresswoman DeLauro.
    Now sick leave is a matter of keeping Americans safe from 
this pandemic, and from the next one or whatever it may be. 
Experts estimate that if workers simply followed the CDC 
guidelines and stayed home, the number of people affected by 
pandemic flu would be cut by up to one-third. If paid sick 
leave had been the reality when this pandemic began, we would 
be in far better shape across the Nation.
    So, I want it in place immediately to help parents and 
workers, and I want it in place before the next pandemic, which 
will come. I guarantee it will. And once again we'll be sitting 
here asking ourselves the same questions once again. It's a 
matter of fairness for workers, in my view, and it's a matter 
of safety for all others.
    I welcome our witnesses this morning, and thank them for 
their time, and hope that we can help families not only in our 
individual States, but across the Nation, who are worried about 
this pandemic and anxious for some answers.
    Our first witness is Congresswoman Rosa DeLauro, who is no 
stranger, having worked with me a number of years ago as my 
chief of staff in the U.S. Senate when I first came here. She 
knows this side of the Hill as well as anyone, and has been a 
remarkable Member of Congress now for a number of years, and 
has been the author of this legislation on the House side for 
many, many years
    Rosa, it's a pleasure to have you back in the committee.
    Ms. DeLauro. Thank you.
    Senator Dodd. You used to sit on this side, back here.
    Ms. DeLauro. I did, indeed, Senator. Senator Enzi, it's a 
pleasure to see you this morning. If you just bear with me, 
what a wonderful opportunity for me to be able to testify 
before the subcommittee today.
    Senator Dodd. I'm going to have Mike Enzi make an opening--
--
    Ms. DeLauro. Fabulous.
    Senator Dodd [continuing]. Statement.
    Ms. DeLauro. Go ahead, Senator.

                   Opening Statement of Senator Enzi

    Senator Enzi. I would have been happy to wait until----
    Senator Dodd. No, no, no.
    Senator Enzi [continuing]. Others gave theirs, but, in 
keeping with the tradition--Mr. Chairman, today Americans 
across the country are trying to protect themselves and their 
families from the threat of the flu pandemic that's threatening 
the lives of children and pregnant women around the world. Yet, 
when they show up at the doctor, they're being told that there 
are no more vaccines and that due to shortages in supply, 
they'll have to be put on a waiting list until the next 
shipment arrives. Mr. Chairman, they're learning that their 
government has failed to prepare the country for the threat of 
a flu pandemic that was foreseeable and preventable, with 
better coordination and preparedness.
    The 2009 H1N1 virus was first detected in Mexico in March 
2009; a month later, in the United States; today it's spread to 
48 States including my home State of Wyoming. Yet, most 
Americans who want to protect themselves by vaccination have 
been left in the lurch and told that a supply of vaccines may 
not even be available before the pandemic is over.
    Now, in light of the bill that we're considering, some 
employers might wonder if the vaccine isn't there, shouldn't 
the Federal Government reimburse the employer for the time that 
he has to provide paid sick leave, and perhaps even the parent 
be reimbursed for the inconvenience?
    I do have to mention a good program that's happening in my 
State. One of the problems people face is when you have your 
child in daycare, and they get sick. They don't want to infect 
the rest of the daycare ones, so the parents have come and pick 
them up. In Gillette, WY, the hospital has a sick-child 
daycare, where you can then take your child, and they'll get 
care, as well as being taken care of during the day. I think 
it's a rather innovative approach to it.
    This summer, the Administration promised Americans that 80 
to 120 million doses of the vaccine would be distributed by 
mid-October, yet here we are a month past that deadline, and 
only 36 million doses are available. As for the doses that are 
available, the
Administration appears to be taking inadequate precautions to 
ensure fair and appropriate distribution. The media's full of 
stories of vaccines going to populations that don't fit the 
high-risk profile, such as terrorism suspects being held at 
Guantanamo Bay, instead of those populations at risk, such as 
small children and pregnant women.
    With death tolls rising and almost no access to the 
vaccine, it's no wonder that we're concerned. Every person left 
unvaccinated is an opportunity for H1N1 to spread exponentially 
and to mutate into a more deadly strain.
    I'm pleased that we have a representative of the Center for 
Disease Control here today to shed light on what's gone wrong 
and to tell us what improvements can be made. I also want to 
welcome Dr. Scott Gottlieb to the committee today to discuss 
some of the policies that have contributed to the vaccine 
shortage and provide recommendations for ways to improve our 
response to pandemic flu in the future.
    Some of these issues include the decision of the Department 
of Health and Human Services to order single-dose instead of 
the more efficient multidose vials. Multidose vials are 
produced more quickly and can out-produce single dose vials 10 
to 1. We have also yet to approve the use of adjuvants in flu 
vaccines, which decrease the amount of vaccine needed in a 
single dose, which would allow us to vaccinate more people with 
the same amount of vaccine. Adjuvants are currently used in the 
flu vaccine sold in Europe, but not yet approved for use in flu 
vaccines in the United States.
    Another shortfall we face is regarding the production 
process. Today the United States still depends on chicken eggs 
for their vaccine production. All other nations are using more 
advanced cell-based manufacturing processes that are not 
dependent on a supply of eggs and can more quickly increase 
vaccine production. One way the Federal Government can improve 
our production capability is through increases in funding for 
BARDA. We also need to approve the cell-based manufacturing 
process for the flu vaccine so that manufacturers will not need 
to wait for FDA approvals the next time our Nation faces the 
threat of a pandemic flu.
    It is imperative that the United States increase its 
capabilities to produce better technology that will increase 
our preparedness in the future.
    Today's hearing will focus on the impact that H1N1 has on 
sick and healthy Americans every day, but let us not lose sight 
of the opportunity for Congress to learn from this experience 
and continue to force our Nation to increase our preparedness 
capabilities.
    The alarm that the H1N1 virus has raised in many households 
also translates to our workplaces. Employers recognize that an 
outbreak of the epidemic among their employees could shut down 
a business for weeks and longer. And in the absence of 
widespread access to the vaccine, they're taking steps to 
protect their employees. They're providing information about 
flu prevention, hand sanitation tools, and similar products. 
They're preparing for telecommuting and running their 
operations with smaller staff.
    One of today's witnesses, Ms. Elissa O'Brien, will testify 
about her company's vigorous H1N1 flu prevention efforts. Her 
company has also adopted a leave policy which generously 
provides a starting level of 26 days of paid leave and short-
term disability coverage, enough to accommodate the flu needs 
of every employee, but which would be up-ended if the one-size-
fits-all Healthy Families Act became law.
    Reading through her testimony, I was reminded that 
Washington does not have a monopoly on good ideas, and that 
whenever we act prescriptively, we also decrease flexibility 
and creativity. What works in one place of business may not 
work in another. And what we inflexibly mandate may not be best 
for all.
    I think sometimes Congress has a union mentality that the 
employer is out to hurt the employee, and the mistaken idea 
that they won't do the right thing unless they're forced to.
    As we all remember, the Healthy Families Act was a priority 
of our late chairman, Senator Kennedy. Before I entered public 
service, I was a small-business owner, so I'm speaking from 
experience when I say the goal of the legislation is something 
we all share. In a small business, employees are like family 
members. The smaller the business, the more like family 
members.
    Employers know that if they want to attract and keep good 
employees, they must give them the flexibility they need to 
care for their own health and their loved ones. Indeed, in the 
most recent member benefit survey conducted by the Society for 
Human Resource Management, some 86 percent of the respondents 
reported that their companies provided sick leave either under 
a separate sick leave program or as part of a general paid-
time-off plan. Over 80 percent of the respondents also 
indicated they provide both short-term and long-term disability 
insurance coverage, and an increasing number utilize even more 
creative approaches, such as paid time off and sick leave banks 
or pools.
    The beauty of these creative approaches is that they're 
responsive to the needs and wants of employees, the changing 
costs of providing different benefits, and the ability of the 
employer to provide such benefits while staying in business. I 
remember lots of times, when I was in business, that you'd have 
that ``sit up in the middle of the night and wonder how you're 
going to make payroll the next day.'' You never considered 
laying off people. That was absolutely a last choice. Sometimes 
you did without in order to be able to pay them.
    In contrast, the type of leave mandate by this and similar 
bills would create complete inflexibility. It also would add to 
the practical problems human resource officers deal with every 
day by importing intermittent leave and medical verification 
rules which have proven problematic in other statutes.
    In addition, this bill provides no deterrents for abuse of 
the leave entitlements, and raises privacy concerns, two issues 
that employers have found innovative ways to resolve in the 
absence of a mandate. Most employers provide sick leave 
benefits both because they know that a healthy workforce 
benefits their business, and because they know that in a 
competitive labor market, they must address this issue to 
attract and retain quality employees.
    Today, the average cost of employee benefits for all 
employers in the private sector is nearly $8.02 an hour. 
Average benefits now comprise 30 percent of total payroll 
costs. While the number of employers finding ways to provide 
paid leave as part of their benefit package continues to 
increase, there are some employees who do not have paid sick 
leave available to them at their place of work. The bulk of 
these individuals are employed by smaller employers who, 
especially in the challenging times like these, are struggling 
to maintain current payrolls. And that's getting harder and 
harder.
    Friday's job numbers showed we lost another 190,000 jobs 
last month, and the unemployment rate reached a 26-year high of 
10.2 percent.
    Hitting small business and startups with new costs and 
unfunded mandates is never advisable, and it's even more 
irresponsible during a time when job creation should be a top 
priority.
    I notice that whenever we hold a hearing on small 
businesses, I'm always asked by the media, ``How come more 
small businesses didn't show up?'' I know the reason for that. 
It's that if they had an extra employee so that they could come 
and listen to a hearing, they'd fire one person, because they'd 
have one too many people. They just don't have any extras, so 
the flexibility isn't there that's in the bigger businesses.
    It's a simple fact, whenever we impose unfunded mandates on 
employers, the money necessary to pay those increased costs 
must come from somewhere. They can't just print it, the way 
Washington does. No matter how desirable the goal, one cannot 
simply dismiss the cost as unimportant or inconsequential.
    Here, the costs are decidedly not inconsequential, 
particularly for the smaller businesses. The pool of available 
labor dollars is not infinite, and when we mandate their 
expenditure for a specific purpose, we always run the risk of 
unintended consequences, such as adding to the growing pool of 
unemployed workers.
    A dollar that must be spent here often results in a dollar 
that will not be spent elsewhere. Imagine the irony of an 
employee who's granted sick leave under this bill, but whose 
employer decides to eliminate or reduce health plan benefits.
    The H1N1 pandemic has raised concerns for Americans looking 
to protect themselves and their families, as well as for 
employers seeking to keep their businesses going and their 
employees healthy. These concerns, however, are layered on top 
of the economic worries that have recently plagued us and the 
unemployment numbers, which continue to rise. Now, more than 
ever, we should be lifting up America's small businesses where 
the growth starts and create sustainable jobs. This is not the 
time to compound problems. Small businesses are facing another 
unfunded, inflexible mandate from Washington.
    I thank the Chairman and look forward to hearing from the 
witnesses.
    Senator Dodd. Well, I thank you, Mike, for that statement.
    We're now going to ask for the Congresswoman to express 
some views.
    I should have pointed out, Rosa has been a Member of 
Congress since 1990, and it seems like only yesterday, when you 
were sitting here and introduced the Healthy Families Act, 5 
years ago, same time Senator Kennedy did, as well. You've been 
a tireless advocate on behalf of working families.
    Thank you. Your testimony and any supporting documents, 
Congresswoman, will be included in the record.

        Statement of Hon. Rosa L. DeLauro, U.S. Representative 
                            for Connecticut

    Ms. DeLauro. Thank you very much, Mr. Chairman. I might 
just say, it was in 1990 that I had the pleasure of having you 
stand next to me as I campaigned for this job. So much, much 
appreciated. As I say, I'm grateful to see you, Senator Enzi, 
this morning, delighted to come before this committee.
    I have wanted to say something when the Senator--Senator 
Enzi didn't speak first, because there's always that sense, as 
a staff person--you know, I was a staff person for so many 
years, so I sympathize with the folks behind the chairs there. 
Once a staff person, always a staff person.
    I am so grateful to be here today. And to you, Senator 
Dodd, I want to just say it, because I did have the opportunity 
of working with you as you put together--which was a 
fundamental change in public policy in the United States at a 
time when most people were not thinking about the problems and 
the concerns of working families, and that produced the Family 
Medical Leave Act. It also produced the Childcare Development 
Block Grant and other countless measures that have helped 
American workers and their families. As I say, it was 
groundbreaking and visionary public policy to meet the needs 
that people were facing in their lives, and we are all grateful 
to you for that effort.
    Today, I speak not only of a issue of basic fairness, but 
one of growing importance to our economy, particularly given 
the experience with the H1N1 virus this year, and an issue to 
which my friend and your colleague, the late Senator Kennedy, 
was passionately committed to, and that is paid sick days.
    I believe that paid sick days are a basic question of right 
and wrong, as Senator Kennedy did. Yet, as you pointed out, 
Senator Dodd, unlike 145 other nations, including 19 of the 20 
most economically competitive countries in the world, that is 
to say everyone but us, everyone but the United States, does 
not guarantee a single paid sick day to workers. Not one day. 
The Family and Medical Leave Act, which covers 60 percent of 
the workforce, is, as we all know, unpaid leave. As such, right 
now 57 million Americans cannot take time from work when they 
are sick or when they need to stay home to care for an ailing 
child or an elderly relative. And yes, it is a good thing to 
have a program that takes care of sick children while you're 
working. I think we all know, and we could talk to the medical 
profession, about how much quicker kids recover from an illness 
if they have their parent or parents with them as they're going 
through whatever the illness is.
    In fact, almost half of all private-sector workers--79 
percent of low-income workers--do not have a single paid day 
off.
    The numbers are particularly galling in the food service 
industry, where only 15 percent of workers have paid sick days. 
Food service is not an industry where we want employees showing 
up to work with contagious viral infections. All of these 
workers are forced to put their jobs on the line every time 
they take a day off.
    According to a 2008 study, one in six workers report that 
they or a family member had been fired, suspended, punished, or 
threatened with firing for taking time off due to personal 
illness or to care for a sick relative. This is unacceptable. 
It goes against who we are as a Nation.
    Even if you do not agree that providing paid sick days is a 
question of basic American values, there is more to the issue. 
Establishing paid sick days is also about economic 
competitiveness, income security for families, and, as HINI has 
proved to us this past year, primarily the public health. In 
fact, presenteeism, the practice of coming to work sick, costs 
our national economy more than it would cost to provide paid 
sick days. According to one study, $180 billion is lost 
annually; meaning that right now employers pay an average of 
about $255 per employee per year in lost productivity, more 
than the cost of absenteeism and medical and disability 
benefits.
    The argument that we cannot afford to institute paid sick 
days right now does not hold water. In fact, the opposite is 
true. Passing paid sick days would boost productivity.
    For all of these reasons and more, Senator Kennedy and I 
first introduced the Healthy Families Act, 5 years ago. Our 
bill would require employers with 15 or more workers to provide 
7 days of earned paid sick leave annually for their own medical 
needs or to care for a family member. For every 30 hours 
worked, a worker earns 1 hour of paid sick leave. It's up to a 
maximum of 56 hours. That's 7 days.
    We re-introduced the bill last May. We have 120 cosponsors 
in the House, 21 cosponsors in the Senate. The legislation is 
supported by a broad coalition of over 130 State and national 
groups, including the National Partnership for Women and 
Families, the American Association of University Women, 
MomsRising, and Business and Professional Women.
    Paid sick days has always been a good and common sense 
idea. But, in light of the recent H1N1 epidemic, it has also 
become a necessary one. Since H1N1 was first diagnosed and the 
dangers posed by widespread infection have been recognized, we 
have seen countless public health officials, even the President 
of the United States--they're on the television, they're on the 
radio to ask folks to follow a simple guideline: If you get 
sick, stay home from work or school, limit contact with others 
to keep from infecting them.
    Well, it may be all right for the President and others to 
be on TV saying that that's what folks ought to do. Yet, 
following this critical advice is virtually impossible for far 
too many Americans right now. The President has wisely called a 
national emergency to deal with H1N1, but in this economy too 
many workers cannot answer the call. When more and more workers 
are feeling economically vulnerable and afraid to even miss 1 
workday, we face an extraordinarily serious health risk that 
spreads much more quickly if the sick do not stay at home.
    Which is why I'm happy to be working with you, Mr. 
Chairman, on emergency legislation that will address the need 
to act now on this issue. Our emergency legislation would 
reflect the core principles of the Healthy Families Act. It 
would allow workers, not employers, to decide when they are too 
sick to work and when they are healthy enough to return. It 
would cover caregiving, so that parents can stay home with sick 
kids without risking their family's economic security. It would 
provide job security for workers who are too sick to come to 
work.
    Passing the Healthy Families Act or emergency legislation 
that reflects its core principles would finally give American 
workers and their families the freedom to care for themselves 
or a sick relative when they need to. It would save employers 
money, encourage productivity, help to boost our economy. Most 
importantly, right now it would protect the public health by 
helping to stop the spread of dangerous viral infections like 
H1N1.
    I hope that we, in the Congress, can honor Senator 
Kennedy's legacy by finding the strength and the will to get 
this legislation passed for America's workers and families. 
They have already waited too long.
    I thank you again for the opportunity to be here this 
morning to testify.
    [The prepared statement of Ms. DeLauro follows:]

               Prepared Statement of Hon. Rosa L. DeLauro

    Good morning. Thank you, Chairman Dodd, for the opportunity to 
testify before the subcommittee today, and for all your leadership on 
behalf of the American people. Through your hard work and tireless 
advocacy, we now have the Family and Medical Leave Act, the Child Care 
Development Block Grant, and countless other measures that help 
American workers and families. I thank you for your continued 
commitment to this cause.
    I speak today not only on an issue of basic fairness, but one of 
growing importance to our economy, particularly given our experience 
with the H1N1 virus this year. And an issue to which my friend and your 
colleague, the late Senator Kennedy, was passionately committed: paid 
sick days.
    I believe that paid sick days are a basic question of right and 
wrong, as did Senator Kennedy. Yet, unlike 145 other nations, including 
19 of the top 20 most economically competitive countries in the world--
that is to say, everyone but us--the United States does not guarantee a 
single paid sick day to workers--not one day. The FMLA, which covers 60 
percent of the workforce, is, as we all know, unpaid leave.
    As such, right now 57 million Americans cannot take time off work 
when they are sick, or when they need to stay home to care for an 
ailing child or elderly relative. In fact, almost half of all private 
sector workers--and 79 percent of low-
income workers--do not have a single paid day off. The numbers are 
particularly galling in the food service industry, where only 15 
percent of workers have paid sick days. Suffice to say, food service is 
not an industry where we want employees showing up to work with 
contagious viral infections.
    All of these workers are forced to put their jobs on the line every 
time they take a day off. According to a 2008 study, one in six workers 
report that they or a family member had been fired, suspended, punished 
or threatened with firing for taking time off due to personal illness 
or to care for a sick relative.
    To my mind, this is completely unacceptable. It goes against who we 
are as a nation. But, even if you do not agree that providing paid sick 
days is a question of basic American values, there is more to this 
issue. Establishing paid sick days is also about economic 
competitiveness, income security for families, and, as H1N1 has proved 
to us this past year, primarily the public health.
    In fact, ``presenteeism''--the practice of coming to work sick--
costs our national economy more than it would cost to provide paid sick 
days. According to one study, $180 billion is lost annually, meaning 
that, right now, employers pay an average of $255 per employee per year 
in lost productivity, more than the cost of absenteeism and medical and 
disability benefits. So, the argument that we cannot afford to 
institute paid sick days right now does not hold water--In fact, the 
opposite is true: passing paid sick days would boost productivity.
    For all of these reasons and more, Senator Kennedy and I first 
introduced the Healthy Families Act 5 years ago. Our bill would require 
employers with 15 or more workers to provide 7 days of paid sick leave 
annually for their own medical needs or to care for a family member.&
    We re-introduced the bill last May, and have almost 120 co-sponsors 
in the House and 21 co-sponsors in the Senate. This legislation is also 
supported by a broad coalition of over 130 State and national groups, 
including the National Partnership for Women and Families, the American 
Association of University Women, Moms Rising, and Business & 
Professional Women. &
    Paid sick days has always been a good, common sense idea, but, in 
light of the recent H1N1 epidemic, it has also become a necessary one. 
Since H1N1 was first diagnosed and the dangers posed by widespread 
infection have been recognized, we have seen countless public health 
officials, and even the President, take to the airwaves to ask folks to 
follow a simple guideline: If you get sick, stay home from work or 
school and limit contact with others to keep from infecting them.&
    And yet, following this critical advice is virtually impossible for 
far too many Americans right now. The President has wisely called a 
national emergency to deal with H1N1, but in this economy, too many 
workers cannot answer the call. In fact, the convergence of a deadly 
contagion like H1N1 spreading in this economic climate could well be 
catastrophic. Right when more and more workers are feeling economically 
vulnerable and afraid to even miss 1 workday, we face an 
extraordinarily serious health risk that spreads much more quickly if 
the sick do not stay at home.
    That is why I am also happy to be working with the Chairman on 
emergency legislation that will address the need to act now on this 
issue. Our emergency legislation would reflect the core principles of 
the Healthy Families Act. It would allow workers, not employers, to 
decide when they are too sick to work and when they are healthy enough 
to return. It would cover care-giving, so parents can stay home with 
sick kids without risking their family's economic security. And it 
would provide job security for workers who are too sick to come to 
work.
    Passing the Healthy Families Act, or emergency legislation that 
reflects its core principles, would not only do right by American 
workers and families, and finally give them the freedom to care for 
themselves or a sick relative when they need to. It would save 
employers money, encourage productivity, and help boost the economy. 
And, most importantly right now, it would protect the public health by 
helping to stop the spread of dangerous viral infections like H1N1.
    It would also give us one more chance to honor the life's work of a 
true champion of working people, Senator Kennedy. I wish he could have 
been here today to help make this case. He cared very deeply about this 
issue, and I know his passion and his eloquence would have steered us 
all to action. Now that he has left us, I very much hope we in Congress 
can honor his legacy once more, by finding the strength and the will to 
get this legislation passed for America's workers and families. They 
have already waited too long.
    Thank you.

    Senator Dodd. Well, Congresswoman, thank you very, very 
much. Once again, eloquent testimony, and well researched, as 
well. We thank you for your commitment, going back so many 
years, on this issue.
    I always, at times like this, like to thank colleagues, as 
well. Dan Coats and Kit Bond, who were my cosponsors of the 
Family Medical Leave Act, in a bipartisan effort in those days. 
Orrin Hatch was my cosponsor on the Childcare Development Block 
Grant Program, going back 25 years ago, now, in those areas.
    We exempt, of course, a lot of small businesses, because 
obviously--and I agree with Senator Enzi in that point, that 
when--the smaller the business, the greater the likelihood 
there's an understanding; as the numbers grow larger, they 
become far more difficult for people to accommodate those 
concerns and interests.
    The statistic in my own opening statement, that still sort 
of stunned me when I kept on reading it over and over again--
the fact that a person with H1N1 going to work, according to 
the CDC, could contaminate or affect 10 percent of that 
person's workforce, is rather breathtaking. So, beyond the 
question of the impact, obviously, the idea that we would allow 
a situation to persist that poses that much of a threat to our 
country--and we're going to get these over and over again. Now, 
this is--we'd like to think these are rare occasions. I only 
wish they were. But, the reality of our world in which we live 
today is that these kinds of issues will happen with great 
frequency. We need to get smartened up and realize it's here, 
and begin to deal with it in a comprehensive fashion, or we're 
going to find ourselves stumbling through these issues, year 
after year, without having the kind of national policy as to 
how we address these questions.
    We've always talked about a sick person in the family, or 
you being sick--today we're looking at at least 600 school 
districts closed across the country, or the ones we've had in 
our home State of Connecticut. A lot of cases, that child 
that's leaving school is not sick, you're not sick--so, we talk 
about, normally, whether--when someone is ill. We've got a new 
situation emerging. Today, with so many parents both holding 
jobs, there isn't anyone at home. The neighborhoods that we 
grew up in--I certainly did in the 1950s and 1960s, where there 
was always someone around there who could take on the 
responsibility, there was always the next-door neighbor, there 
was always the aunt, there was the grandparent, all those 
things--that's a bygone era. They don't exist anymore. They're 
not there, in most neighborhoods.
    When you're coming back, and your child all of a sudden is 
being told, ``Go home,'' there isn't anyone home. As Jane Grady 
pointed out yesterday, when you've got an 11-year-old, and 
you're sending him home, where there's no one there. These 
situations demand far more creative thinking than we've been 
able to provide. Well, we're going to find more serious 
problems with it.
    Anyway, you've answered the question, to some extent, in 
your testimony but, the question is, How can the need for paid 
sick days, that we're seeing during the H1N1 situation, point 
to a need for a broader Federal policy? That's one question I'd 
ask you to address.
    And, second, this notion, again, that, in a competitive 
environment, where we're going to--we now spend three times 
that of our major global competitors, economically, to run 
healthcare, and obviously to a significant disadvantage as we 
try to compete globally in a more competitive global economy. 
The fact that we're in the company--and I say this respectfully 
of these countries, but Lesotho, Liberia, Papa New Guinea and 
Swaziland----
    Ms. DeLauro. They can do it.
    Senator Dodd [continuing]. Those are the four other 
countries that we're--and the United States--the fifth. Those 
are the five countries that don't have paid sick leave in the 
world. That's nice company--that say this--five nations, four 
of whom are struggling economies, barely surviving as nation-
states, along with the richest, most affluent country in the 
world. The arguments we hear about this are the one's we've 
heard historically. When it comes to work hours, occupational 
safety standards, it's always the same argument, in a sense. We 
would be in a very different place in this country had we not 
had the imaginative and forceful legislation of Senator Kennedy 
and others over the years to try and make it possible and 
understand the value of having an American worker that can 
produce and be productive.
    I wonder if you might comment on that, as well as on the 
idea of looking for a broader national Federal policy.
    Ms. DeLauro. Oh, I would be happy to. I think what has 
really focused people's attention on the whole issue of paid 
sick days--because Senator Kennedy and I have been talking 
about this, and others have been talking about it for last 5 
years--but, what I think has crystallized the issue for all of 
us is the H1N1 crisis. The admonition to people is, ``Stay 
home. Be home.'' What does that mean for a single parent? What 
does that mean for a two-family parent? Yeah, when I got sick, 
my mother worked, Dad worked. I went to my grandmother's pastry 
store, and I had great care and great pastry. That is not the 
circumstance for 57 million people who work in the private 
sector. They don't have that advantage.
    Now, I think, given that, as you have pointed out, one 
needs to deal with the underlying issue, the more fundamental 
issue of uniformity of a policy, a national policy, that is 
uniform. We could all come up with--you could have 50 States 
coming up with a particular plan to meet a need.
    Emergencies will continue to occur. The basic underlying 
fact is that 57 million people in the United States of 
America--one, as you pointed out, of four countries, certainly 
not amongst the industrialized countries, all of whom are 
experiencing, quite frankly, economic difficulties--find that 
this is basically the right thing to do, to allow for paid sick 
days. Let us have a national policy that meets the needs of 
working families today.
    Also, in terms of that competitive edge, that study that I 
made reference to was done by Cornell University, that talked 
about, in fact, that it was better, in terms of bottom line, 
because of the loss in productivity, the loss of potentially--
an average, over $250 per employee, that if that person had 
paid sick days, and you were dealing with both disability and 
benefits, that you would not be losing as much by not having 
any paid sick policy at all.
    I understand the comment about small businesses, and 
there's a real awareness in the legislation with regard to 
small business. The Healthy Families Act includes a small-
business exemption. If a company has fewer than 15 employees, 
HFA does not apply. There was a recognition that small 
businesses have challenges that others may not have. The 
threshold is consistent with title VII and other labor laws.
    Let me just also mention this to you, that if--because, 
Senator Enzi, as you said--that there are others who have a 
more generous policy. Well, as a matter of fact, what the 
legislation says is that employers who already provide at least 
56 hours of paid leave, paid sick time, paid time off, do not 
have to change their existing policies, as long as the time can 
be used for the purposes that are set out in the Healthy 
Families Act.
    We want to recognize that there are people and employers 
who have made accommodations and understand the needs of their 
employees. But, you can't fly in the face of 57 million people 
who work in the private sector who do not have that 
opportunity.
    I'll make one other comment. You know, we work in the 
public sector. We go to the head of the line when we're ill, 
and probably when our families are ill. We can take as much 
time as we want. There is no one saying, ``Your job isn't going 
to be there,'' ``Your salary isn't going to be there,'' or, 
``You can't do it.''
    I'll end with this--and Senator Dodd may not be pleased 
with me for saying this--but I had a direct experience 23 years 
ago. Diagnosed with ovarian cancer, I went to my employer at 
that time--Senator Christopher Dodd--and explained my 
situation. I was about to take leave from the Senate office to 
head up a re-election campaign in 1986. Senator Dodd said to 
me, ``Rosa, go get yourself well. Don't worry about your job as 
chief of staff, don't worry about the campaign. It's there. It 
begins when you get back.''
    That's not the situation for 57 million people in this 
country. We are not special. We don't live in a rarified air. 
We need to walk in the shoes of the millions of Americans who 
work hard every day to support their families. Yes, they get 
sick, whether they're in a large business or in a small 
business. And my view is that we do have moral obligations and 
responsibilities as Members of Congress to help people meet the 
challenges that they face in their lives. That's why I hope we 
can, in fact, pass emergency legislation and the Healthy 
Families Act.
    I thank you again for the opportunity to testify.
    Senator Dodd. Thank you very much, Congresswoman. Thank you 
for that story. By the way, we won that election when you came 
back.
    [Laughter.]
    Ms. DeLauro. Yes we did.
    Senator Dodd. Senator Enzi.
    Senator Enzi. Mr. Chairman, in keeping with the tradition 
of the committee, I won't have a question for the 
Congresswoman. But, I will raise a few points in response to 
some of the things that have been said here.
    [Laughter.]
    Numbers aren't telling the whole story in this case. No 
doubt there are small businesses who are not able to have a 
paid leave policy in place officially. But, I guarantee you 
that they handle those people's situation on a case-by-case 
basis. They can't have sick people at work. Customers can tell 
if somebody's sick. They don't want sick people around them. 
Those people are taken care of, and if they want to keep them, 
they're taken care of in a method that provides them with some 
pay.
    Now, every employer won't be able to do that. I would tell 
you that I think the small employers probably want to do it 
more than the big employers. To the small employer, the 
employee is really a person. To the big employers, it's a 
number out there, and if you've got to make the bottom line 
come out right, you move the numbers around to where it fits. 
But, that doesn't happen in small business, for the most part. 
There are always exceptions.
    I have some real-life examples, too. I have a daughter that 
has one of my grandchildren. And she has a babysitter. If one 
of the kids at the babysitter is sick, all of them get sent 
home. That means that my daughter has to take off from work and 
go home and be with the baby. There's a leave policy, but it's 
not a paid leave policy. I understand this, and I suppose some 
would assume I ought to really be rooting for it on the basis 
of my daughter. She really likes the flexibility that she gets 
in her job, and she likes what she gets paid, and so, it is 
worth it to her to accommodate that.
    It's been mentioned that we can take as much time as we 
want here. I couldn't, when I had a small business. If I got 
sick, I had to show up, because there wasn't anybody that was 
going to do what I did. If I was really sick, and I couldn't 
show up, the business suffered.
    I'm a little surprised at your statement that your mom sent 
you to the bakery.
    [Laughter.]
    We're going to be handling food safety here, pretty quick.
    Ms. DeLauro. But I didn't handle the food.
    Senator Enzi. This bill takes the small business definition 
down from 50 employees that are presently covered by FMLA, 
which is not paid leave, down to 15. And the smaller the 
business is, the less flexibility with spare employees there 
is. We're in an economy now, where if I'm the guy that has 15 
employees, do you think I'd hire a 16th one, with us 
considering this piece of legislation? I wouldn't be able to. 
That would force me into a situation. As a small business 
employer we had paid sick leave, so I know the problems that 
come with sick leave, as well. You have some employees that 
never take it, and you have others that don't have a half a day 
of earned sick leave available to them because the minute they 
do, they take it, for whatever purpose. It's pretty hard to 
question those purposes.
    I'll be interested in reviewing, in the bill, what the 
exceptions are. I'm curious as to whether it can be accrued, 
whether it carries over from year to year, and whether you get 
compensated for unused sick leave if you leave the business? 
Those are all questions that the employers have to deal with, 
plus the part-of-an-hour times that people are gone, for 
whatever medical reason. A lot of bookkeeping things are 
involved in this and the more of these things that you add to 
business, the less likely they are to be able to expand and 
hire other employees, in a time when we need to be hiring other 
employees. We need to be getting people employed.
    People are waiting now on startups on business, waiting to 
see what kind of rules and regulations they're going to have to 
have when they start up. They are concerned we could take away 
their flexibility and make all businesses the same in this 
area. I don't think that'll help the employment situation.
    I don't have any questions.
    Senator Dodd. Rosa, we thank you immensely. I don't know if 
Congressman Merkley or--I said Congressman--Senator Merkley--
Jeff, I apologize--it was Congresswoman DeLauro.
    Senator Murray, welcome, as well. Do you have any questions 
for the Congresswoman?
    Senator Merkley. Thank you very much, Mr. Chair. I'd just 
like to give the Congresswoman a chance to elucidate on some of 
those questions on carryover, or compensation for unused sick 
leave, or any of those other details that might be helpful to 
understanding how this would work when the rubber hits the 
road.
    Ms. DeLauro. The legislation is silent on those issues, and 
those are the details that can get worked out.
    I just might add that I can recall very similar kinds of 
conversations when we were going through the Family and Medical 
Leave, that we were going to, really--that American business 
was going to go to hell in a hand basket, quite frankly. That 
it was going to end--our small businesses--it was going to 
bring that to a crashing halt. I think we haven't seen that to 
be the case with Family and Medical Leave. I think there are 
lots of the details obviously to get sorted out and worked out, 
which is the way they did with Family and Medical Leave, and 
how it can proceed forward.
    I will give you another example of where I found this to be 
so poignant. I had the opportunity to meet with the families of 
some of our troops overseas, in Iraq and Afghanistan, and, as 
it turned out, most of the families were young women with small 
children. I will tell you that it was a real awakening, in 
terms of talking about emergencies and so forth, of what comes 
up. We think about H1N1.
    These young women were really frightened. Obviously, 
they're frightened on a whole variety of issues that have to do 
with the survival of a spouse. But, they were working women. 
They did have their kids in daycare, or where ever they had 
them during the day. They didn't have paid sick time--they got 
sick, their kids got sick. I know, personally, because we had a 
case in our office, where we went to bat for a young woman who 
was told, her job was coming to an end because she took 3 days 
off with a child.
    This is a real issue for working men and women in this 
country. If we don't believe we have to address it, as we have 
other public policy issues that directly affect working 
families, we're not going back to an economic situation where 
you have someone who is home all day, and who is waiting for 
children to come home or can stay there. That's not what our 
opportunity is. I think we can get to sorting out what the 
details are, and making sure that we're not putting--the goal 
is not to put people out of business. The goal is to try to 
make sure we have a public policy that ensures that people have 
adequate kinds of assistance when they get sick, or their kids 
get sick, or an elderly relative gets sick.
    Senator Dodd. Thank you very much, Congresswoman.
    Thank you, Senator Merkley.
    Senator Merkley. Thank you.
    Ms. DeLauro. Thank you, Senator.
    Senator Dodd. Senator Murray.
    Senator Murray. Mr. Chairman, I do not have a question for 
Representative DeLauro. I do thank you for being here.
    I really want to thank you for having this hearing. This is 
such a dilemma for families today, with the current H1N1 issue. 
Families are having to decide between a tough economy, where 
they don't have income, and following the regulations of 
staying home that CDC has issued. We shouldn't put families in 
that bind. We should make sure that they stay home when they're 
sick, so that they don't spread the flu, but they don't lose 
their ability to put food on the table and pay their mortgage 
at the same time. I really appreciate your holding this hearing 
today.
    Senator Dodd. Thanks very much. Thank you, Senator, very 
much.
    Congresswoman, we thank you immensely.
    Ms. DeLauro. Thank you Mr. Chairman, thank you Senator 
Enzi. Thank you.
    Senator Dodd. Let me invite our second panel to come on up 
and join us.
    Welcome Deputy Secretary Seth Harris to the subcommittee 
today. I look forward to his testimony on behalf of the 
Department of Labor. Mr. Harris was nominated to be Deputy 
Secretary of Labor on February 23, 2009. Prior to his position 
at DOL, Mr. Harris was a professor of the law at New York Law 
School, and director of its labor and employment law programs. 
He's also a member of the National Advisory Commission on 
Workplace Flexibility. He also served at the Department of 
Labor during the Clinton administration. And is a graduate of 
NYU and Cornell University.
    We thank you, Mr. Harris, for joining us.
    I'd also like to welcome Rear Admiral Anna Schuchat. Did I 
pronounce that correctly, the last name? Doctor, we welcome you 
very much. Dr. Schuchat first joined the CDC in 1988. She has 
done extensive work in preventing infectious diseases in 
children. She has worked in a variety of countries, on topics 
including meningitis and pneumonia vaccine studies, 
surveillance, and prevention; and SARS emergency response and 
epidemiological studies. Dr. Schuchat attended Swarthmore 
College, Dartmouth Medical School, and now serves as CDC's 
deputy director for science and program.
    We welcome you, Doctor, to the committee, as well.
    Why don't we begin with you, Secretary Harris, and then 
we'll go right to Dr. Schuchat.

   STATEMENT OF HON. SETH D. HARRIS, DEPUTY SECRETARY, U.S. 
              DEPARTMENT OF LABOR, WASHINGTON, DC

    Mr. Harris. Thank you very much, Chairman Dodd, Senator 
Enzi, Senator Murray, and Senator Merkley. I appreciate the 
opportunity to testify about workplace flexibility and paid 
leave in the context of the 2009 H1N1 flu pandemic.
    Mr. Chairman, I'd like to begin by acknowledging your 
outstanding leadership on these most critical issues. You're 
the father of the Family and Medical Leave Act, and one of the 
Nation's most important advocates for America's working parents 
and their children. Whether fighting to ensure that children 
receive the H1N1 vaccine, or to extend the Family and Medical 
Leave Act to our military heroes, you've shown over and over 
again your deep and abiding commitment to Americans who are 
struggling to perform their jobs while also caring for 
themselves and their loved ones at home. It's essential work, 
and we're fortunate to have you leading the way, sir.
    I'd also like to acknowledge Congresswoman DeLauro for her 
comments this morning, and for her continuing and tireless work 
on behalf of our Nation's hardworking families.
    Mr. Chairman, we live in a time of pandemic. Much has been 
done to prepare for the 2009 H1N1 public health emergency, but 
more must be done to protect the economic security of working 
families when illness strikes. Our current system forces too 
many sick workers to go to work, and too many working parents 
to send sick children to school or daycare. This system poses a 
threat to our public health, our economic future, and a social 
system that depends heavily on people caring for themselves and 
their family members.
    Full economic security for workers who must tend to their 
own illnesses or the illnesses of their family members requires 
two assurances. First, workers who take leave must not lose 
their jobs or suffer some other form of discipline from their 
employers. And second, they must have a source of income during 
any leave period. Under our existing legal regime, millions of 
workers get neither of these two assurances. Current Federal 
law does not mandate employers to provide paid, job-protected 
leave to their workers.
    The Family and Medical Leave Act has helped millions of 
workers take unpaid leave without fear of firing or discipline, 
but the FMLA protects only those workers employed by employers 
with more than 50 employees, and only if the employees meet 
certain eligibility criteria. Even if both the employer and the 
employee are covered by the FMLA, leave is available only for 
serious health conditions, which would not include a large 
percentage of cases of the 2009 H1N1 flu, the seasonal flu, and 
other common and contagious diseases. Equally important, many 
workers simply cannot afford to take the unpaid leave provided 
by the FMLA.
    In 2008, the Bureau of Labor Statistics found that only 61 
percent of private sector employees are offered paid sick leave 
for their own illness or injury, and high-wage workers were 
more likely to have paid leave than low-wage workers; only 49 
percent of low-wage workers have access to paid sick or 
personal leave. Other Federal laws and programs also do not 
provide workers with job security or income when they're sick 
or need to take time off to care for their family members.
    Unemployment insurance and disaster unemployment assistance 
cover workers only if they are able and available to work. A 
worker who cannot work because of illness or caregiving 
responsibilities would not be eligible. The bottom line for 
sick workers and workers with sick family members is that 
taking leave risks their jobs and their ability to support 
their families.
    The situation is a concern for employers as well as 
employees. The CDC reports--as you said, Mr. Chairman--on 
average, that an individual who comes to work with the H1N1 flu 
will infect 10 percent of his or her coworkers. Instead of one 
sick worker staying home, an employer could end up with dozens 
of sick workers, who are unproductive, making their coworkers 
unproductive, and potentially spreading a contagious disease to 
their families and friends. It is common sense and good 
business sense. Workers should be able to stay home if they are 
ill.
    On August 19, 2009, Secretary Solis joined the Secretaries 
of Health and Human Services, Commerce, and Homeland Security 
in announcing the CDC's updated guidance to employers on how to 
respond to the 2009 H1N1 pandemic. The guidance notes that, 
``Employers play a key role in community mitigation.'' That is, 
efforts by all of us to limit the pandemic's effects. Central 
to community mitigation is that all people with influenza-like 
illness should stay home and away from the workplace.
    That's why this Administration strongly supports the 
Healthy Families Act. This legislation would ensure that 
millions more of working Americans will be able to earn up to 
56 hours of paid sick time for family care or self care. 
Simply, the Healthy Families Act provides the assurances that 
workers need. It assures them job security when they take sick 
leave or leave to care for a family member, it provides short-
term continuation of the workers' income, while they recuperate 
from illness or provide needed care to a family member.
    Mr. Chairman, the current system is broken. We welcome the 
opportunity to work with you and the other members of this 
committee to fix it.
    Once again, thank you very much for inviting me to testify 
today. I look forward to your questions.
    [The prepared statement of Mr. Harris follows:]

                   Prepared Statement of Seth Harris

    Good morning Chairman Dodd, Ranking Member Alexander, and members 
of the committee. I am pleased to join you and share the regards of 
Secretary Solis.
    The vision of the Department of Labor (DOL) is good jobs for 
everyone. One important component of this vision is ensuring workplace 
flexibility for family and personal care-giving. While much has been 
done to help prepare for a public health emergency like the current 
2009 H1N1 pandemic, the Administration believes that more must be done 
to help protect the economic security of working families who often 
must choose between a pay check and their health and the health of 
their families.
    Today, I will address current Federal leave law and regulations as 
they pertain to the private sector, the challenges which arise during 
times of widespread illness, such as H1N1, and the Administration's 
support for paid leave and increased workplace flexibility policies 
such as the proposal introduced earlier this year by Senator Kennedy, 
the Healthy Families Act.
    Current Federal law does not mandate that employers provide paid 
leave to their workers. Rather, the only Federal law on leave, the 
Family and Medical Leave Act (FMLA), requires employers with 50 or more 
employees to provide unpaid leave to eligible workers under a limited 
set of circumstances. Under FMLA, covered and eligible employees are 
entitled to take up to 12 workweeks each year of job-protected, unpaid 
leave for the ``serious health condition'' of the employee or of the 
employee's son, daughter, spouse or parent where the reason for the 
leave meets the strict requirements of the FMLA. In many instances of 
leave needed in response to a widespread public health emergency, such 
as the 2009 H1N1, the FMLA will simply not provide protections. An 
estimated 60 percent of the workforce is covered and eligible for 
unpaid leave but only when the leave is for reasons that qualify 
pursuant to the strict FMLA standards.
    Other Federal laws and programs generally do not provide much 
assistance to workers needing job security and income when they are 
sick or need to take time off to care for family members.
    Unemployment Insurance (UI) and Disaster Unemployment Assistance 
(DUA) do not cover workers who may lose their jobs and are not ``able 
and available to work'' (with a limited exception under DUA for workers 
injured by a disaster). During a pandemic, individuals who are laid off 
because their work site is closed or because business has declined due 
to an outbreak would be eligible for regular UI as long as they are 
able to, available for, and actively seeking work. The UI program does 
not cover individuals who are sick, are caring for someone who is sick, 
are caring for well children dismissed from school, or are otherwise 
not available and actively seeking work.
    Individuals ineligible for regular UI who lost their jobs as a 
direct result of a major disaster declared due to severe pandemic flu 
and individuals who are unemployed because they contract the flu and 
are unable to work might qualify for DUA. However, individuals who are 
unemployed because they are caring for sick family members, are caring 
for children whose schools have been closed, or are quarantined, are 
generally not ``able and available'' and would not be eligible for DUA. 
DUA would also not be payable to individuals whose unemployment is only 
indirectly related to the severe pandemic flu outbreak and is only 
available if there is a disaster declaration.
    In 2008, the Bureau of Labor Statistics (BLS) surveyed private 
sector employers about their leave policies. While approximately 7 in 
10 employees received paid leave to attend jury duty and funerals, only 
61 percent of private sector employees were offered sick pay for their 
own illness or injury. Thirty-seven percent of employees were offered 
paid time off for personal reasons, and 8 percent were offered paid 
leave for family reasons. Federal, State and local government 
employees' access to paid and unpaid leave is greater than private 
sector employees' for all types of leave.
    A variety of factors are associated with the availability of paid 
leave. In its March 2008 National Compensation Survey, the BLS found 
that the availability of paid leave increases with income. Eighty-three 
percent of the highest-paid workers (wages in the top 10th percentile 
and above) had access to paid sick leave, compared to just 23 percent 
of the lowest paid workers (bottom 10th percentile). In addition, 54 
percent of the highest paid workers were able to access paid leave for 
personal reasons compared to 17 percent of the lowest paid workers.
    Low-wage workers have less access to paid leave, and thus are more 
likely to go to work even if they are sick or their child is sick. Only 
49 percent of low-wage workers have access to paid sick leave or 
personal leave or family leave or vacation.\1\ Particularly vulnerable 
are the 3.7 million working adults in households with children under 14 
years old and no other adult or older child to share child caring 
responsibilities. Single parents and low-wage workers can find it 
challenging to stay home even for a few days.
---------------------------------------------------------------------------
    \1\ Low-wage workers are defined as workers earning less than $7.25 
an hour in March 2008. Iris S. Diaz and Richard Wallick, ``Leisure and 
illness leave: estimating benefits in combination,'' Monthly Labor 
Review, February 2009, Volt. 132, No. 2.
---------------------------------------------------------------------------
    The lack of paid leave and other workplace flexibilities has 
significant impacts on the Nation's workforce. This lack of access to 
paid leave forces many workers to choose between taking care of their 
health and the health of their families and paying their bills. This is 
made even more troublesome when the illness is contagious, like 
seasonal and pandemic influenza, given that the consequences of 
employee's decisions to go to work when ill or to send a sick child to 
school can adversely affect many others.
    Flu activity is now widespread in 48 States. According to the CDC, 
of all visits to doctors nationally, the proportion that are for 
influenza-like-illness continues to increase steeply and is now higher 
than what is seen at the peak of many regular flu seasons. In addition, 
flu-related hospitalizations and deaths continue to rise
nationwide and are above what is expected for this time of year.
    In the context of the current 2009 H1N1 pandemic, FMLA job 
protections may be available to relatively few workers who need leave. 
For example, healthy workers who stay at home to care for their healthy 
children while schools are closed would not be covered. Additionally, 
FMLA leave would only be available if the covered and eligible 
employee's or family member's medical condition meets the definition of 
a ``serious health condition.'' For example, where the individual with 
2009 H1N1 is not hospitalized, the employee or family member would have 
to receive in-person treatment from a health care provider within 7 
days of the onset of incapacity and have a second in-person treatment 
visit within 30 days or otherwise meet continuing regimen of treatment 
requirements for the illness to qualify as a ``serious health 
condition,'' a requirement that may be difficult to meet if public 
health officials recommend that the majority of sick individuals not 
seek medical treatment absent complications. Moreover, even where an 
employee's leave is covered by FMLA, this law does not address the 
problems associated with employees lacking access to pay while on 
leave. Even in the rare instances when the illness is serious enough to 
meet these qualifications, this law does not help those who cannot 
afford to take time off because their employer does not offer paid 
leave or if they have used whatever paid leave they have. It also does 
not help those who need to care for their extended family members.
    Employer-provided workplace flexibilities could help workers who 
need time off during a pandemic--as well as in ordinary times. However, 
according to BLS, private industry employers offer formal flexible 
workplace arrangements \2\ to only 5 percent of workers. Like paid sick 
leave, eligibility for flexible work arrangements is higher for full-
time workers than part-time and increases with income.
---------------------------------------------------------------------------
    \2\ Flexible workplace arrangements are ``the ability to work an 
agreed-upon portion of a work schedule at home or some other approved 
location, such as a regional work center.''
---------------------------------------------------------------------------
    Given the lack of Federal laws regarding paid leave, five States 
have used temporary disability insurance programs to provide income to 
workers who experience non-occupational illnesses or injuries. 
California and New Jersey have implemented paid leave programs in 
addition to their temporary disability insurance programs. In addition, 
several cities have passed ordinances requiring certain employers to 
provide paid sick leave to their employees, though these plans were 
established many years ago--not necessarily in response to current 
conditions.
    The scope of the current 2009 H1N1 public health emergency 
demonstrates the need for paid leave and flexible workplace policies. 
The goal of the U.S. Government and its State and local partners to 
date has been to slow the spread of a pandemic and mitigate its social 
and economic impact through the use of antivirals and non-
pharmaceutical interventions, often referred to as community mitigation 
strategies. The Federal Government adopted community mitigation as 
Federal policy in 2007.\3\
---------------------------------------------------------------------------
    \3\ See Community Strategy for Pandemic Influenza Mitigation (CMG).
---------------------------------------------------------------------------
    On August 19, 2009, Secretary Solis joined the Secretaries of 
Health and Human Services, Commerce and Homeland Security in issuing a 
letter announcing the Centers for Disease Control and Prevention's 
(CDC) updated guidance to employers on how to respond to the 2009 H1N1 
pandemic. CDC notes in their guidance that businesses and other 
employers play a key role in protecting employees' health and safety, 
as well as in limiting the negative impact of influenza outbreaks on 
the individual, the community, and the Nation's economy. I would like 
to share a few highlights from this guidance that are most relevant to 
the question before the subcommittee today.
    First, the guidance recognized that all employers must balance a 
variety of objectives when determining how best to decrease the spread 
of influenza and lower the impact of influenza in the workplace. They 
should consider and communicate their objectives, which may include one 
or more of the following: (a) reducing transmission among staff, (b) 
protecting people who are at increased risk of influenza-related 
complications from getting infected with influenza, (c) maintaining 
business operations, and (d) minimizing adverse effects on other 
entities in their supply chains.
    Second, the guidance noted that during an influenza pandemic, all 
people with influenza-like illness should stay home and away from the 
workplace. If the severity of illness increases, employers should be 
ready to implement additional measures and public health officials may 
recommend a variety of methods for increasing the physical distance 
between people (called social distancing) to reduce the spread of 
disease. These could include school dismissal, child care program 
closure, canceling large community gatherings, canceling large 
business-related meetings, spacing workers farther apart in the 
workplace, canceling non-essential travel, and utilizing work-from-home 
strategies for workers who can conduct their business remotely.
    CDC recommends that people with influenza-like illness remain at 
home until at least 24 hours after they are free of fever (100 F 
[37.8 C]), or signs of a fever without the use of fever-reducing 
medications to reduce the number of people infected. In most cases, 
this means staying home 3 to 5 days.
    CDC has asked employers to allow sick workers to stay home without 
fear of losing their jobs and to develop other flexible leave policies 
to allow workers to stay home to care for sick family members or for 
children if schools dismiss students or child care programs close.
    While the Federal Government has been working diligently to provide 
guidance and implement community mitigation strategies, these 
strategies often do not help address the economic conditions facing 
families without leave.
    For example, during a severe pandemic, compliance with community 
mitigation measures, including home isolation, quarantine and school 
closures (particularly extended school closures), would have a negative 
economic impact on many workers and their families. As I mentioned 
previously, a significant number of workers do not have access to 
sufficient paid or unpaid job-protected leave, nor do many have access 
to other workplace flexibilities, such as telework, which would allow 
them to stay home when sick or when exposed to someone who is sick 
(self-quarantine), to care for a family member who is sick, or to care 
for a child dismissed from school.
    Staying home from work in compliance with community mitigation will 
cost workers income because they are on unpaid leave--or could cost 
them their jobs if they are laid off because they cannot come to work. 
These issues are of particular concern for low-wage, part-time and 
otherwise vulnerable workers. Such single parents and low-wage workers 
will find it particularly challenging to care for a child dismissed 
from school for an extended period of time during a severe pandemic.
    The economic cost to working families associated with the lack of 
paid leave is significant not only during times of influenza pandemics. 
These are decisions that working families must make daily--choices 
between keeping their jobs and taking care of their health and the 
health of their children.
    In addition, paid leave represents a relatively small share of 
total compensation costs. In its June 2009 Employer Costs of Employer 
Compensation survey, BLS calculated the costs of paid leave borne by 
employers. All types of paid leave for private industry add up to 6.8 
percent of total compensation costs, or $1.85 per employee hour out of 
$27.42. BLS also reports employer costs for paid leave across different 
occupational groups. Workers in the highest paid category--management 
and professional--earn a total of $48.96 per hour and their paid leave 
equals 8.4 percent of total compensation. The lowest paid occupational 
group--service workers--earn on average $13.15 per hour, only slightly 
more than 25 percent of the rate for management and professional. Paid 
leave for this group accounts for only 4.2 percent of their total 
compensation.
    The Healthy Families Act offers an important opportunity to provide 
workers with economic security by assuring that they have the ability 
to stay home if they are sick without fear of losing their jobs or 
being forced to go to work sick because they cannot afford to stay 
home. We support this bill and look forward to working with you on it 
as it moves through the legislative process.
    As mentioned, the vision for the Department of Labor is good jobs 
for everyone. And one of the key components of a good job is having 
workplace flexibility for family and personal caregiving. We believe 
that work-life balance includes policies such as paid leave, flexible 
work schedules and teleworking, employee assistance programs, 
childcare, and elder-care support. Jointly with our colleagues in the 
Cabinet, DOL is working to improve work-life policies, and efforts are 
underway to see how we can better meet the needs of modern working 
families.
    Finally, an important part of helping families stay healthy and 
ensuring employers have a productive workforce is health insurance 
reform. Health insurance reform can relieve the burden of rising health 
care costs on small businesses, increase accessibility for young 
adults, increase transparency and accountability in the insurance 
industry, empower consumers, lower costs, reform the delivery system, 
improve the quality of care, simplify the administrative bureaucracy, 
and give consumers more knowledge and more bargaining power. We 
encourage the Senate to pass health insurance reform.
    In conclusion, it is clear that while much has been done to help 
prepare for a national health emergency like 2009 H1N1, more is needed 
to help protect the economic security of working families who must 
choose between a pay check and their health and the health of their 
families. That is why the Administration supports the Healthy Families 
Act and other proposals that advance workplace flexibility and protect 
the income and security of workers. I appreciate your time today, and I 
am happy to answer any questions you may have.

    Senator Dodd. Thank you very much, Secretary Harris.
    Doctor, we welcome again. You've been before the committee 
in the past, so we welcome you here again.

        STATEMENT OF ANNE SCHUCHAT, M.D., ACTING DEPUTY 
 DIRECTOR FOR SCIENCE AND PROGRAM, CENTERS FOR DISEASE CONTROL 
   AND PREVENTION AND ASSISTANT SURGEON GENERAL, U.S. PUBLIC 
 HEALTH SERVICE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, 
                          ATLANTA, GA

    Dr. Schuchat. Thank you, Mr. Chairman, and thank you, 
Senator Enzi and members of the committee. It's a pleasure to 
update you on the Administration's response to the H1N1 virus, 
and comment on the impact this pandemic is having on work, 
school, and our society.
    Many millions of Americans have already been infected with 
the 2009 H1N1 strain. Thousands of hospitalizations and more 
than 1,000 deaths have occurred already. The virus is 
widespread now, in 48 States. So far there is no change in the 
illness pattern caused by the virus.
    This is disproportionately a younger person's disease. It 
disproportionally affects adults with chronic conditions such 
as asthma, diabetes, conditions that are far too common in 2009 
in America. It also disproportionally affects pregnant women, 
who have suffered hospitalizations and deaths to a great 
extent.
    So far, our CDC scientists have found no change in the 
virus. There's been no genetic change that would make this--
escape the protection that vaccines will afford, and no change 
to rapidly increase the proportion of strains that are 
resistant to our medicines, like TAMIFLU. However, influenza is 
unpredictable, and it is unpredictable what trajectory this 
virus will have in the weeks and months ahead. Only time will 
tell.
    CDC's role in this H1N1 response has been aggressive and 
science-based. I'd like to thank the Congress and this 
committee for the many years with which you have recognized 
that public health is integral to public safety. The 
investments that Congress has made in preparedness over the 
past several years mean that we are far better prepared for 
this response than we would have been. I shudder to think how 
we would be doing had H1N1 hit our shores 4 or 5 years ago.
    We rapidly identified this new virus and characterized it; 
we developed a candidate vaccine strain and handed it off to 
industry to develop vaccines; we carried out epidemiologic and 
laboratory surveillance in the United States and abroad. We 
have had an aggressive, comprehensive, and science-based 
response, rapidly deploying CDC assets, like life-saving anti-
viral medicines that were part of our strategic national 
stockpile. Laboratory kits that were rapidly developed through 
pandemic flu investments were shipped to all of the public 
health labs in the United States and to more than 150 other 
countries so we cold track the spread of this virus and 
understand whether it was changing, and make sure that the 
vaccines under development would still work.
    We deployed field teams to provide technical assistance at 
home and abroad. We've issued a series of science-based 
guidance that we have updated as the science has changed or 
come to light. We've shared these with key sectors, including 
the healthcare system. We've focused on prevention for schools, 
businesses, and healthcare workers, and on treatment with 
antivirals, focusing on outreach to providers, to pharmacies, 
and to the public. We have had an aggressive and multifaceted 
communication strategy, using traditional media and new media. 
We have focused on the shared responsibility each of us plays 
in responding to the H1N1 virus, stressing that ill people 
should stay home from school or work, and avoid spreading the 
virus to others. We have launched a voluntary immunization 
program.
    The vaccination effort has been unprecedented, from 
developing the strain virus for vaccine development, the 
exquisitely expert clinical trials that the NIH carried out, 
issuing science-based recommendations for use of these 
vaccines. It is a public-private partnership.
    We are very disappointed in the initial production of the 
vaccine. These are made using biologic processes, egg-based 
technology that is tried and true, but that is fragile. We are, 
to some extent, a victim of a slow-growing virus that has not 
cooperated. Now the production is accelerating and we are 
seeing substantial amounts of vaccine becoming available. We 
are receiving, ordering, delivering, rapidly, the vaccine 
doses. As of today, 41.1 million doses of H1N1 vaccines are 
available for the States to order. Three-fourths of this is in 
the form of injectable vaccine and one-quarter is the nasal 
spray. The pace of our progress is truly picking up.
    We have prioritized five groups for early use of the 
vaccine, the groups that are at highest risk for disease or its 
complications or most likely to spread infection. The State and 
local health authorities are in the position of making 
decisions on the best ways to reach these priority populations. 
It is important for us to use every dose of vaccine as it 
becomes available to slow the spread of this pandemic and to 
protect the most vulnerable parts of our population.
    We have developed this vaccine in record time without any 
shortcuts on safety. We have also enhanced our vaccine safety 
system to be ready for concerns, to try to make sure that if 
there are unanticipated problems, we find them quickly and 
respond appropriately. We are working hard across Health and 
Human Services and with all of the Federal Government to manage 
this response, but fundamentally we are relying on State and 
local public health to direct the vaccination efforts in their 
communities.
    This pandemic did not come at a good time for our economy, 
and the public health infrastructure around the country has 
been frayed. But, H1N1 does highlight the need for long-term 
investing in that infrastructure. This hearing, though, 
highlights the human and economic impact of influenza and other 
illness on the workplace and on business continuity. Our CDC 
guidance has recommended that individuals stay home when they 
are sick and not spread infection in the workplace. We've asked 
businesses to be flexible about leave policy, and, where 
appropriate, to encourage issues, like telecommuting, that 
would reduce spread in the workplace.
    It's really important to have the right policies in place 
and to plan for contingencies, but our goal really is to make 
it easy for people to make the right choices, to make the 
healthy choices. I really applaud the committee for taking this 
issue seriously.
    My colleagues and I at CDC and across Health and Human 
Services are committed to sustaining communication and to 
answering your questions going forward.
    [The prepared statement of Dr. Schuchat follows:]

         Prepared Statement of Rear Admiral Anne Schuchat, M.D.

    Chairman Dodd, Ranking Member Alexander, members of the committee, 
thank you for this opportunity to update you on the public health 
challenges of 2009 H1N1 influenza.
    CDC and our colleagues throughout the Department of Health and 
Human Services (HHS) are working in close partnership with many parts 
of the Federal Government, as well as States and localities, under a 
national preparedness and response framework for action that builds on 
the efforts and lessons learned this previous spring and from past 
influenza preparedness trainings. Working together with governors, 
mayors, tribal leaders, State and local health departments, the medical 
community and our private sector partners, we have been monitoring the 
spread of H1N1 and facilitating prevention and treatment, including 
starting to implement a vaccination program.
    Influenza is probably the least predictable of all infectious 
diseases, and the 2009 H1N1 pandemic has presented considerable 
challenges--in particular the delay in production of a vaccine due to 
slow growth of the virus during the manufacturing process. Today I will 
update you on the overall situation, provide an update on vaccination 
status, and discuss other steps we are taking to address these 
challenges.
    This hearing is also an important opportunity to consider the 
impact this pandemic has had on work, school, and society. And although 
we are focused this year on the impact of the H1N1 pandemic, it is 
important to remember that even in a normal year, individuals and 
institutions are impacted by illnesses, as reflected in lost work and 
school days and lower productivity. Data from our National Center for 
Health Statistics in 2008 show, for example, that employed adults 18 
years of age and over experienced an average of 4.4 work-loss days per 
person due to illness or injury in the past 12 months, for a total of 
approximately 698 million work-loss days.

               TRACKING AND MONITORING INFLUENZA ACTIVITY

    One major area of effort is the tracking and monitoring of 
influenza activity, which helps individuals and institutions monitor 
and understand the impact of the 2009 H1N1 virus. Since the initial 
spring emergence of 2009 H1N1 influenza, the virus has spread 
throughout the world. H1N1 was the dominant strain of influenza in the 
southern hemisphere during its winter flu season. Data about the virus 
from around the world--much of it collected with CDC assistance--have 
shown that the circulating pandemic H1N1 virus has not mutated 
significantly since the spring, and the virus remains very closely 
matched to the 2009 H1N1 vaccine. This virus also remains susceptible 
to the antiviral drugs oseltamivir and zanamivir, with very rare 
exception.
    Unlike in a usual influenza season, flu activity in the United 
States continued throughout the summer, at summer camps and elsewhere. 
More recently, we have seen widespread influenza activity in 48 States; 
any reports of widespread influenza this early in the season are very 
unusual. Visits to doctors for influenza-like illness as well as flu-
related hospitalizations and deaths among children and young adults 
also are higher than expected for this time of year. We are also 
already observing that more communities are affected than those that 
experienced H1N1 outbreaks this past spring and summer.
    Almost all of the influenza viruses identified so far this season 
have been 2009 H1N1 influenza A viruses. However, seasonal influenza 
viruses also may cause illness in the upcoming months--getting one type 
of influenza does not prevent you from getting another type later in 
the season. Because of the current H1N1 pandemic, several additional 
systems have been put in place and existing systems modified to more 
closely monitor aspects of 2009 H1N1 influenza. These include the 
following:
    Enhancing Hospitalization Surveillance: CDC has greatly increased 
the capacity to collect detailed information on patients hospitalized 
with influenza. Using the 198 hospitals in the Emerging Infections 
Program (EIP) network and 6 additional sites with 76 hospitals, CDC 
monitors a population of 25.6 million to estimate hospitalization rates 
by age group and monitor the clinical course among persons with severe 
disease requiring hospitalization.
    Expanding Testing Capability: Within 2.5 weeks of first detecting 
the 2009 H1N1 virus, CDC had fully characterized the new virus, 
disseminated information to researchers and public health officials, 
and developed and begun shipping to States a new test to detect cases 
of 2009 H1N1 infection. CDC continues to support all States and 
territories with test reagents, equipment, and funding to maintain 
laboratory staff and ship specimens for testing. In addition, CDC 
serves as the primary support for public health laboratories conducting 
H1N1 tests around the globe and has provided test reagents to 406 
laboratories in 154 countries. It is vital that accurate testing 
continue in the United States and abroad to monitor any mutations in 
the virus that may indicate increases in infection severity, resistance 
to antiviral drugs, or a decrease in the match between the vaccine 
strain and the circulating strain.
    Health Care System Readiness: HHS is also using multiple systems to 
track the impact the 2009 H1N1 influenza outbreak has on our health 
care system. HHS and CDC are in constant communication with State 
health officials and hospital administrators to monitor stress on the 
health care system and to prepare for the possibility that Federal 
medical assets will be necessary to supplement State and local surge 
capabilities. To date, State and local officials and health care 
facilities have been able to accommodate the increased patient loads 
due to 2009 H1N1, but HHS is monitoring this closely and is prepared to 
respond quickly if the situation warrants.
    Implementing a Flu-related School Dismissal Monitoring System: The 
Centers for Disease Control and Prevention (CDC) and the U.S. 
Department of Education (ED), in collaboration with State and local 
health and education agencies and national non-governmental 
organizations, have implemented a flu-related school dismissal 
monitoring system for the 2009-2010 school year. This monitoring system 
generates a verified, near-real-time, national summary report daily on 
the number of school dismissals by State across the 130,000 public and 
private schools in the United States, and the number of students and 
teachers impacted. The system was activated August 3, 2009. This has 
helped us to calibrate our messages and guidance and may have 
contributed to the smaller number of school closings seen in the fall 
relative to those seen in the spring.

                    PROVIDING SCIENCE-BASED GUIDANCE

    A second major area of effort in support of individuals and 
institutions is to provide science-based guidance that allows them to 
take appropriate and effective action. Slowing the spread and reducing 
the impact of 2009 H1N1 and seasonal flu is a shared responsibility. We 
can all take action to reduce the impact flu will have on our 
communities, schools, businesses, other community organizations, and 
homes this fall, winter, and spring.
    There are many ways to prevent respiratory infections and CDC 
provides specific recommendations targeted to a wide variety of groups, 
including the general public, people with certain underlying health 
conditions, infants, children, parents, pregnant women, and seniors. 
CDC also has provided guidance to workers and in relation to work 
settings, such as health care workers, first responders, and those in 
the swine industry, as well as to laboratories, homeless shelters, 
correctional and detention centers, hemodialysis centers, schools, 
child care settings, colleges and universities, small businesses, and 
Federal agencies.
    With the holidays coming up, reducing the spread of 2009 H1N1 
influenza among travelers will be an important consideration.
    CDC quarantine station staff respond to reports of illness, 
including influenza-like illness when reported, in international 
travelers arriving at U.S. ports of entry. Interim guidance documents 
for response to travelers with influenza-like illness, for airline 
crew, cruise ship personnel and Department of Homeland Security port 
and field staff have been developed and posted online. As new 
information about this 2009 H1N1 influenza virus becomes available, CDC 
will evaluate its guidance and, as appropriate, update it using the 
best available science and ensure that these changes are communicated 
to the public, partners, and other stakeholders.
    In preparation for the upcoming months when we expect many families 
and individuals to gather for the holidays, we are preparing to launch 
a national communications campaign to encourage domestic and 
international travelers to take steps to prevent the spread of flu. 
Plans are to display public advertisements with flu prevention messages 
in ports of entry and various other advertising locations, such as 
newspapers and online advertisements, both before and during the 
upcoming holiday travel season.

          SUPPORTING SHARED RESPONSIBILITY AND ACTION THROUGH 
                         ENHANCED COMMUNICATION

    A third major area of effort is to support shared responsibility 
and action through enhanced communication to individuals. Our 
recommendations and action plans are based on the best available 
scientific information. CDC is working to ensure that Americans are 
informed about this pandemic and consistently updated with information 
in clear language. The 2009 H1N1 pandemic is a dynamic situation, and 
it is essential that the American people are fully engaged and able to 
be part of the mitigation strategy and overall response. CDC will 
continue to conduct regular media briefings, available at flu.gov, to 
get critical information about influenza to the American people.
    Some ways to combat the spread of respiratory infections include 
staying home when you are sick and keeping sick children at home. 
Covering your cough and sneeze and washing your hands frequently are 
also effective ways to reduce the spread of infection. Taking personal 
responsibility for one's health will help reduce the spread of 2009 
H1N1 influenza and other respiratory illnesses.
    CDC is communicating with the public about ways to reduce the 
spread of flu in more interactive formats such as blog posts on the 
Focus on Flu WebMD blog, radio public service announcements, and 
podcasts.
    Through the CDC INFO Line, we serve the public, clinicians, State 
and local health departments and other Federal partners 24 hours/day, 7 
days/week, in English and Spanish both for phone and e-mail inquiries. 
As of midnight November 4, CDC-INFO had responded to 98,377 phone calls 
and 38,628 e-mails from the general public, and 14,782 inquiries from 
clinicians, for a total of 151,700 inquiries since the onset of the 
H1N1 response in April.
    Our information is updated around the clock so we are well-
positioned to respond to the needs and concerns of our inquirers. Our 
customer service representatives get first-hand feedback from the 
public on a daily basis. In addition to the H1N1 response, we continue 
to provide this service for all other CDC programs.

                     PREVENTION THROUGH VACCINATION

    A fourth major area of effort is prevention through vaccination. 
Vaccination is our most effective tool to reduce the impact of 
influenza. Despite rapid progress during the initial stages of the 
vaccine production process, the speed of manufacturing has not been as 
rapid as initially estimated. CDC characterized the virus, identified a 
candidate vaccine strain, and our HHS partners expedited manufacturing, 
initiated clinical trials, and licensed four 2009 H1N1 influenza 
vaccines all within 5 months. The speed of this vaccine development was 
made possible due to investments made in vaccine advanced research and 
development and vaccine manufacturing infrastructure building through 
the office of the Assistant Secretary for Preparedness and Response 
(ASPR), Biomedical Advanced Research and Development Authority (BARDA) 
over the past 4 years, and in collaboration with CDC, the National 
Institutes of Health (NIH), and the Food and Drug Administration (FDA). 
The rapid responses of HHS agencies, in terms of surveillance, viral 
characterization, pre-clinical and clinical testing, and assay 
development, were greatly aided by pandemic preparedness efforts for 
influenza pandemics set in motion by the H5N1 virus re-emergence in 
2003, and the resources Congress provided for those efforts.
    Pandemic planning had anticipated vaccine becoming available 6-9 
months after emergence of a new influenza. 2009 H1N1 vaccination began 
in early October--5 months after the emergence of 2009 H1N1 influenza. 
Critical support from Congress resulted in $1.44 billion for States and 
hospitals to support planning, preparation, and implementation efforts. 
States and cities began placing orders for the 2009 H1N1 vaccine on 
September 30. The first vaccination with 2009 H1N1 influenza vaccine 
outside of clinical trials was given October 5. Tens of millions of 
doses have become available for ordering, and millions more become 
available each week. Although significant delays in vaccine production 
by manufacturers have complicated the early immunization efforts, 
vaccine will become increasingly available over the weeks ahead, and 
will become more visible through delivery in a variety of settings, 
such as vaccination clinics organized by local health departments, 
healthcare provider offices, schools, pharmacies, and workplaces.
    CDC continues to offer technical assistance to States and other 
public health partners as we work together to ensure the H1N1 
vaccination program is as effective as possible. Since September 30th, 
although the number of H1N1 vaccine doses produced, distributed, and 
administered has grown less quickly than projected, States have begun 
executing their plans to provide vaccine to targeted priority 
populations. Although we had hoped to have more vaccine distributed by 
this point, we are working hard to get vaccine out to the public just 
as soon as we receive it.
    H1N1 vaccines are manufactured by the same companies employing the 
same methods used for the yearly production of seasonal flu vaccines. 
H1N1 vaccine is distributed to providers and State health departments 
similarly to the way federally purchased vaccines are distributed in 
the Vaccines for Children program. Two types of 2009 H1N1 vaccine are 
now available: injectable vaccine made from inactivated virus, and 
nasal vaccine made from live, attenuated (weakened) virus.
    CDC's Advisory Committee on Immunization Practices (ACIP) has 
recommended that 2009 H1N1 vaccines be directed to target populations 
at greatest risk of illness and severe disease caused by this virus. On 
July 29, 2009, ACIP recommended targeting the first available doses of 
H1N1 vaccine to five high-risk groups comprised of approximately 159 
million people; CDC accepted these recommendations. These groups are: 
pregnant women; people who live with or care for children younger than 
6 months of age; health care and emergency services personnel; persons 
between the ages of 6 months through 24 years of age; and people from 
ages 25 through 64 years who are at higher risk for severe disease 
because of chronic health disorders like asthma, diabetes, or 
compromised immune systems. These recommendations provide a framework 
from which States can tailor vaccination to local needs.
    Ensuring a vaccine that is safe as well as effective is a top 
priority. CDC expects that the 2009 H1N1 influenza vaccine will have a 
similar safety profile to seasonal influenza vaccine, which 
historically has an excellent safety track record. So far the reports 
of adverse events among H1N1 vaccination are similar to those we see 
with seasonal flu vaccine and not unexpected, but we will remain alert 
for the possibility of rare, severe adverse events that could be linked 
to vaccination. CDC and FDA have been working to enhance surveillance 
systems to rapidly detect any unexpected adverse events among 
vaccinated persons and to adjust the vaccination program to minimize 
these risks. Two primary systems used to monitor vaccine safety are the 
Vaccine Adverse Events Reporting System (VAERS), jointly operated 
between CDC and FDA, and the Vaccine Safety Datalink (VSD) Project, a 
collaborative project with eight managed care organizations covering 
more than nine million members. These systems are designed to determine 
whether adverse events are occurring among vaccinated persons at a 
greater rate than among unvaccinated persons. CDC has worked with 
partners to strengthen these vaccine safety tracking systems and we 
continue to develop new ways to monitor vaccine safety, as announced 
earlier this week by the Federal Immunization Safety Task Force in HHS. 
In addition, based on the recommendation of the National Vaccine 
Advisory Committee (NVAC), HHS established the H1N1 Vaccine Safety Risk 
Assessment Working Group to review 2009 H1N1 vaccine safety data as it 
accumulates. This working group of outside experts will conduct 
regular, rapid reviews of available data from the Federal safety 
monitoring systems and present them to NVAC and Federal leadership for 
appropriate policy action and follow-up.
    More than 36,000 people die each year from complications associated 
with seasonal flu. CDC continues to recommend vaccination against 
seasonal influenza viruses, especially for all people 50 years of age 
and over and all adults with certain chronic medical conditions, as 
well as infants and children. As of the fourth week in October, 89 
million doses of seasonal vaccine had been distributed. It appears that 
interest in seasonal flu vaccine has been unprecedented this year. 
Manufacturers estimate that a total of 114 million doses will be 
brought to the U.S. market.

REDUCING THE BURDEN OF ILLNESS AND DEATH THROUGH ANTIVIRAL DISTRIBUTION 
                                AND USE

    In the spring, anticipating commercial market constraints, HHS 
deployed 11 million courses of antiviral drugs from the Strategic 
National Stockpile (SNS) to ensure the Nation was positioned to quickly 
employ these drugs to combat 2009 H1N1 and its spread. In early 
October, HHS shipped an additional 300,000 bottles of the oral 
suspension formulation of the antiviral oseltamivir to States in order 
to mitigate a predicted near-term national shortage indicated by 
commercial supply data. In addition, the Secretary authorized the 
release of the remaining 234,000 bottles of pediatric Tamiflu on 
October 29. We will continue to conduct outreach to pharmacists and 
providers related to pediatric dosing and compounding practices to help 
assure supplies are able to meet pediatric demand for antiviral 
treatment. Finally, CDC and FDA have also worked together to address 
potential options for treatment of seriously ill hospitalized patients 
with influenza, including situations in which physicians may wish to 
use investigational formulations of antiviral drugs for intravenous 
therapy. The FDA issued an emergency use authorization (EUA) on October 
23, 2009, for the investigational antiviral drug peramivir intravenous 
(IV) to be used for certain hospitalized adult and pediatric patients 
with confirmed or suspected 2009 H1N1 influenza infection. Physician 
requests for peramivir to be used under the EUA are managed through a 
CDC web portal.

                            CLOSING REMARKS

    CDC is working hard to limit the impact of this pandemic, and we 
are committed to keeping the public and the Congress fully informed 
about both the situation and our response. We are collaborating with 
our Federal partners as well as with other organizations that have 
unique expertise to help CDC provide guidance to multiple sectors of 
our economy and society. There have been enormous efforts in the United 
States and abroad to prepare for this kind of challenge.
    Our Nation's current preparedness is a direct result of the 
investments and support of Congress over recent years, effective 
planning and action by Federal agencies, and the hard work of State and 
local officials across the country. We look forward to working closely 
with Congress as we address the situation as it continues to evolve in 
the weeks and months ahead.
    Again, Mr. Chairman, thank you for the opportunity to participate 
in this conversation with you and your colleagues. I look forward to 
answering your questions.

    Senator Dodd. Well, thank you very much, Doctor.
    Let me jump right in on some of the questions. Senator Enzi 
raised some of them in his opening comments, and they're a lot 
of questions we're getting, as well, on a regular basis. I know 
you probably get them all the time, as well.
    I understood, by the way, that there are basically five 
companies that are producing the vaccine, and all but one of 
them are located outside of the United States. Is that correct?
    Dr. Schuchat. Yes, that is right.
    Senator Dodd. Well, how did that happen?
    Dr. Schuchat. Well, I think one good feature is that we 
have contracts with five companies, and that was intended to 
reduce our risk that one company or another would have a 
problem. Our problem, of course, is this slow-growing virus has 
been a problem for four of the companies.
    We are in better shape than we were a few years ago. At 
2004, we only had one company producing vaccine for the United 
States, and now we have five companies with license to produce 
influenza vaccine for seasonal use. Most of those companies, as 
you say, produce overseas. There have been investments in 
encouraging manufacturing here in the United States and 
expanding that capacity, but this is not an issue that changes 
overnight.
    Senator Dodd. Now, one of the issues I've heard raised is 
that, in some of these countries, the political community have 
passed legislation prohibiting the exportation of the vaccines 
outside until all of their needs are being met domestically. Is 
that true?
    Dr. Schuchat. There are contracts in place in different 
countries, and some of them do have those policies. The global 
capacity to produce influenza vaccine is not large. It's much 
larger than it was 5 years ago, but it's not sufficient for the 
entire world's population. We are vulnerable. We were lucky 
that the HHS had gotten contracts in place with these five 
companies and that our contracts, for the most part, are being 
honored.
    Senator Dodd. What are the lessons we've learned about--I 
appreciate the fact that you say this is--and by the way, let 
me commend you and others and the people who work at CDC. You 
do a remarkable job. I should have begun my comments by 
thanking you and others for the tremendous efforts that are 
made. I don't want these questions to be seen as just the 
critical questions, but the questions we're getting----
    Dr. Schuchat. Sure.
    Senator Dodd [continuing]. All the time. What have we 
learned in this phase of it? I appreciate that we're better off 
today than we were 4 or 5 years ago, but we're constantly 
learning. What have we learned here, given the anticipation, 
last summer, of having--I forget the exact numbers we were 
anticipated to have of vaccines--obviously came way short of 
that number. Now we're trying to catch up with it. What have we 
learned as a result of that, that we would now close that kind 
of a gap?
    Dr. Schuchat. Right. I think that we've learned some things 
about technology. Of course, you can't change this overnight, 
there are long-term investments needed to strengthen our 
technology for vaccine production, particularly for influenza.
    I think we've also learned something about managing 
expectations. The companies have produced a lot of vaccine in a 
record time, but I think the expectations that were set have 
been difficult to meet. We tried to let people know that bumps 
could happen, that manufacturing of influenza vaccine is always 
unpredictable. Yet, I think we didn't get that message out 
sufficiently.
    Senator Dodd. So the expectation we set earlier on was 
unrealistic.
    Dr. Schuchat. Well, I think that we tried to qualify it, 
but perhaps we didn't achieve--it wasn't as well absorbed as we 
would have liked.
    Senator Dodd. Talk to me a bit about--I had a meeting 
yesterday--I don't know if you were in the room when I 
mentioned, yesterday--I had a roundtable conversation with my 
department of health in the State of Connecticut and others and 
the chief epidemiologist in the State. He pointed out to me, 
we're going to face a third wave, as he described it--Dr. Carta 
did--of H1N1 probably in late December, January, February--and 
that at the height, I guess it would be the flu season, as 
well. Share with us what we can anticipate.
    Dr. Schuchat. It's impossible to predict exactly what 
course we'll see. We do look to history. In 1957 there was a 
pandemic that did occur early in the fall, like what we're 
seeing right now, and things got better in December, and then, 
after the first of the year, there was a second wave of 
increase in deaths around the country. We're very mindful that 
that has happened in the past.
    We, of course, had disease in the spring, are seeing much 
more disease now in the fall, just as we had expected, and hope 
that our vaccination effort will blunt the impact that this 
virus is having. We like to say that the influenza season 
typically lasts until May, and so, I think we need to be on 
alert through that period.
    Senator Dodd. Again, there have been these reports, 
obviously, of detainees in Guantanamo receiving the vaccines. 
There were reports last week that Wall Street, for instance, 
got a dose of vaccine. Now, again, those headlines alone can 
provoke their own almost predictable responses. Tell me what 
the thinking was in both those cases.
    Dr. Schuchat. Yes. I think that communication is vital, and 
misinformation is rampant in any kind of 2009 health emergency. 
My understanding is that the Department of Defense has vaccine 
for Active Duty personnel and that the information about the 
detainees was not correct.
    The issue with Wall Street--let me explain, again, that CDC 
distributes vaccine to places that the State or city health 
departments designate. The States and cities are in much better 
shape than CDC in Atlanta, or HHS in Washington, to know how 
best to reach priority populations in their midst. They are 
primarily directing this vaccine to hospitals, to private 
providers, to local health departments, to schools, and to some 
employee-based clinics.
    Many adults are vaccinated with seasonal flu in the 
workplace. It's a very convenient place to be vaccinated. I 
believe this is what was going on with the New York City area. 
Apparently their initial distributions were to hospitals, 
private providers, schools, and health departments, and it was 
only in their second tier that they started to ship vaccine to 
employers.
    Senator Dodd. Again, we're talking about--our priority 
populations here are pregnant women, children, and the elderly.
    Dr. Schuchat. No, oh, I'm sorry.
    Senator Dodd. No, I'm sorry, go ahead, you correct me.
    Dr. Schuchat. For seasonal flu that's absolutely right. For 
the H1N1 virus, it is disproportionately affecting younger 
people. The five priority groups that our advisory committee 
recommended be vaccinated early in the response were pregnant 
women, children and young adults from 6 months to 24 years of 
age, adults that are working age who have chronic health 
conditions--diabetes, asthma, cancer and so forth--adults 25 to 
64 with those conditions--and parents of newborns under 6 
months, as well as healthcare workers or emergency medical 
service personnel. Many adults--either because they're parents 
of a newborn, because they have a common disease, like diabetes 
or asthma, or those adults in the healthcare or emergency 
medical service personnel, and then adults who are pregnant, 
who are in the workforce--could easily be reached through 
employer clinics. We really look to the cities and States, who 
are directing the implementation of vaccine, to know how best 
to get vaccine into the path of priority populations. We want 
it to be convenient, accessible, and available, and we all 
really do want pregnant women and other adults with risk 
conditions, to be vaccinated promptly.
    Senator Dodd. Last two questions I'll have for you here 
is--tell me about the coordination between CDC, HHS, Department 
of Labor. How is that working?
    Dr. Schuchat. It has been a real privilege to be part of 
the Federal team that's responding to H1N1 since the early days 
in April. I would say that there's tremendous coordination 
within HHS--daily phone calls, actually multiple times a day. 
We have liaisons at different parts of HHS. Extreme close 
cooperation with the Department of Labor, Department of 
Education, Commerce, and, of course, the Department of Homeland 
Security.
    Pandemics do not know borders, and they don't respect 
sectors. Pandemics do not restrict themselves to the health 
sector. We have really looked to Labor to help with the 
flexible leave policy, to Education to help with updated school 
guidance, as well as a surveillance system that is giving us 
vital information.
    Senator Dodd. And last, on the issue--what recommendations 
does CDC make to employers to help them limit the spread of 
H1N1? What specific guidelines do childcare facilities and 
schools use to prevent the spread? And when it comes to H1N1 
virus, what are the biggest challenges you hear from employers 
and schools, State and local public officials?
    Dr. Schuchat. Our guidance to schools, childcare centers, 
and business all stress the importance of staying home when 
you're sick, or keeping your child home if they are sick. We 
have updated the guidance, based on the spring, learning from 
the course of this virus, to suggest staying home for 24 hours 
after your fever is gone without taking antifever medicines, 
and that you could return to school or the workplace at that 
point. We've stressed to businesses the importance of having 
flexible leave policies so it's easy for your employees to do 
the right thing.
    The Secretaries of Labor and Health and Human Services sent 
letters out to business. I've spoken with the U.S. Chamber of 
Commerce. We've really tried to get that message out, to make 
it easy for people to do the right thing.
    Senator Dodd. What's the period of time we're talking 
about--is it 2 days, 3 days? Roughly. I realize this is a tough 
question. Roughly, what do you anticipate?
    Senator Dodd. Right. For most people, the recommendation to 
stay home 24 hours after the fever is gone would mean 3 to 5 
days. Of course, if you get sick on a Friday, you wouldn't miss 
so much.
    Senator Dodd. Right.
    Dr. Schuchat. In the spring our guidance was to stay home 
for 7 days, and that was very disruptive to schools, and also 
disruptive to the workplace.
    Senator Dodd. Of course you're--then, with the 
inconsistency, in a way, obviously, of recommending these 
policies, and yet we don't really have an overall strategy. We 
kind of lurch from pandemic to pandemic on these matters. 
That'll be another question.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman. I'll just do a few 
followup questions on what you asked.
    The first one being on this apparent confusion over the 
Department of Defense. Shouldn't the DOD's Guantanamo vaccine 
order be canceled and re-directed to the CDC, so that you can 
be sure that every child and pregnant woman that would have the 
vaccine that wants it can have it? Shouldn't that be the first 
priority?
    Dr. Schuchat. The Department of Defense purchase of H1N1 
vaccine is directed for Active Duty personnel and for the 
dependents and others affiliated with the DOD. That would be 
carried out through the CDC central distribution effort, so, I 
think that the DOD was really trying to make sure that Active 
Duty personnel could be vaccinated promptly. Really, force 
readiness is a vital factor for them.
    Senator Enzi. I think anybody that's infected with it 
considers it a very vital factor.
    Now, the Administration announced ambitious goals for the 
vaccine production, claiming that the United States would have 
access of 80 to 120 million doses of the H1N1 vaccine by mid-
October. We're now in November, and we only have 36 million 
vaccines. What went wrong at CDC or HHS? What caused such a 
drastic overestimation?
    It's my understanding that the manufacturers did not report 
similar targets. Is that true?
    Dr. Schuchat. The estimates for vaccine projections for 
this fall were given by manufacturers to Health and Human 
Services. We shared those estimates with the State and local 
health departments, who were keenly needing information in 
order to be able to plan the school clinics and the other mass 
clinics. As information changed, we updated the information.
    Every time we've talked about influenza vaccine production, 
really from June onwards, we've talked about how unpredictable 
it can be. Many may remember 2004 and 2005, when, October 5th, 
we learned that half of the U.S. vaccine supply was lost 
because of manufacturer challenges. I think that while we have 
tried to qualify projections, it's been difficult to get that 
message out. It is extremely frustrating and disappointing to 
everyone, I think, that we have had this delayed start.
    That said, we have twice as much vaccine right now as we 
had about 2 weeks ago, and the pace is really picking up. We 
are seeing the ability, more and more every day, to meet the 
incredible demand that we have for vaccine.
    Senator Enzi. Of course, I'm hearing from the people that 
are standing in line for clinics, and then getting up to the 
front of the line and finding out that there isn't enough 
vaccine there to take care of them and their children, some 
waiting in line for more than 1 or 2 hours.
    Dr. Schuchat. Absolutely. It's difficult to see that, and 
especially pregnant women, people with their children, children 
with these disabilities. It's very hard. The good news is, a 
poll recently showed that 9 out of 10 people who looked for 
vaccine and were not able to get it plan to look again, that 
they understand that the supply is limited right now, but do 
hear that more is coming. I wish it were much easier, more 
convenient for everyone who wants to be vaccinated to be 
vaccinated. I think the next several weeks will be a delicate 
effort to really try to reach these priority groups, and after 
that, the others in need.
    Senator Enzi. I'm also hearing from some people who, at 
their clinic, have been asked if they wanted the vaccine. They 
said, ``Well, I thought that was in short supply, and I'm not 
in that eligible group.'' And their answer from the clinic was, 
``We don't have enough people in that eligible group, but we 
have vaccines.''
    Is there anything being done to cause a redistribution 
there? Those people that realize they shouldn't have it are 
still getting it, and somebody else is not getting it.
    Dr. Schuchat. You raise a really important issue about the 
challenges of supply and demand at that very local level. Our 
advisory committee on immunization practices thought carefully 
about how to prioritize vaccine when it was in short supply--
again, learning from the 2004-2005 experience. At that point, a 
very narrow set of priorities were given, and people did step 
aside, as you say, and we ended up having to throw out vaccine. 
Our advisory committee came up with a pretty broad priority 
population--it's about half of the U.S. population--but said, 
at any level--at local, at the provider level, at the county 
level--the decisions about when to expand beyond the priority 
groups should be made, rather than at the national level, 
really locally, because the local attitudes about vaccine, 
whether people are concerned about the disease or are really 
seeking the vaccine, are different, area to area. We may see 
differences, week to week, and our advisory committee wanted 
there to be a very low threshold for providers to be able to 
continue to offer vaccine to others, especially as it's 
continuing to be produced each day.
    Senator Enzi. You keep referring back to that 2004-2005 
incident. I can remember when Senator Byrd and Senator Dodd and 
Senator Kennedy and I were in a room trying to work out some of 
the problems of this.
    Can you point to any internal barriers at the Department of 
Health and Human Services that have contributed to the vaccine 
shortage? Or are there positions that haven't been filled that 
would exacerbate the vaccine shortage? Are there some things we 
need to do?
    Dr. Schuchat. You know, I think the key barrier to our 
vaccine immunization--or, to our immunization effort--is really 
the fragility of the public health infrastructure, that even 
with the doses that are coming out, we are dependent on the 
local and State public health system to direct these doses to 
providers, to local clinics, to hospitals. You know, there have 
been about 15,000 jobs lost in that sector over the last 2 
years. The emergency funds for pandemic have helped a lot, but 
the core is really eroded.
    Senator Enzi. Are there any positions, though, in the 
Federal Government, that we haven't filled yet, that need to 
be, to work on this?
    Dr. Schuchat. I'm not aware of there being, but we could 
get back to you on that.
    [The information referred to may be found in Additional 
Material.]
    Senator Enzi. Thank you.
    Senator Dodd. Thanks.
    I am receiving a note, by the mayor's office in New York, 
that Goldman Sachs requested 5,400 H1N1 doses, but received 
200, which was consistent with the average number of employees 
who may be pregnant. That's the note I'm reading.
    The other problem they manage--that, for instance, they 
report an average of 23 percent of parental consent rate for 
vaccines in school-age children in New York City, and they're 
attributing that to the fact that New York City has a 
relatively low rate of H1N1. Therefore, the parents may be less 
reluctant to be asking for it. Parental consent is critical, 
obviously, for those things. That's a pretty low number, that 
23 percent.
    Dr. Schuchat. Yes. Parental consent is a vital part of 
successful school-located immunization. We have success stories 
around the country, and we have some areas that have seen more 
challenges. In some areas, this is something that parents are 
used to. You know, they've been offering seasonal flu vaccine 
in the schools, and the consents are higher--more in the 30-, 
40-, or 50-percent range. We got fantastic results from Maine 
recently about very high acceptance rates. The logistics of 
school-located clinics are pretty tricky, and we really applaud 
the hard work that the States and cities have been doing to 
carry them out.
    Senator Dodd. Senator Murray.
    Senator Brownback. Were children vaccinated without 
parental consent?
    Dr. Schuchat. I believe there may have been one or two 
situations like that, but I don't have the details. There's a 
consent form that's provided. In fact, CDC developed draft 
consent forms this summer, so States could be ready. And we 
really wanted, working with the Department of Education, to 
raise that awareness on the part of the schools and the parents 
about when the vaccine gets there, there won't be that much 
time to get all the ducks in a row, so let's work on everything 
we can up front. You know, this is an enormous undertaking, and 
there will be aberrations.
    Senator Brownback. And there were.
    Senator Dodd. Senator Murray.
    Senator Murray. Thank you very much.
    Dr. Schuchat, first of all, thank you so much. I know 
everybody's working really hard. Expectations were high. We 
have all watched, with frustration, long lines at home, in many 
places where parents with young kids, and pregnant women, have 
stood in line and found out, at the end of the day, there 
wasn't enough for them. I heard your explanation, that 
manufacturing didn't happen as soon as possible, some 
distribution.
    A two-part question. First of all, when will we see those 
lines gone, so that people will be able to get access to the 
vaccination, so we can give them that assurance? Second, what 
are the lessons learned in distribution, so we know, next time, 
for December-January, or for several years from now?
    Dr. Schuchat. Yes, thank you, those are both really 
important issues. You know, I think that more and more doses 
are getting out to providers, and the health departments are 
also directing vaccine for these mass clinics and school 
clinics. I think the pressure will be decreasing. Things could 
change very quickly if demand changes. Right now there's very 
high demand for vaccine in most, but not all, communities.
    I can't tell you an exact day when things will be better in 
any one community. I can say that the supply is much more 
reliably increasing now, and that demand could change quickly. 
It's really when you reach that sweet spot of supply and 
demand.
    I can't give you a number of doses by which everything will 
be fine. But, certainly when there's more doses out there in 
the school-located clinics and the doctors' offices, the 
numbers who need to attend the mass clinics will be reduced.
    The second question was about lessons learned, and I think 
a critical lesson is about communication. We have really been 
trying to support the State and local health departments and 
give them information in order to be able to do their planning 
and their outreach. As the supply changed, their planning had 
to really change, and they had to recommunicate information. I 
think the American public has been great about this, but I 
think if they understood, in any one locality or State, how 
vaccine is being distributed, there would be a lot easier time. 
Many States and cities are doing that, but to say we're 
initially shipping to hospitals, then we're starting these 
school programs----
    Senator Murray. But that's a State decision as to whether 
it goes to hospitals or schools.
    Dr. Schuchat. Yes, that's right. What CDC does is set 
national guidance about priority populations. States and cities 
are in the best position to know their community, to know their 
provider capacity, to know their health system, to know the 
partners--the church and faith-based communities, to know, How 
can we reach these people who need to be vaccinated most 
effectively?
    We are letting the State and local health departments 
direct the vaccine. I think there are some places where the 
State-to-local health department communication could be better, 
but, fundamentally, I think public health at the local and 
State level have been doing a phenomenal job. Fundamentally the 
problem has been less vaccine than we all expected.
    Senator Murray. Right.
    Mr. Harris, I wanted to ask you--as I said in my opening 
remarks, I am very concerned that CDC has issued these 
guidelines, they want people to stay home, it's absolutely the 
right thing to do, to stop the spread of this and to make sure 
that we're doing the right thing. We're doing this right at a 
time when our economy is really struggling, and many workers 
today can't take sick leave, or they lose income.
    Obviously we're looking at legislation today to impact that 
for paid sick leave. I think that that is the right thing to 
do. Can you tell us today what some of the best practices 
you're giving to employers today so that they can make sure 
their workforce remains healthy?
    Mr. Harris. We can, and we share the concern that you just 
expressed, Senator. We've been working very closely with Dr. 
Schuchat and our friends at HHS, as well as the Commerce 
Department and the Department of Homeland Security, to provide 
that kind of guidance to employers and other institutions that 
are large gathering places.
    The philosophy of community mitigation is to avoid illness, 
to the extent possible, using social distancing and other 
strategies. What we've encouraged employers to do--the most 
important principle, is that if someone is sick, they shouldn't 
come to work; if they arrive at work sick, they should be sent 
home. The goal should be for sick people to stay away from 
healthy people so that we don't spread the illness.
    For a lot of workers, as you said, that's a difficult thing 
to do, because they give up a day's pay, they risk their job in 
some cases. There's no protection against discipline for a 
large percentage of workers. We may well have reached the stage 
where--or we believe we have reached the stage where we need 
legislation that makes it easier for employers to--in this 
tightly competitive environment--to make that choice, to make 
that decision for workers to stay home; for workers to make 
that decision for themselves to stay home.
    Senator Enzi mentioned that in a lot of businesses you have 
employers who would like to have workers stay home, and make 
informal arrangements. In the tough competitive environment 
we're experiencing right now, it's hard for employers to make 
that kind of an individual arrangement. They need the added 
help. If we make all competitors comply with a basic labor 
standard, that kind of decision--that social distancing, 
staying home if you're sick--becomes easier.
    Senator Murray. Thank you very much, I appreciate it.
    Thank you both.
    Senator Casey. Mr. Chairman, thank you very much.
    Doctor, I want to thank you for your work, and your 
commitment to public service, especially under difficult 
circumstances.
    Deputy Secretary Harris, great to have you here.
    Doctor, first of all--and this is by way of repetition, but 
that's important around here. I know you've testified to this, 
one way or the other. I just want to be clear, in terms of some 
of the numbers here, to the extent that you can answer this 
question.
    The gap, or the disconnect, between the demand or the need 
for treatment, as opposed to what is in the pipeline for the 
vaccines--can you give me a general sense of those numbers?
    Dr. Schuchat. Yes. Today, 41.1 million doses of H1N1 
vaccine are available for the States to order. It's about twice 
what we had 2 weeks ago.
    We don't have a precise number of doses that we think will 
be enough. We don't know the long-term demand. We have some 
baselines or background to use. With seasonal influenza, about 
one out of three people for whom it's recommended actually gets 
the vaccine. We do a bit better with seniors; about 70 percent 
of seniors get the vaccine. In the younger age groups, we don't 
do very well. If one out of three people in this recommended 
group of 159 million actually sought the vaccine, we'd be 
pretty close to where we needed to be right now. We know, 
though, that demand is higher than that right now.
    What I have been saying is that exactly where demand will 
be in the weeks ahead is difficult to predict. We're grateful 
that 9 out of 10 people who sought vaccine and couldn't find it 
plan to look again. They may get frustrated, and we hope they 
don't. We're hopeful that we can address the concerns that some 
people have about the safety of the vaccine, or about the 
threat of the virus, so that they take seriously the benefits 
the vaccine can offer when it's available to them.
    We don't know exactly what week or day in any particular 
area we will have that perfect mix of supply and demand. This 
actually happens every year with seasonal flu vaccine. We have 
more than we want, or not enough. People think the pharmacy's 
got it before the doctors' offices. It's very challenging. It's 
just something that--seasonal flu vaccine is pretty much a 
private-sector enterprise. This H1N1 program, of course, is 
publicly directed, and we're really stressing the importance of 
communication to let people know what to expect and how to 
protect themselves.
    Senator Casey. With regard to H1N1, you're saying 41.1 
million doses are available.
    Dr. Schuchat. As of today.
    Senator Casey. OK. And when you say ``available,'' what 
does that mean?
    Dr. Schuchat. That's right. ``Available'' means that it's 
come from the manufacturers to our central distributor. It's 
been checked in, and it wasn't damaged. It didn't need to be 
quarantined or set aside. It is ready for the States to order. 
The States have a pro-rata share of the vaccine, based on their 
population, and every day the States or the big city health 
departments are putting in orders for vaccine to be shipped to 
the sites that they designate.
    We have the capacity to ship to up to 150,000 sites. We're 
not shipping to that many yet. As supply increases, we can ship 
to many places directly. The 41.1 million is the doses that, 
this morning, the States were offered--the cumulative total 
that they were able to order from.
    Senator Dodd. That is exactly the question--it is 
cumulative? That's the number available now?
    Dr. Schuchat. This is the total that have become available 
since the program began on September 30.
    Senator Dodd. What do you have available now?
    Dr. Schuchat. I would have to get that back to you.
    [The information referred to may be found in Additional 
Material.]
    Dr. Schuchat. Basically, a key point is that the States are 
ordering every day, and most of the States are ordering the 
vast majority of what's allocated to them, so there's not a lot 
sitting around. This is in and out.
    We've really, over the past couple weeks, sped things up. 
You know, once we understood it was a trickle that we were 
getting, we said, ``Well, we'd better speed up every drop of 
vaccine that we get, focusing on overnight shipment.'' To 90 
percent of the sites, or a guarantee that it we will reach the 
provider site within 24 hours for 90 percent of deliveries, 
focusing on shipping the needles and syringes at the same time 
as the vaccine doses. Initially we were going to ship the 
needles the day before, so you'd be sure you got them. We've 
really sped up everything we can speed up, and have been 
offering outreach to States that are having trouble keeping up 
with their orders.
    Senator Dodd. No, I understand. No, I apologize for 
interrupting, I just wanted that cumulative----
    Senator Casey. No, that's OK. You're the Chairman.
    [Laughter.]
    With regard to H1N1, what have you learned--or what have we 
learned--not just you, but all of us--and, I guess, what have 
you learned--just on this topic: distribution or delivery of 
the vaccines--what have we learned, and what are the biggest 
challenges in the next couple of weeks and months on this? Just 
on the distribution challenge.
    Dr. Schuchat. We have been learning how best to manage the 
central distribution and support of the State and local health 
departments. Some of our systems were ready, because we had 
transitioned to a central distributor system for our childhood 
vaccination program, the Vaccine for Children Program. Eighty 
million doses of routine vaccines goes in and out of this 
system every year.
    This is a large-scale, short-term influenza program on top 
of that, and some of our systems weren't ready. We are in the 
process of upgrading the information system by which providers 
order vaccine. In the future, we hope that providers can just 
order right in their own offices, without having to go through 
the State and local health departments, but that system wasn't 
yet ready.
    The weeks ahead, the second thing we've learned is how 
fragile the State and local public health system is. I can't 
tell you how many times in our outreach to our counterparts we 
got messages back--automatic messages--``It's Friday, we're 
furloughed.'' Or, ``No one is here today.'' You know, really a 
hard time for public health to mount this kind of response. 
They've been really rising to the occasion in a tremendous way.
    In the weeks ahead, anything can happen. This can be 
unpredictable, although many of the things that have happened, 
we had contingency plans for. I think, in the weeks ahead, 
we're going to reach a point where, instead of not having 
enough vaccine, we have vaccine that's not being used. It's 
critically important that we are ready with aggressive 
outreach, particularly to the vulnerable populations that may 
not be in the mainstream, getting the messages, to make sure 
that we're able to protect people who want to be protected, and 
that we can address the concerns that they have.
    Senator Casey. Well, I think I'm over time. I've got a 
couple more, but I'll hold.
    Senator Dodd. Thank you, Bob.
    Senator Hagan.
    Senator Hagan. Thank you, Mr. Chairman.
    In response to your last statement, when you said, ``In the 
weeks ahead, we will probably have an oversupply,'' what is 
your strategy to try to be sure that people are educated that 
they really do need to come in and get the H1N1 vaccination?
    Dr. Schuchat. Yes. We've been working with a comprehensive 
communications strategy with public service announcements, with 
partners, lots of outreach to local trusted partner groups. The 
White House has organized a whole set of outreach to the faith-
based and community-based organizations to help us reach people 
who may not trust, certainly, the government in Atlanta or 
Washington, but not necessarily even their State or local 
government, so that we are able to raise demand where demand is 
just a function of lack of information.
    There's been this tricky period, right now, where we'd like 
to make sure that we have sufficient supply before we raise 
demand further, because we don't want people even more 
frustrated about the lines and inability to access vaccine. 
We've been really holding frequent discussions about when do we 
turn on that part of the strategy, rather than it being so 
early that it backfires, but not too late to benefit the people 
who could take advantage of protection.
    Senator Hagan. I wanted to ask a question on individuals 
that don't have paid sick leave. It's my understanding that in 
many places, schoolbus drivers don't have access to that. I 
think that's a shocking fact. I know that the CDC strongly 
recommends that anyone who is ill should stay at home. Have 
there been any particular efforts made to ensure compliance 
among those professions that are most likely to cause the 
spread of disease, such as teachers, bus drivers, healthcare 
workers?
    Mr. Harris. We've been engaged, working with CDC and 
working with HHS and the Commerce Department. We're doing 
outreach into the business community, through the Chamber of 
Commerce and other organizations; not targeted to particular 
occupations, but targeted to particular industries. You 
highlight a very important fact, and that is that a lot of 
workers, particularly low-wage workers in service-based 
industries, who have a tremendous amount of customer contact, 
are among the least likely workers to have paid leave, to be 
able to take time off from work. Exactly the opposite of what 
you would want. From a public health perspective, you have 
workers in contact with people who are coming in to work sick--
food service workers, hotel workers, childcare workers, bus 
drivers, and others, the Chairman mentioned cafeteria workers 
in schools--exactly the situation that we don't want to have. 
One in four low-wage workers has paid leave. And in those 
service industries, about 78 percent have no leave. That's the 
reason why we're advocating for the Healthy Families Act, to 
try and address that problem.
    Senator Hagan. I know there's a lot of concern lately 
regarding the healthcare professionals who have decided not to 
get vaccinated--or to get the vaccine. Is that prevalent? Is 
that causing distress and problems within medical offices and 
hospitals?
    Dr. Schuchat. You know, it's a sad feature of this pandemic 
that some vocal healthcare workers have not wanted to be 
vaccinated, or have discouraged their patients from being 
vaccinated. As a doctor and a public health expert, it's just 
vital to me to do no harm, to not spread flu to my patients, 
and to protect myself and those around me. I believe that we 
will have a greater uptake of influenza vaccine in healthcare 
workers, both the seasonal and the H1N1, over the course of 
this season and the future ones, because I think people are 
beginning to realize that the flu can be serious and that the 
influenza vaccines, while not perfect, offer better protection 
than risking the disease. I do expect, in the years ahead, 
we'll be making more progress with that. It's gotten a lot of 
attention this year, and we certainly strongly promote 
healthcare worker vaccination. It's been less than half of 
healthcare workers, in the past several years of surveys, that 
have taken advantage of the vaccine.
    Senator Hagan. Thank you.
    Senator Dodd. Senator Hagan, thank you very much.
    I appreciate you raising the issue of the schoolbus 
drivers. Earlier today, I raised the issue, as well. I was told 
100 percent of school bus drivers do not have any sick leave 
pay. That number, obviously, is a pretty staggering number. I'm 
told, unlike other areas, it's just almost universal in that 
area.
    That question that Senator Hagan has raised is one that--
because, here again, we're talking about this fact situation, 
and Senator Enzi pointed out that, we first became aware of 
this in March, and obviously we had numbers that predicted a 
certain amount of dosages being available this summer. We 
didn't reach that. What's quite clear to all of us is that 
we're living in a world today where, because of the 
interconnectibility, these kinds of conditions are going to 
become more common. It's not the rarity any longer, it's the 
predictable. To what extent, then--whereas, as we did after 9/
11, began thinking about how we deal with this in a 
comprehensive way, as part of a Federal policy, to deal with 
these issues--whether it's sick leave, or whatever other 
aspects of this, I think it will be very, very important so 
that we don't find ourselves, kind of, lurching and having 
dramatic hearings and asking questions of why didn't we know 
better this time around than the next time? I think all of us, 
in the midst of everything else, would love to get some 
thoughts and ideas from the CDC, obviously HHS, and others--
private sector, Department of Labor--all of the pieces that 
come together, as to how we can frame a structure, an 
architecture that would allow us to be able to respond to these 
fact situations, when they emerge, in a way with far greater 
predictability, so they become, while important events, ones 
that we're structurally capable of responding to in a 
thoughtful manner. I certainly would welcome that kind of 
suggestion, as well.
    I just have one question, for you Mr. Harrison--I apologize 
that, due to the time, and so forth, I didn't get to ask--I'll 
submit some questions. I have several of them for you.
    [The information referred to may be found in Additional 
Material.]
    Senator Dodd. Is it the Administration's view that you 
would support the Healthy Families Act? Is that true?
    Mr. Harris. Yes.
    Senator Dodd. I appreciate that.
    We're also working on some emergency legislation to deal 
with this kind of a situation, and we don't have it framed yet, 
but we'd very much welcome the Administration's participation. 
In fact, we welcome anyone's participation in this, to help us 
put together something that might help us respond to this 
situation.
    With 600 school districts closing their doors across the 
country because of H1N1--I've had 10 in my State alone. It 
isn't just the sick parent or the sick child, it's the healthy 
parent and healthy child that find themselves all of a sudden 
with no one watching out for them, with working parents. How do 
we accommodate that? We've got to try to think about a 
structure, here, that can be more acceptable. We look forward 
to working with you on that.
    Mr. Harris. Thank you, sir.
    Senator Dodd. I'll leave the record open for some 
additional questions, as well.
    I thank our two witnesses, very, very much.
    Let me, if I can now, move to our third panel. Let me 
introduce our witnesses. Debra Ness is a good friend. I'll 
acknowledge, at the outset, is president of the Partnership for 
Women and Families.
    Ms. Ness, welcome again, to this committee. We appreciate 
your taking the time to talk to us today about paid sick days 
and Healthy Families Act.
    Ms. Ness has been president of the National Partnership for 
Women and Families for 5 years, was previously the executive 
vice president of the National Partnership for 13 years. She's 
worked for over two decades in the areas of social justice, 
health and public policy, attended Drew University and Columbia 
University School of Social Work. She draws upon years of work 
in areas important to women and working families.
    We're happy to have you with us.
    Desiree Rosado is a constituent of mine and--delighted to 
have you here, Desiree. Thank you for coming down--welcome to 
the Children's and Family Subcommittee--from Groton, CT, taking 
the time to be with us. Ms. Rosado lived in Groton, with her 
husband and three children, for 12 years. She works as a 
special education assistant in the Groton public schools, very 
active in the community, is a member of the MomsRising. She and 
her husband led the praise and worship department in their 
church.
    We thank you very much for joining us, as well.
    Elissa O'Brien is active. She's the director of human 
resources for Wingate Healthcare, in Massachusetts, which has 
4,000 employees. Ms. O'Brien is also an active volunteer for 
the Society for Human Resources and Management and is currently 
serving a 2-year term as director for the Rhode Island State 
Council of the organization.
    We thank you, for joining us here, as well, Ms. O'Brien.
    We have with us Scott Gottlieb. Dr. Scott Gottlieb is a 
fellow of the American Enterprise Institute. Dr. Gottlieb--
welcome to the committee--is a fellow of the American 
Enterprise Institute, as well as a practicing physician, has 
served in several capacities at the Food and Drug 
Administration, as well as a senior policy advisor at the 
Centers for Medicare and Medicaid Service--CMS.
    And we thank you, for joining us, as well, this morning.
    We'll begin in the order that I've introduced you. We'd ask 
you to keep your remarks to about 5 minutes, if you could, so 
we can get to some questions.
    Debra, nice to see you. Thank you for being here.

 STATEMENT OF DEBRA NESS, PRESIDENT, NATIONAL PARTNERSHIP FOR 
               WOMEN AND FAMILIES, WASHINGTON, DC

    Ms. Ness. Thank you.
    Good morning, Chairman Dodd, Ranking Member Enzi, Senator 
Casey. Thank you, for inviting us all here to talk about the 
policies that America's workers urgently need during this H1N1 
flu emergency.
    I'm Debra Ness, president of the National Partnership for 
Women and Families, a nonprofit, nonpartisan, advocacy group. 
I'm here to testify in support of the Healthy Families Act, 
ground- breaking legislation that is tremendously important to 
working people across the Nation, especially during this 
national emergency.
    The National Partnership leads a very broad-based coalition 
in support of paid sick days. I'm testifying here today on 
behalf of the millions of individuals represented by civil 
rights, women's, disability, children's, faith-based, 
antipoverty, labor, health, and research communities. We all 
urge you to quickly pass the Healthy Families Act, the bill now 
before Congress that offers the best solution to this problem.
    What is the problem? Quite simply, that millions of 
hardworking people in this country have no paid sick days. 
Almost half of private-sector workers and more than three-
quarters of low-wage workers, most of them women, don't have a 
single paid sick day. At a time when the H1N1 virus has 
infected millions and is widespread in 48 States, our failure 
to provide a minimum standard of paid sick days is exacting a 
terrible toll. Over the past few months, as this national 
emergency has progressed, experts and public officials from the 
CDC to the President of the United States have told us all: Be 
responsible, stay home, keep sick children home, to prevent the 
spread of the virus. It's excellent advice. Unfortunately, as 
the Congresswoman pointed out earlier today, taking that advice 
is simply not an option for millions of workers. They want to 
do the right thing. No one wants to spread the flu. Frankly, 
what's responsible when staying home means risking a paycheck 
or a job that your family depends on?
    Working people need paid time off to recover from H1N1, to 
care for sick family members, to prevent spread of the virus. 
This is particularly true for those who do the caregiving. The 
highest H1N1 virus attack rate is among children and youth, 
many of whom need a parent to care for them when they get sick. 
That's why the lack of paid sick days is especially challenging 
for working women, who often have primary responsibility for a 
child as well as eldercare in their families.
    Our failure to provide a minimum standard of paid sick days 
also is putting our public health at risk. Only 22 percent--
less than a quarter--of food service and public accommodation 
workers have paid sick days. Workers in childcare centers, in 
nursing homes, disproportionately lack paid sick days. They are 
forced to work when they're sick, and, in so doing, they put 
their coworkers, the people they care for, and the public at 
risk.
    While the need for paid sick days is particularly 
compelling during this H1N1 flu emergency, the reality is that 
working families struggled without paid sick days prior to this 
emergency, and they will continue to do so until Congress acts. 
Every year the seasonal flu and other illnesses strike millions 
of us, and every year the failure to let workers earn paid sick 
days puts the economic security of millions of families at 
risk.
    Senators, I certainly don't need to tell you how 
devastating the current economic crisis has been for families. 
Many families that once relied on two incomes are managing now 
with just one or none. A survey commissioned last year by the 
Public Welfare Foundation found that one in six workers 
reported that they or a family member had been fired, 
suspended, punished, or threatened with being fired, simply for 
taking time off due to personal illness or to care for a sick 
relative. That was before H1N1 and the recession. The pressures 
now, are even worse.
    Another survey, conducted just a month ago, found that five 
in six workers say that the recession is creating added 
pressure to show up for work even when they're sick. In a 
humane and rational society, that's just not a choice workers 
should be forced to make.
    Furthermore, we know that paid sick days are good for 
businesses. Responsible employers know that. They know that 
when they take care of workers, workers stay on the job. They 
know that workers with paid time off are more loyal and 
productive. They know that keeping trained workers on the job 
is less expensive than replacing them. They know that paid sick 
days reduce presenteeism--people going to work sick and getting 
other people sick. They know that paid sick days are not only 
the right thing to do, but the smart thing to do.
    In conclusion, just like the minimum wage, America needs a 
Federal minimum standard of paid sick days that protects all 
employees. The Healthy Families Act will provide that standard. 
It would let workers earn up to 7 paid sick days a year to 
recover from short-term illness, to care for a family member, 
to seek routine medical care, or to seek assistance related to 
domestic violence, sexual assault, or stalking. Congress should 
waste no time in passing this bill.
    I thank you for the opportunity to testify here today. We 
look forward to working with you to pass the Healthy Families 
Act.
    Senator Dodd, I want to echo what Congresswoman DeLauro 
said and recognize your leadership that has spanned more than 
three decades on behalf of working families, understanding, to 
your core, that it is time for our Nation's workplace policies 
to catch up with the realities that families struggle with, day 
in, day out.
    [The prepared statement of Ms. Ness follows:]

                  Prepared Statement of Debra L. Ness

    Good morning Chairman Dodd, Ranking Member Alexander, members of 
the subcommittee and my distinguished fellow panelists. Thank you for 
inviting us to talk about the policies our Nation's workers urgently 
need during this H1N1 flu emergency.
    I am Debra Ness, President of the National Partnership for Women & 
Families, a non-profit, non-partisan advocacy group dedicated to 
promoting fairness in the workplace, access to quality health care, and 
policies that help workers meet the dual demands of work and family. I 
am here to testify in support of the Healthy Families Act, 
groundbreaking legislation that is tremendously important to working 
people across the Nation--especially during this national H1N1 flu 
emergency. The National Partnership for Women & Families leads broad-
based coalitions that support the Healthy Families Act. These 
coalitions include children's, civil rights, women's, disability, 
faith-based, community and anti-poverty groups as well as labor unions, 
health agencies and leading researchers at top academic institutions. 
They include 9 to 5, MomsRising.org, the Leadership Conference on Civil 
Rights, the AFL-CIO and SEIU, the Family Values @ Work Consortium, the 
National Organization for Women and dozens of other organizations. 
Together, we urge Congress to pass the Healthy Families Act.

       WORKERS NEED PAID SICK DAYS DURING THIS H1N1 FLU EMERGENCY

    In recent months, much attention has focused on the H1N1 virus and 
the best ways to contain it--and with good reason. H1N1 is a novel flu 
virus that experts predict may result in many more illnesses, 
hospitalizations and deaths this year than would be expected in a 
typical flu season.\1\ Forty-eight States had ``widespread flu 
activity'' as of Oct. 24, according to the Centers for Disease Control 
and Prevention (CDC).\2\ The CDC recorded nearly 26,000 
hospitalizations and more than 2,900 deaths related to H1N1 flu between 
Aug. 30 and Oct. 24.\3\ The virus is now so widespread that the CDC and 
World Health Organization are no longer keeping track of the number of 
individual cases. Officials estimate if 30 percent of the population 
contract the virus, it could mean approximately 90 million people in 
the United States could become ill, 1.8 million may need to be 
hospitalized, and approximately 30,000 could die.\4\ As a result, 
President Barack Obama declared the H1N1 flu outbreak a national 
emergency, allowing hospitals and local governments to quickly set up 
alternate sites for treatment and triage procedures if needed to handle 
any surge of patients.\5\
---------------------------------------------------------------------------
    \1\ U.S. Dept. of Health and Human Services, ``About the Flu,'' 
http://pandemicflu.gov/individualfamily/about/index.html.
    \2\ Centers for Disease Control and Prevention, 2009-2010 Influenza 
Season Week 42 ending October 24, 2009, http://www.cdc.gov/flu/weekly/.
    \3\ CDC, 2009 H1N1 Flu U.S. Situation Update, 10/2/09, http://
www.cdc.gov/h1n1flu/updates/us/.
    \4\ The President's Council of Advisors on Science and Technology. 
``Report to the President on U.S. Preparations for 2009--H1N1 
Influenza'', 8/7/09, www.whitehouse.gov/assets/documents/
PCAST_H1N1_Report.pdf.
    \5\ New York Times, ``Obama Declares Swine Flu a National 
Emergency'', www.nytimes.com/aponline/2009/10/24/health/AP-US-Obama-
Swine-Flu.html?scp=3&sq=obama%20national%20 
emergency%20swine%20flu&st=cse, 10/24/09.
---------------------------------------------------------------------------
    Week after week, government officials urge sick workers to stay 
home and keep sick children at home to prevent the spread of the H1N1 
virus. Commerce Secretary Gary Locke said that ``if an employee stays 
home sick, it's not only the best thing for that employee's health, but 
also his co-workers and the productivity of the company.'' \6\ Health 
and Human Services Secretary Kathleen Sebelius said that ``one of the 
most important things that employers can do is to make sure their human 
resources and leave policies are flexible and follow public health 
guidance.'' \7\
---------------------------------------------------------------------------
    \6\ Associated Press, ``Government enlists employers' help to 
contain flu,'' 8/19/09.
    \7\ HHS News Release, 8/19/09, www.hhs.gov/news/press/2009pres/08/
20090819a.html.
---------------------------------------------------------------------------
    The CDC has also issued recommendations: ``People with influenza-
like illness [must] remain at home until at least 24 hours after they 
are free of fever . . . without the use of fever-reducing 
medications.'' \8\ In addition to the guidance for workers, officials 
have stated that schools and child care providers will need to rely on 
parents to keep children at home if they are feverish.\9\ This is 
excellent advice, as far as it goes, but unfortunately, taking this 
advice isn't an option for millions of workers. They may want to do the 
right thing and do all they can to prevent the spread of the H1N1 
virus. But for many, doing their part means risking their paychecks and 
even their jobs, because they lack job-protected paid sick days.
---------------------------------------------------------------------------
    \8\ CDC, Recommendations for the Amount of Time Persons with 
Influenza-Like Illness Should be Away, www.cdc.gov/h1n1flu/guidance/
exclusion.htm.
    \9\ Center for Infectious Disease Research & Policy, Univ. of 
Minn., www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/
aug0709schools3.html.
---------------------------------------------------------------------------
    Working people need paid time off from their jobs to recover from 
the H1N1 flu and care for sick family members--and prevent further 
spread of the virus. Yet, the reality is that nearly half (48 percent) 
of private-sector workers lack paid sick days.\10\ The same is true for 
nearly four in five low-wage workers--the majority of whom are 
women.\11\ Women also are disproportionately likely to lack paid sick 
days because they are more likely than men to work part-time, or to 
cobble together an income by holding more than one part-time position. 
Only 16 percent of part-time workers have paid sick days, compared to 
60 percent of full-time workers.\12\
---------------------------------------------------------------------------
    \10\ Vicky Lovell, Institute for Women's Policy Research, Women and 
Paid Sick Days: Crucial for Family Well-Being, 2007.
    \11\ Economic Policy Institute, Minimum Wage Issue Guide, 2007, 
www.epi.org/content.cfm/issueguides_minwage.
    \12\ Vicky Lovell, Institute for Women's Policy Research, No Time 
to be Sick, 2004.
---------------------------------------------------------------------------
    Especially during this epidemic, workers with caregiving 
responsibilities in particular have an urgent need for paid sick days. 
The highest H1N1 virus attack rate is among 5- to 24-year-olds, many of 
whom need to stay home from school when sick--often with a parent to 
care for them.\13\ That's why the lack of paid sick days is 
particularly challenging for working women--the very people who have 
primary responsibility for most family caregiving. In fact, almost half 
of working mothers report that they must miss work when a child is 
sick. Of these mothers, 49 percent do not get paid when they miss work 
to care for a sick child.\14\
---------------------------------------------------------------------------
    \13\ CDC, Novel H1N1 Flu: Facts and Figures, www.cdc.gov/h1n1flu/
surveillanceqa.htm.
    \14\ Kaiser Family Foundation, ``Women, Work and Family Health: A 
Balancing Act,'' Issue Brief, April 2003.
---------------------------------------------------------------------------
   OUR FAILURE TO ESTABLISH A PAID-SICK-DAYS STANDARD IS PUTTING THE 
            PUBLIC HEALTH AT RISK DURING THE H1N1 EMERGENCY

    Our Nation's failure to provide a minimum standard of paid sick 
days is putting our public health at risk. Many of the workers who 
interact with the public every day are without paid sick days. Only 22 
percent of food and public accommodation workers have any paid sick 
days, for example. Workers in child care centers and nursing homes, and 
retail clerks disproportionately lack paid sick days.\15\ Because the 
lack of paid sick days forces employees to work when they are ill, 
their coworkers and the general public are at risk of contagion.
---------------------------------------------------------------------------
    \15\ Vicky Lovell, Institute for Women's Policy Research, No Time 
to be Sick, 2004.
---------------------------------------------------------------------------
    Research released this year by Human Impact Partners, a non-profit 
project of the Tides Center, and the San Francisco Department of Public 
Health, found that providing paid sick days to workers will 
significantly improve the Nation's health. This groundbreaking study 
found that guaranteeing paid sick days would reduce the spread of 
pandemic and seasonal flu. More than two-thirds of flu cases are 
transmitted in schools and workplaces. Staying home when infected could 
reduce by 15 to 34 percent the proportion of people impacted by 
pandemic influenza.
    The Human Impact Partners analysis also found that if all workers 
had paid sick days, they would be less likely to spread food-borne 
disease in restaurants and the number of outbreaks of gastrointestinal 
disease in nursing homes would reduce. The researchers provided 
evidence that paid sick days may be linked to less severe illness and 
shorter disability due to sickness, because workers with paid sick days 
are 14 percent more likely to visit a medical practitioner each year, 
which can translate into fewer severe illnesses and hospitalizations. 
They also found that parents with paid time off are more than five 
times more likely to provide care for their sick children.
    Recent data on the impact of the H1N1 virus in Boston, MA shows 
that the outbreak has hit certain mostly low-income communities harder 
than other communities. The Boston Public Health Commission reported 
that more than three in four Bostonians who were hospitalized because 
of H1N1 were black or Hispanic.\16\ Boston's experience is not unique. 
Communities of color all across the country face similar health 
disparities and they may be due, in part, to the fact that low-wage 
workers are less likely to have paid sick days.
---------------------------------------------------------------------------
    \16\ Cases of swine flu higher among city blacks, Hispanics, 
Stephen Smith, Globe Staff, August 18, 2009, http://www.boston.com/
news/local/massachusetts/articles/2009/08/18/cases_of_ 
swine_flu_higher_among_bostons_blacks_hispanics?mode=PF.
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                       BEYOND THE H1N1 EMERGENCY

    While the need for paid sick days may seem particularly compelling 
during the H1N1 emergency, the reality is that working families 
struggled without paid sick days prior to this emergency, and they will 
continue to struggle after this emergency unless Congress takes action. 
Paid sick days aren't just about protecting the public's health--they 
are also about protecting the economic security of millions of workers 
and their families. One in six workers report that they or a family 
member have been fired, suspended, punished or threatened with being 
fired for taking time off due to personal illness or to care for a sick 
relative, according to a 2008 University of Chicago survey commissioned 
by the Public Welfare Foundation. To put a face on some of those 
statistics, I'd like to share with you a few stories from working 
people:

     Heather from Cedar Crest, NM told us:

          ``In October, I got very sick with diverticulitis. My doctor 
        put me on bed rest for 2 weeks. While I was out, my boss 
        hounded me to come back, but I was way too sick. I told him I 
        would be back as soon as I could. I was not receiving sick pay 
        at all. When I did go back to work early, he fired me and told 
        me he needed someone he could count on. I worked for this man 
        for 2 years. I was shocked. Sometimes things happen and you get 
        sick. How are you to foresee these things?''

     Noel from Bellingham, WA wrote to us:

          ``I had to work while having bouts of awful bronchitis and 
        walking pneumonia. I got no time off at all even when I was in 
        severe pain, coughing up phlegm or vomiting. Instead I had to 
        act like I wasn't sick, and keep up the same standards and 
        smiling face . . . I couldn't take unpaid days off from work 
        because I couldn't afford to do that. I needed the money to pay 
        for things like rent and food. When my quality of work suffered 
        substantially from having to go to work while so sick, I was 
        fired from my job because according to my then-supervisor, I 
        did not create a happy environment for the customers.''

    The H1N1 outbreak has come during a painful recession, and both 
have exacerbated the need for paid sick days. I don't need to tell you 
that the economic crisis has been devastating for working families. 
More than 11.6 million workers have lost their jobs, and millions more 
are underemployed. In October, the unemployment rate was 10.2 percent--
the highest level since December 1983. The unemployment rate for 
African-Americans was 15.7 percent, the rate for Hispanics was 13.1 
percent, and the rate for whites was 9.5 percent in October 2009.\17\ 
For many families that once relied on two incomes, this crisis has 
meant managing on one income or no income at all. As a result, families 
are not only losing their economic stability, but their homes: one in 
nine mortgages is delinquent or in foreclosure.\18\
---------------------------------------------------------------------------
    \17\ U.S. Bureau of Labor Statistics, Economic News Release, 
Employment Situation Summary, Nov. 6, 2009, http://data.bls.gov/cgi-
bin/print.pl/news.release/empsit.nr0.htm.
    \18\ Center for American Progress, www.americanprogress.org/issues/
2009/03/econ_snap 
shot_0309.html, March 2009.
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    Five out of six workers (84 percent) say the recession and the 
scarcity of jobs are creating more pressure to show up for work, even 
when they are sick.\19\ Workers are understandably anxious about their 
job security, and many are unable to take any risk that might 
jeopardize their employment--even if they are stricken with H1N1. 
Especially now, when so many workers are suffering terribly, we must 
put in place a minimum labor standard so taking time off for illness 
doesn't lead to financial disaster. Workers have always gotten sick and 
always needed to care for children, family members and older 
relatives--and they have always managed to be productive, responsible 
employees. But without a basic labor standard of paid sick days, 
families' economic security can be at grave risk when illness strikes.
---------------------------------------------------------------------------
    \19\ Angus Reid Strategies for Mansfield Communications online 
survey of 1,028 workers, conducted 9/10-9/12/09. Margin of error: +/-
3.1% points.
---------------------------------------------------------------------------
    In addition, as our population ages, more workers are providing 
care for elderly parents. When working people have to take unpaid time 
off to care for a parent, spouse or sibling, they face often-terrible 
financial hardship. More than 34 million caregivers provide assistance 
at the weekly equivalent of a part-time job (more than 21 hours per 
week), and the estimated economic value of this support is roughly 
equal to $350 billion \20\--a huge contribution to the health and well-
being of their families. Caregivers contribute more than time; 98 
percent reported spending on average $5,531 a year, or one-tenth of 
their salary, for out-of-pocket expenses.\21\ Yet, many lose wages each 
time they must do something as simple as taking a family member to the 
doctor.
---------------------------------------------------------------------------
    \20\ Gibson, Mary Jo and Houser, Ari, ``Valuing the Invaluable: A 
New Look at the Economic Value of Family Caregiving.'' AARP, June 2007.
    \21\ Jane Gross, ``Study Finds Higher Costs for Caregivers of 
Elderly,'' New York Times, 11/19/07.
---------------------------------------------------------------------------
            businesses benefit from paid sick days policies
    Research confirms what working families and responsible employers 
already know: when businesses take care of their workers, they are 
better able to retain them, and when workers have the security of paid 
time off, their commitment, productivity and morale increases, and 
employers reap the benefits of lower turnover and training costs. 
Furthermore, studies show that the costs of losing an employee 
(advertising for, interviewing and training a replacement) is often 
much greater than the cost of providing short-term leave to retain 
existing employees. The average cost of turnover is 25 percent of an 
employee's total annual compensation.\22\
---------------------------------------------------------------------------
    \22\ Employment Policy Foundation 2002. ``Employee Turnover--A 
Critical Human Resource Benchmark.'' HR Benchmarks (December 3): 1-5.
---------------------------------------------------------------------------
    As mentioned previously, paid sick days policies also help reduce 
the spread of illness in workplaces, schools and child care facilities. 
In this economy, and during this time of a national health emergency, 
businesses cannot afford ``presenteeism,'' which occurs when, rather 
than staying at home, sick employees come to work and infect their co-
workers, lowering the overall productivity of the workplace. 
``Presenteeism'' costs our national economy $180 billion annually in 
lost productivity. For employers, this costs an average of $255 per 
employee per year and exceeds the cost of absenteeism.\23\ In addition, 
paid sick days policies help level the playing field and make it easier 
for businesses to compete for the best workers.
---------------------------------------------------------------------------
    \23\ Ron Goetzal, et al, Health Absence, Disability, and 
Presenteeism Cost Estimates of Certain Physical and Mental Health 
Conditions Affecting U.S. Employers, Journal of Occupational and 
Environmental Medicine, April 2004.
---------------------------------------------------------------------------
    Already, many savvy employers have responded to the H1N1 outbreak 
by expanding or improving their paid sick days policies. For example, 
Medtronic Inc. has reacted by granting all its employees, including 
hourly workers, 3 additional paid sick days. Best Buy has instructed 
its managers to send employees home if they arrive at work sick, and to 
pay them for the remainder of the day, even if they do not have any 
sick time.\24\ Texas Instruments, Inc. has relaxed its sick days 
policy, allowing workers to take as many days as they need to recover, 
by granting them the option of borrowing against future leave.\25\ 
These businesses and many others know that it is in their best interest 
to make sure that they do not have masses of sick workers on the job. 
They know that paid sick days must be part of their operating plans if 
they are going to keep their doors open and their businesses thriving 
during these difficult economic times.
---------------------------------------------------------------------------
    \24\ Next test: Flu 101, Suzanne Ziegler, Minneapolis Star Tribune, 
September 23, 2009 www.startribune.com/lifestyle/health/
60463767.html?elr=KArksi8cyaiUo8cyaiUiD3aPc:_Yyc:aU 
U.
    \25\ Sick Time: Employers Gear Up for Swine Flu, Betsy McKay and 
Dana Mattioli, Wall Street Journal, November 2, 2009, http://
online.wsj.com/article/SB20001424052748704746304574508 
110025260366.html.
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    THE NATION NEEDS POLICIES THAT ALLOW WORKERS TO MEET THEIR JOB 
                      AND FAMILY RESPONSIBILITIES

    Our Nation has a proud history of passing laws that help workers in 
times of economic crisis. Social Security and Unemployment Insurance 
became law in 1935; the Fair Labor Standards Act and the National Labor 
Relations Act became law in 1938, all in response to the crisis the 
Nation faced during the Great Depression. Working people should not 
have to risk their financial health when they do what all of us agree 
is the right thing--take a few days to recover from contagious illness, 
or care for a family member who needs them. Now is the time to protect 
our communities and put family values to work by adopting policies that 
guarantee a basic workplace standard of paid sick days.
    At present, no State requires private employers to provide paid 
sick days. The cities of San Francisco, the District of Columbia and 
Milwaukee have passed ordinances requiring that private employers 
provide paid sick days. This year, more than 15 cities and States have 
considered paid sick days laws to ensure that this basic labor standard 
becomes a right for all workers. This is a National movement now, and 
we expect it to expand to more than 25 campaigns next year. But illness 
knows no geographic boundaries, and access to paid sick days should not 
depend on where you happen to work. That's why a Federal paid sick days 
standard is so badly needed.
    Like the minimum wage, there should be a Federal minimum standard 
of paid sick days that protects all employees, with States and 
individual employers given the freedom to go above the Federal standard 
as needed to address particular needs of their residents or workers. 
The Healthy Families Act would create just that: a Federal floor that 
allows workers to earn up to 7 paid sick days a year to recover from 
short-term illness, to care for a sick family member, for routine 
medical care or to seek assistance related to domestic violence, sexual 
assault or stalking.
    Congress should waste no time in passing the Healthy Families Act 
so that working people can earn paid time off and help prevent the 
spread of the H1N1 virus and other illnesses--without jeopardizing 
their economic security.
    Chairman Dodd and members of the subcommittee, I thank you for the 
opportunity to participate in this important discussion, and we look 
forward to working with you to ensure that America's workers have a 
basic right of paid sick days.

    Senator Dodd. Well, thank you, as well. I appreciate those 
kind comments, and I thank you for your work over the years, as 
well. You've been a great asset and help in helping us craft 
these ideas. I thank you. A pleasure to have you with us today.
    Ms. Rosado, we welcome you. It's nice to have a constituent 
from Connecticut come on down and be with us. You can give us 
some valuable information. We welcome your comments this 
morning.

        STATEMENT OF DESIREE ROSADO, WORKER, GROTON, CT

    Ms. Rosado. Thank you.
    First of all, I want to thank you, Senator Dodd and members 
of the subcommittee, for holding this hearing on the costs of 
being sick. It is an issue that matters deeply to families like 
mine, in Connecticut and around the country. Thank you also for 
giving me the opportunity to testify here today.
    Like Senator Dodd said, my name is Desiree Rosado. I've 
been married for 13 years. I have three children, ages 12, 10, 
and 6. My oldest daughter, Isabella, is in the seventh grade, 
in middle school. My middle daughter, Alicia, is in the fifth 
grade. And my son, David, is in the second grade.
    Like most, we are a working family. I've lived in Groton, 
CT, for 12 years, and I've worked in the Groton public school 
system for the last 3 years. My job is in special education, 
and I work as a one-on-one assistant in the school that Alicia 
and David attend. My husband works as a security guard, third-
shift supervisor, at the Groton Naval Submarine Base. He's been 
working there for about 5 years. We are members of a church 
called International Family Worship Center, where my husband 
and I head the Praise and Worship Department.
    In our community, I can't even tell you how many sick kids 
we've seen sent home from school or kept home due to illness, 
these last several weeks. I think it's fair to say that just 
about every family has either been affected by the illness or 
is worried that their children will be infected.
    Mine were. All three of my children were sick this fall. 
They've been healthy for about a week and a half now. It was 
rough going, for a while. First, Alicia, my middle daughter, 
got a terrible headache, followed by fever of about 102 that 
lasted for almost a week. She had stomach pain, dizziness, and 
body aches. I had to miss work to stay home and take care of 
her for that week. The very day Alicia was able to go back to 
school, I went back to work, and I had been in class for about 
1 hour when the school nurse called to tell me that my son, 
David, had a fever of 101 and he had to go home. My daughter, 
my oldest daughter, Isabella, she fell ill that same day, and 
she and David were both sick for about a week. And then 
Isabella developed a sinus infection and bronchitis, as well, 
after the flu.
    In all, I missed about 2 weeks of work to care for my kids. 
I get no sick pay from my job, so my paycheck for that period 
was almost nothing. That caused tremendous hardship for my 
family.
    My husband and I live paycheck to paycheck right now, 
because we have no choice. We're trying to pay down our debts 
and make our family financially stable, but it is a hard road. 
And it's made a lot harder because, whenever we get sick or our 
children get sick, we have to decide whether to stay home 
without pay or to disregard doctor's orders and risk getting 
sicker and infecting others by going to work or school.
    When I don't get paid, it wreaks havoc on our family 
budget. My husband handles the finances, and he is able to 
juggle things around so we can make ends meet. Sometimes we end 
up having to borrow from our rent money that we've put aside, 
and we hate to do that, but sometimes we have no choice.
    That's one of the reasons I joined MomsRising, a wonderful 
million-member online organization that represents mothers like 
me across the country. MomsRising supports the Healthy Families 
Act because families like mine need to be able to earn paid 
sick days so we don't have to borrow from our rent money and go 
deeper into debt every time our kids get sick.
    When I was asked if I would come here and share my story 
and tell you how my family's been affected by this, I was more 
than willing, because having no paid sick days has really hurt 
our family's finances and economic stability. I'm speaking not 
only for myself, but for many other moms and families who are 
dealing with the same thing right now, and who really need 
relief.
    Being able to earn paid sick days would help so many 
parents and families I know through my work, church, and my 
community, and many more people that I don't know personally, 
but who are struggling with these same issues.
    I'm honored to be here today to take part in this hearing 
and to have a chance to tell you my story. I hope it will make 
a difference and convince you to pass the Healthy Families Act 
so all workers will be able to earn paid sick days.
    Thank you.
    Senator Dodd. Well, we thank you very much, Ms. Rosado. It 
takes a lot of courage to come and tell a personal story.
    Ms. Rosado. Thank you.
    Senator Dodd. And with that thing spreading through your 
family, which is not uncommon.
    Ms. Rosado. Yes.
    Senator Dodd. I'm learning about--I used to understand this 
issue intellectually.
    [Laughter.]
    Now that I have a 4-year-old and an 8-year-old, I've 
learned about it personally. Living with a Petri dish is 
usually a fascinating experience. I'm told I can anticipate 
having six colds a year, I think is what they anticipate, 
anyone with young children in school age, not to mention a time 
now, when obviously there's a heightened degree of problems 
with these issues.
    Anyway, we thank you very, very much, and honored that 
you're here.
    Ms. Rosado. Thank you.
    Senator Dodd. Ms. O'Brien.

    STATEMENT OF ELISSA C. O'BRIEN, VICE PRESIDENT OF HUMAN 
  RESOURCES, WINGATE HEALTHCARE, ON BEHALF OF THE SOCIETY OF 
             HUMAN RESOURCE MANAGEMENT, NEEDHAM, MA

    Ms. O'Brien. Chairman Dodd, Ranking Member Enzi, and 
distinguished members of the subcommittee, my name is Elissa 
O'Brien. I'm vice president of Human Resources at Wingate 
Healthcare, which operates and manage skilled nursing 
facilities and assisted living residents throughout 
Massachusetts and in New York.
    I appear today on behalf of the Society for Human Resource 
Management, or SHRM. As one of SHRM's more than 250,000 
members, I thank you for this opportunity to be here today to 
examine our Nation's response to H1N1 and paid sick leave 
proposals.
    Most employers and HR professionals are doing their part to 
respond to the current H1N1 flu pandemic by educating employees 
and taking common sense steps to prevent the spread of the 
virus in the workplace while maintaining critical business 
functions.
    I will briefly outline what Wingate Healthcare is doing to 
protect its facilities and employees, and then discuss a 
broader issue of mandated paid leave.
    At Wingate, we offer a very generous paid-time-off plan, 
which we like to call PTO. That provides our 4,000 employees 
with paid leave to use for any reason. Providing care to the 
sick, disabled, and elderly on a 24/7 basis requires that we 
make every effort to prevent the spread of illness in our 
facilities and to our patients. Therefore, Wingate's policy 
encourages employees to stay at home if they are experiencing 
any flu-like symptoms, and advises them to stay at home until 
they are free from fever. Wingate also offers alternative 
scheduling and telecommuting options for some employees to care 
for their sick family member.
    Wingate has taken other specific measures to protect our 
employees and patients. For example, we have provided our staff 
with the seasonal flu vaccines, although we are experiencing 
some backlogs. We are also working to obtain the H1N1 vaccine, 
although this, too, has proven very difficult.
    Obviously, the current H1N1 threat has thrust the issue of 
paid leave into the national debate. Employers and HR 
professionals have long understood the value of providing 
voluntary paid leave plans to employees as a recruitment and 
retention tool. Paid sick leave, mandated, however, could 
negatively impact those organizations who are already providing 
generous paid leave benefits.
    SHRM has a strong concern with a one-size-fits-all mandate 
encompassed in S. 1152, the Healthy Families Act, or HFA. I 
would like to note four significant challenges with the bill, 
from an HR professional's perspective.
    First, the HFA, like the current FMLA, proscribes a series 
of vague and ill-defined qualifying events that may trigger 
leave eligibility for an employee.
    Second, the HFA would likely disrupt current employer paid 
leave offerings. For example, it is unclear how the HFA's paid 
sick leave requirement would impact paid time-off plans.
    Third, the HFA would not pre-empt any State or local laws 
that provide a greater paid leave and leave rights, thus 
forcing employers to comply with a patchwork of varying 
Federal, State, and local leave laws.
    And finally, the HFA inflexible approach could cause 
employers to reduce wages and other benefits to pay for the 
leave mandate and associate a compliance cost, thereby limiting 
employees' benefits and compensation options.
    SHRM believes we need to adopt a different approach to all 
leave policies, an approach that reflects the needs of today's 
more mobile, diverse and flexible 21st-century workforce.
    Based on HR's years of experience on the front line in 
implementing leave statutes like FMLA, we believe Congress 
should offer incentives for employers to do more, not to risk 
unintended consequences of another government mandate.
    SHRM has developed a set of five principles to help guide 
the creation of this new leave policy. Briefly stated:
    First, SHRM believes that a new workplace leave policy must 
meet the needs of both the employees and employers.
    Second, employees should be encouraged to voluntarily 
provide paid leave to help employees meet work and personal 
life obligations through a safe-harbor leave standard.
    Third, a new policy should encourage maximum flexibility, 
creativity, and innovation for both employees and employers.
    Fourth, this policy must avoid a mandated one-size-fits-all 
approach and instead recognize that paid leave offerings should 
accommodate the increasing diversity of the workforce needs and 
environments.
    And fifth, the policy must support a variety of work 
options, such as telecommuting, flexible work arrangements, job 
sharing, and compressed and reduced schedules.
    SHRM is committed in working with Congress to determine a 
workplace flexibility policy that will lead more organizations 
to offer this type of paid leave and other benefits that make 
the most sense for employees and families.
    I thank you for your time today, and I look forward to your 
questions.
    [The prepared statement of Ms. O'Brien follows:]

               Prepared Statement of Elissa O'Brien, SPHR

    Chairman Dodd, Ranking Member Alexander and distinguished members 
of the subcommittee, my name is Elissa O'Brien. I am the Vice President 
of Human Resources for Wingate Healthcare, a privately owned health 
care provider that operates and manages high quality, skilled nursing 
facilities and assisted living residences throughout Massachusetts and 
New York.
    I appear today on behalf of the Society for Human Resource 
Management (SHRM), the world's largest association devoted to serving 
the needs of human resource professionals and to advancing the HR 
profession. On behalf of SHRM's more than 250,000 members, I thank you 
for the opportunity to appear before the subcommittee to examine our 
Nation's response to H1N1 and paid sick leave proposals.
    Clearly, the top-of-mind issue for this committee is the current 
H1N1 flu pandemic and what Congress can do to help Americans deal with 
a potential health care crisis. A national health emergency such as 
H1N1 comes along extremely infrequently, and few institutions, public 
or private, can be fully prepared--as we cannot predict the severity of 
the impact. Despite this uncertainty, employers must take every 
precaution to educate our employees and take common-sense steps to 
prevent the spread of the virus in the workplace. Our efforts must 
focus both on ensuring the well-being of our employees, and making sure 
plans are in place to maintain critical business functions. In my 
testimony today I will briefly outline what Wingate Healthcare is doing 
to protect its facilities and employees, the efforts SHRM has 
undertaken to educate our members and the profession on H1N1, and 
discuss the broader issue of mandated paid sick leave.
    At Wingate, we offer a very generous paid time off (PTO) plan that 
provides our 4,000 employees with paid leave to use for any reason. The 
nature of our business--providing care for the sick, disabled and 
elderly on a 24-7 basis--requires that we make every effort possible to 
prevent the spread of illness in our facilities and to our patients. 
Wingate policy, therefore, encourages employees to stay home if they 
are experiencing any flu-like symptoms such as fever, cough, or fatigue 
and advises them to remain at home until they are free from fever. Our 
policies are designed to provide maximum flexibility for our workers, 
and include a PTO bank consisting of 26 days of paid leave for new 
employees, growing to 33 days for those who have been with Wingate for 
7 years or more. A flexible PTO policy such as ours supports and 
encourages employees to stay home for their illness, or if needed, to 
stay home to care for a close family member with an illness. Wingate 
also offers alternative schedules and a telecommuting option for some 
employees to use to care for a sick family member.
    In addition to encouraging sick workers to use their paid time off 
and recuperate at home, Wingate has taken other specific measures in 
our facilities to protect our employees and patients from the spread of 
illness. This includes distribution of a ``Wingate Bag'' that includes 
Lysol, tissues, hand sanitizer and information on how to keep healthy. 
These bags have been distributed organization-wide to our employees who 
work in an office setting. We have also installed hand sanitizer 
throughout our facilities. As part of our proactive measures, as we do 
every year, we have provided our staff with the seasonal flu vaccine at 
the company's expense, although we are experiencing some backlogs in 
obtaining the vaccine this year. In addition, Wingate is working to 
obtain the H1N1 vaccine for our employees, although this too has proven 
difficult.
    As I stated, no institution can be fully prepared--but we are 
confident that we are doing everything we can to protect our facilities 
from the H1N1 virus. We are also proud that our efforts have been 
recognized by SHRM as an example to employers and human resource 
professionals on how to best prepare for a health emergency such as 
H1N1. SHRM's leadership in the employer community on this issue has 
been extremely beneficial, and I believe will help lessen the impact of 
the H1N1 pandemic in workplaces throughout the country.
    With the early outbreak in 2008 of H1N1 influenza, SHRM and HR 
professionals across the country began to prepare for a more serious 
and widespread pandemic in 2009. In preparation, SHRM and the Center 
for Infectious Disease Research & Policy (CIDRAP) at the University of 
Minnesota partnered together to host a 2-day summit, ``Keeping the 
World Working During the H1N1 Pandemic: Protecting Employee Health, 
Critical Operations, and Customer Relations.'' Leaders and presenters 
of four breakout sessions encouraged candid sharing among attendees, 
keeping the focus on practical tools, tips, and resources that can be 
put into action right away.
    Following the summit, SHRM consulted with the government's leading 
health authorities--the Centers for Disease Control and Prevention 
(CDC), and the U.S. Occupational Safety and Health Administration 
(OSHA)--to compile information for employers to prepare for and respond 
to a widespread influenza pandemic in the workplace. In collaboration 
with CIDRAP, we created the toolkit, Doing Business During an Influenza 
Pandemic: Human Resources Policies, Protocols, Templates, Tools, & Tip.
    From SHRM's perspective, most employers and HR professionals are 
responding appropriately and proactively during this national 
emergency. While Wingate's flexible paid time off policy may be an 
example of an ``effective practice''--other employers are doing what 
they can by relaxing attendance or absenteeism policies, allowing more 
alternative schedules, promoting telecommuting, or simply addressing 
employee needs as required. In a poll of its members conducted last 
May, 67 percent of SHRM members indicated that they either planned to, 
or were currently sending employees home if they came to work with flu- 
or cold-like symptoms. As the national focus on H1N1 has grown in 
recent months, we believe that it is highly likely that an even larger 
percentage of employers have adopted a similar approach.

                    FLEXIBLE PAID TIME OFF PROGRAMS

    Obviously, the H1N1 pandemic has thrust the issue of paid sick 
leave into the national debate. Employers and HR professionals have 
long understood the value of providing paid leave to employees. For 
example, according to the SHRM 2009 Examining Paid Leave in the 
Workplace Survey, 81 percent of responding SHRM members reported that 
their organization offered some form of paid leave while 88 percent 
offered paid vacation leave. In addition, 2008 data from the Bureau of 
Labor Statistics suggests that 83 percent of private sector workers had 
access to paid illness leave. Because many employers already offer 
generous paid leave, efforts to mandate paid sick leave would likely 
result in unintended consequences that could negatively impact both 
employers and employees, as discussed later in my testimony.
    The current flu pandemic illustrates the need for a 21st Century 
workplace flexibility policy that adapts to emergency situations, 
reflects the nature of today's workforce, and meets the needs of both 
employees and employers. It should enable employees to balance their 
work and personal needs while providing predictability and stability to 
employers. Most importantly, such an approach must encourage employers 
to offer greater flexibility, creativity and innovation to meet the 
needs of their employees and their families.
    At Wingate, our flexible PTO program allows our employees to 
schedule their time off to meet personal and individual needs, 
including observing holidays, caring for a family member, illness or 
injury, vacation, or tending to personal matters. For most employees, 
unused days are automatically rolled into an employee's ``Extended 
Illness Bank,'' which ensures compensation for illness and injury that 
last more than 5 days. After an absence of more than 15 days, our Short 
Term Disability benefit is available for employees, providing much-
needed assistance. I have attached a copy of Wingate Healthcare's Paid 
Time Off Policies and Procedures for the record.
    Wingate's PTO program reflects the principles for paid leave that 
the Society for Human Resource Management advocates. Both SHRM and 
Wingate believe that any Federal leave policy should:

     Provide certainty, predictability and accountability for 
employees and employers.
     Encourage employers to offer paid leave under a uniform 
and coordinated set of rules that would replace and simplify the 
confusing--and often conflicting--existing patchwork of regulations.
     Create administrative and compliance incentives for 
employers who offer paid leave by offering them a safe-harbor standard 
that would facilitate compliance and save on administrative costs.
     Allow for different work environments, union 
representation, industries and organizational size.
     Permit employers that voluntarily meet safe harbor leave 
standards to satisfy Federal, State and local leave requirements.

    I have attached a copy of SHRM's Principles for a 21st Century 
Workplace Flexibility Policy for the record.
    The collective membership of SHRM represents the professionals who 
develop and implement human resource policies in organizations 
throughout the country and, as such, are responsible for administering 
employee benefit plans, including paid time-off programs. Our members 
are also constantly looking for ways to adapt and design workplace 
policies that improve employee morale and retention--two essential 
elements in developing and maintaining a productive workforce. It just 
makes sense that offering a solid benefits program makes it easier for 
organizations to attract and retain great employees.
    Given the practical experience SHRM and its members possess, we 
believe we are uniquely positioned to provide insight on a sensible 
Federal leave policy that ensures fairness and balance for employees 
and employers and we urge Congress to take a serious look at adopting 
policies that will encourage employers to adopt the type of flexible 
paid time off program that has worked so well for Wingate Healthcare 
and its employees.

                      FAMILY AND MEDICAL LEAVE ACT

    As Congress considers workplace leave policy, I'd like to take a 
moment to point out the pitfalls that can accompany a new government 
mandate. Since its enactment in 1993, the Family and Medical Leave Act 
(FMLA) has helped millions of employees and their families, yet not 
without consequences. Key aspects of the regulations governing the 
statute's medical leave provisions, however, have drifted far from the 
original intent of the act, creating challenges for both employers and 
employees.
    As you know, the FMLA provides unpaid leave for the birth, adoption 
or foster care placement of an employee's child, as well as for the 
``serious health condition'' of a spouse, son, daughter, or parent, or 
for the employee's own medical condition.
    From the beginning, HR professionals have struggled to interpret 
various provisions of the FMLA. What began as a fairly simple 12-page 
document has become 200 pages of regulations governing how the law is 
to be implemented. This is the result of a well-intentioned, but 
counter-productive attempt to anticipate and micro-manage every 
situation in every workplace in every industry--without regard for the 
evolving and diverse needs of today's workforce.
    Among the problems associated with implementing the FMLA are the 
definitions of a serious health condition, intermittent leave, and 
medical certifications. Vague FMLA rules mean that practically any 
ailment lasting 3 calendar days and including a doctor's visit, now 
qualifies as a serious medical condition. Although we believe Congress 
intended medical leave under the FMLA to be taken only for truly 
serious health conditions, SHRM members regularly report that 
individuals use this leave to avoid coming to work even when they are 
not experiencing serious symptoms. This behavior is damaging to 
employers and fellow employees alike.
    However well-intended the original FMLA legislation was, 
proscriptive attempts to micro-manage how, when and under what 
circumstances leave must be requested, granted, documented and used are 
counter-productive to encouraging flexibility and innovation. This is 
an especially important lesson when considering legislation that would 
mandate paid sick leave.

                          HEALTHY FAMILIES ACT

    SHRM has strong concerns with the one-size-fits-all mandate 
encompassed in S. 1152, the ``Healthy Families Act'' (HFA). The bill 
would require public and private employers with 15 or more employees 
for 20 or more calendar workweeks in the current or preceding year to 
accrue 1 hour of paid sick leave for every 30 hours worked. Under the 
HFA, an employee begins accruing the sick time upon commencement of 
employment and is able to begin using the leave after 60 days. The paid 
sick time could be used for the employee's own medical needs or to care 
for a child, parent, spouse, or any other blood relative, or for an 
absence resulting from domestic violence, sexual assault or stalking.
    We share the goal that employees should have the ability to take 
time off to attend to their own or a close family member's health, and 
that the leave should be paid. However, at a time when employers are 
facing unprecedented challenges, imposing a costly paid leave mandate 
on employers could easily result in additional job loss or cuts in 
other important employee benefits. While the HFA presents a host of 
practical concerns, I would note four significant challenges with this 
bill from an HR professional's perspective.
    First, the HFA, like the current FMLA, prescribes a series of vague 
and ill-defined qualifying events that may trigger leave eligibility 
for the employee. Under the current FMLA, employers and employees alike 
must make a determination if the requested leave is eligible for 
coverage as a qualifying event. While in many instances this 
determination of leave eligibility under the FMLA can be made easily, 
in others it requires the employer and employee to make a rather 
subjective, sometimes intrusive determination to determine leave 
eligibility--often leaving both parties frustrated and distrustful of 
each other. Unfortunately, we anticipate that employers and employees 
will have a similar experience under the HFA in trying to determine 
leave eligibility.
    Second, although it may not be the intention of the bill sponsors, 
the HFA would disrupt current employer paid leave offerings. For 
example, if an employer's existing paid leave policy fails to meet all 
the requirements of the act, the employer's plan would need to be 
amended to comply with the HFA requirements. In addition, it is unclear 
how the HFA's paid ``sick'' leave requirement would impact paid time 
off plans, programs that are growing in popularity. In fact, more and 
more employers have begun to offer Paid Time Off plans, similar to the 
one offered at Wingate Healthcare, in lieu of other employer-sponsored 
paid leave programs because these types of plans are preferred by 
employees and employers. According to the SHRM 2009 Examining Paid 
Leave in the Workplace Survey, 42 percent of employers offer PTO plans 
to their employees. Congress should build on the progress that is 
already being made by offering incentives for employers to do more--not 
risk the unintended consequences of an onerous government mandate that 
could very well result in decreased benefits and fewer new jobs.
    Third, the HFA specifically states that the act does not supersede 
any State or local law that provides greater paid sick time or leave 
rights, thus forcing employers to comply with a patchwork of varying 
Federal, State and/or local leave laws--as well as their own leave 
policies. As it stands now, employers consistently report challenges in 
navigating the various conflicting requirements of overlapping State 
and Federal leave and disability laws. The HFA would only add to the 
already complex web of inconsistent but overlapping leave obligations 
under Federal and State laws.
    Finally, the HFA's inflexible approach could cause employers to 
reduce wages or other benefits to pay for the leave mandate and 
associated compliance costs, thereby limiting employees' benefit and 
compensation options. This is because employers have a finite pool of 
resources for total compensation. If organizations are required to 
offer paid sick leave, they will likely ``absorb'' this added cost by 
cutting back or eliminating other employee benefits, such as health or 
retirement benefits, or forgo wage increases, a potential loss to 
employees who prefer other benefits rather than paid sick leave.
    SHRM believes the Federal Government should encourage paid leave--
without creating new mandates on employers and employees. As has been 
our experience under the FMLA, inflexible mandates and proscriptive 
regulations are counter-productive to encouraging flexibility and 
innovation. As a result, the focus is on documentation of incremental 
leave and the reasons for the leave, rather than on seeking innovative 
ways to help employees to balance the demands of both work and personal 
life. Another rigid Federal mandate would be more of the same.

                               CONCLUSION

    SHRM and the 250,000 human resource professionals it represents 
believe that it is time to give employees choices and give employers 
more predictability when it comes to a Federal leave policy. We believe 
employers should be encouraged to provide the paid leave their 
workforces need--and let employees decide how to use it. From our 
perspective, a government-mandated approach to providing leave is a 
clear example of what won't work--particularly during a time of 
economic crisis.
    It is clear that the H1N1 pandemic presents extreme challenges to 
business, government and non-profit organizations of all types. SHRM 
and its members are focused on keeping their workforces as safe and 
healthy as possible and keeping their businesses running until this 
public health threat has run its course. In the meantime, we caution 
against rushing to impose new mandates that will do more harm than 
good. Rather, we welcome the opportunity to work with Congress to 
develop a more modern workplace flexibility policy. Thank you for the 
opportunity to testify before the committee and I welcome your 
questions.

                Attachment 1.--Wingate Healthcare, Inc.
                 Paid Time Off Policies and Procedures

                             EFFECTIVE DATE

    This document describes the Wingate Healthcare Paid Time Off 
(hereinafter referred to as ``PTO'') policy in effect as of January 1, 
2005.

                               DISCLAIMER

    This policy supercedes all prior ``time off '' policies and 
procedures, including any representations or interpretations of ``time 
off '' policies or procedures that are inconsistent with this 
memorandum.

                ELIGIBLE USES OF SCHEDULED PAID TIME OFF

    The Company's PTO policy provide employees with the flexibility to 
schedule their time off to meet personal and individual needs, 
including observing holidays, caring for a family member, illness or 
injury, vacation, or tending to personal matters.

                              ELIGIBILITY

    Full and part-time employees that are regularly scheduled to work 
at least 24 hours per ``Pay Period'' (defined as Sunday through 
Saturday) accrue PTO on a weekly basis. Pay-in-lieu of benefits, per 
diems and temporary employees are ineligible for PTO benefits.
    PTO does not accrue during the first 90 days of employment. Upon 
successfully completing 90 days of employment, employees will be 
credited with PTO from the first day of employment. Employees who cease 
employment prior to 90 days are not entitled to any PTO benefits.

                             ACCRUAL PERIOD

    PTO accrues and resets every 12 months, beginning on each 
employee's employment ``Anniversary Date'' (defined as the employee's 
date of hire). Such 12-month period is referred to herein as an 
``Employment Year''. PTO balances will reset to zero annually, on the 
employee's Anniversary Date and unused PTO balances do not carry 
forward to the following Employment Year for hourly non-exempt 
employees. However, unused PTO will automatically transfer to the 
employee's Extended Illness Bank. Please see the section on Extended 
Illness Bank below, for bank maximums and details. Management and 
exempt-level employees are allowed to carry over a maximum of 1 week 
PTO time into the following year and any outstanding unused PTO will 
automatically transfer to the employee's Extended Illness Bank. Please 
see the section on Extended Illness Bank below, for bank maximums and 
details.

                             ACCRUAL RATES

    PTO accrues on a weekly basis, based on the number of hours an 
employee works in a Pay Period. PTO does not accrue on any hours worked 
in excess of 40 in a Pay Period. The amount of PTO employees accrue is 
based on their position and seniority with the Company, as detailed in 
the following chart.


----------------------------------------------------------------------------------------------------------------
                                   0 through 3 Years      4 Years  of      5 and 6 Years  of    7 or More Years
                                      of Service            Service             Service           of Service
         Position Level          -------------------------------------------------------------------------------
                                    Maximum Weekly      Maximum Weekly      Maximum Weekly      Maximum Weekly
                                        Accrual             Accrual             Accrual             Accrual
----------------------------------------------------------------------------------------------------------------
Administrators, DNS, Department   5.08 Hrs/ Week      5.08 Hrs/ Week      5.39 Hrs/ Week      5.54 Hrs/ Week
 Heads, Managers, Including        (33 Days/Year).     (33 Days/Year).     (35 Days/Year).     (36 Days/Year).
 Exempt Level Staff.
All Other Staff.................  4.00 Hrs/ Week      4.77 Hrs/ Week      4.92 Hrs/ Week      5.08 Hrs/ Week
                                   (26 Days/Year).     (31 Days/Year).     (32 Days/Year).     (33 Days/Year).
----------------------------------------------------------------------------------------------------------------
This chart reflects accruals based on a full-time, 40-hour-per-week position. Part-time employees accrue PTO on
  a prorated basis.

                        REQUESTING AND USING PTO

    To use PTO, employees must complete a Time Off Request Form at 
least 2 weeks in advance, typically before the applicable work schedule 
is posted. Though we attempt to accommodate employees' PTO requests, 
approval is based on the needs of the facility. In the event of 
scheduling conflicts, PTO will be granted on the basis of seniority 
and/or the date of request. Scheduling and approving PTO requests is 
the responsibility of the Department Head or Supervisor and is subject 
to final approval by the Administrator.
    PTO may be taken as it accrues and in increments of one (1) hour. 
No more than forty (40) hours may be taken in a Pay Period. PTO request 
over 2 weeks will not be approved. Facilities reserve the right to 
limit PTO request on no more than a week in peak time off months. 
Employees who need to take an extended time off must apply for a Leave 
of Absence. Policy is detailed in the Company's Employee Handbook.
    PTO balances must be used during the Employment Year in which it 
accrues. PTO balances do not carry forward to the following Employment 
Year except for management and exempt-level personnel who are allowed 
to carry over no more than 1 week of PTO (maximum 40 hours) in an 
Employment Year. Please refer to the Accrual Period section of this 
policy for details.

                            APPROVAL PROCESS

    In order to assist staff in planning for time-off, approval or 
denial of PTO requests will be completed within 2 weeks of the request.

                          BUYING BACK PTO DAYS

    Hourly, non-exempt employees may buy back up to 24 days of their 
accrued PTO in any Employment Year. However, employees may not buy back 
more than one (1) day per pay period and two (2) days in any single 
month.
    PTO time may be bought back on accrued time only. Employees cannot 
borrow time for buy back purposes.
    Employees must complete the Buy Back Section of the Time Off 
Request Form and submit it to their Supervisor for approval. Every 
attempt will be made to process your request within the next payroll 
cycle following approval.

                             BORROWING PTO

    Employees may borrow up to 1 week (5 days) of unaccrued PTO for 
time off purposes only and not for buy back purposes, as long as the 
employee is able to accrue the borrowed PTO within their employment 
year. Borrowing PTO is subject to the Administrator's approval. If an 
employee terminates employment prior to accruing the borrowed days, the 
Company will deduct the cash value of the borrowed time from the 
employee's final paycheck at their rate of pay in effect at the time of 
their termination.

                              PTO ADVANCE

    As a convenience to our employees who may have difficulty accessing 
their banks during travel on a vacation lasting 5 or more consecutive 
days, the Company will advance (pre-pay) up to 5 days of accrued PTO 
pay. The employee must give the Payroll Department 2 weeks prior 
written notification. Advances are subject to the Administrator's 
approval. The Company will not advance unaccrued PTO time. 
Unfortunately, for administrative reasons, we are unable to process PTO 
advances for employees who use direct deposit for their paycheck.

                             MAJOR HOLIDAYS

    The company recognizes Fourth of July, Thanksgiving, Christmas and 
New Year's Day as major holidays. These days are hereinafter referred 
to as ``Major Holidays''.
Working A Major Holiday
    All hourly regular, non-exempt, per diem, pay-in-lieu of benefit, 
temporary and new employees (still within their first 90 days of 
employment) will be paid ``Holiday Premium Pay'', equal to one-half 
(\1/2\) their regular base rate of pay for hours worked on a Major 
Holiday in addition to their regular base hourly pay.
Major Holiday Unscheduled Day Off
    If an employee works a Major Holiday, but takes an unscheduled day 
off the day before or the day after the Major Holiday, they will be 
paid their regular hourly rate of pay for hours worked on the Major 
Holiday, therefore, losing any Holiday Premium Pay.
    If an employee does not work on a Major Holiday and takes an 
unscheduled day off the day before or the day after the Major Holiday, 
they will not receive PTO pay for the Major Holiday observed unless 
approved by the Administrator.

                            UNSCHEDULED DAYS

Attendance and Tardiness
    It is understandable that unexpected circumstances arise which may 
make it difficult for an employee to provide appropriate advance notice 
to request time off. However, employees are expected to comply with the 
Company's Attendance and Tardiness policies detailed in the Company's 
Employee Handbook and the Attendance Policy contained within the 
Employee Performance Improvement Program.
    If more than three (3) incidents of unscheduled time off occur 
during a 12-month period, the employee may be subject to disciplinary 
action up to, and including, termination of employment.
No Call No Show
    If an employee is a no call no show they will not be able to use 
PTO time for that day. Additionally, the employee will be subject to 
disciplinary measures as outlined in the No Call No Show policy 
detailed in the Company's Employee Handbook and in the Attendance 
Policy contained within the Employee Performance Improvement Program.

                         EXTENDED ILLNESS BANK

    Employees must use their PTO balance during the Employment Year in 
which it accrues. PTO balances do not carry forward to the following 
Employment Year. However, the Company will deposit any accrued, unused 
PTO days at the end of the Employment Year into the employee's Extended 
Illness Bank for use in the event the employee becomes ill or injured 
for 5 or more consecutive days. The maximum number of Extended Illness 
Bank hours is 120 hours.
    Extended Illness Bank days are ineligible for payment upon 
termination, unless the employee has been employed for 10 or more 
years.
    Employees who have been employed with the company for ten (10) or 
more years are eligible to be paid for a portion of their Extended 
Illness Bank days when they leave the company, as follows:


------------------------------------------------------------------------
                                                          % of Extended
                                                           Illness Bank
                    Years of Service                       Eligible For
                                                             Payment
------------------------------------------------------------------------
10-14 Years............................................             50%
15-19 Years............................................             75%
20 or More Years.......................................            100%
------------------------------------------------------------------------

                       BENEFITS UPON TERMINATION

    Upon termination of employment, the Company will pay employees for 
a portion of their accrued PTO balance based on the ``vacation time'' 
value of their PTO balance and the employee's position, as follows:


------------------------------------------------------------------------
                                                              % of PTO
                                                             considered
                                                             ``Vacation
                         Position                            Time'' Upon
                                                             Termination
                                                                 of
                                                             Employment
------------------------------------------------------------------------
Administrators and Directors of Nursing Managers/                   35%
 Department Heads, and Exempt Level Staff.................
All Other Staff...........................................          25%
------------------------------------------------------------------------

    Employees may not take PTO days during their resignation period 
unless approved by the facility Administrator. If approved, time off 
taken during the resignation period will be deducted from the 
employee's PTO balance.
    If you have questions regarding this policy, please contact your 
Human Resources Representative in the Business Office.
     Attachment 2--Society for Human Resource Management (SHRM) \1\
---------------------------------------------------------------------------
    \1\ The Society for Human Resource Management (SHRM) is the world's 
largest association devoted to the human resource profession. Founded 
in 1948, SHRM represents 250,000 human resource professionals in 
thousands of small and large employers representing every sector of the 
U.S. economy.
---------------------------------------------------------------------------
       Principles for a 21st Century Workplace Flexibility Policy

    The Society for Human Resource Management (SHRM) believes the 
United States must have a 21st century workplace flexibility policy 
that meets the needs of both employees and employers. It should enable 
employees to balance their work and personal needs while providing 
predictability and stability to employers. Most importantly, any policy 
must encourage--not discourage--the creation of quality new jobs.
    Rather than a one-size-fits-all government approach, where Federal 
and State laws often conflict and compliance is determined under 
regulatory silos, SHRM advocates a comprehensive workplace flexibility 
policy that, for the first time, responds to the diverse needs of 
employees and employers and reflects different work environments, union 
representation, industries and organizational size.
    For a 21st century workplace flexibility policy to be effective, 
SHRM believes that all employers should be encouraged to provide paid 
leave for illness, vacation and personal days to accommodate the needs 
of employees and their family members. In return, employers who choose 
to provide paid leave would be considered to have satisfied Federal, 
State and local leave requirements. In addition, the policy must meet 
the following principles:

    Shared Needs--Workplace flexibility policies must meet the needs of 
both employees and employers. Rather than an inflexible government-
imposed mandate, policies governing employee leave should be designed 
to encourage employers to offer a paid leave program (i.e., illness, 
vacation, personal days or a ``paid time off '' bank) that meets 
baseline standards to qualify for a statutorily defined ``safe 
harbor.'' For example, SHRM envisions a ``safe harbor'' standard where 
employers voluntarily provide a specified number of paid leave days for 
employees to use for any purpose, consistent with the employer's 
policies or collective bargaining agreements. In exchange for providing 
paid leave, employers would satisfy current and future Federal, State 
and local leave requirements. A Federal policy should:

     Provide certainty, predictability and accountability for 
employees and employers.
     Encourage employers to offer paid leave under a uniform 
and coordinated set of rules that would replace and simplify the 
confusing--and often conflicting--existing patchwork of regulations.
     Create administrative and compliance incentives for 
employers who offer paid leave by offering them a safe harbor standard 
that would facilitate compliance and save on administrative costs.
     Allow for different work environments, union 
representation, industries and organizational size.
     Permit employers that voluntarily meet safe harbor leave 
standards to satisfy Federal, State and local leave requirements.

    Employee Leave--Employers should be encouraged voluntarily to 
provide paid leave to help employees meet work and personal life 
obligations through the safe harbor leave standard. A Federal policy 
should:

     Encourage employers to offer employees with some level of 
paid leave that meets minimum eligibility requirements as allowed under 
the employer's safe harbor plan.
     Allow the employee to use the leave for illness, vacation, 
personal and family needs.
     Require employers to create a plan document, made 
available to all eligible employees, that fulfills the requirements of 
the safe harbor.
     Require the employer to attest to the U.S. Department of 
Labor that the plan meets the safe harbor requirements.

    Flexibility--A Federal workplace leave policy should encourage 
maximum flexibility for both employees and employers. A Federal policy 
should:
     Permit the leave requirement to be satisfied by following 
the policies and parameters of an employer plan or collective 
bargaining agreement, where applicable, consistent with the safe harbor 
provisions.
     Provide employers with predictability and stability in 
workforce operations.
     Provide employees with the predictability and stability 
necessary to meet personal needs.

    Scalability--A Federal workplace leave policy must avoid a mandated 
one-size-fits-all approach and instead recognize that paid leave 
offerings should accommodate the increasing diversity in workforce 
needs and environments. A Federal policy should:

     Allow leave benefits to be scaled to the number of 
employees at an organization; the organization's type of operations; 
talent and staffing availability; market and competitive forces; and 
collective bargaining arrangements.
     Provide pro-rated leave benefits to full- and part-time 
employees as applicable under the employer plan, which is tailored to 
the specific workforce needs and consistent with the safe harbor.

    Flexible Work Options--Employees and employers can benefit from a 
public policy that meets the diverse needs of the workplace in 
supporting and encouraging flexible work options such as telecommuting, 
flexible work arrangements, job sharing, and compressed or reduced 
schedules. Federal statutes that impede these offerings should be 
updated to provide employers and employees with maximum flexibility to 
balance work and personal needs. A Federal policy should:

     Amend Federal law to allow employees to balance work and 
family needs through flexible work options such as telecommuting, flex-
time, part-time, job sharing and compressed or reduced schedules.
     Permit employees to choose either earning compensatory 
time off for work hours beyond the established workweek, or overtime 
wages.
     Clarify Federal law to strengthen existing leave statutes 
to ensure they work for both employees and employers.

    Senator Casey [presiding]. Thank you very much.
    We're down to two of us now, Senator Enzi and I. I'm 
standing in for Senator Dodd.
    Dr. Gottlieb.

 STATEMENT OF SCOTT GOTTLIEB, M.D., RESIDENT FELLOW, AMERICAN 
              ENTERPRISE INSTITUTE, WASHINGTON, DC

    Dr. Gottlieb. Thanks a lot. I want to thank the members of 
the committee for having me here today.
    I also have a longer written statement I'd like to submit 
for the record.
    This flu has taken a substantial toll on Americans, and I 
believe our focus should be on ways we can mitigate these risks 
in the future if more Americans can benefit from vaccination 
earlier in the course of these kinds of pandemics.
    The good news is that we're much better prepared to deal 
with this flu than we would have been as recently as 5 years 
ago. This owes to steps taken by the current Administration to 
start development of an H1N1 vaccine early last spring, and 
other steps that they took to make the development processes 
easier when the virus first emerged. It also owes, in addition, 
to extensive pandemic planning undertaken by the Bush 
Administration, which left us with a much better capacity to 
deal with this crisis.
    There are still gaps in our preparedness, and nagging 
vulnerabilities. Too many of our policy choices, with respect 
to development of this vaccine, forced us to sacrifice on the 
speed and reliability of the vaccine production in order to 
assuage concerns about vaccine safety.
    With the right tools and investments, going forward, we 
should be able to have more effective vaccines and predictable 
supply while maintaining our very high degree of safety, and 
this should be our focus.
    Having an adequate domestic capacity for developing 
pandemic vaccines is a matter of national security. European 
countries share our regulatory standards and our focus on 
safety, but they are far ahead of us in using new and more 
reliable technology in their production of new flu vaccines.
    One step for improving our readiness for the future is to 
better integrate the use of vaccine additives called adjuvants 
into our pandemic planning. First, FDA should write formal 
guidance on the development of adjuvants as part of pandemic 
vaccines.
    The United States should also consider stockpiling pre-
approved vaccine preparations that could be used in public 
health emergencies. The European strategy of having pandemic 
vaccines pre-approved as mockups was a prudent step.
    We also need to invest in new manufacturing. Using cell 
cultures instead of chicken eggs cuts 3 to 4 weeks from the 
time required to mass-produce a vaccine. The biggest advantage 
of cell-based manufacturing is its more rapid scale-up and its, 
potentially, better predictability.
    We also need to make sure that an adequate proportion of 
the worldwide influenza vaccine production capacity is 
domiciled in the United States. It's hard to envision other 
nations allowing limited supply of vaccine raw material to be 
shipped outside their borders in the event of a lethal 
pandemic. This was already made clear to us, as Senator Dodd 
commented on earlier, and this isn't even a truly lethal 
pandemic. It's a very serious virus, but it could have been far 
worse. Yet, already we saw the Australian government pressure 
vaccine-maker CSL to keep its vaccine home, in Australia, 
instead of fulfilling its contract for 36 million doses for the 
United States. In Canada, where GSK maintains one of its two 
flu vaccine production facilities, the other being in Germany, 
but the Canadian facility is the one that supplies the U.S. 
market, the company had to assure the Canadian government that 
the Canadians would be served first from that facility before 
the United States could receive its H1N1 orders.
    This risk is compounded by the fact that all but one of the 
vaccines production facilities we depend on is located outside 
the United States. There are also significant limitations in 
global fill/finishing capacities, and also there aren't enough 
facilities domiciled here in the United States.
    There are business impediments to building new facilities. 
Production sites require large investments, and the financial 
return of flu vaccine is typically small. If the same company 
produces flu vaccines at two different facilities, completely 
separate clinical trials and separate approvals are required 
for each vaccine. This drives developers to expand existing 
facilities rather than create new ones. There may be better 
ways to enable more cooperation between requirements set forth 
by different regulators, or make use of studies that could 
bridge between products from a single manufacturer's different 
manufacturing lines, to incentivize manufacturers to build 
redundant facilities.
    Other measures that would help create more domestic 
capacity include guaranteed markets for seasonal flu vaccines. 
This would create additional incentives for building U.S. 
manufacturing capacity, especially if the tender process 
favored domestic manufacturers.
    In closing, some of our policy choices contributed to the 
limited availability of vaccine this season. These trade-offs 
can be reduced in the future if we take steps today to increase 
our capacity for timely development of safe, effective, and 
innovative vaccines in the future.
    Thank you very much.
    [The prepared statement of Dr. Gottlieb follows:]

              Prepared Statement of Scott Gottlieb, M.D.*

                              INTRODUCTION

    Mr. Chairman and members of the committee, I wish to thank you for 
the invitation to appear before you today to address issues related to 
our preparedness for H1N1 flu. While this influenza is, so far, proving 
less virulent than once feared, it is still a very dangerous virus.\1\ 
This is especially true for vulnerable populations such as pregnant 
woman,\2\ young children, and those with compromised immune systems or 
lung disease.\3\ \4\ H1N1 infections are expected to decline in 
November and December 2009 but then peak again with higher mortality 
from March to May 2010. In this respect, some experts believe H1N1 may 
emulate the 1957 pandemic--
decreasing late this year only to pick up again in the spring.\5\
---------------------------------------------------------------------------
    * Dr. Gottlieb is a practicing physician and Resident Fellow at the 
American Enterprise Institute. From 2005 to 2007 he served as the 
Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food 
and Drug Administration. Dr. Gottlieb is partner to a firm that invests 
in healthcare companies.
---------------------------------------------------------------------------
    As we are here today to discuss, this flu has taken a substantial 
toll on Americans. It has affected their health but also their 
financial security, whether it's through lost wages, missed workdays, 
or increased job insecurity during a deep recession. But legislation 
creating employment benefits specifically targeted to this flu doesn't 
appear to be the right focus for our resources or response. It would be 
hard to administer. There also doesn't seem to be a compelling public 
policy case for singling out this particular flu from others--many of 
which have actually hit the older and working age populations harder in 
the past.
    Instead, I believe our focus should be on ways we can mitigate 
these risks in the future, if more Americans were able to benefit from 
vaccination earlier in the course of a pandemic.
    The good news is that we were much better prepared to deal with 
this flu than we would have been as recently as 5 years ago. This owes 
to steps taken by the current Administration to contract for 
development of an H1N1 vaccine early last spring, when the virus first 
emerged. Collaborative steps to speed vaccine production were 
undertaken immediately, even before it was clear a vaccine would be 
needed, including work between U.S. Government agencies, international 
partners, and drug firms to provide viral reference strains and 
reagents needed for vaccine production. These tasks were accomplished 
in record time despite technical challenges. In addition, extensive 
pandemic planning undertaken by the Bush administration \6\ left us 
with much better capacities to deal with this crisis. But there are 
still significant gaps in our preparedness, and nagging 
vulnerabilities.
    Too many of the policy choices we were confronted with in this 
crisis forced us to sacrifice on the speed and reliability of vaccine 
production in order to assuage concerns about vaccine safety. Vaccine 
supplies are increasing, but we still do not have the quantities we 
expected, in the time frame that we needed.\7\ Among other things, we 
chose to forgo the use of vaccine additives that could \8\ boost 
effectiveness and might have helped us stretch our limited supply of 
vaccine raw material over more shots. We are compelled to rely on old, 
unpredictable manufacturing technology because we haven't developed the 
necessary capacities with more modern tools. We also lack domestic 
vaccine manufacturing facilities. In at least two cases we know of, 
this put the United States behind other countries in getting vaccine 
orders filled.
    The bottom line is we have relied for too long on outdated capacity 
for our flu vaccines, in part because of our cultural reluctance to 
embrace new methods. This is not simply a regulatory issue, but 
reflects the public mood when it comes to vaccine products.
    There are good reasons why the regulation of vaccines is distinct. 
Vaccines are given to millions of otherwise healthy people, and 
administered over a compressed time period. This is especially true for 
flu vaccines. That rapid and widespread administration limits the 
ability to uncover ``latent'' risks after products are approved and 
marketed. It means that, by the time we intervene to prevent exposure 
to an emerging side effect, millions of people might have already 
received a seasonal product. This is a unique risk. For these reasons, 
a strong pre-market regulatory process is imperative. New vaccine 
technology, like any innovation, invariably brings some new 
uncertainties--heightening regulatory caution.
    For all of these reasons and many others, we are slow to embrace 
change to flu vaccine production. But with the right tools and 
investments, we should be able to mitigate any reasonable risk. We can 
have more effective vaccines, and more predictable and timely supply, 
while maintaining our high degree of safety. This should be our focus.
    Right now, our decisions to stick with safe and familiar methods 
also obligate us to embrace too much uncertainty about product supply. 
In the setting of a pandemic, these tradeoffs are simply not 
acceptable. While manufacturing problems at the drug firms contributed 
to delays in vaccine availability this year, the bottom line is that 
the policy choices we made also played a role. The drug makers are easy 
targets in our political culture and have recently received the brunt 
of official criticism from some public officials. But fault for today's 
shortages don't rest with them alone, any more than it rests with the 
public health officials overseeing our pandemic response. These are 
problems of biology and technology. Still, I worry that too much time 
spent finger pointing obscures the mission we should be focused on. 
Fixing blame will not improve our readiness. It will not increase our 
vaccine supply.
    These issues are matters of national security. The fact is that 
European countries share our regulatory standards and our focus on 
vaccine safety. But they are far ahead of us in using new and more 
reliable technology into their production of new flu vaccines. It's 
true we remain farther ahead with other vaccine products, such as our 
adoption of conjugate vaccines or live attenuated approaches. But when 
it comes to pandemic planning, and response to flu, there is more we 
need to be doing.
    Understanding the tradeoffs made by our policy choices, the gaps in 
the technology we use, and the steps we must take to improve future 
readiness--these things should be our focus.
      use of vaccine additives to improve yield and effectiveness
    One step to improving our readiness for the future is to better 
integrate the use of vaccine additives called adjuvants into our 
pandemic planning.
    An adjuvant is a substance incorporated into a vaccine that 
enhances or directs the immune response of the vaccinated patient. 
Adjuvants are designed to bring the vaccine's antigen into contact with 
the immune system and, therefore, enhance the magnitude of immunity 
produced as well as the duration of the immune response.
    Novartis \9\ and GSK, among other drug firms, have done innovative 
work incorporating new generations of adjuvants into vaccines marketed 
in Europe this fall for H1N1. A lot of the recent activity in Europe to 
deploy adjuvants was based on ``mock up'' preparations of pandemic 
vaccines that those nations had been pre-
approved and stockpiled.
    In the United States, our decision to forgo use of adjuvants, that 
can work to increase the protective effects of a given quantity of 
vaccine, limited our ability to stretch our already limited stock of 
H1N1 vaccine raw material (the vaccine antigen).\10\ It is worth noting 
that no country has had earlier large supplies of vaccine, including in 
Europe. The three countries first out with substantial vaccine (the 
United States, Australia and China) all used non-adjuvanted egg-based 
vaccines. So the capacity issues, and challenges are a global problem. 
But to improve for the future, we need to be better prepared to embrace 
these new methods.
    In 2008, GSK became the first company to obtain a European license 
for an adjuvanted prepandemic vaccine, Prepandrix. This vaccine is 
designed to raise immune protection against several strains of the H5N1 
(Avian) flu virus.\11\ GSK also recently became the first drug 
manufacturer to get U.S. Food and Drug Administration (FDA) approval 
for a modern adjuvant that is used in conjunction with a vaccine 
distributed domestically. That vaccine, Cervarix is administered to 
prevent cervical cancer and precancerous lesions caused by human 
papillomavirus (HPV) types 16 and 18. Cervarix contains the adjuvant 
ASO4, which is a combination of aluminum hydroxide \12\ and 
monophosphoryl lipid A (MPL).\13\ It is the first vaccine licensed by 
the FDA that includes MPL as an adjuvant. ASO4 is a close cousin of the 
adjuvants that are already in wide use in Europe, and shares some 
similarities \14\ to adjuvants included in some of the versions of H1N1 
vaccine being used around the world.
    There is no adjuvant approved for use in a flu preparation in the 
United States and no adjuvanted H1N1 vaccine available in this country. 
Integrating an adjuvant into the United States. H1N1 vaccine would not 
have been as easy as borrowing the data used by Europe.
    For one thing, the European approvals for pandemic vaccines, and 
most of the clinical data that were reviewed by the European Medicines 
Agency (EMEA) to support them, are not with the identical vaccine 
antigens or from same facilities from which the United States H5N1 
vaccines are manufactured. There are differences that potentially can 
occur when different antigens are mixed with different adjuvants. So 
it's not a sure bet that the antigen available for the U.S. vaccine 
could be effectively used in conjunction with the same adjuvants being 
used in the European vaccines. The safety profile of vaccines can also 
be affected by minor changes in how a protein is presented. 
Nonetheless, there is good reason to believe that for most patients, 
these adjuvants (one is already used in a U.S. stockpiled vaccine that 
targets pandemic avian flu) \15\ could boost our present supply of a 
H1N1 vaccine as much as fourfold,\16\ or even more when an adjuvant is 
used in a vaccine for children.\17\ \18\
    U.S. public health authorities laid some groundwork toward the use 
of adjuvants in the event that the H1N1 vaccine proved to be 
ineffective in the absence of these components. It was with the strong 
urging of the FDA that studies by vaccine manufacturers and National 
Institutes of Health (NIH) included both adjuvanted and non-adjuvanted 
formulations of H1N1 vaccine. The Department of Health and Human 
Services (HHS) also purchased and filled and finished a large stockpile 
of adjuvant in case it was needed.
    In addition, U.S. public health authorities asked for data that 
could inform the effects of adjuvants and whether they would be 
beneficial and needed for H1N1 vaccine. The studies that regulators 
around the world relied on to evaluate the immunogenicity of both non-
adjuvanted and adjuvanted vaccines are largely the result of requests 
for this data by FDA. The United States worked to keep an adjuvant 
option ``on the table'' were it to be needed.
    Despite the foundational work done by FDA and others, the United 
States might not have been prepared to license an adjuvanted H1N1 
vaccine through our customary regulatory process should it have been 
necessary. In all likelihood, if we had to incorporate adjuvant this 
fall, we would have been forced to make an adjuvanted H1N1 vaccine 
available under an Emergency Use Authorization (EUA),\19\ which is an 
authority that authorizes use of a product for treatment or prevention 
of well-defined, public health emergencies when the relevant product 
has not already been approved for this specific use by the FDA.\20\ A 
vaccine supplied through such an expedited authorization would have 
surely raised public concerns about its safety, perhaps reducing 
vaccination rates and offsetting any public health gains achieved by 
the use of the adjuvant. As a result, while the option of using an 
adjuvant was kept on the table, it was set on the very edge of the 
table.
    Ultimately, the U.S. decision to not employ adjuvants was based on 
clinical data that showed an excellent response to standard doses of 
the licensed vaccines in the absence of any adjuvants. But that meant 
that the H1N1 vaccine required much higher quantities of vaccine raw 
material (antigen) than would have been required if adjuvants had been 
incorporated.\21\ \22\ While the amount of antigen in the U.S. H1N1 
vaccine is equivalent to the quantity used in the seasonal flu vaccine 
distributed around the world each year, in this case, we had very 
limited quantities of H1N1 antigen. Stretching supply was imperative. 
In the United States, we were compelled to spread a limited supply of 
vaccine antigen across fewer shots than Europeans.
    In a future pandemic, we may not have this same opportunity. Even 
today, the decision to forgo the use of adjuvant has to be considered 
as one of the tradeoffs contributing to our current H1N1 vaccine 
shortage. This kind of tradeoff doesn't need to exist in the 
future.\23\
    What measures can be taken to improve our process for evaluating 
vaccine adjuvants? First, FDA should consider creating formal guidance 
on the development and use of adjuvants to help guide product 
developers. The EMEA developed formal guidance on adjuvants 3 years 
ago. The document is available on that agency's Web site.\24\ FDA 
doesn't have a similar guidance document, and while it hasn't indicated 
it plans to write one, the FDA held a meeting on the topic in December 
2008. Its workshop could serve as a prelude to the development of 
formal guidance-writing process.
    The United States should also consider stockpiling pre-approved 
vaccine preparations that could be used in a public health emergency. 
There is now ample experience in Europe on which we can draw.\25\ 
Adjuvants are not approved as stand alone substances because they do 
not always perform the same with different vaccines or types of 
vaccines or, at times, even with different versions of the same 
antigen.\26\ Nonetheless, the European strategy of having pandemic 
vaccines pre-approved, as mock-ups, was a prudent step.

                 UPGRADING OUR MANUFACTURING TECHNOLOGY

    Seasonal flu vaccines and the H1N1 vaccine are still made by the 
same process that has been used for 50 years: they are grown inside 
chicken eggs.\27\ This process is unpredictable, slow, and difficult to 
scale. It is also expensive, costing more than $300 million to build a 
new plant and requiring more than 5 years to bring an egg-based 
production facility online.
    Here is how the egg-based process works: Flu, as with any virus, 
will grow only in living cells. In the case of flu vaccine, production 
of the vaccine components has used the cells of embryonated 
(fertilized) hens' eggs. The success of this system is primarily 
dependent upon the availability of adequate flocks of chickens. These 
flocks must be hatched about 6 months in advance to achieve maturity at 
the time that the eggs are needed. A bipartisan investment that helped 
improve our readiness was support of year-round flocks. Nonetheless 
this egg-based process requires long lead times and has other risks.
    The flocks, for example, are susceptible to their own diseases.\28\ 
Another challenge of the egg-based process is virus yield. This refers 
to the number of viral particles that come out of an egg that could be 
used to make the vaccine. As a rule of thumb, one to three eggs are 
needed to produce each individual shot of the seasonal flu vaccine. 
Eggs are typically low-yield factories for the production of vaccine 
components.
    This was certainly true this year. The H1N1 virus that was adapted 
by the Centers for Disease Control (CDC) for growing inside the chicken 
eggs, and sent to the manufacturers as the ``seed'' stock \29\ (for 
jumpstarting manufacturing lines) was slow in being shipped to the drug 
firms owing to the difficulty in developing this template strain. Once 
it arrived, it was not well-suited to the production lines, and yielded 
low quantities of vaccine antigen.\30\ \31\ Manufacturers spent several 
weeks before they realized this seed stock was yielding low vaccine 
quantities. It took still more weeks for the drug firms to re-engineer 
the seed stock to come up with a more effective template for growing 
vaccine antigen in the chicken eggs.\32\ \33\ This experience 
underscores the unpredictable qualities of our present flu vaccine 
manufacturing process, and how vulnerable we are as a result of our 
dependence on it.
    Because of the uncertainties and delays inherent to this production 
process--and because the emergence of pandemic strains of influenza 
virus may occur outside the normal timeframe for vaccine production 
(when chicken flocks are not at peak availability) we need alternative 
production systems for flu vaccine. The principal alternative to the 
egg-based process is tissue culture cell lines that can be used as 
incubators for viral replication.\34\
    Using cell cultures instead of chicken eggs cuts 3 to 4 weeks from 
the time required to mass-produce a vaccine. But the biggest advantage 
of cell-based manufacturing is its more rapid scale-up and is 
potentially better predictability. These attributes are typically more 
variable using older egg-based processes. Moreover, the use of hundreds 
of thousands of eggs can be a more dirty process, making it prone to 
production glitches.\35\
    There are many approved cell culture vaccines made in the United 
States--this includes most of our viral vaccines such as Measles, Mumps 
and Rubella (MMR) as well as vaccines for polio and Zoster, among 
others. An issue for flu vaccines has been getting good yield and a 
good clinical response using cell cultures. Only in recent years has 
there been real progress on these steps. As a result, the United States 
has recently begun to scale up work on cell-based manufacturing for 
influenza vaccines. More needs to be done. Our current vulnerabilities 
are too significant to be satisfied with merely incremental progress.
    The Biomedical Advanced Research and Development Authority (BARDA) 
awarded one Federal contract for $487 million last spring to Novartis 
for the construction of the first U.S. facility to manufacture cell-
based flu vaccine.\36\ That facility is scheduled to open this year, 
but it won't be producing licensed vaccine until 2014.\37\ \38\ GSK and 
Sanofi-Aventis are also working on cell-based production of influenza 
vaccine.\39\ Baxter recently became the first company to gain marketing 
authorization by the European Commission for a cell-based vaccine.\40\ 
That cell-based vaccine product is not available in the United 
States.\41\
    Cell-based vaccine production is not without its own obstacles, and 
risks. In addition to issues around getting adequate yields from cell-
based production processes, there are also challenges with 
immunogenicity \42\ and reactogenicity.\43\ All of these problems have 
come up in past attempts to scale cell-based production processes. 
There is also a remote and theoretical safety concern around the 
ability of genetic material to jump from the cell lines, into the 
vaccine, and then integrate into human tissues. FDA has issued a 
guidance to provide a pathway for safe use of novel cell substrates 
that tries to address the proper testing that flu vaccine manufacturers 
should undertake in order to rule out these risks.
    Given the strategic advantages of the cell-based process, we need 
to invest in developing this capacity more quickly. BARDA should 
support development of similar facilities to the one being constructed 
in North Carolina. A typical cell-based facility costs as much as $600 
million and would only be able to produce about 40 million doses of 
seasonal ``trivalent'' flu vaccine a year. The Novartis facility will 
be able to produce around 150 million doses of ``monovalent'' vaccine--
containing just one viral strain, as opposed to the seasonal flu 
vaccine, which contains three different viral strains--in the event of 
a pandemic.
    All of this illustrates the more challenging economics of vaccine 
production, for which significant upfront expenditures are required to 
build facilities capable of producing largely fixed capacities of 
vaccine. So long as seasonal flu vaccines remain commoditized products, 
with slim margins and little product differentiation (public health 
agencies want vaccines coming from different manufacturers to be 
largely interchangeable) then there will not be large enough private 
profits to support substantial new investments in manufacturing 
infrastructure. Getting additional facilities on-line will require 
Federal investment. This capacity, however, is a matter of national 
strategic security and should be a U.S. priority.\44\ \45\

               ENSURING DOMESTIC PRODUCTION CAPABILITIES

    We also need to make sure that an adequate proportion of the 
worldwide influenza vaccine production capacity is domiciled in the 
United States--enough to adequately supply a reasonable portion of the 
U.S. market in the event of a pandemic.
    It is hard to envision other nations allowing limited supply of 
vaccine raw material to be shipped outside their borders in the event 
of a full-blown pandemic with a very dangerous flu. More likely, 
nations would take steps to nationalize their domestic production 
capacity.
    The drawback to relying on foreign plants was made clear recently 
when foreign countries claimed priority for the H1N1 vaccine produced 
in their own countries. That was the case in Australia, where the 
government pressured vaccine manufacturer CSL to keep its vaccine at 
home instead of fulfilling its contract for 36 million doses of swine 
flu vaccine for the United States.\46\ \47\ \48\ In Canada, where GSK 
maintains one of its two flu vaccine production facilities, the company 
had to assure the Canadian government that the Canadian population 
would be served first from that facility before any other countries 
that rely on that manufacturing site--including the United States--
received fulfillment of their H1N1 vaccine orders.\49\
    This risk is compounded by the fact that all but one of the vaccine 
production facilities we depend on is located outside the United 
States.\50\ There are five companies licensed to sell seasonal flu 
vaccine in the United States. But only one, Sanofi-Pasteur, has a 
domestically located plant. The others--GlaxoSmithKline, Novartis, CSL 
Ltd. and MedImmune--use plants in England, Germany and Australia.
    After the U.S. firm MedImmune was acquired by AstraZeneca, 
additional production capacity was located in Cambridge, UK in 2008. 
Novartis, based in Switzerland, operates a cell-culture vaccine 
production facility in Marburg, Germany. The cell culture facility 
maintained by Baxter for production of flu vaccine is located in the 
Czech Republic.
    There also appears to be significant limitations in global fill and 
finishing capacities for flu vaccine. This also limits supply. In 
addition, concerns about trace amounts of the mercury-containing 
vaccine preservative thimerosol, found in multi-dose vials of flu 
vaccine, prompted public health officials to request drug firms 
manufacture more single-dose syringes. This took longer and added 
delays to vaccine availability.
    There are lingering concerns that thimerosol is linked to autism, 
despite well-conducted studies that show that the vaccine preservative 
is safe. If we are going to let these kinds of theoretical fears drive 
decisions about how vaccines are packaged, then we ought to invest in 
better finishing capacity or safe and effective preservatives that wont 
so easily fall prey to theoretical risk. Ideally, we also need more of 
the companies that produce flu vaccines to locate new filling and 
finishing facilities in the United States.
    There are business impediments to building new facilities--these 
production sites require substantial investments and the financial 
return on flu vaccine, in particular, is small. Flu vaccines generate 
modest margins relative to other vaccines and drug products.
    One of the additional business impediments companies face in making 
investments in multiple, differently situated vaccine production 
facilities stems from how these facilities are regulated. The vaccine 
produced from each facility needs to be separately licensed by both the 
FDA and the EMEA. That means that if the same company produces flu 
vaccine at two different facilities (even in cases where it uses the 
same processes at each facility) the company often has to conduct 
separate clinical trials for each vaccine. While FDA has approved 
vaccines where little or no United States-specific data was available, 
there remain many situations where redundant trials were required or 
European data was not fully leveraged.
    This drives developers to expand existing facilities rather than 
create new ones. Since the clinical trials require substantial 
investments of time and money, it is far more economical to maintain a 
few very large vaccine production facilities. After all, each 
facility's vaccine will be treated as a completely new product with its 
own expensive clinical trials. There are good scientific reasons why 
biologicals coming from distinct facilities are treated independently 
by drug regulators. But there may be better ways to enable more 
cooperation between requirements set forth by different regulators or 
make use of studies that could bridge between products from a single 
manufacturer's different manufacturing lines.
    The ability to conduct these kinds of bridging studies, if they 
could streamline the requirements for entirely separate clinical 
trials, could save time and money. It would also reduce the economic 
impediments firms face to creating redundant manufacturing capacity.
    Other measures that would help create more domestic capacity 
include guaranteed markets for seasonal flu vaccines. This would create 
additional incentives for building U.S. manufacturing capacity, 
especially if the tender process favored domestic manufacturers.

                      OTHER AREAS FOR IMPROVEMENT

    We also need to develop new types of vaccines. BARDA has made 
grants available to fund research into completely new platforms for 
vaccinating against flu. Just this past June, BARDA awarded a research 
and development contract for work on a recombinant flu vaccine. We are 
making incremental but meaningful progress. We should be undertaking a 
more robust process to put substantial resources behind these 
scientific efforts.
    The complexity of developing a vaccine against pandemic flu is 
similar to the problems posed by development of the seasonal flu shots. 
The vaccine needs to be adapted to match each specific strain of the 
flu virus. In the case of the seasonal flu, we have to develop a new 
vaccine each year to guard against that season's circulating strains of 
influenza.
    It also means that we depend on just-in-time delivery when it comes 
to flu vaccine. This owes to the fact that the vaccine targets proteins 
on the surface of the flu virus that itself undergo easy mutation. 
Since these proteins change easily, a new vaccine must be developed to 
target the unique proteins found on each particular strain of 
influenza.
    Better technologies can enable development of vaccines that require 
much shorter development timelines, or that protect against a broader 
range of flu strains.
    On the first point, for example, Virus Like Particles (VLPs) have 
been suggested as a promising platform for new viral vaccines. In the 
light of a pandemic threat, VLPs have been recently developed as a new 
generation of non-egg-based cell culture-derived vaccine candidates 
against influenza infection.\51\
    Influenza VLPs are formed by a self-assembly process incorporating 
structural proteins of the flu virus.\52\ These particles resemble the 
virus from which they were derived but lack viral nucleic acid, meaning 
that they are not infectious. VLPs used as vaccines are often very 
effective at eliciting both T cell and B cell immune responses. The 
human papillomavirus and Hepatitis B vaccines are the first VLP-based 
vaccines approved by the FDA.
    Research suggests that VLP vaccines could provide stronger and 
longer lasting protection against flu viruses than conventional 
vaccines.\53\ Production may begin as soon as the genetic sequence of 
the virus is published online, without an actual sample of the agent, 
and it may take as little as 12 weeks, compared to 9 months for 
traditional vaccines.\54\ The VLP may be grown in either plants or 
insect cells. As it contains no genetic material, some ingredients of 
traditional vaccines such as formalin and detergent treatments, are not 
needed.\55\ In some recent clinical trials, VLP vaccines appeared to 
provide complete protection against both the H5N1 avian influenza virus 
and the 1918 Spanish influenza virus.
    There is also opportunity to create a vaccine that protects against 
a broader variety of influenza strains, reducing the need to tailor a 
new vaccine to each individual strain of circulating flu. A universal 
vaccine would target more ``conserved'' regions of the flu virus's 
structural proteins--parts of the flu virus architecture that do not 
undergo much mutation and, therefore, are unlikely to change, 
regardless of the particular strain of flu.
    Right now, our vaccines target proteins that are on the outer 
surface of the flu virus. Since our immune systems attack these 
proteins, the proteins themselves undergo adaptation, mutation, and 
change in order to evade our immune response. But structural proteins 
that are core components of the architecture of all flu viruses would 
be less likely to undergo mutation, regardless of the pressure from 
nature to change in order to survive.
    Theoretically, to target these core proteins, a universal vaccine 
would need to recruit our T cells to attack the flu virus, as opposed 
to today's vaccines, which recruit an antibody response. For that 
reason, some suggest that such a ``universal'' vaccine would more 
likely be a therapeutic tool, as opposed to a protective vaccine. There 
is some literature to suggest that a T cell response alone may not be 
sufficient to protect us fully from flu, but work continues, and a 
universal vaccine is at least possible.
    Drug firms sometimes complain that there is a disconnect between 
the advice and goals of different government agencies, especially 
between those charged with trying to develop new technologies (BARDA) 
and those charged with ensuring their safety (FDA).
    It remains important for FDA to preserve its distinct mission to 
assure product safety and effectiveness and for the agency to remain 
independent. But when it comes to areas of critical public health need, 
where the government is engaged in a substantial effort to fund 
development of new technology, there's more we can do. FDA meets early 
with academic and industry developers of novel technologies especially 
for critical public health needs like flu and terrorism. But there may 
be more opportunities to create clearer pathways to market by also 
engaging FDA more closely in the government procurement process.
    One opportunity is to couple BARDA funding of new technology with 
regulatory programs that provide additional, early feedback to sponsors 
developing those new methods. Multiple studies have shown that early 
and frequent FDA feedback helps sponsors avoid mistakes and results in 
timelier access to safe and effective products. This kind of regulatory 
effort is time and labor intensive, however, and would need to be 
funded inside FDA.
    Finally, we also need to spend time examining how limited vaccine 
has been distributed during this pandemic, and take steps to put in 
place a better process for the future. My own view is that we should 
have relied more on the clinical community as a way to target the 
vaccine to high risk Americans. Doctors who treat high-risk patient 
populations--for example obstetricians that see pregnant women or 
pulmonologists who treat people with lung disease--in many cases had no 
access to the vaccine in many States. To target these populations of 
patients, we need to work through, and target, the doctors that care 
for them.

                               CONCLUSION

    The Obama team deserves credit for ordering vaccines early last 
spring when H1N1 first emerged and for acting quickly to support their 
development. It wasn't clear, at that moment, whether H1N1 would emerge 
as a pandemic or fade into the summer and fail to re-emerge in the 
fall. The Administration's decision to undertake a crash effort to 
field vaccine saved lives.\56\ Moreover, many of the shortcomings in 
our current preparedness are not the product of policy choices, but are 
challenges that relate to biology and the inherent complexity of 
targeting viruses that change rapidly and frequently. The fact that the 
United States has quickly fielded a program with high quality licensed 
vaccines despite the old technology and processes we relied on is a 
substantial public health accomplishment.
    This shouldn't, however, obscure the fact that at many points we 
made deliberate decisions to rely on those old methods rather than 
adapt new ones because of our concerns about safety and our comfort 
with the tried and true approaches. Some of our policy choices did have 
consequences, and contributed to the limited availability of vaccine. 
These tradeoffs can be reduced in the future if we make a concerted 
effort today to increase our capacity for timely development of safe, 
effective and innovative vaccines.

                               References

    1. A Kumar, R Zarychanski, R Pinto, DJ Cook, et al., for the 
Canadian Critical Care Trials Group H1N1 Collaborative. Critically Ill 
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the American Medical Association 2009;302(17):1872-1879. Published 
online October 12, 2009 (doi:10.1001/jama.2009.1496)
    2. Pregnant women are among the groups of people who have been hit 
particularly hard by the swine flu, and officials recommend they be 
vaccinated. Since the H1N1 virus was first discovered in April, more 
than 100 pregnant women have been hospitalized and 28 have died, 
according to the most recent government figures.
    3. JK Louie, M Acosta, K Winter, C Jean, et al., for the California 
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who do contract the virus have had serious complications.
    5. Dr. Paul Auwaerter, clinical director of the division of 
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of the H1N1 vaccine doses will be delivered by early December. He added 
that H1N1 infections will likely decline in November and December 2009 
but then peak again with higher mortality between March to May 2010. 
Redd added that the infections may decrease by late this year and pick 
up again in the spring, similar to the 1957 pandemic.
    6. Under the HHS Pandemic Influenza Plan (November 2005), the 
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critical workforce; Develop sufficient domestic manufacturing capacity 
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    7. J Norman. H1N1 Flu Vaccine Supply Expected to Increase Soon. 
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incorporating these additives, making a smaller quantity of vaccine as 
effective as a larger dose. The human immunogenicity data for the H1N1 
vaccine do not show a difference so far in the antibody response to the 
vaccine for the majority of the populations studied. Inclusion of an 
adjuvant may be most substantive in truly immunologically naive 
situations, for example with H5N1, or in young children, where there is 
no pre-existing immunologic memory. This is still a potentially 
important contribution.
    9. John Carroll, ``Novartis Readies Key Adjuvant for Swine Flu 
Use,'' Reuters, April 30, 2009.
    10. The antigens are basically components of the virus that have 
lost their property to infect people but remain similar to wild-type 
virus. When injected as part of a vaccine, they stimulate our immune 
systems to develop antibodies that will target the natural, ``wild-
type'' virus.
    11. I. Leroux-Roels et al., ``Antigen Sparing and Cross-Reactive 
Immunity with an Adjuvanted rH5N1 Prototype Pandemic Influenza Vaccine: 
A Randomised Controlled Trial,'' The Lancet 370, no. 9,587 (August 18, 
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    12. Gupta RK. Aluminum compounds as vaccine adjuvants. Adv Drug 
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    13. FDA News Release. FDA Approves New Vaccine for Prevention of 
Cervical Cancer, October 16, 2009. Available at http://www.fda.gov/
NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm.
    14. MPL works differently than oil in water, another adjuvant, 
although the two do have in common novelty.
    15. Steve Usdin and Erin McCallister, ``Opportunity in Crisis.''
    16. For example, an adjuvanted H1N1 vaccine being used in Europe 
contains 3.75 micrograms of vaccine stock. The same vaccine in the 
United States, without the adjuvant, requires 15 micrograms of vaccine 
for equal potency.
    17. Data shows the adjuvanted vaccine produced by GlaxoSmithKline 
can produce close to 100% protection in children with 1.9 microgram of 
vaccine antigen whereas 15 micrograms are required for the U.S. 
licensed vaccine that doesn't contain adjuvant.
    18. We may see a pattern where the effects of adjuvants may not be 
as profound when there is some background immunologic memory in the 
population. But data are either not readily available or are pending, 
many of the studies do not examine lower levels of non-adjuvanted 
vaccines. In some, lower levels of non-adjuvanted may also turn out to 
be immunogenic in some select populations.
    19. The Project BioShield Act of 2004 (Public Law 108-276), among 
other provisions, established the comprehensive EUA program. EUA 
permits the FDA to approve the emergency use of drugs, devices, and 
medical products (including diagnostics) that were not previously 
approved, cleared, or licensed by FDA or the off-label use of approved 
products in certain well-defined emergency situations. Issuance of an 
EUA is predicated on a Declaration of Emergency that justifies the 
authorization of the EUA by the Secretary of HHS. Following the HHS 
Secretary's Declaration, the FDA commissioner may issue an EUA if he or 
she concludes that: (1) the agent listed in the emergency declaration 
can cause a serious or life-threatening disease or condition; (2) on 
the basis of the totality of scientific evidence available, it's 
reasonable to believe that the medical product may be effective in 
diagnosing, treating or preventing this disease or condition or a 
serious or life-threatening disease or condition caused by another EUA-
authorized product or an otherwise approved or licensed product; (3) 
the known and potential benefits of the medical product outweigh the 
risks, both known and potential; and (4) no adequate, approved, 
alternative medical product is available.
    20. SL Nightingale, JM Prasher, and S Simonson. Policy Review: 
Emergency Use Authorization (EUA) to Enable Use of Needed Products in 
Civilian and Military Emergencies, United States, Emergency Infectious 
Diseases. Volume 13, Number 7. July 2007.
    21. FC Zhu, H Wang, HH Fang, JG Yang, et al. A Novel Influenza A 
(H1N1) Vaccine in Various Age Groups. Published at www.nejm.org, 
October 21, 2009 (10.1056/NEJMoa0908535). Available at http://
content.nejm.org/cgi/content/abstract/NEJMoa0908535v1.
    22. ME Greenberg, MH Lai, GF Hartel, CH Wichems, et al. Response 
after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine--
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(10.1056/NEJMoa0907413). Available at: http://content.nejm.org/cgi/
content/full/NEJMoa0907413.
    23. It's important to note that it isn't clear how much of the U.S. 
reluctance to embrace adjuvants is a function of our caution, and how 
much is a function of sponsors. More likely, it's an element of both. 
One reason Novartis' older adjuvanted vaccine hasn't been approved in 
the United States is that they acquired it from Chiron, which wasn't 
able to implement a formal U.S. regulatory or commercial strategy. The 
adjuvanted vaccine was approved in Italy in 1997, although only for the 
elderly and using antigen from a specific EU facility. Apportioning 
blame between FDA and the drug firms would be clearer if Novartis or 
GSK had filed an application to license an adjuvanted vaccine in the 
United States and FDA had rejected it, but they haven't. It's hard to 
know if this is because FDA has discouraged it or for other reasons. 
But none of these facts change the steps we should be focused on.
    24. Available at www.emea.europa.eu/pdfs/human/vwp/13471604en.pdf.
    25. See European Medicines Agency, ``Guideline on Adjuvants in 
Vaccines for Human Use,'' EMEA/CHMP/VEG/.
    26. As one example, aluminum compounds--which are the only 
adjuvants used widely with routine human vaccines and are the most 
common adjuvants in veterinary vaccines--do not work with influenza 
vaccine.
    27. C Gerdil, ``The Annual Production Cycle for Influenza 
Vaccine,'' Vaccine 21, no. 16 (May 1, 2003): 1,776-79.
    28. DJ Alexander, ``A Review of Avian Influenza in Different Bird 
Species,'' Veterinary Microbiology 74, nos. 1-2 (May 22, 2000): 3-13.
    29. N. Bardiya and J.H. Bae, ``Influenza Vaccines: Recent Advances 
in Production Technologies,'' Applied Microbiology and Biotechnology 
67, no. 3 (May 2005): 299-305.
    30. Virus yield is increased substantially by using strains of the 
virus that are specially tweaked to make them produce more viral 
particles and survive better in the eggs. That is because the ``wild-
type'' viruses that are isolated from patients do not grow well in the 
eggs that are used for their manufacture. Therefore, the wild-type 
viruses need to be altered or re-assorted to grow well in eggs while 
still retaining the ability to make the viral antigens that are needed 
for an effective vaccine. But this process of making re-assortant 
strains takes time. At present, there are not many labs that are 
capable of working on developing these re-assortants.
    31. Both CDC and FDA used the state-of-the-art technology, called 
reverse genetics, as their method to create pandemic H1N1 reference 
viruses, which were provided to manufactures to develop their own seed 
viruses for vaccine production
    32. B McKay, C Simpson and J Whalen. Obama Targets Swine-Flu 
Response. The Wall Street Journal, October 26, 2009. A1
    33. J Burns. Health Officials Frustrated by H1N1 Vaccine Shortage. 
The Wall Street Journal, November 4, 2009. B1
    34. M.G. Pau et al., ``The Human Cell Line PER.C6 Provides a New 
Manufacturing System for the Production of Influenza Vaccines,'' 
Vaccine 19, nos. 17-19 (March 21, 2001): 2,716-21.
    35. Steve Usdin and Erin McCallister, ``Opportunity in Crisis,'' 
BioCentury, May 4, 2009.
    36. Dr. Bruce Gellin, director of the HHS National Vaccine Program, 
recently noted publicly that other Federal collaborations with private 
companies for expedited development of new vaccine technologies are 
also underway, although he has not cited the names of other companies.
    37. U.S. Department of Health and Human Services, ``HHS Awards $487 
Million Contract to Build First U.S. Manufacturing Facility for Cell-
Based Influenza Vaccine,'' news release, January 15, 2009, available at 
www.hhs.gov/news/press/2009pres/01/20090115d.html (accessed May 6, 
2009).
    38. It's also worth noting that the North Carolina Novartis plant 
will also produce an adjuvant, MF59.
    39. 21. Bruce Japsen, ``Flu Vaccines No Easy Remedy: Low Sales Mean 
Lack of Incentive for Drugmakers,'' Chicago Tribune, April 29, 2009.
    40. Baxter's Celvapan H1N1 pandemic vaccine using Baxter's Vero 
cell technology. Celvapan H1N1 is the first cell culture-based and non-
adjuvanted pandemic influenza vaccine to receive marketing 
authorization.
    41. Baxter Receives European Commission Approval for CELVAPAN H1N1 
Pandemic Influenza Vaccine, October 07, 2009. http://www.baxter.com/
about_baxter/press_room/press_releases/2009/10_07_09-celvapan.html. 
Press Release.
    42. Immunogenicity is the ability of a particular substance, such 
as an antigen or epitope, to provoke an immune response.
    43. Refers to the ability of some biologics to cause unwanted 
immunological reactions.
    44. The margins made on flu vaccines are also narrow by drug-
industry comparisons. Flu vaccine doses cost about $3 each to 
manufacture, according to industry insiders. This does not include the 
depreciated costs of the capital needed to invest in manufacturing 
facilities. Each vaccine ultimately sells for $10-12 for each dose. The 
fixed costs related to quality assurance, administration, and 
depreciation are estimated to account for 60 percent of total 
production costs.
    45. ``After Decades of Malaise, the Vaccine Industry Is Getting an 
Injection,'' Knowledge@Wharton, November 2, 2005, available at http://
knowledge.wharton.upenn.edu/article.cfm?articleid=1306 (accessed Nov 4, 
2009).
    46. J Norman. H1N1 Vaccine Delayed for Priority Groups Until 
January. CQ Healthbeat. November 4, 2009.
    47. One CSL Biotherapies' vaccine manufacturing facility (which it 
shares with CSL Behring) is located in King of Prussia, PA. It has been 
supplying vaccine in the United States since the 2007-2008 flu season. 
Its parent company, CSL Limited, is located in Melbourne, Australia. On 
August 18, 2009 FDA licensed CSL's new vaccine filling and packaging 
facility, located in Kankakee, IL. CSL Biotherapies may use it to fill 
and package H1N1 vaccine if requested to do so by HHS. CSL 
Biotherapies' contract for bulk antigen with HHS is $180 million.
    48. DG McNeil. Nation Is Facing Vaccine Shortage for Seasonal Flu. 
New York Times, November 4, 2009. A1
    49. GSK maintains two flu vaccine production sites, in Germany and 
the other in Canada. The German facility is licensed to supply vaccine 
to Europe while the Canadian facility supplies other countries, 
including the United States.
    50. That domestic facility, operated by Sanofi, was supported by 
grants from HHS/BARDA that significantly increased its capacity. FDA 
licensed an additional production line this May at that facility. See 
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm149577.html.
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based on virus-like particles. Virus Res. 2009 Aug; 143(2):140-6. 
Electronic publication 2009 Apr 15.
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hemagglutinin (HA), neuraminidase (NA) and M1 proteins, and may include 
additional influenza proteins such as M2.
    53. TP Luo, Z Yang, M Gao, Z Pan. Virus-like particle vaccine 
comprised of the HA, NA, and M1 proteins of an avian isolated H5N1 
influenza virus induces protective immunity against homologous and 
heterologous strains in mice. Viral Immunology 2009 July;22(4):273-81.
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Influenza Strains. American Society for Microbiology. 5-18-2009. http:/
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    56. S. Gottlieb. Why You Can't Get the Swine Flu Vaccine. The Wall 
Street Journal, October 28, 2009. A22.

    Senator Casey. Thank you very much.
    I wanted to, first of all, thank each of our witnesses for 
appearing today and for your testimony and for the work you're 
doing on these issues.
    I'll be rather brief, and I know that our Ranking Member, 
Senator Enzi, might have questions, as well.
    First of all, I wanted to just say, we're happy everyone's 
here. Ms. Rosado, we're especially grateful that you're here, 
in light of what you've been through the last couple of weeks 
in your own family. I was noting, each of your children that 
you mention in your testimony--Isabella, Alicia, and David--
should be very proud of the testimony you gave. I know it's not 
something every parent likes to do, which is to catalog the 
sickness that has run through your home, and the consequences 
for your family, but we're grateful that you brought your own 
story to Washington. I know it's not easy to get all the way 
down here. We won't ask you about the travel.
    At the risk of starting a big argument here--I don't want 
to do that--but, some constructive debate and dialogue is 
important. I guess I wanted to start with Debra Ness, in terms 
of what you heard from Ms. O'Brien. And if you could provide, 
if you want to, some rebuttal. There's somewhat of a conflict 
here between your testimony and hers, in terms of what we 
should be doing, and I want to give you that opportunity, and 
then, Ms. O'Brien, you certainly can provide your own rebuttal. 
Just with regard to the legislation. I'm a cosponsor of this. I 
obviously support it very strongly. We also want to hear the 
competing arguments.
    Ms. Ness. Well, I want to start by saying that we would 
welcome the opportunity to work with all of you, members of 
this panel and this subcommittee, to ensure that this is, at 
the end of the day, legislation that works for both employers 
and employees. I wish we lived in a world where we all did the 
right thing all the time. The bottom line is that today there 
are at least 100 million workers in this country who wouldn't 
be able to take a paid sick day to stay home with a sick child. 
There are many workers--and we heard the stats over and over 
again today--three-quarters of low-wage workers--we're talking 
about workers in food service, workers in public 
accommodations, nursing-home workers, school workers, etc.--
they don't have a lot of flexibility. They don't have much 
opportunity to innovate. When they need to take the time to 
take care of themselves or their family, they need the 
protection of basic labor standard that would allow for them to 
do that without losing their pay or part of their paycheck or 
putting their job on the line. And today, that's what happens 
for millions of workers in this country.
    It would be terrific to work to fashion this legislation in 
a way that works for both. We do believe that the Healthy 
Families Act is actually good for the bottom line, that it 
would actually help employers. All the research shows that it 
actually makes more sense to give workers the time that they 
need to get better, as opposed to having them come to work 
sick, and particularly for those workers who interface with the 
public or who take care of our elderly or our children; even 
more important that we give them the time to be home when 
they're sick, or take care of their kids.
    I think while we're all for flexibility and innovation, we 
need a basic standard to ensure that, at a minimum, when 
somebody is sick, when a worker is sick, they can take care of 
themselves or take care of their family member.
    Senator Casey. Ms. O'Brien, I wanted to give you equal 
time, in the time remaining that I have. I also wanted you to 
think about this and respond to it in the context of what Ms. 
Rosado provided--not in just in a particular sense, but in a--
her family being representative of some of the challenges many 
families face. I mean, I'm reading from her testimony, ``Alicia 
gets a terrible headache, followed by a fever of 102 that lasts 
for almost a week.'' Then her mom has to miss work to stay at 
home and take care of her. Then she's able to get Alicia back 
to school, and then her son David is sick.
    How do we----
    Ms. O'Brien. Right.
    Senator Casey [continuing]. Deal with those real-world--not 
theoretical, but real-world--situations?
    Ms. O'Brien. Well, first of all, I can empathize with you. 
Currently, my son was diagnosed with the swine flu, last week, 
and my daughter has that right now. I understand the challenges 
of being a working mom and a two-family working mom. I 
understand that, I do truly understand that. However, I also 
understand that we need flexibility in the workplace. We need--
not a one-size-fits-all type of mandated government regulatory 
compliance issues that we need to juggle. We juggle with many, 
many different aspects of different laws, like FMLA and HIPAA, 
and we can go on and on in how those all interact with 
something like the Healthy Families Act.
    One thing I do want to go back to--Ms. Ness specified 
nursing-home facilities. Workers do not get paid time off for 
sick time. I have to say, I have to disagree with that. We 
employ 4,000 employees. We are not a publicly held company, we 
are a privately owned company, nursing home facility. We offer 
PTO time, which we feel is more flexible for our employees, 
because not only are they able to take time off if they want to 
take care of a sick parent, sick loved one, or want to, maybe, 
go on vacation, or may want to take care of a personal 
situation, or, by any chance, maybe they're not Catholic, so 
maybe they don't recognize Christmas, so maybe they want to 
work on Christmas, or different types of holidays that they'd 
rather save up that PTO time to do something to care for, 
maybe, a sick loved one or--what we find is paid-time-off 
policies actually give more flexibility to employees.
    I might add, as well, that we also give out buy-backs. 
That's very, very critical in today's environment. If our 
employees do not use all their PTO time, or don't choose to use 
their PTO time, we actually give out paybacks for those PTO 
times. Financially, they even gain better under a PTO flexible 
workplace.
    Again, one-size-fits-all--we are very, very different 
industries. We are a 24/7 facility. We are mandated to have a 
certain number of staff on our floors. If our patients are not 
being cared for, we suffer, they suffer, and we could actually, 
potentially, close down. Which, from what I understand, is a 
constant struggle, especially in my industry, because we've 
seen so many cuts, on a State level, with Medicaid. We had not 
seen Medicaid cuts in over 25 years. Those are the struggles 
that we are facing on a day-to-day basis.
    When you impose a mandate to employers, OK, they have to 
choose. There's only a finite amount of resources that we have 
to pay for employees' pay, comp, and benefits. It's about 30 
percent of our operating costs. Again, it's going to be 
stretched. We're going to have to make very difficult 
decisions--very difficult decisions. Like, we were faced, this 
year, when we had to make a very, very difficult decision 
whether or not to lay off people or not give pay raises. I know 
that that's a different discussion. Again, you have to 
understand the day-to-day challenges we face as employers. My 
employer is very different than in manufacturing or from a 
public-sector employer.
    Senator Casey. Thank you very much. And thank you, for 
bringing your personal story, as well.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman.
    I want to thank everybody for testifying.
    I'm not going to have time to ask all of the questions that 
I'd like to ask, so I will be submitting some of them to you in 
writing, in hopes of getting back an answer that will help us 
as we move through the legislation.
    [The information referred to may be found in Additional 
Material.]
    Senator Enzi. Now, I've been going through the HELP 
Committee markup on the health bill, and then the group of six 
negotiations--days and days and days of that, from morning 
until night--and then the Finance markup. During that time, we 
got to meet with the Congressional Budget Office a number of 
times to find out what the cost of the bill was. Some of these 
costs that we are putting on business--the question that we 
always asked was, Will the cost of that benefit be passed on to 
the employee? In every instance, they said, ``Yes, it would be, 
in the way of reduced salary later, which spreads the cost to 
the employee, but it's still a cost of the benefit.'' We have 
to be real careful on that.
    This bill does have ``use it or lose it'' in it. What I 
found out from being an employer is that most employees won't 
pay any attention to that. If they're sick, they'll use what 
they have. But you always have some that, if it's ``use it or 
lose it,'' that last week, if they still have a week--and they 
usually don't, they usually have half a day, because they take 
half a day or an hour every chance that they accumulate it, 
they will take the rest of the time, feeling that if it's 
something the government said that they should get, that they 
certainly don't want to lose any of that paid leave time. 
That's going to be a real problem with the bill.
    Dr. Gottlieb, I really appreciate your testimony. You may 
have noticed that in my opening remarks I used some of it to 
emphasize what you had said. I still have a lot of questions on 
vaccines, but I want to take advantage of Ms. O'Brien while 
she's here.
    I was a member of the Society of Human Resource Management.
    Ms. O'Brien. Yes.
    Senator Enzi. I'm, I think, the only Senator that's been a 
registered professional in human resources.
    Ms. O'Brien. I remember when you were first elected.
    Senator Enzi. That's how I wound up on this committee, a 
little encouragement from that organization. I joined that 
organization because, as a small businessman, I had trouble 
interpreting a lot of the Federal regulations. And, I've got to 
say, that hasn't eased any. That's an organization that can 
help you to understand what the stuff that we write actually 
says. I am particularly concerned about the H1N1 pandemic, at 
the moment.
    Ms. O'Brien, how helpful have the Federal and State 
Government resources been as you prepared for this flu season? 
Do you have any suggestions on what the government could do to 
be more helpful? And have you run into any legal barriers as 
you've been preparing?
    Ms. O'Brien. Well, again in my testimony, we have been 
trying--first of all, we need to get more of the seasonal 
vaccines, not only for our employees, but for our residents, as 
well. For some reason, we are experiencing a huge backlog on 
the vaccinations that we have ordered. We ordered those early. 
We are also trying to get our hands on the H1N1 vaccine, as 
well.
    Now, New York State, which we do operate in, required all 
healthcare facilities to have the H1N1 and the seasonal flu 
vaccine, I believe. They have now lifted that requirement. They 
lifted that requirement because they--grassroots effort--there 
was a huge complaint that we couldn't get our hands on it. Even 
though our intent is to pay for the vaccines for our employees, 
because we feel it is the right thing to do, we can't get our 
hands on the vaccines. If you're asking me if the government 
has been very helpful in that, no, they have not.
    Senator Enzi. OK.
    Ms. O'Brien. No, they have not.
    Senator Enzi. We'll do some more questions on the----
    Ms. O'Brien. However, I must say, I do visit the Center for 
Disease Control, and they have given us a lot of good 
information to pass on to our employees.
    Senator Enzi. Now, you mentioned a little bit of a conflict 
with the State. I'm going to move back over into the Healthy 
Families Act.
    Ms. O'Brien. Oh, yes.
    Senator Enzi. And your company has facilities in two 
States, one of which is New York, and it already mandates paid 
leave through an insurance scheme.
    Ms. O'Brien. That's correct.
    Senator Enzi. Can you describe the multiple levels of 
mandates that you'd be required to comply with, should this 
bill go into effect?
    Ms. O'Brien. Sure. We operate in New York and 
Massachusetts, so we have the New York insurance fund and we 
also have, in Massachusetts, the Small Necessities Leave Act. 
Now, I'm not too sure of how that--I would really have to kind 
of study it a little bit to find out how that would interact 
with that.
    I used to be an HR practitioner in Rhode Island. I actually 
live in the State of Rhode Island.They also have a different 
type of leave. We are a company that is growing, and we are 
growing into different States.
    My concern is the administrative burdens, the headaches, 
and the time that is spent to patchwork all these different 
leaves. It gets very, very confusing when you are trying to 
administer. Because we want to do the right thing. It becomes 
very, very difficult.
    I'm also very concerned about--with the Healthy Families 
Act and the recent GINA and also HIPAA. My understanding is, 
from this act, we are going to have to ask people why they are 
out. We don't want to get into a situation we're on the other 
side of the law on those very important Federal regulations. We 
are struggling with that, and it is a constant struggle for us, 
as HR professionals.
    Senator Enzi. Thank you.
    I'll be asking some questions of you about some of the 
misuses and the way that the law fits in with that. I'll want 
some more detailed answers on that, so I'll send that to you--
--
    Ms. O'Brien. OK.
    Senator Enzi [continuing]. In writing.
    Again, I've been one of those small businessmen in that 
position of trying to decide what additional benefits to give 
and what raises to give, and have been in those times when you 
have to decide whether you're going to have to let some people 
go.
    Ms. O'Brien. The worst decision.
    Senator Enzi. I'm really worried about--I'm curious as to 
why this legislation is changing the number from 50 people down 
to 15 people, when we never have corrected the things that 
we've held numerous hearings on in this committee that are 
problems with administering the 50 level.
    Ms. O'Brien. Right.
    Senator Enzi. And the employers with 15 people are going to 
have a whole lot less capability of doing it than the people 
with 50 or more employees. I think we probably ought to make 
all those corrections. Those are some of the things we'll have 
to consider.
    Again, I thank all the members of the panel. I will have 
specific questions, for each of you and will appreciate your 
answer.
    Ms. O'Brien. Thank you.
    Senator Casey. Thank you, Senator Enzi.
    Before we go, I just have one or two questions for Ms. 
Ness, and then we'll conclude.
    And, Dr. Gottlieb, you'll be, I guess, answering a lot of 
questions in writing. I don't know whether that's good or bad.
    [Laughter.]
    You'll be getting a lot of those.
    Ms. Ness, two questions. One is, what's your sense, based 
upon your work and observation of how sick leave policies have 
been implemented, with regard to two issues: First, how have 
cities done when they've implemented sick leave policies--to 
the extent that you can tell us that. And second, if you could 
amplify or summarize what you had said before with regard to 
the positive business impact of having this legislation in 
place.
    Ms. Ness. I don't have specific statistics on how cities 
are doing, compared to States or private-sector employers, but, 
in general, public-sector employers are doing a better job on 
this front than the private sector. And, as we all know, the 
Federal Government makes 13 paid sick days available per year 
to workers.
    I do want to say, in response to Ms. O'Brien's comments--
first, I commend her. It sounds like you are a model employer 
and the kind of employer that we need more of.
    I think that there are some misunderstandings about the 
legislation, because it sounds to me, from what you've 
described, that this legislation wouldn't require you to change 
anything.
    One of the things we've tried to do, in working with 
members of this subcommittee in crafting this legislation, is 
to keep it as simple as possible and as easy for employers to 
implement as possible. Again, we want to make this be something 
that works well for both employers and employees. And we 
believe that it should. As I said earlier, it's good business 
sense. It makes sense to give people time off when they're 
sick. All the research shows that the costs of presenteeism--
people going to work sick--is actually higher than the cost of 
giving people the time they need to get better, because--it's 
common sense. People take longer to get better, they get other 
people sick, there's more absenteeism. It also costs more, 
generally, to recruit and hire and train a new employee than to 
give somebody a few days to get better.
    No matter how you look at it, it generally is common sense 
and good for the bottom line for businesses to do this, as well 
as essential to working families' economic security.
    I want to underscore, we're in the middle of a major 
healthcare debate in this country, and one of the challenges 
that we're all grappling with is the terrible disparities we 
see in health outcomes and health status in this country. 
There's this clear evidence that the lack of paid sick days is 
something that falls disproportionately hard on low-income 
workers and communities of color. And there's growing evidence 
that the H1N1 virus is hitting communities of color harder than 
other communities.
    We recently saw some information from the Boston Public 
Health Commission that made it clear that in the African-
American community and the Hispanic community, the incidence of 
H1N1 was much higher, and the percentage of hospitalizations 
was much higher in those communities. There's a correlation 
between that and people not being able to stay home when 
they're sick, not being able to get to a doctor because they 
don't have the time to do so.
    All of these issues interrelate, as we think about this as 
an economic security issue for workers and families. It's a 
serious public health issue. It is related to our quest to 
eliminate the terrible disparities we face in this country when 
it comes to health outcomes.
    Senator Casey. Well, thank you very much.
    I do want to say, as we conclude here, that at the end of 
the hearing we need to emphasize that the record will be open 
for 10 days for anyone who would like to submit statements. Of 
course, as I mentioned, there will be further questions 
submitted.
    I do want to thank our witnesses for your presence here, 
and especially for both the Rosado and the O'Brien families, 
who have particular challenges right now. We hope that it all 
works out and everyone stays healthy. We're grateful for that.
    I want to thank Senator Dodd for chairing this hearing, 
Senator Enzi for being here with us today. And we're grateful.
    This hearing is adjourned.
    Thank you very much.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                  Prepared Statement of Senator Harkin

    Recently President Obama declared the H1N1 outbreak to be a 
national emergency. This important step will allow us to speed 
up the government's response to this disease and make better 
use of our public health resources.
    But fighting H1N1 isn't just a task for the government--
each and every American has to do their part. That means taking 
preventive measures to avoid illness and--if you do become 
sick--following proper guidelines to avoid spreading the 
disease to others.
    These guidelines are simple: If you get sick, stay home 
from work or school and limit contact with others. Indeed, the 
CDC strongly recommends that people with H1N1 stay home at 
least 24 hours after their fever ends.
    Unfortunately, too many Americans cannot follow this common 
sense prescription. Almost half of all private sector workers--
including 79 percent of low-wage workers--have no paid sick 
days they can use to care for themselves or a sick family 
member. For these workers, taking a day off means losing a 
much-needed paycheck, or even putting their jobs in danger. In 
this tough economy, workers without paid sick days effectively 
have no choice: they have to go to work. Even if they're sick, 
even if they're contagious, even if they have a sick child at 
home, they have to go to work.
    The lack of paid sick days is a crisis for public health 
that will make the H1N1 outbreak worse. Studies show that a 
single sick worker who is infected with a highly contagious 
disease like H1N1 is likely to infect almost 20 percent of the 
coworkers they come into contact with. The likelihood of 
transmission is even greater for workers who handle food or 
provide hands-on care to children, elderly, or disabled 
Americans. Unfortunately, these are the workers least likely to 
have paid sick days.
    Lack of paid sick days is also a crisis for America's 
working families. Parents forced to choose between a job and 
caring for a child often have no choice but to leave sick 
children home alone. These children are unable to see their 
doctors for diagnosis or medication and are at serious risk if 
their condition worsens. They are also unlikely to recover as 
quickly. There is strong medical evidence that sick children 
have shorter recovery periods, better vital signs, and fewer 
symptoms when their parents share in their care, but for 
parents without paid sick days staying home just isn't an 
option.
    That's unacceptable. As President Obama has said, ``Nobody 
in America should have to choose between keeping their jobs and 
caring for a sick child.''
    That's why I am glad that Senator Dodd has called this 
hearing today, and why I am a proud supporter of the Healthy 
Families Act. This critical legislation allows workers to earn 
up to 7 days of paid sick leave each year. Employees can use 
this time to stay home and get well when they are ill, to care 
for a sick family member, to obtain preventive or diagnostic 
treatment, or to seek help if they are victims of domestic 
violence.
    The Healthy Families Act would be a common sense policy 
even in normal times. Every worker has to miss days of work 
because of illness. Every child gets sick and needs a parent at 
home to take care of them. Every person needs to see a doctor 
on occasion for preventive care. Hardworking Americans deserve 
the chance to take care of these needs without putting their 
jobs on the line.
    But this bill is even more critical when we are facing a 
public health crisis. Now more than ever, workers want to do 
the responsible thing and stay home when they're sick. And they 
want to be able to protect their health and their family's 
health by taking the time they need to get vaccines and 
treatment.
    The Healthy Families Act is an essential part of our 
national response to the H1N1 outbreak. It will protect our 
families, and protect our nation. Experts estimate that if 
workers followed the CDC's guidance and stayed home from work 
when they are sick, it could reduce the number of people 
infected by a pandemic flu by 15-34 percent. Passing this bill 
will, quite literally, save lives, both now and in the future.
    I hope all of my colleagues will join me in supporting the 
Healthy Families Act.

                  Prepared Statement of Senator Murray

    Thank you, Senator Dodd, for holding this hearing.
    I appreciate the witnesses who have taken the time to be 
here today to discuss how we can help protect our workers, 
families, businesses, and communities from illness.
    This is especially important now as we see H1N1 spread 
across the Nation.
    I would like to start by saying once again just how much we 
miss our dear friend Ted Kennedy--especially as we discuss this 
issue. He was such a strong champion for paid leave in the 
workplace, and his hard work has moved us closer to that goal.
    And that goal is so critical.
    Since my time as a State Senator and a working mother I 
have been fighting to ensure that working Americans can take 
care of themselves and their families when they are sick--and 
not have to worry about losing their jobs.
    I was so proud to stand with Senator Dodd in my first year 
as a U.S. Senator as we passed the Family and Medical Leave 
Act.
    That was a great step forward--but the work is far from 
done.
    Our families are facing the toughest economic environment 
since the Great Depression. Too many are asking themselves how 
they're going to pay their rent, their health care premiums, or 
how they will put food on the table.
    But one thing they should never have to worry about is 
losing their jobs or their paychecks just because they or a 
family member gets sick.
    That's why I am proud to be an original co-sponsor of the 
Healthy Families Act that would allow workers to earn up to 56 
hours of paid leave to care for themselves or their family.
    This problem is not new, but the current H1N1 crisis has 
demonstrated so clearly the consequences and costs of employees 
coming into work sick--and the very real need for a policy that 
will allow them to stay home.
    This is not just good for workers--it is critical for 
businesses that want to keep their workforce healthy and 
productive during a national health care crisis like H1N1.&
    The CDC has issued guidance to help employers plan for and 
respond to H1N1. This guidance urges employers to allow sick 
workers to stay home without fear of losing their jobs and to 
allow workers to care for sick family members or for children 
if schools dismiss students.
    We've been told by the CDC that on average, an individual 
who comes to work with H1N1 will infect 10 percent of his or 
her coworkers.
    Those workers could then infect even more workers--
including those who are particularly vulnerable to the flu, 
such as those with underlying health conditions or women who 
are pregnant.
    Workers and businesses have a responsibility to each other 
and to the public to prevent the spread of serious illnesses 
like H1N1.
    Ensuring that workers have paid leave makes the decision to 
stay home much easier for employees who are struggling to pay 
the bills.
    Let's also not forget that our health care professionals, 
who will be the front line for all Americans in tackling this 
crisis, are employees as well.
    And good leave policies will help them choose to care for 
themselves without being concerned about keeping their job.
    I encourage my colleagues to pay close attention to this 
health crisis.
    To consider the value of guaranteed paid leave not only for 
our workers and businesses, but to help keep illnesses like 
H1N1 under control.
    And to support the Healthy Families Act.
    Thank you.

           Prepared Statement of the American Association of 
                        University Women (AAUW)

    Thank you for the opportunity to submit testimony for the 
subcommittee's hearing on paid sick days and the H1N1 flu.
    Founded in 1881, the American Association of University Women 
(AAUW) is a membership organization founded in 1881 with approximately 
100,000 members and 1,300 branches nationwide. AAUW has a proud 128-
year history of breaking through educational and economic barriers for 
women and girls, and continues its mission today through education, 
research, and advocacy. AAUW believes that creating work environments 
that help employees balance the responsibilities of work and family is 
good public policy. In fact, AAUW's 2009-2011 member-adopted Public 
Policy Program is committed to ``greater availability of and access to 
benefits and policies that create a family-friendly workplace 
environment,'' which are critical for women to achieve ``equitable 
access and advancement in employment.''\1\
    Despite the Family and Medical Leave Act (FMLA) and a patchwork of 
State laws and employer-based benefits--many of which AAUW members 
helped to pass--family and personal sick leave remain elusive to many 
working Americans. Further, despite the relative wealth of the United 
States, our family-oriented workplace policies lag dramatically and 
embarrassingly behind those in much of the rest of the world--including 
all high-income countries and many middle- and low-income countries as 
well.\2\
    This year particular attention must be paid to workplace policies 
which shape how families and workplaces respond to an outbreak of 
pandemic flu. As we all know, the H1N1 flu has become widespread, and 
many employers are working toward developing plans to help employees 
avoid presenteeism\3\ and ensure that business continues. AAUW supports 
the Healthy Families Act (S. 1152) as the solution to keeping families 
healthy and economically secure--and businesses solvent and open--
during this and future flu seasons.

            EMPLOYEES NEED PAID SICK DAYS, ESPECIALLY WOMEN

    AAUW has long supported flexible workplace policies to address the 
family responsibilities of employees. Offering workers the option of 
taking time off when they or a family member is sick is not just good 
for families, it's good for business. At least 145 countries worldwide 
provide paid sick days, with 127 providing a week or more annually. 
More than 79 countries provide sickness benefits for at least 26 weeks 
or until recovery.\4\
    But many hardworking Americans do not have access to the important 
benefit of paid sick leave. In fact, just under half (43 percent) of 
the private sector workforce has no paid sick days.\5\ Low-wage workers 
are especially hard hit, with about half receiving no paid sick 
days.\6\ In the industries that employ the most women--retail trade and 
accommodations/food service, which coincidentally have immense public 
health implications due to their accompanying contact with the public--
almost 9 million women do not have paid sick days.\7\ Further, 27 
percent of low-income women put off getting health care because they 
cannot take time off from work and 18 percent of women at all income 
levels face this situation.\8\ More than 22 million working women do 
not have paid sick days,\9\ and as a result half of working mothers 
report that they must miss work and often go without pay when caring 
for a sick child.\10\
    Paid employment should not be at odds with family responsibilities. 
In fact, finding solutions so that the two roles might better coexist 
is in the best interest of businesses. Current models of benefits are 
out of touch with the realities of the 21st century workforce, where 
households are often headed by dual-earning couples out of necessity, 
or a single parent whose juggling act can be particularly difficult. 
Furthermore, elder care responsibilities affect nearly 4 in 10 adults, 
and this number is likely to grow higher as nearly two-thirds of 
Americans under age 60 expect to be responsible for the care of an 
elderly relative in 2008.\11\ But work is not a choice for the majority 
of Americans, and most cannot afford to forfeit their paycheck or their 
job when a family member is sick; the Healthy Families Act provides a 
reasonable solution to this everyday crisis faced by families 
nationwide.

                        THE HEALTHY FAMILIES ACT

    Without paid sick days, employees often come to work sick, 
decreasing productivity and infecting co-workers. We've seen increased 
attention to this community health issue during the recent H1N1 flu 
pandemic, with CDC officials urging schools to close and workers 
presenting symptoms to stay home.\12\ In addition, the CDC guidance 
recommends that employers institute flexible workplace and leave 
policies for sick workers, those who stay home to care for ill family 
members, and those who must stay home to watch their children if 
dismissed from school. The lack of available paid sick days forces 
families with children to confront difficult choices that impact not 
only their families but potentially their communities as well. Such 
decisions can become a catch-22. For the 86 million Americans who do 
not have paid sick days,\13\ a decision to stay home to care for a sick 
child or family member jeopardizes their family income or even their 
job in an economy where it is difficult to find another. In addition, 
employees themselves are unable to make smart decisions to stay home to 
prevent infecting others because they cannot go without a day's wages.
    The Healthy Families Act would require employers with at least 15 
or more employees to guarantee workers 7 days of accrued paid sick 
leave annually. By ensuring that hard working Americans have access to 
a minimum number of paid sick days that can also be used to care for 
sick dependents, employees will no longer have to make the difficult 
choices between caring for loved ones--or themselves--and losing much-
needed income. In these challenging economic times, that decision is an 
especially difficult one for families to make.
    In the 111th Congress, the Healthy Families Act was introduced with 
an important new provision. The bill's paid sick days would be 
available for use for treatment, recovery, and activities necessary to 
deal with an incidence of domestic violence. This includes, but is not 
limited to, activities such as filing a restraining order, making a 
court appearance, moving into a shelter, and seeking medical treatment. 
We know that the aftermath of domestic violence costs employers, at a 
minimum, between $3 billion and $5 billion annually in lost time and 
productivity.\14\ And even more importantly, victims of intimate 
partner violence lose 8 million days of paid work each year.\15\ Paid 
sick and safe days are a necessity to victims and AAUW supports this 
new provision in the bill.
    This Congress, the Health Family Act ensures employees paid sick 
days through a mechanism that is business friendly. Employees now 
accrue up to 7 paid sick days a year based on the hours they work--a 
method that is similar to the allocation of other benefits employers 
may already have in place. This is also a method that ensures that 
part-time workers are included.
    Not only is offering paid sick days a positive step for businesses 
to stay in tune with the makeup and needs of the 21st century 
workforce, paid sick days produce savings for businesses through 
decreased turnover and increased productivity. The Institute for 
Women's Policy Research estimates that the Healthy Families Act would 
result in a net savings, after covering costs of paid leave, of $8 
billion per year. In addition, we are fortunate to be able to examine 
the policy already in place in San Francisco, where it was shown that 
implementing paid sick days resulted in a minor impact on employers and 
strong job growth in relation to the region.\16\

                               CONCLUSION

    The recent H1N1 flu pandemic has brought long overdue attention to 
the tenuous balance a majority of workers and families seek to 
establish between a paycheck and their own health needs. Families 
cannot go without a paycheck when one member is sick, but presenteeism 
in the workplace will only serve to increase the public health risk and 
spread of disease. The Healthy Families Act is a long-term workable 
solution that contains principles necessary to any paid sick days 
legislation--ensuring that workers are economically secure, protected 
in their jobs, and able to care for their families and themselves when 
illness strikes. For these reasons, AAUW strongly urges passage of the 
Healthy Families Act.
    Thank you for the opportunity to submit testimony.
    For more information please contact Lisa Maatz, director of public 
policy and government relations, at (202) 785-7720 or [email protected].

                               References

    1. American Association of University Women. (July 2007). 2007-09 
AAUW Public Policy Program. Retrieved April 8, 2009, from http://
www.aauw.org/advocacy/issue_advocacy/upload/2007-09-PPP-brochure.pdf.
    2. Hegewisch, Ariane and Janet Gornick. (May 2008). Statutory 
Routes to Workplace Flexibility in Cross-National Perspective. 
Institute for Women's Policy Research. Retrieved April 8, 2009 from 
http://www.iwpr.org/pdf/B258workplace 
flex.pdf.
    3. When employees come to work in spite of illness.
    4. The Institute for Health and Social Policy. (2007). The Work, 
Family, and Equity Index: How Does the United States Measure Up? 
Retrieved January 15, 2008, from http://www.mcgill.ca/files/ihsp/
WFEIFinal2007.pdf.
    5. U.S. Department of Labor, Bureau of Labor Statistics. (August 
2007). National Compensation Survey: Employee Benefits in Private 
Industry in the United States, March 2007, Table 19. Retrieved January 
16, 2008, from http://www.bls.gov/ncs/ebs/sp/ebsm0006.pdf.
    6. U.S. Department of Labor, Bureau of Labor Statistics. (August 
2007). National Compensation Survey: Employee Benefits in Private 
Industry in the United States, March 2007, Table 19. Retrieved January 
16, 2008, from http://www.bls.gov/ncs/ebs/sp/ebsm0006.pdf.
    7. Ibid.
    8. Salganicoff, Alina, Usha R. Ranji, and Roberta Wyn. (2005) Women 
and Health Care: A National Profile. Kaiser Family Foundation. 
Retrieved January 15, 2008 from http://www.kff.org/womenshealth/
7336.cfm.
    9. Institute for Women's Policy Research. (February 2007). Women 
and Paid Sick Days: Crucial for Family Well-Being. Retrieved January 
15, 2008 from http://www.iwpr.org/pdf/B254_paidsickdaysFS.pdf.
    10. Kaiser Family Foundation. (April 2003). Women, Work and Family 
Health: A Balancing Act. Retrieved January 15, 2008 from http://
www.kff.org/womenshealth/loader.cfm?url=/commonspot/security/
getfile.cfm&PageID=14293.
    11. National Partnership for Women and Families. (June 2004). Get 
Well Soon: Americans Can't Afford to Be Sick. Accessed January 24, 2008 
from http://www.nationalpartnership.org/site/DocServer/
GetWellSoonReport.pdf?docID=342.
    12. http://cdc.gov/h1n1flu/business/guidance/.
    13. Lovell, Vicky. (May 2004). No Time to be Sick: Why Everyone 
Suffers When Workers Don't Have Paid Sick Leave. Institute for Women's 
Policy Research. Accessed January 5, 2008 from http://www.iwpr.org/pdf/
B242.pdf.
    14. Bureau of Nat'l Aff., Special Rep. No. 32, Violence and Stress: 
The Work/Family Connection 2 (1990).
    15. Centers for Disease Control and Prevention, Costs of Intimate 
Partner Violence Against Women in the United States (2003).
    16. Institute for Women's Policy Research. (October 2008). Job 
Growth Strong with Paid Sick Days. Retrieved May 6, 2009 from 
www.iwpr.org/pdf/B264_JobGrowth.pdf.

   Prepared Statement of the Center for Law and Social Policy (CLASP)

    The Center for Law and Social Policy (CLASP) is a nonpartisan 
national nonprofit that develops and advocates for policies at the 
Federal, State, and local levels that improve the lives of low-income 
people. CLASP's mission is to improve the economic security, 
educational and workforce prospects, and family stability of low-income 
parents, children, and youth, and to secure equal justice for all.
    CLASP strongly encourages passage of the Healthy Families Act (H.R. 
2460/S 1152). The Healthy Families Act would allow those who work for 
businesses with 15 or greater employees to earn up to 7 paid sick days 
per year. These days could be used for: an absence related to a 
physical or mental illness, injury, or medical condition; obtaining 
professional medical diagnosis or care, or preventive medical care for 
the employee; obtaining the same types of care for a family member; and 
seeking services to recover from domestic violence.
    Having paid sick days is a basic labor standard that needs to be 
legislated because the lack of a mandate has resulted in about half of 
all private-sector workers having no ability to take a day off when 
sick without losing pay. Too many are at risk of losing jobs as well. 
The lack of paid sick days disproportionately affects low-income 
people, heightens public health risks, and creates an uneven playing 
field for businesses.
    The lack of paid sick days particularly hurts low-income workers: 
Nearly half of all private-sector U.S. workers (47 percent) do not 
receive any sick time and 70 percent do not have sick days to care for 
sick children. It's worse for low-income workers. Fully 77 percent of 
workers in the bottom wage quartile--nearly 24 million--do not have any 
paid sick leave.\1\ When these workers fall ill, or their children or 
other family members get sick, they are forced to choose between their 
badly needed pay check and often their job security, and their health. 
Parents with paid time off are more than five times as likely as other 
parents to stay home with sick children, which helps with recovery, yet 
only 41 percent of working mothers have paid sick days consistently.\2\ 
Many workers who do have paid time off are permitted to use it only for 
their own illness, not to care for a sick family member.
    The lack of paid sick days threatens our public health: President 
Obama has declared the H1N1 flu outbreak a national emergency, and the 
Centers for Disease Control and Prevention has issued guidelines 
recommending that employees experiencing flu-like symptoms stay home 
from work or school and limit contact with others. Employees are unable 
to heed these warnings if they do not have paid sick days and cannot 
afford to stay home from work or risk losing their jobs.
    The danger resulting from the spread of viruses and disease is 
especially acute in the service industry, where workers interact 
regularly with the general public. Because service workers earn low 
wages, they usually cannot afford to miss a day of work during an 
illness. Further, workers in the food and accommodation industry are 
least likely to have access to paid sick days.\3\ Without paid sick 
days, some employees continue to go to work and interact with patrons 
while sick, which creates a public health concern.\4\
    While some businesses may have responded to the recent flu outbreak 
by providing time off for employees to protect public health, many 
businesses have not changed their policies. A government policy that 
sets a labor standard floor is essential.
    Providing paid sick days is good for business: A minimum labor 
standard on paid sick days is critical to ensure that businesses, 
especially small businesses, have a level-playing field. Competition 
with other firms that do not offer paid sick days discourages many 
businesses from voluntarily offering paid sick days to their employees, 
even when they would like to do so.\5\ A small firm that wants to 
provide paid sick days to its employees typically cannot afford to do 
so unless the firm's competitor provides them as well. The smaller a 
firm's profit margin, the greater the need for a level-playing field.
    Costs associated with high rates of turnover are substantial. Paid 
sick days would reduce the incentive for employees to leave one firm 
for another with better working conditions. Unhealthy workers also are 
unproductive workers. ``Presenteeism,'' or the cost incurred when sick 
employees go to work but perform under par due to illness, constitutes 
a ``hidden'' loss in productivity for businesses. Health conditions of 
sick employees often worsen when they do not rest at home or seek 
medical care, thereby exacerbating the loss in productivity. And, 
sickness is spread easily in the workplace from one employee to 
another.\6\ Flu contagion in the workplace costs our national economy 
$180 billion annually in lost productivity.\7\ For employers, this 
costs an average of $255 per employee per year and exceeds the cost of 
absenteeism and medical and disability benefits.
    There is some concern that mandated paid sick days legislation 
would lead to job loss and raise the unemployment rate. But a recent 
study has found that there is no statistically significant effect of 
mandated paid sick days or leave on national unemployment rates.\8\ 
However, paid sick days could pay off by restricting the costly spread 
of contagious diseases.
    The public supports a minimum standard; other nations already 
provide it: Because paid sick days are critical to public health and 
are good for business, it is not surprising that 21 of the world's 22 
highly ranked countries in terms of economic and human development 
provide paid sick days. The United States is the only country among 
that group that has failed to adopt a national policy guaranteeing that 
workers receive paid sick days or paid leave.\9\
    There is widespread public support for paid sick days as a basic 
labor standard. According to a survey conducted for the Public Welfare 
Foundation, 82 percent of respondents considered paid sick leave for 
themselves a ``very important'' employee benefit. In addition, 75 
percent of respondents ``strongly favored'' a law guaranteeing all 
workers a minimum number of paid sick days.\10\
    The Healthy Families Act provides our Nation with an opportunity to 
provide paid sick days to workers, including the many low-wage workers 
who cannot afford to do without them. CLASP strongly urges passage of 
the Healthy Families Act.

                               References

    1. Vicky Lovell, ``No Time to be Sick: Why Everyone Suffers When 
Workers Don't Have Paid Sick Leave,'' Institute for Women's Policy 
Research, Washington, DC, 20004. Low-income is defined as less than 200 
percent of the Federal poverty line.
    2. Jody Heymann, ``The Widening Gap: Why America's Working Families 
are in Jeopardy and What Can be Done About It,'' Basic Books, 2000.
    3. Institute for Women's Policy Research, ``No Time to Be Sick: Why 
Everyone Suffers When Workers Don't Have Paid Sick Leave.''
    4. Jodie Levin-Epstein, ``Here's a Tip: When Restaurant and Hotel 
Workers Don't Have Paid Sick Days, It Hurts Us All,'' Center for Law 
and Social Policy, February 2007, http://www.clasp.org/publications/
heres_a_tip.pdf.
    5. Jodie Levin-Epstein, ``Responsive Workplaces: The Business Case 
for Employment that Values Fairness and Families,'' The American 
Prospect, February 2007, http://www.prospect.org/cs/
articles?article=responsive_workplaces.
    6. Jodie Levin-Epstein, ``Presenteeism and Paid Sick Days,'' Center 
for Law and Social Policy, February 2005, http://clasp.org/
publications/presenteeism.pdf.
    7. Ron Goetzal, et al., ``Health Absence, Disability, and 
Presenteeism Cost Estimates of Certain Physical and Mental Health 
Conditions Affecting U.S. Employers,'' Journal of Occupational and 
Environmental Medicine, April 2004.
    8. John Schmitt, et al., ``Paid Sick Days Don't Cause 
Unemployment,'' Center for Economic and Policy Research, June 2009.
    9. Jody Heymann et al., ``Contagion Nation: A Comparison of Paid 
Sick Day Policies in 22 Countries,'' Center for Economic and Policy 
Research, May 2009.
    10. Public Welfare Foundation, ``Paid Sick Days: A Basic Labor 
Standard for the 21st Century,'' National Opinion Research Center, 
August 2008, http://www.norc.org/NR/rdonlyres/D1391669-A1EA-4CF4-9B36-
5FB1C1B595AA/0/Paid 
SickDaysReport.pdf.

    For more information please contact: Jodie Levin-Epstein--
[email protected]; or Lexer [email protected].

       Prepared Statement of Deborah L. Frett, CEO, Business and 
                    Professional Women's Foundation

                              INTRODUCTION

    Thank you for this opportunity to submit testimony on behalf of 
Business and Professional Women's Foundation in support of the Healthy 
Families Act (S. 1152/H.R. 2460).
    Business and Professional Women's Foundation (BPW Foundation) works 
with women, employers and policymakers to create successful workplaces 
that practice and embrace diversity, equity and work-life balance. 
Through our groundbreaking research and our unique role as a neutral 
convener of employers and employees, BPW Foundation leads the way in 
developing and advocating for polices and programs that ``work'' for 
both women and businesses. A successful workplace is one where women 
can succeed and businesses can profit.
    BPW Foundation has a network of supporters in every community 
across the country which includes both employers and employees. Both 
our employee and employer members support paid sick days because they 
know it's good for business and workers.

                         THE CHANGING WORKFORCE

    One of the most significant trends of the past 50 years has been 
the movement of women, especially mothers, into the paid labor force 
and the growth of women-owned businesses. Women now make up half of the 
U.S. workforce and are projected to account for 49 percent of the 
increase in total labor force growth between 2006 and 2016.\1\ Women-
owned firms represent 30 percent of all U.S. businesses and between 
1997 and 2004 the number of women-owned firms increased by 17 percent 
nationwide--twice the rate of all firms.\2\
---------------------------------------------------------------------------
    \1\ U.S. Department of Labor, Bureau of Labor Statistics, 
Employment and Earnings, 2008 Annual Averages and the Monthly Labor 
Review, November 2007.
    \2\ U.S. Department of Labor, Bureau of Labor Statistics, 
Employment and Earnings, 2008 Annual Averages and the Monthly Labor 
Review, November 2007.
---------------------------------------------------------------------------
    Achieving a sustainable work-life balance is of paramount concern 
for working women and their families. One-third (\1/3\) of women 
believe that the difficulty of combining work and family is their 
biggest work-related problem, and nearly three-fourths (\3/4\) think 
the government should do more to help.\3\ Many women business owners 
say they left their previous employer to start their own businesses to 
have greater work-life balance, and therefore they are more likely to 
offer that flexibility to their employees. Women-owned firms in the 
United States are more likely than all firms to offer flex-time, 
tuition reimbursement, and profit sharing to their employees.\4\
---------------------------------------------------------------------------
    \3\ Families and Work Institute, ``National Study of the Changing 
Workforce,'' 2002.
    \4\ Business and Professional Women's Foundation, ``101 Facts on 
the Status of Working Women,'' October 2007.
---------------------------------------------------------------------------
    Despite the current economic downturn, there is ample evidence that 
we are headed toward a workforce shortage. There will be more jobs than 
workers and the jobs of the future are going to call for more 
education, more critical thinking and more compassion--all skills at 
which women excel. The number of jobs requiring either an associate's 
degree or a post secondary vocational credential will grow by 24.1 
percent during this decade. By 2020 it is estimated that there will be 
15 million new U.S. jobs requiring college preparation; yet at the 
current rates there is the potential for 12 million unfilled skilled 
jobs.\5\
---------------------------------------------------------------------------
    \5\ Bureau of Labor Statistics, ``Occupational Outlook Handbook,'' 
2002-2003 Edition.
---------------------------------------------------------------------------
    The make-up of the workforce has changed. Women account for 51 
percent of persons employed in management, professional and related 
occupations categories; 63 percent of sales and office occupations; 
and, 45 percent of workers in public administration.\6\ Other data 
shows that businesses with more women in senior positions are more 
profitable, women make a majority of the buying decisions within a 
family and younger workers are demanding more flexibility in their 
workplaces.\7\ Investing in policies that support working women is 
simply good for business.
---------------------------------------------------------------------------
    \6\ U.S. Department of Labor, Bureau of Labor Statistics, 
Employment and Earnings, 2008 Annual Averages and the Monthly Labor 
Review, November 2007.
    \7\ Roy D. Adler and Ron Conlin, ``Profit Thy Name is . . . 
Woman?'' Miller-McCune.com, February 27, 2009, http://www.miller-
mccune.com/business_economics/profit-thy-name-is-woman-1007; Business 
and Professional Women's Foundation, ``101 Facts on the Status of 
Working Women,'' October 2007.
---------------------------------------------------------------------------
    The increasing work commitment of American families and the 
changing workforce is putting new pressure on employers and 
policymakers to address the problem of work-life balance. BPW 
Foundation believes that greater attention to work-life policy 
initiatives, such as paid sick days, is good for business and will 
result in improved employee retention, positive human capital outcomes, 
a more productive workforce and healthier and happier families.
    BPW Foundation supports the Healthy Families Act (S. 1152/H.R. 
2460) because it is an important and necessary step towards achieving 
work-life balance.

                HEALTHY FAMILIES ACT (S. 1152/H.R. 2460)

    BPW Foundation supports the Healthy Families Act and its goal to 
guarantee full-time workers seven (7) paid sick days each year to 
recover from an illness, care for a sick family member, seek routine 
medical care, or seek assistance related to domestic violence.
    Women make up half of the U.S. workforce. Currently there are no 
State or Federal laws that guarantee all workers a minimum number of 
paid sick days. Nearly half (48 percent) of private-sector workers 
don't have a single paid sick day to care for their own health or that 
of a family member.\8\ The lack of this benefit has forced millions of 
Americans to choose between their paychecks and their health or the 
health of a family member. The Healthy Families Act is much needed 
change.
---------------------------------------------------------------------------
    \8\ Vicky Lovell, Institute for Women's Policy Research, ``Women 
and Paid Sick Days: Crucial for Family Well-Being,'' 2007.
---------------------------------------------------------------------------
    The lack of paid sick days particularly hurts working women, who 
still bear a disproportionate responsibility for care of the family. 
According to the National Compensation Study, more than 22 million 
working women self report that they do not have paid sick days.\9\ Half 
of all working mothers report that they have had to miss work to care 
for an ailing child and of those half reported that they lost wages in 
the process.\10\
---------------------------------------------------------------------------
    \9\ Institute for Women's Policy Research analysis of the March 
2006 National Compensation Survey, the November 2005 through October 
2006 Current Employment Statistics, and the November 2005 through 
October 2006 Job Openings and Labor Turnover Survey.
    \10\ Kaiser Family Foundation, ``Women, Work and Family Health: A 
Balancing Act,'' Issue Brief, April 2003.
---------------------------------------------------------------------------
    The following story was shared with us on the condition of 
anonymity. The author is a mother who works as a security guard for a 
large corporation and feared recrimination just for talking about her 
struggles due to a lack of paid sick leave.

          I would love to have paid sick leave. I'm a mother of two 
        girls, 3 and 13. When I was pregnant with my first child I had 
        no clue what to expect. Being pregnant, you have to go to the 
        doctor a lot. My job didn't provide any leave at all. If you do 
        not work, you do not get paid. Every time I had a doctor's 
        appointment, I had to check my calendar and make sure I could 
        afford to take off. I worked up to my 32d week and it took 3 
        months to get back to work. In that time with no income I had 
        to go on welfare and food stamps.
          With a child, I had to leave work for emergencies more 
        frequently because any problem with your child is top priority. 
        It would be great to be able to take leave to handle such 
        things and not feel guilty or scared about missing work!
          With my second child I was a little more prepared, but it was 
        the same story: miss work and you don't get paid. Well, this 
        time around I was put to the test; I had rent, electric, gas 
        and transportation bills. I lost my apartment because I had no 
        income while out with a new child. I'm not saying that having 
        paid sick leave would have saved my apartment, but I would have 
        had better options and managed my time off better. I currently 
        work M-F 7 a.m.-3 p.m. and overtime whenever possible. If I 
        need to take my children to annual check-ups, I have to take 
        unpaid leave. There would be a lot less stress in those 
        situations if I had time I could take with no reprimand.
          Being a single mother is hard enough. A few days of sick 
        leave could mean a great deal to anyone out here trying to 
        raise a family and be a responsible parent.

    The lack of paid sick days also hurts men. Thirty percent of 
working fathers report having had to take unpaid leave to care for 
themselves or a family member.\11\ More than 2 million fathers are the 
primary caregivers of children under 18, a 62 percent increase since 
1990.\12\ Due to lingering stereotypes about gender roles, some men 
report having been denied leave to care for a family member.
---------------------------------------------------------------------------
    \11\ Kaiser Family Foundation, ``Women, Work and Family Health: A 
Balancing Act,'' Issue Brief, April 2003.
    \12\ Business and Professional Women's Foundation, ``The State of 
Work-Life Effectiveness,'' June 2006, PP. 4 & 20.
---------------------------------------------------------------------------
    The lack of paid sick days hurts families. It hurts moms and dads, 
kids and grandparents and singles--everyone gets sick. This fact has 
been driven home by the spread of the H1N1 flu virus. It is difficult 
for many families to heed the government warning to stay home from work 
and to keep sick children home from school when they lack job-protected 
paid sick days. Many workers will risk their paychecks and even their 
jobs if they stay home when they or their children contract the flu. 
Unpaid time impacts the entire household because of the lost income. 
And not taking sick time impacts your health and ability to do 
preventive and wellness care. Without paid sick days, workers and 
families face financial difficulty in cases of illness or family health 
emergencies like H1N1 flu virus.
    The American family has changed dramatically in the last 50 years. 
Employee benefits should reflect the way we live now. In the 1960s, the 
overwhelming majority--70 percent--of American families with children 
had a mother who stayed home to provide around-the-clock childcare. 
Today, that statistic is reversed: two-thirds of families with children 
have either two employed parents, or a single employed parent, most of 
whom now work full-time.\13\
---------------------------------------------------------------------------
    \13\ U.S. Census Bureau, ``America's Families and Living 
Arrangements: 2006,'' http://www.census.gov/population/socdemo/hh-fam/
cps2006/tabFG1-all; Bond, et al., ``Highlights of the National Study of 
the Changing Workforce,'' 2002.
---------------------------------------------------------------------------
    If we are really committed to the American family, leave policies 
must be created so that everyone can achieve the work-life balance that 
is so frequently talked about. It is not enough for a few companies to 
offer paid sick days; it must be widely recognized as key to a 
successful workplace. In this economic climate many working women are 
backing off from their flexible work schedules and not taking sick days 
for fear of losing their jobs. A benefit that employees are afraid to 
take advantage of is no benefit. If we are truly interested in 
fostering a strong and productive workforce and strong families, then 
we must ensure that there are workplace policies that support employee 
success. And paid sick days is such a policy.
    Paid sick days are good for business. The lack of paid sick days 
leads to what is known as ``presenteeism.'' Presenteeism is the 
practice of employees coming to work sick, being unproductive and 
infecting their co-workers. That is bad for business. Ultimately, it 
costs businesses less to allow a sick person to stay home with pay than 
it does if the sick worker causes the illness of others in the 
workplace. The American Productivity Audit and studies in the Journal 
of Occupational and Environmental Medicine, the Employee Benefit News, 
and the Harvard Business Review show that presenteeism is a large drain 
on productivity--larger than that of either absenteeism or short-term 
disability.
    Companies that provide paid sick days tend to have lower job 
turnover rates, lower recruitment and training costs, lower unnecessary 
absenteeism, and a higher level of productivity than firms that do not 
offer this benefit.\14\ The stock market is showing favorable signs to 
support work-life policies as well. A recent Harvard Business article 
cited a research study of stock market reaction to the announcement of 
Fortune 500 firms adopting work-family programs. The results showed a 
positive swing of the stock--on average 0.48 percent.\15\
---------------------------------------------------------------------------
    \14\ Jane Waldfogel, ``The Impact of the Family Medical Leave 
Act,'' Journal of Policy Analysis and Management, vol. 18, Spring 1999; 
Christine Siegwarth Meyer, Swati Mukerjee, and Ann Sestero, ``Work-
Family Benefits: Which Ones Maximize Profits?'' Journal of Managerial 
Issues, 13(1):28-44, Spring 2001; Families and Work Institute, Business 
Work-Life Study, 1998, available at http://www.familiesandwork.org/
summary/worklife.pdf; Children's Defense Fund, ``Minnesota, Parental 
Leave in Minnesota: A Survey of Employers,'' Winter 2000; and ``Limits 
of Family Leave,'' Chicago Tribune, May 4, 1999.
    \15\ Freek Vermeulen, ``The Case for Work/Life Programs,'' Harvard 
Business blog, April 2009.
---------------------------------------------------------------------------
    The Healthy Families Act also contains important protections for 
business. To meet the concerns of small businesses, companies with 15 
employees or fewer are exempted. And if a company already provides paid 
sick days, nothing changes. In addition, paid sick days will be 
calculated using an accrual method so an employee will earn those days 
over time rather than getting them all at once. At first glance, many 
business owners thought that offering paid sick days would be a burden, 
but the numerous who have initiated this benefit have found that it is 
an easy adjustment and the pay-offs in productivity and happy employees 
are well worth it.
    Business research firms have calculated the ROI (Return on 
Investment) of companies who execute work-life effectiveness policies 
to those that do not and found that there are positive business profits 
for those who do. For example, companies on ``best companies to work 
for'' lists (e.g. excellent HR practices) produced four times the 
bottom line gains as compared to other indexes such as the S&P 500.\16\
---------------------------------------------------------------------------
    \16\ Business and Professional Women's Foundation, ``The State of 
``Work-Life Effectiveness,'' June 2006, pp. 2 & 12.
---------------------------------------------------------------------------
                               CONCLUSION

    BPW Foundation believes in a three-pronged approach to creating a 
successful workplace.

    1. Legislation like the Healthy Families Act;
    2. Working with businesses to proactively implement and update 
their own workplace policies; and
    3. Empowering women through education.

    Paid sick days are important to BPW Foundation because they are 
important to the health and well-being of women, families and 
workplaces. The Healthy Families Act will start us on the road toward 
successful workplaces for employers and employees.
    Thank you.
                                 ______
                                 
National Federation of Independent Business (NFIB),
                                         November 23, 2009.
Hon. Tom Harkin, Chairman,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Mike Enzi, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC 20510.

    Dear Chairman Harkin and Ranking Member Enzi: On behalf of the 
National Federation of Independent Business (NFIB), the Nation's 
leading small business advocacy organization, I am writing in 
opposition to the proposed paid leave mandate to combat the spread of 
the H1N1 virus. NFIB believes that short-term problems cannot be solved 
by long-term mandates, especially when unemployment is at a 26-year 
high of 10.2 percent.
    NFIB's opposition to mandated paid leave to prevent the spread of 
contagious illnesses does not mean we do not take this issue seriously. 
A one-size-fits-all mandate may not prevent the spread of contagious 
illnesses, like the H1N1 virus, but will certainly be burdensome for 
small businesses. NFIB is educating small business owners via our Web 
site and through cooperation with Federal agencies (for example, at 
http://www.nfib.com/business-resources/business-resources-item/cmsid/
50072/ and http://www.nfib.com/small-business-legal-center/compliance-
resource-center/compliance-resource-item/cmsid/49902/). After all, 
small businesses cannot afford to lose employees to any illness and 
small employers make every effort to accommodate their workers' leave 
requests. According to the NFIB 2004 Small Business Poll on Family and 
Medical Leave, 82 percent of small employers handle family and medical 
leave requests on a case-by-case basis, and 95 percent granted the most 
recent request for short-term leave for important personal matters. 
This type of flexibility is essential for small businesses. 
Unfortunately, the proposed mandate's vague language would impinge upon 
the employer's ability to offer flexible leave policies for his/her 
workers, creating more hurdles for small business. This is especially 
harmful as our economy continues in its struggle to recover.
    The proposal severely lacks clear guidance regarding employee 
classification, compensation, the definition of ``illness'' and how it 
impacts current policies and requirements. Despite the inclusion of a 
``sunset'' provision, history assures us that this will be anything but 
temporary. And although the bill attempts to provide a safe harbor for 
firms with fewer than 15 employees, the language does not clearly 
define the terms of coverage for part-time employees, temporary or 
contract employees. It also does not take into account Paid Time Off 
plans or make clear the requirements for disqualification from the safe 
harbor provision. Under the Family Medical Leave Act, employees need a 
certificate from a doctor stating that they can return to work 
following an illness. There is no similar provision in this bill, 
forcing the employer to play doctor. As a result, it is unclear whether 
the employer will be held liable should they not demand that an 
employee go home at the first possible sign of illness.
    The mandate is clear, however, in dissuading employers from hiring 
more than 15 employees. This proposal will make it more difficult for 
small firms to expand and create jobs. Small business owners will delay 
creating jobs or expanding their business when faced with additional 
Federal mandates. At a time when unemployment hovers at 10 percent, now 
is not the time to discourage small businesses--America's job 
creators--from creating new jobs. According to NFIB's Small Business 
Economic Trends (SBET) survey, small business owners continue to have a 
negative view of the economy, although their optimism has risen 
slightly each month since the lowest point reported, in March 2009. In 
the last 3 months, 8 percent of small business owners increased 
employment, but 19 percent reduced employment (seasonally adjusted). 
NFIB strongly believes that small business owners should be free to 
create policies that work best for their employees and their business--
especially given current economic conditions.
    NFIB opposes paid sick leave mandates in general and we oppose H.R. 
3991, Emergency Influenza Containment Act, which was recently 
introduced in the House of Representatives.
            Sincerely,
                                             Susan Eckerly,
                              Senior Vice President, Public Policy.
                                 ______
                                 
        National Small Business Association (NSBA),
                                         November 24, 2009.
Hon. Chris Dodd, Chairman,
Senate HELP Committee, Children and Families Subcommittee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Lamar Alexander, Ranking Member,
Senate HELP Committee, Children and Families Subcommittee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

    Dear Chairman Dodd and Ranking Member Alexander: On behalf of the 
National Small Business Association (NSBA), I am writing to provide 
comments for the Nov. 10 hearing, ``The Cost of Being Sick: H1N1 and 
Paid Sick Leave.'' The following comments focus on proposed H1N1 sick 
leave policies, suggested roles for the Federal Government to address 
the H1N1 flu season, and efforts already underway by small businesses 
to ensure a healthy workforce.
    NSBA is the Nation's oldest small-business advocacy group 
representing employers in every State. As an organization, we represent 
all sectors and industries of the U.S. economy from retail to trade to 
technology--our members are as diverse as the economy which they fuel. 
More than one in two people in the U.S. private workforce--an estimated 
70 million--work for or run a small business, according to data from 
the U.S. Small Business Administration Office of Advocacy and U.S. 
Census Bureau. Small business comprises 99.7 of all U.S. private 
employers, or 29.6 million businesses, and creates more than half of 
U.S. gross domestic product.
    There is no doubt that H1N1, or swine flu, is a potential threat to 
our Nation's small businesses. The Centers for Disease Control and 
Prevention have acknowledged that flu activity is widespread in 48 
States. The CDC also notes a significant increase in flu-related 
hospitalizations and deaths thus far this year vis-a-vis this time last 
year. NSBA shares the goals of employers, employees, and the government 
in protecting the workforce and the public from the impact of H1N1. 
However, current proposed sick leave policies would do more harm than 
good for small businesses, their employees, and their families; thus, 
Congress must take a deliberative approach in developing a Federal 
Government role in combating the impact of H1N1 that does not implement 
costly, unfunded mandates on small employers.
     house and senate proposed legislation for hini paid sick leave
    Currently, the only Federal law providing employee leave is the 
Family and Medical Leave Act (FMLA), which requires employers with 50 
or more employees to provide unpaid leave to eligible workers meeting 
certain requirements. FMLA provides employees who meet these 
requirements up to 12 work weeks a year of job-protected, unpaid leave. 
Anticipated H1N1 paid sick leave legislation would fundamentally alter 
the nature of employee leave policy that has existed since 1993 to the 
detriment of small businesses.
    Representative George Miller introduced the Emergency Influenza 
Containment Act of 2009 (H.R. 3991), which would require employers who 
send employees home, or tell them to stay home due to symptoms of a 
contagious illness, or because they have been in close contact with a 
person who has a contagious illness, to pay the employees sick leave 
for each workday the employee is out of work, up to a maximum of 5 work 
days during a 12-month period. The bill would apply to any employer 
with more than 15 employees, and to all full- and part-time employees. 
The act would take effect 15 days after it is signed into law and would 
expire in 2 years.
    Indications from the Nov. 10 hearing and Chairman Dodd's office 
note that he will be introducing similar legislation with significant 
modifications, including a provision that would provide 7 paid sick 
days instead of 5 for employees to take leave for ``flu-like symptoms, 
medical diagnosis or preventive care, to care for a sick child, or to 
care for a child whose school or child care facility has been closed 
due to the spread of flu.'' In addition, the discretion on the need for 
sick leave would be left to the employee, although medical 
certification could be required through regulation by the Department of 
Labor.
    In lieu of implementing costly mandates on small businesses in the 
form of required sick leave, Congress should consider other areas of 
Federal support to employees and employers that do not put restrictive, 
nationalized, one-size-fits-all standards on small businesses. In 
addition, Congress should recognize and account for small businesses' 
existing paid time off (PTO) programs and workplace flexibility 
initiatives that are already under way before hastily passing 
legislation without proper deliberation.

                            FEDERAL SUPPORT

    Despite the clear signs of a pending pandemic that emerged in 
spring 2009, our public health infrastructure is insufficiently meeting 
the needs of our society. Only certain individuals have had access to 
H1N1 vaccinations, and even those often waited hours in line to get 
vaccinated. While vaccination production and distribution have improved 
in recent weeks, individuals that are outside of the ``high-risk'' 
populations--many of which work for small businesses--remain vulnerable 
in the early stages of this year's flu season.
    There are more suitable and efficient Federal public policies to 
pursue rather than mandated sick leave. First, greater focus and 
attention should be paid to the education and preparation for the flu 
season. Publicizing personal hygiene best practices and other public 
health-related information can go a long way to prevent the spread of 
H1N1 in the workplace. NSBA has been working to provide this kind of 
critical information to our members via our Web site for the past 
several months. Second, the Federal Government has a direct role in 
ensuring that the public health infrastructure is prepared and capable 
to meet the needs of our society. Timely vaccinations for small-
business employees and their families can shield them from the impact 
and spread of contagious diseases. Small businesses should not have to 
pay the price for the Federal Government's inability to protect the 
public through our public health system.

                     FLEXIBILITY AND PAID TIME OFF

    In the wake of the current economic recession, small businesses 
need to maintain flexibility in order to survive, grow and provide 
jobs. In addition, small employers are already taking steps to address 
the potential impact of H1N1 on employees and their families. Many 
employers are addressing H1N1 threats by considering workplace 
flexibility options, including telecommuting, job sharing, schedule 
changes, shift swapping and other PTO arrangements for employee's own 
illness or to care for ill family members.
    Proponents of paid sick leave proposals often cite the lack of 
dedicated paid sick leave benefits offered to employees as the impetus 
to pass Federal legislation. However, this data does not take into 
account the flexible benefit arrangements small businesses design to 
meet the needs of their business, their employees, and there families, 
including the PTO benefit arrangement. In fact, the vast majority of 
employers voluntarily offer generous paid leave benefits. According to 
the Department of Labor, 82 percent of private employers currently 
offer some form of paid leave to their workforce. Nevertheless, PTO 
does not account for the individual by individual agreements that 
small-business owners frequently make with their employees to 
accommodate each parties' needs.
    More importantly, NSBA recently provided comments to a Senate work 
group on workplace flexibility, and is strongly supportive of their 
efforts to develop consensus-based, bipartisan solutions that work for 
both employers and employees. Flexible scheduling can ease the burden 
of unpredictable illness of employees and family members, and PTO can 
undermine the potential for abuse of dedicated paid sick leave 
policies.

                               CONCLUSION

    Similar to any other flu season, small-business employers are 
sensitive to the threats of H1N1. In fact, the old cliche of small-
business owners and their employees being a family is never truer than 
in times of an employee's ill-health. An employer's greatest asset is 
their employees, and it doesn't take a public health official to tell a 
small-business owner that the flu can spread and cripple their 
business. There are pragmatic solutions to address the threats 
presented by H1N1, but the current paid sick leave proposals are not 
the answer.
    With so much economic pressure on the shoulders of our Nation's 
small businesses, it is unfathomable that Congress would consider 
legislation mandating additional costly requirements on small 
businesses. Proposed H1N1 sick leave mandates comes on top of 10 
percent unemployment rates and economic challenges that, in combination 
with mandated sick leave, pose dire consequences for the job-creation 
role of small businesses.
    NSBA looks forward to the opportunity to work with you so as to 
explore policy alternatives to the currently proposed sick leave 
policies. Meanwhile, NSBA welcomes the opportunity to work with you in 
continuing our role of educating small-business owners, their 
employees, and their families in preparation for the pending flu 
season.
            Sincerely,
                                 Todd O. McCracken,
                                                 President.
                                 ______
                                 
          Response to Questions of Senator Dodd by Seth Harris

    Question 1. The Federal Government, through the CDC, has issued 
several important guidances to employers for utilization during the 
H1N1 pandemic. These guidances generally encourage employers to be 
flexible in their leave policies and permit workers to stay home 
without risking their jobs. While some employers have adjusted their 
leave policies, many haven't--and unfortunately many of those employ 
low-income workers who are least likely to have access to paid leave to 
begin with. Many people argue that employers are capable of addressing 
their employees' needs and the Federal Government does not have a role 
to play here. Why is it not enough to encourage employers to be 
flexible in their leave policies? Why is further direction from the 
Federal Government needed?
    Answer 1. The Department applauds the efforts of responsible 
employers who adjust their leave policies in response to the public 
health threat of the 2009 H1N1 pandemic; however, not all employers 
have heeded the CDC guidance and many workers have only unpaid leave 
available to them.\1\ Since only 49 percent of low-wage workers have 
access to paid sick leave or personal leave or family leave or 
vacation, unpaid leave may provide job security but not the income they 
must have to keep paying for basic necessities. Low-wage workers cannot 
afford to go unpaid even for a few days, and therefore will go to work 
when they are sick--infecting others and spreading disease.
---------------------------------------------------------------------------
    \1\ New York Times ``Lack of Paid Sick Days May Worsen Flu 
Pandemic'' November 2, 2009; Washington Post ``H1N1 exposes weak leave 
policies'' November 9, 2009; CNNMoney.com ``Swine flu--and no paid sick 
leave'' October 4, 2009; AP ``Millions Without Sick Leave Fear Swine 
Flu'' November 1, 2009; AP ``Swine Flu or Not, Many Workers Can't Stay 
Home'' May 4, 2009; Christian Science Monitor'' Swine Flu: With No Paid 
Sick Leave, Workers Won't Stay Home'' November 14, 2009.
---------------------------------------------------------------------------
    Further direction is needed because in spite of the guidance and 
encouragement from the Federal Government, some workers did not have 
access to the leave they needed during the 2009 H1N1 outbreak. In 
addition, many workers do not have access to paid sick leave for 
ordinary illnesses and injuries that are not a public health threat but 
still can endanger their job or income.

    Question 2. You mentioned in your testimony that several States and 
cities in the United States have implemented either temporary 
disability insurance programs or paid sick days laws. Has the 
Department of Labor heard of any ill effects on employers that these 
leave policies have imposed? Is a piecemeal, State-by-State or city-by-
city provision of paid sick days an effective or adequate way of 
providing employees with the leave they and their families need?
    Answer 2. I am not aware of any studies done on the impact of 
temporary disability insurance (TDI) programs (other than the impact on 
working parents regarding maternity leave) or paid sick leave laws on 
employers in those States or cities that require them. It should be 
noted that only the programs in Hawaii and Puerto Rico are funded by 
employers, so the TDI programs in California, New Jersey, Rhode Island 
and Washington would have no direct monetary impact on employers.
    Secretary of Labor Hilda L. Solis' vision is Good Jobs for 
Everyone. One of the key components of a good job is having workplace 
flexibility for family and personal caregiving. The Department believes 
that work-life balance is enhanced by policies such as paid leave and 
must be available to all workers.

    Question 3. My staff recently spoke with the owner of a restaurant 
in West Hartford, CT who provides his employees with paid sick and 
vacation time. This owner provides his employees with paid leave 
because he says it increases morale, drastically reduces turnover, 
saves his business money, and helps him maintain loyal customers. Some 
argue that providing paid sick leave is detrimental to employers' 
bottom lines. Is this true or is the restaurant owner in CT correct in 
saying that this benefit can save businesses money? Can paid leave 
benefit businesses?
    Answer 3. We believe it is common sense and good business sense 
that workers are able to stay home if they are ill without fear of 
losing their job, and do not have to work when ill simply because they 
do not have paid leave. Keeping employees with infectious illnesses 
home can help businesses reduce the spread of illness in their 
workplace and keep more employees working--which will help employers' 
productivity. Some studies have found a relationship between work-life 
benefits and positive employer outcomes although the Department is not 
aware of any recent studies updating these findings.

    Question 4. You said in your testimony that workers can jeopardize 
their job security by having to stay home from work because they are 
sick. Is this especially true during the current economic downturn? If 
so, why is that?
    Answer 4. Some employers have policies that penalize employees for 
absences from work, resulting in some cases with the employee being 
fired. The Department is not aware of any studies regarding changes to 
these types of leave policies during economic downturns. Of course, 
during an economic downturn with a high unemployment rate, it can be 
harder for workers who are fired to find new jobs.

    Question 5. The CDC guidances also tell workers and families not to 
go to work if they are sick and to keep their children home from school 
if their children are sick. Secretary Sebelius and Secretary Locke, 
among others, have repeated these instructions. I have been listening 
to these recommendations over the last several months and I can't help 
but feel that they are ignoring what is a reality for far too many 
workers--that many employees don't have the economic ability to take 
time off of work without pay, and they don't have access to paid leave. 
There seems to be a significant inconsistency between what the Federal 
Government is telling employees will be most effective in slowing the 
epidemic and what people are actually able to do. Do you agree that 
this discrepancy exists? Would the Healthy Families Act help to fill 
this gap?
    Answer 5. We have not seen any studies yet quantifying the number 
of employers who heeded the advice of Secretaries Sebelius, Locke and 
Solis to allow workers with influenza-like illness to stay home and 
away from the workplace. Even if some employers are providing leave to 
their employees who are ill with the H1N1 virus, the Healthy Families 
Act would ensure that many more employees could stay home when they are 
sick without fear of losing their job or losing income.

    Question 6. In your testimony you mentioned that DOL has been 
working with other agencies on the H1N1 flu pandemic. Can you describe 
this collaboration and why it is important on an issue such as this 
one?
    Answer 6. The Department strongly supports the interagency efforts 
led by the White House and the Departments of Health and Human Services 
and Homeland Security in responding to the 2009 H1N1 pandemic. DOL has 
been involved since 2005 in the Federal planning to prepare our Nation 
for a possible pandemic. All our efforts acknowledged that a severe 
pandemic would have enormous human and economic consequences. DOL's 
involvement ensured that choosing the right response, one that would 
minimize the overall negative impact on our society, took into account 
the specific effects on workers and workplaces. All Federal partners 
brought similar program and policy expertise to the planning process so 
that our guidance anticipated all possible consequences.
    The release of the National Implementation Plan in 2005 was just 
the start of the interagency work. Since then, DOL has been an integral 
part of the ongoing planning efforts as well as the continual 
assessment of Federal, State and local readiness. DOL's involvement in 
developing the 2007 Community Strategy for Pandemic Influenza 
Mitigation and in subsequent guidance documents ensured that policies 
and plans that affected workplaces, and particularly the safety and 
health of workers, was addressed. For example, DOL, along with the 
Equal Employment Opportunity Commission, published FAQs on the 
workplace issues to be considered by employers in writing and 
implementing their pandemic plans. DOL's Occupational Safety and Health 
Administration (OSHA) also provided guidance to workers and employers 
on how to keep workers safe and healthy during a pandemic. (see http://
www.osha.gov/dsg/topics/pandemicflu/index.html.)
    With the onset of the 2009 H1N1 outbreak, DOL has worked very 
closely with our partner agencies in helping our Nation respond to this 
novel virus. We worked with CDC and others on the Guidance for 
Businesses and Employers to Plan and Respond to the 2009-2010 Influenza 
Season and released new resources specific to H1N1 (see http://
www.osha.gov/h1n1/index.html). Through the Federal Advisory Council on 
Occupational Safety and Health (FACOSH), the Assistant Secretary for 
OSHA who chairs FACOSH, convened a subcommittee of Federal agencies and 
labor representatives to address the challenges of responding to the 
2009 H1N1flu pandemic within the Federal community. FACOSH's 
recommendations, which appear in its final report, ``Recommendations 
for Consideration by the Secretary of Labor on Pandemic-H1N1 Influenza 
Protection for the Federal Workforce,'' are being evaluated for further 
action. This coordination has allowed the Federal agencies to speak 
clearly and with one voice to help individuals, communities and 
businesses respond quickly and effectively to this novel virus.

   Response to Questions of Senator Dodd, Senator Reed, Senator Enzi 
                   and Senator Hatch by Anne Schuchat

                       QUESTIONS OF SENATOR DODD

    Question 1. Can you talk about what you expect to see happen with 
H1N1 as we head into the traditional flu season? How is CDC preparing 
for it?
    Answer 1. It is possible that the pandemic will wane over time as 
the season progresses. However, there are also possibilities for 
worsening that we should consider as we head into the traditional flu 
season: (1) Seasonal H3 influenza arrives in strength in the winter, 
and (2) 2009 H1N1 influenza has increased activity. Either possibility 
might occur alone, or together.
    HHS' CDC has had systems in place to monitor changes in virus 
circulation for many years including tracking of influenza-like 
illness, geographic spread, hospitalizations and deaths due to 
influenza, and changes in the virus itself that may make it more lethal 
or resistant to antiviral medications. We also routinely track changes 
in the relative circulation of influenza strains, and monitor for new 
strains that may be different from the current vaccine strains. We have 
enhanced these systems during the pandemic by augmenting our 
relationships with State and local health departments in the area of 
virus testing (subtype characterization and antiviral resistance 
monitoring), expanding collaborative agreements with key medical 
centers nationwide (identifying and tracking trends in disease 
severity), increasing our interaction with laboratories across the 
country (subtype monitoring), and adding a number of electronic data 
sources to track illness spread, antiviral use, school closures, and 
impact on communities.

    Question 2. Dr. Schuchat, with respect to the response to this 
pandemic, could you also talk about the level of coordination between 
CDC/HHS and other Departments, especially the Department of Labor?
    Answer 2. CDC/NIOSH (National Institute for Occupational Safety and 
Health) has coordinated with the Department of Labor (DOL)/Occupational 
Safety and Health Administration (OSHA) on several matters related to 
worker safety and health during the course of this pandemic, and DOL/
OSHA has been a partner with CDC in reaching out to labor unions to 
keep them informed of CDC guidance related to worker safety and health. 
In particular, OSHA played a significant role in the development of 
HHS/CDC's interim infection control guidance for healthcare settings 
for the 2009-2010 influenza season, as well as in the development of a 
companion piece to this document which focused on strategies to 
mitigate the impact of shortages of appropriate respiratory protection 
for healthcare workers. OSHA has also been a partner with CDC/NIOSH on 
a regular series of conference calls with a wide array of labor unions, 
in which updates are provided about the current status of the pandemic, 
and questions are fielded from the labor audience.
    During the summer of 2009, CDC/NIOSH staff participated as subject 
matter experts in the DOL/OSHA-sponsored Federal Advisory Council on 
Occupational Safety and Health (FACOSH) emerging issues workgroup, 
which was convened to review agency experience in protecting Federal 
employees from 2009 H1N1 influenza. FACOSH advises the Secretary of 
Labor on issues related to the occupational safety and health of the 
Federal workforce. The workgroup gathered information from Federal 
agencies and labor organizations representing Federal employees. It 
also sought insight from technical experts who provided perspective on 
the occupational safety and health-related gaps that exist in pandemic 
planning within the Federal Government and provided recommendations for 
the Secretary of Labor, including providing better all-around pandemic-
related training within Federal agencies and facilitating the 
coordination of 2009 H1N1 influenza information to improve consistency 
and clarity.

    Question 3. In your testimony you mentioned what individuals can do 
to prevent the spread of illness. What recommendations does the CDC 
make to employers to help them limit the spread of H1N1? What specific 
guidelines should child care facilities and schools use to prevent the 
spread of H1N1?
    Answer 3. In a guidance document titled, ``CDC Guidance for 
Businesses and Employers To Plan and Respond to the 2009-2010 Influenza 
Season,'' CDC outlines the measures which businesses can take to help 
protect their workforce and to maintain business continuity during this 
pandemic. The recommendations are framed for two scenarios: the first 
aimed for pandemic conditions similar to those experienced during the 
Spring wave of 2009 H1N1 influenza; and the second targeted for a 
pandemic more severe, based on the level of illness typically caused by 
the virus. Under current conditions, the guidance recommends that 
businesses take the following steps to keep staff from getting sick 
with the flu.

     Ensure that sick workers stay home,
     Monitor employees for illness and send sick workers home,
     Practice good hand and cough hygiene,
     Clean surfaces and items that are frequently touched by 
many people,
     Encourage employees to get vaccinated for both seasonal 
and 2009 H1N1 influenza,
     Take measures to protect employees who are at higher risk 
for complications of influenza,
     Make plans to maintain business continuity in the face of 
rising absenteeism, and
     Advise employees on proper measures to take when traveling 
overseas.

    Should pandemic conditions become more severe, based on increased 
virulence of the 2009 H1N1 virus, further measures which CDC recommends 
include:

     Consider active screening of employees for illness,
     Provide alternative work environments for employees at 
higher risk of flu complications,
     Increase social distancing in the workplace,
     Cancel non-essential business travel, and
     Prepare for the effects that school closures could have on 
work absenteeism.

    CDC recommends that schools and early childhood programs take the 
following steps to help keep students, teachers, and staff from getting 
sick with influenza. These steps should be followed all the time and 
not only during a flu pandemic.

     Encourage all school and early childhood program staff and 
students to get vaccinated for seasonal flu and 2009 H1N1 flu.
     Educate and encourage staff and students to cover their 
mouth and nose with a tissue when they cough or sneeze and provide easy 
access to tissues and trash cans. Teach children to cover coughs or 
sneezes using their elbow instead of their hand when a tissue is not 
available.
     Remind staff and students to practice good hand hygiene 
and provide the time and supplies for them to wash their hands with 
soap and water as often as necessary. Help younger children wash their 
hands properly and frequently.
     Remind staff to stay home and parents to keep a sick child 
at home when they have flu-like symptoms. Sick people should stay at 
home until at least 24 hours after they no longer have a fever or signs 
and symptoms of a fever (has chills, feels very warm to the touch, has 
a flushed appearance, or is sweating) without the use of fever-reducing 
medicine.
     Send sick students, teachers, and staff home and advise 
them and their families that sick people should stay at home until at 
least 24 hours after they no longer have a fever or signs of a fever 
(without the use of fever-reducing medicine). Early childhood program 
staff should perform a daily health check of children and make sure 
that contact information for parents is up-to-date so they can be 
contacted if they need to pick up their sick child.
     Move sick students and staff to a separate, but 
supervised, space until they can be sent home. Limit the number of 
staff who take care of the sick person and provide a surgical mask for 
the sick person to wear if they can tolerate it. Have surgical masks 
available for school nurses and others who care for sick people at the 
school or early childhood program.
     Routinely clean surfaces and items that children 
frequently touch with their hands (or mouths in early childhood 
programs) with the household disinfectant that is usually used, 
following the directions on the product label. Additional disinfection 
beyond routine cleaning is not recommended.
     Encourage early medical evaluation for children and staff 
at higher risk of complications from flu. They will benefit from early 
treatment with antiviral medicines if they are sick with flu.
     Stay in regular communication with local public health 
officials. It may be necessary to temporarily close an early childhood 
program or selectively dismiss a school with a large proportion of 
children at higher risk for influenza complications if flu transmission 
is high in the community. Local public health officials will also know 
if the influenza starts to cause more severe disease, calling for 
additional strategies to be implemented.

    Question 4. The Advisory Committee for Immunization Practices 
(ACIP) has identified children 6 months to adults 24 years of age to be 
among the vaccine priority groups. Can you talk about the adequacy of 
vaccines, equipment and other medications to treat children? Do you 
believe that our Nation's emergency departments and emergency medical 
personnel are adequately trained and equipped with proper medicines and 
devices suitable for children?
    Answer 4. We expect the 2009 H1N1 influenza vaccine to have a 
similar safety profile as seasonal flu vaccines, which have a very good 
safety track record. Over the years, hundreds of millions of Americans 
including children have received seasonal flu vaccines. HHS/CDC and 
HHS' Food and Drug Administration (FDA) will be closely monitoring for 
any signs that the vaccine is causing unexpected adverse events and we 
will work with State and local health officials to investigate any 
unusual events.
    For pediatric patients the antiviral drugs available are Tamiflu 
oral suspension and Tamiflu (30 mg and 45 mg) capsules. Relenza may 
also be used for treatment of influenza for children 7 years of age and 
older. There are adequate supplies of Tamiflu capsules and Relenza in 
the commercial supply chain. There were limited supplies of Tamiflu 
oral suspension available however, as of November 30, 2009, the 
manufacturer of Tamiflu has announced they are increasing the supply of 
Tamiflu pediatric oral suspension in the commercial supply chain. This 
product is now being made available.
    For children who are too young to use Relenza or who can not 
swallow capsules, if commercial Tamiflu oral suspension product is not 
available, pharmacies may compound Tamiflu suspension using adult 
capsules. In addition, Tamiflu 30 and 45 mg capsules may be mixed into 
a sweetened liquid by a caregiver.
    The training of personnel for management of infectious patients 
should not be very different between adult and pediatric care. Compared 
with training and equipment, staffing and space limitations are likely 
to be more challenging in these settings. In case of shortages in 
resources, HHS/CDC's Strategic National Stockpile contains supplies, 
equipment, and medications to support children as well as adults should 
there be a need to supplement locally available resources.

    Question 5. When it comes to the H1N1 virus, what are the biggest 
challenges you hear from employers? Schools? State and local public 
health departments?
Employers
    Answer 5. In the Spring when the 2009 H1N1 influenza virus first 
emerged, the biggest challenge for employers was adapting their 
pandemic plans to a pandemic that was milder than most plans had 
anticipated. Additionally, employers found that the WHO pandemic 
phases, which were planned to be utilized as triggers for further 
actions, were not actionable based on actual pandemic conditions. In 
response to these concerns and the key roles that businesses play in 
protecting the health of the workforce, CDC issued guidance for 
businesses and employers, encouraging them to develop pandemic plans 
that are flexible and sensitive to changes in the pandemic severity. 
Businesses and employers needed specific guidance regarding measures to 
use and advice on the timing of their implementation. In August, CDC 
updated that guidance and included recommendations for both the current 
level severity of pandemic and a more severe pandemic scenario.
Schools
    Since the beginning of the pandemic in Spring of 2009, schools have 
been concerned with decreasing exposure to regular seasonal flu and 
2009 H1N1 flu, implementing school closure guidance where necessary, 
and mitigating the effects that can come with closure. The decision to 
dismiss students should be made locally and should balance the goal of 
reducing the number of people who become seriously ill or die from 
influenza with the goal of minimizing social disruption and safety 
risks to children sometimes associated with school dismissal. While 
dismissal can be an effective means of decreasing the spread of disease 
in a community, it can also lead to negative consequences, including 
interruption of students' education, students being left home alone, 
workers missing shifts when they must stay home with their children, 
and low-income students missing free or reduced price meals.
State and Local Health Departments
    One of the biggest challenges we hear about from State and local 
public health officials is vaccine availability and the impact that it 
has had on State and local vaccination planning efforts. Many State and 
local health departments have reported that demand for vaccine has been 
greater than vaccine supply in their jurisdictions. In addition, 
challenges related to the limited ability to project future vaccine 
supply as well as concerns about inaccurate or unpredictable vaccine 
allotment numbers have complicated State and local long-term planning 
efforts. State and local public health departments are concerned about 
their ability to sustain very high workload due to the pandemic while 
maintaining the ability to respond to other public health events in 
their jurisdictions. The State laboratories have been especially 
impacted by the demand for testing for the 2009 H1N1 virus. Other 
challenges include additional personnel needs, particularly for 
administrative, vaccinator, and support staff personnel. A related 
challenge is the need for improved hiring processes to address 
recruiting difficulties. State and local health officials also have 
indicated a desire for more streamlined data collection and reporting 
requirements.

                       QUESTIONS OF SENATOR REED

    Question. I am deeply worried that Rhode Islanders, especially 
those at high risk of contracting H1N1 influenza, will not have access 
to adequate protection. In addition to the 160,631 doses of ANTIVIRALS 
that will be provided to Rhode Island at no cost to the State, the CDC 
recommended that the Rhode Island purchase an additional 112,981 doses 
of the H1N1 vaccine in order to immunize residents. The Federal 
Government offered to subsidize 25 percent of the cost of purchasing 
these additional doses. However, the current economy has hit Rhode 
Island particularly hard, and the State was only able to allocate 
sufficient resources for the purchase of 38,849 additional doses. 
Similarly, due to the State's budgetary constraints, I have heard 
concerns that there will be inadequate levels of personnel to staff 
preparedness activities and respond to the surge in illness. How does 
the CDC plan to address the need for additional vaccines and personnel 
in States that have been hardest hit by the current economy, and, as 
such, unable to adequately prepare to protect residents from the H1N1 
influenza?
    Answer. HHS pandemic influenza preparedness plans includes having 
enough antiviral drugs to treat 25 percent of the U.S. population (75 
million courses) with additional product available to support 
containment efforts (6 million courses). The goal is for the Federal 
Government to procure 50 million courses of antiviral drugs, and for 
project areas to procure 31 million courses which would be made 
available for purchase of HHS subsidized contracts. Of the 31 million 
courses, approximately 25.5 million courses have been procured by 
project areas.
    In the spring, approximately 11 million regimens of antiviral drugs 
were deployed from the Strategic National Stockpile (SNS) to the 62 
project areas. We understand that there was only modest use of this 
product at the State level. Thirteen million regimens of antiviral 
drugs were purchased to replenish the SNS assets deployed and have been 
incorporated into SNS inventory over the summer. HHS has also made an 
additional purchase of 16 million regimens of antiviral drugs that are 
anticipated to be delivered through February 2010 into SNS inventory, 
offsetting the gap that is present in State stockpiles (5.5 million 
regimens).
    Release of additional SNS antiviral drugs to States is determined 
based on multiple factors including disease progression, demand for 
product, and changes in product supply (commercially and within State 
stockpiles).
    Furthermore, all 2009 H1N1 vaccine is being purchased by HHS at no 
cost to the States, local health departments or other vaccinators.
    CDC has taken several steps to help alleviate State and local 2009 
H1N1 staffing needs, including temporarily assigning Federal staff to 
State and local health departments to provide support of State and 
local 2009 H1N1 response activities on a short-term basis. These 
temporary 2009 H1N1 field staff augment existing Federal field staff 
already fully involved in the 2009 H1N1 pandemic response, including 
preparedness and immunization field staff, career Epidemiology Field 
Officers, and Epidemic Intelligence Service officers. CDC will consider 
the requests based on Federal staff availability to meet anticipated 
needs.
    In addition, CDC's 2009 H1N1 Public Health Emergency Response 
(PHER) grant funds may be used to hire State personnel needed for 2009 
H1N1 response activities. Of the 62 PHER awardees, 40 reported spending 
an estimated $15.7 million on personnel and fringe benefits through 
October 31, 2009. These funds paid in part or in full for 3,944 
positions. The majority of personnel hired were nurses (38 percent), 
vaccine administrators (10 percent), and preparedness and response 
specialists (7 percent). An additional 20 percent of personnel 
expenditures supported ``other'' positions, including support staff, 
translators, data collection/entry personnel, contract nurses and call 
center support staff.
    Last, PHER funds may be used to support more long-term State and 
local health department staff. Many awardees already have requested 
direct assistance positions, for which CDC is currently in the process 
of recruiting and hiring.

                       QUESTIONS OF SENATOR ENZI

    Question 1. We continue to hear reports about schools closing 
across the country. Can you describe the vaccination programs at public 
schools? How many or what proportion of schools have vaccination 
programs? For those schools without vaccination programs, do they have 
plans to refer students and parents to local clinics that have access 
to the H1N1? What are we doing to assist the schools that have closed 
to vaccinate the children when they return or when they are at home 
because of the closing? Finally, when you calculate the allocation of 
vaccine that you distribute to communities, do you include in that 
calculation the schools in that community?
    Answer 1. During the week of November 23, 2009, there were no 
school closings reported to the CDC. There is no national program to 
vaccinate children through schools, although CDC has posted materials 
to assist State and local health departments with their programs at 
(http://www.cdc.gov/h1n1flu/vaccination/slv/). Because CDC does not 
collect data nationally on the number of schools that participate in 
such programs, there is not a mechanism to describe the proportion of 
schools offering vaccination programs. There is also no way to 
determine, at least on a national level, whether or not schools are 
referring students and parents to local clinics where the 2009 H1N1 
vaccine is being offered. Since every State varies in its approach to 
vaccine distribution, there is no comprehensive mechanism to collect 
this type of information.
    The 2009 H1N1 vaccine is allocated on a pro rata basis. Once 
allocated to project areas, there may be State and local decisions to 
further distribute vaccine on the basis of the number of school 
clinics. Again, each project area varies in its approach to vaccine 
allocation.

    Question 2. In light of the barriers that have been exposed with 
the H1N1, including our country's limited capacity to produce flu 
vaccine and the impact of not approving adjuvants in the flu vaccine, 
what specific steps will the Administration take to better prepare our 
country for the next flu pandemic?
    Answer 2. HHS is in the third year of implementing a comprehensive 
program to better prepare our country for the next influenza pandemic. 
This program supports the advanced development of improved influenza 
vaccines using both cell-based and recombinant and molecular 
technologies to produce vaccines that are not dependent on egg 
supplies. The advanced development program also supports the 
development of adjuvant technologies so they may be licensed for use 
with influenza vaccines in the coming years and be available as 
licensed vaccine for use during the next influenza pandemic.
    This program supports the building and expansion of domestic 
manufacturing infrastructure for influenza vaccine production. HHS 
supported the construction of the first U.S. cell-based facility that 
opened on November 24, 2009 and is expected to be operational by 2011, 
producing a significant portion of the U.S. pandemic vaccine needs 
within 6 months of the onset. HHS also has plans to support the 
construction of a second facility for production of cell-based or 
recombinant influenza vaccine with similar manufacturing surge 
capacity. Further, the domestic infrastructure program supported the 
expansion and upgrade of existing egg-based vaccine facilities in the 
United States.
    Last, this program supports stockpiling of pre-pandemic H5N1 
vaccine antigens and adjuvants. These stockpiles of antigens and 
adjuvants will allow the United States to more rapidly respond to an 
emerging pandemic by using these stockpiles to produce vaccines for an 
initial response.

    Question 3. The United States has historically low flu vaccinations 
rates. What is the Administration doing to improve these rates? How are 
you expanding public awareness about the different types of vaccines 
and why it is important for certain populations to be vaccinated?
    Answer 3. The objective of the 2009-2010 influenza vaccination 
communication campaign is to support the public health goal of 
protecting as many people as possible from both seasonal influenza and 
2009 H1N1 flu, with minimal social and economic disruptions. The 
primary goals of the 2009 influenza vaccination communications efforts 
are to provide timely and accurate information about the Federal 
influenza and pneumococcal vaccination recommendations, the benefits 
and risks of vaccination, and information about vaccine supply that 
helps individuals protect themselves and their families from influenza, 
including helping them make vaccine choices.
    A crucial element of the combined 2009 H1N1 and the 2009-2010 
seasonal influenza communications campaign involves engaging key 
stakeholders to help support and further vaccination messages. These 
stakeholders, including healthcare workers, pharmacists, employers, 
labor organizations and colleges and universities, are integral in 
furthering CDC's recommendations and disseminating these messages to as 
many people as possible. Working in concert with its traditional public 
health partners, we are also utilizing other outreach mechanisms to 
spread the word about influenza vaccines.
    We have developed various print products, social media, and audio/
video tools available in English, Spanish, and additional languages. 
Products include messages for both seasonal and 2009 H1N1 influenza. 
Print products include posters, flyers, brochures, and fact sheets, 
like Vaccine Information Statements. Social media products and 
activities include web banners, buttons, and badges that enable 
partners and external organizations to provide a link back to CDC on 
their Web site, a weekly blog on WebMD, and webinars for bloggers. We 
also are employing audio and video tools such as public service 
announcements (PSAs), podcasts and videos. These are available for 
State and local public health partners to use in healthcare settings. 
New information and materials are posted regularly on flu.gov and 
cdc.gov/h1n1flu.
    HHS/CDC is producing messages and materials for all of the groups 
recommended for seasonal and 2009 H1N1 flu vaccines, as well as 
messages for the general public, including hard-to-reach populations. 
However, because we know that the 2009 H1N1 virus affects certain 
population groups more severely than others, we have crafted targeted 
communication to reach those at the highest risk. For example, pregnant 
women, parents of children aged 18 and under, and adults ages 25 
through 64 years. We have also created plain language materials and 
products tailored for specific ethnic and racial groups.
    CDC is conducting outreach to health care providers through 
multiple channels to educate them on the importance of vaccination 
among their patients and to help address the challenge of low 
vaccination rates among health care personnel. Some examples of this 
outreach include a teleconference with leaders from the Nation's 
healthcare provider and healthcare personnel organizations and HHS 
Secretary Kathleen Sebelius and a partnership with Medscape to produce 
a weekly video series to provide updated information to physicians, 
nurses, pharmacists, and other healthcare professionals.
    CDC has invited minority media outlets, particularly African-
American and Hispanic media to hear from experts about the seriousness 
of the seasonal flu virus and 2009 H1N1 influenza virus, as well as to 
learn the importance of receiving both immunizations. Agenda topics for 
these briefings have included: flu season overview, importance of 
vaccinations, impact of influenza on specific ethnic and minority 
populations especially children, prevention and treatment, perspectives 
and attitudes of these specific populations. There is also time 
allotted for open discussion and one-on-one interviews, as requested.

    Question 4. The Administration projected that the United States 
would have access to 80-120 million doses of the H1N1 vaccine by mid-
October, but we all know that those goals were way off the mark. In 
your opinion, do you think that it would have been possible to produce 
that many vaccines within the timeframe that was given to 
manufacturers?
    Answer 4. Theoretically it would have been possible to produce the 
projected number of doses within the targeted time period. However, the 
realities of production posed unanticipated and unforeseeable delays. 
Potential production delays such as manufacturers changing delivery 
schedules due to country prioritization, extremely low production 
yields, prolonged seasonal influenza vaccine manufacturing campaigns, 
and day-to-day logistical and production line problems were not 
incorporated into our projections. These vaccine production capacity 
numbers were developed in July 2009.
    HHS has been transparent throughout the process, providing 
estimates and projections of vaccine manufacturing capacity 
availability based on our most current knowledge of vaccine delivery 
logistics and information from vaccine manufacturers, with the 
necessary caveats that vaccine manufacturing has numerous variables, 
many of which are inherent in the science of the virus and beyond our 
control. Changes in projections reflected delays in vaccine 
availability and not reductions in the total amount that will be 
available.
    Development of the 2009 H1N1 influenza vaccine began in late May 
2009 when the five U.S.-licensed manufacturers received virus reference 
strains from CDC and began making virus seed stocks. Commercial scale 
manufacturing of the vaccine began in late June to early July. The U.S. 
Government began receiving shipments of vaccine in late September with 
shipments expected every week at least through January 2010.

                       QUESTIONS OF SENATOR HATCH

    Question 1. The Biomedical Advanced Research and Development 
Authority (BARDA) was set up to provide incentives for companies to 
manufacture new products that could aid the United States in responding 
to biological, chemical and radiological threats. This mechanism helps 
companies bear the costs associated with moving products through the 
research and development pipeline by assisting with that financial 
burden. This system has worked well for incenting new products but was 
not intended for existing products or technology. The current pandemic 
has highlighted the uncertainties.
    Answer 1. The success of our response to a Public Health Emergency 
depends most of all on medical countermeasures for treatment and 
prevention of disease to help reduce the spread of infections, reduce 
health consequences, and ultimately save lives.
    Secretary Sebelius has asked the Assistant Secretary for 
Preparedness and Response to lead a review of its entire public health 
and emergency medical countermeasures enterprise, to be completed in 
the first quarter of 2010. The goal of this review is a modernized 
countermeasure production process that promotes promising discoveries, 
more advanced development, more robust manufacturing, better 
stockpiling, and more advanced distribution practices.
    The U.S.-pandemic preparedness strategy for establishing a domestic 
manufacturing surge capacity to produce sufficient pandemic vaccine for 
the entire United States within 6 months of pandemic onset involves an 
integrated approach utilizing vaccine development and U.S.-based 
manufacturing facility building. Advanced development of new influenza 
vaccines using tissue culture, recombinant DNA, and molecular 
technologies is the foundation for providing more flexible, robust, and 
less-vulnerable ways to manufacture influenza vaccines. Further, 
advanced development of antigen-sparing technologies for existing and 
new influenza vaccines using adjuvants provides opportunities to expand 
the vaccine manufacturing base multifold at different points towards 
the final surge capacity goal. Coupling the enhancement of existing 
U.S.-based manufacturing facilities that produce egg-based influenza 
vaccines with the building of new domestic facilities that will 
manufacture 
cell-, recombinant-, or molecular-based influenza vaccines is the 
natural extension to vaccine advanced development and should achieve 
the U.S.-pandemic vaccine surge capacity goal.
    The seeds planted since the investments were initiated in 2006 have 
thus far generated the trees that will bear fruit in the next several 
years. Specifically, the HHS cell-based influenza vaccine program 
supports the advanced development of six cell-based programs. Two of 
these vaccines are nearing completion of final clinical testing and are 
expected to seek U.S.-licensure in 2010-11. One of these two companies 
has started to build a plant for the production of cell-based vaccines 
here in the United States with assistance from HHS. This facility may 
be available for vaccine production in less than 2 years in a pandemic 
emergency. Other cell-based vaccine candidates are earlier in the 
development pipeline.
    In June 2009, HHS made its first award for advanced development of 
a recombinant vaccine. Recombinant and molecular technologies do not 
depend on the ability to grow the virus in an egg or a cell to 
manufacture vaccine and thus may be available much sooner after 
pandemic onset. It is projected that this first program will be 
licensed for use in the United States in 3 years. A second request for 
proposals (RFP) was released in September 2009 to support additional 
recombinant and molecular influenza vaccine candidates; multiple 
proposals were received for review and contract awards are expected 
early in 2010.
    In early 2007 HHS made awards for three antigen-sparing technology 
programs. These technologies reduce the amount of vaccine needed to 
vaccinate a person and thus increase the total supply. These 
technologies are in late stage of development with 2009 H1N1 vaccines 
and are expected to seek U.S.-licensure in 2010.
    Additional influenza vaccine manufacturing facilities in the United 
States would augment existing and nearly completed influenza vaccine 
manufacturing facilities implementing new cell-, recombinant-, or 
molecular-based technologies and is consistent with HHS' pandemic 
influenza preparedness activities. HHS plans to issue RFPs in 2010 to 
support the construction of a new cell-based manufacturing facility in 
the United States and to expand the domestic fill-finish vaccine 
manufacturing network.
    Additionally, new vaccine production technologies and technologies 
that expedite the vaccine production and delivery process will be 
pursued, such as new and faster ways to measure how vaccine potency, 
which will provide better estimates of vaccine production.
    Together, these programs of advanced development and building 
domestic manufacturing infrastructure will enable the United States to 
meet its pandemic preparedness vaccine goals in the next 3 years.

  Response to Questions of Senator Dodd and Senator Enzi by Debra Ness

                       QUESTIONS OF SENATOR DODD

    Question 1. Some critics have expressed concern about the impact 
that passing a bill like the Healthy Families Act would have on 
American businesses and our global economic competitiveness. However, 
you testified in opposition to that claim. What do both international 
experiences and our early experiences with the San Francisco paid leave 
ordinance tell us about the impact that the Healthy Families Act would 
have on businesses and our Nation's economic competitiveness?
    Answer 1. Based on research on international experiences and early 
experiences with the San Francisco paid sick days ordinance, we 
conclude that the availability of paid sick time does not negatively 
impact economic competitiveness and employment.\1\
---------------------------------------------------------------------------
    \1\ Earle, Alison and Jody. Heymann. 2006. ``A Comparative Analysis 
of Paid Leave for the Health Needs of Workers and their Families Around 
the World.'' Journal of Comparative Policy Analysis. 2006; 8 (3): 241-
257.
---------------------------------------------------------------------------
    The U.S. lags far behind other countries in paid sick day 
standards. In fact, a global consensus exists around the guarantee of 
job-protected paid sick days: 163 nations guarantee paid leave for 
workers to recover from their own health conditions. The United States 
and the Republic of Korea are the only industrialized nations that lack 
a standard of paid sick days.\2\
---------------------------------------------------------------------------
    \2\ Heymann, Jody. Raising the Global Floor. 2009.
---------------------------------------------------------------------------
    The World Economic Forum, which brings together the top business 
leaders from around the world, ranks the most competitive national 
economies. The United States is alone among the 20 most competitive 
countries in not guaranteeing workers paid sick days. Eighteen of these 
countries provide 31 or more sick days with pay. In fact, the countries 
which are most economically competitive are more likely to guarantee 
paid sick days for employees' own health and to care for the health 
needs of children and adult family members. According to the 
researchers, by guaranteeing paid sick days, these nations are 
guaranteeing a healthy workforce, which is essential to competition.\3\ 
\4\
---------------------------------------------------------------------------
    \3\ Heymann J., A. Earle, & J. Hayes. (2007). The Work, Family, & 
Equity Index: How Does the United States Measure Up?. Boston/Montreal: 
Project on Global Working Families. www.mcgill.ca/files/ihsp/
WFEIFinal2007.pdf.
    \4\ Earle A. & J. Heymann. (2006). A comparative analysis of paid 
leave for the health needs of workers and their families around the 
world. Journal of Comparative Policy Analysis 8(3):241-257.
---------------------------------------------------------------------------
    While San Francisco became the first jurisdiction in the United 
States to guarantee workers paid sick days in 2007, their early 
experiences have been similar to those internationally. Economic 
indicators do not show that San Francisco's paid sick days law had an 
adverse affect on the city's economy. In fact, in the 12-month period 
following the effective date of the policy, employment in San Francisco 
expanded by 1.1 percent, the same rate as neighboring Marin and San 
Mateo counties and substantially above the rate of employment change in 
Alameda, Contra Costa and Santa Clara counties.
    According to a statement to the House Education and Labor 
Committee's Subcommittee on Workforce Protections by Donna Levitt, 
Manager of San Francisco's Office of Labor Standards Enforcement:
        ``I am not aware of any employers in San Francisco who have 
        reduced staff or made any other significant changes in their 
        business as a result of the sick leave ordinance. While San 
        Francisco, like every community, has suffered in the current 
        recession, to my knowledge no employers have cited the sick 
        leave requirement as a reason for closing or reducing their 
        business operations in the city.'' \5\
---------------------------------------------------------------------------
    \5\ Donna Levitt, Statement for the Record to the House 
Subcommittee on Workforce Protections, 6/25/2009.

    Question 2. Has the FMLA been unduly burdensome on employers to 
implement?
    Answer 2. No; in fact, the FMLA has demonstrated conclusively that 
family-friendly workplace policies are good for businesses as well as 
good for workers and families. Since 1993, workers have used the FMLA 
more than 100 million times to take the unpaid time off that they need 
to care for themselves or their families, without sacrificing their 
jobs and long-term economic stability.\6\ During the efforts to pass 
the FMLA, advocates withstood, and overcame, relentless scare tactics 
from businesses that claimed the law would be the end of them. Over 15 
years later, the FMLA is well established, and businesses have 
flourished with it in place. Data from the most recent national 
research on it, conducted by the U.S. Department of Labor, show that 
the vast majority of employers in this country report that complying 
with the FMLA has a positive/neutral effect on productivity (83 
percent), profitability (90 percent), growth (90 percent), and employee 
morale (90 percent).\7\ The act benefits employers in numerous ways, 
most notably from the savings derived from retaining trained employees, 
from productive workers on the job, and from a positive work 
environment.
---------------------------------------------------------------------------
    \6\  Dept. of Labor. The Family and Medical Leave Act Regulations: 
A Report on the Department of Labor's Request for Information 2007 
Update at 129. We based this estimate on multiplying the Employer 
Survey Based Estimate by 15. Unfortunately, the data we have on FMLA 
leave use is quickly becoming out of date. The Dept. of Labor last 
surveyed employers and employees on the FMLA in 2000. Since then, the 
Dept. has not conducted any national survey on the FMLA. The Department 
needs to conduct scientifically sound survey research on the FMLA so 
that policy decisions can be made based on that information, rather 
than on selected employers' complaints.
    \7\ Dept. of Labor. FMLA Survey Report. 2000. www.dol.gov/whd/fmla/
chapter6.htm.
---------------------------------------------------------------------------
    The Department of Labor agrees that the FMLA is working well. 
According to its 2007 Report:

        Department is pleased to observe that, in the vast majority of 
        cases, the FMLA is working as intended. For example, the FMLA 
        has succeeded in allowing working parents to take leave for the 
        birth or adoption of a child, and in allowing employees to care 
        for family members with serious health conditions. The FMLA 
        also appears to work well when employees require block or 
        foreseeable intermittent leave because of their own truly 
        serious health condition. Absent the protections of the FMLA, 
        many of these workers might not otherwise be permitted to be 
        absent from their jobs when they need to be.\8\
---------------------------------------------------------------------------
    \8\ Dept. of Labor.2007 Report.
---------------------------------------------------------------------------
                       QUESTIONS OF SENATOR ENZI

    Question 3. The Healthy Families Act covers small employers that 
employ 15 or more employees. This is a much lower threshold than the 
Family and Medical Leave Act of 1993 (FMLA), which set a 50 employees 
threshold. As we heard from Ms. O'Brien's testimony, the FMLA has been 
extremely burdensome to administer for the employers it governs. Now, 
you are advocating multiplying that burden and extending it to more 
than 600,000 new employers who may not have sophisticated HR 
departments. Why is it appropriate to include employers who are 
exempted from the FMLA?
    Answer 3. The Healthy Families Act uses an employer-size threshold 
different from the FMLA because its scope and purpose is entirely 
different. The FMLA provides unpaid, job-protected leave for up to 12 
weeks a year to care for a newborn, newly adopted or foster child, to 
care for a seriously ill family member, or to recover from an 
employee's own serious illness. The Healthy Families Act offers leave 
that is for a much shorter time--7 days. The FMLA does not address many 
workers' day-to-day health needs. FMLA coverage for illnesses is 
limited to serious, longer-term illnesses and the effects of long-term 
chronic conditions. The law does not offer time off to workers to deal 
with common illnesses that do not meet the FMLA standard of ``serious'' 
or for routine medical visits for themselves and their families. The 
Healthy Families Act aims to offer leave for common, short-term illness 
like the cold or the flu.
    Unlike the FMLA, the need for paid sick days is largely based on 
public health concerns: to prevent the spread of contagious illness 
within our workplaces, schools and communities. Workers in jobs that 
involve the most interaction with the public are among those least 
likely to have paid sick days. Only 22 percent of food and public 
accommodation workers have any paid sick days, for example. Workers in 
child care centers, retail clerks, and nursing homes also 
disproportionately lack paid sick days.\9\ To fulfill the purpose of 
safeguarding public health, a 15-employee threshold makes more sense 
than a larger, 50-employee threshold, which would exempt 40 percent of 
the workforce. Any higher threshold for the Healthy Families Act would 
be tantamount to creating holes in mosquito netting.
---------------------------------------------------------------------------
    \9\  Vicky Lovell. Institute of Women's Policy Research. Valuing 
Good Health: An Estimate of Costs and Savings for the Healthy Families 
Act, 2005.

    Question 4. The nonpartisan Congressional Budget Office estimated 
that this bill will cost private employers $11.4 billion over 5 years. 
A substantial amount of that will fall on smaller employers that are 
already struggling to make payroll in these difficult economic times. 
Indeed, as we can see from the current 10.2 percent unemployment rate, 
many are not able to maintain current payrolls. If this bill is 
enacted, won't employers be forced to adjust somewhere--either by 
reducing current healthcare or retirement benefits, or by downsizing 
their number of employees and adding to the ranks of the unemployed?
    Answer 4. Paid sick days policies can be implemented without 
negative impacts for employers. For a case in point, we can examine 
efforts to raise the Federal minimum wage, which set off a wave of 
similar business claims. According to a 2006 statement from 650 
economists, increasing the minimum wage ``can significantly improve the 
lives of low-income workers and their families, without the adverse 
effects that critics have claimed'' \10\ and result in higher 
productivity, lower turnover and improved worker morale. While a paid 
sick days policy would impose modest costs, economists predict that is 
also likely to help business by reducing turnover and improving worker 
productivity.
---------------------------------------------------------------------------
    \10\ See the economists' statement at www.epi.org/minwage/epi--
minimum--wage--2006.pdf.
---------------------------------------------------------------------------
    It is also important to consider San Francisco's experience. The 
city's labor enforcement official has publicly stated that she is not 
aware of any employers in San Francisco who have reduced staff or made 
any other significant changes in their business as a result of the sick 
leave ordinance. Furthermore, despite an economic slowdown affecting 
employment in all counties in the Bay Area in 2007, after passing paid 
sick days, San Francisco maintained a competitive job growth rate that 
exceeded the average growth rate of nearby counties. In the 12-month 
period following the 2007 effective date of the new policy, employment 
in San Francisco expanded by 1.1 percent, substantially above 
neighboring areas without this ordinance.

    Question 5. The Healthy Families Act ``employers with existing 
policies'' section only applies to employers that offer leave ``under 
the same conditions outlined'' in the bill. Would an employer that 
offers 5 days of paid leave per year but allows unused leave to carry 
over annually qualify? Would undesignated leave that could be used for 
sick leave or any other purpose qualify if an employee made the 
decision to use all available leave for vacation leave? Does the term 
``same conditions'' include the terms of enforcement and remedies?
    Answer 5. The Healthy Families Act is aimed to address the needs of 
workers who have no paid time off to deal with their own health needs 
or the health and well-being of their families. Employers who offer 
paid leave policies that allow employees to use the leave in the same 
method and for the same purpose as the paid time off offered by the 
Healthy Families Act will not be required to change their policies. We 
expect that administrative details will be fleshed out through the 
Federal regulatory process. During that time, both the employer and 
employee communities will have an opportunity to weigh in.

    Question 6. Some smaller local governments that rely on part-time 
and seasonal employees for services such as mowing the grass in public 
spaces are concerned that mandating paid sick leave for these employees 
will impose high cost and bureaucratic burdens. These local governments 
would be forced to consider shifting their employment practices away 
from part-time work. But working part-time is an option many employees 
seek because of the flexibility it provides, particularly teenagers 
looking for after-school work and parents who can only work during 
school hours. Do you understand the value work opportunities like these 
provide and do you think they are worth preserving?
    Answer 6. While we understand the value of part-time and seasonal 
work opportunities, we also understand workers' need for paid sick 
days. Part-time workers are more likely to work in industries that 
require frequent contact with the public, and without paid sick days, 
are more likely to put the public's health at risk. For example, two in 
five food-service workers are employed part-time, about twice the 
proportion of workers across all industries.\11\ These workers not only 
directly interact with customers, but also come into contact with food 
and drink, which may facilitate the spread of contagion. The accrual 
system in the Healthy Families Act allows part-time workers to accrue 
paid sick days, but to address the needs of employers, part-time 
workers will earn less time annually than full-time workers. Similarly, 
to accommodate the needs of employers with seasonal employees, the 
Healthy Families Act permits employees to use their earned paid sick 
time only on the 60th day of their employment.
---------------------------------------------------------------------------
    \11\ Bureau of Labor Statistics. Food Services and Drinking Places. 
www.bls.gov/oco/cg/cgs023.htm#emply.
---------------------------------------------------------------------------
        Response to Questions of Senator Dodd by Elissa O'Brien

    Question 1. You mentioned in your testimony that earlier this year 
67 percent of SHRM members indicated that they either planned to or 
were currently sending employees home if they came to work with flu- or 
cold-like symptoms. However, this still leaves a large proportion of 
SHRM employers, which do not of course encompass all employers, who do 
not employ such practices. This isn't good enough--we cannot just 
provide these worker protections to some Americans and not others. Why 
do the remaining 33 percent of SHRM members not provide this kind of 
policy during an epidemic and how can we ensure that they do--both for 
the public health and for families--economic well-being?
    Answer 1. The 67 percent response cited in my written statement 
came from a survey of SHRM members conducted in May of 2009, many 
months before the Federal Government declared the H1N1 virus a public 
health emergency. In a more recent poll of SHRM members conducted 
October 15, 2009, 74 percent of HR professionals indicated their 
organization was informing their workforce not to come to work if they 
have flu- and cold-like symptoms. In addition, many employer policies 
already direct employees to stay home if they are experiencing these 
symptoms, so the number of organizations that adhere to this type of 
policy is much higher than 74 percent.
    Organizations have also employed other policies and tactics to help 
reduce the spread of the H1N1 virus in the workplace. In the October 
15, 2009 SHRM poll, HR professionals cited the following as the top 
strategies and programs currently being implemented:

     Educating employees on flu prevention measures=89 percent.
     Monitoring the H1N1 virus situation by following guidance 
from the CDC, WHO, etc.=84 percent.
     Making hand sanitizer, other disinfectants, masks and 
other flu prevention tools readily available across the organization=84 
percent.
     Developed an employee communication strategy related to 
the H1N1 virus=75 percent.

    Question 2. As you correctly note, because Wingate Healthcare 
provides care for sick, elderly, and disabled Americans, it is 
particularly crucial that your company have policies in place to ensure 
that sick workers stay home. Unfortunately, not all health care workers 
have these critical benefits. According to BLS, only 77 percent of 
health care workers in the private sector have any paid sick days at 
all. Do you think that businesses that provide health care services to 
vulnerable populations should provide paid sick days to ensure that 
their workers don't spread illness? Do you think it would harm your 
business if you stopped providing this basic benefit to workers?
    Answer 2. SHRM believes that employers should voluntarily provide 
paid leave to their employees. These benefits are incredibly important 
recruitment and retention tools for employers. In my experience, 
providing generous paid leave benefits and programs has provided 
Wingate with a competitive advantage over similar entities in which we 
compete for talent. It is true that not all health care organizations 
are able to provide paid sick leave to their employees, and it would be 
helpful to know from a public policy perspective what type of financial 
barriers or other obstacles prevent these organizations from offering 
these benefits.

    Question 3. You stated that we should ``encourage'' employers to 
provide adequate paid leave policies for their employees. I agree. 
However, ``encouragement'' is clearly not enough. There continue to be 
many employers who, despite encouragement, still offer no paid sick 
time for their employees. We know that this inequity disproportionately 
impacts those workers in low-wage jobs who cannot afford to take unpaid 
time off when they are sick or to care for an ill family member. What 
should be done about these employees? How can we be satisfied when a 
large proportion of our workforce has inadequate workplace rights and 
benefits?
    Answer 3. According to the Bureau of Labor Statistics, 83 percent 
of all private sector employees have access to paid illness leave. 
Unfortunately, as you point out, this means that a small percentage of 
employees are left without access to paid time off to address their 
health needs or those of their family members. Rather than pursue a 
one-size-fits-all paid leave mandate that ultimately penalizes those 
employers who are already providing generous paid leave benefits, 
public policy should do more to encourage employers to offer paid 
leave.
    As it stands today, unlike other areas of Federal law, there is no 
Federal law or statute that incentivizes employers to provide this type 
of benefit. For example, the government provides real incentives to 
homeowners to make their homes more energy efficient by providing them 
tax credits for replacement windows. Struggling employers need 
encouragement in the form of real incentives too. That's why SHRM has 
proposed a set of principles for a 21st Century Workplace Flexibility 
Policy that encourages employers to provide paid leave by allowing them 
to meet a safe harbor standard of leave. By voluntarily meeting this 
safe harbor leave standard, an employer would opt out of other Federal, 
State and local leave requirements. Additionally, tax credits for small 
employers and/or those organizations that can least afford to offer 
paid leave benefits would be another way to incentivize employers to 
offer paid leave.

    Question 4. I applaud your efforts at Wingate to provide employees 
with the tools they need to balance work and family, and you argue that 
paid time off offers a flexible option for employers that should be 
encouraged. A concern you raise is that the Healthy Families Act could 
cause employers to reduce wages or other benefits, and therefore limit 
flexibility. While research does not support this claim, how would 
providing a Federal floor from which employers, such as Wingate, could 
offer more generous benefits to their employees cause costs different 
than offering paid time off policies? What evidence do you have that 
employers will scale back other benefits if this law passes? Why would 
employers respond in that way to a law that will ultimately save them 
money?
    Answer 4. As you know, employers have only a finite pool of 
resources to devote to employees' total compensation, which includes 
wages and other important benefits such as health care and retirement 
plans, educational assistance, and paid time off. When the government 
imposes a Federal floor or mandate, it confines or restricts employers' 
discretionary spending on other benefits and current benefit offerings 
are often scaled back to meet that minimum requirement given compliance 
costs incurred as a result of the mandate. Since enactment of the 
Family and Medical Leave Act (FMLA), SHRM members have reported during 
focus groups and other venues that they have in fact scaled back leave 
benefits to meet the added costs and minimum requirements of the FMLA.

    Question 5. You state that the Family and Medical Leave Act (FMLA) 
has been difficult for employers to implement and that the Healthy 
Families Act would be similarly difficult. Employers are already 
required to keep track of the hours that their employees work and our 
paid sick days bill would simply require them to provide 1 hour of paid 
sick time for every 30 hours worked. Employers have the option to 
require medical certification for an absence of more than 3 days, but 
even that option--which is entirely the employer's choice--imposes 
minimal burdens. In a survey, 60 percent of employers said that the 
FMLA took less than 30 minutes per case to request and review. How, in 
your view, would the Healthy Families Act impose an undue burden on 
employers?
    Answer 5. It is true that requests for FMLA leave for the birth, 
adoption or foster care placement of a child impose minimal burden on 
HR professionals and employers and SHRM data supports this assertion. 
In the 2007 SHRM FMLA and Its Impact on Organizations Survey, only 13 
percent of HR professionals reported challenges in administering leave 
under the FMLA for the birth or adoption of a child.
    On the other hand, administering medical leave under the statute 
can prove challenging. Among the problems associated with implementing 
the FMLA are the definition of a serious health condition, intermittent 
leave, and medical certifications. In fact, 47 percent of SHRM members 
responding to the 2007 FMLA Survey reported that they have experienced 
challenges in granting leave for an employee's serious health condition 
as a result of a chronic condition (ongoing injuries, ongoing 
illnesses, and/or non-life threatening conditions). Medical 
certifications that allow for intermittent leave for a chronic, 
episodic condition make managing absenteeism extremely difficult. 
Moreover, vague FMLA rules mean that practically any ailment lasting 3 
calendar days and including a doctor's visit, now qualifies as a 
serious medical condition. Under the HFA, eligible employees could use 
paid sick leave for many broader purposes than the FMLA's serious 
health condition standard.
    As you mention, employers may request a medical certification under 
the HFA, but only if the leave extends for more than 3 consecutive 
workdays. This then would enable an employee to use paid sick leave 
every other day for 2 weeks, without notice, forcing the employer to 
either forgo production or shift that employee's workload to another 
employee.
    Many of the HFA provisions, including intermittent leave, are 
modeled on the FMLA. For example, employees would be able to use HFA 
leave on an intermittent basis, in small increments of time. During the 
Department of Labor's multi-year review of the FMLA regulations, the 
Department reported an explosion in sporadic, unscheduled leave--
particularly the inappropriate use of medical leave--which was never 
envisioned by FMLA's authors. This unfair use of leave created enormous 
challenges for managers of time-sensitive operations such as emergency 
responders, public safety and public health operations run by State and 
local governments, as well as for employers in the transportation and 
communications industries. Allowing paid sick leave to be used on an 
intermittent basis would only exacerbate these challenges, especially 
given that some employees would be eligible to use both HFA and FMLA 
leave on an intermittent basis.

    Question 6. You have raised concerns about the impact of the 
Healthy Families Act on businesses with existing policies that provide 
paid time off that can be used for a variety of purposes. However, the 
Healthy Families Act contains specific language addressing this 
concern, stating that: ``Any employer with a paid leave policy who 
makes available an amount of paid leave that is sufficient to meet the 
requirements of this section and that may be used for the same purposes 
and under the same conditions--as leave provided under the act does not 
have to change their existing policies. This language says that as long 
as an employer provides leave that can be used for illness, caregiving, 
or preventive care--and as long as there are not excessive restrictions 
on when or how employees can use that leave--the employer is not 
impacted by this law at all. Why would responsible businesses with paid 
time off policies object to this law if it requires no change in their 
existing rules?
    Answer 6. SHRM appreciates the efforts the sponsors of the Healthy 
Families Act have made to alter the bill language to address concerns 
regarding paid time off (PTO) plans. As you know, paid time off plans 
are a growing trend among many of the nation's top employers (many of 
which are recognized by Working Mother Magazine and others) because 
they allow for maximum employee flexibility while providing employers 
with certainty and predictability. Yet, despite the above stated 
changes to the HFA, SHRM members are concerned that the HFA could be 
interpreted by regulators in a manner that would disrupt current PTO 
programs, and ultimately force these plans to meet additional 
requirements.
    For example, many employer PTO plans include ``no-fault 
attendance'' policies, whereby an employer may take disciplinary action 
against an employee for failure to adhere to the employer's notice 
requirements for using PTO leave. The HFA, however, prohibits employers 
from taking any negative action that would impact an employee's ability 
to take leave under the act, so it is unclear whether these types of 
PTO plans would meet the HFA requirements.

              Questions of Senator Dodd to Scott Gottlieb

    Question 1. In your written testimony you said that there does not 
seem to be a compelling public policy case for singling out this 
particular flu from others and then you go on to say other flus have 
hit older working-age populations much harder in the past. You also 
said that employment policy does not appear to be the right focus of 
our resources and response. There are 2.1 million births each year to 
women in our workforce. As you know, children have been 
disproportionately affected by this pandemic and most are too young to 
care for themselves. In light of your testimony, what do you think is 
an appropriate response for working parents whose children have become 
infected with H1N1?

    Question 2. You talk in your testimony about vaccine production. 
Can you address what you see as the underlying reasons why the Federal 
Government has continued to rely on older egg-based technology for 
vaccine manufacturing? What obstacles do you see at the Federal level 
to moving to more modern vaccine development process such as cell-
based, recombinant technology?

    [Editor's Note: The response to the above questions was not 
available at time of print.]

        Response to Questions of Senator Enzi by Scott Gottlieb

    Question 1. Dr. Gottlieb, can you please provide the committee with 
specific ways in which Congress can act to improve vaccine production 
capabilities? How can Congress help our manufacturers to increase the 
number of cell-based manufacturing facilities producing flu vaccine?
    Answer 1. First, we need to invest--through Federal grants if 
necessary--in additional facilities for manufacturing flu vaccine, in 
particular cell-based facilities. These plants could be scaled more 
quickly than current manufacturing processes (that depend on culturing 
virus in specially-hatched chicken eggs) to enable rapid production of 
a pandemic vaccine. A certain amount of this production capacity needs 
to be maintained domestically. In a full-blown pandemic, with a very 
deadly strain of flu causing mass casualties, it is hard to envision 
that foreign nations would allow limited supplies of potentially life-
saving vaccines to be shipped outside their borders. The reaction to 
H1N1 demonstrated how quickly international panic can set in, prompting 
governments to take extraordinary and sometimes severe measures. Canada 
and Australia effectively nationalized the facility that the United 
States relied on for its vaccine. In the case of Australia, the 
government pressured vaccine maker CSL Limited to turn over 36 million 
doses of H1N1 vaccine contracted for by the United States and produced 
in an Australian-based manufacturing plant. Meanwhile, in Canada, where 
British drug maker GlaxoSmithKline maintains its U.S.-focused flu 
vaccine facility, the company had to assure the local government that 
Canadians would be served from that manufacturing plant before 
Americans could receive any of their vaccine orders. In a full-blown 
pandemic, we can expect vaccine-manufacturing facilities to be 
nationalized. Yet much of the flu vaccine production capacity exists 
outside the United States. The creation of more domestic capacity for 
rapid vaccine production should be viewed as a strategic asset that we 
need to develop and maintain. But ultimately, we need to move away from 
the current process that relies on the direct culturing of the virus 
for production of vaccine (in order to develop the vaccine antigen) to 
a process that relies on the direct development of the antigen. For 
example, new processes such as recombinant technologies allow the 
manufacture of small fragments of virus (called virus-like particles or 
VPLs rather than relying on collecting and culturing whole copies of 
the virus. This and similar innovations (that don't rely on direct 
culture of the virus itself) can yield more vaccine in shorter periods 
of time--about 10-12 weeks to scale up a big production run of VPLs, 
compared with 26 weeks using an egg-based vaccine or 16 for a cell 
culture. The newer methods give us a better chance to intervene with 
vaccine during the first wave of a pandemic.

    Question 2. Dr. Gottlieb, what would the impact be of approving the 
use of adjuvants in flu vaccines in the United States in terms of 
spreading the supply of the vaccine to reach more people? What are the 
barriers to approving the use of adjuvants in vaccines sold in the 
United States?
    Answer 2. One step to improving our readiness for the future is to 
better integrate the use of vaccine additives, called adjuvants, into 
pandemic planning. An adjuvant is a substance incorporated into a 
vaccine that enhances or directs the immune response of the vaccinated 
patient. Adjuvants are designed to bring the vaccine's antigen into 
contact with the immune system and, therefore, to enhance the magnitude 
of immunity produced as well as the duration of the immune response.
    Novartis and GlaxoSmithKline (GSK), as well as other drug firms, 
completed innovative work incorporating new generations of adjuvants 
into vaccines for H1N1 marketed in Europe during the H1N1 outbreak last 
year. Much of the activity in Europe that enabled countries to deploy 
adjuvant as part of HIN1 vaccines was based on mock-up preparations of 
pandemic vaccines that Europe countries had pre-approved and 
stockpiled. In the United States, our decision to forgo the use of 
adjuvants, which can work to increase the protective effects of a given 
quantity of vaccine, limited our ability to stretch our already 
constrained stock of H1N1 vaccine raw material (the vaccine antigen). 
Ultimately, because the HIN1 virus ended up being less virulent and 
widespread then feared, that limited the vaccine supply that we have 
available, and its delayed availability, does not appear to have 
triggered public health consequences. Indeed, it proved sufficient. But 
in the future, with a more virulent pandemic, we may not be so lucky. 
To improve our readiness, we need to be better prepared to embrace new 
methods. What measures can be taken to improve our process for 
evaluating vaccine adjuvants? First, the FDA should consider creating 
formal guidance on the development and use of adjuvants to help guide 
product developers. The EMEA developed formal guidance on adjuvants 3 
years ago. The document is available on that agency's Web site. The FDA 
does not have a similar guidance document. The United States should 
also consider stockpiling pre-
approved vaccine preparations that could be used in a public-health 
emergency. The country can draw on Europe's ample experience to inform 
this process. Adjuvants are not approved as stand-alone substances 
because they do not always perform the same way with different 
vaccines, types of vaccines, or, in some circumstances, with different 
versions of the same antigen. Nonetheless, the European strategy of 
having pandemic vaccines pre-approved, as mock-ups, was a prudent step.

    Question 3. Dr. Gottlieb, you discussed the impact that ordering 
single-dose shots had on our vaccine supply. Can you think of any other 
country that has ordered both multi-dose and single-dose flu vaccines? 
Why would the U.S. Government order both?
    Answer 3. Each country, as well as the United States, ordered both 
single-dose and multi-dose vaccine. But it has been argued that the 
United States asked manufacturers to shift production toward the 
development of more single-dose vials. Developing these single-dose 
vials required more time, and is blamed for at least some of the delay 
in making available the supply of H1N1 vaccine. One of the concerns 
around the multi-dose vials that led to an apparent decision to pursue 
more single-dose shots, was that the multi-dose vials require the use 
of some preservatives that contain thimerosal, a mercury-containing 
vaccine preservative that continues to stir concern that it can trigger 
childhood autism, even though this association has been firmly 
disproven.

    Question 4. BAKDA was set up to provide incentives for companies to 
manufacture new products that could aid the United States in responding 
to biological, chemical and radiological threats. This mechanism helps 
companies bare the costs associated with moving products through the 
research and development pipeline by assisting with that financial 
burden. This system has worked well for incenting new products but was 
not intended for existing products or technology. The current pandemic 
has highlighted the uncertainties associated with flu vaccine 
production and you have testified about the importance of developing 
newer technologies for producing influenza vaccines if we are to be 
prepared for future epidemics. Is there a need to create some 
incentives for companies that are producing traditional products such 
as influenza vaccine so that we can ensure an adequate and timely 
domestic supply when needed and that the United States can compete 
favorably with other countries when vaccine supplies are needed?
    Answer 4. The technology for developing improved influenza vaccines 
is in development. The stumbling block has always been the demand for 
these products. Vaccines are purchased by public, health entities that 
value lower cost over the kinds of innovation that can lead to improved 
production processes. In addition, they favor vaccines that are 
commoditized and can be used interchangeably, since differentiated 
vaccines are harder to deliver over large populations--for example, 
requiring public health agencies to match a specific vaccine to certain 
groups of patients. We would see more investment in improved vaccines 
and better production processes if we had a predictable demand for 
these products. To these ends, the government should also guarantee the 
annual purchase of a certain amount of seasonal flu vaccine. This would 
enable the industry to reliably forecast demand, spurring investment in 
new facilities that could also be used to produce vaccine in a 
pandemic. The annual procurement should favor vaccines produced in U.S. 
plants and with newer, cell-based methods. The procurement process 
could also favor vaccines with certain technological improvements that 
align with better pandemic preparedness--for example vaccine derived 
from processes that don't require the direct culturing of the virus. 
Purchased vaccine could be distributed domestically, or better still, 
donated to Asian nations such as Vietnam. Flu strains often originate 
in Asia and we rely on local Asian governments to undertake vigorous 
surveillance and share emerging virus strains. Giving them free shots 
would encourage vaccination to reduce spread and give nations more skin 
in global efforts to stem outbreaks.

    Question 5. The FDA is charged with ensuring the safety of drugs, 
devices and medical products. It does so through a variety of 
mechanisms culminating in approval of these products after careful 
review using an external advisory committee as well as internal 
safeguards. This process was shortened during the recent pandemic using 
a mechanism called Emergency Use Authorization so that drugs that had 
not yet completed the process of review but which had a sufficient body 
of evidence to be presumed safe could be released for use in treating 
people hospitalized in intensive care units with pandemic influenza. In 
your testimony you suggested that for novel technologies for critical 
public health needs a closer working relationship might need to be 
developed between FDA and manufacturers to ensure that we have timelier 
access to safe and effective products when we need them. Could you 
elaborate on how that closer working relationship might be structured 
and what hurdles might need to be overcome to put such a process in 
place?
    Answer 5. Often times, FDA has found itself placed in uncomfortable 
roles in moments of public health emergency--where there is a political 
effort to expedite the availability of medical products to respond to a 
crisis. FDA's feedback about the process for validating the safety and 
effectiveness of medical products is vital to the rapid development of 
any countermeasure. At the same time, the FDA believes that its role as 
an independent arbiter of the science places constraints on how much it 
should be involved in discussions and efforts to expedite the 
availability of products, even in moments of crisis. We could benefit 
from a more formal consideration of how this process should work--where 
there is a need for FDA to play a very hands-on role in guiding the 
development of product, but where the agency needs to maintain some 
impartiality in order to maintain its regulatory independence. One 
consideration might be the formalization of a process that maintains 
very separate FDA teams for just such scenarios: one team for working 
with product makers for expediting the development of countermeasures, 
and another team for evaluating the safety and effectiveness of any 
resulting products. If there were a pre-established SOP in place, this 
would provide transparent assurance that components of FDA could be 
engaged in helping to expedite development of a product, while other 
elements in the agency remained far enough removed to maintain their 
impartiality But the bottom line is we should consider how best to 
structure a formal process in advance of the next public health crisis, 
since this challenge exists in perpetuity.

    [Whereupon, at 12:04 p.m., the hearing was adjourned.]

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