[Congressional Record Volume 151, Number 129 (Thursday, October 6, 2005)]
[Senate]
[Pages S11220-S11222]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. CLINTON (for herself and Mr. Roberts):
  S. 1828. A bill to amend the Public Health Service Act to improve and 
secure an adequate supply of influenza vaccine; to the Committee on 
Health, Education, Labor, and Pensions.
  Mrs. Clinton. Mr. President, today, I am pleased to introduce the 
Influenza Vaccine Security Act with Senator Roberts.
  In recent months, our public health professionals have been sounding 
the alarm about the increasing incidence of avian influenza. Since 
December 2004, 70 cases of avian influenza have been confirmed in 
Indonesia, Vietnam, Thailand and Cambodia--and 27 of these cases have 
been fatal. In countries across Asia and Europe, farmers have been 
culling their poultry stocks because of fears of infection.
  Various agencies--from the Department of State to the Department of 
Health and Human Services--have begun to mobilize in preparation for 
when--not if, but when--avian influenza hits our shores.
  What is particularly worrisome to me, when thinking about our 
Nation's ability to face the threat posed by pandemic or avian 
influenza, is the fact that we aren't even prepared to deal with the 
seasonal influenza epidemic that we face every year.
  Last fall, we witnessed senior citizens lining up for hours to obtain 
flu vaccine, unscrupulous distributors attempting to sell scarce 
vaccine to the highest bidder, and millions of Americans delaying or 
deferring necessary flu shots.
  This wasn't the first time that our vaccine production and 
distribution system has failed. Since 2000, our Nation has experienced 
three shortages of influenza vaccine.
  Fortunately, we had a relatively mild influenza season this past 
year, but we cannot count on such luck to save us every time we have a 
flu vaccine shortage.
  Approximately 36,000 Americans die of the flu each year, and these 
deaths are largely preventable--we could stop them if we increased 
immunizations, if we had a secure vaccine market, and if we made sure 
that everyone understood the importance of vaccines.

[[Page S11221]]

  For several years now, I've been asking the Secretary of Health and 
Human Services to undertake reforms to fix our flu vaccine supply 
problems, and the legislation I'm introducing with Senator Roberts 
today provides a mechanism through which we can develop a stable supply 
and distribution system for our seasonal flu vaccine.
  There is a great deal of risk involved with developing an annual flu 
vaccine. Because the dominant strain changes from year to year, 
manufacturers must develop doses on an annual basis, without being able 
to store or resell any excess vaccine the following year. There's also 
no steady demand for a flu vaccine, largely because shortages have 
confused so many of us as to when we should or shouldn't get 
vaccinated.

  This legislation will help create a stable flu vaccine market for 
manufacturers by increasing coordination between the public and private 
sectors, so that we can set targets and procedures for dealing with 
both shortages and surpluses before they hit.
  Stabilizing the vaccine market will also require increasing demand 
for vaccination. This bill increases the funding for the CDC's 
educational initiatives, and sets up grants through which State and 
local health departments, in collaboration with health care 
institutions, insurance companies, and patient groups, can increase 
vaccination rates among all Americans, but, in particular, priority 
populations.
  Another major problem with our national influenza supply mechanisms 
is that we rely on production methods that haven't kept pace with our 
other biomedical advances. In order to make a vaccine, strains of 
influenza virus are cultivated in chicken eggs, a non-sterile 
environment. Many of the contamination problems we have seen with 
vaccine result when problems arise in this cultivation process.
  Although we've got to rely on this technology for the time being, we 
need to increase research into safer, faster, and more reliable methods 
of vaccine production. This legislation would provide the National 
Institutes of Health with increased funding for research into 
alternative forms of vaccine development.
  Of course, vaccine does us no good if it can't get to the people who 
need it, and in last season's epidemic, we had problems matching 
existing stocks of vaccine to the high priority populations, like 
senior citizens, who were in need of vaccine. It took weeks before we 
could determine how much vaccine was actually in communities, and where 
it was needed. We wasted lots of time and resources--valuable public 
health resources--in trying to track this vaccine.
  This bill sets up a tracking system through which the CDC and State 
and local health departments can share the information they need to 
ensure that high priority populations in all parts of the country will 
have access to vaccine.
  Improving our system for vaccine manufacture and distribution will 
not only help us in the event of a pandemic, but will help us every 
winter when senior citizens, children, and chronically ill individuals 
need to get a flu shot to protect them from the virus.
  I hope that the legislation Senator Roberts and I are introducing 
today will call attention to the immediate needs of our priority 
populations, and I look forward to working with our colleagues in the 
Senate on both seasonal and pandemic prevention initiatives.
  Mr. ROBERTS. Mr. President, I am pleased to be introducing the 
Influenza Vaccine Security Act with Senator Clinton today because I 
believe this legislation is critical to strengthening our public health 
preparedness here in the U.S. The experiences of the flu vaccine 
shortage last year made us all aware that our system needs improvement. 
This legislation takes a comprehensive approach to addressing the root 
causes of seasonal flu vaccine shortages by creating stability in the 
U.S. vaccine market.
  Our legislation requires the Department of Health and Human Services 
to set annual production targets for the flu vaccine, to stockpile up 
to 10 percent of the vaccine each year in the event of a shortage, and 
to create a vaccine buyback program to provide market guarantees for 
our vaccine manufacturers. This legislation also provides a much-needed 
framework for public health officials to track vaccines and provides 
increased education and outreach about getting an annual flu vaccine.
  I now want to turn to some of the provisions in this legislation that 
deal with an issue I believe deserves our utmost attention: pandemic 
influenza. I think we can agree that we all learned a good lesson from 
Hurricane Katrina: government at all levels must be prepared to deal 
with a large-scale public health emergency. Unfortunately, our 
government is not currently not prepared to deal with pandemic 
influenza. Our legislation seeks to address this by strengthening the 
underlying public health infrastructure to heighten our ability to 
respond to both seasonal and pandemic flu.
  As Chairman of the Senate Intelligence Committee and a member of both 
the Senate Agriculture Committee and Senate Health, Education, Labor 
and Pensions (HELP), I take the threat of an influenza pandemic very 
seriously. I view it as not only a public health concern, but a 
national security concern. The timing for a large-scale worldwide 
influenza outbreak is ripe. Many experts believe the next flu pandemic 
will come in the form of avian flu.
  Unlike the seasonal flu, humans have no natural immunity to avian 
flu. A routine flu shot for more common influenza viruses won't protect 
against the deadly avian flu. The Department of Health and Human 
Services is working with vaccine manufacturers to develop a vaccine, 
but it is unclear when and how many doses will be ready.
  Other than a vaccine, the only defense against a new flu strain such 
as avian flu is an antiviral medication such as Tamiflu. Currently, the 
United States currently only has enough pills to treat less than one 
percent, or about 2.3 million people.
  This is why experts believe the effects of avian flu in the U.S. and 
around the world could be devastating. Some have predicted the loss of 
life could reach as high as 160-200 million. A pandemic might infect a 
third of the U.S. population and cost more than $100 billion alone in 
medical treatments. A pandemic of this sort could also have 
catastrophic economic or social effects.
  It is for these reasons I am pleased our legislation addresses some 
of the underlying public health infrastructure concerns that can help 
us effectively respond to pandemic flu. Our vaccine industry here in 
the U.S. is extremely fragile and our manufacturers need the necessary 
tools to effectively produce and deliver vaccines in the event of 
either seasonal or pandemic flu. First and foremost, our legislation 
ensures vaccine manufacturers and health care providers are not held 
liable in the event of a public health emergency involving pandemic 
influenza. Without this necessary liability protection, the ability to 
develop or deliver a vaccine during an outbreak could be significantly 
hampered.
  Our legislation also encourages improved technologies for influenza 
vaccine development by providing additional funding for NIH research 
into alternative methods of vaccine development, such as cell-based 
cultures and a permanent flu vaccine. Currently, flu vaccine production 
is a strenuous process and takes several months, leaving us extremely 
vulnerable in the event of a large-scale outbreak and a subsequent need 
for a mass production of vaccines.
  Our legislation encourages more companies to enter the U.S. market 
with domestic-based production facilities and to improve the ability of 
the current manufacturers to remain in the market. Manufacturers 
currently do not have the capacity to simultaneously produce enough flu 
vaccine for seasonal flu and an avian flu vaccine in the event of an 
outbreak. We must assist our manufacturers in increasing production 
capacity.
  Aside from vaccines, our legislation also requires the government to 
purchase and store additional antiviral medications, such as Tamiflu, 
to protect against an influenza epidemic.
  Finally, our legislation provides a framework to identify public 
health professionals that can provide services in the event of a public 
health emergency through the use of a medical personnel registry linked 
at the Federal, State and local levels.

[[Page S11222]]

  I am pleased to introduce the Influenza Vaccine Security Act with 
Senator Clinton today. We need to fix our seasonal flu vaccine 
production and distribution problems not only to prevent future 
shortages, but also to strengthen our public health infrastructure in 
case of pandemic.
  As Senator Clinton knows, the HELP Committee will soon be considering 
legislation to develop countermeasures to protect the U.S. from 
deliberate and natural public health threats. This legislation, known 
as Bioshield II, will present a great opportunity to build on the first 
steps we take in this legislation to protect against pandemic flu. I 
look forward to working with Senator Clinton and my other colleagues on 
the committee to deliver a comprehensive package to ensure we are 
prepared and can respond to all types of public health threats.
                                 ______