[Congressional Record Volume 151, Number 8 (Tuesday, February 1, 2005)]
[Senate]
[Pages S741-S742]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DeWINE (for himself and Mrs. Clinton):
  S. 226. A bill to amend the Public Health Service Act to improve 
immunization rates by increasing the supply of vaccines; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. DeWINE. Mr. President, I rise today, along with my colleague from 
New York, Senator Clinton, to introduce the Improved Vaccine Supply 
Act--a bill that would help ensure that our Nation's public health 
system has an adequate vaccine supply.
  We all know that vaccinations are critical in our efforts to keep our 
population, particularly children and the elderly, healthy. They are 
key to protecting the elderly from influenza during flu season and 
protecting children from contracting polio or the mumps. Vaccinations, 
inoculations, immunizations--whatever you want to call them--also help 
lessen the threat of bacterial or viral infections and potential 
disease outbreaks.
  Currently, it is recommended that children receive 12 routine 
vaccinations against preventable diseases. These vaccinations are given 
in a series of shots and booster shots by the age of two, with an 
additional four doses later in life. This ends up being about 16 to 20 
doses of vaccines for children.
  Any shortage of vaccines is not acceptable, and we should do all we 
can to prevent any future shortage. As a Senator, and more importantly, 
as a parent of eight and grandparent of eight, I believe that nothing 
is more important than the health and safety of our children. While we 
are not currently experiencing a shortage, we know that the vaccine 
market is unstable and unpredictable. According to the Centers for 
Disease Control's National Immunization Program, there were several 
reasons for the shortages in past years. The CDC concluded and posted 
on its website that the ``reasons for these shortages were multi-
factorial and included companies leaving the vaccine market, 
manufacturing or production problems, and insufficient stockpiles.''
  The CDC did as good a job as it could, considering the vaccine 
shortages our Nation has faced in past years. The agency's website has 
posted information about shortages and released revised vaccine 
schedules to keep our public informed and knowledgeable about 
vaccination shortages. But, even with the strong efforts of the CDC, we 
need to work toward preventing a future vaccine shortage. We need a 
more permanent solution. The bill I am introducing will go a long way 
toward doing just that.
  The bill we are introducing today--the Improved Vaccine Supply Act--
would help bring some stability to our fragile vaccine supply. Unlike 
drug manufacturers, vaccine manufacturers do not have to give notice 
when they stop making a vaccine, whether the vaccine is withdrawn from 
the market intentionally or because the manufacturer is simply unable 
to continue making the vaccine. Essentially, these manufacturers leave 
the marketplace with no notice and no warning. Most doctors and 
hospitals--and more importantly parents and older adults--often have no 
idea that a vaccine is in short supply until they line up for a flu 
shot or go to the doctor for their child's immunizations.
  Our bill would change this. It would require any manufacturer of a 
vaccine to give a one-year notice of discontinuance. By giving notice, 
the Centers for Disease Control (CDC) and the Food and Drug 
Administration (FDA) would be better able to ensure an adequate vaccine 
supply for our Nation's population. Additionally, our bill would 
require all drug and vaccine manufacturers to give notice when they 
withdraw from the market. This change would ensure that we have a 
better sense of who is making vaccines and drugs and would allow the 
CDC and FDA to monitor the manufacturer's production and release of 
vaccines.
  Let me explain why this is important. Vaccines, or biological 
products, are difficult to develop and manufacture. They are more 
complex than drugs. Because of this, it takes longer for a biological 
product to reach the market. For example, a pharmaceutical company that 
manufactured tetanus vaccine stopped producing it, leaving only one 
company to produce tetanus vaccine for the entire country. The 
remaining company increased production to accommodate all of the needs 
of the United States. Despite this, it still required about 11 months 
for the vaccine to be ready for release. In other words, it took 11 
months for the company to ramp-up production to meet demand. Our bill 
would create a notification mechanism to capture those drugs and 
vaccines leaving the market so we can avoid future vaccine and drug 
shortages.
  Our bill also would require the Secretary, acting through the CDC, to 
develop a plan for the purchase, storage, and rotation of a supply of 
vaccines sufficient to provide routinely recommended vaccinations for a 
six-month period for children and adults. Essentially, it would create 
a framework for the CDC to develop a national vaccine stockpile to 
ensure that childhood vaccine shortages simply do not occur.
  Our children need and deserve timely vaccinations. When childhood 
vaccinations are in short supply or are unavailable, they do without, 
living unprotected against disease. That should never happen. The bill 
we are introducing today is another step toward ensuring that children 
get the vaccines they need and that they get them at the right time. I 
urge my colleagues to join me in support of this important public 
health legislation.
  I ask unanimous consent that the text the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 226

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Improved Vaccine Supply 
     Act''.

     SEC. 2. SUPPLY OF VACCINES.

       Title XXI of the Public Health Service Act (42 U.S.C. 
     300aa-1 et seq.) is amended by adding at the end the 
     following:

                 ``Subtitle 3--Adequate Vaccine Supply

     ``SEC. 2141. SUPPLY OF VACCINES.

       ``(a) In General.--
       ``(1) Plan.--Not later than 6 months after the date of 
     enactment of this section, the Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     shall develop a plan for the purchase, storage, and rotation 
     of a supply of vaccines sufficient to provide routinely 
     recommended vaccinations for a 6-month period for--
       ``(A) a national stockpile of vaccines for all children as 
     authorized under section 1928(d)(6) of the Social Security 
     Act (42 U.S.C. 1396s(d)(6)); and
       ``(B) adults.
       ``(2) Supply.--The supply of vaccines under paragraph (1) 
     shall--
       ``(A) include all vaccines routinely recommended for 
     children by the Advisory Committee on Immunization Practices; 
     and
       ``(B) include all vaccines routinely recommended for adults 
     by the Advisory Committee on Immunization Practices.
       ``(3) Supply authority.--The Secretary shall carry out--
       ``(A) paragraph (2)(A) using the authority provided for 
     under section 1928(d)(6) of the

[[Page S742]]

     Social Security Act (42 U.S.C. 1396s(d)(6)); and
       ``(B) paragraph (2)(B) using--
       ``(i) the authority provided for under section 317; and
       ``(ii) any other authority relating to the vaccines 
     described in such paragraph.
       ``(b) Submission of Plan.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall submit the 
     plan developed under subsection (a) to--
       ``(A) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(B) the Committee on Finance of the Senate; and
       ``(C) the Committee on Energy and Commerce of the House of 
     Representatives.
       ``(2) Inclusions.--The plan shall include a discussion of 
     the considerations that formed--
       ``(A) the basis for the plan; and
       ``(B) the prioritization of the schedule for purchasing 
     vaccines set forth in the plan.
       ``(c) Implementation of the Plan.--Not later than September 
     30, 2007, the Secretary shall fully implement the plan 
     developed under subsection (a).
       ``(d) Notice.--
       ``(1) In general.--For the purposes of maintaining and 
     administering the supply of vaccines described under 
     subsection (a), the Secretary shall require by contract that 
     the manufacturer of a vaccine included in such supply provide 
     not less than 1 year notice to the Secretary of a 
     discontinuance of the manufacture of the vaccine, or of other 
     factors, that may prevent the manufacturer from providing 
     vaccines pursuant to an arrangement made to carry out this 
     section.
       ``(2) Reduction of period of notice.--The notification 
     period required under paragraph (1) may be reduced if the 
     manufacturer certifies to the Secretary that good cause 
     exists for reduction, under the conditions described in 
     section 506C(b) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356c).
       ``(e) Proceeds.--Any proceeds received by the Secretary 
     from the sale of vaccines contained in the supply maintained 
     pursuant to this section, shall be available to the Secretary 
     for the purpose of purchasing additional vaccines for the 
     supply. Such proceeds shall remain available until expended.
       ``(f) Ongoing Reports.--
       ``(1) In general.--Not later than 2 years after submitting 
     the plan pursuant to subsection (b), and periodically 
     thereafter, the Secretary shall submit a report to the 
     Committees identified in subsection (b)(1) that--
       ``(A) details the progress made in implementing the plan 
     developed under subsection (a); and
       ``(B) notes impediments, if any, to implementing the plan 
     developed under subsection (a).
       ``(2) Recommendation.--The Secretary shall include in the 
     first of such reports required under paragraph (1)--
       ``(A) a recommendation as to whether the vaccine supply 
     should be extended beyond the 6-month period provided in 
     subsection (a); and
       ``(B) a discussion of the considerations that formed the 
     recommendation under subparagraph (A).
       ``(g) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for each of fiscal years 2006 
     through 2011.''.
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