[Congressional Record Volume 150, Number 127 (Friday, October 8, 2004)]
[Senate]
[Pages S10861-S10864]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REED (for himself, Mr. Kennedy, Mr. Warner, Mr. Daschle, 
        Ms. Snowe, Mr. Dodd, Mrs. Clinton, Mr. Dorgan, Mr. Bayh, Mr. 
        Schumer, Mr. Johnson, and Mr. Dayton):
  S. 2968. A bill to amend the Public Health Service Act to address the 
shortage of influenza vaccine, and for other purposes; to the Committee 
on Health, Education, Labor, and Pensions.
  Mr. REED. I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2968

       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 ``Emergency Flu Response Act 
     of 2004''.

     SEC. 2. EMERGENCY FLU RESPONSE.

       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--Influenza Vaccine

     ``SEC. 2141. DEFINITION.

       ``In this subtitle, the term `priority group' means a group 
     described as a priority group for vaccination with influenza 
     vaccine in recommendations entitled `Interim Influenza 
     Vaccination Recommendations - 2004-2005 Influenza Season', 
     dated October 5, 2004, or any successor to such 
     recommendations issued by the Secretary.

     ``SEC. 2142. EMERGENCY ACCESS TO INFLUENZA VACCINE.

       ``(a) Declaration of Emergency.--
       ``(1) In general.--Under section 564(b)(1)(C) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
     3(b)(1)(C)), the Secretary shall immediately declare the 
     shortage of influenza vaccine in the United States for the 
     2004-2005 influenza season to be an emergency justifying an 
     authorization for a product under section 564 of such Act (21 
     U.S.C. 360bbb).
       ``(2) Determination.--For the purpose of making 
     determinations under section 564(b)(1)(C) of such Act to 
     carry out paragraph (1), the Secretary--
       ``(A) shall deem the shortage to be a public health 
     emergency described in such section; and
       ``(B) shall deem influenza virus to be a biological agent.
       ``(3) Construction.--Nothing in this subsection shall be 
     considered to invoke the authorities described in section 
     319, or to limit the ability of the Secretary to invoke such 
     authorities.

[[Page S10862]]

       ``(b) Seeking Influenza Vaccine.--The Secretary shall 
     promptly consult with the health ministries of Canada, 
     countries that are members of the European Union as of 
     January 1, 2003, Japan, and Switzerland to assess the 
     availability of influenza vaccine for the 2004-2005 influenza 
     season that--
       ``(1) has been approved, licensed, or otherwise cleared for 
     marketing by the relevant regulatory agency in such a 
     country; and
       ``(2) is in excess of the needs in such country for the 
     vaccination of persons at high risk for complications from 
     influenza.
       ``(c) Issuance of Authorization.--
       ``(1) In general.--The Secretary shall promptly evaluate 
     available influenza vaccine (as identified under subsection 
     (b)) to determine whether the vaccine meets the criteria for 
     issuance of an authorization under section 564(c) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3(c)).
       ``(2) Criteria.--For the purpose of making determinations 
     under section 564(c) of such Act to carry out paragraph (1), 
     the Secretary--
       ``(A) shall deem influenza virus to be an agent that can 
     cause a serious or life-threatening disease or condition; and
       ``(B) shall deem the shortage described in subsection 
     (a)(1) to be sufficient evidence that there is no alternative 
     described in section 564(c)(3).
       ``(d) Vaccine Purchase.--Not later than 30 days after the 
     date of enactment of the Emergency Flu Response Act of 2004, 
     the Secretary shall purchase, at a reasonable price, 
     available influenza vaccine identified under subsection (b) 
     for which the Secretary has issued an authorization under 
     section 564(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bbb-3(c)).
       ``(e) Vaccine Distribution.--Notwithstanding any other 
     provision of law, the Secretary shall promptly import and 
     distribute any influenza vaccine purchased under subsection 
     (d), giving first priority to persons in priority groups.
       ``(f) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal year 2005.

     ``SEC. 2143. EFFECTIVE RESPONSES TO VACCINE SHORTAGES.

       ``(a) In General.--The Secretary shall award a grant to 
     each State to allow such State to develop and implement a 
     plan to respond to the shortage of influenza vaccine in the 
     United States for the 2004-2005 influenza season.
       ``(b) Use of Funds.--A State that receives a grant under 
     this section shall use the funds made available through a 
     grant under subsection (a) to develop--
       ``(1) a voluntary plan to ensure that the influenza vaccine 
     is, to the maximum extent possible, administered to priority 
     groups;
       ``(2) a system to notify health care providers about 
     revisions in guidelines for administering influenza vaccine;
       ``(3) an awareness campaign to inform the public about 
     recommendations concerning groups that are priority groups 
     for vaccination with influenza vaccine; and
       ``(4) procedures to allow for the voluntary donation of 
     vaccine as described in section 2145.
       ``(c) Amount.--The amount of a grant under subsection (a) 
     shall be proportional to the population of the State and the 
     severity of the shortage of influenza vaccine in such State, 
     as determined by the Secretary.
       ``(d) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal year 2005.

     ``SEC. 2144. EFFECTIVE MONITORING OF THE NATION'S INFLUENZA 
                   VACCINE SUPPLY.

       ``(a) Manufacturers.--Not later than 15 days after the date 
     of enactment of the Emergency Flu Response Act of 2004 and 
     every 30 days thereafter, any person who manufactures 
     influenza vaccine for introduction into interstate commerce 
     shall prepare and submit to the Secretary a summary report 
     that lists--
       ``(1) each client, both public and private, who purchased 
     influenza vaccine from the manufacturer during the period 
     covered by the report; and
       ``(2) the number of doses of influenza vaccine sold to each 
     client during the period.
       ``(b) State Public Health Agencies.--To be eligible to 
     receive a grant under section 2143(a), a State through its 
     public health agency shall, not later than 15 days after the 
     date of enactment of the Emergency Flu Response Act of 2004 
     and every 30 days thereafter, prepare and submit to the 
     Secretary a summary report describing--
       ``(1) the number of doses of influenza vaccine available in 
     the State during the period covered by the report;
       ``(2) the number of such doses that were given to each 
     priority group during that period; and
       ``(3) to the extent that such information is readily 
     obtainable by the State, the manner in which such doses were 
     distributed to consumers during such period, such as by 
     distribution through public health agencies or private health 
     care providers.

     ``SEC. 2145. CLEARINGHOUSES FOR VOLUNTARY DONATION OF 
                   INFLUENZA VACCINE.

       ``The Centers for Disease Control and Prevention, and each 
     State public health agency described in section 2144(b), 
     shall establish a clearinghouse to--
       ``(1) enable persons to voluntarily donate influenza 
     vaccine doses; and
       ``(2) distribute the doses for administration to 
     individuals in priority groups.

     ``SEC. 2146. PURCHASES OF INFLUENZA VACCINE.

       ``(a) In General.--The Secretary shall establish a program 
     through which the Secretary may--
       ``(1) purchase from private employers, vaccine wholesalers, 
     and other appropriate individuals and entities, doses of 
     influenza vaccine that are not needed for the vaccination of 
     priority groups; and
       ``(2) distribute the doses purchased under paragraph (1) 
     for administration to individuals in priority areas.
       ``(b) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal year 2005.

     ``SEC. 2147. USE OF INFLUENZA VACCINE.

       ``(a) Executive Branch.--The head of each Executive agency 
     (as defined in section 105 of title 5, United States Code) 
     shall ensure that any influenza vaccine in the possession of 
     the head of the agency shall--
       ``(1) be administered only to employees of the agency who 
     are in priority groups; and
       ``(2) provide to the Secretary any doses of the vaccine 
     that are not needed for the vaccination of individuals in 
     priority groups, so that the Secretary can distribute the 
     doses for administration to individuals in the priority 
     groups.
       ``(b) Legislative Branch.--The Attending Physician of the 
     Capitol shall ensure that any influenza vaccine in the 
     possession of the Attending Physician shall--
       ``(1) be administered only to employees of the legislative 
     branch of the Federal Government who are in priority groups; 
     and
       ``(2) provide to the Secretary any doses of the vaccine 
     that are not needed for the vaccination of individuals in 
     priority groups, so that the Secretary can distribute the 
     doses for administration to individuals in the priority 
     groups.

     ``SEC. 2148. ENHANCING EXISTING COUNTERMEASURES AGAINST 
                   INFLUENZA.

       ``(a) Authorization to Purchase.--The Secretary may, 
     subject to amounts appropriated under subsection (d), 
     purchase at a reasonable negotiated price, such additional 
     amounts of any drug approved by the Commissioner of Food and 
     Drugs to treat influenza as are determined necessary by the 
     Secretary.
       ``(b) Addition to Stockpile.--The Secretary shall include 
     any drug purchased under subsection (a) in the stockpile 
     established under section 121 of the Public Health Security 
     and Bioterrorism Preparedness and Response Act of 2002.
       ``(c) Increasing the Effectiveness of Existing Vaccine 
     Supplies.--The Secretary, acting through the Director of the 
     National Institutes of Health, shall conduct a clinical trial 
     or trials to determine whether influenza vaccine can be 
     diluted and continue to retain its effectiveness in 
     preventing influenza in individuals in priority groups.
       ``(d) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section such 
     sums as may be necessary for fiscal year 2005.

     ``SEC. 2149. NATIONAL QUARANTINE COMPENSATION PROGRAM.

       ``(a) In General.--There is established the National 
     Quarantine Compensation Program to be administered by the 
     Secretary under which compensation shall be paid to 
     individuals who are subjected to an order of quarantine 
     issued by a Federal or State health agency.
       ``(b) Amount.--An individual's compensation under the 
     National Quarantine Compensation Program shall be equal to 
     wages lost as a result of such individual being subjected to 
     the quarantine.
       ``(c) Appropriations.--There are authorized to be 
     appropriated and there are hereby appropriated to carry out 
     subsections (a) and (b) such sums as may be necessary.

     ``SEC. 2150. EMPLOYMENT RIGHTS AND PROTECTIONS RELATING TO 
                   FEDERALLY MANDATED HEALTH-RELATED QUARANTINE.

       ``(a) Definitions.--In this section:
       ``(1) Employer.--The term `employer'--
       ``(A) means any person engaged in commerce or in any 
     industry or activity affecting commerce; and
       ``(B) includes--
       ``(i)(I) any person who acts, directly or indirectly, in 
     the interest of a person described in subparagraph (A) to any 
     of the employees of such person; or
       ``(II) any successor in interest of a person described in 
     subparagraph (A);
       ``(ii) any public agency, as defined in section 3(x) of the 
     Fair Labor Standards Act of 1938 (29 U.S.C. 203(x));
       ``(iii) the Government Accountability Office, the 
     Government Printing Office, and the Library of Congress; and
       ``(iv) all other legislative branch entities identified as 
     employing offices in the Congressional Accountability Act of 
     1995 (2 U.S.C. 1301 et seq.).
       ``(2) Employment benefits.--The term `employment benefits' 
     means all benefits provided or made available to employees by 
     an employer, including group life insurance, health 
     insurance, disability insurance, sick leave, annual leave, 
     educational benefits, and pensions, regardless of whether 
     such benefits are provided by a practice or written policy of 
     an employer or through an employee benefit plan, as defined 
     in section 3 of the Employee Retirement Income Security Act 
     of 1974 (29 U.S.C. 1002).
       ``(3) Secretary.--

[[Page S10863]]

       ``(A) In general.--Except as otherwise provided in 
     subparagraph (B), the term `Secretary' means the Secretary of 
     Labor.
       ``(B) Exceptions.--In the case of actions brought regarding 
     employees--
       ``(i) of the Government Accountability Office, the term 
     `Secretary' means the Comptroller General of the United 
     States;
       ``(ii) of the Government Printing Office, the term 
     `Secretary' means the Public Printer;
       ``(iii) of the Library of Congress, the term `Secretary' 
     means the Librarian of Congress; and
       ``(iv) of any other legislative branch employer, the term 
     `Secretary' means the Office of Compliance.
       ``(b) Employment Rights, Benefits, and Protection from 
     Discrimination.--
       ``(1) Restoration to position.--Any individual subjected to 
     an order of quarantine issued by a Federal or State health 
     agency shall be entitled, on return from such quarantine--
       ``(A) to be restored by the employer of such individual to 
     the position of employment held by the individual when the 
     quarantine of such individual commenced; or
       ``(B) to be restored to an equivalent position with 
     equivalent employment benefits, pay, and other terms and 
     conditions of employment.
       ``(2) Benefits.--An individual restored to such 
     individual's position, or equivalent position, pursuant to 
     paragraph (1) shall be entitled to the seniority and other 
     rights and benefits that the individual had on the date when 
     the quarantine of such individual commenced, plus the 
     additional seniority and rights and benefits that the 
     individual would have attained had the individual not been 
     subjected to a federally mandated health-related quarantine.
       ``(3) Protection from discrimination.--It shall be unlawful 
     for an employer to discharge or in any other manner 
     discriminate against any individual on the basis of such 
     individual's being, or having been, subjected to a federally 
     mandated health-related quarantine.
       ``(c) Investigative Authority; Enforcement.--
       ``(1) In general.--The Secretary shall ensure compliance 
     with the provisions of subsection (b) and enforce violations 
     of subsection (b).
       ``(2) Same authorities.--In order to carry out paragraph 
     (1), the Secretary shall have the same authorities as 
     provided to the Secretary under sections 106 and 107 of the 
     Family and Medical Leave Act of 1993 (29 U.S.C. 209 and 210) 
     to ensure compliance with and enforce violations of the 
     Family and Medical Leave Act of 1993.
       ``(d) State and Local Laws.--Nothing in this section shall 
     be construed to supersede any provision of any State or local 
     law that provides greater rights than the rights established 
     under this section.''.

     ``SEC. 2151. ASSURING THAT INDIVIDUALS IN PRIORITY GROUPS 
                   RECEIVE VACCINES.

       ``(a) Determinations.--Not later than 30 days after the 
     date of enactment of the Emergency Flu Response Act of 2004, 
     and every 30 days thereafter, the Secretary shall review the 
     effectiveness of measures taken under sections 2142 through 
     2147 and determine whether the measures have ensured the 
     distribution of influenza vaccine for administration to 
     individuals in priority groups. If the Secretary determines 
     that the measures have not ensured that distribution, the 
     Secretary--
       ``(1) may take the actions described in subsection (b) if 
     the Secretary determines that such actions are needed to 
     protect the public health; and
       ``(2) shall notify the appropriate committees of Congress 
     of such determination.
       ``(b) Assuring the Individuals in Priority Groups Receive 
     Vaccines.--On making the determination described in 
     subsection (a), the Secretary may require that a person, not 
     including a person that is a manufacturer of influenza 
     vaccine, who possesses influenza vaccine sell such person's 
     supply of the influenza vaccine to the Federal Government, as 
     an exercise of the Federal Government's power to take private 
     property for public use, for just compensation.
       ``(c) Prioritization.--The Secretary shall distribute the 
     doses of influenza vaccine obtained under subsection (b) in a 
     manner determined appropriate by the Secretary to ensure that 
     such vaccine is administered to individual in priority 
     groups.''.
  Mr. KENNEDY. Mr. President, it is a privilege to join Senator Jack 
Reed in introducing the ``Emergency Flu Response Act of 2004.'' I 
commend him for his leadership on this important issue. I also commend 
our colleagues, Senator Bayh and Senator Craig, for their thoughtful 
proposal.
  The Emergency Flu Response Act gives the nation's health agencies the 
tools they need to respond to the current shortage of flu vaccine, to 
protect the public health from the danger of influenza and to maximize 
the value of our reduced vaccine stocks.
  During last year's flu season, we experienced unprecedented public 
demand for the flu vaccine. Fears that last year's flu strain was more 
virulent than those of previous years fueled the public's demand and 
resulted in the administration of all 87 million doses produced. 
Anticipating a similar demand for this upcoming flu season, the two 
companies that manufacture the flu vaccine planned to produce 100 
million doses for the United States.
  On Tuesday, one of those companies lost its license due to 
manufacturing concerns and is unable to ship approximately 48 million 
doses. In one day, America lost about half the country's supply of the 
flu vaccine--and fifteen States have lost their entire supply of 
influenza vaccine for adults.
  Clearly, Congress should take action to strengthen the Nation's 
supply of flu vaccine. My colleagues, Senator Bayh and Senator Craig, 
have offered thoughtful proposals on strengthening the flu vaccine 
supply in future years, and these proposals merit careful consideration 
by Congress. Many members of our Health committee have also shown great 
leadership on vaccine issues.
  Due to the long period of time necessary to produce more vaccine, 
however, measures to increase the supply of new vaccine will have 
little effect on the current shortage.
  We must make every effort to see whether additional flu vaccine can 
be found. The bill requires the Secretary of Health and Human Services 
to seek to purchase additional vaccines available in Europe, Canada or 
Japan, and directs the FDA to review those vaccines using the flexible 
and expedited review process provided under the Project BioShield 
legislation. We should also provide NIH with the resources and the 
clear direction to determine whether existing flu vaccine stocks can be 
diluted and still retain their effectiveness. NIH provided a valuable 
service to the nation by conducting similar studies with smallpox 
vaccine.
  These measures may increase the effective supply of vaccine available 
to the nation, but even these measures may not be sufficient to meet 
the nation's needs. With flu season imminent, Congress must take steps 
immediately to give our health agencies the resources and authority 
they need to make best use of the supply currently available.
  Our health professionals should make sure that those most at risk for 
complications from flu get vaccinated first. We must learn from the 
lessons from last year's flu season and use that knowledge to ensure 
that at Americans at highest risk have priority access to the flu shot.
  We must act quickly. We know that there are 54 million doses 
available and we need to ensure that every one of them reaches those at 
highest risk of complications from flu. The bill provides funding for 
states to develop plans to effectively distribute vaccines to high 
priority groups. It also requires the tracking of available vaccines, 
so that doses can be directed to those who need it most.
  Many employers contract directly with vaccine manufacturers to 
provide a supply of vaccines for their workforce. Our bill establishes 
a vaccine clearinghouse to facilitate the voluntary donation of vaccine 
from individuals or companies with employees at low risk of infection 
to individuals at high risk. Further, this bill gives HHS the ability 
to purchase vaccine back from employers and wholesalers for 
redistribution.
  The Federal government should set an example of good vaccination 
practices. Our bill requires Federal Departments and the Attending 
Physician of the Capitol to abide by CDC recommendations on who should 
receive vaccine. If Members of Congress and their staffs cannot reserve 
flu vaccine for those most in need, how can we ask the American public 
to do so?
  We must also learn from Canada's experience with the SARS outbreak in 
Toronto last year. During that outbreak, many people were forced to 
remain home from work to prevent the spread of SARS. Some lost their 
wages during that time, and some even lost their jobs. Even more 
worrisome is that some people ignored the quarantine orders out of fear 
of repercussions at work. Our bill will assure that those who lose 
wages in complying with a Federal or State quarantine order will be 
fully compensated, and will be protected from losing their employment 
or related benefits.
  Finally, we must recognize that voluntary measures may not be enough 
to

[[Page S10864]]

avert a crisis. For this reason, the legislation gives HHS emergency 
authority to require that vaccine supplies be administered to those in 
highest need if it determines that voluntary measures have failed, and 
that to do otherwise would pose a significant danger to the public 
health.
  Let's not let history repeat itself. We need to be prepared for flu 
vaccine shortages and influenza pandemics in the future, and we need to 
respond effectively to the current shortage. I urge my colleagues to 
support the ``Emergency Flu Response Act of 2004.'' We face a crisis, 
and Congress should not delay in enacting this needed legislation.

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