To amend the Public Health Service Act to address the shortage of influenza vaccine, and for other purposes.

November 19, 2004

Mrs. LOWEY (for herself, Mr. VAN HOLLEN, Mr. BISHOP of New York, and Mr. ISRAEL) introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Public Health Service Act to address the shortage of influenza vaccine, and for other purposes.

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.

`(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-

`(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.'.

END