[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2548 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 2548

To suspend further implementation of the Department of Defense anthrax 
  vaccination program until the vaccine is determined to be safe and 
  effective and to provide for a study by the National Institutes of 
                        Health of that vaccine.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 19, 1999

  Mr. Gilman (for himself, Mrs. Kelly, and Mr. Filner) introduced the 
following bill; which was referred to the Committee on Armed Services, 
   and in addition to the Committee on Commerce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
To suspend further implementation of the Department of Defense anthrax 
  vaccination program until the vaccine is determined to be safe and 
  effective and to provide for a study by the National Institutes of 
                        Health of that vaccine.

    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 ``Department of Defense Anthrax 
Vaccination Moratorium Act''.

SEC. 2. SENSE OF CONGRESS.

    It is the sense of Congress that--
            (1) a single force protection measure such as the mandatory 
        anthrax vaccine immunization program should not be implemented 
        by the Department of Defense without regard for that measure's 
        own effects on morale, retention, recruiting, and budget; and
            (2) an insufficiently proven vaccine should not be 
        advocated as a substitute for research, development, and 
        production of truly effective vaccines and essential 
        antibiotics, adequate personal protective equipment, detection 
        devices, and nonproliferation measures.

SEC. 3. MORATORIUM OF VACCINATION PROGRAM.

    The Secretary of Defense shall suspend implementation of the 
anthrax vaccination program of the Department of Defense. After the 
date of the enactment of this Act, no further vaccination may be 
administered under the program to any member of the Armed Forces except 
in accordance with this Act.

SEC. 4. STUDY BY NATIONAL INSTITUTES OF HEALTH.

    (a) Study.--
            (1) In general.--The Director of the National Institutes of 
        Health shall require the appropriate national research 
        institute to conduct or oversee an independent study of the 
        effectiveness and safety of the vaccine used in the Department 
        of Defense anthrax vaccination program.
            (2) Matters to be studied.--The Director shall include in 
        the study under paragraph (1) determination of the following 
        with respect to that vaccine:
                    (A) Types and severity of adverse reactions.
                    (B) Long-term health implications, including 
                interactions with other (existing and planned) vaccines 
                and medications.
                    (C) Efficacy of the anthrax vaccine for protecting 
                humans against all the strains of anthrax pathogens 
                members of the Armed Forces are likely to encounter.
                    (D) Correlation of animal models to safety and 
                effectiveness in humans.
                    (E) Validation of the manufacturing process 
                focusing on, but not limited to, discrepancies 
                identified by the Food and Drug Administration in 
                February 1998 (especially with respect to the filter 
                used in the harvest of anthrax vaccine, storage times, 
                and exposure to room temperature).
                    (F) Definition of vaccine components in terms of 
                the protective antigen and other bacterial products and 
                constituents.
                    (G) Such other matters as are in the judgment of 
                the Director required in order for the Director to make 
                the determinations required by subsection (b).
            (3) Limitation.--The Director may not use for purposes of 
        the study any data arising from the experience of inoculating 
        members of the Armed Forces with the vaccine studied because of 
        the lack of informed consent and inadequate recordkeeping 
        associated with such inoculations.
    (b) Report.--Upon completion of the study, the Director of the 
National Institutes of Health shall submit to the Committee on 
Government Reform of the House of Representatives and the Committee on 
Governmental Affairs of the Senate and to the Secretary of Defense a 
report setting forth the results of the study. The report shall include 
the Director's determination, based upon the results of the study, as 
to each of the following:
            (1) Whether or not the vaccine used in the Department of 
        Defense anthrax vaccination program has an unacceptably high 
        systemic reaction rate.
            (2) Whether or not the vaccine is effective with respect to 
        noncutaneous transfer of anthrax.
            (3) Whether or not the vaccine will be produced in a manner 
        acceptable to the Food and Drug Administration.

SEC. 5. GENERAL ACCOUNTING OFFICE STUDY.

    (a) In General.--The Comptroller General shall conduct a study of 
the inoculation program referred to in section 3 and of the effect of 
the use of contractor-operated facilities for that program. As part of 
the study, the Comptroller General shall study the following with 
respect to the inoculation program:
            (1) Effects on military morale, retention, and recruiting.
            (2) Civilian costs and burdens associated with lack of 
        military medical care and loss of civilian sick leave and work 
        capacity for members of the reserve components who experience 
        adverse reactions while not in military status.
            (3) A system of accurately recording medical conditions of 
        members of the Armed Forces and other patients before and after 
        inoculation, including off-duty reactions and treatment of 
        reserve component members and including screening for allergens 
        and contraindications, to include prior adverse reactions.
    (b) Public Comment.--The Comptroller General shall publish the 
study under subsection (a) for public comment.
    (b) GAO Review.--The Comptroller General shall review the 
Secretary's written report and provide comments to Congress within 75 
days after the Secretary files the report.

SEC. 6. BOARDS FOR CORRECTION OF MILITARY RECORDS.

    The Secretary of Defense shall direct that the respective Boards 
for Correction of Military Records of the military departments shall, 
upon request by individual members or former members of the Armed 
Forces, expedite consideration of applications for remedies for adverse 
personnel actions (both voluntary and involuntary) that were a result 
of the mandatory anthrax vaccine immunization program, to including 
rescission of court-martial convictions, rescission of administrative 
discharges and separations, rescission of retirements and transfers, 
restoration of flying status, back pay and allowances, expunging of 
negative performance appraisal comments or ratings, and granting of 
physical disability certificates.

SEC. 7. CONTINGENT RESUMPTION OF VACCINATION PROGRAM.

    (a) Contingent Authority for Resumption.--If the Director of the 
National Institutes of Health determines in the report under section 
3(b) that the vaccine used in the anthrax vaccination program of the 
Department of Defense meets each of the criteria stated in subsection 
(b), the Secretary of Defense may resume the Department of Defense 
anthrax vaccination program. Any such resumption may not begin until 
the end of the 90-day period beginning on the date of the submission of 
the report under section 3(b).
    (b) Criteria for Program Resumption.--The criteria referred to in 
subsection (a) are the following:
            (1) That the vaccine used in the Department of Defense 
        anthrax vaccination program does not have an unacceptably high 
        systemic reaction rate.
            (2) That the vaccine is effective with respect to 
        noncutaneous transfer of anthrax.
            (3) That the vaccine will be produced in a manner 
        acceptable to the Food and Drug Administration.
    (c) Requirement for Use of New Vaccine.--If the anthrax vaccination 
program is resumed under subsection (a), the Secretary of Defense may 
only use newly produced vaccine for vaccinations after the resumption 
of the program.
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