Mercury-Free Vaccines Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to provide that a vaccine is a banned mercury-containing vaccine if one dose of the vaccine contains 1 or more micrograms of mercury in any form.
Authorizes the Secretary of Health and Human Services to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period.
Requires the Secretary to prohibit the distribution of banned mercury-containing influenza vaccines that are approved as biological products to: (1) any child under the age of three years old (effective July 1, 2006); (2) pregnant women if the vaccine contains thimerosal (effective July 1, 2006); and (3) any child under the age of six (effective July 1, 2007).
Requires the Secretary to revise the vaccine information included with mercury-containing vaccines to include: (1) a statement that indicates the presence of mercury in the vaccine; (2) information on the availability of any mercury-free or mercury-reduced alternative vaccine and instructions on how to obtain such an alternative vaccine; and (3) a recommendation against administration of any mercury-containing vaccine to a pregnant woman.
Expresses the sense of Congress that the Centers for Disease Control and Prevention (CDC) should disseminate, with any vaccine-related information, a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 881 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 881
To amend the Federal Food, Drug, and Cosmetic Act to reduce human
exposure to mercury through vaccines.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 17, 2005
Mr. Weldon of Florida (for himself and Mrs. Maloney) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to reduce human
exposure to mercury through vaccines.
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 ``Mercury-Free Vaccines Act of 2005''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) In July 1999, the Public Health Service and the
American Academy of Pediatrics issued a joint statement, which
was later endorsed by the American Academy of Family
Physicians, proclaiming: ``[The] Public Health Service, the
American Academy of Pediatrics, and vaccine manufacturers agree
that thimerosal-containing vaccines should be removed as soon
as possible. Similar conclusions were reached this year in a
meeting attended by European regulatory agencies, the European
vaccine manufacturers, and the US FDA which examined the use of
thimerosal-containing vaccines produced or sold in European
countries.''.
(2) In July 2000, the Public Health Service, the Advisory
Commission on Immunization Practices, the American Academy of
Pediatrics, and the American Academy of Family Physicians
issued a joint statement, providing: ``The AAFP, [the] AAP, and
the PHS in consultation with the ACIP reaffirm the goal set in
July 1999 to remove or greatly reduce thimerosal from vaccines
as soon as possible for the following reasons: 1) the removal
or substantial reduction of thimerosal from vaccines is
feasible, 2) the progress in removal which has been made to
date is substantial, 3) the discussions between the Food and
Drug Administration and the vaccine manufacturers in removing
thimerosal are ongoing, and 4) the public concern about the use
of mercury of any sort remains high. Based on information from
the FDA and manufacturers, the PHS projects that the United
States will complete its transition to a secure routine
pediatric vaccine supply free of thimerosal as a preservative
(i.e. at least two vaccine products each for Hep B, Hib, and
DTaP) by the first quarter of 2001.''.
(3) The Institute of Medicine's Immunization Review
Committee concluded that significant reasons existed for
continued public health attention to concerns about thimerosal
exposure and neurodevelopmental disorders and recommended the
removal of thimerosal from vaccines administered to children
and pregnant women.
(4) Federal regulatory agencies and manufacturers have
taken positive steps to remove thimerosal from some medical
products, most notably routinely administered childhood
vaccines.
(5) Considerable progress has been made in reducing mercury
exposures from childhood vaccines, yet 5 years after the July
1999 statement, thimerosal remains in several nonroutinely
administered childhood vaccines and many pediatric and adult
influenza vaccines.
(6) There is no law or regulation to prohibit the
reintroduction of thimerosal into any products from which it
has been removed, leaving open the possibility that it may be
reintroduced at some point in the future in new vaccines or
vaccines from which it has already been removed.
(7) The Environmental Protection Agency has estimated that
as many as 1 in 6 infants are born with a blood mercury level
that exceeds the Agency's safety threshold.
(8) Cumulative exposures to mercury, a neurotoxin, are
known to cause harm, particularly in young children and
pregnant women.
(9) Taking steps to reduce mercury exposures through
vaccines is an important way to reduce direct exposures to
mercury and mercury compounds.
SEC. 3. BANNED MERCURY-CONTAINING VACCINES.
(a) Prohibition.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the
following:
``(j) If it is a banned mercury-containing vaccine under section
351B of the Public Health Service Act.''.
(b) Amendment to PHSA.--Title III of the Public Health Service Act
(42 U.S.C. 241 et seq.) is amended by inserting after section 351A the
following:
``SEC. 351B. BANNED MERCURY-CONTAINING VACCINES.
``(a) In General.--For purposes of section 501(j) of the Federal
Food, Drug, and Cosmetic Act, and subject to subsection (b), a vaccine
is a banned mercury-containing vaccine under this section if 1 dose of
the vaccine contains 1 or more micrograms of mercury in any form.
``(b) Public Health Emergency Exception.--
``(1) Exception.--Subsection (j) of section 501 of the
Federal Food, Drug, and Cosmetic Act shall not apply to a
vaccine during the effective period of a declaration issued by
the Secretary for such vaccine under this subsection.
``(2) Declaration.--The Secretary may issue a declaration
concluding that an actual or potential bioterrorist incident or
other actual or potential public health emergency makes
advisable the administration of a vaccine described in
subsection (a) notwithstanding the mercury content of such
vaccine.
``(3) Limitation.--The Secretary--
``(A) shall specify in any declaration under this
section the beginning and ending dates of the effective
period of the declaration; and
``(B) may not specify any such effective period
that exceeds 12 months.
``(4) Renewals.--At the end of the effective period of any
declaration under this section, the Secretary, subject to
paragraph (3), may issue another declaration for the same
incident or public health emergency.
``(5) Publication.--The Secretary shall promptly publish
each declaration under this section in the Federal Register.
``(c) Effective Dates.--This section applies only to the
introduction, or delivery for introduction, of a banned mercury-
containing vaccine into interstate commerce on or after the earlier of
the following:
``(1) July 1, 2006, if the vaccine is listed in the
January-June 2005 version of the recommended childhood and
adolescent immunization schedule of the Centers for Disease
Control and Prevention (other than an influenza vaccine).
``(2) January 1, 2009.''.
SEC. 4. RESTRICTIONS ON ADMINISTRATION OF MERCURY-CONTAINING INFLUENZA
VACCINES TO CHILDREN AND PREGNANT WOMEN.
(a) Application.--This section applies only to a vaccine that--
(1) is a banned mercury-containing vaccine (as that term is
defined in section 351B(a) of the Public Health Service Act (as
amended by section 3));
(2) is an influenza vaccine; and
(3) is manufactured for use in the 2006-2007 influenza
season or any subsequent period.
(b) Restrictions on Administration of Vaccine to Children.--Any
approval by the Secretary of Health and Human Services of a biologics
license under section 351 of the Public Health Service Act (42 U.S.C.
262) for any vaccine described in subsection (a) shall provide that
such vaccine is being approved as a biological product subject to
subpart H of part 314 of title 21, Code of Federal Regulations (or any
successor regulations). Under such subpart H, the Secretary shall
establish the following restrictions on the distribution of the
vaccine:
(1) Effective July 1, 2006, the vaccine shall not be
administered to any child under the age of 3 years old.
(2) Effective July 1, 2006, if the vaccine contains
thimerosal, the vaccine shall not be administered to any
pregnant woman.
(3) Effective July 1, 2007, the vaccine shall not be
administered to any child under the age of 6 years old.
(c) Transitional Provision.--In the case of a biologics license
under section 351 of the Public Health Service Act (42 U.S.C. 262) that
was approved before the date of the enactment of this Act for a vaccine
described in subsection (a)--
(1) at the request of the holder of the license, the
Secretary shall modify the license to include the restrictions
described in subsection (b); or
(2) if the holder of the license fails to submit such a
request, the Secretary shall revoke the license as applied to
vaccines manufactured for use in the 2006-2007 influenza season
or any subsequent period.
(d) Public Health Emergency Exception.--This section shall not
apply to a vaccine during the effective period of a declaration issued
by the Secretary for such vaccine under section 351B(b) of the Public
Health Service Act (as amended by section 3).
SEC. 5. INFORMATION ON MERCURY CONTENT.
Section 2126 of the Public Health Service Act (42 U.S.C. 300aa-26)
is amended by adding at the end the following:
``(e) Mercury Content.--Not later than 2 months after the date of
the enactment of this subsection, the Secretary shall revise the
vaccine information materials developed and disseminated under this
section to ensure that, in the case of any vaccine described in
subsection (a) that contains mercury, the materials include--
``(1) a statement indicating the presence of mercury in the
vaccine;
``(2) information on the availability of any mercury-free
or mercury-reduced alternative vaccine and instructions on how
to obtain such alternative vaccine; and
``(3) a recommendation against administration of any
mercury-containing vaccine to a pregnant woman.''.
SEC. 6. SENSE OF CONGRESS.
It is the sense of the Congress that the Director of the Centers
for Disease Control and Prevention should include, in any information
disseminated by the Centers to the public or to health care providers
relating to the administration of vaccines, a recommendation against
administration of any thimerosal-containing vaccine to a pregnant
woman.
SEC. 7. REPORT TO CONGRESS.
Not later than 1 year after the date of the enactment of this Act,
and annually thereafter, the Commissioner of Food and Drugs shall
submit a report to the Congress annually on the progress of the
Commissioner in removing mercury from vaccines.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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