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The Fair Labeling and
Informed Consent Act (Introduced in House) HR XXXX
110th CONGRESS
H. R. XXXX
IN THE HOUSE OF REPRESENTATIVES
xx (month) yy (day), 2008
Mr. xxxx introduced the following amendment to the [Federal Food, Drug
and Cosmetic Act], which was referred to the Committee on [Energy and
Commerce]
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A BILL
To amend labeling requirements and informed consent procedures for all
vaccines and medical products using aborted fetal material in any form
including but not limited to cells, cell lines, tissues, DNA, recombinant
DNA, monoclonal antibodies, blood, proteins or components thereof, in
manufacturing or development.
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 ‘F.L.I.C.A.’
SEC. 2. PURPOSES.
It is the purpose of this Act to--
(1) require the manufacturers and distributors
to provide information if the development or manufacture of their product
uses aborted fetal material in any form including but not limited to cells,
cell lines, tissues, DNA, recombinant DNA, monoclonal antibodies, blood,
proteins or components thereof, in manufacturing or development.
(2) specifically, require the manufacturers and
distributors to provide such information the product label; and
(3) require the revision of the Vaccine
Information Statement (VIS) currently provided under 42 USC, § 300AA-26,
prior to vaccination, to include the information as described in (1).
4) protect the legal right of patients to give
their valid informed consent by requiring that attending physicians, nurses,
midwives, pharmacists or any other health care provider with the appropriate
knowledge, shall provide all such information to patients before dispensing
any product or treatment that contains human cell lines, tissues, proteins,
DNA, recombinant DNA, monoclonal antibodies or any other components derived
from elective abortion by amending the Vaccine Information Sheet. (VIS) as
required under 42 USC § 300AA-26.
5) protect the legal right of physicians,
nurses, midwives, pharmacists or any other health care professional to
receive and provide valid informed consent for themselves and their patients
prior to purchasing or dispensing any product or treatment that contains
human cell lines, tissues, proteins, DNA, recombinant DNA, monoclonal
antibodies or any other components derived from elective abortion, by
amending the manufacturer package insert and VIS.
6) protect the civil rights of all such
individuals when the use of such drugs and vaccinations would violate a
person’s religious or moral convictions; and to prohibit all forms of
discrimination, coercion, or liability upon such persons by reason of such
refusal.
SEC 3: ENACTMENT
a) Revision
of Package Insert (See Sec. 7 Addendum 1.)
All vaccines and medical
products using aborted fetal material in any form including but not limited
to cells, cell lines, tissues, DNA, recombinant DNA, monoclonal antibodies,
blood, proteins or components must include the term “from elective
abortion” in the package insert description, immediately following these
ingredients.
b) Revision of the Federal Food, Drug and
Cosmetic Act, 502 (e) to the end of paragraph (iii) the word
“and”, followed by new paragraph:
(iv) the term “from
elective abortion” must appear next to any ingredients including, but
not limited to human cell lines, tissues, proteins, DNA, recombinant DNA,
monoclonal antibodies or any other components that take their origin in
elective abortion.
c) Revision of Vaccine
Information Statement (VIS) to include section of Informed Consent on any
product using aborted fetal materials as described in Paragraph (a) (See
Sec. 7 Addendum 2)
d) Revision of US Code: 42
USC §300aa-26, paragraph (c) ‘Information requirements’
(4) a statement of
Informed Consent when aborted fetal materials are used in any current or
future vaccines or drugs, and
e)
Revision of US Code: 42 USC §300aa-26 to add paragraph (e)
(E) VIS shall be
prepared and required for all vaccines or drugs utilizing aborted fetal
materials as described in Section (a).
SEC. 4: CURRENT POLICY
a) It is the current
policy of the United States through the Federal Food and Drug and
Administration to provide information on the ingredients in the labeling of
all prescription and non-prescription drugs including, but not limited to
the descriptions found in the Code of Federal Regulations 21 CFR Part 201,
Labeling and 42 USC, § 300aa-26 and the Federal Food, Drug and Cosmetic
Act, 502 (e).
b) In accordance with such
procedures of 21 CFR 201.56 and 201.57, all prescription and
non-prescription drugs and vaccinations must be labeled in the required
format to include: “Description”, “Clinical Pharmacology”, “Indications and
Usage”, “Warnings”, “Precautions”, “Adverse Reactions”, “Drug Abuse and
Dependence”, “Overdose”, Dosage and Administration and “How Supplied”.
Section 201.57 specifies the exact information that is required to appear in
these sections.
c) It is the current
policy of the United States under US Code, Title 15, Chapter 39, §1451 that,
‘Informed consumers are essential to the fair and efficient functioning of a
free market economy. Packages and their labels should enable consumers to
obtain accurate information and should facilitate value comparisons.
Therefore, it is hereby declared to be the policy of the Congress to assist
consumers and manufacturers in reaching these goals in the marketing of
consumer goods.”
d) It is the current
policy of the United States under USC 42 § 289g–1 (c) and (g) to provide
informed consent to researchers whenever fetal tissue or such cell
components are used in research projects
e) It is the current
policy of the United States under 42 USC, § 300AA-26, to provide the Vaccine
Information Statement to patients or their guardians prior to vaccination
f) It is the current
policy of the Federal and State laws of 48 states and the District of
Columbia to allow religious and or philosophical exemptions to vaccination
when the use of such products would violate religious beliefs, tenets or
practices. (DS Form 122.1 and related State exemption laws)
SEC. 5: DEFINITIONS
a) "Health care provider"
means any public or private corporation, partnership, association,
organization, agency or other legal entity that is involved directly or
indirectly in providing health care services, including, without limitation,
any public or private hospital, clinic, medical center, research facility,
medical school, nursing school or other medical training institution,
laboratory or diagnostic facility, physician's office, infirmary,
dispensary, ambulatory surgical treatment center, public health center or
school administering vaccinations, prescription or non-prescription drugs or
medical treatments.
b) "Prescription or
non-prescription drug" means any medical product or treatment prescribed by
or administered by health care personnel to patients.
c) “Patient” means any
human being or any parent or legal guardian
of a person acting in behalf of a human being, receiving a prescription or
non-prescription drug, vaccination or medical treatment subject to the
regulations of this Act.
d) “Elective abortion”
means: "All the measures which impair the viability of the zygote
[newly-conceived embryo] at any time from the moment of fertilization
through the completion of labor constitute,
in the strict sense, procedures for inducing abortion," as defined in the
U.S. Public Health Service Leaflet, #1066, US Department of Health,
Education & Welfare, 1963, Pg 27.
e) “Fair labeling” shall
mean that the human fetal or embryonic cell lines, proteins, DNA,
recombinant DNA, monoclonal antibodies or any other components derived from
elective abortion shall be clearly labeled as such and listed under the
product’s “Description” in the manufacturer package insert.
f) “Informed consent”
means that patients, attending physicians, nurses, midwives, pharmacists or
any other health care professional are provided with the appropriate
foreknowledge through the amended VIS in order to freely decide to receive,
produce, or dispense any product or treatment that contains human fetal or
embryonic tissue, cell lines, proteins, DNA, recombinant DNA monoclonal
antibodies or any other components derived from elective abortion.
SEC. 6: FREEDOM OF CONSCIENCE
a) All persons have the
right not to receive, produce, provide, perform, assist, or participate in
directly or indirectly the use of health care products as described herein
that would be contrary to their religious or moral convictions or
conscience.
b) No individual shall be
civilly or criminally, legally or administratively liable to any person for
any refusal to produce, provide, use, assist, or participate directly or
indirectly in the use of health care products as described herein that
violate one’s religious or moral convictions or conscience.
c) No person shall
discriminate against, penalize, discipline, or retaliate against any
individual in employment, privileges, benefits, remuneration, promotion,
termination of employment; or in eligibility for, admission to, renewal or
participation in, or graduation from any educational, study, or training
program; or in any grant, contract, research or other program because of his
or her refusal or unwillingness to provide, use, perform, assist, or
participate directly or indirectly in the use of health care products as
described herein that violate his or her religious or moral convictions or
conscience.
d) It shall be unlawful
for any person, public or private institution, or public official to
discriminate against any person, association, health official or corporation
refusing to provide health care products as described herein that violate
his or her religious or moral convictions or conscience in any manner,
including but not limited to, deprivation, or disqualification of financial
aids, assistance, benefits, or any other privileges.
SEC. 6: AUTHORITY TO ENFORCE THIS ACT
a) The United States may
bring an action for injunctive or declaratory relief to enforce compliance
with this Act including but not limited to: (1) Suspension of product
licensing, and (2) Criminal penalties and fines as recorded in 21 USC, FDC
Act, Chapter 9, Subchapter III, § 333(a)(2)
b) No rule or regulation
shall impair or delay any person who believes that his or her or its rights
under this Act have been violated from bringing an action in any State or
Federal court.
Sec. 7: ADDENDUM
1) SAMPLE PACKAGE INSERT REVISION - MMR VACCINE:
MERUVAX ll (Rubella Virus Vaccine Live), the Wistar
RA 27/3 strain from elective abortion
of live attenuated rubella virus propagated in
WI-38 human diploid lung fibroblasts
from elective abortion.
2) SAMPLE VIS CHANGE FOR POLIO VACCINE
- INSERT PARAGRAPH - INFORMED CONSENT-
Informed Consent
Is there anything else I
should know?
Informed Consent Doctrine
requires that health care professionals provide patients with all relevant
information about a proposed procedure including: the nature of the
procedure, the risks, the benefits and the availability of alternative
treatment, (including no treatment) and the risks and benefits thereof.
Informed consent
protects the patient by providing him/her with complete information on which
to make an informed decision.
Because some
patients may have religious or moral concerns about abortion, you are
entitled to know that some[ polio] vaccines are propagated on cell lines
obtained from electively aborted fetuses. Those vaccines contain residual
DNA, cell components and proteins from the aborted fetal cell line.
There are also
other versions of [IPV] available in the US using non-human cell lines. Ask
your doctor for more information on these alternatives. See Section 1 for
more information on the disease.
- End VIS Revision-
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