Fair Labeling and Informed Consent Act
Background - Purpose of this Act

In August of 2003, Australia passed legislation that ensures consumers have the right to know when human embryos, human embryonic stem cells or materials derived from embryos or stem cells are used in the manufacture or testing of pharmaceuticals.  Their reasoning was three-fold:

1)      Consumers are entitled to make informed decisions as to whether they wish to use these products or non-objectionable, ethical alternatives

2)      Current labeling practices from the pharmaceutical companies are inadequate

3)      The right of conscience and informed consent must be upheld for all citizens

The legislation will also require that American pharmaceutical companies currently exporting their products into Australia to comply with the government regulations.

In the United States , the current regulatory requirements for labeling do not give adequate information to the consumer.  We enclose for your perusal, current package inserts for some of these products that are using aborted fetal cell lines so that you can see why the existing labeling is clearly insufficient and must be amended in order to:

1)      Allow medical professionals and pharmacists to be informed of the product contents

2)      Allow the medical professionals, pharmacists and consumers to purchase ethical alternatives

3)      Protect the right of conscience and religious freedom for all citizens who wish to abstain from these products, as afforded to them through religious exemption laws in 48 states

4)      Protect the federal government from ensuing lawsuits from citizens who have unknowingly used products directly violating their religious beliefs

5)      Encourage the production of ethical alternatives by competing pharmaceutical companies

We attach a special section with letters from the American public that must be heard.  For if the medical professionals and pharmacists prescribing these drugs do not understand the language of the package inserts, how is the consumer to know and make an informed decision?

In Scotland thousands of angry Muslims protested after their children unknowingly received a vaccine containing pork preservatives as it violated their religious beliefs.  Other countries such as Australia are becoming increasingly aware of the need to provide informed consent on medical and vaccine product content in order to protect the rights of their citizens.  In order to be a truly democratic society, the United States must be a leader in defending religious and civil rights as more and more products are being brought to market that utilize morally objectionable sources.  But how can one abstain from a product that is morally or religiously objectionable when they have no idea what the product contains or how it was obtained?

And what is the incentive for the pharmaceutical industry to produce medical treatments in an ethical manner when they are not held accountable for exposing this truth to the public?  In order to encourage ethical research and protect the rights of all Americans as well as the citizens of foreign countries who use our products, the current method of labeling and informed consent must be amended.  

Children of God for Life, Et al

The following draft Federal statute is proposed by:

Debra L. Vinnedge, Executive Director
Children of God for Life
943 Deville Drive East
Largo, FL  33771-1122
Phone: (727) 584-3332  Fax:  727 530-7564  Email: debi@cogforlife.org

And supported by the enclosed petitioners - See Attachment A.

JANUARY 20, 2004 - PROPOSED DRAFT - REVISED JUNE 2004

Entitled
"Fair Labeling and Informed Consent Act 2004"

SECTION 1. SHORT TITLE.
This Act may be cited as the F.L.I.C.A. in the following sections.

SEC. 2. FEDERAL JURISDICTION

The F.L.I.C.A. applies to -

a) Any prescription or non-prescription drug or medical treatment that is currently in use and uses human fetal or embryonic tissue, cell lines, DNA or components from procured abortion in the manufacturing or production of the product or treatment.

b) Any new prescription or non-prescription drug or medical treatment that will use human fetal or embryonic tissue, cell lines, DNA or components from procured abortion or in-vitro fertilized embryos that have been donated or otherwise produced or reproduced in research.

c) Any health care provider, researcher, technician or other person required to perform or assist in the administration or research of prescription or non-prescription drugs, vaccinations or medical treatments.

d) Any person required to fill and dispense such prescription or non-prescription drugs, vaccinations or medical treatments.

e) Any person or patient who is the recipient of a prescription or non-prescription drug, vaccination or medical procedure that would involve the use of human fetal or embryonic tissue, cell lines,  DNA or components from procured abortion or in-vitro fertilized embryos that have been donated or otherwise produced or reproduced sexually or asexually in research.

f) Any manufacturer or distributor of a prescription or non-prescription drug, vaccination or medical procedure.

g) Any Institutional Review Board (IRB), Hospital Ethics Committee (HEC)or other committee reviewing and/or recommending experimental or therapeutic research or medical provision of a prescription or non-prescription drug, vaccination, or medical procedure that would involve the use of aborted fetal or embryonic tissue, DNA, cell lines, components or parts.

SEC. 3: POLICY AND PURPOSES

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.

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 purpose of this Act to require that the current labeling practice in 21 CFR 201.56-57 for all prescription and non-prescription drugs, vaccinations or medical procedures involved in such pharmaceutical treatments be amended to include full descriptions of human cell lines, tissues, DNA or cell components that take their origin in procured abortion or in-vitro fertilized embryos that have been donated or otherwise produced or reproduced sexually or asexually  in research.

d) It is the purpose of this Act to protect the legal right of patients to give their valid informed consent by requiring that researchers, technicians, 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, DNA or components derived from procured abortion or from human embryos that have been donated or otherwise produced or reproduced sexually or asexually in research.

e) It is the purpose of this Act to protect the legal right of researchers, technicians, attending physicians, nurses, midwives, pharmacists or any other health care provider to give their valid informed consent by requiring that they be provided all such information before producing or dispensing any product or treatment that contains human cell lines, tissues, DNA or components derived from procured abortion or from human embryos that have been donated or otherwise produced or reproduced sexually or asexually in research."

f) It is the purpose of this Act to 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.

g) It has always been the policy of the United States to protect the rights of religious freedom and to recognize the fundamental rights of the people including the rightsto freedom of thought and conscience, which are protected in numerous international agreements and declarations as well as in the US Constitution.

h) It is the current policy of the Federal and State laws of 48 states and the District of Columbia to allow religious exemptions to vaccine requirements when the use of such products would violate religious beliefs, tenets or practices. Yet without informed consent and fair, truthful labeling such rights have been duly violated. (DS Form 122.1 and related State exemption laws)

SEC. 4: Definitions

As used in this F.L.I.C.A:

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) "Health care personnel" means any nurse, nurses' aide, midwife, medical school student, professional, paraprofessional or any other person who furnishes, or assists in the furnishing of, health care services.

d) "Patient" means any human being or anyparent 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.

e) "Procured abortion procedure" means: "All the measures which impair the viability of the zygote [newly-conceived embryo] at any time from the moment of fertilization throughthe 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.

f) "human embryo" means any human organism produced sexually (fertilization) or asexually such as blastomere separation, blastocyst splitting, or any other method of cloning or artificial reproduction.

g) "Medical treatment" means any medical care given in the context of standard medical practice, or in therapeutic or experimental research protocols which involves the direct transfer to a patient of a product which is derived from, contains or uses human fetal or embryonic tissue, DNA, components or cell lines or is obtained from procured abortion or human embryos that have been donated or otherwise produced or reproduced sexually or asexually in research.

h) "Research" means any theoretical or practical investigation or experimentation which uses, produces, or reproduces human fetal or embryonic tissue DNA, components or cell lines obtained from procured abortion or human embryos that have been donated or otherwise produced or reproduced sexually or asexually in research.

i) "Fair labeling" shall mean that the procured aborted fetal or embryonic cell lines, DNA or components shall be clearly labeled as such and listed under the product's "Description" in the product insert and packaging.

j) "Informed consent" means that patients, researchers, technicians, attending physicians, nurses, midwives, pharmacists or any other health care provider are provided with the appropriate knowledge they need in order to freely decide to receive, produce, or dispense any product or treatment that contains human cell lines, tissues, DNA or components derived from procured abortion or from human embryos that have been donated or otherwise produced or reproduced sexually or asexually in research.

k) "Religious or moral convictions" means genuine positions of an individual based on sincerely held religious or moral norms of conduct."

l) "Conscience" means a person's judgment that particular actions are right or wrong based on sincerely held religious or moral convictions.

SEC. 5: 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 that would be contrary to their religious or moral convictions

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 that violate his or her religious or moral convictions.

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 that violate his or her religious or moral convictions.

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 that violate his or her religious or moral convictions 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.

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