Fair Labeling and Informed Consent Act 2007
Background
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 also requires that American pharmaceutical companies currently exporting their products into Australia 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 protected by State and Federal laws
5) Encourage the production of ethical alternatives by competing pharmaceutical companies
Over 585,000 US citizens have expressed their outrage at the lack of informed consent yet if the medical professionals and pharmacists prescribing these drugs do not understand the language of the package inserts, how is the consumer supposed to know and make an informed decision?
Not only will revisions to current law allow consumers to make informed decisions on which medical products they wish to use, it will also provide immediate incentives for the pharmaceutical industry to utilize morally acceptable and readily available alternatives in future vaccine production.
In addition, competing pharmaceutical companies willing to provide ethical alternatives for vaccines utilizing aborted fetal cell lines will have the assurance of a fair share of the market. We believe that in order to encourage ethical research and protect the rights of all Americans as well as the citizens of foreign countries who import our products, the current method of labeling and informed consent must be amended.
These proposed changes would provide proper information to all members of the medical profession, including pharmacists and public health officials so that alternatives may be selected in advance of purchase. Such changes are consistent with existing Federal Law requiring clear, non-evasive language in consumer packaging and informed consent including, but not limited to the descriptions found in 21 CFR Part 201, Labeling and 42 USC, § 300aa-26 and the Federal Food, Drug and Cosmetic Act, 502 (e).
Method of Delivering Proposed Changes
There are currently two avenues for providing labeling and consent information to the public:
1) Package inserts – used primarily by health care professionals
2) VIS or Vaccine Information Statements provided for some vaccines under Federal Law to consumers
Package insert information is the source used by the Physician’s Desk Reference, a medical volume containing all information on every prescribed drug through the book’s publication date. This reference is kept in virtually every medical practice office in the US and is published annually with all changes and additions to the package inserts.
However, package insert revisions alone are not sufficient since they are never given to patients unless the drug is new, therefore revisions must be made to both the package insert and VIS.
Revision in the package insert would require 2 actions:
1) The addition of 3 words: “from elective abortion” next to aborted fetal materials listed or referenced in the ingredients section of all package inserts
2) A revision of 502 (e) of the Federal Food, Drug and Cosmetic Act, adding one paragraph.
Vaccine Information Statements - Background
At present, Federal Law under 42 USC, §300aa-26 requires vaccine recipients or legal guardians of children to receive Vaccine Information Statements (VIS) published by the Centers for Disease Control (CDC) prior to immunization for some, but not all vaccines.
Under the National Childhood Vaccine Injury Act (NCVIA) all healthcare providers are required to provide this information for all vaccines listed in their Vaccine Injury Table (VIT) The VIS is kept updated as needed with important information for consumers.
Those vaccines for which Federal Law requires dispensing of VIS are:
Diphtheria, Tetanus, Pertussis, Measles, Mumps, Rubella, Polio, Hepatitis A, Hepatitis B, Haemophilus Influenza type b (HiB), Varicella (Chickenpox), Influenza, Pneumococcal Conjugate.
When there is no VIS for combination vaccines such as Pediarix, (Diphtheria, Tetanus, Pertussis, Polio and HiB); Pentacel (Diphtheria, Tetanus, Pertussis, Polio and Hepatitis-B) or Twinrix, (Hepatitis A plus Hepatitis B) Federal Law requires that the VIS must be given for each vaccine component listed.
The CDC also provides VIS for other vaccines not listed in the VIT. Those vaccines are:
HPV, PCV, PPV, Rabies, Rotavirus, Shingles, Typhoid, Yellow Fever.
Note: Vaccines that are highlighted use aborted fetal cell lines.
Revision of the VIS would require 2 actions:
1) The inclusion of any product using aborted fetal cell lines to the VIS distribution requirements found in 42 USC §300aa-26
2) Revision of the VIS to add one paragraph on Informed Consent
Informed Consent – Background
“Informed consumers are essential to the fair and efficient functioning of a free market economy.”
(US CODE - TITLE 15 CHAPTER 39 § 1451
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.
In 2001 parents opposed to the use of aborted fetal cell lines filed a lawsuit against their physician who insisted aborted fetal cell lines were not used in the chickenpox vaccine he would be giving their child. While the physician had no knowledge that the only chickenpox vaccine licensed in the US did in fact, have residual cell components, proteins and DNA from the aborted fetal cell lines, the parents trusted they were receiving a different version and accepted the vaccine, thus violating their right to a State provided religious exemption.
Likewise, the physician’s right to informed consent or at least foreknowledge on the source of the vaccine ingredients was duly violated, causing severe damage to his own medical credibility and patient relationships. If the product labeling had contained clear, accurate information, both he and his patient would have had proper information to make a decision on the risks, benefits and moral concerns.
In summary, the changes proposed in FLICA are consistent with the policies and regulations currently employed by Federal Law. Supporting documentation attached, including language for the proposed bill is as follows: