The 21st Century Cures Act legislation was originally passed in the house last year on July 10, 2015 as HR 6.
– FDA Fast Tracking of ALL New Vaccines (3091 and 3092)
– Unconscionable Pharma and Vaccine Administrator Liability Shield for Fetal Vaccine Injury or Death Caused by Vaccines Given in Pregnancy (3093)
NVIC issued a press release on July 22, 2015 and Barbara Loe Fisher, NVIC Co-founder and President, released a referenced commentary in opposition to this proposed legislation in which she said,
“The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” said Barbara Loe Fisher, NVIC Co-founder and President. “Making experimental drugs quickly available for the sick and dying, who voluntarily choose to use them, is one thing but Congress should not be greasing the skids to license experimental vaccines that government will recommend and legally require healthy children and adults to use. It is a prescription for disaster.”
After passing the house in 2015, the legislation stalled. Many of the provisions of HR 6 were broken up into several smaller bills, but over the Thanksgiving holiday, the legislation was quickly reassembled into a new version including some sections from HR 6 and adding some new sections, amending them all onto bill HR 34. HR 34 was originally a bill that only addressed “Tsunami Warning, Education, and Research”, but was passed by the US House of Representatives on November 30th as an 824 page monstrosity!
National Vaccine Information Center Says Proposed 21st Century Cures Act Will Endanger the Public Health by Lowering FDA Licensing Standards
WASHINGTON–(EON: Enhanced Online News)–The non-profit National Vaccine Information Center (NVIC) says the proposed 21st Century Cures Act (H.R. 6) will endanger the public health by lowering scientific and informed consent standards used by the Food and Drug Administration (FDA) to license experimental biological products (vaccines), drugs and medical devices in order to expedite delivery to the U.S. market. Under the proposed law, drug companies could avoid conducting large randomized clinical trials and researchers would be able to test new products on humans without obtaining informed consent.
“if the proposed clinical testing poses no more than minimal risk”
The bill passed the U.S. House of Representatives on July 10, 2015. It mandates that an additional $9 billion be given to National Institutes of Health (NIH) to develop new vaccines and drugs and $550 million be given to the FDA to fast track licensure.
“The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” said Barbara Loe Fisher, NVIC Co-founder and President. “Making experimental drugs quickly available for the sick and dying, who voluntarily choose to use them, is one thing but Congress should not be greasing the skids to license experimental vaccines that government will recommend and legally require healthy children and adults to use. It is a prescription for disaster.”
The proposed law would allow drug companies to use surrogate endpoints to evaluate the effectiveness of experimental vaccines and drugs, and would permit the FDA to accept novel statistical analyses and clinical experience evidence instead of requiring drug companies to produce evidence from large randomized clinical trials. The legislation states that “if the proposed clinical testing poses no more than minimal risk,” informed consent would not be required from test subjects, but it is not clear who decides what constitutes “minimal risk.”
“Informed consent is the gold standard in human experimentation and the practice of ethical medicine, and there is no substitute for the requirement that drug companies conduct large, well designed randomized clinical trials before the FDA licenses a new vaccine,” said Fisher. “Moving numbers around in a computer is a poor substitute for actually proving a new vaccine works and does not kill and injure real human beings before it is recommended and used by millions of people.”
Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science
Here comes the 21st Century Cures Act (H.R. 6),7 which is a Pharma-driven bill8 blessed by the FDA9 that seriously compromises the integrity of the FDA drug and vaccine licensing process. 10 The 362-page bill sailed through the U.S. House of Representatives on July 10, 201511 and mandates that about $9 billion dollars be given to NIH to develop more drugs and vaccines and $550 million be given to the FDA to fast track products to market.12
Bill Lowers FDA Licensing Standards
The bill allows the FDA to lower licensing standards for testing of experimental drugs, medical devices and “biological products” – a category that includes vaccines -13 14 15 so companies will no longer be required to conduct large, case controlled clinical trials16 17 18 to evaluate safety and effectiveness. Instead, FDA can accept novel statistical analyses 19 and “clinical experience,”20 such as anecdotal evidence from patients.21
It is interesting that clinical experience and anecdotal evidence will constitute “good science” for the purpose of demonstrating a vaccine is safe before it is licensed, while clinical experience and anecdotal evidence has never been good enough to demonstrate that a vaccine is unsafe after it is licensed.22 23 24 25
Greasing Skids to License Drugs and Vaccines
Sick in bedThe 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.26 However, greasing the FDA licensure skids to make experimental drugs available for the sick and dying, who voluntarily choose to use them, is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use, is something quite different.27 28 29 30 31
Nearly every single vaccine that the pharmaceutical industry creates and the FDA licenses for child use is eventually recommended for all children and mandated by state governments for daycare and school entry.32 33 34 35 36 And, now, many adults are being brought into the vaccine mandate net as well.37 38 39
Ensuring Drugs & Vaccines Dominate U.S. Health Care
Coming on the heels of the Affordable Health Care Act,40 which guaranteed that the pharmaceutical industry and their products will continue to dominate the most expensive health care system in the world,41 42 43 44 45 46 there are so many breathtaking ways the 21st Century Cures Act will endanger the public health that it is hard to know where to begin. The word “vaccines” is not being publicly uttered by anyone sponsoring the bill. However, the Biotechnology Industry Organization (BIO), which represents more than 1,500 pharmaceutical and other health product corporations, is already crowing about how they managed to influence Capitol Hill politicians to incorporate the “Vaccine Access, Certainty and Innovation Act of 2015” into the 21st Century Cures Act.47 48
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