Tag: experimental drugs
National Vaccine Information Center Says Proposed 21st Century Cures Act Will Endanger the Public Health by Lowering FDA Licensing Standards#android#iPad#retweet
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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.
“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”
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.”…