21st Century Cures Act risks public health
The act would lower informed and scientific consent standards that are currently used to license drugs, experimental biological products (vaccines) and medical devices.
“The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” Barbara Loe Fisher, NVIC co-founder and president, said. “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 act seeks to lower these standards to speed the delivery of these products to the U.S. market. With the new law, drug companies could bypass large, randomized clinical trials. Additionally, researchers could test new products with human subjects without any 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,” Fisher said. “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.”