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Kaiser Health News reports on work published in the Journal of the American Medical Association (DOI: 10.1001/jama.2017.5150). In the journal article, the researchers concluded that
Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events [...]
According to the Kaiser Health News article, the 21st Century Cures Act, enacted in December,
[...] offers ways to speed drug approval by pushing the FDA to consider different kinds of evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for more unsafe approvals.
additional coverage:
(Score: 2) by Gaaark on Sunday May 14 2017, @12:30PM (1 child)
We don' need no steeenking drug safety! We need more profits for drug companies!!
Let the drug companies set high prices, and then if people die, hope the company made enough money that quarter to pay off the families. Everyones happy, no?
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 0) by Anonymous Coward on Sunday May 14 2017, @09:32PM
That's why we need major Tort Reform to protect businesses from unscrupulous sick people who had the nerve to die after taking their drugs.