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 Rivenaleem on Monday May 15 2017, @08:34AM
I'm of the belief that generations into the future we'll be telling the same horror stories about modern medicine as we currently do about leeches and "cutting for the stone". However it takes great fortitude to acknowledge that for every 9 people that are saved by drug X a tenth person may be killed. Like the use of cars, and the hundreds of thousands of deaths caused by them, we take it as an acceptable risk for the benefits that they bring the society as a whole. If we banned, or severely restricted the use of things known to kill people, then there are a lot of things higher up the priority list for this treatment than the drugs described in this research.