A study published by Yale University researchers in a recent edition of the Journal of the American Medical Association found that nearly one third of drugs approved by the U.S. Food and Drug Administration (FDA) over a 10-year period were affected by one or more post-market safety events. That is downright scary. Researchers tracked 222 novel therapeutics approved by the FDA between 2001 and 2010. Between the date of approval and 2017, a total of 123 safety events were reported, associated with 71 individual drugs.
The events reported were largely boxed warnings and safety communications from the FDA to the drug manufacturers, but also included three withdrawals of the products from the market. The study authors found that safety events were statistically significantly more likely among drugs categorized as biologics or psychiatric therapeutics, as well as drugs receiving accelerated approval from the FDA. The fast track program has been heavily abused by Big Pharma.
While the results of the study demonstrate that the FDA actively monitors the safety of drugs after their approval, they also demonstrate the importance of this monitoring. Further, because drugs receiving accelerated FDA approval are statistically more likely to be associated with a safety event, the study demonstrates the risks of pushing for faster evaluation of drug safety and approval. Currently, the FDA drug approval process generally involves about six months’ worth of trials, involving about 1,000 patients. Shortening the time period or decreasing number of individuals exposed prior to approval has the potential to lead to even more post-market safety events. The FDA must balance the importance of developing new drugs with the risks of accelerated approval highlighted by this study.
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