In the first quarter of 2014, a drug Hetlioz was approved by the FDA. It’s used to treat non-24 sleep-wake disorder, it’s a rare health condition related to sleeping issues that completely offset the internal body clock. However, according to a consumer advocacy group the agency mistakenly widened the market beyond its anticipated limits. In fact, on the label, it was mentioned that it was intended only for patients who are also blind, but this script was actually omitted.
The FDA realized its mistake in the latter half of the year 2014. But instead of correcting the product labeling, the agency issued a second approval letter. In this letter, it was mentioned that that the original letter contained an error about the approved use, but they committed another mistake by changing the description of the approved use to match the incorrect product labeling, according to Public Citizen, the consumer group.
According to the consumer group’s Health Research department the FDA has allowed a potentially dangerous medication to be given to people, for whom there was no sufficient evidence that it was safe and effective and this is the failure of the agency.
This mistake was compounded by the fact that FDA took a reverse decision to further expand the approved indication and it was to recommend it to non-blind individuals, rather than correct the grave error made by the agency.
Source: http://goo.gl/z9PYi9
