In an extremely controversial move, the Food and Drug Administration approved an exceptionally powerful opioid painkiller in spite of condemnation that the medicine could be a threat to public health. In doing so, the act of approval has promoted wider regulatory thinking for endorsing such a medicine while the country is in the middle of a nationwide epidemic of overdoses and deaths attributed to opioids.
The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous use, but is administered under the tongue. Using an eye dropper to administer the dose, it makes the medicine perfect for military use and was a priority for the Pentagon, a point that factored heavily into the decision according to FDA Commissioner Scott Gottlieb.
Although an FDA advisory committee last month recommended approval, the agency was urged by critics not to endorse the drug because it is 10 times more powerful than Fentanyl, a highly addictive opioid.
In 2017, the FDA denied approval of the medicine over concerns about usage directions. FULL STORY AT STAT NEWS
- Don Stuck