With the strength of the ongoing opioid epidemic, it may come as a surprise that the regulatory agency which oversees the approval of pharmaceuticals is only just now pulling an opioid from the shelves because of its addictive nature.
On Thursday, the FDA announced that they would recalling Opana ER solely because of its likelihood to trigger addiction and cause dependency. Endo Pharmaceuticals, the company that makes Opana ER has been ordered by the FDA to recall the drug.
FDA Commissioner Dr. Scott Gottlieb issued a statement on the decision, openly announcing that the recall was the first of its kind.
“We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse. We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
It is encouraging to see that the FDA is willing to take such decisive action in the battle against the opioid crisis. Critics of big pharma no doubt expected the FDA to continue sheltering pharmaceutical companies, but this major step is a warning to opioid producers everywhere: you are responsible for what your drugs do.
Opana ER is reportedly much stronger than many other leading opioids, meaning that this recall may not be applied to some of the epidemic’s biggest offenders. Still, the precedent is now in place for the FDA to regulate not just on the safety of the drug as used, but in its capacity for misuse.
This, along with efforts to rehabilitate addicts, raise awareness about dangers of opioids, and litigate against healthcare centers that over-prescribe, may begin to make a legitimate difference in this ongoing crisis of addiction affecting Americans nationwide.