In what is being considered a first, a pharmaceutical manufacturer is being asked by the FDA to pull its drug from the market citing its potential to cause abuse.
Endo Pharmaceuticals sells hundreds of millions of dollars worth of the opioid Opana ER every year. Designed for users with chronic pain, Forbes says the drug was actually reformulated in 2012 to make it harder to abuse. A coating was added that allegedly made it more resistant to physical and chemical tampering methods that made it easier to crush and snort. But instead of helping, the change resulted in a sharp increase in users injecting it instead, which was blamed for a tragic outbreak of HIV in Southern Indiana where 190 people in Scott County tested positive for the disease between 2015 and 2016.
Forbes cited a statement where Janet Woodcock, the head of the FDA's Center for Drug Evaluation and Research, specifically attributed the decision to recommend Opana's removal with that outbreak.
FDA Commissioner Scott Gottlieb also said that regulatory steps like this one will continue when the agency determines that an opioid product’s risks outweigh its benefits – whether it’s being used as it was intended, or not.
If a manufacturer chooses not to honor the FDA's request to removing a product from the market, the agency can take legal action to force it to do so.
I’m David Mantey and this is IEN Now.