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FDA moves to kick prescription painkiller off the market

The Federal Drug Agency took an unprecedented step in the fight against the opioid epidemic Thursday, asking a drug manufacturer to pull one of its painkillers from the market. But while the FDA is trumpeting the move as essential, experts argue that it will likely have very little impact on the opioid crisis, and could ultimately distract from solutions that will.

“We must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb said in a statement announcing that the agency had asked Endo Pharmaceuticals withdraw the opioid Opana ER. “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.”


Researchers have found that Opana ER isn’t actually all that great at its medical purpose, relieving pain. Worse yet, “in high doses it looked as abusable as oxycodone,” Shanna Babalonis, a University of Kentucky College of Medicine researcher, told VICE News. “And so that’s like the worst possible combination of effects.”

It’s not guaranteed that Endo Pharmaceuticals will take Opana ER off the market; the company has already signaled that it plans to take the FDA to court over its request. But this isn’t the first time that Opana ER has been the target of national scrutiny. Between 2015 and 2016, nearly 200 people in Indiana tested positive for HIV, apparently after sharing needles loaded with dissolved Opana ER. Endo Pharmaceuticals had added a coating to Opana ER pills, which was supposed to make it harder to snort or inject the drug, in 2012, but the effort evidently didn’t work.

But Northeastern University School of Law professor Leo Beletsky isn’t convinced the FDA’s request will do anything to help the crisis.

“It allows policymakers at the FDA and elsewhere to feel like they’re doing something,” explained Beletsky, who studies drug policy. He predicts the powerful pharmaceutical industry will likely scare the FDA out of asking more drug makers to pull their products, and says the government’s focus should be on treatment, not regulation and supply. “The crisis is no longer being driven by prescription drugs. It’s being driven by black market drugs.”

“I can’t tell how big an impact this is going to have in the real world, given the absolute flood of opioids that are out there and that this is just a drop in the bucket,” added Caleb Banta-Green, a University of Washington professor who studies the opioid epidemic at the school’s Alcohol and Drug Abuse Institute. Very few people use Opana ER, he said, and those that do probably won’t stop using opioids just because their brand of choice disappears.

Instead, Banta-Green and Beletsky want the FDA and other agencies tasked with dealing with drug policy to focus on providing and shaping ways to help people, like addiction training for physicians and opioid-alternative treatments.

Banta-Green and both Beletsky pointed to the example of OxyContin, which was redesigned in 2010 to supposedly make it harder to abuse. Years later, researchers found that the redesign had worked, sort of: Fewer people were abusing OxyContin — because they’d turned to heroin.

“That could happen on a very small scale here,” Beletsky said.