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Political debate leaves opioid implant hanging in the balance

Posted on 03-17-16 in Addiction Treatment, Recovery

Political debate leaves opioid implant hanging in the balance


Editor’s note: As of May 26, 2016:

Today the Federal Drug Administration approved Probuphine use for stabilized opioid recovery patients. The nod comes four months after the FDA’s advisory committee recommended the opioid agonist implant. Braeburn Pharmaceuticals CEO Behshad Sheldon says training for administering doctors can begin as soon as Memorial Day weekend and the implant, inserted as a quartet of devices, could be in patients by the end of June.

Editor’s note: As of March 22, 2016:

A hopeful Braeburn Pharmaceuticals – maker of opioid implant Probuphine – announced that it’s still moving forward and investing $20 million to plant a research and development manufacturing site in Durham, North Carolina. This follows a recent volley of developments regarding opioid treatment.

Editor’s note: As of March 17, 2016:

Amid the changing of the guard from the current Food and Drug commissioner to President Obama’s nomination, Robert Califf, M.D., the FDA delayed its decision on approving use of Probuphine. Congress, meanwhile, had threatened to hold a political quarantine on confirming the nominee until the FDA agreed to give its opioid painkiller protocol a face-lift.

The politics of pain

Sen. Ed Markey spearheaded the FDA appointment delay attempt in an effort to force a sit-down with the FDA to review its current prescription opioid best practices and get a commitment from the agency to set up special committees for vetting prospective pharmaceutical companies.

“We’re coming to kind of a showdown on this issue [opioids]. … The time has finally come for us to have this national debate on the floor of the Senate,” Markey emphasized.

Markey and several other outspoken senators’ criticisms of the FDA’s response to the opioid epidemic may be received as preaching to the choir. Califf, who served as deputy commissioner for medical products and tobacco for one year before his appointment, has seemingly had enough time in the administration to survey the FDA’s current landscape and observe what improvements he believes the administration needs. He says congress has every reason for concern.

“I don’t think anyone 10 years ago anticipated that these drugs would be associated with so much societal harm. So, how to take into account societal risks when you look at the risk-benefit of a drug – that’s complicated,” Califf said to the Washington Post, and added, “We’re contracting with the Institute of Medicine to get a broad, societal perspective on that. As we go through all the things we outlined in our plan, we’ll keep revising what we are doing to get it right.”

Critics of the FDA complain the administration has doled out too many opioid medications to the public, fueling the fire of addiction nationwide. Criticism still rains on the FDA after it approved Oxycontin for children last year.

Physicians treating addiction are just as frustrated, with 66 percent reporting patient demand far exceeds the FDA’s 100-patient limit. All sides want a formidable response to the opioid epidemic nationwide.

As reported in part two of this series, for a second time the FDA’s advisory committee has recommended the opioid addiction implant, to no immediate avail.

Debate upends opioid implant approval

The argument over approving the opioid implant remains heavy on both sides after the FDA’s Feb. 20 suspending of approval on the panel’s recommendation back in January. Despite some senators’ efforts to build a protest against Califf, he was confirmed on Feb. 20, 89 to 4. Califf emphasizes he’s going to use his position for action and collaboration.

“We’re also aware that there are 10 to 12 million Americans with severe, chronic pain that needs treatment. So, we’ve got to work with [the National Institute of Health] and the industry to develop nonaddictive, more effective treatments. And we have to work with [the Centers for Medicare & Medicaid Services] and payers to create practice environments where you can actually use nonopioid, behavioral treatments … so I feel like I have a good bully pulpit to talk from to say, ‘Yes, we’re going to step up to the plate at the FDA.’ But we also need everyone else to join us and step up to the plate.”

As it relates to the Probuphine implant, the dissenters who argue the test trials were too short, too few and inaccurate may have found an attentive ear in the new FDA head, who pledges to be proactive without jumping the gun on treatments.

Judith Kramer is a professor emerita at Duke University – where Califf is an alumnus – and is the FDA advisory panel’s acting chairwoman. Although the majority of her cohorts voted to recommend the implant, she did not.

“We all desperately want something to be available,” says Kramer, but adds in response what she believes was a premature nod for the implant, saying, “I’m very concerned about the precedent this sets.”

Braeburn Pharmaceuticals has reported it expects an FDA decision on the implant by May 27, 2016. We will keep you updated on the latest developments with this story.

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About the author

Sovereign Health Group staff writer Kristin Currin is a mindful spirit swimming in metaphysical pools with faith as her compass. Her cover: a 30s-something Cinderella breadwinner of an all-sport blended family. Her repertoire includes writing poetry, lifestyle articles and TV news; editing, radio production and on-camera reporting. For more information and other inquiries about this media, contact the author at