FDA postpones decision on opioid addiction implant_ Probuphine

“This is a policy report in the media referring to research that developed an implant to decrease opioid crave for six months. The medical issues are complicated. I don’t have the original report. Deciding on approval of this implant has more considerations than a short-lived oral medication. Let’s hope there is found to be a safe way to use this breakthrough.” Bill Chesnut, MD

 FDA postpones decision on opioid addiction implant_ Probuphine

 The Boston Herald (2/20, Kalter) reported that the Food and Drug Administration “postponed its decision on a matchstick-sized implant that would reduce cravings for people battling opioid addiction.” An advisory committee had recommended the approval of Probuphine in January. The device releases a steady dose of buprenorphine over a six-month period.

In a related story, according to STAT (2/19, Scott), a report issued by Senator Ed Markey (D-MA) accused the Food and Drug Administration of “failing to properly consult with its advisory committees to vet the approval of certain opioid drugs.” In the report, Markey said he “would continue to oppose the nomination of Dr. Robert Califf” until “the FDA changed its procedures.”

AMA News February 21, 2016.__WASHINGTON — The Food and Drug Administration is failing to properly consult with its advisory committees to vet the approval of certain opioid drugs, Massachusetts Senator Ed Markey alleges in a new report and letter obtained by STAT.

Markey, in a Feb. 19 letter to Health and Human Services Secretary Sylvia Mathews Burwell, said that until the FDA changed its procedures, he would continue to oppose the nomination of Dr. Robert Califf, President Obama’s choice to be the agency’s next commissioner. The first Senate floor vote, a procedural vote, on Califf’s nomination will be held Monday evening.

The report produced by Markey’s office laid out three problems from his point of view: First was that so-called “abuse-deterrent” opioids can still be abused. Second, since 2010, the FDA has not always consulted advisory committees when approving abuse-deterrent opioids.

“[The] FDA needs outside expert advice on all opioid approval decisions,” Markey wrote. “Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers.”

Markey and other lawmakers, including Senator Joe Manchin of West Virginia, have used Califf’s nomination to urge changes at the FDA that would address the opioid crisis, which is killing nearly 30,000 Americans a year.

The report underlines problems with the FDA’s approval process, said Andrew Kolodny, chief medical officer at Phoenix House, which runs dozens of addiction centers in the United States.

Kolodny emphasized that the abuse-deterrent drugs the FDA is approving can still be abused. Abuse-deterrent drugs are usually intended to only stop the pill from being crushed or injected, Kolodny said. Many people end up addicted to opioids by simply swallowing the pills.

“I have had very serious concerns about the FDA’s opioid decision-making for a long time,” he said. “I’m actually pleased that [Markey is] taking a stand on this.”

The agency has recently endured significant controversy for not consulting with advisory committees. The approval of Oxycontin for children saw backlash, including from Democratic presidential candidate Hillary Clinton. An advisory committee was not consulted on the approval, and those critical of the decision, including Kolodny, said they didn’t believe a committee would have favored it.

The episode was one of those highlighted by Markey’s report, which charged that the FDA “ignored its own guidance calling for an advisory committee when a question of ‘pediatric dosing’ is involved.”

Third, and the point that Markey focused on in his letter, the opioid action plan that the agency released earlier this month in response to the addiction crisis still allows some abuse-deterrent opioids to be approved without an advisory committee being consulted.