FDA delays decision on Probuphine opioid implant
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.
May 27 is the new D-Day. This, according to opioid implant makers Braeburn Pharmaceuticals. The Food and Drug Administration (FDA) reportedly put off giving its ruling on the twice-proposed implant, Probuphine until 90 days after its original action date.
That delay followed news Congress would meet to tackle the FDA’s process for approving opioids and lasso in the requirements for physicians to complete training on addiction.
Debate over FDA approval
The FDA’s appointed advisory committee – to which the administration typically adheres – recommended approval three years ago. Supporters of the implant point to the fact that it “cannot be diverted; cannot be stolen, sold or lost; cannot be abruptly stopped by the patient; carries no risk of accidental pediatric exposure; and cannot be accidentally overdosed.”
In spite of the recommendations of the advisory board and other supporters, the FDA rejected the implant in 2013. Now that the panel has for the second time proffered their approval to the FDA, opponents of the implant argue that a nod is still premature.
Pharmacist Tracy Rupp is the director of public health policy initiatives with a nonpartisan group that analyzes health data. She cites several missteps in the re-recommendation. First, Rupp notes the advisory committee’s approval comes after just one clinical study. Second, missing urine tests in that study were marked as negative – signifying patients had no drugs in their system. Rupp notes that a common tactic to skirt a positive detection in treatment is to skip tests.
Judith Kramer, the advisory committee’s acting chairwoman, said she voted no on Probuphine’s approval because clinicians don’t yet know if it’s effective past the six-month trial. Recovering addicts are unique and will often need longer than half a year to wean, she warns.
Amid the political opioid debates and inadequate research apprehension, there remains a slow-drip of privacy concerns as well.
Lingering questions of privacy
A scenario: Martin served time as a juvenile for possession and attempt to smuggle narcotics with his uncle. He was released, his record sealed. As a young man, he again struggled with opioids and received the Probuphine opioid implant to reduce cravings. On a trip, he’s flagged at the airport and pat down. With a fresh scar and a noticeable bulge under his skin, he’s pulled in for questioning. Terrified his past will come up and unsure of how much he has to divulge, what rights does he have?
The National Alliance of Advocates for Buprenorphine Treatment (NAABT) endorses privacy for users of opioid treatment medicine.
“The confidentiality of alcohol and drug dependence patient records maintained by a practice/program are protected by federal law and regulations. Generally, the practice/program may not say to a person outside the practice/program that a patient attends the practice/program, or disclose any information identifying a patient as being alcohol or drug dependent unless:
- “The patient consents in writing;
- The disclosure is allowed by a court order, or
- The disclosure is made to medical personnel in a medical emergency or to qualified personnel for research, audit, or practice/program evaluation.”
No answer was given when NAABT was asked to comment whether Probuphine users will also benefit from the same privacy protection by law.
Another privacy concern is whether recovering addicts would be unleashing the hounds into their personal day-to-day if they accept Probuphine treatment as a condition of parole. If Martin, in our example, agrees to have the implant, and an updated version expands the scope to overall health monitoring, a feedback mechanism per se, or probation tracking, does he now have to concede to the software updates?
A Braeburn Pharmaceuticals representative affirmed, “While we know that certain drugs are being approved with compliance/tracking technology, that is not currently a feature of the Probuphine implant.”
The Sovereign Health Group stands behind our mantra, The Sovereign Way. This means each client’s background and issues are unique; likewise, treatment must be holistic and match each patient’s individuality. We offer tailored treatment regimens in our residential, outpatient and partial-hospitalization tracks for lasting rehabilitation.
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 firstname.lastname@example.org.