The former chief executive of Indivior pleaded guilty to misbranding Suboxone Film, a medicine used to treat addiction to opioids and narcotics, one year after the company was charged with engaging in a multibillion-dollar fraudulent scheme to increase prescriptions.
Shaun Thaxter, who had led the company since 2009 before stepping down Monday, was charged with misrepresentations made to a state Medicaid program about the safety of the dissolvable film strip, according to court documents. Misbranding is a broad statute that makes it a crime to mislabel a drug, fraudulently promote it, or market it for an unapproved use. He agreed to pay $600,000 in fines and faces up to one year in prison.
The guilty plea is the product of long-running civil and criminal investigations into the sales and marketing of Suboxone Film, which was originally sold by Reckitt-Benckiser before its Indivior pharmaceutical unit was spun out in 2014. Last year, Reckitt Benckiser agreed to pay up to $1.4 billion to settle the charges, although Indivior continues to separately face similar charges.
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For the record…
Opioids and narcotics are 2 names for the same thing. Saying “opioids and narcotics” is redundant.
In FDA parlance, “mislabeling” includes promoting (as broadly defined) outside of the FDA-approved prescribing information (label). So the other items mentioned here: fraudulent promotion and marketing for an unapproved use, each fall under “mislabeling”.
I don’t see this as an example of pursuing a company because it is contributing to the opioid crisis. Claims of being less likely to be diverted or misused are in comparison to other forms of opioid use disorder treatments, most relevantly the older form of Suboxone that was about to lose patent protection at the time. The mislabeling was about making an unproven claim that the Film formulation was safer. This was done to drive Rx switching from the oral form prior to losing exclusivity. Claiming the Film was safer doesn’t mean it is less safe than other forms of buprenorphine or buprenorphine/naloxone.
Finally, my understanding is that these sorts of opioid use disorder treatments, while technically opioids themselves, do not cause euphoria. If they are sought by opioid dependent people, it is because using them prevents the highly unpleasant symptoms of opioid withdrawal. So facilitating connections between patients and prescribers isn’t contributing to opioid abuse — it is simply facilitating patients being prescribed the patent-protected form of buprenorphine/naloxone.
Not defending the behavior — it is in fact mislabeling and defrauding tax payers via higher costs to Medicaid, Medicare and the VA. But it did not exacerbate the “opioid crisis”.
Hi TW,
Thanks for your thoughtful note.
A couple of points. I was colloquially referring to the ways that misbranding may be interpreted by authorities to pursue alleged wrongdoing. Here’s the FDA info, for what it’s worth..
https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
Meanwhile, as for Indivior, I had previously written about the FTC probe that stemmed from the switching from tablet to film. This was all about boxing out competition. Here is the back story ( a link to this same story already appears elsewhere in the story you have just read)…
https://www.statnews.com/pharmalot/2019/07/11/reckitt-indivior-opioid-suboxone/
Finally, I do think the feds see such infractions through a prism of alleged abuse by companies seeking to market opioids. The events that led to this outcome are, of course, different than bribing doctors to write prescriptions, but what’s in common is the alleged willingness to improperly tout the products.
As noted at the time the company was indicted last year, the feds alleged the company deceived doctors into believing the medicine was safer and less prone to diversion and abuse than other such treatments ( a link to that story from April 2019 also appears in the story you just read).
The former ceo pleaded guilty to misrepresentations to Medicaid, but as the court documents noted, certain Indivior employees subsequently shared false and misleading safety information with agency officials about the risks of accidental pediatric exposure with the Suboxone Film. And the feds alleged this came about as a result of a strategy he asked employees to devise.
So there is a common denominator here that factors into the larger policy issue. But feel free to disagree.
As to opioids and narcotics, the nuances are tricky, as per this page from the DEA…
https://www.dea.gov/taxonomy/term/331
Hope this helps.
regards
ed at pharmalot