Regarding a prior post, I carefully read through the entire Citizens Petition’ filed with the FDA by Reckitt-Benckiser. I have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone.
The document explains that the company hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film. The results are spelled out in detail in the Citizens Petition.
They show an increase in exposure to Suboxone Tabs over the past ten years. They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed. Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site: ‘The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.’
To meet that requirement, RB claims that they instructed their sales force to be double, extra-especially careful to tell doctors to remind patients to avoid giving Suboxone tablets to their children. No, I’m not making this stuff up… although the ‘double, extra-especially’ part is my own hyperbole. I don’t remember exactly how it was worded in the petition.
RB wrote that the warning is actually part of their mitigation strategy—that they expect an impact on pediatric exposure, if their salespeople tell doctors to tell patients to keep the pills out of the hands of children. Gosh—good thing they did that! I’m picturing all those people who having their 2-year-old kids managing their Suboxone!
But telling doctors to tell patients this ridiculous bit of information did not solve the problem, so RB claims they needed to do more. They decided that every dose of Suboxone must be individually packaged. But they had problems with the stability of naloxone while producing individually-packaged Suboxone Tabs, leading them to make the Film form of the drug.
To read the petition, the expiration of their patent on the tabs had nothing to do with anything. And the long, new patent on the Film has nothing to do with anything.
I have a couple questions at this point. First, the obvious one—did RB REALLY have a discussion about having their salespeople remind doctors to remind patients to protect their children? Do they really think that patients and doctors are that stupid—that their salespeople can make a difference in that regard?
Second, do they really find it necessary to individually wrap each dose of Suboxone, a combination of an opioid partial agonist plus an opioid antagonist, when oxycodone, hydromorphone, hydrocodone, and other potent opioid agonists are sold by the bottle? I could go on and on about this issue… most patients on Suboxone guard each tablet carefully, as they are prescribed to match up with the number of days in each month… whereas opioid agonists are usually prescribed to take ‘as needed’, meaning the tabs are much more likely to end up in kitchen cupboards or otherwise unaccounted for.
Why would a company hire another company to find fault with their product? One might think that the manufacturer of a substance would be, if anything, pointing out the safety of their product—not arguing that it is unsafe. This is where cynicism starts to set in; where I wonoder if they are really just ‘Here to Help.’ I’m supposed to believe that RB discovered a problem with their product, hired a company to assess that problem, and then voluntarily withdrew the product from the market.
To believe the RB line, I have to accept a number of coincidences. They wrung profits out of the tabs for almost ten years, and just happened to figure out this danger within a year after patent expiration—just when generic pharmaceutical companies were able to manufacture cheaper forms of buprenorphine. The company has been dreading the flow of generics for years; heck, their reps spend more time talking about THAT issue than they do about pediatric exposures! It is also an odd coincidence that RB just happened to be pushing the Film like crazy to insurers and Medicaid agencies, well before their ‘discovery’ of the danger of pediatric exposure to tablets.
To really understand the situation, you must read all the way to the top of page 29 of the Citizens Petition. There, the attorneys for RB point out to the FDA that if a manufacturer voluntarily withdraws a medication for safety reasons, the FDA is not allowed to approve any new drug application for a generic that is based on the withdrawn medication.
Wow. They have some darn good attorneys at RB.