Amid a raging controversy over its strategy for promoting the Suboxone treatment for opioid dependence, Reckitt Benckiser has hired a career government bureaucrat who can help the company better navigate the curious world of opioid treatment programs and federal regulations. In a little-noticed move, Nicholas Reuter joined Reckitt earlier this month as manager of treatment health policy and government affairs, a Reckitt spokesman confirms.
Reuter, who spent 37 years with the federal government, was most recently a senior public health analyst with the Substance Abuse & Mental Health Service Administration, or SAMHSA. And his crowning accomplishment was shepherding the rulemaking process for getting buprenorphine - which is sold as Suboxone and other names - into opioid treatment programs, according to Alison Knopf, editor of Alcoholism & Drug Abuse Weekly, which first reported the hiring.
The rule, which took effect last month, allows opioid treatment programs to dispense the drug without various take-home restrictions. "He is a godsend to them and a huge loss to the federal government, and to anybody who wants to come up with another, cheaper alternative" to Suboxone, Knopf says. "He knows the regulations by heart, for OTPs and for... laws allowing physicians to get waivers to treat opioid addicts with an opioid. He is an encylopedia."
His arrival may not help Reckitt with all of its myriad issues surrounding Suboxone, but the timing is certainly fortuitous. Apart from combating problems with diversion and abuse, the company is working furiously to promote a newer sublingual, or film version, of its drug, while preventing generic drugmakers from selling low-cost versions of its older tablet, which is being withdrawn from the US market.
Toward this end, Reckitt has argued that children could be accidentally harmed by easy access to tablets that are marketed in bottles as a justification for withdrawing its tablet. Reckitt recently cited specially commissioned data showing higher rates of "accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, which can only be accessed by tearing open individual blister packaging but was never used for its tablets.
At the same time, Reckitt filed a Citizen’s Petition with the FDA, asking the agency not to approve any generic versions of Suboxone tablets unless manufacturers implement "national public health safeguards" to reduce pediatric risk (back story). The FDA asked Reckitt to work with generic drugmakers to develop a Risk Evaluation & Mitigation Strategy, or REMS, but has been accused of feigning cooperation as a delaying tactic to build Suboxone film sales.
These various moves have, in turn, generated pushback. Generic drugmakers have asked the FDA to deny the Citizen's Petition (read more here). And lawsuits have been filed by Suboxone customers who charge Reckitt acted in an anti-competitive manner by conspiring to suppress generic competition and maintain high prices for its newer Suboxone film (you can read two lawsuits here and here).
Indeed, as Knopf notes, Reckitt still has "major hurdles - transitioning everyone to film, fighting off generics, ... what the FDA is doing with their citizen's petition, huge problems with diversion and abuse, DEA breathing down their necks, getting it paid on formulary - and some serious problems with uninformed politicians who think people should not be on maintenance medications forever."
Nonetheless, Reuter, who also worked as a consumer safety officer in the FDA Office of Health Affairs, can clearly offer some relief. "He's got a wealth of experience working at FDA and SAMHSA," says Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, which works with federal agencies and state substance abuse authorities on opioid treatment policy. "It is a very smart move for Reckitt to have brought someone on with his knowledge of federal regulatory and policy rulemaking."
26 Comments
This stuff is garbage. I can see why Reckitt loves it - your customers are addicted. And sure, fight generic competition with the silly argument that it is dangerous to children - what pharmaceutical isn't? Should everything be converted to a film?
And I agree with MC RPh...the pediatric safety argument is spurious.
From my vantage point suboxone is a high margin cash cow for the detoxes, with little benefit to patients unless they plan to audition for "The Walking Dead".
www.SuboxoneAbuse.Wordpress.com
Also, if you want to read about it from those that are addicted to Suboxone, go here:
www.Subsux.com .
I had to leave my own country to get help getting free of yet another adidiction. Reckitt want you to believe that an addict can not live opiate free. I have seen rehabs put their clients on this drug who has already been thru withdrawl. Readdicted them to the hardest drug I ever kicked. Now 4yrs clean and a sober coach I fear asking kids to go to rehab. Every time I do I get a call telling me the rehabs pushing them to start on suboxone. This drug is going to take out more addicts then street herione. At least with herione it's possible to end that addiction. I am ashamed of my country when it comes to addiction. Even worse, I FEAR this country when it comes to addiction! I have been blessed I had the opportunity to leave this country for a treatment that actually ended my active addiction. I was blessed I was off suboxone for a year before I had my treatment or would have thought I was just predestined to live my life addicted to dope! Sad, shameful, sinful.
Apparently they will say anything necessary to keep the money rolling in, including the fact that children will choose to ingest Suboxone (but only in pill form) while overlooking all the other RXs in the medicine cabinet.
Think Suboxone is such a bad idea? start your own Citizens petition to withdraw the drug from the market and see how far you get.
While you are at it, petition withdrawing methadone form the market, because its not a cure for heroin addiction either, right?
Do you have any non-anecdotal non-made-up reference to support that, idiot?
Please provide a WORKING reference with more than 9 people this time.
....To quote the emeritus idiot OII: "LMFAO"
Since you know soooo much more than the entire FDA, I'm sure the agency dying to hear from you and your insurance company colleagues.
You just want people to die of liver failure on cheap percocet so you can collect insurance company premiums and provide less service. You missed your calling; you should be working in car insurance!!!!!
Nice try, INSURANCE COMPANY SHILLER
Cant answer a simple question for a bona-fide reference. "LMFAO HAHAHHAH".... as the Senior idiot likes to say
Hey: I think the FDA is full of idiots and the insane, but that pales in comparison to your idiocy of making claims with ZERO references and collecting money while trying to deny care to the patients you are supposed to be insuring.
You insurance company jerks make obamacare seem like a great idea.
You can hate auto and health insurance all you want but you will be breaking the law by not having them. So make your big statement, cancel all of your insurance, and pay the penalties.
By the way dim bulb, you do realize that insurance companies are going to make out like bandits with Obamacare mandating health insurance right? He has secured the future for all of us in managed care while you'll be lucky to pick up the crumbs.
HAHAHHAH – sorry, now I am laughing at you.
Awesome. Now YOU do a google search on problems with oxycodone, hydrocodone, morphne and heroin.
Which google search gets more hits?????
No more Lear jets or second homes in the South of France for you, RPH!!! Awwww....
HAHAHHAH – sorry, now I am laughing at you.
...says the OII-idiot who has had more posts removed from pharmalot for foul and inappropriate language than any other poster....
HAHAHHAH