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PostPosted: Sun Oct 14, 2012 12:59 pm 
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This whole business with Reckit discontinuing Suboxone tablets for "pediatric exposure" is ridiculous. I read about it often..all the updates, etc.. It BLOWS MY FREAKIN MIND. Why so much risk management and blah blah for Suboxone? What about methadone, oxycontin, percocet, vicodin, etc that is prescribed MUCH MUCH MUCH MUCH MORE. (Sorry little angry here).

I mean, I gotta say, I see right through Reckit. I was reading some of their "explanations" and its ridiculous. Did you KNOW that they actually have the tablets in individual blister packs in other countries? But when asked why they can't do it here they said something to the affect of the integrity of the pill being damaged when removed from the package. ARE YOU KIDDING ME? I really hope no one believes that. I'm sorry, Reckit, but if you can do it in the UK you can do it here.

And then I find out that the VERY REASON why there are no generics yet is because of Reckit!!!!!! The FDA required 2 other companies wanting to make generic to develop a single risk management strategy for all the companies making it, and to develop it with Reckit..but guess what? Reckit is not helping. So, it looks like Reckit is doing just fine manipulating the FDA, which amazes me...cause the real reason for this crap is so clear.

And then they want the FDA to deny these other generics unless they have blister packs. I mean, COME ON. THE FDA HAS GOT TO SEE THIS FOR WHAT IT IS RIGHT? They have to!!!!!!

Sorry, I am very passionate right now, don't post on here too often, but my frustration about this has been building.

Clean 4 years from all drugs and alcohol. Went from living on the streets to having 2 college degrees and like many of you, living a life as if I was NEVER addicted to drugs, all because Suboxone. Amazing!

Seriously, FDA...recognize Reckit for what it is really doing. And FDA, worry about the other drugs that are causing so many more deaths. Please. My gosh. PLEASE! It just seems insane to me that a government agency can be so illogical? Like, this is 2012, right? We aren't dumb here.

PS. I know this was a loaded post. Unfortunately, I usually post on here because I need to vent, so just keep that in mind. I am frustrated right now.


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PostPosted: Sun Oct 14, 2012 1:24 pm 
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[font=Comic Sans MS]Hey there, I think it's pretty safe to say that everyone on here feels the same way that you do!
Don't worry about venting on here....VENT AWAY!!! Especially about those money hungry bastards!
They actually have me pretty sick to my stomach over it, and I don't even pay for my meds. I just hate
to see ANYONE get taken advantage of, just for a profit that , lets be honest, they dont even NEED!
Most of their profit comes from cleaning products anyway! Screw them. Karma is a bitch....especially when you're one.
LOLOL!

Try to relax, and sign every petition that circulates. I plan to. I've signed one as of right now.
Have a good day, and feel free to vent anytime you need to...that's what we are here for!
Take Care~[/font]

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PostPosted: Sun Oct 14, 2012 5:03 pm 
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Hello again!!!!!

yes, I completely agree, with your WHOLE post!!!! No need to apologize, in MY opinion!!!!!!!!!!

http://suboxforum.com/viewtopic.php?p=59500

HERE ^^^^^ is another thread about it, where a few other members (subox doc, too) had a vent about it!!!!

check that out, LOL

seriously, you would hope this BILLION dollar organization (FDA) would be ABLE to 'see' right thru them,
and if NOT,
then it makes ME wonder, how much are they paying THEM???????????????

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That's TRUE STRENGTH
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PostPosted: Sun Oct 14, 2012 8:30 pm 
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It's true about the blister packs.

The TGA in Australia made sure Subutex and Suboxone tablets were packaged in blister packs as far back as 1999 to prevent (a) pediatric overdose and (b) reduce decomposition of its ingredients into potentially toxic compounds. So they've known for a VERY long time that they could prevent pediatric exposure with blister packs ... btw as far as I know there's been no pediatric exposure of Subutex / Suboxone in Australia from opening blister packs.

Given that fact, it's pretty clear that Reckitt have some explaining to do about their contribution to pediatric overdoses from Suboxone in countries where they didn't package in blister packs. If anything, they are responsible.

As for the FDA seeing through RB's bullshit. I'm pretty sure they would. The problem isn't whether they can see through their bullshit. It's how hard / how well RB's lobbyists work in Washington to get their own way. How many golf clubs they donate to pollies that pull the strings, their political donations etc. Sure the FDA's meant to be "independent", but they're also human and as such there is some vulnerability to lobbying.

The TGA in my country is meant to be independent. Initially they blocked the release of Suboxone film in this country because it had little benefit over the tablets, and potentially more risk because of the instability of naloxone in film form. However that decision was overturned when a number of high profile addiction doctors (most of whom attended RB's lavish launch dinner) and the pharmacy guild of Australia (who have recently been implicated in receiving payments from pharma companies) lobbied the TGA to have it overturned.

RB are really quite an evil company in how they operate. And the culture extends to their reps. I occasionally read the RB rep forum on cafe pharma and I tell you, these reps are angry bitter people ... and are constantly in panic over losing their market to generics.


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PostPosted: Sun Oct 14, 2012 8:37 pm 
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You tell em Dr. J!!! :D

Quote:
Reckitt's Suboxone Strategy Is Really About Patients Or Profits?


Late last month, Reckitt Benckiser created a stir by unexpectedly announcing that its Suboxone tablet for treating opioid dependence will be withdrawn from the US market sometime over the next six months. The reason? The drugmaker, which is based in the UK and actually best known for household cleaning products, expressed concern that children could be accidentally harmed by easy access to tablets that are marketed in bottles.

In making its case, Reckitt cited specially commissioned data showing “consistently and significantly higher rates of accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. Specifically, the rates for Suboxone tablets were roughly eight times greater (please read here).

Reckitt Benckiser Pharmaceuticals has a moral obligation to act as quickly as possible on safety data relating to its products,” a spokesman wrote us, noting that a risk management strategy, which included patient education, was in place since 2003 in an effort to minimize accidental exposure to children. But data indicated a rising rate of pediatric exposure in recent years, at least until the film version was introduced in 2010.

“…Based on the safety and public health issues raised by the recent findings and the availability of treatment advancements in the United States that have shown reduced pediatric exposure, such as Suboxone Film, Reckitt Benckiser Pharmaceuticals believed it would be unethical to continue supply of Suboxone Tablets and therefore informed the FDA of its decision,” he continued.

The very same day, though, Reckitt also filed a Citizen’s Petition with the FDA, asking the agency not to approve any generic versions of Suboxone tablets unless the manufacturers implemented “national public health safeguards involving pediatric exposure educational campaigns and child-resistant, unit-dosed packaging to reduce the risk of pediatric exposure” (here is the statement and here is the citizen’s petition).

To generic drug makers, some physicians and Wall Street analysts, however, the moves amounted to a transparent one-two punch designed to delay lower-cost generic tablets from reaching the market. The patent on Suboxone tablets, in fact, expired two years ago, while patent on Suboxone Film expires in 2022, according to the Reckitt spokesman. “If Reckitt is so concerned about safety,” says one industry source, who asked not to be named, “then why not take the tablets off the market right away? Their tablets are still on the market without blister packing, which they themselves say is unsafe.”

Meanwhile, Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients. The current wholesale average cost (WAC) for a bottle of 30 Suboxone Tablets is $161.70 for the 2 mg dose and $289.80 for the 8 mg dose, according to the Reckitt spokesman. In July, however, the same bottle of the 2 mg dose cost $140.00 and the 8 mg WAC was $252.00, industry sources say. Meanwhile, Suboxone film pricing has held steady: WAC pricing for a carton of 30 Suboxone Film strips remains $117.85 for the 2 mg dose and $211.15 for the 8 mg dose.

More recently, sales of Suboxone tablets fell 19 percent between August 2011 and August 2012, to $658.5 million, according to IMS Health, while sales of Suboxone film doubled to more than $764 million during the same period. “They are (removing the tablets) because generics are expected in 2013 on the tablet,” says Sanford Bernstein analyst Ronny Gal. “The critical question is whether their argument that film is always safer for children will convince FDA not to approve any oral solid generic.”

For these reasons, the back-to-back announcements have been met with outrage. “They have known for years that a generic tablet could destroy their golden calf — and Suboxone is Reckitt Benckiser, from an earnings standpoint. If they do not destroy the tablet, it destroys them,” Jeff Junig, a psychiatrist at the University of Wisconsin Oshkosh Student Health Service and an assistant clinical professor of Psychiatry at the Medical College of Wisconsin, wrote in a letter to Alcoholism & Drug Abuse Weekly.

“I’m sure I sound… paranoid? Cynical?,” wrote Junig, who also authors a blog about Suboxone. “But it is so frustrating when you see marketing trump science. This will discourage generics from making buprenorphine, which will keep the price high, which will cause deaths. Shame on them.” Buprenorphine is one of two active ingredients in the Suboxone medicines; the other is naloxone. About 20 percent of profits are reportedly derived from pharmaceuticals, although this is dwarfed by household products.

“Doctors are questioning Reckitt’s motives, because there are tons of kids who die from ingesting other narcotics, including methadone, and these aren’t required to be (packaged) in film or are in film,” says Alison Knopf, editor at Alcoholism & Drug Abuse Weekly, which is read by policymakers, addiction treatment specialists and government agencies. “They think eliminating generic competition is the real reason this is being done and they’re concerned because they know there’s demand for a less expensive medication” than the film.

“Because there are numerous NDA and ANDA products in the buprenorphine class, in the interest of public health and to reduce the burden on the healthcare system of multiple unique REMS programs, we have determined that a single, shared system to implement these REMS programs is needed. You must contact the sponsor of the reference listed drug for your ANDA, Reckitt Benckiser Pharmaceuticals Inc., regarding the development of the single shared system,” the FDA wrote to generic drugmakers last year (here is the excerpt).

For months, though, this effort has stalled, according to industry sources, who tell us Reckitt has not given any indication that it will cooperate in designing such a REMS and has not shared some of the specifics with the generic drugmakers. “There are many components in their REMS, and these can be very stringent, but Reckitt won’t tell us what they are. They’ve seized upon this and used the situation to their advantage. And no progress has been made,” says a source.

The Reckitt spokesman, however, denies this. The drugmaker “has been diligently participating in discussions with both the FDA and other constituents on the development and structure of a joint REMS program to address the risks associated with the misuse, abuse and pediatric exposure of buprenorphine products for the treatment of opioid dependence. While the company cannot discuss specific details about the program, Reckitt Benckiser Pharmaceuticals has been actively engaged in these multiparty discussions,” he wrote us.

Nonetheless, a single, classwide REMS has yet to emerge. And by filing the Citizen Petition last month, Reckitt will likely delay generic competition for several months more. Why? The FDA can take up to 180 days to respond. Between the lack of a unified REMS and the agency obligation to review the citizen petition, generic rivals will likely remain on the sidelines. Meanwhlie, Reckitt will continue to sell both versions of Suboxone.

At the same time, questions have also been raised about Reckitt’s willingness to design blister packaging for Suboxone tablets. Experts say blister packaging is preferable to bottles. “Child resistant caps on pill bottles help, they are a deterrent, but are far from perfect,” says Rick Dart, director of the Rocky Mountain Poison and Drug Center and executive director of the RADAR System, which Reckitt retained to analyze Suboxone safety data. “There are other ways of making products resistant to children… Blister packs are one way.”

Reckitt actually sells the tablets in blister packaging in other countries, such as Canada (see page 22 of the monograph) and the UK. Critics say the drugmaker should have been able to do the same in the US and note that the company has acknowledged pursuing such packaging, but a Reckitt spokesman maintains there were several reasons this was not pursused, including a different formulation in the US.

“Any changes to the packaging would require a new submission with supporting data to the FDA and would take an extended period of time,” he writes us, adding that Reckitt tried to package the Suboxone Tablets into blister packs and “faced many challenges, including stability. With the development of Suboxone Film, the company was able to introduce child resistant, unit-dose packaging with the same active ingredient before it was able to identify and resolve the packaging issues experienced with Suboxone Tablets.”

In a footnote in the citizen’s petition, Reckitt also stated the company did not develop unit-dose packaging for their Suboxone tablets due to “technical issues involving the integrity of the tablet when attempting to remove it from the packaging.”, and that “later studies revealed that unit-dose packaging of Suboxone may be feasible” but “RBP focused its resources on the development of Suboxone Film” (this is footnote 57 on page 22.)

To Junig, the debate over packaging is a side show. “If it is impossible to produce the tabs in unit-dose form, they are essentially blocking generics if unit-dosing is required, since only (Reckitt) can make the film,” he writes us. “And if they can convince the FDA that they pulled the tab for safety reasons, that kills any new application for generic Suboxone. If they just stopped making the tab for any other reason, they would lose that ‘protection.’ It’s pretty tricky.”


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PostPosted: Mon Oct 15, 2012 1:58 am 
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im confused.. as of this moment i can still get generic subutex right?


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PostPosted: Mon Oct 15, 2012 2:24 am 
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As far as I know, yes you can still get generic Subutex. Reckitt is trying to stall the release of generic Suboxone tablets, but I'm not sure if they are trying to get the generic Subutex tablets pulled off the market, but as of now they are still available.

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PostPosted: Mon Oct 15, 2012 11:08 am 
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I truly think when it comes to drugs that help addicts the pharmaceutical companies have zero compassion and they go by the theory of "well its still cheaper then when you bought dope". It seems like they will go to any lengths to keep making the big bucks.


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Fond Du Lac Psychiatry
Dr. Jeffrey Junig, M.D., Ph.D.

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