FDA Denies Reckitt Petition Over Generic Suboxone

WE ARE REPEATING THIS FROM THE WEEKEND: In a huge blow to Reckitt Benckiser, the FDA late last week rejected a citizen petition the company had filed last fall in hopes of thwarting generic rivals to its best-selling Suboxone tablet for treating opioid dependence. Moreover, the agency also referred the issue to the US Federal Trade Commission in response to comments filed by generic drug makers that Reckitt had engaged in anticompetitive business practices.

The decision, which was accompanied by FDA approval of two generic versions, caps a long-running controversy over the Reckitt strategy to maintain its Suboxone franchise. The drugmaker, which is based in the UK and best known for household cleaning products, has used various tactics to convince the FDA that lower-cost generic versions could raise safety issues for children, while bolstering sales of a newer product with a longer patent life.

Since 2010, Reckitt has aggressively promoted its new sublingual Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. The patent on Suboxone tablets expired three years ago, while the patent on Suboxone Film expires in 2022. And Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients to the newer version (back story).

Meanwhile, Reckitt asked the FDA not to approve generics unless the risk of accidental pediatric exposure was addressed and child-resistant, unit-dose packaging was used, and not until establishing Reckitt was withdrawing Suboxone tablets due to safety issues. Toward that end, Reckitt provided specially commissioned data showing rates of accidental unsupervised pediatric exposure was eight times greater than with its newer Suboxone Film.

In rejecting the citizen's petition, however, the FDA maintains that Reckitt failed to provide sufficient evidence that specific educational measures and unit-dose packaging caused a verifiable decline in accidental pediatric exposures. As a result, the agency determined there is insufficient justification to require such specific steps from generics. Suboxone tablets, by the way, were never sold in unit-dose packaging.

After dispensing with these points, the FDA then laces into Reckitt. For one, the agency notes the drugmaker has not yet withdrawn Suboxone tablets, so that determining whether the tablets are being withdrawn is simply not necessary at this time. And "Reckitt's own actions undermine, to some extent, its claims with respect to the severity of the safety issue," the FDA writes (HERE IS THE LETTER FROM THE FDA TO RECKITT).

Although its own citizen's petition cites data showing an increasing rate of accidental pediatric exposure through early 2010 and the death of a child in June 2010, Reckitt did not seek to halt marketing of multi-dose containers of Suboxone tablets for more than two years. And the FDA then adds that as of last August, Reckitt indicated the Risk Evaluation & Mitigation Strategy, or REMS, had been "successfully implemented" and no changes were planned.

Then, the FDA takes up the anticompetitive complaints from generic drugmakers. "The timing of Reckitt's September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for thie product was expected to begin, cannot be ignored," write Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research.

There is more to this, however. As we reported previously, generic drugmakers were told by the agency to work with Reckitt on developing a class-wide REMS for their tablets. But the effort stalled, and Reckitt was accused of failing to give any indication that it will cooperate in designing such a REMS and has not shared some of the specifics with the generic drugmakers.

The shared REMS requirement "established a perverse incentive structure and allowed Reckitt to engage in... mishcief," wrote lawyers for Actavis (ACT). "...We are aware of no other context in which a New Drug Application holder has been given direct control over the approvability of Abbreviated New Drug Applications for follow-on generic products" (here is the Actavis letter; read more from the Amneal Pharmaceuticals response here and its latest statement here. The FDA aproved generics from both drugmakers).

The FDA did not actually deny the petition over this issue, but Woodcock did write that the matter is being referred to the FTC, "which has the administrative tools and expertise to investigate and address anticompetitive business practices." And so, instead of getting the FDA to take its side, Reckitt not only lost agency backing, but must now also contend with an FTC probe into its actions.

As we noted the other day, Reckitt already faces lawsuits filed by Suboxone customers, including the Rochester Drug Cooperative, which 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).

"It seems that FDA’s response will dovetail nicely into the private antitrust lawsuits already filed against Reckitt Benckiser for its transparently illegal and monopolistic behavior," says one source familiar with the FDA and its deliberation over citizen's petitions, but who asked not to be named. We asked Reckitt for comment and will update you accordingly.

31 Comments

Feb 25, 2013 - 1:16am
Even the most casual observed can tell that this was a BS move by Reckitt Benckiser motivated by noting but $$.

Its not like its even a novel drug -- just the combination of two EXISTING compounds! Additionally, NOTHING about this combination justifies its absurd price of ~$10 per dose. Reckitt Benckiser is just another money hungry company trying to gouge the consumer, and I hope the FTC thoroughly investigates this case.

Anyway, the FDA finally did the right thing for a frickin change.

Feb 25, 2013 - 6:08am
Question: Didn't Purdue manage to get and keep generic competitors off the market, at least for a period of time?

While this may be a company that has used aggressive strategies, given the recent Alabama ruling and FDA precedent, brand name companies will probably take more aggressive steps to protect themselves from generic competition.

Feb 25, 2013 - 5:19pm
Let's hope this is the final nail in the coffin for patent holders use of citizen petitions to delay generics. Even GSK surrendered in the antitrust lawsuit over its baseless Flonase petitions.

Of course, Big Pharma in-house counsel will only come up with new ways to protect Blockbuster profit margins - their bonuses depend on it!

Feb 25, 2013 - 7:06pm
Damn right, you don't see Apple, IBM, GM, Toyota, Alcoa, Sony, Hewlett Packard, Boeing, or any other research-based company giving away its IP without a fight.

Nor would you if you had ever invented something of value.

Feb 25, 2013 - 7:34pm
Citizen's Petitions can be valuable to industry when you hire the right K Street guns to run legal interference for you on the FDA docket. We filed a delaying petition on Synthroid in 1997 that took FDA four years to answer concerning the onjections to the FDA classification of levothyroxine as new drugs, and our varuious objections to making LT4 generic.

We were basically able to gum of the works enough to keep generics off the market long enough to bring in an additional two to three billion in revenue. More moolah if you count the time between 1995-1997 when we successfully suppressed the paper by Dong et al which showed bioequivalence between Synthroid and generic LT4's. Things were going great until the Wall Street Journal spilled the beans in 1996.

http://www-hsc.usc.edu/~hrkaslow/Teach/Supplementary%20Material/Synthroid/Synthroid-1996-04-25-WSJ.pdf

Feb 26, 2013 - 8:21pm
RB created this market in 2000 with the change in laws allowing doctors to prescribe for addictions treatment in an outpatient setting. They took all the risk, and it was a huge gamble. When they introduced Suboxone in the US in 2003, they had no idea what to expect. Now ten years later, they fought to protect the market THEY invented. Prior to Suboxone, patients had to go to methadone clinics (yuck) or expensive detox centers that didn't work. RB had every right to protect its drug....these generics wouldn't even exist if it weren't for RB and their gamble. Now everyone wants a piece after RB did all the hard work. Generics, knock off products, etc.
Mar 12, 2013 - 3:41pm
So we know that Boo Hoo is a communist who is in favor of big pharmacutical companies making billions of dollars while the patients that need their medications go broke. Do you understand that we are paying between $10-12 dollars PER PILL? I pay over $600 a month. Plus all my bills, do YOU have that kind of money? And yes, people NEED this medication. Why is it okay for all other medications whose patent has run out to have more affordable generic options but suboxone should NEVER have a generic? This company is money hungry and keeps increasing the cost of suboxone and really thought they would get away with denying generic versions. I bet the world that if it was a medication you PERSONALLY take you would be crying your little tear ducts out if there were no generic. You dont understand anything about this drug so educate your little ignorant mind before commenting. Go do something productive with your life.

I am all for my Rx being cheaper, which it was today since the generics were released recently, THATS GREAT! Addiction is a life long battle, I def know that. Just wondering why It costs you $600 for your Rx? That would break me as well, may have been impossible actually since, I, like everyone else, have a daughter to support along with paying my rent and all other bills while maintaining a sober life with the aid of Suboxone. Maybe my insurance could possibly be better and that's why mine is so much cheaper. Mine originally cost $30, but I paid $10 for generic, so it is a significant price drop :) I just hope your doing the right thing all around, staying sober, working and contributing to society but also making sure your spare time after that is used wisely and PRODUCTIVELY. Ya know, so you don't relapse and take steps back. Meetings are very positive and motivating...IMO though AA is the meeting to attend because my experience with NA wasn't good, there were ppl who clearly weren't clean and were just there to socialize and get connected. I can only speak for where I'm from in MA though. Anyways good luck and I hope you get generics as well :)
 

Mar 12, 2013 - 5:13pm
Shut up, why don't you take responsibility for your disease and get yourself into NA and get a sponsor. Meetings are free, a buck if you want to throw it in the basket. I love how you junkies keep blaming society or your doctors for creating your addiction and how the Blue Meanies, ie Big Pharma is keeping you from getting clean. Like the saying goes:

YOU ARE RESPONSIBLE FOR YOUR ADDICTION; YOU ARE RESPONSIBLE FOR YOUR RECOVERY.

Mar 12, 2013 - 5:37pm
@oii - "....YOU ARE RESPONSIBLE FOR YOUR ADDICTION; YOU ARE RESPONSIBLE FOR YOUR RECOVERY...."

I don't think this is the self-righteous yelling you can do at the people in the nursing homes. Different story there, right?

Mar 12, 2013 - 8:05pm
When I visit the nursing homes I yell at the staff, not the patients.
Mar 12, 2013 - 8:14pm
Karma has a way of correcting arrogance including as that of OII.
Mar 12, 2013 - 10:26pm
Ya and i am tired of people judging do you think i asked to have my hip broke during child birth and a kidney disease that required pain medication addiction can happen to anyone and when you can't walk or are in immense pain would you go to the hospital for help or lay there in pain to the point you wanna kill your self ya suboxone is a god send to an extent but the prices outrageous i am raising four children and can barley afford anything with paying for them and this medication so yes i don't think they should be the only company to sell them i truly think the pills are safer then the strips i could sleep with my bottle of pills in my bra and walk around all day with them in my bra a baby could open them strips and you can't fit the box in your bra so you have to put them somewhere a kid could move a chair to get.... either way as long as i have them strip or pill at this point i don't care but they should not cost you more then your house payment
Mar 13, 2013 - 1:17am
I feel for you Sheena, but:

wall. of. text.

Your post is hard to read. please punctuate.

Mar 13, 2013 - 3:45am
I just want to say...kiss my a** to all the jerks who judge some of us who depend on suboxone. We are not all just a bunch of partying losers who want to only stay high all the time. If I were wanting to just get high I wouldn't be paying over 1100 a month for these pills and strips! I was in a severe auto accident that caused severe burns to my body.I didn't have insurance at the time so I was pushed out the door just as soon as possible after being used to taking several i.v. shots of morphine per day for over a month everyday.This in turn triggered the disease of addiction in me! Suboxone has been a Godsend for me,but the cost of these have made my life very hard! I have a good job with insurance, but the cost is so high my insurance refuses to pay for them! This monopoly should have been stopped a long time ago! I am so tired of all of the discrimination we recovering addicts have to endure! I hope whatever company puts out the generic bust these crooks a## on sales! Karma is real and it does eventually come back to visit you....good or bad!

That is terrible and absurd that your NECESSARY Rx is 1100/mo with insurance (thats more than some ppls rent -_-) and whether the insurance  refuses to pay for most of it or all of it...shame on them!!! Well I really hope you got the generics because I did today for the first time and I get mine monthly. The price was reduced from $30 to $10!!! Woohoo :) that's more that half off for me so I hope yours works out in your favor like that!! GOOD LUCK 

Mar 13, 2013 - 8:11am
To paraphrase Chief Brody, "you're gonna need a bigger bra".
Mar 13, 2013 - 8:14am
"I was pushed out the door just as soon as possible after being used to taking several i.v. shots of morphine per day for over a month everyday.This in turn triggered the disease of addiction in me!"

Repeat and rinse:

YOU ARE RESPONSIBLE FOR YOUR ADDICTION; YOU ARE RESPONSIBLE FOR YOUR RECOVERY.

Mar 13, 2013 - 8:45am
"YOU ARE RESPONSIBLE FOR YOUR CANCER YOU MUST BE RESPONSIBLE ENOUGH TO DIE QUICKLY, LEST YE BANKRUPT YOUR FAMILY."

-Big Pharma

Don't worry, my children. They will all burn in Hell.

P.S. Addiction is also a disease. If you can say that about addiction, hold all disease patients to your same idiotic standard....and then burn in Hell.

Cheers!

-JC-

Did you read your comment back to yourself and actually think about it before you hit send? Addiction is a "disease", yes,  but no way in reality could anyone actually compare the two diseases, they couldn't be anymore DIFFERENT. Totally different standards apply to addiction considering its something you make a decision to do, whether the decision was influenced by trauma or whatever is irrelevant, you still had a choice and self created your disease. Do cancer pt's have that choice? I mean we could go on and on about how some cancers are caused by the bad decisions you've made in life, from getting a tan, smoking cigarettes etc. But now we have left room for a debate that would never end. Stick to the facts, realistically they aren't comparable in the slightest. I'm not tryin to attack you for your opinion like you did in your comment response, I just thought your opinion could have been expressed in a different way, maybe a little more mature, and not as sarcastic and rude.....

Mar 13, 2013 - 8:58am
Different standard. Addiction is a self created disease. Once you losers come out of denial you will understand this. Get into a program for crying out loud.

YES!! Addiction may be a disease...BUT, big but here, AGREED with the author of the this comment, Original Indust....AMEN dude, I couldn't have said it better or in a more simple way than that. Addiction is A SELF CREATED disease (yes still a disease though), COMPLETELY DIFFERENT STANDARD ppl. Take responsibility for your addiction and also for your recovery. How can someone take responsibility for their Pancreatic cancer??? insensitive d***s for even trying to put the two "diseases" in the same category, WOW, smh!!!!  -_-
I'm a recovering addict myself who had child hood trauma, but my addiction was my fault for saying yes. I seriously couldn't agree more, I got your back lol!! Check out my reply to their sarcastic ignorant reply to you ;)

Mar 13, 2013 - 10:38am
"YOUR DECISIONS, ACTIONS, AND BEHAVIOR IN LIFE WILL HAVE CONSEQUENCES.

IF YOU SMOKE - YOU MAY GET LUNG CANCER.

IF YOU ABUSE ALCOHOL - YOU MAY GET ESOPHAGEAL CANCER.

IF YOU ABUSE IV DRUGS - YOU MAY GET HEPATITIS C.

IF YOU DO ENGAGE IN THE ABOVE BEHAVIORS AND ARE AFFLICTED YOU ARE SOLEY RESPONSIBLE AND SHOULD BE PREPARED TO ACCEPT THE CONSEQUENCES."

Regards:

DGoR

Mar 13, 2013 - 10:40am
I'm going to join in with OII on this one, at least in part.

The addictive properties of these drugs are troubling. If you take them for legitimate pain, and you become dependent, you need to seek assistance dealing with the problem in a constructive manner. You have the right to be angry that this situation occurred, and created the burden of having to deal with the dependency issue.

On the other hand, the first time you lie to your doctor about pain levels to get medically unnecessary drugs, visit multiple doctors to get parallel prescriptions, or buy/steal street drugs to manage your dependence, you're fully responsible for the consequences of that. The drug did not make you do any of these things.

Ford is responsible when you hit a tree because of sudden brake failure. When the collision occurs because you decided to drive drunk, its on you.

Mar 13, 2013 - 11:20am
Don't mess with Demi God, or me, his pappy, for that matter.
Mar 13, 2013 - 11:39am
@oii - "...When I visit the nursing homes I yell at the staff, not the patients...."

For what? Medicaid billing errors?

War/Slave/Drug Lords on global economic steroids thanks to "military intervention"?

"...same as it ever was..."

whiskey from USA, oil from Arabia, opium from the Karakoran Pass...the 1%ers....Savage flank of the barbarians in full control of medical research in USA...

http://en.wikipedia.org/wiki/Taliban

Between 1996 and 1999 Mullah Omar reversed his opinions on the drug trade, apparently as it only harmed kafirs. The Taliban controlled 96% of Afghanistan's poppy fields and made opium its largest source of taxation.[210] Taxes on opium exports became one of the mainstays of Taliban income and their war economy.[210] According to Rashid, "drug money funded the weapons, ammunition and fuel for the war."[210] In the New York Times, the Finance Minister of the United Front, Wahidullah Sabawoon, declared the Taliban had no annual budget but that they "appeared to spend US$ 300 million a year, nearly all of it on war." He added that the Taliban had come to increasingly rely on three sources of money: "poppy, the Pakistanis and bin Laden."[210]

At least the Ruskies had a big bonfire on their way out...the "dealors" in USA all doing PR wars on Pharmalot comments section - oiy.

Mar 13, 2013 - 2:21pm
dz, you actualy believe, after refering to me as some big shot rich evil greedy c-suite parachutist that I would be impoverished enough to stoop to placing me or a loved one in the grasp of Medicaid?
Mar 13, 2013 - 5:47pm
@oii - Pfffhhht - of course not, but you might have "inwested" in nursing homes and billing Medicaid and Medicare for all the opiod users needs careful bean counter oversight for "shareholders".

"....one for you, one hundred for me., one for you, one hundred for me..."

BTW, I never said this or implied it, you're re-interpreting:

"....after refering to me as some big shot rich evil greedy c-suite parachutist...."

I did call you cheap for being un-relentless in figuring out what that Girl Scout did with the 5 bucks you gave here for a box of cookies. C'mon, getting your buddies to filtch a copy of the Girl Scout Organization's finances to see how much they get to keep from the cookie drive is, well, odd, to say the least. But I guess that's how to get rich, count the pennies someone else gets. Used to be the mafia got 25 cents of every dollar in NJ, what's it now after nanosecond trading by wunderkinder's algorithms on Wall Street? Wait, let me guess, leveraged 40% - so now a buck forty to the mafia for every buck of Fiat $$ printed...hand out another pink slip and follow them home to put up the foreclosed sign...one big happy circle jerk...

Childhood trauma?  Did your shrink tell you that justifies you as a junkie.  Probably false memorey syndrome and DID due to an incompetent shrink.

Ok, I had to comment on this issue. Of course, if u have insurance, the suboxone will be cheap. Idiots like myself, have given them thousands of dollars for this drug! What is really sad is, if u r self pay, the generic is still around $500 to $600. " Thanks for the wonderful generic asshole companies." Makes me want to get off the drug and I plan on it. Bottom line is, self payers get screwed and even the generic is outrageously expensive. So, enough said!!

However, if I had a mental disability or children, I could get the Rx for free.  How is this fair?  I have buddies who get it for free and sell them for $ 20 a pill or film!!  Its just not fair-I go to college, and work full time-no assistance except a little coupon! Give me a break!!!