WASHINGTON, D.C. — U.S. Senator Joe Manchin (D-WV) said he will pursue an investigation into the Food and Drug Administration’s approval of Zohydro, the first single-ingredient hydrocodone drug ever cleared for use by U.S. patients.

“What’s coming out in Zohydro is pure hydrocodone.  It can be crushed.  It can be snorted.  It can be injected.  Two pills are said to kill a human being,” said Manchin.

Zohydro is a painkiller and can contain at least five times more hydrocodone than previously available in combination pills like Vicodin.  Currently, hydrocodone is the most frequently abused prescription drug in the United States, according to information from the Drug Enforcement Agency.

Manchin worked with the FDA to change the scheduling for hydrocodone in an attempt to limit access to it.

“We finally got them, this year, to agree to schedule from a Schedule III to a Schedule II and, by the time they were doing that, they come out and approve Zohydro,” said Manchin.  “Then I go completely insane.”

The FDA approved the powerful and highly addictive Zohydro last year against advice from its own experts.  Members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 against allowing the painkiller to advance in the approval process.

“Pay-to-play” allegations have surrounded FDA conferences held prior to the drug’s approval.  It’s alleged the manufacturer of Zohydro and other makers of painkillers paid for entry into a series of meetings with FDA officials through other academic channels.

Those with the FDA have denied the allegations, but Manchin is not convinced.  He and Senator David Vitter (R-La.) are requesting financial records for two groups tied to the University of Rochester, one of the alleged organizers of the meetings.

Manchin said Zohydro, which could soon be available to patients, has the potential to add dramatically to the already epidemic levels of prescription drug abuse in West Virginia and across the country.  He’s already introduced legislation to reverse the FDA’s approval of Zohydro unless it is reformulated to prevent abuse.

“This is life or death in West Virginia and it’s life or death around this country,” said Manchin on Wednesday’s MetroNews “Talkline.”

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Comments

  • Michael

    Mylan has been down since Zohydro was launched. Enter Manchin, his daughter is Mylan's CEO and markets several narcotic pain medicines that directly compete with Zohydro


    http://seekingalpha.com/article/2108623-mylan-7-different-insiders-have-sold-shares-this-month

  • Michael

    Isn't Manchin's daughter CEO of Mylan Pharmaceuticals, makers of Extended Release Morphine Sulphate 200MG (non-tamper resistant!?!?), oxycodone and hydrocodone/APAP, which are DIRECT COMPETETORS to Zohydro. Mylan is Manchin's #2 campaign contributor. Why isn't he screaming about Mylan's Morphine 200mg, using his math this pill could kill 2 people! What a sorry excuse for an elected politician. His campaign contributor and daughter's company make MORE POTENT OPIATES and he goes after the weakest opiate on the market.
    http://seekingalpha.com/article/2107543-why-they-have-it-wrong-about-zogenix-and-you-would-be-right-to-buy

    • Wowbagger

      Hmmm...

      Why doesn't this surprise me?

      "Daddy, I know you really couldn't get me the MBA, but would you please kill Zohydro for me? That bad company Zogenix is going to destroy my company's bottom line this quarter and make me look bad to the shareholders."

  • 2XLPatriot

    When the pill heads start dropping like ripe apples, maybe someof them wil finally wise up. It's a pipe dream, I know. Look at it from this perspective; If parents become more involved in their childrens lives instead of Playstation, Xbox or TV, maybe the ones at risk will take another path. Rehab only works if the person WANTS to quit. You can't force sobriety. Far too long has our society tried to "Save" the unsaveable. Sad but true, let natural selection take its course and in the process, teach a harsh lesson in reality to those who even consider trying these drugs. Only terminal cancer patients and those with debilitating conditions should have access to this drug. Manchin is a pansy trying to flex his perceived muscles.

  • KK

    Please explain the "pay to play" allegations. I'd love to hear how a little company that didn't even exist yet bought off the FDA. But you won't explain it, because you will look ridiculous. So just keep swallowing you journalistic integrity and print the innuendo. Meanwhile, the FDA can get on with pulling approval on schedule three hydrocodone meds in favor of schedule two Zohydro.

  • Jorge Mendez

    Maybe, you daughter should stop making the addicted drug then your state would be in a great shape. Didn't you give her company a tax break in your state?

  • nobody

    Now is time to open up a funeral home.

  • Jason412

    "Each extended-release Zohydro pill, a painkiller, is said to contain at least five times more hydrocodone than previously available in combination pills like Vicodin."

    It comes in 10, 20, 30, 40, or 50mg. To say "each capsule contains 5 times more" is misleading at best. A 10mg Zohydro contains the same 10mg of hydrocodone as a 10mg Vicodin.

    For Manchin to say "its life or death" is absurd. He didn't bother to mention Mylan is one of the largest producers of Fentanyl, which is estimated to be 80x stronger miligram to miligram than heroin. Also a large producer of 30mg oxycodone, pure oxycodone with no additives.

    • Shauna Johnson

      Jason412,

      I understand there are different dosages which is why I wrote "at least" as a general statement.

      Thank you for providing additional clarity for our readers.

      • ryan

        Will you be doing a story on Sen manchins conflict of interest between him and mylan and his daughter the ceo ?

      • Jason412

        Shauna,

        I apologize if that came off as offensive, that was a comment more directed at what Joe Manchin was saying on Talkline, as opposed to you. I just used your quote as a vehicle to make the point because I assumed by saying "each pill is said" you were paraphrasing his words, since he kept saying it was 5 or 10x stronger than current hydrocodone.

  • mikeyd

    Like I said before joe is and always will be for family and friends what a joke CAN YOU SAY FREE MASTER DEEGREE

  • Take care of home first

    Joe you have a very serious problem rt hear in your own backyard take care of it before you go on this crusade that don't matter to no one there are a lot of dangerous drugs out there and people have a choice on taking them or not but water is a necessity and you and your boys haven't fixed the problem we have here.

  • Manchin lies

    Manchin is spewing lies and half-truths. If Metro News spent 20 minutes researching Manchin the would quickly find out his daughter is the CEO of Mylan, a competitor of Zogenix.

    He trying to nix the competition of his daughter's company.

    Shauna, you're just repeating his lies as though they were true. Disgusting.

  • The Truth

    Don't be fooled by this dirty Senator's hidden agenda folks. Zohydro is safer than the drugs being pumped out by his daughter's company, Mylan Inc. It's all a smear campaign to keep his CEO daughter's company competition down and line his pocket with profits. Stand up WV and vote the corrupt clown out of office. http://bit.ly/1p0TZ1y

  • Cliffcali

    Conflict of interest? Senator Joe Manchin (WV) is leading the terror attack against Zohydro. The link between Mylan pharmaceuticals (which his daughter is CEO) and trying to ban Zogenix's Zohydro ER (direct competitor of daughters company). Also the second highest contributor to Daddy's campain (over $220,000,000.00). What a scumbag pretending like he cares for the people of WV. By the way, Mylan produces more than one opiate painkiller, Hydrocodone (which is what Zohydro is) and extended release Morphine pills stronger than Zohydro without abuse deterrent technology.

  • wvman75

    "Two pills are said to kill a human being,” said Manchin.

    Take three and call back in the morning.

    • Butch

      You need to be reported like the most recent nut that threatened Senator Manchin.

  • ViennaGuy

    You would think that with its advisory committee voting 11-2 against approval that the FDA would stand up and take notice, but I guess not.

    • KK

      The advisory found the medication to be safe and effective. They were concerned about abuse, but all they were supposed to be advising on was safety and effectiveness, which is why the FDA went against the recommendation, which it does about 10% of the time. Now you know.

      • ViennaGuy

        What's to stop someone who has a legal prescription for Zohydro from abusing it? Is that not a safety issue?

        • ryan

          Also zohydro is being crossly miss represented. Inside the capsule are BB's that are very difficult to crush.

        • ryan

          It clearly states not to in the pharmacy print out the goes with each prescription. Also its against the law. I can tamper with my microwave oven and stick my hand or my head in it with possible deadly results but it was never intended to be used recklessly in that manner.

  • gnarly dude

    I prefer mj brownies and pepperoni rolls. That's the route Joe should be on.