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

  • Chad Nutter

    It doesn't matter what is legal or not. It doesn't matter what is safe or not. It doesn't matter if it's ethical or not. What DOES matter is people still make their own choices. People will abuse drugs if they choose to, prescription or not. Population control is the overwhelming issue here and everywhere in this day and age. The deadliest drugs are the legal ones, for a reason. In order; tobacco, alcohol and prescription drugs...the three causes of the most fatalities in the U.S. every year. On another note, give it a couple of years and Mylan will make the generic for Zohydro and Joe will be right on board.

  • ryan

    Zohydro uses the same time release technology as a drug called kadian that contains morphine. Morphine is stronger than hydrocodone. This drug has been out for many years and doesn't have the problems associated with it that oxycontin or methadone have.

  • northforkfisher

    It so sad to see people abuse their power of office to attack something that is not their concern, except for votes and greed. Maybe he should focus on why non FDA approve drugs can be used on the military, but not on piece of s*** prisoners.
    Since the 1st Gulf war, the Dept of Defense has a waiver to give the meds to troops.

  • northforkfisher

    It's sad to see people abuse their power of office to attack something that is not their concern, except for votes and greed.
    Maybe he should focus on why non FDA approve drugs can be give to the troops, but not piece of s*** prisoners.
    The Dept. Of Defense has a waiver to give the meds to troops since the 1st gulf war.

  • Jodi

    Manchins daughter is CEO of MYLAN pharm. His 2nd biggest campaign contributor.

    Her co. makes tamper resistant generic Vicodin. SAME DRUG as ZOHYDRO but with deadly acetaminophen.

    Please someone report this. He is trying to put a little company out of business.

  • Whip

    This daughter was also given a phony degree by WVU. I situation that put a horrible black eye on WVU. A bad situation that she never acknowledged or accepted any responsibility. Joe is a career politician that will never come close to the national political influence carried by Robert C. Byrd. He is insignificant in Washington. This is something that eats at his soul. The very reason he would like to make another run at governor.

  • Woodchuck

    Thanks for the information about Joe's family reasons for this article. Now we know the rest of the story and there is always more to Joe then what comes out his mouth.

  • Voter

    The feds have already cut down the amount of tylenol we can have in these drugs. Most people who take legitimate pain medications will not have a problem. Those who abuse illegal medication are the ones who will overdose. If they aren't smart enough to take illegal drugs properly, well so be it.

  • Facts Please

    So much misinformation only hurts legitimate patient need. Responsible patients should not be penalized for the inappropriate use by those who abuse, divert or misuse medicine. Zohydro 10 mg is equil to Vicodin 10 mg but media only mentions the 50 mg dosage. This new pain med is in no way the most potent available. It is the only single ingredient pain med available WITHOUT acetaminophen and offers a viable alternative to millions. From the liver foundation in 2010, over 30 million have liver disease and should not take acetaminophen. That does not count those with kidney disease and allergies to ibuprofen, acetaminophen and aspirin, found in ALL other pain meds that are far more abused and easier to prescribe, Vicodin, Norco, etc - none tamper resistant. The FDA stated that Oxy is the only real tamper resistant opioid approved to date. There is a NEED for this single ingredient pain medicine without acetaminophen. It is also concerning there is no mention of the Senator having received large campaign contributions from a major competitor Mylan Pharm. whom his daughter is CEO and a maker of generic forms of hydrocodone pain medicine-not tamper resistant and widely abused. It is a sad day when corrupt politics and addicts take precedent over legitimate patient needs.

  • 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.