Prescription Pills
MetroNews staff photo

WASHINGTON, D.C. — A Washington Post article outlining a clandestine “pay-to-play” scheme involving the Food and Drug Administration and giant pharmaceutical companies has U.S. Sen. Joe Manchin asking for a Senate investigation.

“I want to find out how they have adopted the policy of pay to play,” said Manchin.

The system outlined in the Post article indicated two professors set up a panel in consultation with members of the FDA on how to test the safety and effectiveness of prescription pain killers. Industry representatives, for the sum of $25,000, gained access to the meeting. Manchin was furious over the suggestion regulators could be influenced by leaders of the very industry they are charged with overseeing.

“This is ridiculous to have a government agency and a watchdog to approve what’s on the market to help patients and they are using these kinds of tactics,” said Manchin. “I’m not accusing anybody of doing anything wrong, but I’m certainly going to find out.”

Manchin is especially interested in the matter because for months he has sought a rescheduling of the painkiller hydrocodone. The FDA advisory panel approved the change to drop hydrocodone from Schedule 3 to Schedule 2, which would reduce the amount of the narcotic doctors could prescribe to patients at one time. Manchin said the rescheduling was approved eight months ago on a vote of 19-10 by the FDA panel. However, it’s not yet been implemented and Manchin said he’s been unable to find out why.

“This is ridiculous to have a government agency and a watchdog to approve what’s on the market to help patients and they are using these kinds of tactics.” — U.S, Sen. Joe Manchin

“If I find out that’s their reason because someone with the pharmaceutical industries who make these drugs don’t want anyone to throttle back their ability to sell as many as humanly possible,” Manchin said. “Then I’m going to be looking deeper than just changing the policy, I’m going to be looking if there’s criminal intent involved.”

Manchin sent a letter Wednesday to FDA Commissioner Margaret Hamburg outlining his questions about the reported meetings. Manchin wants to know the date, time, and location of any and all such meetings and how much participants paid the federal agency to attend. His letter also requested the companies that participated, the topics discussed, and any FDA policy that resulted from the gathering.

The Senator said he plans to seek out participants in the meetings to testify under oath at a Senate committee hearing on the investigation.

 

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Comments

  • Highlander

    Doing away with the FDA would be the best solution. That agency is slow to approve treatments that have been shown to work in other countries. Like most other agencies their employees make regulations that hinder one company to benefit another company and then they go to work for the company they helped.

    • Bigfish

      That would be a really good idea. Can you imagine the damage these snake oil salesmen could do if they were unsupervised? We need the FfDA.

  • 2XLPatriot

    Maybe he's furious because he's not getting a cut of the money changing hands.

  • realitycheck

    apparently his daughter's company didn't get the invite and Joe's mad about it....

  • To the Raleigh

    I just wish he would get furious over something that matters. Perhaps, the IRS illegally targeting people. President Obama changing his own healthcare law to exempt whomever he wants or how about the fact the Federal Government spends billions of dollars more each year than it brings in.

  • Joe

    So would the reclassification of the medicine referenced to another classification give Milan a competitive advange for other products the sell or developing?

  • wvman75

    I know we have a problem with prescription drug abuse in our state, but I'd just like to see Manchin's medical degree before he starts telling physicians what and in how what quantity they are permitted to prescribe to their patients.

    If he can prove that someone bought influence from government, then that's a different story. He can see those folks are prosecuted. But, until it's Doctor Manchin, he can pipe down and actually represent the interests of West Virginia instead of following Obama into Socialism and disdain for the industries that keep our citizens working what high paying jobs there are.

    Oh, and keep your mitts off my Second Amendment rights. I don't care what Obama told you.

    • wvman75

      That should be "what and in what quantity". For the grammar police out there.

  • Joe

    Sen. Manchin:

    Why are you allowing you and your staff to be exempted from the Healthcare Exchange and accept subsidies not available to other Americans? The President has wrongly issued guidance stipulating you could do that, but why did you not take the ethical high road of following the law as written and declined.

    Since you brought "following the rules" as a topic of debate to the table, I believe this is a fair question.

    Also, @Wisdom, are you saying Manchin has a relative that runs a pharmaceutical company? Not sure what your comment meant.

  • wvwisdom

    Mr. Lawrence and Metronews insult their readers by omitting any mention of the Mylar pharmaceutical company and its CEO Heather Manchin Bresch. Are your readers so stupid or unthinking that they don't realize that Joe did this to help Mylar?
    As Reagan said: "Government is not the solution to our problem; government IS the problem." And "government" includes senators who don't try to cut back agencies such as the FDA -- which do more harm than good -- but rather try to get the agencies to favor politically connected firms such as Mylar.

    Another tip: read Manchin's statements closely and you'll see that they don't quite make sense. Who is "they"? What is he "going to find out"? What "policy" should perhaps change? That sort of incoherent vagueness is vital when a politician wants to get attention but really has nothing to say.

    • MKU

      It's Mylan.

    • Chuck

      Are you intentionally misspelling the name of the company?

    • Wowbagger

      You have an interesting point. The generic pharmaceutical industry is all about gaining an advantage in being the exclusive provider of a drug when the patent expires for a limited time and charging a big price during that limited period. This is always a legal issue and the reason Milan and other generic companies have big legal departments.

      A CEO with a Senator for a father has an advantage allowing subtle pressure to be applied to the FDA. This could even happen without the Senator's full knowledge, especially since Joe doesn't have a law degree and is relatively new to the drug business.

    • DWL

      Guess it requires one of those”earned” special degrees from WVU!

  • RHytonen

    "Manchin was furious over the suggestion regulators could be influenced by leaders of the very industry they are charged with overseeing."?

    Seriously?

    WHAT ABOUT COAL, OIL, AND NOW GAS??? Especially in WV, where they EVEN own the DPA and the COURTS!

  • ScobyD

    Obama be a democrats. Joe be a democrats. They be pals!

    • RHytonen

      Joe Manchin is NO DEMOCRAT!

      Have you ever before heard of a "Democrat" member of a coservative, INDUSTRY organization like ALEC?

      • RHytonen

        Typo: "conservative"

  • Chris

    Not to change the subject but I wish metro news or someone would do an article as to why Joe was marching in the Forest Festival parade Saturday in Elkins instead of being in D.C working on the budget. He claims how he is working hard to cross the isle but he wasn't working on Saturday.

  • C.H

    You cant say Joe ever misses a chance for self promotion.

    • Luke

      Never misses the chance to change the subject when he says one thing and then votes the other way. "Obamacare's individual mandate should be delayed and the law amended" but then he votes with Harry Reid to defeat a bill that does just that.

      • James

        Right on Luke !!

  • Bill Hill

    If this is true, then you have the answer to the question of why healthcare is so costly. I doubt seriously this is the first time this has happened and doubt seriously Manchin wasn't aware that it was taking place.

  • James

    Come on Joe, with what is happing in Washington D.C. with Obama the Budget and the rest of your Colleges, what's new !!

  • RogerD

    Is Joe just now figuring out that Washington is being run the "Chicago way"?