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Thread: Trump's FDA Tackles Big Pharma On Opioid Crisis

  1. #1
    Veteran Member Madeline's Avatar
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    Thumbs up Trump's FDA Tackles Big Pharma On Opioid Crisis

    It would be difficult for the Trump FDA to do worse than the Obama FDA has done, as to the opioid crisis.

    This is very encouraging news, although far more needs doing:



    The Food and Drug Administration on Thursday asked a drug company to remove its opioid pain medication from the market, the first time the agency has made such a request because of the public health consequences of abuse.

    The agency concluded after an extensive review of Endo Pharmaceuticals’ Opana ER that the “benefits of the drug may no longer outweigh its risks.” The company reformulated the drug in 2012 to make it more difficult to snort, but the FDA said that move actually led to more injections — and a major HIV outbreak.

    FDA Commissioner Scott *Gottlieb, who has pledged to take “more forceful” steps to curb the nation’s opioid epidemic, said the agency’s action reflects its increased focus on the risks posed by the illicit use of opioids. The FDA “is looking broadly at the whole policy framework” used for the painkillers, he said Thursday.

    The medication was approved in 2006 for moderate to severe pain when a round-the-clock painkiller is needed.

    *Snip*

    “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement Thursday. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.”

    If the company declines to remove the product, the FDA will take steps to formally require its removal by withdrawing agency approval.

    In a statement, the company said it was reviewing the FDA’s request but that it “remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”

    Michael Botticelli, director of the Office of National Drug Control Policy for nearly three years under President Barack Obama, said the FDA action is “a real encouraging step. It sounds as if the FDA is using expanded criteria in the way they look at opioids.”

    The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider effects each could have on the nation’s epidemic.

    “This falls in line, I think, with their recently released guidance on how they were going to think of drugs and drug approval,” Botticelli said.

    From 2000 to 2015, nearly 180,000 Americans died of overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved.

    Opana ER brought in $158 million in sales for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site. The company, which is based in Dublin and has its U.S. headquarters in Malvern, Pa., recently announced two rounds of job cuts.
    https://www.washingtonpost.com/natio...=.fc9726421d71

    I hope no Hillarybots here are so partisan, they withhold applause for this vital step towards turning back the wildfire of opioid addiction that is burning down the house for too many American families.

    I still want Trump out, but I realize he has some great policy ideas that we will be losing, if he goes.

    What do you think?
    Thanks from Southern Dad

  2. #2
    Veteran Member Moorhuhn Wanted Champion Hollywood's Avatar
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    Quote Originally Posted by Madeline View Post
    It would be difficult for the Trump FDA to do worse than the Obama FDA has done, as to the opioid crisis.

    This is very encouraging news, although far more needs doing:





    https://www.washingtonpost.com/natio...=.fc9726421d71

    I hope no Hillarybots here are so partisan, they withhold applause for this vital step towards turning back the wildfire of opioid addiction that is burning down the house for too many American families.

    I still want Trump out, but I realize he has some great policy ideas that we will be losing, if he goes.

    What do you think?
    Even a broken clock is correct twice a day.
    Unlike the RW conservatives I will not oppose an idea based on who it comes from.
    Thanks from Devil505 and Madeline

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    Galactic Ruler Spookycolt's Avatar
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    To be fair, is this from Trump or just the FDA?

    I don't recall Trump ever speaking on this issue.
    Thanks from RNG

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    Established Member Coyote's Avatar
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    I think we would be better served to look at the root cause of opioid addiction itself, rather than focusing on a specific medication. Addicts will come up with another source for it, or start using something else. I hope that the people most hurt by this won't be those who rely on it to help manage chronic pain. Having recently been put through something that required me to be on opioids 24/7 for a whole month has given me a little bit more empathy for these folks.
    Thanks from Madeline and Blueneck

  5. #5
    Veteran Member Moorhuhn Wanted Champion Hollywood's Avatar
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    Quote Originally Posted by Spookycolt View Post
    To be fair, is this from Trump or just the FDA?

    I don't recall Trump ever speaking on this issue.
    What does fair have to do with anything here?

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    Veteran Member bajisima's Avatar
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    Quote Originally Posted by Spookycolt View Post
    To be fair, is this from Trump or just the FDA?

    I don't recall Trump ever speaking on this issue.
    He did speak about it when he campaigned here. Opioids are a big issue here. He attended a roundtable discussion as well.

    Trump attends NH opioid round table discussion | NH1
    Thanks from Madeline

  7. #7
    Galactic Ruler Spookycolt's Avatar
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    Quote Originally Posted by bajisima View Post
    He did speak about it when he campaigned here. Opioids are a big issue here. He attended a roundtable discussion as well.

    Trump attends NH opioid round table discussion | NH1
    Didn't know that.

    Sounds like Trump did something everyone will like then.

    Good for him.
    Thanks from Madeline

  8. #8
    Veteran Member Madeline's Avatar
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    Quote Originally Posted by Spookycolt View Post
    To be fair, is this from Trump or just the FDA?

    I don't recall Trump ever speaking on this issue.
    That's his appointee, Spooky. There is probably no lobby as powerful or as active as Big Pharma. This did not happen without Trump's blessing.

    Did you see where Obama's former Director of National Drug Policy praised this move?

    Scott Gottlieb has only been FDA Director for less than a month. That is some "hitting the ground running" level performance on his part.

    https://www.nytimes.com/2017/05/09/h...l?mcubz=0&_r=0

    Too bad Trump hasn't chosen to tweet about this. This is an issue all humans should be able to line up behind him on.
    Thanks from Southern Dad

  9. #9
    Veteran Member Madeline's Avatar
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    Quote Originally Posted by Coyote View Post
    I think we would be better served to look at the root cause of opioid addiction itself, rather than focusing on a specific medication. Addicts will come up with another source for it, or start using something else. I hope that the people most hurt by this won't be those who rely on it to help manage chronic pain. Having recently been put through something that required me to be on opioids 24/7 for a whole month has given me a little bit more empathy for these folks.
    The current epidemic is mainly due to Oxytocin, which can create actual, physical addiction in as little as three months.

    Possibly less.

  10. #10
    Burn it down Macduff's Avatar
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    Quote Originally Posted by Coyote View Post
    I think we would be better served to look at the root cause of opioid addiction itself, rather than focusing on a specific medication. Addicts will come up with another source for it, or start using something else. I hope that the people most hurt by this won't be those who rely on it to help manage chronic pain. Having recently been put through something that required me to be on opioids 24/7 for a whole month has given me a little bit more empathy for these folks.
    Then you already know the root cause for a number of people. Some people start out with legitimate medical pain management needs and become addicted to prescription medications. When the prescriptions run out, then they turn to the streets.
    Thanks from Madeline

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