FDA Announces Plan to Reassess Approach to Opioids


Pill bottles 2-9-16

The U.S. Food and Drug Administration (FDA) has announced it will reassess its approach to opioid medications, in an effort to reverse the epidemic of abuse. The plan comes in response to pressure from Congress, The New York Times reports.

FDA Deputy Commissioner for Medical Products and Tobacco Dr. Robert Califf said Thursday the agency will toughen its response to the opioid crisis, while still allowing patients in pain to have access to effective relief.

The agency said it will convene an expert panel before approving new opioids. It will toughen requirements to study drugs after they come to market, and increase access to pain management training for physicians and other prescribers.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Califf said in a news release. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

The FDA’s plan is part of a wider government effort. Last week, President Obama said he is asking for more than $1 billion in new funding to address the opioid epidemic. The funding would expand access to treatment for prescription drug abuse and heroin use.

Under Obama’s proposal, the new funds would be used to help people with an opioid use disorder to seek and successfully complete treatment and sustain recovery. It would expand access to substance use treatment providers and to medication-assisted treatment for opioid use disorders.

11 Responses

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    February 20, 2016 at 1:02 PM

    Iboga or ibogaine should be legalized to end this long drug crisis, come on lets get on board and its already been proven it works, everyone research iboga it stops addictions with no withdrawals. And you dont have to keep taking it, come on, spread the word,

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    Ken Wolski, RN, MPA

    February 12, 2016 at 9:58 AM

    Removing cannabis from our pharmacopeia 7 decades ago may have resulted in thousands of opioid deaths:
    “From a pharmacological perspective, cannabinoids are considerably safer than opioids and have broad applicability in palliative care. Had cannabis not been removed from our pharmacopeia 7 decades ago and remained available to treat chronic pain, potentially thousands of lives that have been lost to opioid toxicity could have been prevented.”
    “The medicinal cannabis user should not be considered a criminal in any state and the DEA and our legal system should be using science and logic as the basis of policy making rather than political or societal bias.”
    Carter et al. Cannabis in palliative medicine: improving care and reducing opioid-related morbidity. Am J Hosp Palliat Care. 2011.
    Legal medical cannabis has been shown to significantly reduce deaths from prescription opioid painkillers:
    “States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared with states without medical cannabis laws.”
    Bachhuber et al. Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010. JAMA Intern Med. 2014.

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    Michael Rizzi

    February 9, 2016 at 4:04 PM

    This is not to suggest that we give everyone buprenorphine and be done with it, is it?

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    Susan McKee

    February 9, 2016 at 2:33 PM

    The government needs to quite trying to play doctor or the new mess they will have on their hands is the numerous chronic pain patients who need the opiods to have some semblance of a normal life commiting suicide because they can not stand the pain and can not have the meds they need because idiots who are NOT doctors and do not understand what it is to life with chronic pain 24/7 will not allow their doctors to give it to them. Great job FDA And President Obama….NOT

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    Skip Sviokla MD ABAM

    February 9, 2016 at 12:01 PM

    Time to officially raise the patient limit for board certified addiction docs
    Skip Sviokla MD ABAM

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