April 5, 2018

How FDA, the Surgeon General, and NIH plan to target opioid misuse

Daily Briefing

    Trump administration officials this week announced a number of initiatives aimed at combating the U.S. opioid epidemic.

    April 30 webconference: How to develop a comprehensive opioid response strategy

    NIH boosts funds for research on opioid misuse

    NIH Director Francis Collins at the National Rx Drug Abuse and Heroin Summit on Wednesday said NIH under a new initiative called Helping to End Addiction Long-term (HEAL) will nearly double funding for research on opioid misuse from about $600 million in fiscal year (FY) 2016 to $1.1 billion in FY 2018. Collins said Congress made the funding boost possible by providing NIH with an additional $500 million in funding for FY 2018, the Louisville Courier-Journal reports.

    Collins said, in the short term, NIH under HEAL aims to use public-private partnerships to increase the number of treatments available for opioid-related substance use disorders to help prevent overdoses. In the long term, Collins said NIH hopes to find alternative treatments for pain, particularly non-addictive treatments, to prevent opioid misuse. Specifically, NIH under the initiative will:

    • Build a network of clinical trials to simultaneously assess pharmaceutical industry compounds that could be used to treat pain;
    • Build on current research on treatments to curb opioid misuse;
    • Establish best practices for pain management;
    • Evaluate treatments for infants who are born dependent on drugs;
    • Examine ways to expand options for medication-assisted treatments;
    • Examine social and genetic factors that put individuals at risk of misusing opioids;
    • Launch research to study pain;
    • Study post-surgery patients to identify biomarkers that might predict chronic pain;
    • Seek public-private partnerships to develop non-addictive pain treatments; and
    • Work on the national and state level to seek opioid-related substance use disorder treatment options in the criminal justice and health care settings.

    NIH "want[s] to get to the point where we have precision medicine for opioid" misuse, Collins said.

    Surgeon General calls on more US residents to carry opioid reversal treatment

    Separately, U.S. Surgeon General Jerome Adams on Thursday issued an advisory in which he called on more U.S. residents to carry naloxone—a treatment that can to reverse the effects of an opioid-drug related overdose.

    Adams said he hopes expanded availability of naloxone will help reduce the number of opioid-related deaths in the United States. He noted that several opioid-related deaths occur outside of the health care setting, which is why it is crucial for more people to carry overdose reversal treatments.

    "For patients currently taking high doses of opioids as prescribed for pain, individuals misusing prescription opioids, individuals using illicit opioids such as heroin or fentanyl, health care practitioners, family and friends of people who have an opioid use disorder, and community members who come into contact with people at risk for opioid overdose, knowing how to use naloxone and keeping it within reach can save a life," he said.

    Adams said patients and the general public should:

    • Become trained to administer naloxone;
    • Learn the signs of opioid overdose; and
    • Talk with their doctors or pharmacists about obtaining naloxone.

    Adams said he will hold events to discuss the advisory.

    FDA will address illegal online opioid sales, Gottlieb says

    Further, FDA Commissioner Scott Gottlieb on Wednesday said the agency plans to hold a meeting with academics, advocacy groups, and senior leaders of internet companies to address online sales of prescription opioids without valid prescriptions, the Wall Street Journal reports.

    Gottlieb noted that FDA "find[s] offers to purchase opioids all over social media and the internet." He said, "Internet firms are reluctant to cross a threshold—where they could find themselves taking on a broader policing role. But these are insidious threats being propagated on these web platforms."

    Gottlieb urged social media websites, specifically mentioning Facebook and Twitter, as well as internet service providers, to take actions to crack down on the illegal sales of prescription opioids and illicit drugs, such as fentanyl. Gottlieb said the forthcoming meeting will focus on identifying "technology gaps and new solutions" to address illegal online sales of prescription opioids.

    Gottlieb said FDA will ask those who attend the meeting to commit to reducing the number of opioids sold online and to agree to meet again in a year to evaluate progress made on the effort (Ungar, Louisville Courier-Journal, 4/4; Raman, CQ News, 4/4 [subscription required]; Roubein, The Hill, 4/4; Burton, Wall Street Journal, 4/4; Bernstein/Dwoskin, "To Your Health," Washington Post, 4/5; Ungar, USA Today, 4/5; Martin/Wilhelm, "Shots," NPR, 4/5; NIH release, 4/4; Surgeon General advisory, 4/5).

    April 30 webconference: How to develop a comprehensive opioid response strategy

    As the opioid crisis continues to worsen across the country, the provider community sits under a national spotlight with the federal government, states, and patients expecting hospital and health systems to take the lead in solving this epidemic.

    Join our experts on Monday, April 30 to learn how to establish a comprehensive, proactive approach to combating the opioid crisis and get the 29 key performance indicators that will help you track your progress in this ongoing effort.

    Register Now

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