The Food and Drug Administration on Monday announced a shift in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.


The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

MAT, coupled with psychosocial counseling, is widely acknowledged to be the standard of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

In its guidance, the FDA said encouraging drug developers to consider outcomes beyond drug use could yield significant health benefits.

The many outcomes Gottlieb cited included mortality (both overall and from drug overdoses) and disease transmission, given the many communities that have seen outbreaks of HIV/AIDS and hepatitis concurrent with increased rates of injection drug use.

“The FDA’s new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery,” health secretary Alex Azar said in a statement.

Despite early missteps in the way some officials, like former health secretary Tom Price, referred to MAT, the Trump administration has long emphasized more evidence-based treatment as part of its means of treating opioid addiction.

But the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options. On Capitol Hill, lawmakers spent much of June battling over whether to expand access to buprenorphine, a provision that eventually became part of a major House bill.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.

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  • Three cheers for John and Jon and the myth of opioid replacement treatment. Yes indeed treatment focused treatment w medication is appropriate and humane. After that we are supporting a repeat of the purdue pharma debacle

    • Comments like this are why people don’t believe Recovery Matters supports MAT. I know that at least half of the providers mostly ones with leadership in 12 step Recovery themselves have a hard time supporting MAT because they know that 12 step recovery saved their lives and i am sure you just want the Same for your patients; I have am happy that they got well and would never say you should only go to meetings for 5 years and then tapper down to 1 if 7 mettiings a week is what you need Forever that’s better than dying. We need to find some common ground and save lives,

    • Thank you, I am soooooo sick of people talking about “medication assisted treatment” as if it was a real thing. Switching from one drug to another is NOT recovery.

    • Their is no chance at Recovery when you do not have a pulse. John I hope you have meaningful relationships and love and that’s really all I want too. I take 8mg of suboxone each day and it has given me another chance to be myself again. I really tried going to meetings and stopping medication but I was not successful. I have 8 years now and maybe I will try to come off medication again: I have a sponsor who also has helped me. I even found a meeting that I get a lot of support from older AA fellowship.

  • Working at a county rehab in Wyoming, I saw Saboxone and Neltrxone prescribed to most clients, Mostly because of the government subsidies and the cash benefit to the doctors and facility for having clients on the medication.

    Even when the clients were trying to stop taking the meds the doctor advised against it. It is better to find the “Why” the client started and deal with the root of the problem and not the symptom of the hurt. In my opinion.

  • Good Grief!
    They must have removed that testimonial that was peddling herbs for herpes. These health related sites have become a magnet for Multi Level Marketers. We don’t see any of these Health Related Sites , challenging the Pseudo Science, in Fact many have embraced it. In the absence of Facts people just create their own! The FDA chose not to enforce the Laws, allowing this stuff to spread like Herpes! The FTC has till not cracked down on peddling false healthcare claims. This Public Relations Release from the FDA, is just one more example. Wanna bet those new “Guidelines” are profitable, they don’t have to be effective.

  • Who knows, in Post Science America, this might seem reasonable, but there is always a catch. The FDA has opened the door to all kinds of nonsense, and industry profiteering. They have been allowing Pharma to peddle dangerous, alternatives for years. The Administration would like to see more prayers, and Alternate Medicine promoted, because it is profitable. after all the complimentary medicine industry has been peddling their useless treatments for a while now. Anything is better than opioid addiction is a good marketing ploy. They are still lying about the death rates, and extent of this epidemic.

  • Flash! NIDA has been researching in all those directions for years. This seems like more Trump initiatives that were really initiated in prior administrations. FDA wasn’t always this political.

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