FDA Expanding Research Ops to Better Fight the Opioid Epidemic

Buprenorphine is one of three drugs currently approved for medication-assisted treatment of opioid use disorder.
Buprenorphine is one of three drugs currently approved for medication-assisted treatment of opioid use disorder.
Photo: Joe Raedle (Getty Images)

The Trump administration’s approach to the opioid crisis has been at times clumsy and nonsensical. With that in mind, it seems the Food and Drug Administration is preparing to take a big step in the right direction: It plans to widen the scope of medication-assisted treatment, or MAT.


In a speech held at the National Governors Association winter meeting this weekend, Alex Azar, the newly-minted Secretary of Health and Human Services, was forthright about the necessity of MAT, which combines therapy with prescribed drugs that reduce craving and withdrawal symptoms, over “detox” approaches that force people with addiction to quit cold-turkey.

“Medication-assisted treatment works,” Azar said, according to a Politico reporter who was present. “The evidence on this is voluminous and ever growing.” Azar also cited data showing that only a third of specialized addiction treatment clinics offer MAT, reportedly lamenting that failing to provide MAT to people living with addiction is akin to “treating an infection without antibiotics.”

Azar’s stance on MAT is markedly clearer than the position of his predecessor, Tom Price, who eventually resigned after a public backlash over his heavy use of taxpayer-funded charter flights. Price said in an interview last May that older MAT drugs like buprenorphine and methadone—opioids that are used to help decrease symptoms while blocking the euphoric effects of other opioids—wouldn’t move “the dial much,” since it only replaced one opioid for another. The HHS was then forced to clarify its support of MAT, following an open letter signed by nearly 700 doctors and researchers involved in opioid use treatment.

As part of his promise to raise rates of MAT use, Azar said that the FDA would soon unveil two draft guidance documents, intended for drugmakers, that would help improve patients’ ability to access MAT and “correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.”

One of these documents, a senior FDA official reportedly told the New York Times, will encourage drugmakers to develop longer-lasting formulations of currently approved drugs, which also includes naltrexone, a newer MAT drug that blocks opioids from reaching receptors in the brain. These formulations would likely resemble the once-monthly injectable buprenorphine product, Sublocade, that the FDA approved via its fast-track review program last November. It’s hoped that longer-lasting drugs would make it easier for patients to adhere to their regimen, Azar reportedly said, especially in rural areas where transportation can be difficult.

The second guidance would explicitly allow drugmakers to submit a wider range of drugs for FDA approval. The document reportedly makes clear that the agency will consider drugs effective for MAT if they relieve aspects of opioid addiction, such as craving and overdoses, even if they don’t necessarily lead to the complete remission of opioid use.


“We will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent,” a senior FDA official told the NYT.

The FDA’s announced plans are welcome news to those like Leo Beletsky, an opioid policy researcher at Northeastern University.


“The immediate endpoint for opioid use disorder treatment must be reduction in overdose and other health risks, with longer-term goal being improved patient quality of life, functioning, and overall physical and mental health,” Beletsky told Gizmodo via email.

At the same time, there are still some misconceptions about addiction treatment that he worries the agency or its officials might be perpetuating.


“I was frankly surprised to see the implication that addiction can be cured and the moniker ‘totally clean’ in [the FDA official’s quote], since this framing does not reflect the current best practice in substance use treatment,” he said. “It betrays lagging stigma in both how policymakers talk about substance use treatment and how it is actually practiced”

He added, “To me this highlights the imperative that, as the FDA increasingly takes on an overdue leadership role in boosting access to lifesaving medication for those suffering from opioid use disorder, I hope they draw on national experts in this space.”


The FDA is expected to release these draft guidance documents sometime next March, the NYT reports.

[New York Times, Politico]


Born and raised in NYC, Ed covers public health, disease, and weird animal science for Gizmodo. He has previously reported for the Atlantic, Vice, Pacific Standard, and Undark Magazine.



Wait, does the Administration understand that this is a Good, Effective, Scientifically Sound thing for the FDA to be doing? Sounds totally against strategy. Assuming this is a Deep State counter-offensive...