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.
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As part of his promise to raise rates of MAT use, Azar said that the FDA would soon unveil two draft guidance documents, intended for drugmakers, that would help improve patients’ ability to access MAT and “correct a misconception that patients must achieve total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.”
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 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.
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The FDA is expected to release these draft guidance documents sometime next March, the NYT reports.
Original article here.
Written by Ed Cara 2/26/18