DRUGS/FDA/HHS/PHARMA: “In an effort to encourage new treatments for opioid addiction, the Food and Drug Administration plans to begin permitting pharmaceutical companies to sell medications that help temper cravings, even if they don’t fully stop addiction.
The change is part of a wider effort to expand access to so-called medication-assisted treatment, or MAT. The agency will issue draft guidelines in the next few weeks. A senior agency official provided details of the proposal to The New York Times.
The new approach was signaled Saturday by the health and human services secretary, Alex M. Azar II, in remarks to the National Governors Association. Mr. Azar said the agency intended ‘to correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.’
While the Trump administration has generally supported medication-assisted treatment, Mr. Azar’s predecessor, Tom Price, was not completely on board with it. Mr. Price caused an uproar among treatment experts when he dismissed some medications that reduce cravings through synthetic opioids last spring as substituting one opioid for another. He subsequently walked back those comments, saying officials should be open to a broad range of treatment options…
Mr. Azar’s comments echo those of the F.D.A. chief, Dr. Scott Gottlieb, who has made battling opioid abuse a priority for his agency. Dr. Gottlieb has moved to reduce opioid prescriptions by doctors and dentists and to promote more medication-assisted treatment, defined as drugs used to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings, and normalize body functions.”
-Sheila Kaplan, “F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts,” The New York Times online, Feb. 25, 2018