WASHINGTON — Scott Gottlieb, commissioner of the Food and Drug Administration, announced new steps the agency would take to promote the use and development of medication-assisted treatment for substance use disorder at a House hearing on Wednesday.
Gottlieb also rapped the insurance industry for what he called “often inadequate” coverage of existing therapies that combine counseling and medication-assisted treatment.
“To tackle the treatment gap, FDA is planning to convene experts and stakeholders to discuss the evidence of treatment benefits at the population level — such as studies that show community-wide reductions in overdose following expansion of access to therapy,” Gottlieb said.
Widely viewed as one of the Trump administration’s most effective and popular political appointees, Gottlieb has made efforts to address the opioid crisis a signature issue since winning confirmation to lead the FDA in May.
He continued that emphasis during the hearing before the House Committee on Energy and Commerce, outlining a three-pronged approach to encouraging greater MAT use.
The FDA, Gottlieb said, will issue guidance for development of new MAT options, promote efforts to decrease stigma surrounding use of medication in treating substance use disorder, and take further steps to promote use of existing therapies.
“There’s a wealth of information supporting the use of these medications,” Gottlieb said. “We’re focusing on the data in the drug labeling that can help drive broader and appropriate prescribing. So one concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA.”
Gottlieb at one point referred to “all three” options for medication-assisted treatment, presumably referring to methadone, buprenorphine, and naltrexone, a newer formulation for a monthly injectable treatment that blocks many of the sedative or euphoric effects of opioid use.
Many addiction treatment experts, however, are not fully convinced by the results of an early study indicating naltrexone is as effective as more traditional, daily administered MAT.
Expanding access to medication-assisted treatment was among the key recommendations of a White House panel when it released its interim report in late July. That commission’s final report is expected next week.
President Trump pledged last week to declare the opioid crisis a national emergency, and an email from the Office of National Drug Control Policy obtained by STAT invited policy stakeholders to “an event on the nationwide opioid crisis” at the White House on Thursday afternoon.