Scott Gottlieb, commissioner of the Food and Drug Administration, called Wednesday for the expanded use of medication-assisted treatments for opioid addiction, saying they could reduce overdoses and deaths.
During a House hearing on the federal response to the opioid epidemic, Gottlieb said the agency will issue new guidance to manufacturers to promote the development of novel therapies, including ones that treat a wider range of symptoms. Medication-assisted treatment combines drugs and counseling to combat addiction.
There are three FDA-approved medication-assisted treatments to help people reduce or quit their use of heroin and other opioids such as prescription painkillers: Methadone; buprenorphine, also known as Suboxone, and naltrexone, also known as Vivitrol. All work in different ways. Patients receiving these treatments cut their risk of death in half, Gottlieb said in a statement last month.
Patients should be offered all three options so they and their doctors can decide which is best — but often that doesn’t happen because of inadequate insurance coverage, Gottlieb said Wednesday. He said some people might need such medication for years, if not for their entire lives, and the agency is revising drug labels to reflect that.
A report by the Pew Charitable Trusts concluded last year that medication-assisted treatment is the most effective way to deal with opioid use disorder, far superior to behavioral interventions or medication alone. Compared to non-drug approaches, medication-assisted treatment reduces illicit opioid use and decreases fatal overdoses, the report said. But the treatment often is unavailable because of a lack of programs to help people with opioid problems.
Gottlieb, who became commissioner in May, has said repeatedly that combating the opioid epidemic is his top priority. In his statement last month, he said the agency would step up efforts to ensure treatment for people with addiction problems and mental health conditions.
FDA critics have accused it of helping fuel the epidemic by approving too many opioids in past years and not placing more restrictions on their use. Under Gottlieb, the agency has taken several actions aimed at curbing the crisis. It has stepped up its targeting of fentanyl and other synthetic opioid imports at postal facilities and imposed tougher doctor-training rules on opioid manufacturers. The opioid painkiller Opana ER was pulled off the market earlier this year at the FDA’s request.
On Wednesday, Gottlieb also said the agency is planning a meeting on the benefits of expanded addiction treatment at the broader “population level.” He cited a Massachusetts study that showed a greater than 50 percent decrease in the risk of overdose deaths among individuals treated with methadone or buprenorphine following an overdose.
He said the FDA is conducting research that would lead to a label indication calling for such treatment for everyone who has an overdose, based on data showing a reduction in death at a community level. Such a step would be a first for the agency.
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