FDA Aims to Destigmatize Drugs as Treatment for Opioid AddictionBy
Agency looks to broaden use of ‘medication-assisted’ therapy
Commissioner: Opponents use ‘flawed interpretation of science’
As the opioid epidemic in the U.S. continues to kill more and more Americans, the Food and Drug Administration wants to lift the stigma on the idea of using drugs to treat a drug habit.
FDA Commissioner Scott Gottlieb told a U.S. House committee on Wednesday that his agency is looking at ways to broaden the use of “medication-assisted therapy,” or the use of drugs such as methadone and buprenorphine, in conjunction with counseling, to help people overcome addiction to opioids.
Some in the medical community, including former Health and Human Services Secretary Tom Price, have looked down on using drugs to treat addiction to other drugs, instead favoring an approach that emphasizes changing behavior. Insurance companies have also been reluctant to cover drug-assisted therapy.
People who need medication to help them stop taking potentially deadly drugs should not be stigmatized, Gottlieb said.
“This attitude reveals a flawed interpretation of science,” Gottlieb told the House Energy and Commerce Committee. “It stems from a key misunderstanding that many of us have of the difference between a physical dependence and an addiction.”
The Massachusetts Department of Public Health recently found that patients who experienced a nonfatal overdose and were treated with methadone or buprenorphine were 50 percent less likely than those that didn’t receive the treatment to die of a subsequent overdose.
The FDA is considering whether it could change the label of medication-assisted therapies to allow them to be prescribed to anyone who overdoses. The agency is also revising the drugs’ labels to better reflect that people may need a lifetime of treatment, he said.
More than 64,000 Americans died last year from overdosing on opioids, which include both legal and illegal drugs such as heroin, fentanyl and OxyContin, according to the National Institute on Drug Abuse.
Buprenorphine can suppress opioid-withdrawal symptoms and decrease cravings. Methodone can also blunt withdrawal and blocks the euphoric effects of opioids. Buprenorphine products include Suboxone, a film that dissolves under the tongue made by Indivior Plc, as well as dissolvable tablets made by many generic-drug companies. Methodone is available in generic form.
The agency has already broadened the availability of training for doctors who prescribe opioids. It also pushed to have the painkiller Opana ER pulled from the market because the agency said its risk of abuse outweighed any benefit it offered. It’s possible the FDA could restrict prescribing practices or mandate physician training, Gottlieb said.