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Opioid Awareness

To Stem a Crisis, Bringing Medication to Market Is Only the Beginning

Photo: Courtesy of the FDA

Millions of Americans are suffering from addiction to opioid drugs, and millions more live in fear that a friend or loved one could succumb to an overdose. While we need to take new steps to prevent new cases of addiction and break the cycle of opioid abuse, the staggering scope of this crisis underscores the immediate need to help those already suffering from an opioid use disorder transition to lives of sobriety.

Increasing treatment access ​​​​​​​

The FDA plays a critical role in the approval of opioid addiction treatment medications. There are currently three FDA-approved medication-assisted treatment drugs — methadone, buprenorphine and naltrexone — that have been demonstrated to be safe and effective in combination with counseling and psychosocial support, and we also intend to issue new guidance to spur additional treatment options.

But ensuring high-quality, effective treatments are on the market is only the beginning.

These proven medications are only effective if we can get them to those in need. Unfortunately, many people suffering from addiction aren’t offered an adequate opportunity for treatment. We believe that everyone who seeks treatment should have the ability to work with their health care provider to select the treatment best suited to their needs, and our Substance Abuse and Mental Health Services Administration colleagues are doing important work on this front. At the same time, we’re also taking action against those selling unproven, unapproved products claiming to treat or cure opioid addiction and withdrawal, which may delay real treatment or cause undue harm.

Changing negative perceptions

Part of our work to ensure access to, and wider use of, approved treatments is also using our platform to tackle the unfortunate stigma that is sometimes associated with their use. The stigma reflects a view some have: that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness, craving and withdrawal symptoms. Addiction is defined as more than physical dependence; it often includes psychological craving and ongoing use despite harmful consequences. Among other effects, medication-assisted treatment can help manage these dangerous symptoms, which can in turn help prevent relapse and help return patients to their jobs and families. 

Given the scale of the opioid epidemic, we must devote equal vigor to both preventing new addiction and ensuring access to potentially lifesaving treatment for those currently addicted.

Scott Gottlieb, M.D., Commissioner, Food and Drugs, U.S. Food and Drug Administration, [email protected]

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