Scott Gottlieb, M.D.
Commissioner of Food and Drugs, U.S. Food and Drug Administration, U.S. Department of Health and Human Services
The opioid epidemic continues to have a tragic human and financial toll on individuals, families and communities throughout this country. More than 2 million Americans have an opioid use disorder (OUD), and millions more are seeking to help their loved ones get the medical and recovery support they need.
One of the ways the U.S. Food and Drug Administration (FDA) is supporting those with OUD is by using their personal experiences to inform drug development and review considerations. Our goal is to help every American who needs support to get into recovery, and to find new and better ways of treating addiction.
With that in mind, the FDA recently held a meeting to hear directly from those personally impacted by this crisis. We’re extremely grateful for the invaluable perspectives shared by the more than 100 individuals with OUD and family members who participated in person, via webcast or by providing written comments.
One of the strongest themes in the feedback was the impact of the unwarranted stigma and social discrimination they often experience, and the devastating impacts of OUD on their careers and relationships.
From stigma to success
OUD should be viewed similarly to any other chronic condition that is treated with medication, but overcoming the stigma surrounding it will take time and education. One thing is clear and backed by science: Despite what some may think, individuals who successfully transition into medication-assisted treatments (MAT) are not swapping one addiction for another.
With the right treatment and support, recovery is possible, and individuals are able to regain control of their lives and end the hardships that come with opioid addiction. MAT relies on FDA-approved drugs that stabilize brain chemistry, reduce or block the euphoric effects of opioids relieve physiological cravings and normalize body functions. Combined with counseling and other recovery supports, MAT is often the most effective therapy.
We’ve also heard that managing OUD is not “one-size-fits-all,” and it’s important to find treatment that works best for each individual. Additionally, meeting participants discussed the need for long-term treatment, difficulties adhering to and accessing treatment, as well as struggles with relapse.
We agree that more treatment options are critical, and we’re taking steps to help facilitate the development of new treatments and new formulations of existing drugs that could have attributes that are better tailored to individuals’ needs. We’re also facilitating the market entry of generic versions of approved MAT drugs to help improve access. Most of all, we’re committed to doing our part to tackle the stigma that can be associated with MAT. We encourage health care professionals to ensure patients are offered an adequate chance to benefit from these therapies.
Scott Gottlieb, M.D., Commissioner of Food and Drugs, U.S. Food and Drug Administration, U.S. Department of Health and Human Services, [email protected]