In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic.
"We'll need to touch clinical practice in ways that may make some parties uncomfortable," Gottlieb said, pointing to restrictions on prescribing and mandatory education for physicians as possible steps.
"Long ago we ran out of straightforward options," he added.
Gottlieb's remarks come as the US continues to struggle with overdoses that claimed the lives of at least 64,000 people in 2016, according to provisional data from the US Centers for Disease Control and Prevention (CDC).
Gottlieb also said the agency will be taking another look at the benefit-risk framework for opioids in light of the ongoing epidemic to inform its regulatory decisions, "including recommending that products be withdrawn from the market."
In July, Endo Pharmaceuticals voluntarily withdrew its reformulated Opana ER (oxymorphone hydrochloride) from the market less than a month after FDA requested that the company pull the drug due to public health concerns over abuse.
Gottlieb announced several steps FDA will take to promote the development and use of medication-assisted treatment (MAT) for opioid addiction.
The agency is also working to draft guidance to promote the development and use of non-abstinence-based endpoints for addiction treatments and support the development of drugs that address symptoms of addiction, such as cravings.
And Gottlieb said that FDA will do more to promote the use of existing addiction treatments such as naltrexone, buprenorphine and methadone.
"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 the broader population-level," he said, adding that the agency is also considering updating the labeling for such drugs to reflect that they may need to be taken for long periods of time.
Lastly, Gottlieb said that FDA will take steps to address the stigma associated with MATs.
"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," Gottlieb said.
Access and Affordability
During his testimony, Gottlieb said that inadequate insurance coverage is part of the reason some people with opioid addictions do not receive necessary treatment.
Gottlieb also raised the point that currently the vast majority of opioids dispensed in the US are inexpensive, immediate release formulations. Going forward, Gottlieb said that insurance coverage and reimbursement could be an issue for new abuse-deterrent or non-addictive pain treatments.
"It will be the case that some of those newer drugs will be more expensive than the older formulations, and I think we need to think about how we provide incentives for those to be used—perhaps preferentially—if we think the public health outcome is going to be better," he said.