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FDA aims to spur new medication-assisted treatments for opioid addiction

The FDA wants to boost the number of medication-assisted treatments available to those suffering from opioid addiction, FDA Commissioner Scott Gottlieb said Wednesday.

The agency plans to release a guidance that will encourage pharmaceutical companies to develop drugs similar to methadone and buprenorphine so those remedies will be available to more Americans, Gottlieb told the House Energy and Commerce Committee on Wednesday.

"At FDA, we're working across the full scope of our regulatory obligations to impact this crisis," Gottlieb said. That "means doubling our efforts to promote the development of new, less addictive pain remedies."

Gottlieb's remarks come just one before President Donald Trump is expected to formally declare the opioid crisis a national emergency. It's unclear if Gottlieb's and Trump's plans are linked. Gottlieb did not provide details on when the FDA guidance would be released.

"Two of the greatest barriers we face are the stigma and the lack of access to medication-assisted treatment, which we know is the most effective treatment for substance use disorders," said Cynthia Reilly, director of Pew's Substance Use Prevention and Treatment Initiative. "We commend the commissioner for tackling both problems."

Clinicians, however, had mixed reactions to the agency's plans to increase development of these drugs.

While many support the overarching goal, it's unclear if having more medication-assisted treatment options will have a significant impact on the crisis.

"In the same way we can't arrest our way out of this problem, we can't prescribe our way out of this problem," said Dr. Anna Lembke, assistant professor of psychiatry and behavioral sciences at Stanford University.

The Trump administration also needs to address the behavioral health and socioeconomic issues tied to opioid abuse, Lembke said.

Gottlieb on Wednesday said the FDA plans to convene experts and stakeholders to review population-level evidence of opioid treatment benefits, including studies that show communitywide overdose reductions after therapy access expanded.

The government and payers also need to address payment challenges for providers treating addicted patients, experts say. Right now, payment for addiction treatment providers isn't on par with primary care and other health services reimbursements for providers, according to Dr. Corey Waller, legislative advocacy chairman of the American Society of Addiction Medicine, or ASAM.

ASAM notes that Medicare co-pays for outpatient mental health and addiction assessments and follow-up visits are set at 50% of charges. Co-pays for other most other services tend to be set at 20% of charges, the group said.

It's unclear if additional FDA guidance will lead to the development of more drugs, according to Dr. Marvin Seppala, chief medical officer for the Hazelden Betty Ford Foundation. He's heard drugmakers doubt whether there is enough business to offset the development costs of additional opioid treatment drugs.

Of the 20.5 million Americans 12 or older who had a substance use disorder in 2015, 2 million had one involving prescription pain relievers, according to federal data.

"The crisis has escalated so dramatically that perhaps the numbers now make sense," Seppala said.


Virgil Dickson

Virgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Project Japan in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.


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