FDA Will Expand Access To Medication-Assisted Treatment

By Paul Gaita 02/26/18

Current federal data shows that only one-third of specialty substance dependency programs offer medication-assisted treatment.

HHS Secretary Alex Azar
HHS Secretary Alex Azar made the announcement last week Photo via YouTube

Health and Human Services (HHS) Secretary Alex Azar II said that the Food and Drug Administration (FDA) plans to permit pharmaceutical companies to sell medication-assisted treatment (MAT) for opioid dependency.

The decision is part of a large-scale effort by the FDA to expand access to MAT in an attempt to reduce opioid-related overdose deaths in the United States, which claimed approximately 64,000 lives in 2016 alone. The agency will issue two draft guidances in the coming weeks that will direct drug makers to develop new forms of MAT that, when used in combination with therapy and other forms of support, can provide relief from aspects of drug dependency.

Speaking before a session of the National Governors Association on February 24, Azar said in prepared remarks that "medication-assisted treatment works," and noted that a substantial body of evidence exists to support that claim.

Despite this, Azar noted that federal data shows that just one-third of specialty substance dependency programs offer MAT, a scenario he likened to "trying to treat an infection without antibiotics."

To that end, Azar—a former general counsel and deputy secretary for HHS during the George W. Bush administration, as well as former president of pharmaceutical company Eli Lilly & Co.'s U.S. Division from 2012 to 2016—said that the Trump administration wants to raise that number, adding, "It will be nigh impossible to turn the tide on this epidemic without doing so."

Expansion of access to such treatments is also necessary, Azar remarked, in order to "correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective."

Azar's stance on MAT does not echo the opinion of his predecessor, Tom Price, who drew ire during his short tenure at HHS for dismissing MAT programs as "trading one opioid for another."

Azar's support of such treatment options puts the agency back in line with its own internal policy, which approved three drugs—buprenorphine (Suboxone), methadone and naltrexone (Vivitrol)—as safe and effective means of treating dependency issues, a policy also supported by FDA chief Dr. Scott Gottlieb.

The New York Times noted that the guidelines mentioned by Azar, which should be released in March, will encourage pharmaceutical companies to develop newer, longer-acting versions of existing MAT drugs. The guidelines stated that new drugs that do not end addiction, but help relieve symptoms such as cravings, would also be considered for approval by the FDA.

The Times quoted a senior FDA official who said, "We will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent."

The official also told the Times that the agency may support the notion of using different MATs to address various aspects of the dependency if the approach allows the patient to function better, and if used in conjunction with therapy and other forms of support. According to the official, the new guidelines may allow patients and their families to have a say in determining whether a treatment is effective or not.

Dependency and treatment officials voiced some support for the plan, but noted that it does not completely address the full picture with MAT.

Dr. Andrew Kolodny, director of opioid policy research at Brandeis University, said that looking for new treatments is a step in the right direction, but more effort should be made in allowing more patients to use MAT. "We already have an effective treatment that people aren't getting access to," he told the Times. "The primary challenge is getting it to people."

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.