In an effort to encourage new treatments for opioid addiction, the Food and Drug Administration plans to begin permitting pharmaceutical companies to sell medications that help temper cravings, even if they don't fully stop addiction.
The change is part of a wider effort to expand access to medication-assisted treatment. The agency will issue draft guidelines in the next few weeks. A senior agency official provided details of the proposal to The New York Times.
The new approach was signaled Saturday by Alex Azar, secretary of the Department of Health and Human Services, in remarks to the National Governors Association. Azar said the agency intended "to correct a misconception that patients must achieve total abstinence in order for [medication-assisted treatment] to be considered effective."
While President Donald Trump's administration has generally supported medication-assisted treatment, Azar's predecessor, Tom Price, was not completely on board with it. Price caused an uproar among treatment experts last spring when he dismissed some medications that reduce cravings through synthetic opioids as substituting one opioid for another. He subsequently walked back those comments, saying officials should be open to a broad range of treatment options.
Azar, who took office late last month, said he would work to reduce the stigma associated with addiction and addiction therapy, and would not treat it as a moral failing.
The opioid epidemic is considered the most unrelenting drug crisis in U.S. history. In 2016, roughly 64,000 people were killed by opioid-related overdoses, including from prescription painkillers and heroin.
Noting federal data showing that only one-third of specialty substance abuse treatment programs offer medication-assisted treatment, Azar said, "We want to raise that number -- in fact, it will be nigh impossible to turn the tide on this epidemic without doing so."
Azar's comments echo those of the FDA chief, Dr. Scott Gottlieb, who has made battling opioid abuse a priority for his agency. Gottlieb has moved to reduce opioid prescriptions by doctors and dentists and to promote more medication-assisted treatment, defined as drugs used to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings, and normalize body functions.
The FDA has approved three drugs for opioid treatment: buprenorphine, often known by the brand name Suboxone; methadone; and naltrexone, known by the brand name Vivitrol. The agency says they are safe and effective combined with counseling and other support. But the agency said it would soon publish two guidances, recommendations for drugmakers, on the issue.
One encourages the development of new, longer-acting formulations of existing drugs for opioid treatment. The other, which was described in detail to the Times, said new drugs would be eligible for approval that don't end addiction but help with aspects of it, such as cravings, or overdoses, with the goal remaining complete abstinence.
"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," a senior FDA official said.
The official also said the FDA was seeking medications that can help patients function better and can be helpful when used in combination with therapy and other social support, even if on their own the medications don't completely end addiction. Under the new guidelines, patients and their families will have input in assessing how useful a drug is.
Addiction experts were cautious in their praise of the plan, which should be released in March.
"A more thoughtful approach to measuring meaningful clinical improvement could expand treatment options, but there is a danger," said Yngvild Olsen, medical director of the Institutes for Behavior Resources in Baltimore. "Subjective outcomes that are neither here nor there could encourage the development of products of questionable value."
Dr. Andrew Kolodny, a director of opioid policy research at Brandeis University, said the FDA was smart to look for new treatments but warned that the biggest problem now in treatment wasn't lack of effective medication, but lack of access.
"We already have an effective treatment that people aren't getting access to," he said.
A Section on 02/26/2018