The U.S. Food and Drug Administration plans to encourage widespread use among opioid addicts of less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could draw opposition from those in the addiction field who believe abstinence is the only effective treatment.
Speaking before the House Committee on Energy and Commerce on Wednesday, FDA Commissioner Scott Gottlieb outlined a proposal under which every addict who suffers a non-fatal overdose would be treated with an opioid substitute, for long periods if necessary, or even for life.
The United States is battling a growing opioid abuse epidemic that claimed more than 33,000 people in 2015, more than any year on record, according to federal data.
“I know this may make some people uncomfortable,” Gottlieb said of his proposal. Even so, he added, “FDA will join efforts to break the stigma associated with medications used for addiction treatment.”
Gottlieb’s plan mirrors his recent proposal to reduce nicotine in cigarettes while expanding access to potentially less harmful nicotine delivery devices such as e-cigarettes. Both proposals embrace an approach to substance abuse that aims to reduce harm rather than insist on complete abstinence.
President Donald Trump is expected to declare the opioid epidemic a national emergency this week, two months after declaring his intention to do so. It is unclear whether such a declaration will be accompanied by more funds to address the problem.
Gottlieb cited data from the state of Massachusetts that showed a greater than 50 percent reduction in the risk of death from overdose among those treated with methadone or buprenorphine after an overdose.
This kind of data “has immense implications for insurers and policymakers in deciding how to adopt these treatments,” he said. The FDA also plans to examine expanding the labels for existing medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in deaths.
“Such an effort would be a first for FDA,” Gottlieb said. “We believe that granting such an indication in labeling can help promote more widespread use of, and coverage for, these treatments.”
Methadone, a decades-old drug originally introduced by Eli Lilly & Co; buprenorphine, a 15-year-old drug sold in combination with naloxone by Invidior Plc under the brand name Suboxone; and naltrexone, a drug sold by Alkermes Plc under the brand name Vivitrol, act in a way similar to opioids but without delivering the “high” that leads to addiction. They are used to help addicts taper off opioids.
The FDA, Gottlieb said, will issue guidance for drugmakers to promote the development of new addiction treatments and lay out the agency’s interest in “novel, non-abstinence-based” products.
The stigma around opioid alternatives, Gottlieb said, “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.”
Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, which represents the insurance industry, said health plans will review the labels once they are revised and released by the FDA.
Senate Democrats on Wednesday introduced legislation calling for $45 billion to address the opioid crisis and urged President Donald Trump and Republicans in Congress to support the bill, which would provide funding for prevention, detection, surveillance and treatment.
Purdue Pharma LP, which makes the opioid painkiller OxyContin, said on Wednesday it is the subject of a federal investigation. The company is battling a series of lawsuits from states accusing it of deceptive marketing.
Reporting by Toni Clarke in Washington; Editing by Bill Rigby and Steve Orlofsky