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.
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.”
Drugs such as methadone and buprenorphine reduce pain in the same way that opioids do, but without delivering the “high” that leads to addiction. They are used to help addicts taper off opioids, but insurers are not always willing to pay for the treatment.
Gottlieb cited data from the Commonwealth of Massachusetts which found 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.”
The FDA, he 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.