FDA Plans to Expand Access to Certain Opioids

In a sharp departure from its previous policy, the FDA plans to encourage the use of less harmful painkillers among opioid addicts.

Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb, MD, outlined a plan to combat the opioid crisis, including encouraging widespread use among opioid addicts of less harmful opioid drugs such as methadone and buprenorphine.

“Now I know this may make some people uncomfortable,” Gottlieb told the Committee. “That’s why the third step I’m announcing today is that FDA will join efforts to break the stigma associated with medications used for addiction treatment. This means taking a more active role in speaking out about the proper use of these drugs.”

“Given the scale of the epidemic, with millions of Americans already affected, prevention is not enough. We must also help those who are suffering from addiction by expanding access to lifesaving treatment,” Gottlieb added.

Related article: How Should Opioid Addiction Be Treated?

The Commonwealth of Massachusetts found a greater than 50% reduction in the risk of death from overdose among individuals treated with methadone or buprenorphine after a nonfatal overdose, Gottlieb noted. “These kinds of data have immense implications for insurers and policymakers in deciding how to adopt these treatments.”

Under the FDA’s new proposal, every addict who suffers a non-fatal overdose would be treated with an opioid substitute, for long periods if necessary, or even for life. “Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence,” Gottlieb said.

In addition, President Donald Trump has declared the opioid epidemic a public health emergency, but not a national emergency. The move does not release any money to deal with the drug crisis, but does allow some grant money to be used for several efforts at combatting opioid abuse.

Meanwhile, the FDA also plans to look at 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.”