New Head of FDA Pledges to Support Development of Abuse-Deterrent Opioids

The new head of the Food and Drug Administration (FDA), Dr. Robert Califf, told a panel of advisers this week that the agency will support the development of abuse-deterrent opioids, the Associated Press reports.

Califf told the FDA advisers he will do “everything possible under our authority to prevent abuse, save lives and treat dependence.” He was confirmed by the U.S. Senate last week, after some senators said the FDA has not done enough to fight the opioid epidemic.

“What we can do is work with prescribers, professional associations, patient advocates and state and local partners — essentially the entire country — to encourage safe use and disposal of opioid medications,” Califf said Tuesday.

He had previously stated the FDA will add stronger warning labels to the most commonly prescribed opioids. He also pledged to consult more with outside advisers.

Califf said while abuse-deterrent opioids may not be 100 percent effective, “the promise that we are on a path toward products that are effective in preventing abuse both by patients and non-patients is real. And the agency intends to fully support efforts to advance this technology.”

Since 2010, the FDA has approved five abuse-deterrent drugs. According to FDA officials, at least 30 similar drugs are being developed.

Some public health experts warned the benefits of abuse-deterrent opioids may be overstated. It is not clear the new formulations are reducing overdoses or deaths, and most can still be abused if the pills are swallowed, they noted.

“I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse deterrent formulations to do so,” said Dr. Caleb Alexander of Johns Hopkins University.