Science Board Questions FDA’s Opioid Efforts

March 7, 2016

FDA officials detailed their multipronged effort to limit opioid abuse to a skeptical advisory board last week.

Those efforts have included educational outreach to prescribers and consumers, in-house research on abuse-resistant opioid formulations, tougher postmarket approval study requirements on opioid addiction and a review of its risk evaluation and mitigation program strategy for opioid manufacturers.

But multiple science board members questioned the agency’s success thus far.

Anthony Bahinski of the Wyss Institute at Harvard University contended that the FDA’s efforts to convince companies to produce more abuse-resistant opioids had yielded limited results, with only five companies allowed to market their products as such.

“Despite the FDA’s efforts to incentivize deterrence … there was not any impact,” he said. “If we’re not having an impact, then maybe the FDA should redeploy its resources there to other areas.”

Barbara Kowalcyk of RTI International argued that the agency needs to add a maximum dose-warning to opioid medications to prevent more overdoses.