The U.S. Food and Drug Administration (FDA) recently released a draft guidance that is designed to help develop generic abuse-deterrent formulations (ADF) for opioids.
The goal is to create ADF opioids that are just as efficient at deterring abuse as their brand-name counterparts.
Releasing the draft is one way to reassess the FDA’s traditional approach to such opioid medications. The health leaders plan to develop policies that will counteract the opioid abuse epidemic without compromising the effective pain relief that patients can currently access.
“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” FDA Commissioner Robert Califf said. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
To promote that there is further input from people involved in the health industry, the FDA has scheduled a public meeting for later in 2016.
“Collaboration is critical in fostering innovation in the field of abuse deterrence,” Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said. “It is essential that a generic product is no less abuse-deterrent than the brand name product. We look forward to actively engaging in discussions to help inform our thinking about the evaluation of abuse-deterrent technologies.”
