The US Food and Drug Administration (FDA) is working hard to make sure that generic versions of abuse-deterrent opioids are just as deterrent as the brand named opioids.
“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,” said FDA Commissioner Robert Califf, M.D.
“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,” he added.
FDA is encouraging industry to develop pain medicines – opioids in particular –that are far more difficult to abuse. Abuse-deterrent characteristics make certain types of abuse, like as crushing a tablet in order to snort the drugs, or dissolving a capsule in order to inject it, more difficult.
The draft guidance issued in March (“General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”) includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse.
The guidance for generic abuse-deterrent opioids follows the agency’s final guidance for brand name opioids, “Abuse-Deterrent Opioids – Evaluation and Labeling,” which was issued April, 2015.
The FDA will hold a public meeting later this year to discuss the draft guidance on generic abuse-deterrent formulation (ADF) products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse.
“Collaboration is critical in fostering innovation in the field of abuse deterrence,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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.”