FDA issues draft guidance on generic abuse-deterrent opioids

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a draft guidance aimed at facilitating the development of generic opioids with abuse-deterrent formulations (ADF). The agency said the new draft guidance is part of its plan to rethink how it approaches medications with opioids to combat widespread abuse. 

 

The guidance encourages the industry to develop medicines that are difficult to abuse by crushing pills to snort or dissolving a capsule to inject the contents. The agency has in the past required companies creating brand-name opioids with ADFs to conduct longitudinal studies to assess their real-world effectiveness. 

 

“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 Dr. 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.” 

 

The draft guidance contains recommendations on how to demonstrate that a generic drug has the same abuse-deterrent properties as the branded product. The FDA is planning a public meeting this year and is calling for feedback from stakeholder during the 60-day comment period for the guidance.  

 

“Collaboration is critical in fostering innovation in the field of abuse deterrence,” said Dr. Douglas Throckmorton, 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.”