FDA issues draft guidance for abuse-deterrent generic opioids

The FDA has issued a draft guidance encouraging industry efforts to develop generic versions of approved opioids with abuse-deterrent formulations.

The agency said that the guidance represents one of the steps that it outlined in a plan "focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief."

“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,” Robert Califf, MD, FDA Commissioner, said in the release. “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.”

Robert Califf

The FDA noted that the technology will not make opioids impossible to abuse or prevent addiction, overdose or death, but will make opioids more difficult to abuse. The draft guidance is intended to support industry efforts to do this.

"Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding," the agency stated.

The FDA has required long-term epidemiological studies of opioids with abuse-deterrent labeling to evaluate their efficacy in reducing abuse. Because generic products, on average, cost less than brand name products, the FDA is recommending specific studies be conducted "to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product."

The agency plans to host a public meeting to discuss the guidance and other issues related to abuse-deterrent technology.

“Collaboration is critical in fostering innovation in the field of abuse deterrence,” Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”