FDA finalizes opioid guidance

The FDA issued final guidance for abuse-deterrent opioid evaluation and labeling Wednesday, two years after issuing draft guidance and a little over two months before the June 30 deadline that would have cost the agency $20 million if it had failed to deliver.

When answering a question about the role the deadline may have played in today's release, Dr. Douglas Throckmorton, deputy director of regulatory programs at the Center for Drug Evaluation and Research, said the guidance was issued because of its importance. He added that the agency “worked as quickly as [it] could.”

The guidance includes testing recommendations and the types of information a label will likely include, such as a drug's abuse-resistance properties. While the guidance applies to branded opioids, Throckmorton said the regulator is developing draft guidance for generic opioids.

The guidance says the regulator reserves the right to modify a drug's label “if and when abusers can overcome a technology such that it no longer has a meaningful effect in deterring abuse.” Additionally, it acknowledges that opioids without abuse-deterrent properties will remain available because some patients—such as those in hospice care—may have difficulty swallowing pills. An abuse-deterrent formula that is formulated to discourage crushing would render the drug unusable for those patients.

close

Next Article in Pharmaceutical