FDA Draft Opioid Guidance Raises Ethical Concerns With Commenters

FDA draft guidance on developing abuse-deterrent opioids requires too much knowledge of, and potentially unethical interaction with, opioid drug abusers, industry commenters on the draft say.

The draft’s recommendation that premarket evaluation of an abuse-deterrent formulation take into consideration the most common routes of abuse for the opioid proposed prompted pushback.

It is “unreasonable” for the agency to expect sponsors to possess comprehensive knowledge about abusers’ habits, AstraZeneca Director of Global Regulatory Affairs Lynley Thinnes said. One alternative would be to consider the ease with which the opioid can be extracted, she added.

Thinnes and other industry commenters also expressed unease with the draft’s preference for supportive studies in “experienced” opioid abusers and its proposal that enrollees receive doses “known to produce high levels of liking.”

“The risk for triggering further drug abuse for the study volunteers cannot be neglected,” Thinnes said.

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