Despite the limitations of the monograph process, CDER responds to emerging safety problems for OTC ingredients, with loperamide the latest to go under the center's post-marketing scrutiny.

The anti-diarrheal ingredient is being used in high doses by some people as an intoxicant or by others to help endure withdrawal from opioid abuse. Some abuse is leading to cardiac arrhythmia, including some fatalities.

"This is one that is the subject of an ongoing FDA review so I can't really say that we know what to do yet," Throckmorton said, noting loperamide has been "called the poor man's methadone."

He pointed out the loperamide evaluation is an example of CDER looking at the potential impact on public health when an OTC ingredient is misused or abused, a question that should be addressed in product development.

"We have to broaden our thinking, think about the potential impact, the public health impact when it's misused and abused. The industry and developers have a similar responsibility to help think about that same public health impact, to do more than just the minimum," Thorckmorton said.

"There are important things for us to be finding ways to support and incentivize developers as effectively as we can. It's an important area of work for us within the center."

CDER Talks Switches, Monograph 'More Than Ever,' But Mum On Changes

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