Interview: FDA’s Cohen on OTC naloxone labeling study

Regulatory NewsRegulatory News | 29 May 2020 |  By 

Barbara Cohen, FDA

An over-the-counter formulation (OTC) of naloxone could expand the availability of a life-saving tool in addressing the opioid crisis, since the medication can rapidly and safely reverse opioid overdose. The US Food and Drug Administration (FDA) has developed a model consumer label for OTC naloxone and conducted a consumer behavior study; these results were published this week in the New England Journal of Medicine.


FDA labeling study helps clear path for OTC naloxone Regulatory Focus 28 May 2020.

Regulatory Focus interviewed the study’s first author, Barbara Cohen, to learn more about the study and FDA’s efforts to facilitate the availability of OTC naloxone. Cohen, of the FDA Division of Nonprescription Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, provided highlights of the process and next steps.
RF: What was the thinking behind the FDA’s decision to develop a model consumer label and conduct a consumer behavior study – a departure from the usual product development process?
BC: We had heard from some potential industry sponsors, many of them smaller companies, that the workload and resources that might be involved in conducting consumer behavior regulatory studies were a deterrent to product development of OTC naloxone. These companies, for the most part, did not have prior experience with nonprescription drug development.

Given the magnitude and severity of the opioid crisis, we decided that instead of waiting for companies to develop a comfort level with conducting and submitting studies, we would step in and try to provide a tested model Drug Facts label (DFL) so that all companies – small, medium or large – could be more empowered to move ahead with drug development.
RF: The “cognitive walk-through” that investigators conducted with participants was novel to this study. How were these done, and could they be useful in other studies?
BC: First, the participant was provided with as much time as they needed to privately read the model DFL and then signal to the interviewer when they were finished. A standard label comprehension study would have then proceeded with hypothetical scenario questions assessing the ability of the participant to apply their understanding of what they had read to those scenarios.
However, because this DFL mostly involved steps in a sequence, we quickly realized that scenario questions would not adequately address comprehension of the order and content of the steps. Instead, we decided to employ the cognitive walkthrough process for that part of the label, in which the participants says aloud what they would do. Specifically, participants were asked: “Imagine you were in a situation where you had to use this product on a friend. Talk out loud and explain to me what you would do based on the label.”
The interviewer had a checklist to refer to and document participant responses, the sequence of the responses and areas of stated or apparent confusion as participants were walking through the steps. After that, the interview proceeded with more typical label comprehension questions. We very much view this as a technique that could be used going forward for Drug Fact labels that delineate steps in a process.
RF: How might this study ease regulatory efforts to gain approval of an OTC naloxone product?
BC: The model Drug Facts label that we have developed removes much of the label development work that industry sponsors typically need to conduct. Companies will still need to modify and test any part of labeling that needs to be unique to their DFL, such as the comprehension of the directions for use as it applies to their product.

However, in most cases that will represent significantly less work than they typically would have needed to conduct for an OTC product in a new therapeutic category. We have removed many of the challenges of creating a DFL that needs to be quickly understood by people who may be using the product for the very first time under the stress of an emergency.
RF: Are there other updates you would like to share with our readers?
BC: Since the model DFL was published in the Federal Register last year, we have had several companies come in for serious and substantive discussions about developing an OTC naloxone product. Also, our use of pictograms adjacent to the DFL was an innovation that greatly aided in participant comprehension. Companies can consider adopting a similar approach for products that might benefit from visual depictions to enhance understanding.


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