Drug Advertising Expert on FDA’s Boxed Warning Labels

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In part 3 of our interview with Jenny Markell, BA, she discussed drug advertising trends among Alzheimer’s disease drugs and how FDA suggestions are not necessarily followed.

Formerly known as black-box warnings, the FDA’s boxed warning labels are the strongest safety warning that an approved drug can receive.1 Despite the FDA encouraging drugs with greater risk to include these warnings, the FDA does not require them, leading to adverse events and mixed patient preferences for prescription drugs.

“We wanted to understand how boxed warnings affect consumer perception of drugs,” said Jenny Markell, BA, PhD Candidate of Health and Public Policy at the Johns Hopkins Bloomberg School of Public Health. “We wanted to understand how that would affect consumer perception and preference for the drug. That's because, currently, as I said before, there needs to be risks and benefits in these advertisements. There's no requirement that these severe adverse effects be prominently displayed in a certain way.”

Throughout her career, Markell has conducted a breadth of research on various topics, with some of her most recent research focused on drug markets, prescription advertising, and patient perspectives about it all. She recently sat down with Drug Topics to discuss overarching trends within US drug advertising.

Markell presented her research and discussed common trends and occurrences among both drug manufacturers and the FDA. “I think this just has implications in terms of thinking through whether the FDA should consider requiring that these severe adverse effects listed in the boxed warning be prominently displayed in these ads.”

Stay tuned for the full-length podcast version of our conversation with Markell hosted on Over the Counter this coming Thursday afternoon.

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Reference
Delong C, Preuss CV. Box warning. StatPearls Publishing. June 17, 2023. Accessed April 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK538521/
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