FDA Policy/General

Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion and Fors Marsh researchers say two fictitious television disease awareness and prescription drug promotional communications demonstrated that consumers might be confused about a drug’s benefits and risks. Writing in Health Communication, the researchers say (purchase required) consumers “may incorrectly equate the broadly described symptoms and negative consequences of the disease with outcomes addressed by the drug. This misattribution is problematic because it results in confusion about the drug’s characteristics. To date, these undesirable outcomes have been observed in studies of both prescription drug print promotion and Web links.”

The researchers conclude that conflation of product benefits and risks occurred in TV presentations when participants were exposed to both a disease awareness ad and a product ad, regardless of the similarity or proximity to the ads. Greater conflation of benefits occurred, they say, when the disease awareness and product ads appeared in closer proximity.

“Based on these results,” the study says, “temporally proximate and perceptually similar promotional communications and disease awareness communications are more likely to result in consumers conflating information in the two communications. Nonetheless, even absent temporal proximity and perceptual similarity, some degree of conflation is likely to occur, suggesting that pharmaceutical sponsors could consider these variables when developing product and disease awareness campaigns.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome