FDA Policy/General

DTC Ad Study Finds Benefit/Risk Conflation

New studies by FDA drug promotion staff found that consumers conflated a drug’s benefits and risks when they were exposed to both a disease awareness communication and drug advertisement. “Participants more often incorrectly attributed benefits of using the drug to treat or manage the disease (asthma) when the disease awareness communications and drug advertisements were more similar,” an FDA notice says. “Participants also more often incorrectly attributed risks of using the drug when the disease awareness communications and drug advertisements appeared in closer proximity to one another.”

The research found that risk conflation was very low, while benefit conflation was high across all experimental conditions in both studies. “This finding is consistent with prior CDER research of consumer-directed prescription drug television advertising showing better recall of a drug’s benefits compared to its risks and could be due to the differences in how benefits are usually communicated in the two communications,” the agency says. “The benefits of treating a disease featured in a disease awareness communication can be more directly linked to the benefits of a particular drug (e.g., fewer asthma episodes) compared to the risks in disease awareness communications, which communicate the risks of nontreatment. This may make it more difficult to directly link specific drug risks to more general risks of nontreatment.”

FDA says that being aware of the conflation caused by advertising and promotion activities is “important because it offers an opportunity for pharmaceutical companies to consider these features when developing prescription drug advertising and disease awareness communications. For example, companies could space out communications and create greater visual distinctiveness between them.”

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