FDA Policy/General

New DTC Research Needed: Study

Researchers with CDER’s Office of Prescription Drug Promotion and RTI International say new research into effects of direct-to-consumer drug advertising and promotion is needed given the changing environment in which such ads are used. Writing in Health Communication, the researchers say their review synthesized the research literature on patients’ and prescribers’ perceptions of the influences of DTC ads for prescription drugs on the clinical encounter.

They found that few studies explored the influence of DTC ads on specific disease conditions and there were no studies on patient and provider perceptions of DTC-related behaviors outside of mental illness or anxiety disorders, signaling a gap in the literature.

The review also suggested that the literature on DTC ads and health-related behavior is dated, with about 75% of the studies identified in the review more than a decade old. “Given the changing landscape of DTC advertising, where patients are increasingly exposed to online prescription drug promotion on pharmaceutical Web sites or through interactive social media…, for example, further exploration within this new and rapidly changing era of online promotion is warranted,” the report says.

The researchers say that additional study is needed assessing the influence on specific disease conditions (such as cancer); using strong observational designs to consider a broad set of factors that could explain how exposure leads to behavior; and considering the rapidly changing online presence of prescription drug promotion.

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