FDA Policy/General

Drug Promotion Research Landscape Analyzed

Researchers from FDA and RTI International say that as empirical research on prescription drug promotion to consumers and healthcare providers has accelerated, an understanding of the current landscape of the activity will help inform future research. Writing in Research in Social and Administrative Pharmacy, the researchers say their rigorous scoping review of the literature from 2012 to 2021 looked at three questions: (1) the extent to which prescription drug promotion has been empirically investigated with consumers, patients, and healthcare providers; (2) the extent to which content and features of prescription drug promotion have been empirically investigated; and (3) the themes across the literature that allow a better understanding of the current landscape of prescription drug promotion.

“Findings from this scoping review suggest there has been an increase in the number of empirical studies conducted on prescription drug promotion over the past decade,” the paper concludes. “Potential areas that warrant further study include examination of emerging technologies, an expanded focus on target populations, and construct measurement.”

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