FDA Policy/General

Comments Sought on New DTC Study of Superimposed Text

Federal Register Notice: FDA is seeking comments on a new direct-to-consumer (DTC) study proposal submitted to OMB for approval on Superimposed Text in DTC Promotion of Prescription Drugs. The proposed study seeks to extend previous research on the effects of superimposed text in advertising to today’s modern DTC pharmaceutical promotion. “Although earlier research on the effects of supers in other consumer settings suggests that altering text size can influence consumer comprehension of information, it is unclear if these findings extend to DTC promotion of prescription drugs and are applicable over 20 years later when viewing promotional materials using today’s modern technologies (e.g., tablets),” the agency says. “Moreover, other factors such as text/background contrast may also influence both the understanding of the superimposed information and the effects of text size. The proposed research seeks to update these earlier findings and also to answer new questions concerning presentation of supers. ”The proposed study will seek to answer whether the size of superimposed text, the contrast behind the text, or the device type influences the noticeability, recall, and perceived importance of the superimposed information. Also, it will examine whether these factors influence the recall of and attitudes toward a promoted drug. To view the notice, click here.

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