FDA Policy/General

FDA Wants Comments on Proposed DTC Study

FDA is soliciting comments on proposed research entitled “Disease Awareness and Prescription Drug Promotion on Television.” A Federal Register notice says that when pharmaceutical companies market a new drug, “they often also release disease awareness communications about the medical condition the drug is intended to treat. FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion.”

Prior research, the notice says, has documented that in both print and online contexts, consumers tend to conflate the information presented in prescription drug promotional materials with information presented in disease awareness communications. “Specifically,” FDA says, “the results of these studies suggest consumers incorrectly ascribe benefits to a prescription drug as a result of being exposed to information in the disease awareness communication that broadly describes the symptoms and negative consequences of the disease…. The present research seeks to extend previous studies of print and online promotion to the context of television promotion, and broadly examine how perceptual similarity between the two communication types, as well as their temporal proximity and exposure frequency, may impact the nature and extent of viewer confusion.”

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