Drugs

FDA Finds Consumers Have ‘Mixed Understanding’ of DTC Ads Role

Researchers from FDA and RTI International say that two recent direct-to-consumer advertising studies showed that consumers’ understanding of FDA approvals and its authority were mixed. “Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the first study, expressed distrust of the product and the ad after learning about how composite scores are used,” they write in a Journal of Health Communication: International Perspectives article. “In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits.”

When the agency first announced its intent to study how consumers understand composite scores (see earlier story), it raised speculation that FDA may be modifying its enforcement approach to allow certain types of drug advertising claims that are based on sub-attributes of the composite scores. Companies often seek to base claims on the results from individual attributes when the pre-specified measure of effectiveness is based on a composite score. And FDA has regularly cited companies for claiming effectiveness on these individual sub-attributes. For example, a letter to Biogen-Idec on Avonex cited efficacy claims that were based on individual attributes on an aggregate scale.

“Given the frequency of DTC advertising, it is important to determine whether consumers understand composite scores as they are currently communicated and how best to communicate such scores to lay audiences in general,” FDA said in a Federal Register notice. “Because most DTC prescription drug ads do not explicitly state that they used composite scores to demonstrate efficacy or they provide little explanation of how these scores are calculated, it is also important to investigate whether consumers understand how composite scores are used for measuring drug efficacy.”

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