Drugs

Proposed DTC Research on Ad Product Endorsements

FDA is seeking comments on two proposed studies entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The agency intends to examine four types of endorsers in the studies (celebrity, physician, patient, and social media influencer) and it will examine whether the presence of a disclosure of their payment status influences participant reactions. It also proposes to test two different types of disclosure language — one direct and more consumer-friendly, and one less direct, according to an FDA notice.

In both studies, the agency says it is interested in the “role of endorsement and payment status on participants’ recall, benefit and risk perceptions, and behavioral intentions.” Study participants will view one promotional piece and answer questions through the internet. “Dependent variables will include attention to disclosure statement and risk/benefit information; retention of risk/benefit information; recognition of piece as promotion and endorser as paid; perceived benefits and risks, attitudes toward the product, endorser, and ad; and behavioral intentions such as asking a doctor about the drug,” FDA says.

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

Read more

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