Drugs

OPDP Plans Survey on DTC Quantitative Claims

CDER’s Office of Prescription Drug Promotion (OPDP) is planning a survey to better understand quantitative claims in direct-to-consumer prescription drug advertising. The office notes that DTC advertising does include quantitative claims about a drug’s efficacy or risks and there is existing guidance, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,” covering some of the general guidelines and how to present such information, but it is not “fully understood how consumers will interpret specific quantitative claims.”

FDA identifies quantitative efficacy and risk information as referring to information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks. After performing a literature review, OPDP says “many questions remain on how best to communicate certain quantitative information about prescription drugs. For example, we do not have sufficient information about how consumers interpret different claims describing medians (e.g., ‘People treated with Drug X lived for a median of 8 months’ alone or in combination with a definition such as ‘In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months’ or ‘A median is the middle number in a group of numbers ordered from smallest to largest’).”

OPDP’s study aims to survey U.S. adults about their interpretation of specific quantitative claims, according to an agency notice. The study plan is currently open for comments until 6/24.

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