FDA Policy/General

Comments on OPDP Quantitative Claims Research

Novartis says FDA research into quantitative claims in direct-to-consumer (DTC) prescription drug ads could be improved if the examples drawn from DTC ads in the marketplace could include for testing some examples of ads that are consistent with FDA product labeling. The company’s comment letter also says that consumer comprehension may be influenced by health status. Since individuals with a health condition or their caregivers are the intended target of DTC prescription drug advertising, it says, “it would be important to ensure that adequate numbers of such individuals are recruited to provide more meaningful results.”

The National Center for Health Research says it strongly recommends that determining patients’ and consumers’ comprehension of information about the relative risk, absolute risk, relative benefit, and absolute benefit of a drug should also be evaluated by the CDER Office of Prescription Drug Promotion in this research. It also asks that FDA be more specific about the number of interviews it plans to conduct to compile the desired information and what type of demographic diversity the agency will require when selecting people to be interviewed. “A relatively small or homogeneous selection of individuals to interview one-on-one could result in unintentional bias in the survey, which in turn would have implications for the results of the estimated 1,100 completed surveys,” the letter 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

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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