FDA Policy/General

Industry Faults FDA Research on DTC ‘Implied Claims’

Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that research proposed by the CDER Office of Prescription Drug Promotion (OPDP) on implied claims in direct-to-consumer (DTC) drug promotions “lacks practical utility.” The association’s comment letter says it is not clear what the agency intends to do with the research findings and whether or how the research might inform FDA’s regulatory oversight. PhRMA also says FDA has not explained why new research is needed on whether claims can result in a misleading impression.

PhRMA also questions whether the mock ads proposed for the study will have clear and specific implied claims amenable to testing. It recommends that FDA provide the mock ads for public review and comment before moving ahead with the proposed research.

If the agency decides to continue with the research, PhRMA provides recommendations that it says will enhance the quality, utility, and clarity of the survey.

In its comment, AbbVie calls on OPDP to provide the explicit and implied claims that will be used in the research’s mock ads and the 13 characteristics that will be assessed during the conjoint analysis. It also gives specific recommendations on some of the survey questions.

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