FDA Policy/General

Stakeholders Question Disease Awareness Ad Research

AbbVie says it is unclear why FDA considers proposed research into disease awareness versus product-specific television ads to be a priority for the public health such that the study is necessary. In comments on the agency’s proposed research, the company reviews agency and industry efforts to regulate advertising. If the agency intends to carry out the research, it says, testing of mock ads for non-existing products in an artificial environment is not likely to produce meaningful results. AbbVie suggests specific items for FDA to consider should it intend to proceed with the research.

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should establish a clear, over-arching agenda for its research to help ensure that all of its research constitutes useful and non-duplicative collection of information. It also calls on FDA to publish a comprehensive list of its prescription drug advertising and promotion studies from recent years and articulate its research priorities for the near future in light of its completed and ongoing research. “Going forward, FDA should use such priorities to confirm the necessity and utility of its proposed research and to ensure proposed information collections serve as meaningful extensions of the agency’s ongoing research efforts.” The trade group’s comments address the role of disease awareness communications, the fact that the proposed study appears to duplicate prior FDA studies, and opportunities for improvement of the quality, utility, and clarity of the information collected if FDA proceeds with the study.

Bayer says that since companies can’t control how often a consumer will view a disease awareness communication, there is limited utility to researching the impact of the number of exposures. And, it says, since companies cannot control if a consumer will see a promotional ad one day or one week after seeing a disease awareness ad, there appears to be limited utility in researching the impact of the temporal separation. It suggests modification to the number of proposed studies and the study design.

Finally, Lilly says it supports an evidence-based approach to regulation of drug sponsor communications and supports FDA efforts to encourage disease awareness communications. The company provides several specific comments on the proposed research design.

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