FDA Policy/General

Suggestions on DTC Research

Lilly says it supports FDA’s determination to take an evidence-informed approach to regulation of direct-to-consumer (DTC) advertising and notes that the agency’s proposed study of multiple indications in DTC television ads “is a complex study with many variables that will be difficult to control.” In its comment on the agency research proposal, the company offers its suggested improvements to the study objective, research design, and questionnaire that should reduce potential bias and improve study result usefulness.

Novartis’ comment letter says the proposed study fails to consider whether presenting multiple indications of the same disease or condition affects a person’s likelihood to recall and understand the indications. It suggests modifications to the study design.

Bayer thanks the agency “for conducting research that supports the mission of ensuring prescription drug promotion is truthful, balanced, and accurately communicated.” It makes suggestions to “enhance the quality, utility, and clarity of the information collected.”

AbbVie says “DTC advertising of prescription medicines benefits the public health by increasing awareness about diseases, educating patients about treatment options, and motivating patients to contact their physicians and engage in a dialog about health concerns.” The company suggests changes to the research design and study questionnaire.

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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