Mitchell, Gordon R.
(2024)
Food and Drug Administration Senior Scientist Dr. Kathryn Aikin Undergraduate Class Visit on Direct-to-consumer Pharmaceutical Advertising.
Department of Communication, Pittsburgh, PA.
(Unpublished)
Abstract
This transcript captures Dr. Kathryn Aikin's visit to the "Evidence" course at the University of Pittsburgh, an advanced undergraduate communication class that investigates evidence-based medicine. Dr. Aikin, from the FDA’s Office of Prescription Drug Promotion (OPDP), presents to students as part of their curriculum, offering a real-world application of their studies on the psychological impact and regulatory considerations of direct-to-consumer drug advertising. She provides an overview of the OPDP's pivotal role in safeguarding public health by ensuring truthful and balanced communication of drug information. Dr. Aikin details the Paperwork Reduction Act's (PRA) influence on public feedback collection for a proposed FDA study, highlighting the criticality of the public's role in shaping research and policy through a structured comment process involving both the FDA and the Office of Management and Budget (OMB). The transcript includes a student-led Q&A, exploring the FDA's strategies for achieving diverse and inclusive participant recruitment for studies, factoring in variables such as health literacy and internet access. Dr. Aikin underscores the FDA's commitment to representing diverse populations through methodological adjustments like over-recruitment and data weighting. A student's suggestion for an FDA-endorsed informational website leads to a discussion on enhancing consumer engagement and the utility of centralized resources. Dr. Aikin's interaction with the class enriches their understanding of evidence-based communication within the context of public health and regulatory practices. It also supports students opting into an adjacent curriculum assignment enabling them to generate, revise, and submit their own public comments to the FDA during its 60-day comment window (open until February 20, 2024, for this particular study).
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