Marci Kiester

Background

About Marci Kiester

As a Pharmaceutical Advertising Regulatory Expert, I managed a multi-disciplinary team of 17 staff that included the research team, regulatory counsel team, and project management team in OPDP. I am experienced in review of promotional materials across multiple therapeutic areas (e.g, neurology, gastroenterology, diabetes, cardiovascular, HIV, and oncology) along with authoring and secondary review of OPDP letters. I also led teams of OPDP staff in review of launches, accelerated approval submissions, draft product labeling, and TV ads, for prescription drug advertising and promotional labeling within internal timelines. Most recently I am using my regulatory knowledge and experience to contribute to policies that shape the regulatory framework for prescription drug advertising and promotional labeling. I lead and participate in FDA workgroups, collaborating with cross-functional agency teams, to develop policies that consider the regulatory environment, compliance trends, industry feedback, and analysis of OPDP advisory letters to develop policies with actionable recommendations for industry.