Analysis of the Regulatory Environment For Direct-To-Consumer Prescription Drug Ads: a Case Study of Vioxx

Connie Pechmann, University of California, Irvine
This paper will discuss the four categories of prescription drug promotional materials that the FDA does not routinely review: marketing plans, sales representative’s marketing scripts, letters sent in response to physician queries, and marketing research. The paper will present arguments in favor and against FDA review of such materials to help inform decision-making about the FDA’s oversight role. Merck’s promotion campaign for its prescription drug Vioxx will be used as a case example. The case study will identify similarities and differences between the materials that were and were not submitted to the FDA, and assess their consistency with FDA standards.
[ to cite ]:
Connie Pechmann (2008) ,"Analysis of the Regulatory Environment For Direct-To-Consumer Prescription Drug Ads: a Case Study of Vioxx", in NA - Advances in Consumer Research Volume 35, eds. Angela Y. Lee and Dilip Soman, Duluth, MN : Association for Consumer Research, Pages: 106-108.