While the US Food and Drug Administration has no statutory mandate to interpret pharmacoeconomic studies conducted by drugmakers on behalf of their products, in its regulatory role it must ensure that comparative studies make claims that are clearly and definitively proven and justifiable, according to Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
Only the FDA, of all the practitioners of this "relatively new and evolving discipline," must get to grips immediately with what are the standards in advertising containing PE claims, she said. It will be most concerned with the medical outcomes which are put into models for these studies and the establishment of standards in this area, and with establishing parameters for the dissemination of this information.
PE Draft Published "To Gain Feedback" Meantime, the FDA's Division of Drug Marketing, Advertising and Communication has published its proposals for enumerating the principles which it will use when reviewing PE claims in promotional materials. The Division stresses that the purpose of the draft is to obtain feedback on the issue; it does not represent FDA policy or guidance. Moreover, the Division adds: "these principles are not intended to apply to the conduct, analysis or reporting of those PE studies intended to serve as a basis for scientific exchange; several other documents have been advanced to guide the development and accurate reporting of such PE evaluations."
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze