Communicating Benefit and Risk: A View from the Pharmaceutical Industry

Abstract

There is a general expectation among the public that all drugs should be safe for all and result in a favorable clinical outcome. The clinical development process for a new drug is both costly (over $1 billion per successful licensed drug) and lengthy (10-15 years). Despite this investment the complete knowledge of a new drug’s safety and efficacy profile does not emerge until it has been on the market for several years. The Food and Drug Administration (FDA) is consulted during drug development as research protocols to assess benefit and risk are developed. The collected clinical data (as well information on how the drug will be manufactured) is reviewed by the FDA who make a decision based on the expected benefit/risk profile of the drug. The overall assessment of risk is dependent on the benefit (and the severity of the medical indication being treated).

The relevant prescribing information for healthcare providers is synthesized in the drug label and this has recently been reformatted by regulation in an attempt to provide better clarity. A wide variety of information is available to patients some of which is regulated by the FDA (patient package inserts, Medication Guides, company-sponsored direct to consumer advertising which also includes drug specific websites) and some that is not (consumer medication information leaflets handed out at the pharmacy, other non-company sponsored Internet sites, blogs, chat rooms, etc.).

PhRMA’s research regarding benefit/risk perception and communication will be the topic of this presentation.