Beyond the Drug Label: Regulatory-Induced Complexities in Health Information

Abstract

We investigate how content-centric regulation obligates pharmaceutical companies to provide material information that includes balanced information about a drug's benefits and risks to consumers. Paradoxically, this regulatory compliant information results in information so complex it leaves a vacuum of easy-to-digest and useful consumer information. This research compares company-provided information regulated by the Food and Drug Administration (patient package inserts) with consumer-to-consumer provided information, user-generated content in the form of prescription drug reviews (UGC), coded for risk and benefit and calculating readability and linguistic metrics. We apply a consumer-centric information complexity framework which identifies the disconnect between pharmaceutical company practices (as regulated) and UGC (relatively unregulated). Analyses show that UGC drug reviews present risks and benefits in a more balanced manner than manufacturer-created patient labels. Findings identify regulatory complexity as a driver of information inadequacy that may push consumers to UGC, indicating a need for information co-production between consumers, producers and regulators.