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.