Bias at the Gate?: The Pharmaceutical Industry's Influence on the Federally Approved Drug Compendia

Abstract

As of 2002, the Federal Food and Drug Administration (FDA) had approved Neurontin, a drug developed by the pharmaceutical company Pfizer, for two uses, the treatment of epilepsy and pain related to shingles. A staggering ninety-four percent of Neurontin prescriptions in the prior five years, however, were for other (non-FDA) approved uses. These other uses effectively tripled Medicaid’s costs for the drug between 1998 and 2003. Insurance companies covered the off-label uses because they appeared in the Drugdex compendium, a federally authorized listing of drugs that includes evidence regarding the drug’s effectiveness, clinical indications, and proper dosing. Drugdex included an additional forty-eight uses for Neurontin, ranging from bipolar disorder to the hiccups. Two other federally approved compendia existed at that time; one listed seven uses for Neurontin while the other listed only one.