Bias at the gate?: The pharmaceutical industry's influence on the federally approved drug compendia

I. INTRODUCTIONAs 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. 1 A staggering ninety-four percent of Neurontin prescriptions in the prior five years, however, were for other (non-FDA) approved uses.2 These other uses effectively tripled Medicaid's costs for the drug between 1998 and 2003.3 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 effe ctiveness, clinical indications, and proper dosing.4 Drugdex included an additional forty-eight uses for Neurontin, ranging from bipolar disorder to the hiccups.5 Two other federally approved compendia existed at that time; one listed seven uses for Neuron tin while the other listed only one.6A 2003 Wall Street Journal article identified several concerns with Drugdex's off-label listing standards.7 First, Drugdex did not adhere to strict FDA protocols. Instead, it often relied on one-patient observations for evidence of efficacy, and sometimes even disregarded studies showing that certain off -label uses were ineffective.8 Second, Drugdex publisher Thomson ran "continuing medical education" seminars for the pharmaceutical industry. 9 Thomson's customers included companies whose drugs are listed in Drugdex, such as Pfizer, GlaxoSmithKline, and Eli Lilly. 10 Third, one of the six authors of the Neurontin section in Drugdex had a financial relationship with Parke -Davis, the company that initially manufactured Neurontin, which Pfizer subsequently acquired.11 This author received at least $75,000 for speaking engagements on the uses of Neurontin. 12 The article cited concerns with this compendium that spanned from personal conflicts of interest that could affect the interpretation of clinical evidence to corporate conflicts of interest that could produce an overall desire to please the pharmaceutical industry.13Concerns still exist about conflicts of interest, relationships with the pharmaceutical industry, and a lack of transparency in the creation of the drug compendia. These concerns are especially rampant in the field of oncology, which features one of the highest rates of prescriptions for off -label drugs.14 For instance, in 2006 the American Society of Clinical Oncol ogy estimated that fifty percent of cancer treatment drugs are prescribed off-label.15 Concerns about the integrity of the four federally authorized drug compendia that provide cancer treatment information are substantial. Problems such as a lack of transparency and a failure to employ systematic methods for determining which drug indications to include are particularly prevalent in the oncology compendia. 16 Furthermore, the steep costs of oncology drugs coupled with favorable reimbursement policies for off -label uses listed in the compendia provide added encouragement for drug manufacturers to go to great lengths to have multiple indications listed for their oncology drugs. 17Not only do these conflicts of interest have the potential to harm patients by condoning dangerous off-label uses, but they also provide a de facto safe harbor for pharmaceutical companies engaged in illegal off-label marketing when the federal government brings actions under the False Claims Act (FCA). 18 Pharmaceutical companies that influence off-label compendia listings can increase drug reimbursement while protecting themselves from false claims liability; federal prosecutors are unlikely to bring actions if the federal health insurance programs already are reimbursing for a drug use listed in the compendia.Part II of this Note explains the relevant legal and factual background for off - label drug approval and marketing under the Food, Drug, and Cosmetic Act (FDCA). It also details Medicare and Medicaid reimbursement for off -label uses and liability for off-label marketing under the False Claims Act. …