(Washington, DC) District of Columbia Corporation Counsel Robert J. Spagnoletti today announced a nationwide Consumer Protection settlement with Warner-Lambert Company LLC (a wholly owned subsidiary of Pfizer Inc.—the world’s largest pharmaceutical company) resolving allegations of deceptive “off-label” marketing of the blockbuster drug Neurontin®. In settling this consumer protection investigation, Warner-Lambert will pay the District and the states a combined total of $38 million dollars.
This settlement of state consumer protection claims is part of an unprecedented global 50 state and District of Columbia settlement being announced today that also resolves investigations by the National Association of Medicaid Fraud Control Units and the U.S. Attorney’s Office in Boston. In total, Warner-Lambert will pay $430 million dollars under these settlements.
The consumer protection investigation focused on alleged violations of state consumer protection laws that occurred when Warner-Lambert promoted Neurontin for various “off-label” indications—including various psychiatric disorders, back pain, and headache—even though the scientific evidence supporting the use of Neurontin for these indications was lacking. Neurontin is a prescription medication approved by the Food and Drug Administration (“FDA”) for adjunctive treatment of epilepsy and treatment of post-herpetic neuralgia. Approximately 90% of Neurontin prescriptions, however, are for off-label purposes.
It is illegal for pharmaceutical manufacturers to promote the off-label use of their drugs, although doctors are permitted to prescribe for such uses. Warner-Lambert engaged in off-label promotion of Neurontin in a variety of ways, dramatically increasing the prescribing of Neurontin for off-label indications for which there was little or no scientific evidence of efficacy.
Among the methods allegedly used by Warner-Lambert to deceptively promote Neurontin for off-label indications were:
continuing medical education classes (“CMEs”) that lacked fair balance and misrepresented the nature of the CME and provided expensive “perks” to attending physicians;
a “publication strategy” that subsidized the production and dissemination of anecdotal reports favorable to off-label use of Neurontin and were of no scientific value;
payments to prescribers for “research” that were, in effect, kickbacks for off-label prescribing; and
providing incomplete information about Neurontin to the drug reference compendium “Drugdex.”