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OCC Joins Historic Settlement Resolving Off-Label Marketing of Neurontin®

Thursday, May 13, 2004

OCC Joins Historic Settlement Resolving Off-Label Marketing of Neurontin®

(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.”
The settlement, by a formal document called an Assurance of Voluntary Compliance, prohibits Warner-Lambert and its corporate parent Pfizer Inc. from the following activities:
  • making false, misleading or deceptive oral or written claims about Neurontin or promoting off-label uses in violation of the federal Food, Drug and Cosmetic Act; 
  • misrepresenting the nature of scientific evidence relating to Neurontin; 
  • making general dissemination of written materials describing off-label uses of Neurontin that have not appeared in scientific or medical journals, or in reference publications;
  • failing to make disclosures about funding of research and educational events related to Neurontin;
  • failing to require speakers at educational events related to Neurontin to disclose any financial relationships they may have with Warner-Lambert or Pfizer, including whether they had been paid to promote Neurontin;
  • failing to comply with the Pharmaceutical Research and Manufacturers of America Code with respect to payments, gifts and remuneration to health care providers (compliance with this Code has previously been voluntary);
  • failing to comply with Accreditation Council for Continuing Medical Education Guidelines (compliance with the Guidelines has previously been voluntary);
  • misrepresenting the credentials of sales, medical and technical personnel;
  • providing to drug reference compendia information that is misleading or lacking in fair balance; and
  • violating federal anti-kickback laws.

Of the $38 million dollars provided under the consumer protection settlement, $28 million dollars will be used in a national remediation program and $10 million dollars will be distributed to the states’ Attorney General and consumer protection offices to be used for attorney’s fees, costs of investigation and consumer protection enforcement activities.

Under the remediation program, up to $6 million dollars of the fund will go toward a National Advertising Program to provide physicians and other prescribers with fair and balanced information about Neurontin and other drugs in its therapeutic class. At least $21 million dollars will be used to fund a Prescriber and Consumer Education Program, which will make grant monies available to governmental entities, academic institutions and not-for-profit organizations sponsored by a participating Attorney General that provide prescribers and/or consumers with fair and balanced information about drugs. Finally, up to $1 million dollars of the fund will be utilized to evaluate the effectiveness of the remediation program.

The consumer protection investigation was led by Vermont Attorney General William H. Sorrell, Oregon Attorney General Hardy Myers, Florida Attorney General Charles J. Crist, Jr., New York Attorney General Elliot Spitzer, Ohio Attorney General Jim Petro, and Texas Attorney General Gregg Abbott.  The District of Columbia’s Office of the Corporation Counsel, which, like a state Attorney General’s office, enforces the District’s consumer protection laws, joined in this multi-state settlement on behalf of the District.

 In announcing this settlement, Mr. Spagnoletti praised the work of his Consumer & Trade Protection Section, including Section Chief Bennett Rushkoff, and Assistant Corporation Counsel Grant Moy, the lead attorney on this case on behalf of the District. 

 “This is another win on behalf of District consumers,” said Mr. Spagnoletti, “and should illustrate to both large and small companies that the Office of the Corporation Counsel is committed to ensuring that District consumers are afforded the protection the law provides.”