Attorney General: Attorney General Joins In 50-State Settlement With Warner-Lambert On Deceptive Marketing Of Neurontin

Connecticut Attorney General's Office

Press Release

Attorney General Joins In 50-State Settlement
With Warner-Lambert On Deceptive Marketing Of Neurontin

May 13, 2004

Attorney General Richard Blumenthal today announced that Connecticut has joined a $38 million nationwide settlement with Warner Lambert for deceptive marketing of its drug Neurontin. Connecticut's portion of the settlement is $25,000. "This settlement is a powerful victory in the continuing battle against deceptive, unfair promotion by pharmaceutical drug companies," Blumenthal said. "It sets a potent and important precedent." The agreement of is part of an unprecedented 50-state settlement announced today that also resolves investigations by the National Association of Medicaid Fraud Control Units and the U.S. Attorney's Office in Boston. Warner-Lambert, a subsidiary of Pfizer Inc., will pay a total of $430 million under these various settlements. The investigation focused on Warner-Lambert promotion of Neurontin for various "off-label" ailments – including various psychiatric disorders, back pain, and headache – even though the scientific evidence supporting the use of the drug to treat these ailments was lacking. Neurontin is a prescription medication approved by the Food and Drug Administration ("FDA") for treatment of epilepsy and post-herpetic neuralgia. Approximately 90% of Neurontin prescriptions are "off label," meaning they are to treat ailments other than those approved by FDA. 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 heavy "off-label" promotion of Neurontin, which led to a dramatic increase in the use of the drug for non-FDA approved ailments. Warner Lambert's methods to promote "off label" use of Neurontin included:

  • Continuing medical education classes ("CMEs") that lacked balance, misrepresented the nature of the class 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 health care professionals for "research" that were, in effect, kickbacks for off label prescribing.

  • Providing incomplete information about Neurontin to the drug reference compendium "Drugdex."

The settlement 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 on Neurontin.

  • Disseminating written materials that have not appeared in peer-reviewed scientific journals.

  • Failing to disclose information about the funding of research and educational events on Neurontin.

  • Failing to require speakers at educational events on Neurontin to disclose any financial arrangements they may have with Warner Lambert or Pfizer, including whether the speaker 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 dode 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 information that is misleading or lacking in balance to drug reference manuals.

  • Violating Federal anti-kickback laws.

Of the $38 million provided under the consumer protection settlement, $28 million will be used for a remediation program and $10 million will be distributed to the participating Attorney General's offices for attorney's fees and the cost of investigation.

Under the remediation program, up to $6 million of the fund will pay for a national advertising program to provide physicians and health care professionals with fair and balanced information about Neurontin and other drugs.

At least $21 million will go to a health care professional and consumer education program, which will award grants to governmental entities, academic institutions, and not-for-profit organizations sponsored by a participating Attorney General.

Finally, up to $1 million of the fund will be utilized to evaluate the effectiveness of the remediation program.


 



Content Last Modified on 6/15/2005 11:56:16 AM