- From LexisNexis® Mealey’s™ Daily Legal News.
Pfizer has agreed to pay $ 42.9 million to 32 states and the District of Columbia for alleged deceptive marketing of its Zyvox antibiotic and its Lyrica pain drug, according to Dec. 12 press releases by the states’ attorneys general (State of Tennessee, et al. v. Pfizer Inc., No. 12C5083, Tenn. Cir., Davidson Co.).
In complaints filed recently in respective state courts, the attorneys general alleged that Pfizer violated state consumer protection laws by marketing Zyvox as superior to vancomycin although there is no substantial evidence to support that claim. The states say that despite a 2005 letter from the Food and Drug Administration warning Pfizer that an advertisement misbranded Zyvox, Pfizer did not provide adequate guidance to its sales force about what statements were permissible and that the sales reps continued to make superiority claims.
The states are Alabama, Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.
Certain Pfizer sales managers, including a vice president, were aware of and in certain cases encouraged the superiority claims, the states say.
Lyrica Off-Label Marketing
In addition, the states allege that Pfizer marketed Lyrica for treatment of chronic pain, neuropathic pain other than diabetic peripheral neuropathy and post-herpetic peripheral neuropathy and for migraine. Pfizer encouraged its sales force to promote Lyrica as superior to Pfizer’s Neurontin and its generic version, gabapentin, they continue.
The states say Pfizer encouraged doctors to switch their patients from Neurontin to Lyrica and employed sales incentive plans to do so.
In addition to the $ 42.9 million total payment to be divided among the settling states, the final judgment includes Pfizer’s agreement to change its promotional activities; its use of financial incentives for sales and marketing employees; its dissemination of medical information; how it handles unsolicited requests for off-label drug usage; and its practices for providing reprints of medical journal articles, drug samples and clinical research information. In addition, Pfizer agrees to monitor its sales force under a 2009 corporate integrity agreement with the Office of Inspector General in the Department of Health and Human Services.
Promotion To Specialists
Pfizer may not make any claim about a drug that is not supported by substantial evidence. It also may not promote Zyvox or Lyrica to specialists who are unlikely to prescribe the drugs for their FDA-approved uses.
In addition, the company agrees not to seek to include Zyvox or Lyrica in hospital protocols or standing orders unless those orders are for conditions for which the drugs are approved.
The final judgment prohibits the payment of incentives for the off-label marketing of drugs.
Medical Replaces Marketing
Materials developed about the off-label use of Zyvox or Lyrica must be done by Pfizer’s medical staff and not by its marketing staff, the judgment requires. If Pfizer gets an unsolicited request for information about off-label use, it must include a copy of the FDA-approved drug label, a prominent statement that off-label uses are not FDA-approved, unbiased information and a comprehensive list of reference sources.
Pfizer is prohibited from disseminating any information about off-label use that has been rejected by the FDA, under the judgment.
Finally, clinical study information must come from adequately designed studies that show a statistical significance. Pooled data is forbidden.