Massachusetts Attorney General Martha Coakley and 42 State Attorneys General Reach $33 Million Settlement with Pfizer Inc.
Massachusetts Will Receive Approximately $800,000 for Consumer Protection Programs
"Health care costs are driven up for individuals and the state when drug companies engage in unfair and illegal marketing of products for purposes that have not been approved as safe and effective," said Attorney General Coakley. "This settlement includes strong and comprehensive rules to prohibit Pfizer from promoting its drugs improperly. We will continue to hold drug companies responsible for their conduct and halt improper promotion of drugs."
The settlement resolves the Attorney General's allegations that: (1) Pfizer engaged in unfair and deceptive practices by marketing Geodon for a number of "off-label" uses that were not approved by the U.S. Food and Drug Administration (F.D.A), (2) Pfizer misrepresented the safety and efficacy of Geodon, and (3) Pfizer illegally promoted the drug for unapproved uses such as pediatric use and use at high dosage levels.
The settlement contains comprehensive injunctive terms prohibiting Pfizer from promoting Geodon for any off-label use; from using grants or Continuing Medical Education (CME) to market Geodon; from making false or misleading characterizations of scientific data in promotional materials; and from rewarding sales staff based on volume of off-label prescribing. In addition, the settlement requires Pfizer to clearly and conspicuously disclose serious risks associated with Geodon, to disclose information about grants and CME on its website for at least two years, and to disclose, via a prominent and readily searchable listing on its website, all of its payments of at least $25 to any U.S. physician, made for whatever purpose.
Off-label prescribing of pharmaceutical products by physicians - the writing of prescriptions to treat a condition for which the drug is not approved by the F.D.A. - is a common practice and is not unlawful. However, the U.S. Food, Drug and Cosmetic Act prohibits pharmaceutical manufacturers from marketing or promoting off-label uses of their products.
Of the $804,748 that Massachusetts will receive under the consent judgment:
- $750,000 will be distributed to the Commonwealth's Local Consumer Aid Fund and other consumer protection programs related to health care;
- And $54,748 will cover costs and attorney's fees.
Last week, the Attorney General's Office reached a separate agreement with pharmaceutical manufacturer Pfizer Inc., resolving allegations that the company engaged in improper marketing practices to promote sales of a variety of its drugs. Under the terms of that settlement, Pfizer will pay $14,728,408 to the Massachusetts Medicaid Program, which provides funds for health care products and services to eligible low-income individuals, including people with disabilities, children and elder citizens.
The Attorney General's Health Care Division was created in 2007 to place a heightened focus on promoting the interests of consumers as Massachusetts undertook its landmark health reform effort. Since its implementation, the division has taken a variety of actions aimed at protecting consumers against unfair and deceptive trade practices by health insurers and medical discount cards.
The Massachusetts action was handled by Assistant Attorney General Karen C. Tseng with assistance from Division Chief Thomas O'Brien and Paralegal Jordan Akerley, all of Attorney General Martha Coakley's Health Care Division. Joining Massachusetts in this settlement are: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.