Under the settlement agreement, Pfizer must pay the State of Texas a total of $2.387 million. The agreement orders $1.591 million of the settlement funds to be disbursed to the General Revenue or the Supreme Court Judicial Fund, as appropriate, pursuant to Texas Government Code Sec. 402.007. The remaining funds will reimburse the State’s legal fees.
According to the states’ investigation, Wyeth violated state consumer protection laws by misrepresenting the uses and qualities of Rapamune. State and federal law generally prohibits pharmaceutical manufacturers from marketing their drugs for “off-label” uses that have not been approved by the U.S. Food and Drug Administration (FDA).
Today’s judgment requires Pfizer to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any Pfizer product. Among its terms, the judgment prohibits Pfizer from the following actions:
- Making false, misleading, or deceptive claims about any Pfizer product;
- Promoting or distributing information describing any off-label or unapproved use for a Pfizer product;
- Providing Pfizer product samples to health care professionals who would be expected to prescribe the sampled product for an "off-label" use – rather than for an FDA-approved use;
- Seeking the inclusion of Rapamune in hospital protocols or standing orders for an indication that is not FDA-approved; and
- Seeking to influence the prescribing of Rapamune in hospitals or transplant centers in any manner (including through funding clinical trials) that does not comply with the federal anti-kickback statute.
Texas and Oregon led the Executive Committee, which also includes attorneys general from California, Florida, Illinois, Maryland, New York, North Carolina, and Pennsylvania.
Also participating in the settlement are Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, Utah, Virginia, Washington, and Wisconsin.