Pharmaceutical Company to Pay $35 Million for Allegedly Promoting Off-Label Uses of Prescription Drug Rapamune
Massachusetts to Receive $726,000 in Multistate Settlement with Pfizer Subsidiary
BOSTON – A pharmaceutical company has agreed to pay $35 million over allegations involving the unlawful promotion of the drug Rapamune for uses not approved by the Food and Drug Administration (FDA), Attorney General Martha Coakley announced today.
The AG’s Office joined 41 states in a settlement with Wyeth Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer Inc, to resolve claims that the company violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, a drug currently approved by the FDA to prevent organ rejection after kidney transplant surgery.
Under the terms of the settlement, Pfizer will pay more than $726,000 to the Commonwealth, including $100,000 in attorney’s fees and costs, with the remainder to be used to fund programs that benefit Massachusetts consumers.
"Pharmaceutical manufacturers who promote off-label uses for products that have not been approved by the FDA pose health and safety concerns for patients,” AG Coakley said. “This settlement will ensure compliance with strict federal standards for drugs sold in the United States.”
According to the complaint, despite Rapamune’s limited approval for use in kidney transplants only, and despite black box warnings required by the FDA relating to use in lung and liver transplants, Wyeth allegedly promoted Rapamune for off-label uses such as with liver, heart, pancreas, and lung transplant patients.
Allegations also include Wyeth’s unapproved protocol of giving patients Rapamune after initially receiving a different immunosuppressive drug, and using Rapamune in unapproved drug combinations.
The consent judgment requires Pfizer to ensure that its marketing and promotional practices do not unlawfully promote Rapamune or any other Pfizer product. Specifically, the company is prohibited from:
- Making, or causing to be made, any written or oral claim that is false, misleading, or deceptive regarding any Pfizer product;
- Making any claim comparing the safety or efficacy of a Pfizer product to another product when that claim is not supported by substantial evidence as defined by federal law and regulations;
- Promoting any Pfizer product for off-label uses;
- Including mechanisms in its financial incentives to provide incentive compensation for sales that may be attributable to the off-label uses of any Pfizer product;
- Affirmatively seeking the inclusion of Rapamune in hospital protocols or standing orders unless Rapamune has been approved by the FDA for the indication for which it is to be included in the protocol or standing order;
- Disseminating information describing any off-label or unapproved use of Rapamune unless such information and materials comply with applicable FDA regulations and the recommended actions in FDA Guidance for Industry; or
- 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.
In 2009, Pfizer Inc. acquired Wyeth after the company’s alleged unfair and deceptive conduct had occurred.
Also participating in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Indiana, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.