Pfizer to Pay $35 Million For Promoting Off-Label Use of Drug

Pfizer Promoting Off-Label Use of Drug. Drug maker Pfizer will pay $35 million to North Carolina and 41 other states to resolve allegations that it unlawfully promoted the drug Rapamune.

The 42 Attorneys General allege that Wyeth Pharmaceuticals Inc., a Pfizer subsidiary, engaged in unfair and deceptive practices by misrepresenting the uses and benefits of Rapamune (sirolimus), an anti-rejection drug for kidney transplant recipients, according to JDNews. The $35 million will be shared among the 42 participating states.

“Promoting a drug to treat a condition without proof that it could help patients is wrong,” North Carolina Attorney General Roy Cooper said. “Patients and their doctors deserve honest, accurate information about medications,” according to JDNews.

Rapamune’s limited approval for use in kidney transplants

The Massachusetts Attorney General’s office said that despite Rapamune’s limited approval for use in kidney transplants, and despite black box warnings required by the FDA, Wyeth allegedly promoted Rapamune for off-label uses such as with liver, heart, pancreas, and lung transplant patients.

Under the settlement, JDNews reports, Pfizer must reform its marketing and promotional practices. Pfizer may not:

• Make any false, misleading, or deceptive claims about any of its products.
• Compare the safety or efficacy of a Pfizer product to another product when that claim is not supported by substantial evidence.
• Promote any Pfizer product for uses not approved by the US Food and Drug Administration (these are known as off-label uses).
• Provide incentives to encourage off-label uses of any ‘Pfizer’ product.
• Seek to have Rapamune included in hospital protocols or standing orders unless it is to be used for an FDA-approved purpose.
• Share information describing any off-label or unapproved use of Rapamune unless such information and materials comply with FDA regulations.
• Influence the prescribing of Rapamune in hospitals or transplant centers in any manner that does not comply with federal law banning kickbacks, including through funding clinical trials.

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