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Pfizer to pay $35 million to resolve allegations of improper marketing of popular organ transplant drug

Date Posted: Wednesday, August 6th, 2014
Categories:  Consumer Protection Department of Justice DOJ Press Releases Investor Protection

Wilmington – Attorney General Beau Biden announced today that his office has joined 41 other State Attorneys General in reaching a $35 million nationwide settlement with Pfizer Inc, as parent of Wyeth Pharmaceuticals Inc., over allegations the company unlawfully promoted Rapamune, an immunosuppressive drug currently approved by the FDA for use in preventing organ rejection after kidney transplant surgery.  Delaware will receive $423,000, which will be paid to the Attorney General’s Consumer Protection Fund.

 

“We are acting to protect patients by ensuring that pharmaceutical companies market their drugs only for uses that are approved and safe,” Biden said.

 

The states allege that Wyeth violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, including making representations related to the unapproved (off-label) use of the drug following an organ transplant other than a kidney transplant, the unapproved protocol of converting patients to Rapamune after initially receiving a different drug, and using Rapamune in unapproved drug combinations.

 

In addition to its $35 million payment, under the terms of the settlement filed today for approval in Superior Court in New Castle County Pfizer is required to ensure that its marketing and promotional practices do not unlawfully promote Rapamune, or any Pfizer product.  Specifically, Pfizer is prohibited from:

 

  • Promoting any Pfizer Product for off-label uses;
  • Seeking the inclusion of Rapamune in hospital protocols or standing orders unless Rapamune has been approved by the FDA for those specific uses;
  • 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.
  • Making 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;
  • Providing incentive compensation for sales that may be attributable to off-label uses of any Pfizer Product, or;
  • Disseminating information describing any off-label or unapproved use of Rapamune unless such information complies with applicable FDA regulations and guidelines.

 

Today’s action follows a multi-state settlement this past June with GlaxoSmithKline that resolved allegations the company unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin by misrepresenting the uses and qualities of these drugs.  Delaware received $1 million in that action.

 

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