According to the Associated Press, Pfizer plans to pay $35 million to resolve allegations by 42 states that its subsidiary, Wyeth Pharmaceuticals, illegally marketed an organ transplant drug for unapproved uses.
The states’ attorneys general said on August 6, 2014 that Wyeth, which New York-based Pfizer acquired for $68 billion in 2009, trained sales representatives to encourage doctors to prescribe Rapamune for uses other than preventing rejection of transplanted kidneys. Rapamune was approved by the Food and Drug Administration in 1999 only for use in kidney transplant patients, and promoting drugs for uses not cleared by the FDA is illegal.
Rapamune (generic name sirolimus) lowers a person’s immune system to prevent the rejection of a transplanted kidney. It can also lower blood cells that help a body fight infections, making it easier for an individual to bleed excessively from an injury or get sick from being around others who are ill.
Other potential side effects include joint pain, nausea, vomiting, diarrhea, constipation, stomach pain, headache, acne, and skin rash.
Under the terms of the settlement agreement, Pfizer will reform its marketing and promotional practices to avoid unlawfully promoting Rapamune or any Pfizer product, and will not:
- Make false, misleading, or deceptive claims
- Make any claim comparing 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
- Provide incentives to encourage sales for off-label uses
- 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 complies with FDA regulations
- Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner that does not comply with federal law banning kick-backs, including through funding clinical trials
Pfizer said in a statement that the alleged illegal activity occurred before it acquired Wyeth, and did not admit any wrongdoing or liability as part of the settlement. The company agreed to pay nearly $491 million in July 2013 to resolve a similar investigation by the Department of Justice.