Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the alleged unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA). The $490.9 million agreement settles allegations that the company violated the federal False Claims Act and state False Claims Acts and also includes a criminal fine and forfeiture totaling $233.5 million based on the company’s criminal liability for a misbranding violation of the federal Food, Drug and Cosmetic Act (“FDCA”).

The FDCA requires a pharmaceutical manufacturer to specify the intended uses of a product in its new drug application to the FDA.  Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.  In 1999, Wyeth received approval from the FDA for Rapamune use in renal (kidney) transplant patients.  However, according to the criminal information filed against Wyeth, the company trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients.  Wyeth also allegedly provided the sales force with training materials regarding non-renal transplant use and allegedly trained them on how to use these materials in presentations to transplant physicians.  Then, according to the Justice Department, Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales.

This settlement stemmed from two False Claims Act qui tam, or whistleblower, lawsuits. The first qui tam action, United States ex rel. Sandler et al v. Wyeth Pharmaceuticals, Inc., was filed by a pharmacist and a former Rapamune sales representative, who alleged that they were encouraged to promote the drug for heart, lung, liver and pancreas transplants, even though the FDA had only approved it for kidney transplants. The second qui tam action, United States ex rel. Campbell v. Wyeth, Inc., was filed by another former Rapamune sales representative, and it echoed many of the allegations of illegal, off-label promotions.

Of particular note, the Justice Department alleged that the company not only trained sales reps on the drug’s purported effectiveness in transplant patients, but it allegedly used financial incentives to reward sales reps who effectively increased Rapamune sales, both on- and off-label.

More information for whistleblowers is located at the Nolan Auerbach & White website.