The US Department of Justice (DOJ) has announced that Wyeth Pharmaceuticals, now a subsidiary of Pfizer, has agreed to pay $491 million to settle allegations that it had unlawfully marketed the drug Rapamune, a kidney transplant drug, for unapproved uses in other organ transplant populations.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), companies are only permitted to market a drug product for which they have received approval, and then are only permitted to market the drug for the exact indication for which it has been approved by the US Food and Drug Administration (FDA). Marketing drugs for different purposes or at different doses, known as "off-label" marketing-referring to the drug's FDA-approved labeling-is illegal, and violators may be subject to direct fines, as well as derivative fines related to reimbursement for the drug by federal programs like Medicare and Medicaid.
In a statement on 30 July 2013, DOJ staff said the settlement and others like it were intended to preserve the integrity of the regulatory process.
"The FDA approves drugs for certain uses after lengthy clinical trials," said Sanford Coats, US Attorney for the Western District of Oklahoma. "Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses."
Coats added that while FDA had approved Rapamune for limited use in renal transplants-and had specifically required a warning on the drug's label against use in other cases-Wyeth had "trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales."
"This was a systemic, corporate effort to seek profit over safety," Coats continued. "Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties."
Under the agreement, Wyeth has reportedly pleaded guilty to a misbranding violation under the FD&C Act and will pay a $233.4 million criminal fine, $230 million in civil restitution to the US government, and $27.2 million to various state governments.
DOJ Press Statement