Pfizer Coughs Up $35 Million in Rapamune Marketing Violations Settlement

August 12, 2014

Pfizer will pay $35 million divided among 41 states and the District of Columbia to settle allegations it improperly marketed its immunosuppressant Rapamune for unapproved uses, a year after making a $490.9 million deal with the federal government for similar allegations.

Rapamune (sirolimus) is approved only for immediate use after kidney transplants and in limited combination with certain drugs. New York Attorney General Eric Schneiderman — whose state was included in the settlement — alleged that Pfizer’s subsidiary Wyeth improperly promoted Rapamune for use in liver, heart and lung transplants, and for use with unapproved drug combinations.

The drugmaker also violated state consumer protection laws by using Wyeth-retained doctors who conducted misleading presentations of data, and by funding studies at hospitals and transplant centers intended to encourage Rapamune off-label uses, Schneiderman said.

Under the settlement, Pfizer is prohibited from promoting or disseminating information on any unapproved off-label uses for Rapamune. Other prohibitions include providing financial incentives to sales representatives for sales of off-label uses for any Pfizer product and seeking to include Rapamune in hospital protocols for unapproved uses, Schneiderman said.

Pfizer has been accused of improperly marketing Rapamune before. It agreed in July 2013 to pay the Department of Justice $490.9 million to settle similar allegations that Wyeth pushed Rapamune for unapproved uses from 1998 to 2009. The settlement included a criminal fine of $233.5 million and civil settlements of $257.4 million, the DOJ said at the time.

Pfizer noted that the allegations occurred prior to the drugmaker’s acquisition of Wyeth in 2009. The New York-based drugmaker disclosed the issue to the federal government and respective attorneys general in October 2012, Pfizer said.

Pfizer denied any wrongdoing or liability as part of the recent agreement and refused to comment further. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.