In a report titled “Sanofi’s Strategic Use of Third Parties to Influence the FDA,” the Senate Finance Committee said Sanofi SA “contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval” of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.
According a WSJ article (see “Sanofi Pays Doctors to Dis Generic Version of Lovenox”), “between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000” to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine (see “Duke medical researcher named in Senate report“).
Dr. Tapson and the North American Thrombosis Foundation wrote letters to the FDA that claimed generic versions of the anti-clotting medication may not be as safe as the brand-name drug. Nowhere in these letters did Tapson or the Foundation disclose financial connection to Sanofi.
In an internal email, a Sanofi public-relations representative characterized the Society of Hospital Medicine letter as a “key accomplishment.”
“If we were writing the FDA now,” said Larry Wellikson, society’s director, “we would be very clear about our relationship with any partner, including financial support.”