The Senate Finance Committee is raising questions about Sanofi's multimillion-dollar contributions to two medical groups and a thrombosis researcher. The three of them all wrote letters to the FDA, trying to persuade the agency to think twice about approving generic competition for Sanofi's blood thinner Lovenox. According to the committee's report, Sanofi pushed to get those letters written.
The French drugmaker contributed $2.6 million to the Society of Hospital Medicine, plus more than $2.3 million to the North American Thrombosis Foundation and more than $260,000 to Duke University expert Victor Tapson. The contributions came between 2007 and 2010.
In about 2008, the Society of Hospital Medicine's director told Sanofi that he was unsure about contacting the FDA about Lovenox, but that the group wanted "to give any issue that is important to our partner careful consideration." Two months later, the WSJ notes, the society wrote the agency to question whether the Lovenox copies would be as safe as the branded version. The Thrombosis Forum and Tapson wrote to express similar views. None of them mentioned financial relationships with Sanofi.
The FDA ended up approving a generic form of Lovenox last July. With $4 billion in 2009 sales, Lovenox saw U.S. numbers drop significantly after the copycat drug hit the market. And two more companies have generic apps pending.
It's not clear what the Senate committee intends to achieve with this report. But Chairman Max Baucus did say that drugmakers "simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products."
- check out the Senate Finance Committee's statement
- read the WSJ article