Sanofi is under the spotlight in the USA over near-$5 million contributions it made to doctor groups which then urged the country's regulator to delay approving a generic version of the French company's bloodthinner Lovenox.
The US Senate Finance Committee has written to the Food and Drug Administration Commissioner Margaret Hamburg following an investigation into what it describes as Sanofi's "coordinated strategy to delay generic alternatives" to Lovenox (enoxaparin). The Paris-headquartered drugmaker contributed $2.6 million to the Society of Hospital Medicine, plus more than $2.3 million to the North American Thrombosis Foundation. It also gave more than $260,000 to Duke University medical professor Victor Tapson.
The letter notes that in June 24, 2010, the Wall Street Journal reported that the two medical groups and Prof Tapson submitted letters to the FDA in support of a citizen petition filed by Sanofi in 2003. That petition requested that the FDA delay approval of Lovenox generics, expressing concerns about safety; the agency did give the green light to a copycat version last July.
However Senate Finance Committee Chairman Max Baucus and senior Committee Member Chuck Grassley are concerned that the professor and the two doctors groups did not disclose their financial relationship with Sanofi in their letters to the FDA.
Sen Baucus said that generics help keep healthcare costs down "and we absolutely cannot let powerful drug companies keep those life-saving drugs out of reach". He argues that the report "uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy – and that’s wholly unacceptable".
Sen Grassley added that “if the FDA isn’t asking for disclosure of financial relationships, it’s operating from an uninformed standpoint". He went on to say that the agency "has a responsibility to conduct due diligence in this area in order to make sure its reviews have credibility".
Sanofi responded by saying the experts "brought legitimate and important patient safety facts and considerations to the attention of the FDA".