Washington, DC – Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee Member Chuck Grassley (R-Iowa) today sent a letter and a new Committee Report to the Food and Drug Administration (FDA) detailing the financial relationship between the pharmaceutical company Sanofi-Aventis and physicians’ groups that lobbied the agency against approving generic drugs that would compete with Sanofi products.
“Generic drugs help keep health care costs down and we absolutely cannot let powerful drug companies keep those life-saving drugs out of reach,” said Baucus. “This report uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy – and that’s wholly unacceptable. The FDA needs to work closely with doctors, so we must ensure that doctors’ sole motivation is the well-being of their patients.”
“If the FDA isn’t asking for disclosure of financial relationships, it’s operating from an uninformed standpoint. The FDA has a responsibility to conduct due diligence in this area in order to make sure its reviews have credibility. Disclosure here and elsewhere with drug company payments helps to establish accountability when gathering input from experts,” said Grassley.
The Senators requested records from Sanofi following reports that it had financial ties with two medical groups, the Society of Hospital Medicine and the North American Thrombosis Forum, along with a Duke University medical professor, Dr. Victor Tapson.
The investigation found that Sanofi planned a coordinated strategy to delay generic alternatives to its blockbuster blood-thinner drug Lovenox. The strategy took advantage of the FDA’s citizen petition process, which allows individuals and experts to raise concerns about the alternatives. The documents reviewed by the Committee staff showed that the groups involved each participated in the petition process following encouragement from Sanofi. And, the Society of Hospital Medicine and the North American Thrombosis Forum received more than two million dollars each from Sanofi, while Dr. Tapson received more than $200,000.
The Senators’ letter to the FDA follows here. The full report is available on the Finance Committee website here.