Drugmaker Sanofi gave millions of dollars to two medical societies which urged the Food and Drug Adminsitration to delay approving a low-cost version of the company's blockbuster blood thinner Lovenox, according to a Senate investigation released Wednesday.
Investigators for the Senate Finance Committee say Sanofi appeared to encourage the medical groups to write letters asking the FDA to block a generic version of the blockbuster drug, saying it might not be as safe as the original.
According to the committee, the medical groups "served as components of a coordinated public relations strategy by Sanofi to ... prevent or delay generic alternatives to its blockbuster drug."
Documents obtained by investigators show that Sanofi donated more than $2 million each to the Society of Hospital Medicine and the North American Thrombosis Forum. The groups did not disclose the payments in their letters to FDA last year. The letters to the FDA were first reported by The Wall Street Journal.
Paris-based Sanofi said in a statement the medical groups "brought legitimate and important patient safety facts and considerations to the attention of the FDA."
Generic drugs can run a fraction of the cost of branded drugs, saving money for consumers and health care providers. Branded drug companies routinely use a variety of tactics to slow the entry of generic drugs, including filing safety petitions with the FDA.
The FDA ultimately approved the generic version of Lovenox last summer. But Senators Charles Grassley, R-Iowa, and Max Baucus, D-Mont., said the FDA must demand more information about the ties between drugmakers and nonprofit medical groups that contact the agency.
"If the FDA isn't asking for disclosure of financial relationships, it's operating from an uninformed standpoint," Grassley said in a statement. "The FDA has a responsibility to conduct due diligence in this area in order to make sure its reviews have credibility."
Under a 2009 law authored by Grassley, drugmakers must disclose gifts and payments made to individual physicians. However, the law does not cover company payments to nonprofit groups, which often lobby on issues that benefit both physicians and drug companies.