Legal fall-out from BMS’ attempts to keep generic clopidogrel off the shelves continues. Source: Nature

A former executive at Bristol-Myers Squibb (BMS) has been indicted on federal charges for negotiating an undisclosed pact between the company and generic drug maker Apotex, involving Plavix, and then allegedly lying about it to federal regulators.

The indictment, filed Wednesday in Washington, D.C., charged that Andrew G. Bodnar, MD, former senior vice president at BMS, had made a false statement to the Federal Trade Commission (FTC) in describing a 2006 agreement between BMS and Apotex, a Weston, Ontario-based maker of generic drugs, according to the New York Times.

The indictment reported that Bodnar led negotiations to stop Apotex from selling its own version of Plavix, a top-selling BMS blood-thinner.

The indictment stems from a federal investigation, which partly led to the ousting of the previous BMS CEO, Peter R. Dolan, in September 2006, the NY Times reported. BMS pleaded guilty to the charges in June 2007, and paid a $1 million fine.

According to the one-count indictment, Bodnar reassured Apotex during a 2006 meeting that BMS would not launch a generic version of Plavix if Apotex agreed to a settlement that delayed the launch of its Plavix generic until 2011.

At the time, Bristol was bound by a federal consent order requiring it to submit such agreements to the FTC for clearance, according to the NY Times. The FTC was looking for any deals that restrained competition and led to higher prices.

The indictment stated that BMS never disclosed that part of the Apotex agreement to the FTC, after the investigation had begun. Bodnar certified to the FTC that no such deal had been struck, according to the NY Times.

BMS said it never entered into a secret deal but was taking responsibility for the actions of “a former senior executive” in a letter to employees at the time of its guilty plea last year, the NY Times reported. However, Bodnar’s name was never specifically mentioned. 

Bodnar would not comment on the current case, but his lawyer, Elkan Abramowitz, told the NY Times that he would plead not guilty. “All I can say is that we will vigorously contest these charges; we think they are baseless,” Abramowitz said.

If convicted on the single charge, Bodnar, 60, could face penalties of up to five years in prison and a fine of up to $250,000, according to the NY Times.

BMS reported Plavix sales of approximately $4 billion in the U.S. for 2007.