Sanofi’s Genzyme subsidiary has agreed to pay the U.S. government $32.5 million for off-label promotion and misleading claims related to Seprafilm, a film that reduces scarring after abdominal or pelvic laparotomies.
According to the U.S. Department of Justice, between 2005 and 2010, a number of Genzyme sales representatives encouraged healthcare providers to use Seprafilm “slurry” in laparoscopic surgery — an unapproved use. To make the slurry, Seprafilm sheets were cut into small pieces and dissolved in saline. Although Genzyme discouraged sales reps from promoting the unapproved product, several employees “guided surgical staff and directly participated in the preparation of Seprafilm slurry for use in surgical patients,” according to documents filed in the U.S. District Court for the Middle District of Florida.
In addition, Genzyme sales reps provided surgeons with a brochure that claimed Seprafilm was “proven in radical pelvic surgery.” This statement was misleading, the government says, because the patient population in the study for this indication was too small to back the claim.
To settle the charges, Genzyme admitted to its employees actions and will enter a two-year deferred prosecution agreement.
Ongoing Remedial Efforts
The agreement acknowledges Genzyme’s efforts to prevent misconduct related to the slurry. The company has implemented stricter policies for promotional practices, reduced sales quotas and fired employees who commit misconduct related to Seprafilm. One of those terminated was a leading performer for Seprafilm sales and revenue.
Further, after Genzyme became aware of the government’s investigation, the company disclosed that it had been conducting its own internal review of Seprafilm marketing. The firm has put in place a number of compliance policies and enhanced controls to detect any misconduct.
If Genzyme fully complies with the obligations set forward in the deferred prosecution agreement, the government will move to dismiss all charges with prejudice.
This isn’t the first time Genzyme has had to resolve charges related to Seprafilm. In December 2013, Genzyme agreed to pay $22.28 million to settle false claims allegations after two whistleblowers came forward, accusing the company of billing Medicare and Medicaid for off-label uses of Seprafilm slurry.
Seprafilm also raised the ire of consumer advocacy group Public Citizen, which in July filed a petition urging the FDA to rescind its approval of Seprafilm, citing adverse patient events, including at least 21 deaths ().
A Sanofi spokesperson says Genzyme has instituted compliance measures to ensure DOJ’s requirements are met.
“We are confident in these programs and are pleased to move forward,” the spokesperson adds. — Elizabeth Hollis