Genzyme settles US claims over Seprafilm for $32 million
By Erik Larson BLOOMBERG NEWS SEPTEMBER 03, 2015
Genzyme Corp. agreed to pay $32.6 million to settle a US criminal probe into the biotechnology firm’s false marketing of Seprafilm, a gel developed to reduce internal scarring after abdominal and pelvic surgeries.
Genzyme admitted its sales representatives sought to boost sales by teaching surgeons to use Seprafilm in unapproved ways from 2005 to 2010, prosecutors in Tampa, Fla., said Thursday in a statement.
While Seprafilm was approved for use in laparotomy surgeries involving large incisions, sales staff instructed surgeons to blend the film into a “slurry” for use in laparoscopic surgeries involving tiny incisions and tubes, prosecutors said.
“Genzyme sales representatives taught surgeons and other medical staff how to mix the Seprafilm sheets into a liquid ‘slurry’ that could be squirted through the narrow tubes used during laparoscopic surgery, even though Seprafilm was never indicated or FDA-approved” for such use, the government said.
The company agreed to a deferred-prosecution agreement in which the claims will be dismissed in two years if the company complies with promises to revamp its compliance practices.
Genzyme has already cooperated with investigators to resolve the wrongdoing, the government said. A call to the company seeking comment wasn’t immediately returned.
Genzyme, a unit of Sanofi, France’s largest drugmaker, in 2013 paid $22.3 million to resolve the government’s civil case under the False Claims Act related to Seprafilm. The illegal practice ended before Genzyme was acquired by Sanofi in 2011.