Public Citizen wants FDA to pull a membrane device from market.
A public watchdog group has petitioned FDA to pull Sanofi's Seprafilm from the market, citing the agency's own reports of injuries and deaths allegedly related to the device.
Public Citizen filed the 39-page petition, asking FDA to withdraw its 1996 PMA for the bioresorbable membrane, used in abdominal and pelvic surgery to prevent scarring between tissues and organs.
Public Citizen cited 21 reports to FDA linking Seprafilm with patient deaths, and said three "major efficacy studies failed to show clinically meaningful benefits and raised serious safety concerns."
Re-analysis of data from a postmarket study was "highly questionable," the petition says.
Seprafilm was developed by Genzyme Corp., which Bridgewater, NJ-based Sanofi bought in 2011.
"Sanofi and Genzyme remain committed to the safe and effective use of Seprafilm Adhesion Barrier," Sanofi spokesperson Mary Kathryn Steel said in an email to Qmed. "We stand behind the clinical trial results and nearly 15 years of post-marketing surveillance data reported to the FDA for Seprafilm. We continue to advise physicians to follow the approved product labeling, including directions for general use."
Labeling was apparently part of the problem, according to the petition. Following a postmarket study, the petition says, Genzyme filed PMA supplements in 2003 and 2004, asking FDA that the label be updated to indicate that Seprafilm was effective at reducing the incidence of small bowel obstruction requiring re-operation. FDA reviewers raised concerns about the efficacy claim, which the company subsequently withdrew, but FDA eventually accepted many other proposed label modifications, including changes describing adverse events and the results of the postmarket study, the petition adds.
"None of these three studies submitted in support of the Seprafilm PMA application established the product's efficacy in improving any important clinically meaningful outcomes, and two of the studies raised serious safety concerns that have not been adequately addressed by the product's sponsor," the Public Citizen petition continues.
An FDA spokesperson told Reuters that the agency would directly respond to Public Citizen following its review.
FDA's Manufacturer and User Facility Device Experience (MAUDE) database cites at least nine reports of patient deaths linked to Seprafilm in the past 10 years. Public Citizen cited research by a citizen into previous FDA files that indicated the additional deaths.
MAUDE reports from January 1, 1998, through May 27, 2015, indicate 524 reports of adverse events linked to Seprafilm, including bowel obstruction, abscess, peritonitis, fever, fluid collection, inflammatory reaction, leak, fistula, sepsis, and wound dehiscence, the petition says.
Genzyme in 2013 agreed to pay $22.28 million to resolve allegations that it marketed an off-label use of Seprafilm. It was a significant medtech-related U.S. False Claims Act care.
Although FDA did not approve Seprafilm for minimally invasive surgeries, Genzyme sales reps taught doctors and other health staff how to use it in keyhole surgeries, by turning the sheets into a "slurry," according to prosecutors.
Because of the tactic, Genzyme knowingly caused hospitals to submit false and fraudulent claims to federal healthcare programs for Seprafilm uses that were not reimbursable.
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Nancy Crotti is a contributor to Qmed and MPMN.
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