FDA Denies Public Citizen Seprafilm Petition

FDA has denied a Public Citizen 7/7/15 petition asking that the agency withdraw its premarket approval of Genzyme’s Seprafilm and also start a mandatory recall of all remaining unused Seprafilm devices. The agency response says that while it denied the petition, it has requested additional Warnings and labeling changes in response to the concerns raised by Public Citizen. It also points out that Seprafilm remains the only approved product in the U.S. market indicated to reduce adhesion in the abdominal cavity.

“When used according to the approved Indications for Use, Seprafilm provides surgeons with an important clinical tool for use under the incision in patients who have a high likelihood of requiring reoperation through the same incision,” the letter says.

FDA says Public Citizen said the withdrawal of approval and recall were justified because the Seprafilm clinical trials failed to demonstrate convincingly the product’s efficacy and that there is substantial evidence that the product causes serious, sometimes fatal adverse events. The petition cited five grounds for its claims, including clinical trials conducted by Genzyme before and after approval, other published scientific literature, and the FDA MAUDE database.

“FDA disagrees with your analysis of this information,” the denial letter says. “FDA re-reviewed the clinical evidence that supported the approval of Seprafilm’s PMA in addition to the literature cited in your petition as well as additional literature and the data in FDA’s database,” the agency says. “FDA’s analysis … concludes that Seprafilm has a reasonable assurance of safety and effectiveness when used in accordance with its FDA approved labeling. Your petition, therefore, has not established a basis on which FDA could withdraw Seprafilm’s PMA … nor has it established evidence that justifies issuance of a mandatory recall ….”