Ortho-McNeil/Janssen said a Public Citizen petition to the FDA calling for removal of the Ortho Evra contraceptive patch from the market for safety reasons “presents no new information or scientific evidence showing that Ortho Evra is unsafe, ineffective or unnecessary” and should be denied.
Public Citizen claimed in its petition last May that the patch exposes women to dangerous estrogen levels. The company’s response, filed in October, said the allegations are contradicted by existing medical evidence.
The company also said Public Citizen is ignoring the interactions between the FDA and Ortho-McNeil/Janssen on the product and the labeling contents that have been put in place since Evra’s 2001 approval.
“In particular,” the response said, “Public Citizen does not address revised labeling that discusses the difference in estrogen delivery between Ortho Evra and oral contraceptives. Moreover, Public Citizen’s allegations of a greater risk of adverse events for Ortho Evra are predicated on unproven assumptions arising from Public Citizen’s interpretation of pharmacokinetic data.”
Public Citizen’s petition asked for a six-month transition period during which the contraceptive would be available for refill prescriptions to allow women time to meet with their healthcare providers and determine a safer alternative contraceptive method.
From the December 01, 2008 Issue of MM+M - Medical Marketing and Media