Record of Telephone Conversation, August 22, 2012 - EVARREST
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125392/0 Office: OBRR
Fibrin Sealant Patch [EVARREST]
Ethicon, Inc. (Ethicon)
Telecon Date/Time: 22-Aug-2012 01:00 PM Initiated by FDA? Yes
Telephone Number: --b(4)----------
1. Other – Proper Name discussion
Author: TRACY TILGHMAN/Natalya Ananyeva
Internal Teleconference to discuss the proper name for EVARREST in preparation for the external Teleconference with Ethicon scheduled for 23-Aug-12
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The purpose of this internal FDA meeting was to inform Division Director, Dr. Golding, regarding the ongoing negotiations with Ethicon to reach consensus on the proper name for their product, EVARREST. This aspect was previously discussed with Ethicon during the 7 August 2012 telecon, and Ethicon requested a follow-up teleconference with FDA on 23 August 2012.
It is current position of the review committee that the proper name for EVARREST should be Fibrin Sealant Patch. This proper name classification was previously established by FDA for TachoSil (manufactured by Nycomed/Takeda), a similar combination product that consists of fibrin sealant and medical device and is intended for use as an adjunct to hemostasis. This name accurately describes the primary mode of action (fibrin sealant) of EVARREST and the mode of delivery of the biologics to the bleeding site (patch to cover the wound area).
Ethicon considers that the mode of action of their product goes beyond the mode of action of a fibrin sealant because the biological components interact with the matrix to achieve the hemostatic effect, i.e., all three components contribute to the mode of action. In Amendment #18 (30 July 30 2012), Ethicon submitted their justification for the proposed proper name, --b(4)--------------- Ethicon subsequently submitted justification for an alternative name, --b(4)------------------------------------------- on 21 August 2012 by e-mail in preparation for the 23 August 2012 telecon. Both files are attached to the record.
FDA has concerns with the word –b(4)------ as it may imply that the product has activity or interactions with the treatment site that go beyond hemostasis (which is the proposed indication for EVARREST). FDA considers the term –b(4)------- to be misleading and promotional according to 21 CFR 202.1(e)(6) and 21 CFR 312.7. FDA also has concerns with the term “Matrix” as it implies a wound healing activity of EVARREST. This wound healing activity was not demonstrated in adequate and well-controlled clinical studies; thus the evidentiary standards for this claim have not been met.
Division Director concurred with the position of the review committee and supported the proper name, Fibrin Sealant Patch, for EVARREST. Considering that the FDA position was already explained to the Applicant during the 7 August 2012 telecon, Dr. Golding raised a question as to whether FDA needs to continue negotiations on the proper name with Ethicon, or whether the FDA has the authority to designate the proper name.
Action Item for the 23 August 2012 Teleconference:
Ethicon will be informed that under Section 580(c) of the Food, Drug, & Cosmetic Act, the FDA does have the statutory authority to designate a single proper name to products that are considered to be substantially equivalent in design and purpose. Thus, the proper name for EVARREST should be Fibrin Sealant Patch.