NAEVR Meets with FDA To Discuss Change in Ophthalmic Drug Reviewing Division

Left to right: NAEVR Executive Director James Jorkasky, Office of New Drugs (OND) Director John Jenkins, M.D., American Academy of Ophthalmology Medical Director for Government Affairs Michael Repka, M.D. (Johns Hopkins University School of Medicine), Division of Transplant and Ophthalmology Products (DTOP) Deputy Director Wiley Chambers, M.D., American Glaucoma Society (AGS) President Jeffrey Liebmann, M.D. (New York University School of Medicine), and Office of Antimicrobial Products (OAP) Director Edward Cox, M.D., M.P.H.

On January 6, NAEVR joined the American Academy of Ophthalmology (AAO) and the American Glaucoma Society (AGS) in meeting with representatives of the U.S. Food and Drug Administration (FDA) to discuss the implications for ophthalmic drug reviews from the May 2011 reorganization of the Office of Antimicrobial Products (OAP) within the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). In the reorganization, OAP re-aligned its three reviewing divisions, moving ophthalmic review from the previous Division of Anti-Infective and Ophthalmology Products and transplant product review from the previous Division of Special Pathogen and Transplant Products and combining these into a new Division of Transplant and Ophthalmology Products (DTOP), directed by Renata Albrecht, M.D. Wiley Chambers, M.D. continues to serve as the Deputy Director in this new division.

Michael Repka, M.D. (Johns Hopkins University School of Medicine), who serves as the AAO’s Medical Director for Government Affairs and as Chair of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee, led the discussion, which focused on the potential impact of the reorganization on the timeliness of new ophthalmic drug reviews. OND Director John Jenkins, M.D. and OAP Director Edward Cox, M.D., M.P.H., described the OAP reorganization, noting it was primarily done for greater efficiencies in the use of limited resources. Although the pairing of transplant products and ophthalmic products was not designed to be a match-it resulted because each area did not have sufficient volume of reviews to warrant a separate division-OAP is tracking the workload associated with each type of product review to properly align resources. Generally, OND is also centralizing several of the disciplines needed in review (for example, pharmacology, chemistry, statistics) so that they are available to all divisions. Since these centralized reviewers may not have had past experience with a specific division and its products, OND has also established an internal dispute resolution process.

NAEVR used the meeting as an opportunity to discuss the importance of the joint National Eye Institute (NEI)-FDA Endpoints Symposia, which are managed by the Association for Research in Vision and Ophthalmology (ARVO) and engage representatives from CDER and the Center for Devices and Radiological Health’s (CDRH) Division of Ophthalmology, Neurology, and Ear, Nose and Throat Devices. To date, five Symposia have been held, including two on Glaucoma, and one each on Age-related Macular Degeneration (AMD), Visual Prostheses, and Patient Reported Outcomes. AGS President Jeffrey Liebmann, M.D. (New York University School of Medicine) noted that the glaucoma community came together at these events in 2008 and 2010 to discuss the latest in NEI-funded research and how those findings could potentially support the approval of new drug and device diagnostics and therapies.