Eyeworld

23 EW NEWS & OPINION October 2018 and, most importantly, the ulti- mate decision makers in ruling on decisions relating to ophthalmology products were not ophthalmologists. This was despite the fact that an overwhelming majority of product submissions to the combined trans- plant/ophthalmology division were for ophthalmic products. "Could you imagine how disturbed the cardiology community would be, for example, if decisions on whether or not to approve the next genera- tion of drugs for heart disease were being made by an ophthalmologist? The structure simply did not make sense," Dr. Singh said. ASCRS took the lead in bringing this issue to the FDA's attention. Along with the American Acade- my of Ophthalmology (AAO) and National Alliance for Eye and Vision Research (NAEVR), they met with Dr. Woodcock to advocate for an ophthalmologist to lead the oph- thalmic review process. ASCRS also led efforts to send a letter to Dr. Woodcock to further advocate on this issue and gave specific examples of instances where ophthalmologists were overruled on the decisions within the division. The letter was sent from Dr. Singh, Michael Repka, MD, and James Jorkasky on behalf of ASCRS, AAO, and NAEVR in December 2017. After the meeting with Dr. Woodcock and receiving the letter, the FDA made the decisions to separate ophthalmology from the transplant divisions and have it temporarily function as its own de- partment out of the OND at CDER. Dr. Singh said that he had further communication with Dr. Woodcock following the initial meeting, and in June, the FDA issued a press release saying that it would be restructur- ing, and ophthalmology would have its own division. This restructuring is still pending approval by Health and Human Services (HHS), the White House Office of Management and Budget (OMB), and Congress, but if approved, ophthalmology will function as its own division. This approval process could take more than a year. Dr. Singh said this is a signif- icant development and is a direct response to advocacy from ASCRS led efforts. "Not only did we help our own profession but might have helped the FDA more broadly in Contact information Chang: dceye@earthlink.net Singh: kuldev.singh@stanford.edu bringing some of these issues to their attention," he said. "It is crit- ical to have optimally functioning ophthalmology processes at CDER, and I am confident that this is a priority for Dr. Woodcock and her team," he concluded. EW *Developed in coordination with Barry S. Seibel, M.D. Seibel Capsulorrhexis Cystotome Forceps ® KR-Adv-052918-Rev0 05-2363 800-225-1195 • info@katena.com • www.katena.com • Special viewport ps provide tag view during grasping • Etched landmarks on the sha can be used to gauge CCC size • Micro-coaxial 23 gauge design is ideal for small phaco or sideport incisions • Ergonomic, low actua on handle reduces hand fa gue

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