Eyeworld

22 October 2018 EW NEWS & OPINION by Ellen Stodola EyeWorld Senior Staff Writer/Digital Editor fully streamline the process of FDA approval, he said. "This was a prior- ity for ASCRS, and we appreciate the willingness of the FDA to meet and to respond to our concerns." Kuldev Singh, MD, Palo Alto, California, weighed in on the efforts of ASCRS on this issue. Dr. Singh was involved on several levels and played a role in sending the letter to Dr. Woodcock as well as meeting with her and other FDA leaders to discuss the issue. As an ophthalmologist who advises various stakeholders in the advancement of eye care, Dr. Singh expressed an interest in identifying and removing obstacles that may prevent safe and effective products from being available to patients in a timely manner. In his various roles, Dr. Singh has seen first-hand how efficiency in regulatory pro- cesses can influence innovation and investment in a particular disci- pline. Investors in healthcare have a choice regarding where to invest and generally direct funds toward fields where the regulatory process works in supporting the products that improve patient health. "As an ophthalmologist, I want to make sure that we have the absolute best eye regulatory processes, to give investors the confidence to support innovation, and for innovators to have faith that they will receive timely guidance and fair review from regulators to get the products that are safe and effective to the finish line," Dr. Singh said. On the pharma side represented by the CDER, Dr. Singh noted that for many years, ophthalmology did not have its own separate division, I n June, the FDA announced a series of steps by the Center for Drug Evaluation and Research (CDER) to help modernize the organization and functions of the Office of New Drugs (OND). As part of this modernization, led by Janet Woodcock, MD, director of CDER, one aspect, as noted in a press release from the FDA, would be the possible creation of new therapeutic-specific divisions that will have more ability to engage in discrete areas of medicine. "The goal is to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups," according to the press release. FDA Commissioner Scott Gottlieb, MD, also referenced these efforts in a press release in late Au- gust, where he specifically discussed modernizing the organization and breaking down outdated silos. His press release added that "the goal is to enable FDA review teams to be more disease focused, more integrat- ed across the disciplines involved in drug review, and better able to evaluate and analyze data from agile clinical trials through a more struc- tured approach to data review." The structural changes will also be a part of the changes to the organization and function of the OND. Part of this modernization includes the creation of a drug divi- sion specifically for ophthalmology. This change stems from advocacy ef- forts from ASCRS and other organi- zations to point out why a separate drug division is needed for oph- thalmology. Following efforts from ASCRS, its FDA Committee, and ophthalmologists, including send- ing a letter from the ophthalmic organizations to Dr. Woodcock, the FDA made the decision to separate ophthalmology from the transplant division and have it temporarily function as its own department out of the OND at CDER. This is part of the overall reorganization of the OND and expanding the number of review divisions. "This decision by the FDA should be welcome news for ev- eryone in ophthalmology and for our patients," said David Chang, MD, Los Altos, California. "Because a non-ophthalmologist from the transplant division previously had oversight over the approval of oph- thalmic drugs, concerns were raised by a number of sponsors about the appropriateness of some of the test- ing required." Because of the large number of new drug submissions in ophthalmology, this is a significant structural reform that should hope- FDA announces plan to create separate ophthalmology drug division as part of efforts to modernize CDER Dr. Singh (left) with Dr. Woodcock Source: Kuldev Singh, MD " It is critical to have optimally functioning ophthalmology processes at CDER, and I am confident that this is a priority for Dr. Woodcock and her team. " —Kuldev Singh, MD

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