Following advocacy led by ASCRS that an ophthalmologist should head the Food and Drug Administration (FDA) division tasked with reviewing and approving ophthalmic drugs, the agency announced details this week confirming that ophthalmology will officially have its own drug division. This proposal is part of a broader reorganization of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) that will expand the number of review offices from 5 to 9 and the review divisions from 19 to 30. FDA commissioner, Scott Gottlieb, MD, tweeted a photo of the reorganization chart that confirms the plan to have ophthalmology operate as its own drug division.
The proposal is still subject to review by Health and Human Services (HHS), the White House Office of Management and Budget (OMB), and Congress. The reorganization and approval process will most likely take more than a year but appears very positive for ophthalmology.
As a reminder, the ASCRS FDA Committee identified the need for ophthalmic leadership in the FDA drug review and approval process. Previously, under the OND, ophthalmology was combined with the transplant division and many ophthalmic drug approvals were denied due to decisions by professionals without experience with ophthalmic drugs or treating eye diseases. ASCRS, AAO, and NAEVR met with Janet Woodcock, MD, director of the FDA’s CDER, to advocate for an ophthalmologist to lead the division. Dr. Woodcock thanked the groups for bringing this concern to her attention and asked for formal recommendations. In response to Dr. Woodcock’s request, ASCRS took the lead in writing a letter outlining specific examples where decisions made by ophthalmologists were over-ruled and providing our recommendation that an ophthalmologist lead the division. Following the letter, ophthalmology was separated from the transplant division and temporarily functioned out of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER).
FDA’s proposal to permanently have ophthalmology as its own drug division is a direct response to ASCRS advocacy. We applaud the FDA for this proposal and will continue to work with the agency to ensure a robust future for ophthalmic drugs.