guest editorial
FDA Reorganization: What's Best for Ophthalmology?
Altering the Ophthalmology subdivision may be counterproductive.
By Michael S. Gilmore, Ph.D.

The Food and Drug Administration has indicated in a press release issued Dec. 30, 2004, that organizational changes at the FDA are planned for the spring of 2005. Though intended to improve the efficiency of the organization, some in the ophthalmology community are becoming increasingly concerned about one of the proposed changes.

Under the organization that exists currently, the FDA contains an Ophthalmology subdivision, led by a deputy director, specific to the ophthalmology group. Though this group is officially categorized as a subdivision of the Anti-Inflammatory, Analgesic, and Ophthalmic Drug Product Group, it does function with a certain degree of autonomy. The proposed changes call for the ophthalmology subdivision to be moved under the jurisdiction of the Division of Anti-Infective Drug Products. This would place authority for final decisions, sign-offs, meeting representation, and policy discussions with the Anti-Infective division director(s).

The ophthalmology community is concerned that the potential repercussions of such an organizational shift could serve to the detriment of the field. Currently, an ophthalmologist, Wiley Chambers, M.D., leads the Ophthalmology subdivision. In certain instances, final sign off is required at higher levels, such as new molecular entities. However, on most decisions, the authority rests within the ophthalmics group. This allows the ophthalmic experts to be directly responsible for the decisions they make. The ophthalmic group has an impressive record by any measure.

Ophthalmology is a Unique Discipline

The proposed fusion between ophthalmology and anti-infectives appears to be an unnatural chimera. Although cases can be identified where drugs used in ophthalmology have some similarities to those reviewed in almost every other division, the uniqueness of the field is indisputable. The issues of dosing, drug penetration, safety, pre-clinical models, clinical endpoints, and many of the specific considerations for drugs administered ocularly are markedly different in the eye as compared to other systems. Additionally, the ophthalmic drug categories expected to grow at the greatest rate in the coming years include those for macular degeneration, cataracts, dry eye and glaucoma -- areas particularly unique to ophthalmology.

Considering the history, expertise, and distinctiveness of ophthalmology and the role it has occupied at the FDA, it would seem that an ophthalmologist is best equipped to lead the Ophthalmology division forward. Having the input of specialists in numerous areas, i.e., nonclinical, microbiology, clinical trials, is, in fact, important for the review process. Having an ophthalmologist at the helm, however, assures that input from all of these areas will be appropriately balanced and weighed; an ophthalmologist will have the greatest expertise in understanding how each of these specific considerations applies to ophthalmology. In view of the rapidity with which ophthalmologic drugs and devices are currently being developed to meet the needs of an aging population, it's certain there will be greater pressure for rapid, yet careful and knowledgeable review of these products.

Perhaps there are other divisions at the agency more suited to combination than Ophthalmology and Anti-infective, or other means by which the independently functioning unit of the Ophthalmology division can be maintained, even with the impending organizational changes. Whatever the means, it is of concern to ophthalmologists, researchers, and the ophthalmic industry, that the FDA continue to place important decisions regarding ophthalmics into the hands of those with the greatest expertise.

Michael S. Gilmore, Ph.D., is currently Director of Research and Acting CEO, The Schepens Eye Research Institute, and Charles L. Schepens Professor of Ophthalmology, Harvard Medical School. The views expressed above reflect those of Dr. Gilmore, and do not necessarily reflect the views of institutions in which he holds appointments.