We members of the American-European Congress of Ophthalmic Surgery (ACOS) have been fortunate with regard to the ACOS’ relationship with the FDA. As individuals, many of us had appeared before the FDA numerous times and worked on multiple projects with the agency. As members of the ACOS and as individuals, we did not always agree with the FDA, but we always maintained our respect for the personnel at the agency and their mission. The FDA employees dedicated, hard-working, intelligent scientists, physicians, and experts in many fields in a very challenging, high-workload environ- ment. As the ACOS, we knew working with the FDA in any way we could would deliver valuable results for both our members and our patients. Ophthalmology is, of course, technology dependent, and most of our tech- nologies must pass through the FDA. The ACOS made it a goal of the society to interact with the FDA in any way we might.
At the very first ACOS Winter Meeting, we invited Malvina Eydelman as a special guest speaker. Dr. Eydelman attended and graciously participated in a frank discussion with the group of the FDA’s positions and future direction.
Encouraged, in August 2011, as ACOS, we approached the Drug Division of the Center for Devices and Radiological Health with a unique idea for an ACOS-sponsored clinical trial. We recognized the value of corneal cross-linking to arrest the blinding diseases of keratoconus and related corneal dystrophies. Working with Wiley Chambers, MD, we were able to begin the largest FDA trial of corneal cross-linking within 1 year of our initial contact, a shining example of a society and the FDA’s working together quickly and efficiently. This trial grew into the largest FDA trial of corneal cross-linking. To date, 84 investigators have enrolled more than 800 patients, with keratoconus and ectasia diagnoses.
We at the ACOS have continued our dialogue with the leadership of the FDA by inviting Jeff Shuren, head of the Center for Devices and Radiological Health, as a special guest, to our Deer Valley, Utah, Summer Meeting in 2012. There, Dr. Shuren met with ACOS leadership, gave a keynote lecture at the meeting, and took on all questions, answering frankly. After the meeting, Dr. Shuren invited us to Washington, DC, as a society, to explore further ways to work together.
In September 2012, an ACOS leadership team went to Washington, DC, and met with Dr. Shuren, Dr. Eydelman, and their team. We discussed different ways to work together, and we were challenged by the FDA to come back with a project of value that would be centered on the FDA and the ACOS. We created an idea for an expedited pathway for device approvals and have continued to develop that with the agency. We believe we can create an efficient approach in the case of specific devices.
Most recently, we have continued to work with the FDA by becoming one of the first ophthalmic societies to enter into a “network-of-experts” agreement with the FDA. This is a resource group for the agency to gather timely information. As a result, a number of ACOS lead- ers have participated with the FDA in discussions on LASIK, as an example.
For a working relationship of less than 3 years, we at the ACOS have been very pleased. We expect to disagree on some issues, but we know the pathway to new and innovative technology routes through the FDA. We know it is in our patients’ best interest and foremost in our goals as a society to continue to work with and build a relationship with the FDA.
Stephen G. Slade, MD, practices at Slade and Baker Vision in Houston. Dr. Slade may be reached at (713) 626-5544; email@example.com.