David Fell, MD
Vitreoretinal fellow
Tufts/OCB
Dave Brown Interviews Food and Drug Administration Director of the Division of Ophthalmology, Wiley Chambers, MD.
With the audience eagerly awaiting insider discussions on the newest drug developments in ophthalmology, Dr. Brown decided to start off with a few personal questions for Dr. Chambers. After discussing the ways in which his father, an ophthalmologist, inspired him toward a career in medicine and ophthalmology, and how he stumbled into his job at the FDA when he stayed in Washington D.C. because it was a “good place to live as a single guy” at the time, Dr. Brown finally asked him his favorite cartoon character. “Bugs Bunny,” Dr. Chambers responded without hesitation.
The two went on to discuss the recent draft guidance on the drug development for novel medications for exudative age-related macular degeneration. Despite being the first draft guidance release in 25 years, Dr. Chambers assured us that over 30 drafts had been circulated internally over this time with only two released. The main point of this draft guidance is to represent the agency’s thought process at this time and provoke responses and dialogue with the community of drug developers and ophthalmologists.
They dove further into some of the ethics of sham injections in clinical trials, which Dr. Chambers insists are necessary to maintain the strength of a randomized trial, arguing that “patients just try harder when they know they’re on a particular therapy.” They continued on to discuss the usefulness of a p = 0.05 cutoff for statistical significance, the contribution of components when evaluating the necessity of all components of a new drug, and the utility of microperimetry as a potential clinical endpoint used for drug approval.
Dr. Brown ended, again, on a personal note, asking Dr. Chambers about his proudest accomplishment during his tenure at the FDA. While he clearly expressed pride in the way his team was able to play a large part in approving many new drugs over the past 4 decades, it was one controversial decision he made early on in his career that stood out. “It was at a time when the US was facing the AIDS crisis. If you took IV ganciclovir you would die sooner but be able to see longer before you die. From my perspective that is a decision to be made by a patient and his or her physician. Therefore we approved the product.” Finally, when asked when he might consider retirement and what the next phase of life would look like, Dr. Chambers said he plans to retire from the FDA next week. Dr. Brown then thanked Dr. Chambers for his years of service as the auditorium broke out into a standing ovation.
