Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review

Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36 1/2 years, retired from the agency Jan. 13, 2024.

The 65-year-old is now serving as a consultant to ophthalmic pharmaceutical companies through his new company, Ocular Advisors.

Chambers provided some thoughts on his FDA career—which began in August 1987—during an interview with David M. Brown, MD, FACS, at the Atlantic Coast Retina Club Macula 2024 conference, hosted by the International Retinal Imaging Society (IntRIS).

The interview took place Jan. 6, 2024, days before Chambers left the FDA.

He was hesitant when asked to name his biggest accomplishment at the agency, noting that he didn’t do anything alone. A team of ophthalmologists were instrumental in helping him make decisions.

But he said he was proud of having a hand in the review of about 95 percent of the ophthalmic drugs used in the US.

He said he had made mistakes and didn’t expect everyone to agree with his decisions, but he hoped people would understand the reasons behind his rulings.

Toughest Decision

His most controversial recommendation came early in his career, in 1989, and made other tough decisions easier, he said.

At the time, the US was facing the AIDS crisis.

The candidate under review was intravenous ganciclovir, a drug used to treat the symptoms of cytomegalovirus infection in the eyes of immune-compromised individuals, including those with AIDS.

Chambers said: “It became very clear from the studies that if you took IV ganciclovir, you would die sooner. You also would be able to see until you died. So it was a tradeoff of whether you wanted to see and die sooner or whether you wanted to live longer and likely go blind.”

He added that he thought it was a decision that should be made by a patient and the patient’s physician, not by the government. And the way to make that choice available to the patient and physician was to approve the product.

Then, he countered, “It’s very easy to argue that that’s not a benefit-to-risk that you should be allowing people to take, but I happen to think that’s a patient-physician decision.”

Why Chambers Left the FDA

Chambers has been a frequent panelist and speaker at ophthalmic meetings.

He had told meeting attendees in recent years that he was planning to retire from the FDA, but he said during the interview that he wasn’t planning to do so in 2024.

The decision came abruptly as he fought to hang on to $66 thousand in carry-over leave that he would lose if he stayed at the FDA.

At the time of the interview, he was still hoping he could work out the issue and remain at the agency.

Chambers’ Path to the FDA

Born in Washington, DC, and raised in New England, Chambers was the son of an ophthalmologist and planned to join his father at his practice after graduating from medical school.

He earned his undergraduate degree at Colgate University and completed his medical degree and residency in ophthalmology at George Washington University.

He finished his residency just as the sole ophthalmologist working at the FDA left to take a job at a company.

Wiley decided to take the FDA job and stay in Washington.

He continued to practice medicine, as well, serving as an ophthalmologist for three decades at the VA Medical Center in Martinsburg, West Virginia, according to an article by Kuldev Singh, MD, MPH, for Healio.

Chambers also is a clinical professor of ophthalmology and an adjunct assistant professor of computer medicine at George Washington University.

He has received numerous Public Health Service, FDA, and Center for Drug Evaluation and Research awards for his work with the FDA.

In his final role, he held supervisory responsibility for the clinical review of ophthalmic drug products and therapeutic biologic products that were submitted to the Center for Drug Evaluation and Research.

Brown called him “the most approachable regulator and the most helpful” of any he had known.

Post-retirement Changes

Chambers also spoke with John Hovanesian, MD, FACS, and James Mazzo in an Eyeluminaries podcast released March 28, 2024.

Chambers said he works from a home office now in his consulting job, a big change from working at the FDA, where he made the 25-minute commute to his office religiously, including throughout the pandemic.

Advice for Innovators?

Asked what advice he would give an innovator with a new drug idea, Chambers said he thought a good idea was “worth a shot” and “it takes a certain amount of enthusiasm to be able to develop a product and get it through approval.”

But if the data doesn’t show it is effective, move on, he said.

‘Great Deal of Respect’

Hovanesian called Chambers “one of us, an ophthalmologist who practices and understands the challenges that we all face. He’s a straight shooter. If you talk to any company that’s worked with him, they say he sets a bar that is clear and expects that bar to be met for approval of drugs.”

In sum, the ophthalmic industry has a “great deal of respect” for Chambers, Hovanesian said.