BLOG: Outsider's view of the FDA approval process
Read more blog posts from John A. Hovanesian, MD, FACS
Last week, I had the unique opportunity to present before the FDA Ophthalmic Devices Panel the clinical results and experience with the ReSure ocular sealant proposed for approval for sealing leaking cataract wounds.
Some background: When a company’s first-in-class drug or device seeks approval from the U.S. Food and Drug Administration, the FDA works with the company, called the “sponsor,” to design a trial to determine its safety and effectiveness. Before approval, a panel of experts, independent from the FDA, is convened in Washington to hear both the FDA's interpretation of the data and that of the sponsor.
The panel votes either to recommend approval or not. Not binding, the panel's vote gives guidance to the FDA as well as further insights as to the panel’s view of the data and subject matter in general.
In the case of ReSure sealant (Ocular Therapeutix), the data was overwhelmingly positive, demonstrating clear superiority over suture for sealing leaking wounds, even when both sutured and sealed wounds were compared under the challenge of a spring-loaded, calibrated force gauge pressing on the wound edge.
In the end, the independent panel voted to recommend approval of the sealant, but the mixed vote count was not reflective of the overwhelmingly positive feeling among most panel members that the material was safe and effective. Rather, the vote was mixed because of a technicality; some panel members took issue with one or two words in the proposed “indications for usage,” which is the official FDA approved use of the new device.
Because they were advised their vote had to be all or none, some panel members either abstained or voted against recommending approval even though they felt the material was basically safe and effective for its intended purpose.
As a first-timer watching these proceedings, I have the following take-aways:
- The FDA approval process intends to be fair but isn't always. Technicalities that can be brought up unexpectedly can delay approval of an otherwise valuable drug or device.
- The system is subject to the same human frailties as everything else we do. Both the independent panel and the FDA are composed of human beings who do their best to understand a large amount of data and fairly assess its validity. But we all bring inherent bias, and our perception can be altered by what we expect to see. Well-intentioned people sometimes come to inaccurate beliefs because of these human frailties.
- We are lucky to live in a country where genuine concern for the safety and effectiveness of drugs and devices guides decisions rather than ulterior motives. Having had many personal experiences doing volunteer work in the developing world, I feel comforted to know that, however imperfect, we have in the United States a system that at least intends to protect our patients from harm and deliver to them products that have passed muster in an impartial, transparent forum.
Like many colleagues, I’m eagerly awaiting the FDA’s final approval of Resure sealant, which will be a valuable addition to our surgical armamentarium.
Disclosure: Hovanesian is a consultant and investigator for Ocular Therapeutix, which produces Resure sealant.