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Are there advantages to the FDA’s stringent approval process for ophthalmic devices for physicians and patients?
FDA offers many advantages to both physician, patient
 Charles P. Wilkinson |
The device approval process at the FDA is cumbersome, but it offers obvious advantages for patients and their ophthalmologists. Without thorough preclinical analyses and premarket clinical studies, the safety and effectiveness of a variety of devices, ranging from contact lenses to viscoelastics to phacoemulsification equipment, would remain unproven. There are numerous examples of devices that were initially claimed to be “complication-free” and that subsequently became recognized as responsible for predictable problems.
The agency is admittedly understaffed and underfunded, but it is composed of a dedicated and talented group of individuals who are caught in a double-bind of demands for both rapid approval and for reassurance regarding safety and effectiveness. It is unfortunate that funding remains a major factor in prolonging the approval process and perhaps limiting the amount of post-approval research that might be conducted.
Charles P. Wilkinson, MD, is past president of the American Academy of Ophthalmology and Chairman, Department of Ophthalmology, Greater Baltimore Medical Center and Professor, Department of Ophthalmology, Johns Hopkins University.
FDA has advantages, but clouded by politics, costs
The FDA is charged with the important task of protecting the public in regards to food and drugs. The quandary always is, how much should we be protected and at what cost. When the FDA was given this charge, we had hucksters selling snake oil and fake devices to cure illnesses. The FDA has made us a model system for having safe and effective treatments for our population, as well as having a safe food supply. Even with the safety levels we have achieved, there are still occasionally some breakdowns in the system, either in the food supply or drugs and devices.
 Francis W. Price |
Recently our leaders in Congress and the White House have jumped on the FDA because of some of these breakdowns, which are not necessarily the FDA’s fault or unexpected. The peanut problem and Vioxx (rofecoxib, Merck) are two high-profile examples. I think these were cases of grandstanding by our elected officials for political gain at the expense of the good of the country.
The FDA now seems to be moving toward a system in which drugs and devices can have no risk. In order to do this, companies have to participate in increasingly more expensive studies, which both increase the cost of our drugs and devices far above that paid outside of the U.S. and make the threshold to recoup these costs so high that many drugs and devices are never even either brought here or attempted to be developed. Remember, the cost is not just for approving the given item, but also for those from the same company that may not make it all the way to approval. The current system is too expensive.
Francis W. Price Jr., MD, is an OSN Cornea/External Disease Board Member.