In a few short weeks, the Federal Trade Commission (FTC) will be meeting to decide the fate of the contact lens industry and, perhaps inadvertently, the health and well-being of every contact lens wearer in the United States. Focused on consumer rights at the expense of public safety, the FTC will be considering needless and resource-consuming new contact lens documentation requirements. It is also expected to propose generic lens substitution regulation. In this process, the FTC will have ignored the complexity of contact lens materials, the differences between contact lens designs, and, most importantly, the sometimes-devastating reality that contact lenses are medical devices that, when misused or improperly fitted, can cause life-changing harm to wearers.
Without context, it’s easy to overlook the ongoing revolution in contact lens science and engineering. After an avalanche of serious corneal infections made national headlines in the 1980s, the contact lens industry was spurred to develop safer and healthier materials. The materials design work of several industry pioneers stand as breathtaking scientific accomplishments that have driven the industry to new heights of safety and performance. As a result of innovation by major manufacturers, contact lenses are far better but more distinct from each other than ever before. A generic one-size-fits-all approach is a sellout to patient safety that will disincentivize further innovation and potentially harm contact lens consumers.
Will patients purchase generic, no-name contact lenses to save a dollar? History has clearly shown that patients will sometimes do things that are not in their best interests. The ongoing opioid crisis is a sad example of why stringent regulation is needed for drugs and devices that have known risks. The U.S. Food and Drug Administration may have abandoned enforcement of public health-focused, common-sense contact lens device regulation, but that’s certainly no excuse for the FTC to put the public at even greater risk by kowtowing to entities that put profits ahead of patients.
The FTC has also misjudged eyecare practitioners. We are almost universally patient-focused and compliant. Yes, there are some bad apples, but I would venture to suggest that they represent such a small percentage that they are virtually irrelevant from a regulatory perspective. The bigger issue, as many of us are reminded daily, is the contact lens sellers who couldn’t care less about their customers and routinely game the FTC’s passive verification rules to circumvent patient protections. The FTC would be wise to carefully consider the real-world impact of what it proposes.
This article is adapted from Optometric Physician. 2018 Feb 5;18(6).