I certainly understand that many in our profession are upset with the Federal Trade Commission’s (FTC) updated 2020 Final Rule requiring prescribers to release prescriptions at the end of the contact lens fitting and to document that prescriptions have been provided, among other things. The Rule also allows contact lens “sellers” to substitute contact lenses for “private label lenses” if “the substitute lenses are made by the same manufacturer and are identical to the prescribed lenses.” While the Rule went into effect in October 2020, the Final Rule was later delayed for implementation to March 31, 2021.

Throughout the process of updating the rule that began years ago, one of the more concerning aspects was the FTC Commissioner’s statements suggesting that Congress mandate the U.S. Food and Drug Administration (FDA) to study the “therapeutic interchangeability of different kinds of lenses for common ocular ailments, such as nearsightedness,” (Slaughter, 2020). The suggestion that we move to the concept of “generic” contact lenses sparked alarm among many in the medical community.

Taking a step back, it is important to recall the FDA’s regulatory role in its oversight of medical devices, which, as they point out, ranges from “simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems.” (FDA, 2019) Among other things that define a medical device, they are intended to diagnose and treat diseases and conditions “affecting the structure and function of the body in man…” The FDA further categorizes medical devices based on risk, with those in Class I being least risky and those in Class III being categorized as high-risk devices. Soft, daily wear lenses are regulated as Class II medical devices (i.e., moderate risk).

Anyone practicing in the field of contact lenses knows that they can be associated with various complications ranging from symptoms of visual disturbance to inflammation to microbial keratitis. That is exactly the reason why they are regulated as a Class II medical device. While I know of no data that evaluates the substitution of a generic contact lens (without a contact lens fitting) on ocular health, it seems to go beyond conventional wisdom to think that this would not be associated with adverse events and complications. It further speaks to the role and importance of the fitting and follow-up processes associated with contact lens wear. While I understand and appreciate consumer rights, I think that we need to continue to educate legislators and policymakers about to the role of the profession in protecting patient health and safety along these lines.

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