FTC 16 CFR Part 315 Public Workshop Examining Contact Lens Marketplace And Analyzing Proposed Changes To The Contact Lens Rule
As the president of CLAO (the Contact Lens Association of Ophthalmologists) and a practicing ophthalmologist, I am deeply concerned about proposals included in the Federal Trade Commission's proposed amendments to the Contact Lens Rule. Patient safety is paramount and while I would welcome any changes to the Contact Lens Rule that prioritize patient safety, these proposals would create significant burdens on my practice and do nothing to address the fact that sellers of contact lenses have frequently engaged in business practices that exploit loopholes in federal statutes to the detriment of patients. Our practice documents contact lens prescriptions in the medical record, easily accessible to patient requests. Having patients sign an acknowledgement-of-receipt form would not only be an administrative burden for our practice, but would lack benefit to our patients. It is a meaningless attestation that would likely cause confusion and distraction from more valuable efforts than any safeguarding for patients. Such a burden should not be placed on small businesses that are already going to great lengths to comply with the Contact Lens Rule and do so despite serious concerns with the current prescription-verification system that we believe puts our patients at risk. I routinely see patients who misuse contact lenses and underestimate the serious risks of vision loss associated with improper contact lens wear and care (such as infection and inflammation). The current passive-verification system is a major loop-hole and avenue for patient harm. Even in cases when entities comply with attempting verification, 8 business hours is simply too short a time-frame. This process should not even be called passive verification because it does not require actual verification, only an attempt at verification. We know of patients with contact lens complications who had not been seen by an ophthalmologist or optometrist for at least 5 years, but somehow continuously obtain contact lenses through an online seller. Since 2004, the Contact Lens Rule has focused on making the sale of contact lenses as easy as possible. However, contact lenses are medical devices (in fact, extended wear contact lenses are category 3 medical devices, the same level as intraocular lenses!); and any changes to the Contact Lens Rule should NOT be made at the expense of patient eye health. This includes modifications to the expiration of contact lens prescriptions to encourage patients to avoid having their eyes evaluated to ensure appropriate contact lens wear and fit. The American Academy of Ophthalmology's evidence-based preferred practice pattern recommends that contact lens wearers be examined every 1 to 2 years to monitor for adverse effects of contact lens wear and for an update on healthy practices in contact lens wear and care. In this global market, our patients can also access contact lenses easily without a prescription from global websites such as pinky paradise.com and visiondirect.com. Pinky paradise now advertises they require passive verification for US patients, but visiondirect states it does not, even for US patients. This is a major problem. At least for the markets over which the US has regulatory authority, we urge you to maintain stricter policy in the proper purchasing of contact lenses. We strongly urge the FTC to withdraw its proposed changes to the Contact Lens Rule. We feel the FTC should review of the Contact Lens Rule with patient safety as its number one priority. We have seen improper use of contact lenses without oversight result in irreversible vision loss.