16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #03613

Submission Number:
03613
Commenter:
Arthur Epstein
State:
Arizona
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
I am writing to express my concern regarding proposed changes to the Contact Lens Rule. While some eyecare practitioners may have ignored or been unaware of the existing Rule, the majority have been compliant. If the Commission believes that Rule violation is a significant problem, increased practitioner education and more aggressive enforcement would increase compliance without adding additional substantial administrative burden. Promulgating new regulations would unnecessarily penalize innocent and already compliant practitioners and ultimately add additional cost for patients whose interests the Commission is trying to protect. In addition, the proposed changes are grossly imbalanced and largely misdirected. The real transgressors of the current Contact Lens Rule are the online sellers who knowingly fill expired or non-existent prescriptions, abuse passive verification and generally scam the system. This behavior should already be well known to the Commission and is something eye care provider's deal with on a regular basis. While this endangers patient health and safety, the rarity of serious complications obscures the link between unsupervised and illegal lens dispensing and patient harm. As a result, non-compliance with the Contact Lens Rule is far easier to demonstrate than are the devastating outcomes of corneal infection. I urge the Commission to consider that contact lenses are medical devices regulated by the FDA because of their acknowledged and recognized risk. If any changes to the Contact Lens Rule are to be made, non-compliance by online sellers is a far more egregious and insidious issue effecting patient safety that should be addressed by the Commission. In considering any changes to the Contact Lens Rule, I urge the Commission to carefully weigh the impact on eye care providers while balancing consumer interests against the very real risk to an individual patient's sight. Having seen more than my share of devastating contact lens infections during my 40-year career, I respectfully ask that you consider the needs of the individual to be at least as important as those of the consumer.