16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
Dear Sirs, This letter is in regard to your upcoming Contact Lens Rule update. While it's likely that some eyecare practitioners have not followed the existing Contact Lens Rule, the majority have - despite 1-800's claims to the contrary. Why your agency believes that burdening a largely compliant eye care community with more meaningless paperwork would prompt greater compliance by law breakers makes absolutely no sense. If your agency feels that rule violation is a significant issue, you should enforce existing laws, not promulgate new regulations that would only create unjustifiable administrative burden for the innocent practitioner and, ultimately, additional cost for patients whose interests they are trying to protect. And you should enforce those rules equally and fairly for all parties. The precarious imbalance of the your proposed changes is especially vexing. The real transgressors of the current Contact Lens Rule are the online sellers that fill expired or non-existent prescriptions, abuse passive verification and generally scam the system. While this endangers patients, the rarity of serious complications regrettably obscures the link between unsupervised and illegal lens dispensing, and patient harm. As a result, your agency has somehow ignored the clinical reality that contact lenses are medical devices regulated by the FDA, a sister federal agency, because of the acknowledged risk of these devices. I wholeheartedly request that you abandon this burdensome ruling and allow us to be the law-abiding doctors that we are sworn to be. Respectfully, Robert L. Moore, O.D.