16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00485

Submission Number:
Thomas Balitski
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
I feel changes should be made to correct for problems with the law. Currently, the eight business hour waiting time an online seller must wait before filling a CL order is arbitrary and not appropriate for medical devices. A physician who is following someone for high blood pressure requires that the patient return to their office to monitor the patient's blood pressure to make sure it is under proper control before refilling a medication refill. If the contact lens rule was applied to this situation, if the PCP's office did not get back to the pharmacy in eight hours it would just fill it, potentially jeopardizing the patient's health if modification of the treatment medicine was necessary. Contact lenses are medical devices that interact with the living tissue of the eye and should be held to the same criteria as therapeutic medications, including Rx expiration dates and refill requirements. This eight hour waiting time also leads to patients attempting to purchase lenses without an Rx ever being written. Several times a month, we will receive verification requests from online sellers for patients that have never been seen by our practice. These potential buyers acquire our practice information from the internet or phone book, then use that information to place an order, usually after business hours. If we are unable to reject the order through verification within the time constraints (which can happen easily in a busy office), these people receive contacts without a prescription. The waiting period needs to be replaced with something that can prevent this. Also, these "doctor shoppers" should be prosecuted for prescription fraud, just like those who illegally acquire controlled substances. Finally, brick and mortar establishments that dispense contacts like pharmacies or Costcos should also be bound to verification. Patients can purchase a year's supply of contacts from one such store, then another and then potentially online as well. Only the latter would require verification with the current law. This subverts the annual prescription requirement and endangers patient health as they will not return properly for monitoring wellness care to rule out the development of ocular health complications. I feel these changes should be made to protect patients eye health. Patients who who use these loopholes to skirt the system commonly end up abusing their lenses, resulting in emergency red eye visits that cost insurers money. These costs would be reduced if the law requires patients to return for annual wellness visits and the law is enforced. Thank you for considering my comments.