16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #00236

Submission Number:
katherine sanders
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
My husband and fellow OD wrote the message below. I couldn't agree with him more. //Dr. Katherine Sanders Online vendors take advantage of the lack of regulation this rule on a very consistent basis. Contact Lenses are a class II regulated device that has been linked to inflammation and infectious disease leading to permanent visual reduction and potential blindness yet the contact lens rule and Fairness to Consumers Contact Lens Act lays the burden of regulation on healthcare professionals. This is unreasonable and causes a massive administrative burden on said offices. not only do we have to take the time to print a contact lens prescription for the patient(and pay for such materials) but the patient then inputs it into the online vendor site and we have to then turn around and verify it by fax or phone. i.e. anyone (whether they are a patient or not) can go online and simply select any office across the country and select any contact lens(prescribed or not) and place an order. the online vendor then send a fax or calls the office selected(typically on Friday evenenings) and the office must respond within eight business hours or the order is filled. the patient does not have to provide a valid prescription. offices have to respond to requests for their own patients who input the wrong prescription, wrong brand, expired prescriptions and from people are not patients. Even when offices respond the online vendor often sends a duplicate request the following day(s). Each time we must respond of the person will get an illegally filled prescription. I have had patients come in with infections, inflammation that were mild to sight threatening from wearing FDA approved and non-FDA approved contact lenses purchased illicitly online. prominent online vendors like to sell contact lenses as a one size fits all commodity with fictitious "complications" that are made up by their eye doctors to scare them. the well fare and safety of their customers(our patients) is the least of their concern. the responsibility of the FDA and FTC should be just that, however, with rules such as these that are not enforced nor regulated, they are failing their citizens. contact lenses should be prescribed like anyother drug/device through a pharmacy. people selling them should be certified/licensed and regulated to dispense them in specific quantities(i.e. birth control is sold with 13 refills over 12 months. contact lenses should be sold up to an annual amount. you should not be able to go online and buy a 3 year supply with a prescription that expires after 12 months). a paper or electronic prescription given to the patient should not have to be re-verified when used elsewhere(we are doing twice the work!). eye care offices do not practice in ways that risk patients' safety. online vendors do. i'm hopeful that one day the FTC will wake up and realize they are the root cause of the actions of online vendors and alter the way they regulate contact lenses. the burden of prescribing, verifying(and re-verifying) needs to be relieved(i.e. if the patient had to input the doctor's NPI or some CL ID# off the paper prescription it would validate the office as the prescribing entity - this would reduce requests from people who have no affiliation and are simply trying to get contacts without a prescription). i can't tell you how exhausted this topic makes me feel. we deal with it daily and it is a bane on my existence.