16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995 #04270

Submission Number:
John Mandeville
Initiative Name:
16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
Massachusetts Society of Eye Physicians and Surgeons PO Box [redacted] Boston, MA [redacted] Phone: [redacted] Fax: [redacted] E-mail: [redacted] President: John Mandeville, M.D. Executive Director: Tara Gregorio January 25, 2017 On behalf of the Massachusetts Society of Eye Physicians and Surgeons (MSEPS), which represents hundreds of ophthalmologists in Massachusetts, I appreciate the opportunity to provide comments to the U.S. Federal Trade Commission (FTC) regarding "Contact Lens Rule, 16 CFR part 315, Project No. R511995." While we welcome changes to the Contact Lens Rule that prioritize patient safety, we are deeply concerned with the proposed new requirements that prescribers have their patients sign an acknowledgment of receipt form when provided a prescription for contact lenses and keep the form for three years. These additional requirements place an unfair burden on our doctors but do nothing to address the business practices of some online retailers that jeopardize the safety of the patients our doctors treat. As far as MSEPS is aware, ophthalmologists in MA are providing patients with their prescriptions when requested in full compliance with the Contact Lens Rule as it is currently written. Indeed, our members are going to great lengths to comply with this rule despite serious concerns with its prescription verification system that we believe puts our patients at risk. The current rule's passive-verification system forces a rigid, eight-business-hour window on prescribers to verify prescriptions with sellers. After that window closes, the prescription is filled, regardless of whether a physician verified it. The American Academy of Ophthalmology gathered anecdotal evidence which indicated that practices are seeing a significant amount of errors due to incorrect or expired contact lens prescriptions- as high as 40 percent. Contact lens related injuries account for a large number of emergency visits, and these injuries can be exacerbated by ill-fitting contact lenses. Every time I am on call, I see patients with severe pain and redness resulting from corneal damage from contact lenses. Some of these patients develop corneal ulcers, which can cause scarring or permanent vision loss. Rarely, these infections can be so severe that they result in perforation of the eye! It is very important for contact lens prescriptions to be verified, and for patients to have regular exams to check the accuracy of the prescription and the health of their eyes. To compound these issues by creating an additional administrative burden for small business owners, like many of our members, is unfair. Particularly when there is no evidence that our members are not complying with the current rule. MSEPS wishes to emphasize that contact lenses are medical devices and the safety of our members' patients should not be sacrificed to enable the easier sale of these devices. Further, we are not aware of any evidence showing that ophthalmologists are not providing their patients with prescriptions for contact lenses. As such, our members should not face additional administrative burdens under this rule. We strongly urge the FTC to withdraw this proposal and re-approach the Contact Lens Rule with patient safety as its number one priority. Respectfully, John T. H. Mandeville, MD, PhD President [redacted]