16 CFR Part 315; Agency Information Collection Activities: Review; Comment Request; Contact Lens Rule: FTC Project No. R511995
January 29, 2017 Donald S. Clark Federal Trade Commission Office of the Secretary 600 Pennsylvania Avenue NW. Suite CC--5610 (Annex C) Washington, DC 20580 RE: Contact Lens Rule, 16 CFR part 315, Project No. R511995 Nelson O. Yoshioka Jr., O.D., Inc. represents Nelson O. Yoshioka, Cheryl Niitani, and Carla Watase doctors of optometry in Hawaii. Our mission is to use our clinical skills and knowledge base to provide quality eye care to the Hawaii community. Nelson O. Yoshioka Jr., O.D., Inc. appreciates this opportunity to offer comment to the Federal Trade Commission on proposed changes to the Contact Lens Rule [Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Proposed Rules] Foremost, our organization believes that to ensure a competitive and safe contact lens marketplace, there must be full compliance with the Fairness to Contact Lens Consumers Act and the Contact Lens Rule by both prescribers and contact lens retailers. Our organization was disappointed to see that the Commission offered no proposals which would better address the retailers that openly violate the FCLCA and the Rule by selling contact lenses without a prescription. The FTC statement that "The Commission does not find the evidence proffered in this Rule review sufficient to support a conclusion that the Rule inadequately protects consumer eye health" is especially concerning given the number of online and brick and mortar retailers that sell these regulated medical devices without a prescription. Our organization believes that those who violate the Contact Lens Rule should face enforcement action. The Commission indicated that prescribers may be mistaken in assessing their compliance with the Rule and that patients may be confused regarding the timing of prescription release. To address these issues, our organization is committed to continuing education of both prescribers and patients in our state regarding the requirements of the Rule. The FTC has indicated that its objectives are to: remind prescribers to release prescriptions, inform patients of their rights, reduce misunderstandings, and improve the Commission's verification and enforcement ability. We believe that these goals can be achieved through approaches that are reasonable and balanced. We oppose the new FTC proposal to require that all contact lens wearing patients sign an acknowledgement of receipt of a contact lens prescription and that the form be kept on file for three years. This requirement is a heavy-handed step which presupposes that all doctors of optometry are not complying with federal law. It also would disrupt the doctor-patient relationship by communicating to patients, without justification, that they should be wary of their physician and presume that their eye doctor is a violator of federal law. Additionally, while the FTC seems to dismiss the potential burden on physicians for complying with this requirement, the proposal would undoubtedly add new costs for doctors and patients. It would require an additional step in the patient engagement process, which would necessitate ongoing staff training to ensure that doctors are meeting this unprecedented requirement. In the past, FTC has underestimated and subsequently corrected the estimated burden on physicians for complying with the Contact Lens Rule. I am concerned that the FTC is again underestimating the potential impact of these changes. We urge the FTC not to finalize this approach and instead to focus on increased education efforts by partnering with state optometric organizations and the American Optometric Association. Thank you for the opportunity to comment on this important issue. If you need additional information, please contact us at 808-455-3333. Sincerely, Nelson O. Yoshioka, Jr., O.D., Cheryl Niitani, O.D., and Carla Watase, O.D.