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|FTC||RIN: 3084-AB36||Publication ID: Fall 2019|
|Title: Contact Lens Rule|
The FTC promulgated the Contact Lens Rule (Rule) pursuant to the Fairness to Contact Lens Consumers Act (FCLCA), 15 U.S.C. 7601 to 7610, which was enacted to enable consumers to purchase contact lenses from the seller of their choice. The Rule became effective on August 2, 2004. As mandated by the FCLCA, the Rule requires contact lens prescribers to provide prescriptions to their patients on the completion of a contact lens fitting, and verify contact lens prescriptions to contact lens sellers authorized by consumers to seek such verification. Sellers may provide contact lenses only in accordance with a valid prescription that is directly presented to the seller or verified with the prescriber.
As part of its ongoing systematic review of all FTC rules and guides, on September 3, 2015, the Commission requested public comments on, among other things, the economic impact and benefits of the Rule; possible conflict between the Rule and State, local, or other Federal laws or regulations; and the effect on the Rule of any technological, economic, or other industry changes. The comment period closed on October 26, 2015. After Commission staff completed review of the 660 comments received from consumers, eye care professionals, industry members, trade associations, and consumer advocacy groups, the Commission published a notice of proposed rulemaking (NPRM) on December 7, 2016, seeking comment on its proposal to amend the Rule to require contact lens prescribers to obtain a signed acknowledgement after releasing a contact lens prescription to a patient and to maintain it for at least 3 years. In addition, to conform language of the Rule to the language of the FCLCA, the Commission proposed to amend section 315.5(e) of the Rule to remove the words "private label.” The Commission also sought comment on this proposal. The comment period closed on January 30, 2017, and staff reviewed more than 4,000 comments that were received.
On December 8, 2017, the Commission announced that it would hold a public workshop relating to the NPRM and other issues relating to competition in the marketplace and consumer access to contact lens. 82 FR 57889. The workshop was held on March 7, 2018, and the deadline for submitting comments on the issues discussed at the workshop was April 6, 2018. Staff reviewed the more than 3,000 comments received and submitted a recommendation to the Commission during April 2019. On May 2, 2019, the Commission announced the issuance of a Supplemental Notice of Proposed Rulemaking (SNPRM), which was subsequently published in the Federal Register. 84 FR 24664. As detailed in the SNPRM, after a contact lens fitting, prescribers would have to satisfy a new Confirmation of Prescription Release requirement in one of several ways--requesting that the patient acknowledge receipt of the contact lens prescription by signing a separate confirmation statement; requesting that the patient sign a prescriber-retained copy of the prescription that contains a statement confirming the patient received it; requesting that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming the patient received the prescription; or providing the patient with a digital copy of the prescription and retaining evidence that it was sent, received, or made accessible, downloadable, and printable. The prescriber would have to maintain evidence that they satisfied the Confirmation of Prescription Release requirement for at least 3 years. The Commission believes the newly developed modification will achieve the goals of its original proposal, while imposing less of a burden on prescribers.
The Commission also seeks comment on newly recommended Rule modifications affecting prescribers in several other ways: First, by adding to the Rule a definition of the term provided to the patient a copy, the Commission proposes to allow prescribers to provide patients with a digital copy of their prescription instead of a paper copy, with the patient’s consent; Second, the Commission recommends requiring prescribers to provide an additional copy of a patient’s prescription to a designated agent of the patient within 40 business hours of receipt of the request.
Further, to address concerns about incomplete or incomprehensible automated telephone verification messages, the Commission proposes several new requirements for sellers who use such messages to communicate with prescribers, to include requiring that the information be delivered in a slow and deliberate manner and at a reasonably understandable volume and that prescribers be able to repeat the message. The purpose of these proposals is to enable prescribers to fulfill their roles as protectors of patients’ eye health by ensuring they can comprehend sellers’ verification requests.
Finally, the Commission proposes modifications designed to reduce illegal prescription alterations by sellers in violation of the Rule. The Rule already prohibits prescription alteration, but some sellers appear to use passive verification to switch consumers from their prescribed lens to another lens brand. The Commission therefore proposes to amend the prohibition on seller alteration of prescriptions by specifying that alteration includes a seller providing the prescriber with a verification request with the name of a manufacturer or brand other than that specified by the patient’s prescriber, unless such name is specifically provided by the patient.
The Commission also proposes to amend the Rule to require that sellers provide a mechanism that would allow patients to present their prescriptions directly to the seller. These changes are meant to ensure that consumers receive the lenses prescribed for them, consistent with the intent of the FCLCA and the Rule.
The public comment period closed on July 29, 2019. Staff anticipates making a recommendation to the Commission in the winter of 2019-2020.
|Agency: Federal Trade Commission(FTC)||Priority: Substantive, Nonsignificant|
|RIN Status: Previously published in the Unified Agenda||Agenda Stage of Rulemaking: Proposed Rule Stage|
|Major: No||Unfunded Mandates: No|
|EO 13771 Designation: Independent agency|
|CFR Citation: 16 CFR 315|
|Legal Authority: 15 U.S.C. 7601 to 7610|
|Additional Information: https://www.ftc.gov/news-events/press-releases/2019/05/ftc-seeks-additional-public-comment-proposed-changes-contact-lenshttps://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace|
|Regulatory Flexibility Analysis Required: Undetermined||Government Levels Affected: None|
|Small Entities Affected: Businesses, Organizations||Federalism: No|
|Included in the Regulatory Plan: No|
|RIN Data Printed in the FR: No|
|Related RINs: Previously reported as 3084-AA95|
Federal Trade Commission
600 Pennsylvania Avenue NW, CC-10528,
Washington, DC 20580