May 03, 2019
2 min read

FTC proposes changes to Contact Lens Rule

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The Federal Trade Commission is seeking public comment on changes it recently proposed to its Contact Lens Rule.

In a May 2 press release, the commission announced its new proposal resulting from consideration of “thousands of public comments and material received by the commission between 2015 and 2018, including surveys, studies, analyses and information generated at an FTC workshop devoted to the rule and the evolving contact lens marketplace.”

The modifications to an earlier proposal are intended to enhance compliance with the Fairness to Contact Lens Consumers Act requirement that prescribers provide all patients with a copy of their contact lens prescription.

“The FTC believes the newly developed modifications will achieve the goals of its original proposal, while imposing less of a burden on prescribers,” the commission said in the release.

The Supplemental Notice of Proposed Rulemaking has not yet been published, but the FTC outlined in its press release the new proposed requirements. Prescribers would have to satisfy a new Confirmation of Prescription Request requirement through one of these methods:

— a separate confirmation statement signed by the patient;

— a copy of the prescription signed by the patient and retained by the prescriber;

— a copy of the sales receipt signed by the patient and indicating that the patient received the prescription; or

— evidence that the patient received a digital copy of the prescription.

This confirmation would have to be kept on file for at least 3 years.

The proposed changes also address concerns about incomplete or incomprehensible automated telephone verification messages, the FTC said.

Sellers would be required to deliver the information in a “slow and deliberate manner and at a reasonably understandable volume” so that prescribers would be able to repeat the message. The FTC said that the purpose of this requirement “is to enable prescribers to fulfill their role as protectors of patients’ eye health by ensuring they can comprehend sellers’ verification requests.”

Also, the FTC proposes that the verification request must include the name of a manufacturer or brand if it is different than that specified by the prescriber, unless the name is specifically provided by the patient. In addition, the commission proposes to require a mechanism that would allow patients to present their prescriptions directly to the seller to ensure that they receive the lenses prescribed for them, “consistent with the intent of the Fairness to Contact Lens Consumers Act and the Rule.”

Johnson & Johnson Vision issued a statement to eye care providers saying that the company has worked closely with the FTC during the FTC’s 10-year review process “to advocate for regulation that fosters competition and innovation in the contact lens marketplace and prioritizes patient safety and eye health.”

The company said it will partner with ECPs to “navigate the finalized updates to the rule and our evolving contact lens landscape” and that it will work to ensure advancements that “promote patient safety through professional oversight and a strong doctor-patient relationship.”