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2019 FTC Rule Update

2019 FTC Rule Update

Woman with contact lens

 

Johnson & Johnson Vision's Official Comment Summary

Supplemental Notice of Proposed Rulemaking (SNPRM) to the Federal Trade Commission's (FTC) Contact Lens Rule

Highlights from Johnson & Johnson Vision's official comments on the SNPRM as part of our broader commitment to support growth and competition in the contact lens marketplace, while prioritizing eye health and safety.

Prescription Alteration

  • Defintion of "prescription alteration":

    We showed our strong support for FTC’s proposal to expand the definition of prescription alteration to specifically include brand and manufacturer. Aspects of a contact lens prescription – like the shape of the lens and the material used in each brand – are critical to protecting a patient’s eye health. If finalized, this update will prohibit sellers from substituting for a brand or manufacturer that was not prescribed to the patient by their doctor.
  • Prescription presentations to sellers:

    We showed our support for FTC’s proposal to require that sellers have a mechanism for patients to directly upload and share their prescriptions with a seller — creating a stronger prescription “paper trail” and helping to reduce sellers’ reliance on the passive verification process to protect patient health and safety and contribute to the accurate dispensing of prescriptions.
  • Maintaining the term “private label”:

    As we shared in past comments, we requested that FTC maintain the term “private label” to expressly indicate that is the only instance in which contact lens substitution is permissible (i.e., when the lenses are made by the same manufacturer, but sold under a different name) to ensure patients receive the lenses prescribed by their eye care professional that best and most safely meet a patient’s needs.

Prescription Verification

  • Use of automated robocalls:

    We asked FTC to eliminate robocalls as a permissible form of prescription verification and requested that if FTC decides to continue to permit them, that the Commission place additional requirements on sellers to ensure these calls are not burdensome to doctors and better promote patient health and safety.

Automatic Prescription Release

  • Prescription release:

    We asked FTC to apply the prescriber requirement for prescription release to all prescribers—not just those with a direct financial interest in the sale of contact lenses. This will ensure that as contractual agreements between prescribers and sellers change, patients can always be sure they will receive a copy of their prescription.

Additional Recommendation

  • Promoting digital mechanisms to ensure prescription accuracy:

    We requested that FTC add clarifying language to the updated Rule underscoring the Commission's intention to promote the use of technology to ensure a strong paper trail, fewer errors, and reduced reliance on the passive verification process to protect patient health and safety and contribute to the accurate dispensing of prescriptions.

Update to FTC’s Proposed Changes to Contact Lens Rule

What type of announcement is this?

  • It is a Supplement to the FTC’s original Notice of Proposed Rulemaking. Said otherwise, the FTC issued a Notice of Proposed Rulemaking (NPRM) on November 10, 2016, requesting comments to proposed modifications to the Contact Lens Rule (the Rule). This is a supplement to that NPRM in which the FTC is proposing modifications to its prior proposals and offering new proposals to amend the Rule.
  • There is a 60-day window in which the FTC is seeking comments to its modified proposals, between now and early July. The exact date will be announced once the FTC posts the Notice to the Federal Register.


Highlights of the SNPRM

  • Signed Acknowledgement Forms
    • In the original NPRM, the FTC proposed to require a signed acknowledgement form for providers (i.e., a paper that a patient signs stating they received a copy of their contact lens prescription).
    • In the SNPRM, the FTC now proposes greater flexibility on the signed acknowledgement form, proposing to allow providers to 1) use different methods for their patients to acknowledge that they received a copy of their contact lens prescription, including via electronic means; and 2) develop their own acknowledgment language rather than requiring providers use the language offered by the FTC.
  • Robocalls
    • In the SNPRM, the FTC addresses some of the challenges that robocalls present and is recommending steps to ensure that these calls are clearer and more comprehensible.
    • Note that the FTC does not propose an outright ban on robocalls and seems to indicate that they believe such a change would need to be done legislatively.
    • Congressional Advocacy: Modernizing the Verification System
      • Currently, Johnson & Johnson Vision Care, Inc., through its leadership role with the Healthcare Alliance for Patient Safety (APS), is working to introduce a bill in Congress that would modernize the prescription verification process to support better ways for sellers and providers to communicate with each other when verifying contact lens prescriptions.
  • Substitutions
    • The FTC is also reconsidering its stance on illegal substitution and acknowledges the abuse by some sellers of the passive verification process. It is proposing to expand its definition of “prescription alteration” to expressly include instances in the verification process when a seller provides the prescriber with a name other than the brand or manufacturer listed on the prescription.
    • In the SNPRM, the FTC proposes an exception in cases where the patient alters their own prescription to include a brand or manufacturer other than the one on their prescription. We believe that, if questioned, the seller should have the burden of providing evidence that the patient provided the inaccurate prescription, not the seller. The FTC concurs that this is a way to encourage prescription recordkeeping and a stronger paper trail.
  • Private Label
    • In the original NPRM, the FTC proposed to remove the term “private label,” from the section of the Rule explaining the only instance in which alteration is permissible [i.e. when the lenses are made by the same manufacturer, but sold under a different label]. They proposed to remove the term out of concern that it unnecessarily limited third parties from understanding the instance in which they are allowed to substitute for their own private label lenses.
    • In the SNPRM, the FTC did not choose to modify its original proposal but welcomes additional comments on this issue.


Next Steps for Johnson & Johnson Vision Care, Inc.

  • We are going to provide our comments to the SNPRM within the next 60 days. We’ll share a link to our comments once finalized so you can read where we stand.
  • As soon as the public comment portal is live, you can also share your thoughts on the FTC’s proposals. While we wait, please feel free to share with us your feedback and insight on how these proposals may affect you and your patients.
  • As always, we look forward to standing side by side with you to amplify and elevate patient eye health and safety!

 

 

Johnson & Johnson Vision has worked closely with the Federal Trade Commission (FTC) during its 10-year review of the Contact Lens Rule to advocate for regulation that fosters competition and innovation in the contact lens marketplace and prioritizes patient safety and eye health. 

On May 2, FTC issued a supplemental proposed rule, which we are currently reviewing. Johnson & Johnson Vision thanks the FTC for its careful review of the Contact Lens Rule and its contribution to growing and retaining satisfied contact lens wearers in the U.S. We will continue to work closely with the eye care community, policymakers, and regulators to ensure patients’ evolving needs are met today, and in the future.

Johnson & Johnson Vision Advocacy at Work from Vision to Action on Vimeo.

If you haven’t done so already, you can also sign up to receive email updates from us on our latest advocacy efforts and new tools. We look forward to keeping you apprised on relevant updates regarding implementation of the finalized Rule and on other future issues central to your business.