The Health Care Alliance for Patient Safety is pleased to learn that the Food and Drug Administration (FDA) has notified Opternative that their online eye examination is in violation of the Federal Food, Drug, and Cosmetic Act. Though APS supports the development of telehealth to offer better access to Americans, this action by the FDA further demonstrates that online applications cannot currently replace the benefit a patient receives from an in-person, comprehensive eye exam.

Our Alliance and member organizations – which include the American Optometric Association (AOA), Johnson & Johnson Vision, and CooperVision – will continue to advocate for policies that increase patient safety, promote access to quality health care and protect the doctor-patient relationship.

Johnson & Johnson Vision President for North America, Peter Menziuso, provides his company's perspective on how the contact lens rule can continue to provide benefits to patients and promote the safe use of contact lenses.

In December of 2016, during the final days of the Obama administration, the Federal Trade Commission proposed a new regulation that would force eye doctors with small practices, like ones across West Virginia, to require all contact lens-wearing patients to sign an “acknowledgment form.”

FRANKFORT, Ky. (WTVQ) — Online eye exams and prescriptions offered in Kentucky would require a real-time visit with a Kentucky eye care provider under a bill approved today in the House.

House Bill 191 sponsor Rep. Jim Gooch, R-Providence, said the bill is a patient protection measure. It was filed in response to a rise in online companies that allow individuals to get eye exams and prescriptions based on virtual eye exams taken with cell phone or computer apps.

Gooch said HB 191 would not prohibit the use of “safe technology” for online eye care in Kentucky, but would improve on it by requiring a “simultaneous,” or real-time, interaction between consumers and Kentucky-licensed optometrists or physicians who would then have to sign off on the prescription. The bill would also require someone seeking an online eye exam or prescription to have had an in-person eye exam within the previous 24 months, among other requirements.

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The Federal Trade Commission will hold a public workshop in Washington, DC, on March 7, 2018 to explore issues regarding competition in the contact lens marketplace, consumer access to contact lenses, prescription release and portability, and related subjects. 

The workshop is being held in conjunction with the Commission’s regulatory review of the Contact Lens Rule. A Notice of Proposed Rulemaking (NRPM) was issued in December 2016 announcing proposed changes to the Commission’s Contact Lens Rule.

The Rule, in place since August 2004, helps to promote competition in the retail sale of contact lenses by facilitating consumers’ ability to comparison shop for contact lenses. It imposes obligations on both eye-care prescribers and contact lens sellers.

When a prescriber completes a contact lens fitting, the Rule requires the prescriber to automatically provide the patient with a complete copy of the contact lens prescription, and to verify or provide the prescription to authorized third parties.

The Rule also requires that contact lens sellers dispense contact lenses only in accordance with a valid prescription the seller has received from either the patient or prescriber, or has verified via direct communication with the prescriber.

Topics to be discussed at the workshop include, but are not limited to:

• Consumers’ ability to comparison shop for contact lenses;
• The use of electronic health records, patient portals, and other technology to improve prescription portability;
• The interaction between the Contact Lens Rule and emerging telehealth business models;
• The potential for new technology to improve the prescription verification process; and
• Modifications to the Rule to foster competition and maximize consumer benefits, including benefits to eye health.

The workshop is free and open to the public, and the Commission is accepting requests to participate as a panelist from interested parties through January 5, 2018, via email at: [email protected](link sends e-mail). The FTC also welcomes written comments on the issues to be discussed at the workshop. Interested parties may file a comment online until April 6, 2018, at: https://ftcpublic.commentworks.com/ftc/contactlensworkshop.

To file a comment or request to participate on paper, write “Contact Lens Rule, 16 CFR Part 315, Comment, Project No. R511995” on your comment, or “Contact Lens Rule, 16 CFR Part 315, Request to Participate, Project No. R511995,” on your request, and mail your submission to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex F), Washington, DC 20580, or deliver your submission to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex F). Requests to participate must be received on or before January 5, 2018. The public comment period will remain open until April 6, 2018, and comments received will be posted on the workshop’s public webpage.

The workshop will be held at the FTC’s Constitution Center Conference Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date. The Commission vote approving the Federal Register notice announcing the workshop was 2-0.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook(link is external), follow us on Twitter(link is external), read our blogs and subscribe to press releases for the latest FTC news and resources.

Some 45 million Americans depend on contact lenses to correct their vision, and while contacts are very safe overall, not caring for them properly can lead to serious eye infections, health experts warn.

A judge has dismissed Opternative's suit against South Carolina's Eye Care Consumer Protection Law, which specifically bans ocular telehealth. Several states are mulling legislation on telemedicine for eye exams.

The Hubble contacts sitting in front of me are everything the ads promised: two weeks’ worth of soft, daily lenses in robin’s-egg-blue packaging.