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«October 26, 2015 Donald S. Clark Federal Trade Commission Office of the Secretary 600 Pennsylvania Avenue NW. Suite CC–5610 (Annex C) Washington, ...»

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However, the verification process is not triggered when a patient provides a contact lens retailer with a complete copy of a prescription. More and more frequently retailers are encouraging consumers to use mobile technology to submit copies of prescriptions via email or by text message, bypassing the prescription verification process. The checks and balances the FTC anticipated when the Rule was first written do not function in many instances, to the detriment of consumers. The lack of physician involvement, coupled with retailers' ability to sell large quantities of contact lenses, could easily mislead consumers, giving them a false sense of security with regard to their eye health. Including a quantity limit on the prescription would be beneficial to patients’ health and safety. This safeguard would help patients avoid painful eye infections and injuries that could seriously compromise the patient's vision. A quantity limit would also better underscore to consumers that contact lenses are regulated medical devices which can cause harm when misused.

4. What impact has the Rule had on the flow of truthful information to consumers and on the flow of deceptive information to consumers?

The AOA is concerned there is widespread public misunderstanding regarding the basic requirements of the Contact Lens Rule and the need for a prescription when buying and selling contact lenses. Despite the current requirements of the Rule, retailers continue to sell contact lenses without a prescription, which deceptively leads consumers to believe contact lenses are simple over-the-counter products. The AOA has identified 41 online contact lens retailers who we believe may be illegally allowing consumers to purchase contact lenses without a prescription (See Appendix B). Some retailers sell non-corrective, decorative lenses, while others sell corrective lenses. Regardless of the lens type, the FCLCA clearly states that contact lenses require a prescription and those who sell lenses without a prescription will be penalized: “Any person that engages in the manufacture, processing, assembly, sale, offering for sale, or distribution of contact lenses may not represent, by advertisement, sales presentation, or otherwise, that contact lenses may be obtained without a prescription.” The AOA and its members have reported many of these retailers to the FTC in the past year, yet these retailers continue to sell lenses and continue to put the public at risk.

Contact lenses are regulated medical devices that are personally fit to each individual based on the patient’s eye health needs. Therefore, it is critical the availability of contact lenses from a 5 wide range of retailers is not interpreted as an indication that contact lenses are simple products that don't require physician supervision.

While the AOA is not a regulatory enforcement entity, a central mission of the AOA is to serve as a resource to the public for reliable and current information related to eye care and health care policy. As such, AOA investigates our members’ reports of retailers who are selling contact lenses without a prescription. The AOA took just this type of action when reports were received that Global Lens4 was selling contact lenses without a prescription. As of June 30, 2015, Global Lens announced they would begin to require current prescriptions for all orders outside of Canada (See Appendix C). While this policy change is necessary, in the company's announcement of the change, the company also noted to consumers, "Now's your last chance to stock up!" The retailer also indicated “GlobalLens understands the disappointment this will cause many of our customers for which we're truly sorry.”5 This type of deceptive announcement from a retailer misleads and confuses consumers by portraying the eye exam and prescription as an inconvenience, such that consumers are encouraged to inappropriately “stock up” on lenses while they can. This is clearly not how a company should message a policy change which brings it into compliance with US law. This retailer’s action is indicative of a larger problem with online retailers mischaracterizing the requirement for a prescription for contact lenses as an unnecessary burden, rather than a requirement to ensure safety.

1-800 CONTACTS similarly mischaracterizes the legal requirement for a valid prescription in voicemail messages to consumers when an order cannot be filled based on an expired prescription. The message to consumers indicates

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This type of communication pits consumers against their physicians and does not accurately describe anti-competitive impact when an order is denied based on an expired prescription. A

similarly misleading approach is used by Coastal.com which reports to patients the following:

http://www.globallens.com http://www.globallens.com/blog/last-chance/ 6 This message from Coastal.com is inaccurate, as it suggests that the FCLCA requires retailers to communicate to patients when a doctor does not respond to a prescription verification. The way this is communicated to patients suggests some sort of lack of interest or compliance on the part of the physician. This message is also concerning because the form Coastal.com uses for verifying prescriptions does not include an option for physicians to indicate the prescription is accurate (See Appendix D). The AOA believes these types of deceptive messages to patients are purposefully misleading and intended to erode the doctor-patient relationship.

In addition to misleading business practices by large contact lens retailers, the AOA is also very concerned with individuals who hold themselves out as contact lens sellers. Since the FCLCA was passed, social media has evolved to play a huge role in American society. Social media sites allow individuals to become entrepreneurs, selling a variety of services and products. Of significant concern to the AOA is the use of social media to sell contact lenses. The AOA has identified several individuals who attempt to sell contact lenses through Facebook. Many of these individuals have been provided information regarding the legal requirement for a prescription when contact lenses are sold, but this has not impacted individual behavior. The AOA has engaged Facebook on this issue, citing Facebook's own policy of not allowing the sale of regulated goods through its website,6 but to date we have received no response from the company and individuals appear to continue using Facebook as a safe haven to sell lenses without a prescription. As recently as September 22, 2015, one individual attempted to use Facebook to swap or sell "two unopened boxes (6 pack) acuvue oasys [sic] contact lenses -2.50."

The individual wrote she had moved and couldn’t return the lenses and wanted to sell them to another individual through Facebook. Other individuals attempt to sell decorative lenses and claim these lenses do not require a prescription (See Appendix E). There are also e-commerce sites, such as Groupon, that allow retailers to promote contact lenses through their sites and offer discounts to purchases. These advertisements will sometimes refer to the availability of “nonprescription” lenses (See Appendix F). Since all lenses require a prescription, this is entirely misleading to consumers. These types of blatant violations of the FCLCA must be stopped, and the AOA calls on the FTC to increase their enforcement of the current Contact Lens Rule.

It is clear there is widespread public misunderstanding regarding the basic requirements of the Contact Lens Rule and the need for a prescription when buying and selling contact lenses. This misunderstanding comes in part from the high prevalence of retailers who violate the requirements of the FCLCA in addition to lack of enforcement from the FTC. Public misunderstanding regarding the Rule exists despite efforts by the Food and Drug Administration https://en-gb.facebook.com/communitystandards# 7 (FDA) and the Centers for Disease Control and Prevention (CDC) to notify the public of the need for a prescription when purchasing lenses. The FDA has specific guidance to consumers explaining that selling contact lenses as though they are over-the-counter devices both misbrands the device and is a violation of FTC regulations.7 Additionally, for the past two years, the CDC has organized Contact Lens Health Week and specifically warned the public about purchasing lenses without a prescription and the need for appropriate contact lens care.8 The U.S.

Immigration and Customs Enforcement (ICE) National Intellectual Property Rights Coordination Center (IPR Center) has also coordinated a cross-agency effort to stop illegal contact lens sales called “Operation Double Vision.”9 The FDA Office of Criminal Investigations (OCI), ICE Homeland Security Investigations (HSI) and U.S. Customs and Border Protection (CBP) have all partnered to seize counterfeit contact lenses, illegally imported decorative lenses, and lenses unapproved by the FDA. In 2014 alone, this collaboration resulted in more than 20,000 pairs of counterfeit and decorative contact lenses being seized.10 Additionally, just this month, the U.S.

Attorney’s Office carried out Operation ‘Fright Night’ to target retailers of cosmetic contact lenses that were being sold illegally without a prescription thereby putting the public at risk.

Ultimately, ten businesses in Southern California had charges brought against them.11 Others in Southern California were charged in Operation “Cats Eyes” in 2014. Unfortunately, these federal actions and public health information campaigns regarding the need for an appropriate prescription and proper contact lens care is lost on consumers when websites allowing consumers to purchase lenses without a prescription continue to proliferate. A lack of enforcement of the Rule allows deceptive information regarding the legal and regulatory requirements related to the sale of contact lenses to spread unchecked.

It’s also important to recognize that where a patient purchases their lenses may have an impact on the patient’s behavior. In a national online consumer opinion survey which targeted contact lens wearers, 63 percent of those surveyed indicated they would be more likely to follow FDA and doctor-recommended contact lens care recommendations when lenses were purchased from family eye doctors rather than from an online retailers.12 Additionally, 61 percent of those surveyed indicated they would be more likely to routinely see an eye doctor for check-ups if lenses were purchased from family eye doctors, rather than from online retailers. Previously, studies found that contact lens consumers had less awareness13 of and compliance14 with recommended contact lens care. Allowing online retailers to misrepresent the necessary precautions that must be taken when using medical devices may lead to risky patient behavior when wearing and caring for contact lenses. It is also clear certain online retailers are attempting to damage the positive doctor-patient relationships many patients have by misrepresenting the role of the physician in the FCLCA.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts /ContactLenses/ucm062347.htm http://www.cdc.gov/contactlenses/infographic-underwear.html http://www.ice.gov/news/releases/federal-agencies-warn-against-counterfeit-decorative-contact-lenses-0 https://www.ice.gov/news/releases/federal-agencies-warn-against-counterfeit-decorative-contact-lenses-1 http://www.justice.gov/usao-cdca/pr/operation-fright-night-targets-cosmetic-contact-lenses-are-illegally-soldwithout http://www.americaseyedoctors.com/content.aspx?page=pressreleases Wu, Y, et al., “Contact lens user profile, attitudes and level of compliance to lens care,” Contact Lens & Anterior Eye, 33 (2010) 183–188.

Fogel J, et al. “Contact lenses purchased over the Internet place individuals potentially at risk for harmful eye care practices,” Journal of the American Optometric Association, Vo. 79, No 1, January 2008.

8 The AOA is also seriously concerned that over the past ten years 1-800 CONTACTS has been implementing various anti-competitive tactics to deceptively obtain patient consent to act as the patient’s agent and obtain his or her contact lens prescription. While 1-800 CONTACTS has apparently ceased its recent practice of using of a pre-checked box on the bottom of the contact lens order form to attempt to obtain patient authorization, the AOA remains concerned additional deceptive practices may be implemented in the future in an effort to eliminate the physician entirely from the contact lens sale process. The AOA believes allowing retailers to unilaterally initiate a request to a physician for a copy of a customer’s prescription, when that step is not needed in order to fill an order, is an abuse of the plain language of the FCLCA, not an intended result of its prescription release requirement and verification process. The FCLCA requires prescribers to provide the prescription to the patient and those designated by the patient (for example, a caregiver). If the law intended for sellers to step into the shoes of the patient and grab the prescription at any time, then the entire verification process would have been all but unnecessary. Instead, as we know, proper verification is crucial to protect patient’s health and safety.

5. What significant costs, if any, has the Rule imposed on consumers? What evidence supports the asserted costs?

In 2014, the CDC reported Americans make an estimated 930,000 visits to outpatient clinics and 58,000 emergency room visits annually due to eye infections, and at least $175 million in added health care costs were connected to keratitis—a typically preventable eye condition associated with improper contact lens use.15 The AOA's members frequently care for patients who have experienced contact lens-related infections and complications. The eye care visits and treatments associated with these events is an increased cost to consumers. For example, the following

incidents have been reported to the AOA:

• A doctor of optometry reported a patient purchased lenses through GlobalLens.Com, prior to the company's policy change to require a prescription. The patient was not only able to order lenses without a prescription, the patient was also able to purchase lenses that were different from what was originally prescribed. After experiencing discomfort with the lenses, the patient presented to the physician with a conjunctival abrasion.

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