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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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October 26, 2015

Donald S. Clark

Federal Trade Commission

Office of the Secretary

600 Pennsylvania Avenue NW.

Suite CC–5610 (Annex C)

Washington, DC 20580

RE: Contact Lens Rule, 16 CFR part 315, Project No. R511995

The American Optometric Association (AOA) represents 33,000 doctors of optometry and

optometry students. The AOA is the voice of the nation’s family eye doctors and a leading

authority on eye health, vision care, and patient safety issues. On a daily basis, doctors of optometry prescribe contact lenses to patients. However, improper lens use can lead to injuries and infections. Our members are essential in mitigating this risk and ensuring that the use of contact lenses results in optimal vision. Since the passage of the Fairness to Contact Lens Consumers Act (FCLCA) in December 2003, the AOA has educated our members on the requirements of the law and has also guided our members and the public to report violations of the law. We appreciate this opportunity to offer comment on the Contact Lens Rule review (80 Fed. Reg. 53272 (Sept. 3, 2015)).

1. Is there a continuing need for the Rule? Why or why not?

The contact lens rule is required by statue. However, the rule is primarily needed today for patient safety reasons. The original justification to enhance market competition through prescription portability has been solved. That is, the problem of prescription portability that the law and Rule originally sought to address no longer exists. It’s our understanding that one theoretical outcome of prescription portability is narrower price differences between sellers, and in fact there’s less difference in price between sellers today than there was prior to the FCLCA.

Conversely, the rule remains necessary and in need of improvement to address retailers who are acting anti-competitively. During the past ten years, the contact lens marketplace has expanded with the maturation of online channels. To take full advantage of this expanded marketplace, it is imperative common-sense safeguards remain in place to protect the public. The rule remains necessary to ensure that contact lens retailers recognize the risks of contact lens use, treat contact lenses as the regulated medical devices that they are, and not develop business practices that focus on sales and profits while compromising the health of the patients who rely on contact lenses. Such deceptive and unfair practices hurt competition. The rule should be retained to provide the necessary guidance that allows for strong competition in the marketplace including competition for ensuring patient safety. If eye care professionals are the only distribution channel 1 ethically or legally required to protect patient safety, then other competitors in the market have an unfair advantage that will ultimately lead to patient harm and less competition.

Moving forward, the AOA encourages the Federal Trade Commission (FTC) to update the regulations to account for current issues in the market. When the rule was initially developed, the FTC and the public lacked experience with the requirements of the FCLCA. We can now work to improve the rule for patients using the knowledge we have gained over the past ten years.

2. What benefits has the Rule provided to consumers? What evidence supports the asserted benefits?

The ability to shop around for contact lenses is only a clear benefit to patients if those contact lenses can be used safely and all sellers are operating on a level playing field when it comes to consumer safety. The AOA fully supports a robust contact lens marketplace, and believes the competition for price or convenience must not eliminate innovation or concern for patient safety.

While the Rule outlined some basic safeguards to protect patients, the AOA is concerned that lack of enforcement is allowing the Rule to be manipulated by retailers for their own financial benefit. Evidence of anti-competitive and misleading behavior by sellers is detailed later in these comments.

Consumers recognize independent eye care professionals as experts with the highest credentials and the highest quality materials, according to one published study.1 The authors also found consumers recognize Internet seller 1-800 CONTACTS as having the greatest availability of lenses. Internet sellers and discount brick-and-mortar retailers were viewed by consumers as providing the most convenience. The market for contact lenses allows consumers to make these judgments. However, anti-competitive practices by some sellers are threatening the ability of consumers to make accurate distinctions between sellers, undermining the benefit of the Rule.

These results were confirmed this year in a national consumer survey by See Clearly, America, which found consumers are very satisfied with the care they receive from their family eye doctor, and that they trust their family eye doctor most to protect their health information, far more than other contact lens sellers. Conversely, consumers overwhelmingly said it was riskiest to purchase lenses from sellers other than their family eye doctors. Finally, 93 percent of consumers agreed that their family eye doctor is the best source of information about proper use and care of contact lenses.

3. What modifications, if any, should be made to the Rule to increase its benefits to consumers? What evidence supports the proposed modifications? How would these modifications affect the costs the Rule imposes on businesses, including small businesses?

How would these modifications affect the benefits to consumers?

The AOA believes several changes should be made to the Rule to benefit patients. Given the complications that can occur with improper contact lens wear, steps must be taken to ensure contact lens consumers receive necessary eye examinations and instruction on appropriate lens Petito, Olivares, Schnider and Alford, “Study of Market Segmentation in Vision Care: How Consumers Make Choices in Vision Care Purchases,” Journal of the American Optometric Association, Vo. 83, No. 6, June 2012.

2 use to protect the patient’s eye health. At a minimum, the AOA requests greater enforcement of the requirements already outlined in the Contact Lens Rule. Retailers should not be allowed to sell lenses without a prescription, and the FTC must penalize violating retailers to send a message both to the offender and to the larger contact lens retailer community. Large retailers as well as individuals who attempt to sell lenses through websites, such as Facebook, must be penalized in accordance with the FCLCA. It’s our understanding the FTC brought ten different enforcement actions against individuals and entities in the first five years of the Contact Lens Rule, but none in the last five years.

Other agencies have also provided some enforcement of contact lens sale laws in recent years.

For example, Operation Cat Eyes in 2014 and Operation Fright Night in 2015 by the U.S.

Attorney’s Office in California charged retailers for illegally selling contact lenses without a prescription. Also in 2015, Operation Pangea by the FDA and Interpol, which usually fights illegal sales of prescription drugs online, cracked down on illegal sales of medical devices online too. In some cases, websites or specific products were taken down; in other cases, websites lost their ability to accept payments through Visa or Mastercard. It’s our understanding that 1/3 of the sites found by Interpol to be selling medical devices illegally were selling contact lenses.

To ensure that patients are sold lenses that have been appropriately fitted for their eyes and eye health, the type of lens prescribed to the patient should be the lens type sold to the patient, regardless of where the patient purchases the lenses. Retailers must not be allowed to encourage patients to experiment with new lenses as this poses a potential risk to eye health. Additionally, although the passive verification system was delineated in statute, we believe there are serious flaws with this system. The AOA strongly urges the FTC to take steps to better ensure the regulations related to contact lens sales appropriately consider the status of contact lenses as regulated medical devices that require physician oversight. Going beyond the need for increased enforcement of the basic safeguards of the law and to improve the Rule for consumers, the AOA

requests the following:

1) FTC should limit the quantity of contact lens boxes that retailers advertise as being able to be purchased at one time.

2) FTC should prohibit sellers from marketing contact lenses to patients whose prescription has expired, and to include the issue date or expiration date in the information the seller provides to the prescriber to verify.

3) FTC should require contact lens prescriptions to include a maximum quantity of lenses that can be purchased prior to the prescription's expiration.

Needed Modification: Addressing Retailer Advertised Quantities

The FCLCA establishes the default expectation that prescriptions are valid for one year, unless state law provides for a greater time period. However, some online retailers may attempt to circumvent this rule by selling contact lenses in large volumes. For example, 1-800 CONTACTS allows consumers to purchase up to eight boxes of 1-DAY ACUVUE® TruEye® 90-day pack for each eye. An order of eight boxes of 90-day contacts for each eye provides 720 lenses per eye. Similarly, 1-800 CONTACTS allows consumers to purchase up to 24 boxes per eye of the 1-DAY ACUVUE® MOIST® 30 pack. Again, this provides a consumer with 720 lenses per eye.

3 Lens.com allows patients to order up to 50 boxes of Dailies AquaComfort Plus contact lenses per eye. With 90 lenses per box this results in the patient being able to order 4,500 lenses per eye (See Appendix A). Retailers who are able to sell nearly a two-year supply or more of lenses for a prescription that is likely valid for only one year can put the patient at risk, because many patients may experience a change in eye health and/or vision, develop complications that go untreated, or may have been counseled to stop wearing contact lenses. It’s also possible that such large bulk purchases are being used by individuals seeking to illegally re-sell or distribute lenses to others, with no oversight. Imagine if such practices were common among online pharmacies.

It’s time to halt these practices in the contact lens market.

Needed Modification: Respecting and Enforcing Prescription Expirations

One significant step we urge the FTC to take is to ban sellers from marketing to specific customers to reorder their lenses after the prescription has expired (more than one year after the issue date or when the customer originally ordered lenses from the seller) unless the seller has specific knowledge the customer’s prescription is valid for more than one year. Surely the FTC does not intend for sellers to continue supplying contact lenses to consumers long after the prescription has expired. Yet surveys2 and studies3 find a large percent of consumers reorder contact lenses with expired prescriptions. The AOA believes an expired prescription is no longer a valid prescription, and that the FTC should take action against sellers who fill such reorders. A flaw to the prescription verification scheme created by the FCLCA is that a retailer can request verification of an otherwise expired prescription and can ship the lenses if the prescriber does not recognize within eight business hours that the expiration date has passed and inform the seller.

Many patients have prescription changes from year to year. Allowing repurchases based on longexpired prescriptions may be, at the time, convenient for the patient and profitable for the seller, but increases the risk of patient harm. Patients might not have seen the prescriber in years, depriving them of a professional assessment of their eye health and the opportunity for education to reinforce proper lens wear and care habits, which have been shown to mitigate many potential adverse health effects. An expiration date and issue date are required elements of a prescription.

The FTC should require the expiration date or issue date to be provided in prescription verification. This would incentivize sellers to make sure patients know their expirations when placing orders. The AOA believes sellers already know the prescription expiration as they often market to consumers to reorder in the final month or weeks that the prescription is valid. By including the prescription issue and/or expiration date in the verification, sellers would also be aware, nor could they deny, when they are using an invalid prescription. The prescription verification scheme should not be abused by sellers to knowingly push contact lenses to consumers with expired prescriptions, hoping the error is not noticed by whichever prescriber receives the verification request.

Needed Modification: Quantity Limits on Prescriptions

–  –  –

4 In the development of the Contact Lens Rule, the FTC contemplated whether there should be quantity limits noted on prescriptions. Ultimately, the Commission decided not to require the

inclusion of the quantity of lenses or refills allowed on prescriptions. The Commission stated:

It is not necessary to include the quantity of lenses on the prescription to limit patients’ ability to circumvent the expiration date. Section 315.5(b) requires verification requests to contain the quantity of lenses ordered, and as discussed below in section 315.5(d), the quantity ordered may be a legitimate basis for a prescriber to treat a request for verification of a prescription as ‘‘inaccurate.’’ The verification process itself thus generally allows prescribers to prevent patients from ordering excessive contact lenses.

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